European Parliament Pharma Watch

The latest parliamentary questions, declarations, proposals and positions concerning industrial pharmacy from the European Parliament.

Classified status of documentation concerning the European Medicines Agency
Answer given by President Juncker on 12.04.2018 on behalf of the Commission to Question for written answer to the Commission by Patrizia Toia (S&D) (Date : 05-02-2018 Reference : P-000682/2018)

1-2. In the margins of the European Council (Article 50) of 22 June 2017, the 27 Member States endorsed a procedure leading up to a decision on the relocation of the United Kingdom (UK)-based agencies. Under this procedure the Commission was asked to examine the offers submitted by the Member States’ to host one or both of the agencies.

According to the procedure, Member States had the possibility to request that business secrets and other confidential information contained in their offers would not be published. The Commission received from the Secretary-General of the Council both the public and the confidential versions of the offers in order to make its assessment which it submitted on 30 September 2017.

The EU-27 ministers voted on the relocation of the European Medicines Agency in the margins of the General Affairs Council (Article 50) meeting on 20 November 2017. In accordance with the procedure, on 29 November 2017, the Commission adopted a legislative proposal confirming the selection of Amsterdam as the agency’s new seat. As explained in President Juncker’s letter of 23 February 2018 to President Tajani, all documents, including the offers and the Commission’s assessment, have been made publicly available on a dedicated website of the European Council. Although the Commission does not consider the confidential version of the Netherlands’s offer relevant for the legislative procedure, it notes that it is now available on the European Council website.

3. The Government of the Netherlands has confirmed that it will cover the costs related to the temporary premises of the agency. Consequently, the costs entailed by the occupation of this building will have no impact on the EU budget. As regards the permanent building, on 2 March 2018 the agency transmitted a building file to the Budgetary Authority, as prescribed by Article 203 of the Financial Regulation.

Location of the seat of the European Medicines Agency
Answer given by President Juncker on 12.04.2018 on behalf of the Commission to question for written answer to the Commission by Massimiliano Salini (PPE) (Date : 04-02-2018 Reference : P-000652/2018)

Paragraph 15 of the Guidelines for Brexit negotiations of the European Council (Article 50) of 29 April 2017 states that ‘the future location of the seats of EU agencies and facilities located in the United Kingdom (UK) is a matter for the 27 Member States to settle rapidly’.

In the margins of the European Council (Article 50) of 22 June 2017, the 27 Member States endorsed the procedure leading up to a decision on the relocation of the UK-based agencies. The Commission was asked therein to examine the Member States’ offers to host one or both of the agencies and to present its assessment that would serve to inform the process of the 27 Member States for the selection of the agencies’ new seats.

For this purpose, the Commission was provided by the Secretary-General of the Council with both the public and the confidential versions of Member States’ offers.

The Commission’s methodology for assessing the Member States’ offers within the specific mandate that was given to it by the 27 Member States is set out in its Note of 30 September 2017. Due to the limited time available to assess the offers and in order to treat all offers fairly, the Commission decided for its examination to rely solely on the offers as presented by the Member States and did not take any steps to verify the information provided in the offers. In order to put all offers on the same footing, the Commission did not ask Member States to clarify or complete their offers. The Commission’s assessment relies therefore on the accuracy and completeness of the information provided by the Member States in their offers.

The Government of the Netherlands has confirmed that it will cover the costs related to the temporary premises of the European Medicines Agency, including the move into the permanent premises. Consequently, the use of the temporary premises will have no impact on the EU budget. As regards the permanent building, on 2 March 2018 the agency presented a full building file to the Budgetary Authority, on the basis of Article 203 of the Financial Regulation. The building file was adopted by the Agency’s management board on 28 February 2018.

Better monitoring of prescribed medicines
Answer given by Mr Andriukaitis on 11.04.2018 on behalf of the Commission to question for written answer to the Commission by Frédérique Ries (ALDE) (Date : 14-02-2018 Reference : E-000935/2018)

The Commission and the European Medicines Agency (EMA) are aware of the medical innovation in question. Ingestible sensor is a platform technology that can be co-formulated with active pharmaceutical compounds into medicinal product/medical device combinations, integrating measuring of medication adherence into oral pharmacotherapy. The Proteus Raisin System™ has been approved for marketing in the EU as a CE-marked medical device.

As regards the product Abilify (aripiprazole), which was authorised as combination product with an ingestible sensor by US Food and Drug Administration in November 2017, the Commission notes that the medicinal product in itself was authorised via the EU centralised procedure in June 2004. To date, EMA has not yet received any application for variation of marketing authorisation of Abilify to include a formulation with an ingestible sensor.

In December 2015 the EMA’s Committee for Medicinal Products for Human Use agreed on the use of the Proteus® Digital Health™ Inc. technology (ingestible sensor) as a qualified method for measuring adherence in clinical trials.

European Medicines Agency
Answer given by President Juncker on 11.04.2018 on behalf of the Commission to Question for written answer to the Commission by Monika Beňová (S&D) (Date : 31-01-2018 Reference : E-000561/2018)

Paragraph 15 of the Guidelines for Brexit negotiations of the European Council (Article 50) of 29 April 2017 states that ‘the future location of the seats of EU agencies and facilities located in the United Kingdom is a matter for the 27 Member States to settle rapidly’.

In the margins of the European Council of 22 June 2017, the Heads of State or Government of 27 Member States endorsed the procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority, including six criteria which interested Member States should address in their offer to host one or both of the Agencies.

The Commission was asked to examine the submitted offers and to submit by 30 September 2017 its assessment to the Secretary-General of the Council. On the basis of this assessment and following a discussion, on 20 November 2017 the 27 Member States selected the agencies’ new seats.

The Commission did not have any formal role in the selection and it is now for the European Medicines Agency in cooperation with the authorities of the Netherlands to ensure business continuity. The Commission is following the relocation process and assists the agency where relevant.

As regards information on the preparedness of the Amsterdam site, it is the authorities of the Netherlands that can provide the Honourable Member with full and updated information.

The European approach to Alzheimer’s disease
Answer given by Mr Andriukaitis on 11.04.2018 on behalf of the Commission to question for written answer to the Commission by Hilde Vautmans (ALDE) (Date : 22-01-2018 Reference : E-000314/2018)

1. The Commission does not plan to appoint an EU coordinator for dementia.

The Commission is working closely with a number of Member States on dementia through the second Joint Action ‘Act on Dementia’ funded under the EU Health Programme and launched in March 2016.

2. One of the focus areas of the Joint Action with a dedicated work package is diagnosis and post-diagnostic support. It aims to provide Members States with clear, evidence-based and tested information and recommendations on how to implement change and improvement in dementia diagnosis rates and post-diagnostic supports and in using different tools and approaches for diagnosis for people with dementia.

Consensus towards a diagnosis approach for cognitive disorders has already been reached between the partners and will be published in due course.

A report on testing evidence-based examples of best practice in dementia diagnosis will be produced at the end of the Joint Action in 2019.

3. The Commission has been supporting with growing intensity, brain research for many years through the framework Programmes, reaching some EUR 500 million a year for both basic and translational research. Specifically for Alzheimer, EUR 544 million supported 370 projects over the past 10 years.

This investment includes support for the development of novel diagnostic tools’ and new therapies. In addition, the Innovative Medicines Initiative (IMI2), is promoting research on early detection and new drug targets for Alzheimer, with projects such as EPAD, BRIDGET and DACAPO-AD funded by the EU Joint Programming Initiative on Neurodegenerative Diseases which ensures a better coordination of Member States’ efforts on Alzheimer.

Leigh syndrome and orphan drugs
Answer given by Mr Moedas on 06.04.2018 on behalf of the Commission to Question for written answer to the Commission by Nicola Caputo (S&D) (Date : 31-01-2018 Reference : E-000571/2018)

The Commission has been committed to supporting scientific research on rare diseases for more than two decades. Major investments (over EUR 1 billion) have been made in FP7 and Horizon 2020 to more than 200 collaborative rare disease-related projects. The Commission awards project grants to consortia through a competitive, peer-reviewed process. Whilst many rare diseases projects are addressing neurological diseases, research specifically focused on Leigh syndrome has not been funded.

The Commission has continuously provided special incentives to advance the development of orphan medicinal products. It considers that each of the estimated 6 000 to 8 000 rare diseases deserve more attention in terms of awareness raising and research activities. It actively contributes to the International Rare Disease Research Consortium (IRDiRC), a joint-funding initiative bringing together funding bodies and organisations committed to investing in rare diseases research, and focusing on diagnostics and therapies for rare diseases. To ensure patients’ access to the best diagnosis and treatment available, 24 thematic European Reference Networks have been established in 2017, connecting healthcare providers across the EU.

The EU will maintain its commitment to rare disease research. Around EUR 50 million will be dedicated to a Rare Disease European Joint Programme. This and the Commission-supported E-RARE3 programme bring together national research programmes in funding rare diseases research. These programmes as well as more general call topics in Horizon 2020 may offer funding opportunities for research addressing Leigh syndrome.

Documentation regarding Amsterdam’s bid for the seat of the European Medicines Agency
Answer given by President Juncker on 29.03.2018 on behalf of the Commission to question for written answer to the Commission by Marco Valli (EFDD), Piernicola Pedicini (EFDD), and Eleonora Evi (EFDD) (Date : 06-02-2018 Reference : E-000695/2018)

1. Paragraph 15 of the Guidelines for Brexit negotiations of the European Council (Article 50) of 29 April 2017 states that “the future location of the seats of EU agencies and facilities located in the United Kingdom is a matter for the 27 Member States to settle rapidly”.

In the margins of the European Council (Article 50) of 22 June 2017, the Heads of State or Government of 27 Member States endorsed the Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority, including six criteria which interested Member States should address in their offer to host one or both of the Agencies. The Commission was invited to examine the offers submitted by the Member States and to present its assessment to the Secretary-General of the Council.

For this purpose, the Commission was provided by the Secretary-General of the Council with both the public and the confidential versions of Member States’ offers. The offer from the Netherlands for the European Medicines Agency can be found on the website of the European Council, including the part of the offer which initially the Netherlands had wished to keep confidential but in the meantime decided to make publicly available.

2. On 20 November 2017, the 27 Member States selected the agencies’ new seats. It is now for the European Medicines Agency in cooperation with the authorities of the Netherlands to ensure business continuity, as per the criteria of the endorsed procedure. As regards information on the preparedness of the Amsterdam site, it is the authorities of the Netherlands that can provide the Honourable Members with full and updated information.

Relocation of UK-based EU agencies
Answer given by President Juncker on 29.03.2018 on behalf of the Commission to question for written answer to the Commission by Siôn Simon (S&D) (Date : 10-01-2018 Reference : E-000071/2018)

The Commission monitors the composition of Agencies’ staff and, whenever necessary, calls on Agencies to ensure, inter alia, gender or geographical balance. However, as separate legal persons, the Agencies have the power to conduct their own staff policy. The Commission has therefore asked the European Medicines Agency (EMA) and the European Banking Authority (EBA) to provide answers to the questions raised by the Honourable Member. The Commission will forward the Agencies’ answers to the Honourable Member as soon as possible.

Falsified Medicines Directive
Answer given by Mr Andriukaitis on 28.03.2018 on behalf of the Commission to question for written answer to the Commission by Cristian-Silviu Buşoi (PPE) (Date : 13-02-2018 Reference : E-000908/2018)

The Commission and EU Member States are committed to ensuring that the medicines authentication system under the Falsified Medicines Directive is in place by February 2019. The Commission is working closely with Member States and stakeholders to support the implementation of the system. This includes regular discussions with the Expert Group on safety features to facilitate implementation and contacts with stakeholders (marketing authorisation holders, manufacturers, distributors, hospitals and pharmacies). In particular, the Commission has stressed the importance that industry progresses faster in setting up the European and national databases required for authentication and that all stakeholders are ready to verify safety features from February 2019.

Over-the-counter sale of codeine-based drugs
Answer given by Mr Andriukaitis on 28.03.2018 on behalf of the Commission to question for written answer to the Commission by Mireille D’Ornano (EFDD) (Date : 06-02-2018 Reference : E-000714/2018)

The Commission is aware of the adverse effects and misuse of opioids including codeine and is closely following the situation.

Codeine-containing medicines are authorised nationally in the EU, i.e. the marketing authorisations for these products are managed by the national competent authorities and are available either on prescription or over the counter in the different Member States.

Many have been on the market for a long time and have restricted use, e.g. contraindicated for children and patients known to be ultra-rapid metabolisers. The mandatory product information documents advise on the safe use of the products including potential risk of abuse. Controlling the package size is also one of the safety measures. The adverse events and misuse are monitored through pharmacovigilance processes to be followed by marketing authorisation holders, the Member States and the European Medicines Agency (EMA).

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and EMA are closely working together and further information on codeine misuse is available e.g. in the European Drug Report 2017.

Fentanyl
Answer given by Mr Avramopoulos on 28.03.2018 on behalf of the Commission to question for written answer to the Commission by Nuno Melo (PPE) (Date : 31-01-2018 Reference : E-000566/2018)

The Commission is well aware of the increasing abuse of fentanyl and its derivatives and is closely following the developments in the U.S., e.g. through regular dialogues with the U.S.

Fentanyl is a controlled substance widely used for general anaesthesia and for pain management. In the EU, medicines containing fentanyl are authorised either centrally or nationally in accordance with EU legislation. Many of them have been on the market for a long time and are only obtained under strict conditions due to the well-known potential of abuse. The mandatory product information documents advise about the safe use of the product including potential risk of abuse. The misuse is monitored through pharmacovigilance processes to be followed by marketing authorisation holders, the Member States and the European Medicines Agency (EMA).

The following fentanyl derivatives have been or are in the process of being subjected to control measures on European and/or United Nations level: acryloylfentanyl, furanylfentanyl, 4-fluoroisobutyrylfentanyl, tetrahydrofuranylfentanyl and carfentanil.

Further information on fentanyl and its derivatives is available from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), e.g. in the European Drug Report 2017 or on its website in the section “Action on new drugs”.

The new legislative package on new psychoactive substances, which will become fully effective as of November 2018, will enable the EU to respond more effectively to new substances, including new synthetic opioids, coming on the market.

Anti-cancer immunostimulating agents
Question for written answer to the Commission by Nicola Caputo (S&D) (Date : 28-03-2018 Reference :E-001930/2018)

The Stanford University School of Medicine recently conducted studies which provided very promising data on a possible cure for cancer. Specifically, the US scientists demonstrated on an animal (mouse) that the injection of small amounts of two immunostimulating agents (a short stretch of DNA called CpG oligonucleotide and an antibody that binds to OX40 and activates the T cell to lead the charge against the tumorous cells, direct into the solid tumour, thanks to the activation of T lymphocytes) could eliminate all traces of the tumour, even distant metastases.

Can the Commission state, within the limits of its competence:

1. what data it has regarding the above studies and research;

2. if it intends to support future studies on the benefits and potential risks of using these two immunostimulating agents.

Availability of Pre-exposure Prophylaxis (PrEP)
Question for written answer to the Commission by Martina Anderson (GUE/NGL) (Date : 27-03-2018 Reference :E-001858/2018)

Across the island of Ireland, HIV infection rates are climbing among men who have sex with men (MSM), showing a fourfold increase since 2005.

Post-exposure Prophylaxis (PEP) is used to treat those who have been exposed to HIV, with its effectiveness based on a 72-hour window period post-exposure. It is available free at the point of need from any sexually transmitted infection/genitourinary medicine (STI/GUM) clinic across the island.

From December 2017, Pre-exposure prophylaxis (PrEP) was made available in pharmacies in the south of Ireland, but it is, so far, not available in pharmacies in the north.

When introduced into public health services, PrEP has been shown to make sex safer, and can drastically reduce the transmission rate of HIV. The drug can be 86% effective, and some studies show even higher effectiveness.

Does the Commission agree that PrEP is an effective preventative method for reducing the transmission rates of HIV?

Does the Commission agree that charging up to EUR 100 for a month’s prescription of PrEP is clearly exploitation of those who stand at the highest risk of HIV infection?

Does the Commission agree that this divergence in the availability of PrEP in the island of Ireland marks a dangerous precedent?

Medicine shortages
Answer given by Mr Andriukaitis on 22.03.2018 on behalf of the Commission to question for written answer to the Commission by Cristian-Silviu Buşoi (PPE) (Date : 24-01-2018 Reference : E-000365/2018)

Shortage of medicines is a significant problem which affects many patients and represents a threat for the health of patients and the well-being of all citizens. This is part of the broader problem of access to medicines.

The Commission has noticed that shortages are mainly driven by manufacturing problems or economic reasons such as the level of reimbursement of medicines which is under the competences of the Member States.

Nevertheless, the legislation obliges marketing authorisation holders and wholesalers to ensure appropriate and continued supply within the limits of their responsibilities. The Commission is collecting information on the national measures introduced to implement this obligation.

In total, 22 responses to this questionnaire were received between December 2017 and January 2018. A preliminary review of the responses indicates differences in the implementation of the continued supply obligation but also additional measures introduced in the Member States. For example, public service obligations on wholesalers to have a permanent stock to allow daily supply of the region they serve, mandatory reserves for supply of critical medicines and lists of essential/critical medicines for which export is forbidden.

The Commission will prepare a detailed report on the response for discussion with the Member States in the Pharmaceutical Committee and an expert group later in 2018. The Commission will also liaise with the Heads of Medicines Agencies/European Medicines Agency’s Joint Task Force on availability of medicines. The EU and its Member States actively contribute and support the discussions and work on shortages of medicines at the World Health Organisation.

Affordable access to medicines
Answer given by Mr Andriukaitis on 22.03.2018 on behalf of the Commission to question for written answer to the Commission by Liadh Ní Riada (GUE/NGL) (Date : 11-01-2018 Reference : E-000141/2018)

The mission of the European Medicines Agency (EMA) is the scientific evaluation, supervision and safety monitoring of medicines in the EU. The evaluation of medicines by EMA, and their authorisation by the Commission, is based on the objective scientific criteria of quality, safety and efficacy of the medicine concerned, to the exclusion of economic and other considerations.

The organisation of health systems and the pricing of medicines are Member States’ competence. Some Member States have concluded bilateral agreements with the pharmaceutical industry to ensure the entry of new products in to their market and according to their national laws.

The Commission supports the generation of evidence based information and cooperation mechanisms on access to medicines such as the EURIPID project and projects by the Organisation for Economic Cooperation and Development.

The legislative proposal on strengthening the EU cooperation on Health Technology Assessment includes provisions on joint clinical assessments of centrally authorised medicinal products. The proposal is expected to facilitate faster, reliable and more transparent processes for Member States, including for orphan medicines.

European strategic approach to pollution of water by pharmaceutical substances
Answer given by Mr Vella on 20.03.2018 on behalf of the Commission to question for written answer to the Commission by Annie Schreijer-Pierik (PPE) (Date : 24-01-2018 Reference : E-000379/2018)

The Commission is aiming to adopt a communication on a strategic approach to pharmaceuticals in the environment before summer 2018.

The Fitness Check that the Commission has just started on Directive 2000/60/EC (Water Framework Directive) will also cover Directive 2013/39/EU (Environmental Quality Standards Directive (EQSD)). It will assess the relevance, effectiveness, efficiency, coherence and EU added value of the legislation, including whether its objectives are being met and are still appropriate.

In the last review of the EQSD, in 2013, the need to know more about emerging pollutants was taken into account and led to the establishment of an EU-wide watch-list mechanism, which is being used to gather monitoring data on the presence of pharmaceutical substances in the environment.

Available evidence shows that certain drug residues are more difficult than others to remove from raw water used to produce drinking water because of properties such as persistence. On 1 February 2018, the Commission tabled its proposal for a recast of Directive 98/83/EC (Drinking Water Directive) which includes the obligation for Member States to undertake risk-based assessments at the water catchment and supply levels. Under this new proposal, mitigating measures will have to be taken if the level of pharmaceutical substances presents a risk to public health or the environment.

Concerning the upcoming strategy, the Commission is still consulting externally and internally, but the proposed approach will take due account of existing legislation, including the directive 92/43/EEC (Habitats Directive) where relevant, and the objectives of the One Health Action Plan on Antimicrobial Resistance.

Accessibility of content on the European Medicines Agency website for EU citizens
Question for written answer to the Commission by Nadine Morano (PPE) (Date : 20-03-2018 Reference :E-001679/2018)

The website of the European Medicines Agency (EMA) offers content in only one of the EU’s 24 official languages, English. It is not even translated into what are regarded as the EU’s other working languages, namely French and German.

The purpose of the EMA is to protect and promote human and animal health by evaluating and monitoring medicines within the European Union. It therefore plays a major role in informing all European citizens and ensuring the EU is accountable to them.

Tens of millions of people who do not have basic — let alone advanced — English are thus being deprived of access to crucial information and analyses on medicines which may directly affect them.

A kind of two-tiered Europe is emerging, much to our fellow citizens’ justified dismay: the upper tier is the Europe of the educated elite who speak foreign languages, remote and inaccessible to all the others, even though they are no less curious about issues that affect them in their day-to-day lives.

How does the Commission intend to make the content on the EMA website accessible for all Europeans?

Member States’ legislation on the use of psychotropic drugs while driving
Question for written answer to the Commission by Deirdre Clune (PPE) (Date : 20-03-2018 Reference :E-001671/2018)

Driving under the influence of alcohol is a factor in many fatal road crashes, claiming numerous lives in Europe each year. All EU Member States have limits on the amount of alcohol drivers can consume, but legal thresholds are not always so clearly defined for other drugs.

Other substances — both medicines and illegal drugs — pose a road safety problem, either in isolation or in combination with alcohol. Determining the danger becomes more complicated when different drugs are used in combination.

Given the legal disparities among Member States regarding the use of psychotropic drugs while driving, is there an increased risk of road accidents on cross-border journeys?

Human gene editing perspective
Answer given by Mr Moedas on 19.03.2018 on behalf of the Commission to question for written answer to the Commission by Frédérique Ries (ALDE) (Date : 14-02-2018 Reference : P-000932/2018)

Under Horizon 2020, research intended to modify the genetic heritage of human beings that could make such changes heritable, or intended to create human embryos solely for the purpose of research or for the purpose of stem cells procurement, is not eligible for funding. Furthermore, the modifications to the subject’s germ line genetic identity are prohibited under the EU clinical trials legislation.

In 2017, the US National Academy of Sciences, Engineering and Medicine reported that although heritable germline genome editing trials shall not be prohibited, they should only be done for compelling reasons and under stringent conditions. Notably, US federal funds cannot be used for research that destroys embryos nor can the Food and Drug Administration consider a trial on embryo editing.

In reported studies from China and the United States, genome editing in early-stage human development showed neither safety nor efficacy in correcting pathogenic mutations. The current approach to avoid the inheritance of genetic diseases such as Huntington’s disease is preimplantation genetic diagnosis. This approach, legal in 17 Member States and permitted in most of the remaining Member States for certain medical indications, remains the most robust method.

The field of genome editing of non-heritable cells to treat and/or cure diseases is funded in Horizon 2020. In order to support the translation of scientific progress in this area, a number of initiatives have been launched. In preparing the next Framework Programme for Research and Innovation, consideration will be given to ensure that all the research and innovation activities carried out comply with ethical principles and relevant national, EU and international legislation.

Evaluation of Aplidin
Answer given by Mr Andriukaitis on 16.03.2018 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 15-01-2018 Reference : E-000208/2018)

The Commission would like to inform the Honourable Member that on 3 January 2018 the applicant for a marketing authorisation of the medicinal product Aplidin (plitidepsin), Pharma Mar, S.A., requested a re-examination of the opinion of the Committee for Medicinal Products for Human Use (CHMP) which was adopted on 14 December 2017. The CHMP in its plenary meeting in January 2018 appointed re-examination rapporteurs and noted the draft re-examination timetable. The re-examination opinion is expected to be adopted in April 2018.

Some information on the CHMP’s initial assessment of Aplidin is available in the European Medicines Agency (EMA) website. The Commission is not in a position to disclose elements of the ongoing assessment. Following receipt of the CHMP’s final opinion, a Commission decision will be adopted. As for all medicinal products, after adoption of the Commission decision, the EMA will publish standard documents related to the assessment on its website.

Decisions on a marketing authorisation of a medicinal product may differ between different jurisdictions, because of different legal requirements and the scientific evaluation being independent from each other.

Introduction of the Supplementary Protection Certificate Manufacturing Waiver (SPC MW)
Answer given by Ms Bieńkowska on 16.03.2018 on behalf of the Commission to question for written answer to the Commission by Tadeusz Zwiefka (PPE) (Date : 11-01-2018 Reference : E-000157/2018)

The Single Market Strategy announced a targeted revision of the EU Supplementary Protection Certificates (SPC) framework, an update of the ‘Bolar exemption’ and a possible unitary SPC title. Further to the publication of an Inception Impact Assessment in February 2017, a broad public consultation took place between 12 October 2017 and 4 January 2018 covering Supplementary Protection Certificates (SPCs) and patent research exemptions for sectors whose products are subject to regulated market authorisations. A total of 231 contributions were submitted by a very diverse range of public and private stakeholders. The Commission is currently analysing these responses.

In parallel, the Commission has contracted several studies on these SPC related matters, with the final results of the remaining studies expected shortly.

Regarding an eventual legislative initiative for an SPC manufacturing waiver, the Commission will carefully consider all options and their impacts on stakeholders, before taking any decision about a possible proposal.

Petition on implementation of the EU pharmacovigilance legislation after Brexit
Notice to members of the Committee on Petitions in respect of Petition No 0639/2017 by R. B. (Danish) on implementation of the EU pharmacovigilance legislation after Brexit (15-03-2018, PE 619.071v01-00, PETI_CM(2018)619071).

Summary of petition: The petitioner is concerned with Commission Implementing Regulation No 520/2012 and in particular articles 25 and 26 identifying use of internationally agreed forms and standards on pharmacovigilance. In view of the petitioner, industries are uncertain about the future use of standards of communication between national competent authorities on pharmacovigilance. The petitioner considers that problems with implementation of Regulation 520/2012 by the European Medicines Agency after Brexit will have a negative impact on patient safety.

Conclusions: The Commission and the Agency are confident that the transition from previous encoding standards to the new ISO IDMP standards will continue and that implications related to the withdrawal of the UK from the Union will have minor impact on the foreseen timelines for implementation.

Petition on improving pharmaceutical production processes and environmental standards for pharmaceutical companies seeking approvals from the European Medicines Agency
Notice to members of the Committee on Petitions in respect of Petition No 0451/2017 by Martin Jürgens (German) on improving pharmaceutical production processes and environmental standards for pharmaceutical companies seeking approvals from the European Medicines Agency (15-03-2018, PE 619.058v01-00, PETI_CM(2018)619058).

Summary of petition: The petitioner states that antimicrobial resistance (AMR) is a growing concern for public health in the EU. His particular concern relates to the problem of antibiotic residue in wastewater and sewerage, resulting from current antibiotic production processes. He calls for the European Medicines Agency (EMA) to increase the scope of its control in the approval process for antibiotic pharmaceuticals such that it includes the consideration of environmental factors, such as wastewater run-off and the increasing acceleration of AMR contagion. The petitioner highlights the particular problem of non-EU pharmaceutical producers, whose production process may not be in line with EU environmental standards. The petitioner is concerned that such products often end up for sale in the EU pharmaceutical market.

Depakine and other medicines containing valproate
Question for written answer to the Commission by Lola Sánchez Caldentey (GUE/NGL) (Date : 14-03-2018 Reference :E-001561/2018)

Medicines containing valproate (such as Depakine, among others) have been approved in the EU for the treatment of epilepsy and bipolar disorders, and, in some Member States, for the prevention of migraines. If taken during pregnancy, valproate is known to pose a significant risk of birth defects and developmental problems in the baby. Thousands of cases of abnormalities and other permanent side effects have been reported in the Member States. In 2008, and once again in 2018, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that its use should be restricted and that warnings to patients should be stepped up. Despite those efforts, however, many Member States, including Spain, have failed to follow the PRAC’s recommendations, and use of the drug has actually increased.

More than 90 000 people, including 9 000 women of childbearing age, are taking valproate (Depakine) every day in Spain, and they are not being given the necessary information about the potential risks and side effects.

1. Could the Commission share the latest data it has on how many people in the EU have suffered side effects (such as birth defects and developmental problems) as a result of valproate use?

2. What has been done to compensate the victims, and what steps have been taken to amend the pharmacological recommendations in respect of valproate? Has consideration been given to withdrawing it from the market?

3. Does the Commission take the view that, in this case, pharmacovigilance legislation has been successful in safeguarding public health?

The EU in USTR Special Report 301/2018
Question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 12-03-2018 Reference : P-001516/2018)

Recently, the associations PhRMA and BIO which represent the main innovative undertakings in the field of biopharmaceutics in the US and which act as pharmaceutical pressure groups, asked the office of the US Trade Representative (USTR) to include the EU in its Special Report 301/2018.

The report annually reviews the implementation of intellectual property rights (IP) in other countries and is used as a means to put pressure on countries to comply with US requirements on IP for the benefit of its industry.

The reason for the request is the ongoing review, by the European Commission, of existing incentives related to IP for the biopharmaceutical industry, and their impact on innovation and access to medicines. In the request, PhRMA and its members encourage the US government to promote robust protection of IP in the EU and its Member States and call on the US government to seek guarantees that the review will not result in measures that weaken the protection of IP.

What measures in response to these pressures has the Commission planned to take in order to ensure the objectivity and impartiality of the report?

Petition on multidrug-resistant pathogens and the lack of responsibility of the European pharmaceutical sector
Notice to members of the Committee on Petitions in respect of Petition No 0513/2017 by R. N. S. (German) on multidrug-resistant pathogens and the lack of responsibility of the European pharmaceutical sector (12-03-2018, PE 616.938v03-00, PETI_CM(2018)616938).

Summary of petition: The petition addresses the problem of antimicrobial resistance (AMR). The petitioner states that in Germany alone, despite a well-developed public health care system, a large number of AMR-infections are registered annually. As an example, he states that 11,000 infections were recently attributed to MRSA (Methicillin-resistant Staphylococcus aureus) and 8,000 to multiresistant Escheria coli. The petitioner is of the view that the medical profession is no longer able to respond to this problem. He believes that the current legislative framework is ineffective and outdated. In particular, the issue of inadequate pharmaceutical production processes and non-treatment of waste water continues to contribute to a rapid worsening of the problem. The petitioner also highlights the link between AMR in humans and the over-use of antibiotics in the meat industry, and points to the failure of EU agricultural policy to take account of AMR risk when distributing agricultural subsidies. In view of the seriousness of the situation and the worsening prognosis for the future, the petitioner is urging the European Commission and the European Parliament to take action. In particular, the petitioner calls upon the EU institutions to adequately enforce the rights to physical integrity, animal welfare, and environmental protection, as well as taking action in influencing the production processes of the pharmaceutical industry.

Conclusion: The Commission’s awareness of environmental concerns regarding AMR has triggered several initiatives, such as a public consultation on pharmaceuticals in the environment (open until 21.02.2018) and a targeted stakeholder consultation (deadline 21.01.2018). Furthermore, the petitioner is invited to consult the Commission’s new European One Health Action Plan against AMR adopted in June 2017 whose aim is in particular to strengthen infection prevention and control measures against AMR, to promote the prudent use of antimicrobials in humans and animals and to boost research towards development of new antimicrobials and alternative treatments. The Commission will regularly monitor the progress and implementation of the new action plan.

Measures to introduce transparency in the pricing of medicines
Question for written answer to the Commission by Nikos Androulakis (S&D) (Date : 08-03-2018 Reference :E-001467/2018)

The absence of a common system for costing medicines in the European Union has caused considerable differences in the pricing of medicines, affecting mainly smaller countries with less bargaining power.

The price of medicines can fluctuate often without obvious reasons, overburdening national budgets and national health systems as well as European consumers. The situation in my country, Greece, is a case in point.

At the same time, Directive 89/105/EEC on transparency, which is thirty years old this year, needs an immediate overhaul, as there have been significant changes regarding medicines in Europe, the most important of which is the advent of generic medicines.

Given that the current system is causing distortions in the European medicines market, while encouraging corruption, can the Commission say:

— Will it submit a new proposal for the revision of Directive 89/105/EEC, following the withdrawal of the previous proposal in 2015?

— What action does it intend to take to develop common cost accounting and pricing methods for medicines in the European market?

Biocides vs. Medicines – Reaction to a response from the Commission
Question for written answer to the Commission by José Inácio Faria (PPE) (Date : 08-03-2018 Reference :E-001459/2018)

The absence of a common system for costing medicines in the European Union has caused considerable differences in the pricing of medicines, affecting mainly smaller countries with less bargaining power.

The price of medicines can fluctuate often without obvious reasons, overburdening national budgets and national health systems as well as European consumers. The situation in my country, Greece, is a case in point.

At the same time, Directive 89/105/EEC on transparency, which is thirty years old this year, needs an immediate overhaul, as there have been significant changes regarding medicines in Europe, the most important of which is the advent of generic medicines.

Given that the current system is causing distortions in the European medicines market, while encouraging corruption, can the Commission say:

— Will it submit a new proposal for the revision of Directive 89/105/EEC, following the withdrawal of the previous proposal in 2015?

— What action does it intend to take to develop common cost accounting and pricing methods for medicines in the European market?

Shortage affecting more than 80% of medicines in Venezuela
Answer given by Mr Stylianides on 05.03.2018 on behalf of the Commission to question for written answer to the Commission by Nuno Melo (PPE) (Date : 12-10-2017 Reference : E-006412/2017)

The Honourable Member’s first two questions are best answered by the statements which were issued by the High Representative for Foreign Affairs and Security Policy/Vice-President of the Commission on behalf of the European Union on 26 July 2017 and on 2 August 2017.

In respect to the third question, related to the support provided to the European citizens living in Venezuela, as pointed out in the replies to written questions E-003410/2017, E-004165/2017 and E-004490/2017, ‘the humanitarian situation in the country has been severely deteriorating, particularly due to the lack of access to food and health services by the majority of the population. Based on the needs identified, the EU is providing assistance to support basic health and nutrition actions, and will continue monitoring closely the situation’.

Scientific data on aluminium in vaccine adjuvants
Question for written answer to the Commission by Mireille D’Ornano (EFDD) (Date : 02-03-2018 Reference : E-001327/2018)

In its answer of 11 February 2016, the Commission stated that ‘the scientific evidence available supports the safe and effective use of aluminium adjuvants in vaccines’. A report published in September 2017 by the French National Agency for Medicines and Health Products Safety has reignited the debate in the scientific community, however.

The French National Institute of Health and Medical Research (INSERM) has found that aluminium in vaccine adjuvants injected into mice stays in their bodies for several months and eventually reaches the brain. At the same time, a representative of the French National Academy of Pharmacy has argued that animal testing is a poor risk predictor for human beings.

According to Professor Romain Gherardi, a researcher at INSERM, only certain people with genetic variations are likely to experience aluminium-related side effects, such as chronic fatigue. More than 600 cases of macrophagic myofasciitis (MFM), a complex disease that causes joint pain, extreme fatigue and cognitive impairment, have been diagnosed in France. An association for people living with MFM has claimed that the disease is caused by aluminium-based adjuvants.

1. What does the Commission make of these findings?

2. Does it intend to call for further research into the risks posed by aluminium in adjuvants?

Health technology assessment
Question for written answer to the Commission by Roberta Metsola (PPE) (Date : 01-03-2018 Reference : E-001311/2018)

Health technology assessment (HTA) measures the added value of new health technologies (i.e. medicinal products, medical equipment and diagnostic and treatment methods) compared with existing ones.

Can the Commission specify whether its upcoming proposal on HTA will focus on the issue of having multiple national assessments for the same products that sometimes produce different results for patients and industry?

Shortage of medicines owing to parallel trade in Europe
Question for written answer to the Commission by Andrey Kovatchev (PPE) (Date : 01-03-2018 Reference : P-001287/2018)

The re-exportation — or parallel trade — in medicines is considered to be the main reason for the frequent shortage of medicines in many EU Member States. In early 2018, patients’ organisations in Bulgaria reported that around 60% of the medicines imported into that country were re-exported to other European markets. This makes it difficult — and sometimes even impossible — for many patients who require continuous treatment for life‐threatening diseases to procure the medicines they need.

1. Given the significant differences in the availability of medicines between different Member States, does the Commission intend to produce an analysis of the reasons for the shortages of medicines, and more specifically of the impact of parallel trade, as called for in the European Parliament resolution of 2 March 2017 on EU options for improving access to medicines?

2. Does the Commission see any legal or regulatory obstacles to the introduction of a pan‐European system for monitoring medicines, through which to track their movement along the supply chain?

3. Would it be possible, in view of the work done by the Commission in the field of eHealth and electronic prescriptions, to establish an EU register as a means of putting an end to bogus prescriptions? Such a system could store all prescriptions for a period of at least four months in order to ensure that there was a genuine patient every medicinal product sold.

Fixed spending and incentive system under Spanish Government agreement with Farmaindustria
Question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) and Sergio Gutiérrez Prieto (S&D) (Date : 23-02-2018 Reference : E-001125/2018)

We have received the Commission reply to our question No E-007467/2017, but this has no bearing on the agreement on a GDP-based expenditure cap.

The Autonomous Liquidity Fund (ALF) is a credit line created by the Spanish Government to enable it to lend to the autonomous communities and avoid their having to finance their debt in the markets.

In Spain, under the principle of decentralisation as enshrined in the constitution, responsibility for health, including the prescription of medical products, has been transferred to the autonomous communities.

In our view, making ALF financing contingent on acceptance of the agreement with Farmaindustria, the national association that represents manufacturers of branded pharmaceuticals, constitutes a barrier to market access for generic medicines, as the agreement guarantees a fixed level of expenditure on original products. The autonomous communities are obliged, as a condition of access to the ALF, to purchase branded products within the expenditure limit. Farmaindustria is thus, directly or indirectly, guaranteed a set volume of sales as the autonomous communities are under obligation to buy branded pharmaceuticals, and if they do not spend up to the permitted ceiling, central Government activates the incentive system which is also provided for in the agreement.

Can the Commission give us a fresh answer?

Corruption in the health sector
Question for written answer to the Commission by Kostas Chrysogonos (GUE/NGL) (Date : 22-02-2018 Reference : E-001096/2018)

According to surveys, corruption in the crucial health sector, including the payment of bribes to healthcare staff, fraud, embezzlement, misuse of public funds intended for the supply of medicines and medical equipment, and interference in public procurement, is becoming a widespread problem in the EU. In Greece, for example, health is one of the sectors most beset by allegations of corruption and maladministration, while in Italy corruption in the health sector is estimated to be costing around EUR 6 billion annually. At the same time, the EU is failing to monitor the situation or earmark sufficient funding for investigation and countermeasures. This is compounded by a lack of transparency regarding fund management and a serious shortage of integrated and specialised databases considered necessary to identify corruption in the complex health sector and effectively strike at the roots of the problem.

In view of this:

1. Can the Commission say how it intends to address these problems effectively?

2. Will it give its support to in-depth corruption probes in the health sector by means of specific programmes, structures or other measures?

3. Will it take specific measures to enhance transparency regarding fund management in the health sector?

Spanish government agreement with the pharmaceutical industry and access to autonomous financing for the autonomous communities
Answer given by Ms Vestager on 21.02.2018 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) and Sergio Gutiérrez Prieto (S&D) (Date : 04-12-2017 Reference : E-007467/2017)

In December 2016, the Spanish Ministry of Finance and Public Service and the Ministry of Health, Social Services and Equality signed an agreement with the pharmaceutical industry.

This agreement is the renewal of a similar agreement signed in November 2015. It caps the growth of Spanish public expenditure on originator medicinal products relative to the evolution of Spanish gross domestic product. This cap constitutes an example of so-called ‘payback/clawback’ policies aimed at preventing deficits in public budgets. Such policies exist in various Member States.

In general, such policies do not impact on various regulatory measures in place to foster the uptake of cheaper generics in the Member States, for example rules on generic substitution by pharmacists, or on prescription, by the common name of a medicinal product’s active substance.

Therefore, based on available information, such policies, in themselves, do not seem to raise concerns with regard to EU competition rules.

Life expectancy in southern Italy
Question for written answer to the Commission by Michela Giuffrida (S&D) (Date : 20-02-2018 Reference : E-001054/2018)

A recent study by the National Observatory on Health in the Italian Regions shows that the North-South divide is widening instead of narrowing: in the South mortality is rising among the under-70s, and life expectancy is continuing to fall; compared with the European average, the gap is almost eight years.

The prime responsibility for health services still lies with Member States. However, in keeping with Article 168 TFEU and the ‘Together for Health’ strategy in support of Europe 2020, the EU has a major role to play in improving public health as regards the prevention and management of diseases and the harmonisation of health strategies from one Member State to another.

That being the case, what steps will the Commission take to:

— give effect to the conclusions of the EP report on EU options for improving access to medicines concerning the right to medical treatment and the shortage of medicines; and

— encourage the use of IT, mobile devices (smartphones and tablets), and intelligent applications so that healthcare professionals can stay connected?

Boosting blood plasma collection in the EU
Question for written answer to the Commission by Nicola Caputo (S&D), Claudiu Ciprian Tănăsescu (S&D) and Momchil Nekov (S&D) (Date : 20-02-2018 Reference : E-001017/2018)

In the EU today, more and more patients are being diagnosed with rare plasma‐related disorders, which leads to a growing clinical need for plasma‐derived medicinal products. The manufacture of plasma‐derived medicinal products for these life‐threatening health disorders is entirely dependent on having enough blood and plasma donations from citizens.

The current EU policy framework on blood and blood components has not ensured that donations are keeping pace with the increasing need for plasma‐derived medicinal products, thereby jeopardising patient access to care involving such therapies.

In 2017, the Commission published a roadmap for the evaluation of EU legislation on blood and blood components, which will be concluded by the end of 2018 and might possibly result in a revision of the EU Blood Directive.

If such a revision follows the evaluation process, does the Commission agree that the revised EU legal framework should include a wording which allows the Member States to establish national programmes for the collection of plasma through plasmapheresis, in the interests of boosting blood plasma collection in the EU, as well as of ensuring legal certainty for Member States?

Towards harmonisation of penalties to stamp out falsified medicines in the EU
Question for written answer to the Commission by Alain Cadec (PPE) (Date : 16-02-2018 Reference : E-000964/2018)

Directive 2011/62/EU provides for ‘effective, proportionate and dissuasive’ penalties to be applied when falsified medicines are discovered (Article 118a).

However, in practice, those penalties vary considerably from one Member State to another. Prison sentences for falsifying medicines range from 1 to 15 years and fines from EUR 4 300 to 1 000 000. What is more, some countries levy fines for importing and exporting counterfeit products, while others impose only civil penalties for the same wrongdoing.

Will the Commission take measures to make penalties for falsifying medicines more coherent in the EU?

Market for medicinal products in Greece
Answer given by Mr Andriukaitis on 15.02.2018 on behalf of the Commission to question for written answer to the Commission by Nikos Androulakis (S&D) (Date : 07-12-2017 Reference : E-007570/2017)

The competent medicines authority in Greece is responsible for implementing the EU legislation on medicines in Greece and must ensure that marketing authorisation holders and wholesale distributors fulfil their legal obligations to continuously supply medicines and consequently protect public health. In 2018, the European Commission will facilitate the sharing of best practices between Member States for the effective implementation of this continuous supply obligation.

Pharmaceutical companies can distribute their medicines in different ways. Selective distribution is not prohibited by the EU competition rules, to the extent that it is necessary, given the characteristics of the product, and aims to achieve legitimate objectives.

Resellers must be chosen on the basis of objective, qualitative, criteria, which are laid down in advance and uniformly for all potential resellers and which criteria are not applied discriminatorily or go beyond what is necessary to attain legitimate objectives.

To asses a change from one distribution model to another under EU competition rules all the circumstances of the case must be taken into account e.g. the legal and economic context, the position of the parties, the state of competition in the market including competition from other medicines, the objectives pursued, whether the change creates efficiencies and any changes in costs.

The Commission and national competition authorities monitor pharmaceutical markets, cooperating closely. National courts are also competent to apply EU competition law in the context of disputes brought before them.

Fungicides and resistant fungi
Question for written answer to the Commission by Jørn Dohrmann (ECR) (Date : 14-02-2018 Reference : E-000921/2018)

Alarming reports have appeared in the media recently about fungi that have become resistant owing to the use of chemical fungicides in farming and industry. Patients have developed resistant fungal infections in the brain, lungs and other vital organs. Infections caused by resistant fungi cannot be treated with traditional medicine. It is reported that nine out of ten patients therefore die as a result of such infections.

Does the Commission agree that resistant fungi may pose a serious health problem for people in Europe?

Does the Commission agree that research in this area should be carried out right away?

Does the Commission have any initiatives in the pipeline that are geared towards investigating or preventing resistant fungi?

Petition on the tendering system for medicinal products in the Autonomous Community of Andalusia
Notice to members of the Committee on Petitions in respect of Petition No 0636/2017 by J.L.B. (Spanish) on the tendering system for medicinal products in the Autonomous Community of Andalusia (14-02-2018, PE 617.973v01-00, PETI_CM(2018)617973).

Summary of petition: The petitioner says that the tendering system for medicinal products in the Autonomous Community of Andalusia does not guarantee freedom of choice for patients and pharmacists, since they cannot choose medicines freely and only those medicinal products that are successful in the tenders can be dispensed. This restricts competition and hinders the free movement of goods, according to the petitioner.

Conclusion: As the EU legislation clearly places the competence and responsibility for the organisation of health care on the Member States, the Commission is not in the position to intervene in favour of the petitioner.

Withdrawal of innovative medicines from the Greek market
Answer given by Mr Andriukaitis on 09.02.2018 on behalf of the Commission to question for written answer to the Commission by Giorgos Grammatikakis (S&D) (Date : 04-12-2017 Reference : E-007489/2017)

In accordance with Article 168 of the Treaty on the Functioning of the European Union , the Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care, including the allocation of the resources assigned to them.

In the context of the European Stability Mechanism stability support programme, the Greek authorities are therefore called to implement measures to improve the efficiency of the health system, thereby its sustainability, with the specifics of the measures entirely for the authorities to decide.

The EU legislation does not allow for specific tools to influence the availability of medicines on the market of a Member State as a consequence of its national pricing policy and hence the Commission has no legal means to prevent companies from withdrawing products from the market or not marketing products in all Member States.

In the specific context of shortages, the Commission is collaborating with the Member States, the Heads of Medicines Agencies and the European Medicines Agency in order to share best practices with a view to assuring continuous supply of medicines through effective implementation of Article 81 of Directive 2001/83/EC.

Rare diseases
Question for written answer to the Commission by Merja Kyllönen (GUE/NGL) (Date : 09-02-2018 Reference : E-000831/2018)

Rare diseases are life-threatening or chronically debilitating, mostly inherited diseases, with a very low incidence. In EU countries, any disease that affects fewer than 5 in 10 000 people is considered to be rare. Therefore, combined efforts are needed to address them so as to prevent illness, deaths among newborn babies and young children, and substantial impairment of the quality of life or socioeconomic opportunities of sufferers.

A high level of protection of human health is supposed to be ensured in formulating and implementing all Community policies and activities. European Union action, which serves to complement national policies, is intended to improve public health, prevent human diseases and disorders, and eliminate dangers to human health. However, the rarity of diseases presents challenges when it comes to identifying and treating them, rehabilitating patients and providing services, as well as in sufferers’ daily life.

Has the Commission increased the incentives to improve medical devices and diagnostics for rare diseases?

What has been done at EU level to improve the uniform availability of medicinal products for rare diseases and with regard to price setting and determination of reimbursements?

Rare diseases
Question for written answer to the Commission by Merja Kyllönen (GUE/NGL) (Date : 09-02-2018 Reference : E-000830/2018)

Rare diseases are life-threatening or chronically debilitating, mostly inherited diseases, with a very low incidence. In EU countries, any disease that affects fewer than 5 in 10 000 people is considered to be rare. Therefore, combined efforts need to be brought to bear in order to prevent morbidity, neonatal mortality and deaths of young children, and substantial impairment of the quality of life or socioeconomic possibilities for sufferers.

Although decisions concerning the pricing of medicines and the reimbursements payable lie solely within the national sphere of responsibility, Member States all face the major challenge of offering sufferers affordable medicines and making those medicines readily available. Meeting that challenge becomes an unusually difficult problem when the number of patients involved is small and the necessary treatments and medicines are hard to come by and expensive, as is often the case with rare diseases and orphan drugs.

What steps have been taken in the Council to enable Europeans to obtain a high standard of care for rare diseases at an affordable price?

Novartis company guilty of corruption
Question for written answer to the Commission by Stelios Kouloglou (GUE/NGL) (Date : 07-02-2018 Reference : P-000765/2018)

According to initial reports from the Greek judiciary that have now come to light, prosecutors are currently investigating serious corruption charges levelled against the Novartis company in Greece and directly involving ten politicians.

Tens of millions of euros have allegedly been paid in bribes in order to secure high prices for pharmaceuticals manufactured by Novartis. Given the pivotal role played by Greece in determining prices at European level, the tactics employed by Novartis have affected the price of medicines in other Member States also.

In view of this:

1. What steps will the Commission take to determine the extent of the harm, if any, suffered by the Member States?

2. What action will it take to prevent similar cases of corruption, unfair competition and internal market manipulation at EU level?

Building requirements for European Medicines Agency (EMA) relocation
Answer given by President Juncker on 02.02.2018 on behalf of the Commission to question for written answer to the Commission by Răzvan Popa (S&D) (Date : 07-11-2017 Reference : E-006857/2017)

La punctul 15 din Orientările pentru negocierile privind Brexitul, formulate de Consiliul European din 29 aprilie 2017, se aduc următoarele precizări: „Deși stabilirea viitoarelor sedii ale agențiilor și ale structurilor UE situate în Regatul Unit este o chestiune de rezolvat fără întârziere de către cele 27 de state membre, ar trebui să se stabilească înțelegeri pentru facilitarea transferului acestora.”.

În marja Consiliului European din 22 iunie 2017, șefii de stat sau de guvern ai celor 27 de state membre au aprobat procedura care va fi urmată în vederea adoptării unei decizii privind transferul Agenției Europene pentru Medicamente și al Autorității Bancare Europene în contextul retragerii Regatului Unit din Uniune.

Această procedură a definit șase criterii de care statele membre interesate trebuiau să țină seama în ofertele lor de a găzdui una dintre agenții sau ambele. Unul dintre aceste criterii a fost distribuția geografică a sediilor agențiilor. Termenul de depunere a ofertelor a expirat la 31 iulie 2017. Comisia a fost invitată să examineze ofertele prezentate, pe baza celor șase criterii convenite de cele 27 de state membre și să prezinte o evaluare a ofertelor până la 30 septembrie 2017. La 30 septembrie 2017, Secretarul General al Comisiei i-a prezentat Secretarului General al Consiliului evaluarea efectuată cu privire la oferte.

La 12 octombrie 2017, considerând că se impunea o corectare a evaluării efectuate de Comisie cu privire la oferta României de a găzdui Agenția Europeană pentru Medicamente în ceea ce privește „accesul la educație gratuită”, Secretarul General al Comisiei a publicat o rectificare pe site-ul Europa și a informat statele membre în acest sens.

Evaluarea publicată de Secretarul General al Comisiei nu a reprezentat o condiție legală pentru decizia luată în ceea ce privește noile sedii ale celor două agenții. Această decizia a fost luată de cele 27 de state membre în marja reuniunii din 20 noiembrie 2017 a Consiliului Afaceri Generale (articolul 50). Comisia nu a luat parte la această decizie și nici nu a avut vreun alt rol formal în procesul decizional referitor la noile sedii ale celor două agenții.

Official survey of the EMA’s staff on the issue of its relocation
Answer given by President Juncker on 02.02.2018 on behalf of the Commission to question for written answer to the Commission by Răzvan Popa (S&D) (Date : 07-11-2017 Reference : E-006856/2017)

La punctul 15 din Orientările pentru negocierile privind Brexitul, formulate de Consiliul European din 29 aprilie 2017, se aduc următoarele precizări: „Deși stabilirea viitoarelor sedii ale agențiilor și ale structurilor UE situate în Regatul Unit este o chestiune de rezolvat fără întârziere de către cele 27 de state membre, ar trebui să se stabilească înțelegeri pentru facilitarea transferului acestora.”.

În marja Consiliului European din 22 iunie 2017, șefii de stat sau de guvern ai celor 27 de state membre au aprobat procedura care va fi urmată în vederea adoptării unei decizii privind transferul Agenției Europene pentru Medicamente și al Autorității Bancare Europene în contextul retragerii Regatului Unit din Uniune.

Această procedură a definit șase criterii de care statele membre interesate trebuiau să țină seama în ofertele lor de a găzdui una dintre agenții sau ambele. Unul dintre aceste criterii a fost distribuția geografică a sediilor agențiilor. Termenul de depunere a ofertelor a expirat la 31 iulie 2017. Comisia a fost invitată să examineze ofertele prezentate, pe baza celor șase criterii convenite de cele 27 de state membre și să prezinte o evaluare a ofertelor până la 30 septembrie 2017. La 30 septembrie 2017, Secretarul General al Comisiei i-a prezentat Secretarului General al Consiliului evaluarea efectuată cu privire la oferte.

La 12 octombrie 2017, considerând că se impunea o corectare a evaluării efectuate de Comisie cu privire la oferta României de a găzdui Agenția Europeană pentru Medicamente în ceea ce privește „accesul la educație gratuită”, Secretarul General al Comisiei a publicat o rectificare pe site-ul Europa și a informat statele membre în acest sens.

Evaluarea publicată de Secretarul General al Comisiei nu a reprezentat o condiție legală pentru decizia luată în ceea ce privește noile sedii ale celor două agenții. Această decizia a fost luată de cele 27 de state membre în marja reuniunii din 20 noiembrie 2017 a Consiliului Afaceri Generale (articolul 50). Comisia nu a luat parte la această decizie și nici nu a avut vreun alt rol formal în procesul decizional referitor la noile sedii ale celor două agenții.

Errors in the assessment of Romania’s file on the relocation of the EMA
Answer given by President Juncker on 02.02.2018 on behalf of the Commission to question for written answer to the Commission by Răzvan Popa (S&D) (Date : 07-11-2017 Reference : E-006855/2017)

La punctul 15 din Orientările pentru negocierile privind Brexitul, formulate de Consiliul European din 29 aprilie 2017, se aduc următoarele precizări: „Deși stabilirea viitoarelor sedii ale agențiilor și ale structurilor UE situate în Regatul Unit este o chestiune de rezolvat fără întârziere de către cele 27 de state membre, ar trebui să se stabilească înțelegeri pentru facilitarea transferului acestora.”.

În marja Consiliului European din 22 iunie 2017, șefii de stat sau de guvern ai celor 27 de state membre au aprobat procedura care va fi urmată în vederea adoptării unei decizii privind transferul Agenției Europene pentru Medicamente și al Autorității Bancare Europene în contextul retragerii Regatului Unit din Uniune.

Această procedură a definit șase criterii de care statele membre interesate trebuiau să țină seama în ofertele lor de a găzdui una dintre agenții sau ambele. Unul dintre aceste criterii a fost distribuția geografică a sediilor agențiilor. Termenul de depunere a ofertelor a expirat la 31 iulie 2017. Comisia a fost invitată să examineze ofertele prezentate, pe baza celor șase criterii convenite de cele 27 de state membre și să prezinte o evaluare a ofertelor până la 30 septembrie 2017. La 30 septembrie 2017, Secretarul General al Comisiei i-a prezentat Secretarului General al Consiliului evaluarea efectuată cu privire la oferte.

La 12 octombrie 2017, considerând că se impunea o corectare a evaluării efectuate de Comisie cu privire la oferta României de a găzdui Agenția Europeană pentru Medicamente în ceea ce privește „accesul la educație gratuită”, Secretarul General al Comisiei a publicat o rectificare pe site-ul Europa și a informat statele membre în acest sens.

Evaluarea publicată de Secretarul General al Comisiei nu a reprezentat o condiție legală pentru decizia luată în ceea ce privește noile sedii ale celor două agenții. Această decizia a fost luată de cele 27 de state membre în marja reuniunii din 20 noiembrie 2017 a Consiliului Afaceri Generale (articolul 50). Comisia nu a luat parte la această decizie și nici nu a avut vreun alt rol formal în procesul decizional referitor la noile sedii ale celor două agenții.

Relocation of the EMA to Bucharest
Answer given by President Juncker on 02.02.2018 on behalf of the Commission to question for written answer to the Commission by Claudiu Ciprian Tănăsescu (S&D) (Date : 07-11-2017 Reference : E-006847/2017)

La punctul 15 din Orientările pentru negocierile privind Brexitul, formulate de Consiliul European din 29 aprilie 2017, se aduc următoarele precizări: „Deși stabilirea viitoarelor sedii ale agențiilor și ale structurilor UE situate în Regatul Unit este o chestiune de rezolvat fără întârziere de către cele 27 de state membre, ar trebui să se stabilească înțelegeri pentru facilitarea transferului acestora.”.

În marja Consiliului European din 22 iunie 2017, șefii de stat sau de guvern ai celor 27 de state membre au aprobat procedura care va fi urmată în vederea adoptării unei decizii privind transferul Agenției Europene pentru Medicamente și al Autorității Bancare Europene în contextul retragerii Regatului Unit din Uniune.

Această procedură a definit șase criterii de care statele membre interesate trebuiau să țină seama în ofertele lor de a găzdui una dintre agenții sau ambele. Unul dintre aceste criterii a fost distribuția geografică a sediilor agențiilor. Termenul de depunere a ofertelor a expirat la 31 iulie 2017. Comisia a fost invitată să examineze ofertele prezentate, pe baza celor șase criterii convenite de cele 27 de state membre și să prezinte o evaluare a ofertelor până la 30 septembrie 2017. La 30 septembrie 2017, Secretarul General al Comisiei i-a prezentat Secretarului General al Consiliului evaluarea efectuată cu privire la oferte.

La 12 octombrie 2017, considerând că se impunea o corectare a evaluării efectuate de Comisie cu privire la oferta României de a găzdui Agenția Europeană pentru Medicamente în ceea ce privește „accesul la educație gratuită”, Secretarul General al Comisiei a publicat o rectificare pe site-ul Europa și a informat statele membre în acest sens.

Evaluarea publicată de Secretarul General al Comisiei nu a reprezentat o condiție legală pentru decizia luată în ceea ce privește noile sedii ale celor două agenții. Această decizia a fost luată de cele 27 de state membre în marja reuniunii din 20 noiembrie 2017 a Consiliului Afaceri Generale (articolul 50). Comisia nu a luat parte la această decizie și nici nu a avut vreun alt rol formal în procesul decizional referitor la noile sedii ale celor două agenții.

Regulated professions in the Member States
Answer given by Ms Bieńkowska on 30.01.2018 on behalf of the Commission to question for written answer to the Commission by Richard Sulík (ECR) (Date : 27-10-2017 Reference : E-006713/2017)

1. The basis of the newly proposed Directive on a proportionality test is Article 59 of the Professional Qualifications Directive 2005/36/EC as amended by Directive 2013/55/EU and results from the outcome of the mutual evaluation exercise. The content of the proposal directly relates to the experience acquired during that exercise, where thorough assessments were sometimes lacking or the scrutiny of regulation of professions was uneven across the Member States. The material scope of the proposal is the same as for Directive 2005/36/EC, namely all regulated professions.

2. The reform recommendations are non-binding recommendations inviting the Member States to revisit the regulatory framework for the respective professions in the Member States. The Commission is currently exchanging information on the developments and on the follow-up to the recommendation with the Member States bilaterally as well as in the framework of the Group of Coordinators under Directive 2005/36/EC, consisting of Member State’s representatives who are the relevant contacts for the application of the Directive.

3. Whether to commence infringement proceedings lies, according to settled case law of the European Court of Justice, in the discretion of the Commission alone. The use of its discretionary power is further explained in the Communication of the Commission “EU Law: Better Results through Better Application”.

The future of supplementary protection certificates
Question for written answer to the Commission by Joëlle Mélin (ENF) (Date : 30-01-2018 Reference : E-000512/2018)

On 5 September 2017, the French judicial authorities ruled that the supplementary protection certificate (SPC) issued by the Gilead laboratory was not valid. The Netherlands, Sweden and Greece have already rejected the manufacturer’s SPC request and generics are already available. In France, a box can now be bought for less than EUR 200, while the laboratory was selling it for more than EUR 400. However, in other Member States, the SPC is a barrier to access to generics, thus hindering access to preventative HIV treatment.

A British judge opted to request legal clarification on a technical point from the European Court of Justice (ECJ). At the same time as this procedure, the arrangements for the SPCs are being discussed at the Commission, insofar as they are based on a 2009 regulation which seems outdated and vague, leading to differences of interpretation within the European Union.

In this connection, what is the Commission’s timetable for its draft revision of the regulation on the supplementary protection certificate and what stages of the consultations have been opened so far?

Clawback of the Greek pharmaceutical sector
Question for written answer to the Commission by Eva Kaili (S&D) (Date : 29-01-2018 Reference : E-000472/2018)

Following my Written Question E-003237/2017 regarding the clawback of the Greek pharmaceutical sector, a provision for a 30% clawback reduction for 2017 vs 2016 and 15% for 2018 vs 2017 was included in the supplementary memorandum of understanding of the third bailout agreement between Greece and its creditors. It is worth mentioning that pharmaceutical companies in Greece account for 27.3% of total pharmaceutical expenditure, while the average pharma contribution in the EU is 8.6% and the second highest contribution is from Germany at 13.3%. The introduction of a new rebate scheme with an extra 25% (effective retroactively since 1 January 2017) mandatory entrance fee for new drugs also failed to reduce the 2017 clawback. For 2017 the projected contribution of the Greek pharmaceutical industry will reach some EUR 1 billion.

Has the target of a 30% clawback reduction for 2017 vs 2016 been achieved?

If not, and since the 30% reduction was a prerequisite, are the supervising institutions willing to address this matter with the Greek Ministry of Health?

The environment has become highly unsustainable. How will patient access to innovation be affected if companies decide to no longer launch their products in Greece?

Medicinal products that refer to traditional Chinese medicine
Answer given by Mr Andriukaitis on 26.01.2018 on behalf of the Commission to question for written answer to the Commission by Luděk Niedermayer (PPE) (Date : 30-11-2017 Reference : E-007377/2017)

Regulation (EC) No 1924/2006 provides that health claims may only be used if they have been authorised by the Commission. The procedure of authorisation requires the scientific assessment of claims, of the highest possible standard, which is carried out by the European Food Safety Authority. To date, 267 claims have been authorised and put on the lists of authorised health claims.

However, for the particular case of health claims on botanicals used in food/food supplements, the transitional measures provided for in Article 28(5) and (6) of the Claims Regulation apply.

The legality of such health claims that are still falling under the transitional regime may have also to be assessed under national rules in addition to EU rules, the enforcement of which falls in the exclusive competence of the Member States.

The statement ‘according to traditional Chinese medicine’ accompanying a health claim may be in contravention with national and Union law on food labelling. Depending on the circumstances, such statement may for instance be prohibited in food labelling pursuant to Article 7(3) of Regulation (EU) No 1169/2011 as this could be understood by consumers as an information referring to medicinal properties of the food.

Availability and price of cancer drugs
Answer given by Mr Andriukaitis on 25.01.2018 on behalf of the Commission to question for written answer to the Commission by Urmas Paet (ALDE) (Date : 30-11-2017 Reference : E-007368/2017)

Access to medicines is at the core of EU level activities. The 2016 Council conclusions on strengthening the balance in the pharmaceutical systems indicated a clear roadmap for the Member States and the Commission to foster access to the right treatments for European patients in an affordable manner. Similarly, the Parliament adopted a report on EU options for improving access to medicines in 2017.

The Commission is currently conducting factual studies on the impact of the pharmaceutical incentives on innovation as well as availability and accessibility of medicines. These studies will feed into an evaluation of the EU legislation on medicines for children and rare diseases in 2019.

The Commission also supports the European Partnership for Action Against Cancer through projects with Member States known as joint actions. A new Innovative Partnership on Action against Cancer joint action with EUR 4.5 million co-funding from the Health Programme is due in 2018. A joint action on rare cancers is also ongoing with the aim to improve surveillance, share best practices and equality of care.

The Commission is currently finalising an initiative on strengthening EU cooperation on Health Technology Assessment (HTA) which assesses the added value of given health technology over and above existing ones, helping Member States to allocate national resources to effective health interventions. HTA can speed up process of market access and thus improve patient access to innovative technologies.

The Commission also supports possible synergies between the work of regulatory bodies, Health Technology Assessment bodies and payers with the aim to facilitate development and patient access to innovative medicinal products including cancer medicines.

Right to affordable medicines in EU-Mercosur Trade Negotiations
Answer given by Ms Malmström on 23.01.2018 on behalf of the Commission to question for written answer to the Commission by David Martin (S&D) (Date : 28-11-2017 Reference : P-007310/2017)

The EU recognises the importance of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health, allowing the granting of compulsory licences where necessary. The Commission proposes a clause in EU trade agreements referring to the Doha Declaration, which guarantees that in interpreting and implementing the rights and obligations under the new trade agreement, consistency with the Doha Declaration is ensured. The Commission is following this approach in the negotiations with Mercosur.

In the context of international trade, intellectual property right issues are often portrayed in the public debate as the main barrier to access to medicines. However, more than 90% of all essential medicines listed by the World Health Organisation (WHO) are not patent protected. The need to seek holistic solutions is echoed in a joint-report from the WHO, World Trade Organisation and World Intellectual Property Organisation that the “lack of access to medical technologies is rarely due to a single isolated factor”.

In line with the above, the Commission has contributed more than EUR 1.6 billion to the Global Fund improving access and combatting diseases such as HIV/AIDS and malaria from the EU budget and from the European Development Fund since 2001. The Global Fund also receives support from many EU Member States directly, bringing the contribution of the EU collectively to almost 50% of the USD 4 billion that the Global Fund spends every year.

Medicinal products used in hormone treatment for transgender persons
Answer given by Mr Andriukaitis on 19.01.2018 on behalf of the Commission to question for written answer to the Commission by Lola Sánchez Caldentey (GUE/NGL) (Date : 14-11-2017 Reference : E-007014/2017)

According to the pharmaceutical legislation, the package leaflet containing information for the user of the medicines is approved by a competent authority, either by the Commission for the entire European Union or by a Member State for its own territory, as a part of the marketing authorisation.

The Commission notes that inclusion of sub-populations like transgender people can only be added to package leaflets if the Marketing Authorisation Holder (MAH) is applying for their product to be used in such a sub-population. In those cases, the MAH would have to conduct clinical studies for their product and to propose wording for such groups on the basis of the evidence generated.

The Commission acknowledges the importance of consideration of specific subgroups during the development, approval and use of medicines. To combat the discrimination of lesbian, gay, bisexual, transgendered and intersex (LGBTI) people, including transgender people, the Commission published the List of Actions to Advance LGBTI Equality. One of them is the pilot project “Health4LGBTI” (2016-2018). Its objective is to increase the understanding of how best to reduce specific health inequalities experienced by LGBTI people. The project includes the development of training modules aimed at increasing the knowledge, attitudes and skills of healthcare professionals when providing healthcare to LGBTI people. However, currently there are no specific initiatives ongoing or planned to address issues concerning the transgender population in the product information of medicines.

Water pollution and the use of Imidacloprid
Question for written answer to the Commission by Alex Mayer (S&D) (Date : 16-01-2018 Reference : E-000231/2018)

In light of the data from the Water Framework Directive Watch List monitoring, does the Commission have any plans to ban the use of imidacloprid, clothianidin and thiamethoxam in agriculture?

Furthermore, what action is the Commission taking with regard to water pollution caused by the use of imidacloprid as an externally applied veterinary medicine?

Lung cancer
Answer given by Mr Andriukaitis on 15.01.2018 on behalf of the Commission to question for written answer to the Commission by Dubravka Šuica (PPE) (Date : 17-11-2017 Reference : E-007105/2017)

According to the ‘Health at a Glance: Europe 2016 – State of Health in the EU Cycle’ cancer is the second leading cause of mortality in EU Member States after cardiovascular diseases. Lung cancer is the most common cause of death from cancer among men and the second cause of death from cancer among women. It is estimated that smoking is responsible for about 85 % of all instances of lung cancer. The Commission has adopted a number of tobacco control measures intended to protect citizens from the hazardous effects of smoking, including by deterring the initiation of tobacco consumption, particularly as regards young people, and by limiting exposure to second-hand smoke.

The Commission can help Member States by funding initiatives and projects to promote smoke-free policies and healthy life styles, and providing Member States with EU best practices and guidelines to be implemented at national level in the areas of cancer screening, quality assurance in cancer management, integrated cancer control, after-care at community level, and survivorship and rehabilitation.

Moreover, considering the need for a cross-sector and integrated approach to reduce the high mortality rate due to lung cancer, the Country Health Profiles recently published by the Commission will help to provide a better evidence base to ensure that all EU citizens have access to effective cancer care through implementation of innovative, safe, and effective patient centred cancer planning.

In addition, the clinical trials Regulation, which will become applicable in 2019, will make it easier to conduct multinational clinical trials in Europe increasing innovation and facilitating participation in clinical trials.

Regulated professions: French Parliament objects to Commission proposal
Answer given by Ms Bieńkowska on 15.01.2018 on behalf of the Commission to question for written answer to the Commission by Dominique Martin (ENF) (Date : 15-09-2017 Reference : E-005765/2017)

The Commission recalls that the subsidiarity control mechanism laid down in Protocol No 2 to the Treaties obliges the Commission to react to national Parliaments’ reasoned opinions when the thresholds set out in the procedures in Article 7 of Protocol No 2 are met. In addition, the Commission has decided to reply to all opinions from national Parliaments, including their reasoned opinions, in the framework of its political dialogue with the national Parliaments, launched in 2006. All replies to the reasoned opinions concerning the proposal for a Directive on a proportionality test before adoption of the new regulation on professions have been sent to the relevant national Parliaments and made public.

In this context, the Commission recalls that it publishes all opinions from national Parliaments, as well as the Commission’s replies, on the Commission’s website so that all interested parties and stakeholders have access to them, once an opinion has been received or a reply has been sent.

Evaluation procedure for Aplidin
Answer given by Mr Andriukaitis on 08.01.2018 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 04-12-2017 Reference : P-007464/2017)

The Commission is aware of an ongoing procedure at the European Medicines Agency (EMA) for a marketing authorisation application for a medicinal product for treatment of multiple myeloma, containing an active substance plitidepsin.

The Commission has been informed by representatives of the applicant about concerns regarding the procedure. The scientific assessment is the responsibility of the EMA. The Commission relies on the Agency as regards the procedures of scientific evaluation. In accordance with EMA procedures, the applicant has several opportunities to present data in favour of their application. Due to the fact that this is a pending procedure, the Commission is not in position to further comment on it.

The Commission will proceed with the decision-making process as regards the application once the final opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) has been received.

European Medicines Agency
Answer given by Mr Andriukaitis on 08.01.2018 on behalf of the Commission to question for written answer to the Commission by Pilar Ayuso (PPE) and Esteban González Pons (PPE) (Date : 29-11-2017 Reference : P-007342/2017)

The Commission is aware of an ongoing procedure at the European Medicines Agency (EMA) for a marketing authorisation application for a medicinal product for treatment of multiple myeloma, containing an active substance plitidepsin.

The Commission has been informed by representatives of the applicant about concerns regarding the procedure. The scientific assessment is the responsibility of the EMA. The Commission relies on the Agency as regards the procedures of scientific evaluation. In accordance with EMA procedures, the applicant has several opportunities to present data in favour of their application. Due to the fact that this is a pending procedure, the Commission is not in position to further comment on it.

The Commission will proceed with the decision-making process as regards the application once the final opinion of the EMA Committee for Medicinal Products for Human Use (CHMP) has been received.

Banning diclofenac
Answer given by Mr Andriukaitis on 05.01.2018 on behalf of the Commission to question for written answer to the Commission by Linda McAvan (S&D) (Date : 16-11-2017 Reference : E-007074/2017)

The Commission has taken several actions in relation to the use of diclofenac in the EU.

The Member States were requested to carry out an analysis of the risk mitigation measures recommended by the European Medicines Agency (EMA) in its opinion of 11 December 2014 and to indicate in an action plan the measures that have been already implemented or that they would consider to put in place in the future. It should be noted in this respect that veterinary medicinal products containing diclofenac have been authorised only through the national authorisation procedure in a limited number of Member States.

At the meeting of the Veterinary Pharmaceutical Committee that took place on 15 June 2015, it was agreed that the mitigation measures implemented by the Member States should guarantee that where diclofenac is used and vultures (or other relevant necrophagous birds) are present on the territory, they would be able to contain the risk effectively.

Given the Commission’s commitment to follow up on this issue, Member States were invited during the Veterinary Pharmaceutical Committees that took place on 4 July 2016 and on 19 June 2017 to provide an update of the situation in their territories.

Most Member States indicated that they have not authorised diclofenac. Those that have authorised products containing diclofenac indicated that appropriate safety warnings were included in the product literature and that appropriate measures are in place for the safe disposal of fallen stock and the feeding of carrion to birds of prey.

None of the Member States reported deaths of vultures in their territories and no request was made for the initiation of a referral where the withdrawal of the marketing authorisations of products containing diclofenac would be considered.

Synthetic biology risk assessment and institutional oversight
Answer given by Mr Andriukaitis on 05.01.2018 on behalf of the Commission to question for written answer to the Commission by Liisa Jaakonsaari (S&D) (Date : 19-10-2017 Reference : E-006568/2017)

The Opinions of the Scientific Committees considered that Synthetic Biology (SynBio) “is currently encompassed within genetic modification as defined in the European Directives 2001/18/EC and 2009/41/EC,”. They also concluded that current methods of risk assessment “are appropriate and adequate for the management of the risks of SynBio activities (…) However, incremental advances in the knowledge base and tools for risk assessment are recommended (…) to ensure the highest quality risk assessment”.

The Commission funds projects under the current EU Framework Programme for Research and Innovation, in particular under the part ‘Boosting cutting edge biotechnologies as future innovation drivers’.

At the 13th Conference of the Parties to the Convention on Biological Diversity (COP13), the Commission and the Member States used these Opinions to develop the EU position, which was reflected on COP13 decision on SynBio.

The Commission has addressed the need to improve the scientific understanding of new developments in bioscience by requesting the Scientific Advice Mechanism to deliver an explanatory note providing an up-to-date and comparative analysis of conventional, established and new techniques in agricultural biotechnology. The note also briefly outlines the agricultural application of new techniques in the field of synthetic biology.

The Commission is also promoting an open and transparent discussion with all stakeholders and is committed to work with them (including civil society), and with the European Parliament and the Council towards defining a common and constructive way forward for a safe and responsible innovation in the EU. Synthetic Biology is in the scope of this dialogue.

Sale of patients’ data in hospitals in Belgium
Answer given by Mrs Jourová on 04.01.2018 on behalf of the Commission to question for written answer to the Commission by Claude Rolin (PPE) (Date : 31-10-2017 Reference : E-006747/2017)

L’article 8 de la directive 95/46/CE, telle que transposée dans la loi nationale des Etats membres, édicte un régime strict de protection des données à caractère personnel relatives à la santé des individus. Celles-ci ne peuvent être traitées que sur la base de l’une des justifications énumérées à l’article 8(2)-(4) de la directive. En vertu de l’article 8(3), le traitement de ces données par les hôpitaux peut être justifié lorsque le traitement est nécessaire aux fins de la médecine préventive, des diagnostics médicaux, de l’administration de soins ou de traitements ou de la gestion de services de santé et que le traitement de ces données est effectué par un praticien de la santé soumis au secret professionnel, ou par une autre personne soumise à une obligation de secret équivalente. L’article 9 du règlement (UE) 2016/679, qui remplacera la directive 95/46/CE à compter du 25 mai 2018, réaffirme ces règles strictes pour la protection des données relatives à la santé.

Les hôpitaux ne peuvent pas partager les données médicales des patients avec des sociétés privées, sauf dans les cas limitativement prévus dans la législation sur la protection des données. Ce partage des données ne peut se faire que sur la base d’une loi le prévoyant expressément et selon les modalités définies dans la loi, ou sur la base du consentement exprès des patients.

La Commission ne dispose pas de chiffres au niveau européen concernant d’éventuels cas similaires. La surveillance et le contrôle de l’application de la législation sur la protection des données relèvent de la compétence des autorités nationales, notamment des autorités de contrôle de la protection des données et des tribunaux, sans préjudice des compétences de la Commission en tant que gardienne des traités.

Kymriah: the childhood leukaemia treatment accessible only to the rich
Question for written answer to the Commission by Ignazio Corrao (EFDD), Dario Tamburrano (EFDD), Tiziana Beghin (EFDD), and Fabio Massimo Castaldo (EFDD) (Date : 15-12-2017 Reference : E-007787/2017)

CHF 475 000 or just over EUR 400 000: that is the cost of Kymriah, a childhood leukaemia drug developed by a Pennsylvania University researcher and manufactured by the Swiss company Novartis.

The pharmaceutical industry allegedly has a profit margin of 25%, and Kymriah could cost much less.

Kymriah is an exclusive drug and will be used for only 600 treatments a year. No national health care system can afford to finance care of that sort.

Kymriah is the first gene therapy for leukaemia and has been given the go-ahead by the US Food and Drug Administration. In tests on young patients in the US the remission rate was 83%.

Reference might also be made here to Parliament’s resolution P7_TA(2013)0049: Article 168 TFEU; the obligations set out in Article 81 of Directive 2001/83/EC; paragraphs 249 and 250 of the judgment handed down by the Court of Justice on 14 February 1978 in Case 27/76, concerning excessive prices; and Parliament’s resolution P8_TA(2017)0061.

Notwithstanding the fact that the prime responsibility for health-related action lies with the Member States, how will the Commission ensure that European children with leukaemia can be treated even when they do not number among ‘the rich’?

Relocation of the European Medicines Agency
Answer given by President Juncker on 15.12.2017 on behalf of the Commission to question for written answer to the Commission by Ramona Nicole Mănescu (PPE) (Date : 11-10-2017 Reference : P-006365/2017)

Paragraph 15 of the Guidelines for Brexit negotiations of the European Council of 29 April 2017 states that “while the future location of the seats of EU agencies and facilities located in the United Kingdom is a matter for the 27 Member States to settle rapidly, arrangements should be found to facilitate their transfer”.

In the margins of the European Council of 22 June 2017, the Heads of State or Government of 27 Member States endorsed the procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union.

This procedure sets out six criteria which the interested Member States should address in their offer to host one or both of the Agencies. One of these criteria is the geographical spread of agencies’ seats. The deadline for submitting offers expired on 31 July 2017. The European Commission has been invited to examine the submitted offers based on the six criteria agreed by the 27 Member States and to submit an assessment of the offers by 30 September 2017. On 30 September 2017, the Secretariat-General of the Commission submitted its assessment of the offers to the Secretary-General of the Council.

On the basis of this assessment, it is for the 27 Member States to decide on the new locations for the two Agencies. A discussion took place in the margins of the General Affairs Council (Article 50) meeting of 17 October 2017. The 27 Member States took a decision by vote in the margins of the General Affairs Council (Article 50) meeting of 20 November 2017. The Commission did not take part in this vote, nor did it have any other formal role in the decision-making process regarding the new locations for the two Agencies.

Cost of moving European Medicines Agency from London to Amsterdam
Question for written answer to the Commission by Rory Palmer (S&D) (Date : 14-12-2017 Reference : E-007748/2017)

What is the total budget for the costs associated with moving the European Medicines Agency (EMA) from London to Amsterdam, and what are the current total estimated costs?

Regulated professions and the 700 000 jobs « invented » by the Commission
Answer given by Ms Bieńkowska on 14.12.2017 on behalf of the Commission to question for written answer to the Commission by Dominique Martin (ENF) (Date : 15-09-2017 Reference : E-005766/2017)

The Proposal for a Directive of the European Parliament and of the Council on a proportionality test before adoption of new regulation of professions is based on wideranging evidence, not only economic but also legal, including case law, and the difficulties faced by Member States in assessing the proportionality of existing regulation under Article 59 of Directive 2005/36/EC, as amended by Directive 2013/55/EU.

The proposed Directive is designed to help Member States comply with the existing law and their obligations under the EU Treaty. It does not affect the Member States’ competence in regulating professions nor does it aim to introduce a uniform standard of regulation across the EU. The proposal does not introduce any possibility for the Commission to veto the regulation of professions by Member States.

The proposal is accompanied by an extensive impact assessment which contains ample information on the reasons and justification for the proposal. As regards the specific mentioning of potential job creation, the Explanatory Memorandum to the proposal reads as follows: “(…) In terms of job creation alone, an academic study suggests around 700 000 more jobs could be created in the EU through addressing unnecessary and disproportionate regulations.”

In addition, empirical case studies aiming at assessing the impact of reforms in a number of Member States show that removing excessively restrictive regulatory burdens can improve access to professions for young graduates.

Ineffective anti-cancer drugs have recently appeared on the market
Question for written answer to the Commission by Daniel Buda (PPE) (Date : 13-12-2017 Reference : E-007713/2017)

A study by a team of public health researchers in London has shown that over half of new anti-cancer drugs in the EU have no beneficial effect on patients.

Anti-cancer drugs produced between 2009-2013 have been shown to be ineffective on cancer patients. They have not contributed to lengthening survival rates or improving patients’ quality of life.

In the period in question, 48 anti-cancer drugs obtained authorisation for sale from the European Medicines Agency, with 68 specific indications. However, 57% of these treatments were approved without undergoing any tests to show their benefits in improving patients’ survival rates or quality of life.

These drugs have given false hope to cancer sufferers and mean extra expense for them, which in most cases is beyond their means.

What action can the Commission take to monitor these cases of ineffective anti-cancer drugs and what measures does it consider necessary to prevent such cases in future?

Medicines crisis in Member States
Question for written answer to the Commission by Maria Grapini (S&D) (Date : 13-12-2017 Reference : E-007698/2017)

The issue of EU citizens’ health should be an ongoing concern for both Member States and the EU institutions.

The medicines crisis continues to cause victims in many Member States.

Health has a large element of subsidiarity and we should consider that if we are a Union then we should have some leverage to take action when there is a crisis in a Member State that cannot be resolved at national level.

Solidarity should also be shown within the EU, not only towards third countries.

What action can the Commission take to help resolve the medicines crisis that is affecting people’s lives?

Independence of EOPYY
Answer given by Mr Andriukaitis on 13.12.2017 on behalf of the Commission to question for written answer to the Commission by Maria Spyraki (PPE) (Date : 25-10-2017 Reference : E-006652/2017)

As the Honourable Member has noted in the question, the provision of health care is a Member States’ competence and takes place under the conditions established by national laws and practices. As clearly established by Article 168(7) of the Treaty on the Functioning of the European Union, the definition of the health policy and the organisation and delivery of health services and medical care are the responsibilities of the Member States. These responsibilities include the management of health services and medical care and the allocation of resources assigned for this purpose.

Notwithstanding this, if in any review mission or through any other means the Commission notes any improper or unsafe provision of health services it always draws the attention of the authorities to the extent possible.

25 million fake medicines seized in international operation
Answer given by Mr Andriukaitis on 13.12.2017 on behalf of the Commission to question for written answer to the Commission by Nuno Melo (PPE) (Date : 12-10-2017 Reference : E-006414/2017)

The Commission is aware of the annual Pangea operation coordinated by Interpol and involving the European Heads of Medicines Agencies’ Working Group of Enforcement Officers. The Commission does not have access to the findings of the investigation but receives information on the incidents of fake medicines sent by the EU competent authorities through the EU rapid alert on quality defects on medicinal products. The Commission strongly supports the Pangea initiative which has the potential to discourage the falsification of medicines. Member States are responsible for verifying that the requirements of the pharmaceutical law are fulfilled by the online and brick and mortar pharmacies to prevent the entry of falsified medicines. Since 2015, all online pharmacies or retailers legally operating in the EU are required to display a common logo which helps citizens to identify websites which are operating legally. The Commission also developed a tool kit to support Member States in their national information campaigns on the logo.

In addition, the Commission is currently setting up a verification and traceability system for medicines which will apply as of February 2019. In 2018, the Commission will also issue a report to the European Parliament and the Council which may help the Member States to identify best practices and suitable penalties (fines, criminal penalties, and administrative fines) to discourage the falsification of medicines.

Finally, the recent Communication on tackling illegal content lays down guidelines for online platforms to step up the fight against illegal content online in cooperation with national authorities, Member States and other stakeholders.

European Medicines Agency
Questions for written answer to the Commission by Patrizia Toia (S&D) and Elisabetta Gardini (PPE) (Date : 12-12-2017 References : E-007648/2017, E-007649/2017)

Press reports have indicated that the temporary headquarters for the European Medicines Agency in Amsterdam will not be ready by March 2019.

Whereas the Commission had to provide information to Member States in order for them to make an informed decision, and trusted the statements of the Netherlands committing to deliver a permanent headquarters by April 2019;

whereas these commitments will not be fulfilled, causing inconvenience, additional costs to the Agency and repercussions for citizens’ right to health, and obstacles to business continuity, which were the main criteria in the choice of location;

whereas the allocation procedure provided for an opinion of the Commission and the full decision-making power of the Council, and whereas the jurisdiction of the Member states’ representatives at the Council has no legal basis, being recognised only by a non-binding common agreement;

whereas the decision was taken by the Presidency of the Council in camera, by drawing lots, without guarantees or transparency;

The Council is asked:

– Does it still deem the technical evaluation of the Commission, provided before the allocation, to be valid?

– Does it consider that the commitments made have not been respected, and that the allocation procedure should therefore be reopened?

– Can it provide the documents on the procedures followed for the allocation, including on the method of drawing lots, in line with the principle of transparency?

Incentives to develop medicinal products
Answer given by Mr Andriukaitis on 12.12.2017 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 28-09-2017 Reference : E-006081/2017)

1. The Paediatric Report published on 26 October 2017, informs that the Commission is planning a joint evaluation of the EU regulations on orphan and paediatric medicines. The ongoing Commission study on the impact of pharmaceutical incentives, and a new study on orphan medicinal products will feed into this joint evaluation. The aim of the evaluation will be to assess whether the current EU paediatric and orphan legislations continue to deliver the expected results and innovative products for the benefit of patients in Europe.

2. Regarding the European One Health Action Plan against antimicrobial resistance (AMR), the Commission will analyse and benchmark regulatory tools and incentives. Information available through the on-going study on incentives will feed into the analyses conducted under the Action Plan. In addition, a range of push incentives including research grants, loans and inducement prizes was already implemented in the context of the AMR Action Plan.

3. The 2015 Commission Single Market Strategy undertook to explore the introduction of an SPC manufacturing waiver and update of the EU patent exemptions. The Commission published an ‘Inception Impact Assessment’ on these issues, contracted studies, and on 12 October 2017 launched an on-line public consultation. Therefore, the Commission is still in the phase of consultation and analysis.

Multi-stakeholder cooperation on paediatric oncology
Answer given by Mr Andriukaitis on 22.11.2017 on behalf of the Commission to question for written answer to the Commission by Marlene Mizzi (S&D) (Date : 04-10-2017 Reference : E-006236/2017)

In March 2017, the Commission launched a European Reference Network for paediatric cancer (PaedCan-ERN) within the framework of Directive 2011/24/EU on patients’ rights in cross-border healthcare. This European Reference Network will help to reduce inequalities in childhood cancer survival by providing high-quality, accessible and cost-effective cross-border healthcare to children and adolescents with cancer, regardless to where they live. To make specialised expertise for live-saving paediatric oncology treatments available to patients across Europe, the ERN PaedCan will create a roadmap of healthcare centres that are renowned worldwide for their expertise in treating paediatric malignancies.

The PaedCan ERN will also implement eHealth technologies and improve interoperability across different institutions (e.g. via a virtual paediatric oncology tumour board network to share expertise and advice). It will also help young patients and their families make informed choices by providing clear information regarding access, quality and safety for treatments received in another EU country.

The Commission is also in the process of establishing a new mechanism for transferring best practices between EU Member States. A new steering group on health promotion, disease prevention and management of non-communicable diseases will identify best practices from all areas of health care and public health for implementation in interested Member States.

Activities of the European Ombudsman in 2016
European Parliament resolution of 16 November 2017 on the annual report on the activities of the European Ombudsman in 2016 (2017/2126(INI)) (P8_TA -PROV(2017)0449).

The European Parliament, ….

28. Commends the Ombudsman’s work in dealing with issues of general public interest, such as fundamental rights, the safety and efficiency of medicine, the protection of the environment and health, and safeguarding against environmental risks; calls on the Ombudsman to follow up on her proposals to the European Chemicals Agency on disincentives relating to animal testing when new cosmetic products are registered on the market, and to the EPSO on the application of the principle of force majeure and the transparency of EPSO competitions;

30. Supports the Ombudsman’s role in shaping a proactive and transparent policy on the clinical trials carried out by the European Medicines Agency (EMA) and in particular the Ombudsman’s recommendations on the approval of Humira, one of the world’s best-selling drugs, which is used to treat Crohn’s disease; urges the Ombudsman to continue monitoring the EMA to ensure that it meets the highest standards of transparency and access to information on clinical trials, namely standards that are in the public interest and of value to doctors, patients and researchers;

Relocation of the European Medicines Agency
Answer given by President Juncker on 15.11.2017 on behalf of the Commission to question for written answer to the Commission by Christel Schaldemose (S&D) (Date : 21-09-2017 Reference : P-005871/2017)

Paragraph 15 of the Guidelines for Brexit negotiations of the European Council of 29 April 2017 states that “while the future location of the seats of EU agencies and facilities located in the United Kingdom is a matter for the 27 Member States to settle rapidly, arrangements should be found to facilitate their transfer”.

Furthermore, in the margins of the European Council of 22 June 2017, the Heads of State or Government of 27 Member States endorsed the procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union.

This procedure sets out six criteria which the interested Member States should address in their offer to host one or both of the Agencies. One of these criteria is the geographical spread of agencies’ seats. The deadline for submitting offers expired on 31 July 2017. The Commission has been invited to examine the submitted offers based on the six criteria agreed by the 27 Member States and to submit an assessment of the offers by 30 September 2017. On 30 September 2017, the Commission submitted its assessment of the offers to the Secretary-General of the Council.

On the basis of this assessment, it is for the 27 Member States to decide on the new locations for the two Agencies. A political discussion based on the Commission’s assessment took place in the margins of the General Affairs Council (Article 50) meeting of 17 October 2017. The 27 Member States will take a decision by vote in the margins of the General Affairs Council (Article 50) meeting of 20 November 2017. The Commission does not take part in this vote, nor does it have any other formal role in the decision-making process regarding the new locations for the two Agencies.

Importation of medicinal products from India
Answer given by Mr Andriukaitis on 13.11.2017 on behalf of the Commission to question for written answer to the Commission by Mireille D’Ornano (EFDD) (Date : 18-09-2017 Reference : E-005809/2017)

The Commission is aware of the risk that some medicinal products imported from third countries contain insufficient or falsified active ingredients. In 2011, to address this concern, strengthened rules on the importation of active substances were introduced in the EU.

According to EU legislation, active substances imported from third countries need to be accompanied by a written confirmation from the competent authority of the exporting third country confirming that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU.

Member States regularly inspect EU and non-EU manufacturing sites of finished medicinal products and their ingredients to check whether those sites meet EU standards of quality and safety. If an inspection by an EU Member State finds that an active substance manufacturing site does not comply with EU Good Manufacturing Practice (GMP) for active substances, a statement of non-compliance is issued and entered in the publicly available EudraGMDP database.

These measures, complemented with the obligation to test each production batch at import, should ensure the quality of all medicinal products (including generics) to be placed on the EU market.

Based on the above, the Commission does not foresee the need to introduce additional measures to strengthen the controls of medicinal products imported from third countries.

New headquarters for the European Banking Authority and the European Medicines Agency
Answer given on 30.10.2017 to question for written answer to the Commission by Ruža Tomašić (ECR) (Date : 04-07-2017 Reference : E-004537/2017)

The specific criteria and conditions referred to by the Honourable Member are set out in document XT 21045/17 on the procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union, endorsed on 22 June 2017 by the Heads of State or Government of 27 Member States.

All these specific criteria and conditions have to be taken into account when taking the final decision on the host countries.

Economic crisis and healthcare – assessment of health systems in the EU
Answer given by Mr Andriukaitis on 27.10.2017 on behalf of the Commission to question for written answer to the Commission by Theodoros Zagorakis (PPE) (Date : 28-08-2017 Reference : E-005291/2017)

On the basis of the Commission Communication of 4 April 2014 on effective, accessible and resilient health systems and in response Council Conclusions on the economic crisis and healthcare, the Commission developed several initiatives.

For example, in 2014 the Commission has supported the Member States in setting up an expert group on Health Systems Performance Assessment which has produced reports on quality of care and integrated care. The Commission is also supporting a European medicine price data base (EURIPID), and is working on an initiative for EU cooperation on health technology assessment. In addition, the European Pillar of Social Rights, adopted on 26 April 2017, underlines the right of everyone to access affordable healthcare.

As regards health systems’ capacities to deal with crises, the Joint Economic Policy Committee-Commission report of 2016 states that expenditure on health care and long-term care accounts for 8.5% of GDP in the EU and may increase by an additional 2 to 4 percentage points of GDP by 2060. As pointed out repeatedly in the Commission’s Annual Growth Surveys, reforms are needed to enhance the cost-effectiveness of national health systems and ensure adequate access to healthcare, thus improving national health systems’ resilience.

Petition on animal welfare and the use of horse blood for the purpose of biological research and manufacturing veterinary drugs
Notice to members of the Committee on Petitions in respect of Petition No 0133/2017 by Christa Kowerk (German) on animal welfare and the use of horse blood for the purpose of biological research and manufacturing veterinary drugs (26-10-2017, PE 610.635v01-00, PETI_CM(2017)610635).

Summary of petition: The petitioner is forwarding to the European Parliament a petition written on the online platform Avaaz.org bearing her own signature denouncing the practice of extracting blood from horses for pharmaceutical purposes. The petition claims that the European pharmaceutical industry is engaged in wide scale “industrial horse torture” and calls upon the European institutions to put a stop to this practice, also as regards the import of products derived from such practices (e.g. hormones).

Conclusion: The Commission does not currently plan to ban the import of pregnant mare serum gonadotropin. While the Commission will continue raising awareness of this issue among the stakeholders concerned and Member States, it should be noted that the EU cannot impose its animal welfare standards on non-EU countries. For imports into the EU, EU trade policy shall respect the rules of the World Trade Organization. The Commission will however continue promoting, within its remits, the development and implementation of animal welfare standards globally.

Processing of personal data and health-related innovation
Answer given by Ms Jourová on 25.10.2017 on behalf of the Commission to question for written answer to the Commission by Piernicola Pedicini (EFDD) (Date : 25-07-2017 Reference : E-005081/2017)

The rules contained in the EU General Data Protection Regulation (GDPR) for processing personal data, including genetic data, biometric data and data concerning health, will be directly applicable to controllers and processors as from 25 May 2018.

The GDPR provides in particular for the right of the individual to be informed by the controller about the purposes of the processing and about other relevant aspects such as the existence of automated decision-making, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject; the data subject is also entitled to receive information about the intention to further process personal data for other purposes than the initial ones (Articles 13 and 14 GDPR). The individual is also entitled not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her (Article 22 GDPR). Depending on the purposes of the processing and the risks for the rights of individuals, controllers must have in place appropriate technical and organisational measures to ensure that the processing is GDPR-compliant.

The Commission is working closely with Member States to achieve uniform application of the GDPR to achieve a high level of personal data protection across the EU.

New medicinal products based on dimethyl fumarate (DMF)
Answer given by Mr Andriukaitis on 20.10.2017 on behalf of the Commission to question for written answer to the Commission by Nicola Caputo (S&D) (Date : 23-08-2017 Reference : E-005241/2017)

The Commission has indeed granted marketing authorisations to several new medicines to be taken orally rather than by injection, including a dimethyl fumarate-containing medicinal product for the treatment of psoriasis.

The scientific evaluation of marketing authorisation applications for EU centrally authorised medicinal products is performed by the European Medicines Agency (EMA). EMA’s opinions are based on assessment of all available evidence and approval is recommended when the desired effects or ‘benefits’ of a medicine outweigh its undesired effects or ‘risks’. This is the case for the above mentioned product. The European public assessment reports, which contain all the information about the evaluated scientific evidence, are published on the web site of the EMA.

With regard to the dimethyl fumarate-containing product to treat psoriasis and possible occurrence of hepatotoxicity, Skilarence’s Summary of product characteristics (SmPC) notes that the medicinal product must not be used in patients who have severe problems of the digestive system, liver or kidneys. The SmPC of Tecfidera states the product “has not been studied in patients with severe renal or severe hepatic impairment and caution should, therefore, be used in these patients”; Tecfidera’s Package Leaflet warns patients to talk to their doctor before taking it if they have severe liver disease. Aubagio’s SmPC and Package Leaflet state that it must not be used in patients with severe liver disease.

Accessibility of innovative medicines for diabetics
Answer given by Mr Andriukaitis on 20.10.2017 on behalf of the Commission to question for written answer to the Commission by Nicola Caputo (S&D) (Date : 31-08-2017 Reference : E-005446/2017)

The organisation of health systems and delivery of care is the responsibility of Member States. The Commission can therefore not harmonize national legislation on access to medicines. However, the Commission recognises the importance of timely access to innovative medicines for patients and facilitates EU cooperation in different areas concerning access to medicines.

One of the initiatives is Health Technology Assessment (HTA), which assesses the added value of given health technology over and above existing ones, helping Member States to allocate national resources to effective health interventions. HTA can speed up process of market access and thus improve patient access to innovative technologies The Commission is currently preparing an initiative on strengthening EU cooperation on HTA.

The Commission supports improved exchange of information among Member States and promotes voluntary cooperation for example through the Network of competent authorities responsible for pricing and reimbursement, and through a European medicine price data base. It also supports an Organisation for Economic Co-operation and Development project on Sustainable Access to Innovative Therapies.

The Commission has mandated the Expert Panel on Effective Ways of Investing in Health to develop an Opinion on “Innovative payment models for high-cost innovative medicines”, which would assist Member States to develop policies on cost-effective use of medicines.

Vaccines
Answer given by Mr Andriukaitis on 20.09.2017 on behalf of the Commission to question for written answer to the Commission by Dubravka Šuica (PPE) (Date : 11-07-2017 Reference : E-004655/2017)

As the Commission pointed out in its answer to written question E-003863/2017, while vaccination policies are the competence of Member States, the Commission supports Member States in this area, for example by sharing information on vaccination policies within the Health Security Committee and by coordinating preparedness, assessment and outbreak management of vaccine-preventable diseases.

On 31 May 2017, the Commission held a workshop with Member States, civil society, industry and academia on vaccination which provided input for improving cooperation at EU level to counter vaccine hesitancy, address shortages and strengthen routine immunisation. Discussions also addressed issues related to the evidence-base and communication of vaccination programmes.

On the basis of Council conclusions on vaccination as an effective tool in public health and of this workshop, the Commission and Member States are currently developing a Joint Action on vaccination co-funded by the Health Programme to share best practices on national vaccination policies.

In cooperation with the European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO), the Commission is supporting Member States in the course of the European Immunisation Week, raising awareness on the importance of vaccination. In this context, the ECDC supports Member States with guidance on planning and implementing communication activities in relation to immunisation programmes to help to improve the training and education of healthcare professionals by providing them with tools for tailored communication with their patients.

Proposal for a directive on a proportionality test
Answer given by Ms Bieńkowska on 01.09.2017 on behalf of the Commission to question for written answer to the Commission by Richard Sulík (ECR) (Date : 17-07-2017 Reference : P-004909/2017)

Article 59 of the Professional Qualifications Directive introduced the mutual evaluation exercise under which Member States were asked to evaluate their existing regulations. The Commission supported Member States during this exercise by issuing a Communication, analytical grids and by providing guidance, organising workshops etc. The uneven and often insufficient outcome of this exercise made clear that a more structured and transparent approach as to how such assessments need to be made would be beneficial, especially considering the obligation imposed on Member States under Article 59 of Directive 2005/36. The newly proposed Directive is therefore a consequence of Article 59(9) of the Professional Qualifications Directive, which foresees the possibility for the Commission to make proposals for further initiatives depending on the outcome of the mutual evaluation exercise.

The newly proposed Directive on a proportionality test not only provides for clear criteria based on which a proportionality test should be performed, but also includes procedural issues, stakeholder involvement and transparency. These elements were deemed necessary to be introduced for the proper conduct of such assessments. Consequently, it was considered more appropriate to introduce these through a separate legal act. Furthermore, the Directive 2005/36/EC has been amended only recently by Directive 2013/55/EU, for which an implementation report is due in January 2019.

EMA additional staff and budget resources in 2018
Opinion of the Committee on the Environment, Public Health and Food Safety for the Committee on Budgets on the draft general budget of the European Union for the financial year 2018 (2017/2044(BUD)), Rapporteur: Adina-Ioana Vălean (PE 604.869v03-00 – ENVI_AD(2017)604869)

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Budgets, as the committee responsible, to incorporate the following suggestions into its motion for a resolution:

(12) Strongly disapproves of staff reductions in EEA (-3 posts), ECHA (-2), ECDC (-2), EFSA (-4) and EMA (-5), which, given that the tasks and duties of those agencies are growing, will almost inevitably negatively impact their work; demands that they should receive adequate human and financial resources; furthermore, is concerned that in the case of fee-funded agencies, like EMA, the staff cuts imposed in recent years have meant a reduction in staff working on tasks that are actually funded by applicants’ fees and not by the Union budget; such cuts have been carried out without taking into consideration either the additional workload created by increasing numbers of applications, or the corresponding increase in income from fees paid by applicants for the services provided which could have allowed staff increases while avoiding any impact on the Union budget

(14) Notes in particular that EMA will be facing an increased workload and further budgetary needs in 2018 as a consequence of the decision of the UK to withdraw from the Union; calls on the Commission to make available additional staff and budget resources in 2018 so as to ensure that this agency can both continue to carry out its tasks effectively and launch all required activities in preparation for its relocation in 2019; proposes therefore that EMA, in the spirit of sound financial management, be authorised to maintain a budgetary reserve to respond to unforeseen costs that may be incurred in 2018 or beyond, such as a result of unfavourable exchange rate fluctuations.

Production of antibiotics in Asia
Answer given by Mr Andriukaitis on 30.08.2017 on behalf of the Commission to question for written answer to the Commission by Jean-François Jalkh (ENF) (Date : 03-07-2017 Reference : E-004456/2017)

The Commission is aware that Asia is the world’s main producer and supplier of active pharmaceutical ingredients including antibiotics, and shares the growing concern about the development and spread of antimicrobial resistance (AMR) in the environment due to discharges of antimicrobials and their metabolites from various sources including pharmaceutical production plants. As a consequence, the Commission has launched several initiatives aimed at addressing these issues.

The Commission recently adopted its second AMR Action Plan which includes specific actions to improve knowledge about the contribution of the environment to AMR, and to explore possibilities for taking appropriate measures. This includes developing a Strategic Approach to address the risks from pharmaceuticals in the environment. The Action Plan also promotes actions and collaboration at global level. The synopsis report accompanying the Action Plan mentions that some options could relate to manufacturing effluents and to the collection of unused antimicrobials.

The existing Guidelines on Good Manufacturing Practice for active substances require that sewage, refuse, and other waste in and from factory buildings and the immediate surrounding area should be disposed of in a safe, timely and sanitary manner. Although not specifically mentioned in those guidelines, manufacturing facilities have to comply with local regulations to minimise the risk of contaminating the environment.

Proportionality test directive and specific public health needs
Answer given by Ms Bieńkowska on 28.08.2017 on behalf of the Commission to question for written answer to the Commission by Philippe Juvin (PPE) (Date : 30-05-2017 Reference : E-003590/2017)

The Commission proposal on a Directive for a proportionality test to be carried out before adoption of new regulation or introduction of amendments to any existing one, covers all requirements for access and pursuit of a regulated profession in the Member States, including also health professions.

The regulatory criteria and requirements listed in Article 6 of the proposed Directive are neutral and aim at guiding Member States in the assessment of the proportionality in the light of the case law of the Court of Justice (e.g. Case C-570/07 Blanco Perez). Such an assessment should take into account both the specificities of each profession and the public interests to be protected, such as public health.

In that respect, it is not necessary for the Commission to ring-fence specifically health professions or any other profession. The specificities of each and every profession can always be taken into account by the Member States, including the professions referred to by the Honourable Member, when regulating in a justified and proportionate manner.

Restrictions in the availability of emergency contraception in Poland
Answer given by Mr Andriukaitis on 28.08.2017 on behalf of the Commission to question for written answer to the Commission by Terry Reintke (Verts/ALE), Malin Björk (GUE/NGL), Maria Arena (S&D) (Date : 14-07-2017 Reference : E-004885/2017)

The EU pharmaceutical legislation includes derogatory provisions when it comes to contraceptives and abortifacients, namely Article 4(4) of Directive 2001/83/EC. Under those derogations, Member States may prohibit or restrict the use of such products in their territory. In accordance with Article 13(1) of Regulation (EC) 726/2004 this derogation can also be invoked for products, which have been authorised by the Commission on the basis of a scientific opinion of the European Medicines Agency.

Poland recently notified the Commission of its intention to make use of the derogation in accordance with Article 4(4) of Directive 2001/83/EC.

Research into diabetes and degeneration
Answer given by Mr Moedas on 24.08.2017 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 14-07-2017 Reference : E-004841/2017)

Diabetes research has been a priority for the Commission for many years. Most recently, Horizon 2020, the EU Framework Programme for Research and Innovation (2014-2020), has allocated over EUR 286.5 million to 160 projects in this area. Their aim is to gain a better understanding of the very complex pathophysiology of diabetes and its complications and to deliver personalised health and care.

Regarding complications of diabetes affecting the eye, the EU is supporting nine projects with an overall budget of EUR 11.7 million addressing retinopathy and age-related macular degeneration. These projects cover the whole healthcare continuum from aetiology to diagnosis and treatment, to public health and prevention.

Horizon 2020 will provide further opportunities for funding research on diabetes through the remaining calls for proposals. Information regarding these opportunities will be made available on the Research and Innovation Participant Portal.

Combating the sale of false medicines over the Internet
Answer given by Mr Andriukaitis on 14.08.2017 on behalf of the Commission to question for written answer to the Commission by Rachida Dati (PPE) (Date : 27-06-2017 Reference : E-004286/2017)

The Commission is aware of the risks of falsified medicines through internet sales. Since 1 July 2015, a common EU-wide logo is mandatory for all online pharmacies or retailers legally operating in the EU. This makes it easier to distinguish between legal and illegal online pharmacies throughout the EU. The Commission led a proactive communication campaign for the introduction of the EU common logo to identify legal online pharmacies. This included a Commission toolbox in all EU languages that was shared with Member States in order to ensure that a consistent message is given to EU citizens.

The communication material explains the legal framework for online sales in the EU. It clarifies that Member States may impose certain conditions and limitations, e.g. by not allowing online sale of prescription medicines. It warns that a legally operating EU online retailer, if authorised or entitled to supply a prescription medicine, will always require a prescription. It stresses that compliance with this legal requirement is one of the guarantees that the medicine bought online is authentic and safe.

The Commission website remains a key tool to keep citizens informed of the ongoing work to address counterfeit and falsified medicines.

The Commission does not propose any additional measures at this time to combat the sale of falsified medicines over the internet.

Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance
Answer given by Mr Andriukaitis on 08.08.2017 on behalf of the Commission to question for written answer to the Commission by José Inácio Faria (PPE) (Date : 09-06-2017 Reference : E-003872/2017)

The final report on the off-label use of medicinal products published on 28 February 2017 provides a description of practices across Member States, of the positions of all parties, and it investigates the balance between benefits and risks of off-label use for patients.

The report was discussed at the Commission Expert Group on Safe and Timely Access to Medicines for patients (STAMP) on 14 March 2017. Given that off-label prescribing of authorised medicinal products is not regulated by EU law and remains in most Member States the responsibility of the prescribing physician, the Expert Group considered that the options identified in the report relevant to collaborative action could be directly led by Member States. The Expert Group will continue exploring with relevant stakeholders the possibilities for repurposing, one of the options identified in the report to move from “off” to “on” label of medicinal products.

The Commission has no information on investigations by Member States on possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labelled for single use. Nevertheless, Regulation 2017/745 on Medical Devices sets up strict conditions under which reprocessing of single use devices can take place.

As of 1 July 2015, in line with Directive 2001/83/EC and Implementing Regulation (EU) 699/2014, any legally operating on-line retailer, authorised in a Member State of its establishment to sell medicinal products on the internet, should display the logo on every webpage offering medicinal products to sell. The Commission is gathering information on the progress of implementation of these requirements and on the national information campaigns on the logo and danger of falsified medicines.

Proposal for a directive on the proportionality test and the subsidiarity principle
Answer given by Ms Bieńkowska on 04.08.2017 on behalf of the Commission to question for written answer to the Commission by Franck Proust (PPE) (Date : 29-05-2017 Reference : E-003554/2017)

1. The Commission takes the subsidiarity concerns that have been expressed in the reasoned opinions of the French Sénat and Assemblée Nationale on the proposal for a Directive of the European Parliament and of the Council on a proportionality test before adoption of new regulation of professions seriously and has provided written replies.

2. In the view of the Commission, the proposal fully respects the principle of subsidiarity. The legal bases (Articles 46, 53(1) and 62 of the Treaty on the Functioning of the EU) allow for coordinating measures to reach a certain degree of harmonisation of national regulation regarding access to or exercise of professions. In respect of some professions, this has been achieved already at EU level. The current proposal does not aim at such a harmonisation of rules, but merely coordinates how Member States should assess whether requirements that are to be adopted are in line with the principle of proportionality. It does not in any way prejudge the outcome of the national legislative process. The objective of the proposed Directive is not to regulate or deregulate professions in the health, tourism or other sectors of the economy – this remains a national prerogative. It rather aims at ensuring coherent and consistent compliance by all Member States with existing obligations under EU law that national professional requirements are justified, suitable and necessary.

Industrial policy strategy: health sector
Answer given by Ms Bieńkowska on 03.08.2017 on behalf of the Commission to question for written answer to the Commission by Françoise Grossetête (PPE) (Date : 09-06-2017 Reference : E-003859/2017)

The Commission supports the transition to a modern, clean and fair economy, with a comprehensive and results-oriented approach across different policy areas, providing sector-specific solutions when needed.

With regard to the pharmaceutical industry, the Commission is currently conducting a number of initiatives aiming to improve the competitiveness and innovation framework, for example in respect of activities related to the Transparency Directive and the committee established under that directive.

The Commission has acknowledged the importance of intellectual property protection for the pharmaceutical sector and included a package of dedicated measures in the 2015 Single Market Strategy. In that context, the Commission has launched a study analysing the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products, in response to the call by the Council in 2016. The study is being carried out in the course of 2017.

Finally, the Commission will organise another multi-stakeholder workshop as a follow-up to the Process on Corporate Responsibility in the Field of Pharmaceuticals, bringing together Member States, healthcare professionals, patients, and industry to discuss matters such as pricing and reimbursement.

Rental contracts without early termination clauses
Answer given by President Juncker on 02.08.2017 on behalf of the Commission to question for written answer to the Commission by Olaf Stuger (ENF) (Date : 25-04-2017 Reference : E-002901/2017)

1. The rental contracts of the EU agencies vary across agencies and over time, depending on local real estate markets, national applicable rules and related costs (including for break out clauses). In addition, the conditions in which agencies operate differ greatly not only from one Member State to another, but sometimes within the same host State. As long as the seat agreements are negotiated on a case-by-case basis in bilateral discussions, it is difficult to ensure that agencies benefit from a common and most favourable set of conditions.

2. As regards the bearing of the costs, point 26 of the negotiation directives adopted by the Council states that ‘the United Kingdom should fully cover the specific costs related to the withdrawal process such as the relocation of the agencies or other Union bodies’. The final budgetary implications of the withdrawal agreement under Article 50 of the TFEU will be clarified in the course of the Brexit negotiations.

3. By virtue of Article 341 TFEU, the seat of EU institutions shall be determined by agreement of the governments of the Member States. Similar rules apply for the determination of the seats of EU Agencies. As it is the case in the Member States, where even without specific reference in their Constitutions or laws, national agencies and bodies are established in the territory of the concerned Member States, EU agencies and bodies have to have their seat in the European Union.

Moreover, the common agreement of the governments of the Member States which determine the seats of EU Agencies refer to concerned Member States, which indicates that the seat of EU Agencies can only be located in the Member States.

Need to establish a European agency in Cyprus
Answer given by President Juncker on 31.07.2017 on behalf of the Commission to question for written answer to the Commission by Lefteris Christoforou (PPE) (Date : 09-06-2017 Reference : E-003854/2017)

According to Article 341 of the Treaty on the Functioning of the European Union, the seat of the institutions of the Union shall be determined by common accord of the governments of the Member States. The same principle applies by analogy to the seat of EU decentralised agencies.

On 29 April 2017, the European Council (Article 50) adopted guidelines following the United Kingdom’s notification under Article 50 of the Treaty on European Union, which confirm that the seats of EU agencies and facilities located in the United Kingdom should be relocated and that this is a matter for the 27 Member States to settle rapidly.

On 22 June 2017, in the margins of the European Council (Article 50) meeting, the Heads of State or Government of 27 Member States endorsed the Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union.

Shortages of medicines and Greek National Health Service Organisation debts
Answer given by Mr Moscovici on 28.07.2017 on behalf of the Commission to question for written answer to the Commission by Maria Spyraki (PPE) (Date : 31-03-2017 Reference : E-002438/2017)

According to Article 168(7) of the Treaty on the Functioning of the European Union, it is foremost for Member States to decide on how to ensure access to healthcare for their populations and the Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care.

The Commission supports the efforts of the Greek Ministry of Health to enhance the efficiency and effectiveness of the Greek National Health System as well as the quality and accessibility of public health care in order to fully meet the health needs of the population but also to ensure sustainability.

Amongst structural measures specific to the health care sector, the Commission supports the authorities in the broader goal of elimination of arrears and formulation of strategies to manage operations in compliance with the provisions of the Late Payment Directive. The authorities committed to both of these goals, which feature in the Memorandum of Understanding under the stability support programme as per the Council Implementing Decision (EU) 2015/1182 under Regulation 472/2013.

This includes ensuring a regular flow of payments for current expenditure, implementing procedures to monitor average payment delays,while at the same time working to reduce and eliminate the back log accumulated from the past, prior to the merger of social security funds into the current single insurer EOPYY.

Implications of new pharmaceuticals agreement for cancer patients in Greece
Answer given by Mr Andriukaitis on 27.07.2017 on behalf of the Commission to question for written answer to the Commission by Lampros Fountoulis (NI) (Date : 27-06-2017 Reference : P-004268/2017)

The Commission has limited competence to deal with specific situations in the Member States as regards health policy, health care and the organisation of health services.

As the Commission pointed out in its answer to the written question E-003237/2017, which also dealt with the provisions of the Law in question and was raised by the Honorable Member, “As medicinal products have different benefits and costs, the Health authorities of Member States need to carefully decide on reimbursement to ensure good value to the health system in general and to patients. To support the rationalisation of pharmaceutical expenditure, while guaranteeing full access, the Greek authorities revised the criteria to introduce innovative drugs into the list of publicly reimbursed ones.

New criteria have been designed to improve on the shortcomings of the previous method and allow for internal capacity building in the area of Health Technology Assessment (HTA). The Commission through the Structural Reform Support Service together with the World Health Organisation are assisting Greece to build this capacity. In the meantime, the institutions, as part of the MoU implementation agreed with the Greek authorities that these would take an informed decision based on the judgements reached following HTA processes in six Member States. The choice of six Member States was the result of a sensitivity analysis and ensures objectivity. Although this may prolong slightly the time for a decision to be taken in Greece, it will ensure the right balance between supporting patients’ access whilst ensuring sustainability of the health system.”

Delays in clinical investigations into medicines
Answer given by Mr Andriukaitis on 27.07.2017 on behalf of the Commission to question for written answer to the Commission by Maria Spyraki (PPE) (Date : 25-05-2017 Reference : E-003525/2017)

For collaborative projects focused on pharmaceutical research under the EU Framework Programme for Research and Innovation Horizon 2020 Societal Challenge n°1 (Health, Demographic Change and Wellbeing), after a preliminary ad-hoc analysis, Greece currently holds the 16th rank among the EU Member States. For the projects funded under the 2nd Innovative Medicines Initiative (IMI2), Greece currently holds the 19th rank (it held the 13th rank under the previous partnership, IMI1).

Regulation (EU) No 536/2014 on Clinical Trials, which sets streamlined procedures and strict timelines for the assessment of clinical trials applications, will be directly applicable in all Member States of the EU and will replace current national legislation adopted in order to transpose Directive 2001/20/EC. The entry into application of the Clinical Trials Regulation is linked to the full functionality of the EU Clinical Trials Portal and Database, developed by the European Medicines Agency. The Commission has not assessed the compliance of Article 78 of the Greek law No 4472/2017 with the Clinical Trials Regulation since a Regulation is directly applicable in Member States. In any case, the Clinical Trials Regulation does not set the timelines and the procedures for the authorisation to place a new medicine on the market.

Relocation of the European Medicines Agency headquarters after the UK’s decision to trigger Article 50 of the Treaty on European Union
Answer given by President Juncker on 26.07.2017 on behalf of the Commission to question for written answer to the Commission by Andrey Novakov (PPE) (Date : 02-06-2017 Reference : P-003713/2017)

1+2. The Commission would refer the Honourable Member to the Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority, endorsed by the Heads of State or Government of 27 Member States in the margins of the European Council (Article 50) held on 22 June 2017.

3. As regards the bearing of the costs of the relocation, point III.2 of the Directives for the negotiation of an agreement with the United Kingdom states that “the United Kingdom should fully cover the specific costs related to the withdrawal process such as the relocation of the agencies or other Union bodies”. No relevant estimate of the cost of the relocation can be made at this time because essential factors remain to be established.

Difficult to use medication packaging
Answer given by Mr Andriukaitis on 13.07.2017 on behalf of the Commission to question for written answer to the Commission by Merja Kyllönen (GUE/NGL) (Date : 16-05-2017 Reference : E-003363/2017)

With reference to the Honourable Members’ question, it should be noted that in accordance with the pharmaceutical legislation, a marketing authorisation for a medicinal product granted either by the Commission for the entire EU or by a Member State for its own territory, also includes the assessment and approval of its proposed packaging.

The Commission is aware of the problem encountered by older patients in opening medicines’ containers or removing pills from blister packs. The European Medicine’s Agency (EMA) has a Geriatric Medicines Strategy in place since 2011, and one of the first areas of action within that strategy is the suitability of packaging and formulations of medicines to be used by the older population.

The EMA Quality Working Party’s paper concerning quality aspects of medicines for elderly patients looks at different strategies to help the elderly, e.g. using adapted container closure systems with a requirement to test ease of opening, providing additional instructions on the product label and specific and dedicated dose dispensers to avoid medication errors to older people. In May 2017, the EMA’s Committee for Medicinal Products for Human Use adopted this document and it will soon be published for public consultation. Further information can be found on the EMA webpage on Medicines for older people.

Access to new medicines in Greece
Answer given by Mr Andriukaitis on 11.07.2017 on behalf of the Commission to question for written answer to the Commission by Eva Kaili (S&D) (Date : 10-05-2017 Reference : E-003237/2017)

As medicinal products have different benefits and costs, the Health authorities of Member States need to carefully decide on reimbursement to ensure good value to the health system in general and to patients. To support the rationalisation of pharmaceutical expenditure, while guaranteeing full access, the Greek authorities revised the criteria to introduce innovative drugs into the list of publicly reimbursed ones.

New criteria have been designed to improve on the shortcomings of the previous method and allow for internal capacity building in the area of Health Technology Assessment (HTA). The Commission through the Structural Reform Support Service together with the World Health Organisation are assisting Greece to build this capacity.

In the meantime, it was agreed that the Greek authorities would take an informed decision based on the judgments reached following HTA processes in six Member States. The choice of six Member States was the result of a sensitivity analysis and ensures objectivity. Although this may prolong slightly the time for a decision to be taken in Greece, it will ensure the right balance between supporting patients’ access whilst ensuring sustainability of the health system.

In addition, the authorities are taking measures to reduce pharmaceutical prices and incentivising generics penetration, such as incentives to pharmacists to dispense cost-effective generics.

Together with this they revised the rebates system, simplifying it and rendering it transparent. Merging the previous components into one single formula increases efficiency of collection and facilitates providers with more predictable net profits.

Pharmacovigilance and public disclosure of information concerning the safety of the hexavalent vaccine Infanrix Hexa
Answer given by Mr Andriukaitis on 07.07.2017 on behalf of the Commission to question for written answer to the Commission by Piernicola Pedicini (EFDD) (Date : 02-06-2017 Reference : P-003716/2017)

The benefit/risk profile of Infanrix Hexa for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b is considered to be favourable by the European Medicines Agency (EMA).

The Commission is not aware of any recent meta-analysis. It should be noted that any reports received by the Italian Medicines Agency are also transmitted to an EU safety database called EudraVigilance (the system for managing and analysing information on suspected adverse reaction to medicines). EMA performs regular signal detection activities using this data. Moreover, risk-benefit evaluation is conducted during periodic safety assessments of authorised products. The latest evaluation of Infanrix Hexa ended in June 2015 and concluded that the data are globally reassuring with no clear indication of a signal for sudden deaths. In addition to the routine pharmacovigilance activities performed by the marketing authorisation holder (MAH), the Pharmacovigilance Risk Assessment Committee of EMA requested the MAH to continue monitoring sudden death cases and to update the literature review and the observed versus expected analyses (including sensitivity analyses). The next periodic assessment is due in January 2018. So far, no valid signal was identified; therefore further research (such as e.g. a meta-analysis) has not been required.

Supplementary Protection Certificate (SPC)
Answer given by Ms Bieńkowska on 05.07.2017 on behalf of the Commission to question for written answer to the Commission by Mairead McGuinness (PPE) (Date : 10-04-2017 Reference : E-002602/2017)

The Commission Communication of October 2015 on the Single Market Strategy announced a package of possible measures in relation to Supplementary Protection Certificates (SPCs), including a possible initiative on an SPC manufacturing waiver. The Commission believes that this package of measures would result in an important modernisation of SPC rules and facilitate further investment in research and innovation in the fields concerned.

In line with the Commission’s better regulation rules, the preparatory work regarding the evaluation and the optimisation of SPC legislation has started. An inception impact assessment was published on 16 February 2017. A number of studies are now under development and an online public consultation will soon be launched.

The Commission is very conscious of the position of the European Parliament regarding the SPC manufacturing waiver, which is referenced in the above-mentioned inception impact assessment. It has analysed several studies related to the SPC waiver and commissioned an economic study on the potential impact of a SPC manufacturing waiver in the EU, which has now been concluded. The Commission intends to publish this study together with the launch of the online public consultation.

Against this background, the Commission is still analysing the functioning of the SPC system, and it is thus too early at this stage to prejudge whether EU legislation will be revised.

Access to affordable and effective cancer treatments
Answer given by Mr Andriukaitis on 04.07.2017 on behalf of the Commission to question for written answer to the Commission by Lola Sánchez Caldentey (GUE/NGL) (Date : 03-05-2017 Reference : E-003103/2017)

The EU and its Member States did not oppose the proposal made during informal consultations to have an additional paragraph addressing Research and Development and access to medicines aspects in the draft resolution on cancer prevention and control, to be adopted by the 70th World Health Assembly. In these informal consultations, the EU and its Member States took a constructive approach aiming at finding a consensus on this paragraph, taking into account the various views expressed by World Health Organization Member States and supported the final agreement found on this paragraph.

The World Health Assembly resolution was agreed by the EU and the Member States representatives in Geneva, and is in line with agreed EU policies relevant to this resolution, including the EU global health policy, the specific programme implementing Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020) and the Communication from the Commission on action against cancer: European partnership.

Termination of the lease at the European Medicines Agency
Answer given by Mr Oettinger on 28.06.2017 on behalf of the Commission to question for written answer to the Commission by Mireille D’Ornano (ENF) (Date : 05-05-2017 Reference : E-003172/2017)

1. The rental contracts for the Brussels buildings usually do not foresee early termination clauses, as this allows obtaining better contractual conditions. In Luxembourg, lease contracts with private landlords usually do contain a termination clause, when the lessee is obliged to leave by virtue of a decision taken on the basis of Article 341 of the Treaty on the Functioning of the European Union (TFEU). Otherwise, both in Brussels and Luxembourg it is possible to transfer the lease to another EU body or agency without the Landlord’s consent or to transfer the lease to third parties subject to the agreement of the lessor.

Eleven of the buildings hosting the Commission Representations are owned by the EU; in most cases, the rental contracts of the Representations in the Member States allow for early termination.

2,3. The rental contracts of the EU agencies are concluded between the agencies and the host states on a case by case basis in bilateral discussions. They vary therefore across agencies and over time. For more information on individual contracts, the Honourable Member may therefore wish to contact the agencies directly.

Rises in prices of existing medicines on the medicines market
Answer given by Ms Bieńkowska on 26.06.2017 on behalf of the Commission to question for written answer to the Commission by Gerben-Jan Gerbrandy (ALDE) (Date : 24-03-2017 Reference : E-002037/2017)

Measures regulating the prices of medicines and the organisation of the health systems as well as the delivery of care fall under the responsibility of Member States (in line with Article 168 of the Treaty on the Functioning of the European Union).

Given the Commission’s limited role in this field, it encourages Member States to cooperate so as to ensure access to medicines and improve the sustainability of pharmaceutical expenditure, in line with the Commission Communication on effective, accessible and resilient health systems.

The only EU legislation dealing with pricing/reimbursement of medicinal products is the Transparency Directive on the processing of a Member State’s decision regarding the pricing/reimbursement of a medicine, but not the actual price or reimbursement level. With regard to the recording of prices set by Member States, the Commission only supports the “Euripid database project” which is a voluntary and Member States’ driven initiative.

The Council recently called on the Member States to strengthen cost-effective use, availability, accessibility and affordability of medicines by, inter alia, promoting public procurement and the role of generics and biosimilars, appropriate price-control policies, and a rational use of medicines.

Tackling counterfeit medicines
Answer given by Mr Andriukaitis on 21.06.2017 on behalf of the Commission to question for written answer to the Commission by Dominique Bilde (ENF) (Date : 18-04-2017 Reference : E-002776/2017)

1. As the Commission pointed out in its answer to written question E-008233/2016, the Falsified Medicines Directive introduces stricter rules to improve the traceability of medicinal products to ensure that medicines are safe and that the trade in medicines is rigorously controlled. The Directive primarily aims at addressing the problem of falsified medicines in the legal supply chain, and may indirectly help to tackle the infringement of Intellectual Property Rights (IPR), i.e. the problem of counterfeit medicines. The new measures include:

– Obligatory safety features on the outer packaging of the medicines;
– A common, EU-wide logo to identify legal online pharmacies, to make it easier to distinguish between legal and illegal online pharmacies throughout the EU.

The Commission is working intensively with the Member States through an expert group to ensure the smooth implementation of the safety features as of February 2019. The Commission will also continue to work with customs authorities, international partners and industry to ensure a high level of protection for IPRs in the EU. International cooperation is also an essential component of the EU’s strategy for the effective enforcement of IPR. Furthermore, the Commission is finalising an evaluation of the intellectual property rights (IPR) Enforcement Directive which is also looking at the functioning of the enforcement framework for IPR for medicines.

2. The Commission maintains its website as a tool to keep citizens informed of the ongoing work to continue to address counterfeit and falsified medicines and led a proactive communication campaign for the introduction of the EU common logo to identify legal online pharmacies.

Pricing and accessibility of medicines
Answer given by Mr Andriukaitis on 21.06.2017 on behalf of the Commission to question for written answer to the Commission by Roberta Metsola (PPE) (Date : 03-05-2017 Reference : E-003085/2017)

The organisation of health systems and delivery of care as well as the cost containment measures in the area of medicine are the responsibility of Member States.

The Commission is supporting improved exchange of information among Member States and promoting their cooperation on a voluntary basis for example through the Network of competent authorities responsible for pricing and reimbursement, by supporting a European medicine price data base focusing on the appropriate use of current data sets of product prices and implementing effective application of reference pricing to participating Member States and by supporting a Project on Sustainable Access to Innovative Therapies.

To respond to a call by the Council in 2016, the Commission has commissioned a study to analyse the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products. The study will be carried out in the course of 2017.

The Commission is working on an initiative to strengthen EU cooperation on health technology assessment. Finally, the Commission has also mandated the Expert Panel on Effective Ways of Investing in Health to develop an Opinion on “Innovative payment models for high-cost innovative medicines”, which would assist Member States to develop policies on cost-effective use of medicines.

EMA conduct and pharmacovigilance
Answer given by Mr Andriukaitis on 21.06.2017 on behalf of the Commission to question for written answer to the Commission by Piernicola Pedicini (EFDD), Laura Agea (EFDD), Rosa D’Amato (EFDD), Eleonora Evi (EFDD), Laura Ferrara (EFDD), Daniela Aiuto (EFDD), Dario Tamburrano (EFDD), Ignazio Corrao (EFDD) (Date : 26-04-2017 Reference : E-002925/2017)

EU legislation relating to medicinal products for human use relies on the scientific assessment performed by the scientific committees of the European Medicines Agency (EMA) for its decision making process. In the case of the Human papillomavirus (HPV) vaccines review, in particular the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) were involved. Patients’ representatives were also extensively involved during the evaluation so that scientific experts could understand the views of those affected by the two conditions under assessment. Extensive measures are in place, including rules on handling potential conflicts of interests of scientific committee members, to ensure that the committees reach their scientific conclusions in an impartial way without any undue outside pressure particularly while the procedure is ongoing. Once the procedure is completed, a summary of the scientific recommendation enters the public domain. This published assessment report (European public assessment reports) contains a comprehensive summary of the data assessed.

Further explanation regarding the EMA review process is publicly available in the EMA’s response to the questions raised by the Nordic Cochrane Centre.

After a marketing authorisation is granted, medicines in the EU, including the HPV vaccines, are subject to a post-marketing surveillance. New emerging safety information including pharmacovigilance reports and published studies, regardless of their origin, are appropriately considered. The pharmacovigilance reports on suspected adverse drug reactions of all centrally authorised medicines are collected in the EU centralised database.

Administration of antidepressants to children and adolescents and pharmacovigilance in the EU
Answer given by Mr Andriukaitis on 21.06.2017 on behalf of the Commission to question for written answer to the Commission by Piernicola Pedicini (EFDD) (Date : 26-04-2017 Reference : E-002920/2017)

In accordance with Article 168(7) of the Treaty of the Functioning of the European Union Member States are responsible for the organisation and delivery of health services and medical care, including prescriptions for medicinal products.

The Commission supports Member States through the governmental expert group on mental health and well-being as a forum to exchange information and best practices on mental health, where issues such as the use of medicinal products could be discussed.

There are no activities under way or planned to monitor specific treatment for children or teenagers.

More generally, the Commission supports Member States in their efforts to review their mental health policies and share experiences in improving policy efficiency and effectiveness on the basis of the European Framework for Action on Mental Health and Wellbeing.

In addition, the EU-Compass for Action on Mental Health and Well-being provides a forum to report progress and exchange good practices in areas such as prevention of depression and suicide, mental health at work and in schools, e-health and access to mental health care.

Pharmaceutical law in Poland
Answer given by Ms Bieńkowska on 19.06.2017 on behalf of the Commission to question for written answer to the Commission by Alexander Graf Lambsdorff (ALDE) (Date : 01-03-2017 Reference : P-001382/2017)

The Commission is aware of the legislation mentioned by the Honourable Member and has been in dialogue with the Polish authorities on this issue. As mentioned in the replies to written questions E-007113/2016 and P-002868/2016, the Commission also follows developments in other Member States and has engaged in relevant dialogues. Given the confidential nature of such dialogues, the Commission cannot comment on the cases under assessment.

As stated in the replies to written questions P-002868/2016 and P-008962/2016, Member States are entitled to take restrictive measures to address these shortages, provided that the measures are necessary for the protection of health and life of humans. Such restrictions must be appropriate for securing the attainment of the objective pursued and must not go beyond what is necessary in order to attain it. A proportionality assessment is always undertaken in respect of the situation in a particular Member State and in the light of the justification provided.

Investigations into multinational Novartis’s illegal practices
Answer given by Mr Avramopoulos on 19.06.2017 on behalf of the Commission to question for written answer to the Commission by Stelios Kouloglou (GUE/NGL) (Date : 05-01-2017 Reference : E-000040/2017) and question for written answer to the Commission by Nikolaos Chountis (GUE/NGL) (Date : 02-02-2017 Reference : E-000767/2017)

1. It is for Member States to investigate specific allegations of bribery of doctors by pharmaceutical companies. The Commission has prioritised the healthcare sector in its anti-corruption experience sharing programme, including a workshop for national experts held in Rome in November 2015. In addition, the Commission will publish in 2017 an update of a research study first carried out in 2013 on corruption in the healthcare sector, including risks in relations between doctors and pharmaceutical companies. The Commission also supports relevant work at the European Partners against Corruption (EPAC) – European contact-point network against corruption (EACN).

The fight against corruption is part of structural reforms envisaged in Greece’s economic adjustment programme. The programme monitors the implementation of a national strategy against corruption, taking into consideration particular needs in high risk sectors such as national health services. For these sectors, specific strategies are designed with technical assistance from the Organisation for Economic Co-operation and Development (OECD).

2. The Commission fully supports the objective of protecting whistleblowers against retaliation and has taken steps to protect whistleblowers in EU sector-specific legislation, ranging from audit and money laundering to trade secrets protection, market abuse, and other instruments regulating financial services. With a view to strengthening the protection of whistleblowers, the Commission is assessing the need, legal feasibility and scope for horizontal or further sector-specific action at EU level, while respecting the principle of subsidiarity. An impact assessment study is being carried out and a public consultation was launched in March 2017.

3. The European Anti-Fraud Office (OLAF) has competence to investigate alleged misuse of, or damage to the EU budget. Any suspicion of misuse of EU funds by pharmaceutical or medical companies should therefore be referred to the Office. OLAF does not generally comment on cases it may or may not be investigating, to protect the confidentiality of investigations and to ensure respect for personal data and procedural rights.

Escalation in the deregulation of the market in pharmaceutical products
Answer given by Ms Bieńkowska on 15.06.2017 on behalf of the Commission to question for written answer to the Commission by Sotirios Zarianopoulos (NI) (Date : 14-02-2017 Reference : E-000991/2017)

The Euro Summit conclusions of 12 July 2015 confirmed that the Greek authorities had offered to abolish the provision that the ownership of a pharmacy should be limited to pharmacists only. This measure follows a recommendation by the Organization for Economic Cooperation and Development (OECD) and is intended to enhance competition and improve efficiency. However, the Greek authorities are still free to regulate pharmacy services in a way that takes into account public health considerations, as is the case in other Member States where the ownership of pharmacies is not restricted.

In 2016 the Greek legislator adopted the Joint Ministerial Decision No 36277 which carries out the commitment made in 2015 and which states that pharmacy licenses can be granted to non-pharmacists. According to the Decision, pharmacies owned by non-pharmacists are required to take the legal form of a Limited Liability Company (LLC). However, such pharmacies owned by non-pharmacists have to be operated by qualified pharmacists who should participate in the shareholder structure of the above-mentioned LLC as a partner with at least a 20 % share in the capital.

The Commission does not have any evidence that the new law has led to massive unemployment under pharmacists nor that the measure has endangered public health.

Procedure for financing innovative medicines
Answer given by Mr Andriukaitis on 15.06.2017 on behalf of the Commission to question for written answer to the Commission by Maria Spyraki (PPE) (Date : 31-03-2017 Reference : E-002437/2017)

According to Article 168 of the Treaty on the Functioning of the European Union, the definition of the health policy and the organisation and delivery of health service and medical care are the responsibility of the Member States, including pricing and reimbursement decisions. However the Commission recognises the importance of timely access to innovative medicines for patients and facilitates EU cooperation in different areas concerning access to medicines.

One of the initiatives is Health Technology Assessment (HTA), which assesses the added value of given health technology over and above existing ones, helping Member States to allocate national resources to effective health interventions. The Commission launched an initiative on strengthening EU cooperation on HTA which aims at reducing discrepancies of procedures and duplication of efforts for HTA bodies and industry, discrepancies in HTA methodologies, and ensuring uptake of work jointly produced into national HTA activities.

The Commission supports the Greek authorities, in the context of the dialogue within the Memorandum of Understanding to cooperate and exchange information, experience and best practices with other Member States that carry out these assessments in order to increase the cost-effectiveness of public expenditure for health care. Increased cooperation will help Greek authorities in making decisions for their health system that are evidence based and contribute to the development of an effective, efficient, resilient and sustainable health sector.

Psychosomatics and SDG 3
Answer given by Mr Andriukaitis on 15.06.2017 on behalf of the Commission to question for written answer to the Commission by Claudiu Ciprian Tănăsescu (S&D) (Date : 27-04-2017 Reference : E-002969/2017)

The Commission supports the implementation of all the United Nations Sustainable Development Goals. Goal 3 to “ensure healthy lifes and promote well-being for all” includes a target on promoting mental health and well being.

The following are examples of some key Commission activity strands which mainstream a holistic approach to patients:

– Support through the 3rd Health Programme for a project “Supporting Member States in mainstreaming health promotion and disease prevention in health and educational settings”;
– Collection of good practices in the field of health promotion by the joint action on chronic diseases and healthy ageing (CHRODIS);
– Two pilot projects, funded by the European Parliament, are promoting patient empowerment and self-care;
– The European Framework for Action on Mental Health and Well-being, which was the result of a cooperation of 25 Member States, underlines the need for a mental health in all policies approach and addresses mental health in schools, at work, prevention of depression and suicide and access to mental health care in a holistic way;
– The European Guidelines on Quality Improvement in Comprehensive cancer control contains recommendations in person centered approach and psychosocial rehabilitation.

Through the Horizon 2020 programme, the Commission supports health research based on a holistic, patient-centred approach that includes research on mental health and on its impact on physical disorders. Horizon 2020 also supports public health research on effective promotion of mental well-being and resilience.

EU action to help Europeans age in good health
Answer given by Mr Andriukaitis on 14.06.2017 on behalf of the Commission to question for written answer to the Commission by Frédérique Ries (ALDE) (Date : 31-03-2017 Reference : E-002348/2017)

The organisation of health systems and delivery of care are Member States’ responsibility, including the measures in the area of use of medicines by patients.

The Commission is co-financing the project ‘Simpathy’ which aims at developing ways to improve the rational use of medicines in the context of multiple treatments (polypharmacy) and an action group under the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) is focusing on adherence to treatment.

Regarding safe use of medicines, the Commission has also funded several projects through its research programme. For example the ‘Monitoring Medicines’ project in the area of medicine-related patient harm and consumer reporting of adverse events of medicines resulted in practical guidelines available at the World Health Organization website. There is currently a specific focus on projects developing and validating new digital solutions which can contribute to healthy ageing, including on the issue of medications use.

EIP on AHA partners remain committed to the goal of increasing average healthy life years in Europe given the decline in the healthy life years expectancy registered between 2010 and 2014. Further measures to harness the potential of digital innovation to support better treatment, diagnosis and prevention of diseases, notably chronic diseases have been announced by the Commission in the context of the Digital Single Market mid-term review.

EU’s position on the UN High-Level Panel on Access to Medicines at WIPO
Answer given by Ms Bieńkowska on 08.06.2017 on behalf of the Commission to question for written answer to the Commission by Lola Sánchez Caldentey (GUE/NGL) (Date : 02-02-2017 Reference : E-000795/2017)

The Standing Committee on the Law of Patents (SCP) of the World Intellectual Property Organization (WIPO) is a committee of WIPO Member States’ experts that meets twice per year to discuss patent related issues. There are several issues on the agenda of the SCP.

The nature of the discussions remains at the level of an exchange of views and best practices. The Commission does not have an authorisation to open negotiations on any of the issues under discussion at the SCP and there is no consensus amongst the WIPO members as to the desirability to engage in such negotiations at this stage. If any of the current discussions were to turn into negotiations and the Commission received an authorisation from the Council to engage in them, the Commission would ensure full information of the European Parliament in accordance with the Framework Agreement on relations between the European Parliament and the Commission.

The Commission is in contact with stakeholders on a regular basis, also prior to SCP discussions, and coordinates with Member States interventions at the SCP in view of the fact that the current discussions consist of an exchange of views and best practices.

In this context, the Commission welcomes the view on the High Level Panel report taken by the European Parliament in paragraph 53 of its own-initiative Resolution of 2 March 2017 on EU options for improving access to medicines.

Paediatric medicines
Answer given by Mr Andriukaitis on 01.06.2017 on behalf of the Commission to question for written answer to the Commission by Enrico Gasbarra (S&D) (Date : 21-03-2017 Reference : E-001884/2017)

The Commission is currently working on a second report to the European Parliament and Council on the Paediatric Regulation, which will be delivered in 2017. A public consultation to gather feedback and a study with a specific focus on the reward system provided by the regulation and its economic impact will inform the report.

The Commission is confident that this will lead to a comprehensive picture about the strengths and weaknesses of the regulation.

The questions raised by the Honourable Member mirror the calls of a recent Resolution of the European Parliament on paediatric medicines. In this regard, several obstacles to innovation are already being addressed; the new legal provisions on clinical trials will facilitate the conduct of cross-border trials in the field of paediatric medicines; and under the ‘Innovative Medicines Initiative 2’ (IMI2), the creation of a large pan-European paediatric network should facilitate the development and availability of new medicinal products and other therapies.

In the area of rare diseases, of which many are of genetic nature and become clinically evident during childhood, several calls have been carried out or are ongoing.

Additional opportunities for research will be created by future European Reference Networks, which aim at concentrating resources and expertise, including in rare or low-prevalence complex diseases or conditions.

The Commission has already provided dedicated funding for paediatric research under the EU Framework Programme for Research and Innovation Horizon 2020.

Preventing and reducing pharmaceutical waste in freshwater
Answer given by Mr Vella on 26.05.2017 on behalf of the Commission to question for written answer to the Commission by Davor Škrlec (Verts/ALE) (Date : 27-03-2017 Reference : E-002080/2017)

The Commission is aware that certain pharmaceuticals may count among the ‘emerging pollutants’ on which attention is increasingly being focused in the aquatic environment.

In 2015, six pharmaceutical substances were included in the first watch list of substances to be monitored by Member States temporarily in surface waters to determine whether they pose a risk to the environment or to human health via the environment, and thus whether their concentrations in surface waters need to be controlled under the Water Framework Directive.

The results from the first year of monitoring are being analysed. Furthermore, data have also been gathered by Member States on the concentrations of pharmaceuticals in groundwater in the context of the establishment of a voluntary watch list under the Groundwater Directive.

In addition, the Commission is supporting a study on the risks from pharmaceuticals in the environment to inform the development of its strategic approach to pharmaceuticals in the environment. Adoption of the approach will be followed, as appropriate, by proposals for measures. The Commission recently published a roadmap(4) for the initiative, on which feedback may be given.

Twelve new bacteria
Answer given by Mr Moedas on 22.05.2017 on behalf of the Commission to question for written answer to the Commission by Dubravka Šuica (PPE) (Date : 02-03-2017 Reference : E-001460/2017)

The Commission is fully aware of the priority pathogens list recently published by the World Health Organisation (WHO).

It supports research on Anti-Microbial Resistance (AMR) since 1999 with an investment of over EUR 1.3 billion. Research is currently ongoing in the areas of health, veterinary sciences, food and environment. The focus is on antimicrobials, vaccines and alternative therapies to treat infections caused by the pathogenic bacteria on the WHO list and also other relevant bacteria like Mycobacterium tuberculosis.

The Commission is using different instruments to support the development of new antimicrobials, such as Innovative Medicines Initiative (IMI), which is the world’s biggest public–private partnership in the field of AMR. IMI’s new drugs for bad bugs programme has already invested over EUR 650 million, created a drug discovery platform for testing and optimising new antibiotics, and established a Pan-European network of more than 700 hospitals and 500 laboratories in 39 countries.

Through calls-for-research specifically targeted at Small and Medium-sized Enterprises (SMEs), the Commission has strengthened European SMEs involved in AMR research.

Furthermore, the Commission and the European Investment Bank launched InnovFin ID that provides loans to help develop new solutions for infectious diseases such as a HIV monitoring device, a diagnostic tool, and clinical trials of treatments for hepatitis B, human papilloma virus-induced cancers, and tuberculosis.

Efforts are being further stepped up with the preparation of a second EU Action Plan planned to be finalised by summer 2017 to support Member States in the fight against AMR. A public consultation collecting the views and input of citizens, administrations, associations and other organisations on possible activities to include in the new Action Plan closed on 28 April 2017.

Cannabidiol for the treatment of Dravet Syndrome
Answer given by Mr Andriukaitis on 18.05.2017 on behalf of the Commission to question for written answer to the Commission by Liadh Ní Riada (GUE/NGL) (Date : 22-03-2017 Reference : E-001897/2017)

The Commission is not aware of any recommendation to Member States, currently under consideration in the European Medicines Agency (EMA) for the use of cannabidiol through compassionate use programmes for the treatment of Dravet Syndrome.

Compassionate use means making a medicinal product available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product. It falls under the competence of Member States, which notify EMA and may request opinions on the conditions for use, the conditions for distribution and the patients targeted. Therefore, it is not the role of the Commission to propose a roadmap.

In addition, according to Article 5 of Directive 2001/83/EC(1), a Member State, in accordance with its legislation in force and to fulfil special needs, may allow supply of a medicinal product without marketing authorisation in response to a bona fide unsolicited order formulated in accordance with the specifications of a healthcare professional and for use by an individual named patient under the direct responsibility of the healthcare professional.

Collection and donation of pharmaceutical and medical products
Answer given by Mr Andriukaitis on 18.05.2017 on behalf of the Commission to question for written answer to the Commission by Eleftherios Synadinos (NI) (Date : 08-03-2017 Reference : E-001571/2017)

The organisation of health systems as well as measures regulating the price of medicines, the distribution of medicinal products to the public and the handling of unused medicines are Member States’ responsibility.

The Commission is not in a position to establish and fund permanent structures for donation and distribution of pharmaceuticals on a non-profit basis.

High cost of medicines in Cyprus
Answer given by Mr Andriukaitis on 16.05.2017 on behalf of the Commission to question for written answer to the Commission by Lefteris Christoforou (PPE) (Date : 31-03-2017 Reference : E-002364/2017)

The organisation of health systems and delivery of care are Member States’ responsibility as well as the cost containment measures in the area of medicines.

The Commission is supporting improved exchange of information among Member States on pricing and promoting their cooperation on a voluntary basis; such as the Network of competent authorities responsible for pricing and reimbursement, a European medicine price data base and an Organisation for Economic Co-operation and Development Project. The Commission is also working on an initiative to strengthen EU cooperation on health technology assessment.

The Cypriot healthcare sector remains characterised by lack of universal coverage and various levels of inefficiency (i.e. improving competitive public procurement and stronger governance and coordination of the pharmaceutical market). Legislation aiming to create a National Health System and providing public hospitals with greater autonomy are key to improve the capacity and cost-effectiveness of the healthcare sector, but is still pending parliamentary adoption.

Shortage of cancer drugs
Answer given by Mr Andriukaitis on 12.05.2017 on behalf of the Commission to question for written answer to the Commission by Daniel Buda (PPE) (Date : 06-03-2017 Reference : E-001508/2017)

The Commission is ready to support Member States and the European Medicines Agency to tackle the problem of shortages of medicines which can have serious consequences on the health of patients. Some work is already being undertaken by the national authorities, who meet regularly through the Heads of Medicines Agencies network. On 27 March 2017, the Commission also raised the issue of shortages within the Commission’s expert Committee on Pharmaceuticals and some Member States expressed interest to follow-up on the recommendations laid down in the recent own initiative report of the European Parliament on access to medicines.

The Commission has no further means to help with the treatments of patients in Romania, as measures regulating the organisation of the health systems and the delivery of care are Member States’ responsibility. The Member States are also responsible for ensuring the marketing authorisation holders and wholesale distributors’ obligations of continuous supply of medicines to cover the needs of patients. Moreover, a Member State can authorise the placing on the market of a medicine from another Member State or use an unauthorised medicine for the treatment of patients.

In addition, Member States may adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions. It should be noted that some Member States have already taken national measures to prevent shortages of medicines arising from parallel trade.

Petition on the replacement of a generic drug with the original and the subsequent increased cost thereof in the Netherlands

Risks from the use of antimicrobials in animals
Answer given by Mr Andriukaitis on 10.05.2017 on behalf of the Commission to question for written answer to the Commission by Kostas Chrysogonos (GUE/NGL) (Date : 14-03-2017 Reference : E-001703/2017)

1. As highlighted in the European Food Safety Authority opinion, a multi-faceted approach is needed to reduce the use of antimicrobials (AM) in animal husbandry including the development of national strategies; harmonised systems for monitoring AM use; prudent use of AM by veterinarians and farmers and increasing the availability of rapid and reliable diagnostics. The Commission is currently examining how to follow-up to the 2011 Action Plan against Antimicrobial Resistance (AMR) in order to address properly these issues.

2. Since 1999, the Commission has invested more than EUR 1.3 billion in AMR research, including alternatives to AM such as vaccines, phages, phytotherapy or probiotics. Under the most recent EU Programmes for research and innovation, several projects on AMR have been funded. For instance, the currently running project EFFORT aims at providing knowledge on the ecology and transfer of antimicrobial resistant bacteria throughout the food chain but also studies strategies to reduce the use of AM in farming systems.

The Commission continues to support research on AMR under Horizon 2020, with for instance two topics open in the 2017 call, respectively on a European Joint Programme “Co-Fund on “One Health” (zoonoses – emerging threats)” that will have an important component on AMR, and on “Alternative production system to address AM drug usage, animal welfare and the impact on health”.

3. In most cases, antibiotics in humans are used for acute infections for less than two weeks. Exceptions however exist such as the treatment of difficult infections (e.g. endocarditis) and chronic treatment for cystic fibrosis patients. The Commission has not assigned studies on the long-term use of antibiotics in humans.

Misapplication by France of Directive 2011/62/EU on Falsified Medicinal Products
Answer given by Mr Andriukaitis on 04.05.2017 on behalf of the Commission to question for written answer to the Commission by Renaud Muselier (PPE) (Date : 22-02-2017 Reference : E-001188/2017)

The European Union has adopted a number of measures to fight against falsified medicines including the introduction of safety features.

The safety features consist of a unique identifier (a 2-dimension barcode containing a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product) and an anti-tampering device.

The principle of unique identifier across Europe is for prescription medicinal products. Nevertheless, Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier to any medicinal product subject to prescription or subject to reimbursement.

Moreover, all reimbursable medicinal products placed on the French market will have to bear the unique identifier, regardless of the country of origin of the manufacturing authorisation holder.

Consequently, the Commission would like to confirm that the Member States can go beyond the scope of prescription medicines and that the French obligation to extend the scope is compatible with the European legislation.

Bacteriophages
Answer given by Mr Andriukaitis on 04.05.2017 on behalf of the Commission to question for written answer to the Commission by Mairead McGuinness (PPE) (Date : 10-03-2017 Reference : E-001659/2017)

In the light of the growing challenge of antimicrobial resistance (AMR), the Commission is actively encouraging the development of alternatives to antibiotics.

The Commission is aware of the potential merits of bacteriophage therapy. However, studies in livestock have not always been positive. Lately, the EU funded project Camcon did not show consistent reduction of Campylobacter in broiler chicken. The Commission is currently funding the PHAGOBURN project that aims to evaluate the efficacy and safety of phage therapy to treat bacterial infections of burn wounds in a clinical trial. The clinical trial is now running, and results will be available within the coming months. For all latest results, the project website can be consulted.

It should be emphasised that a veterinary medicine cannot be authorised before its safety and efficacy have been appropriately demonstrated. This is not currently the case for bacteriophage therapies, for which very few randomised controlled clinical trials have been conducted to date. Therefore, more robust evidence on bacteriophage treatments and further discussion of the scientific aspects are needed.

In its Proposal for a regulation on veterinary medicinal products, as adopted in 2014, the Commission has not included any specific provisions for the authorisation or use of bacteriophages as veterinary medicines.

Nonetheless, the Commission could, based on an actual application dossier, analyse if a specific product would fall under the scope of Regulation (EC) No 1831/2003 on additives for use in animal nutrition.

Measures to recover useful medicines not yet past their sell-by date
Answer given by Mr Andriukaitis on 03.05.2017 on behalf of the Commission to question for written answer to the Commission by Damiano Zoffoli (S&D) (Date : 01-03-2017 Reference : E-001405/2017)

EU legislation on medicinal products for human and veterinary use requires the Member States to ensure that appropriate collection systems are in place for medicinal products that are unused or have expired. In addition, this legislation requires that, where appropriate, the packaging of medicinal products contains information on specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, as well as a reference to any appropriate collection system in place. The detail of how collection systems should operate is for the Member States to decide. Several have opted for separate collection by pharmacies, free of charge, with subsequent transfer to specialised treatment facilities.

The Commission is aware of the issue of unused medicines and its economic impact on national health systems and of the recent report of the European Parliament on access to medicines. Measures regulating the organisation of the health systems and the delivery of care are a responsibility of the Member States.

Use of diclofenac for veterinary purposes in the EU (III)
Answer given by Mr Andriukaitis on 27.04.2017 on behalf of the Commission to question for written answer to the Commission by João Ferreira (GUE/NGL) (Date : 08-03-2017 Reference : E-001581/2017)

As indicated by the Honourable Member, the Member States were requested to carry out an analysis of the risk mitigation measures recommended by the European Medicines Agency (EMA) in its opinion of 11 December 2014 and to indicate in an action plan the measures that have been already implemented or that they would consider to put in place in the future.

At the meeting of the Veterinary Pharmaceutical Committee that took place on 15 June 2015, it was agreed that the mitigation measures implemented by the Member States should guarantee that, where diclofenac is used and vultures (or other relevant necrophagous birds) are present on the territory, they would be able to contain the risk effectively.

Given the Commission’s commitment to follow up on the effectiveness of the risk mitigation measures introduced in the Member States and on any new information with regard to the death of vultures, the Member States were invited during the Veterinary Pharmaceutical Committee that took place on 4 July 2016 to provide an update of the situation in their territories.

Most Member States indicated that they had still not authorised diclofenac. Those that have authorised products indicated that appropriate safety warnings were included in the product literature and that appropriate measures are in place for the safe disposal of fallen stock and the feeding of carrion to birds of prey.

None of the Member States reported deaths of vultures in their territories and no request was made for the initiation of a referral where the withdrawal of the marketing authorisations of products containing diclofenac would be considered.

Macular degeneration – Illegal practices of pharmaceutical companies
Answer given by Ms Vestager on 20.04.2017 on behalf of the Commission to question for written answer to the Commission by Nikolaos Chountis (GUE/NGL) (Date : 06-02-2017 Reference : E-000841/2017)

The Commission continues to monitor the developments with respect to competition aspects surrounding the off-label use of Avastin for treatment of the age-related macular degeneration (AMD). It also remains in close contact with other National Competition Authorities that are looking into the issue, notably in the context of the regular meetings of the European Competition Network’s Pharma and Health Services Subgroup where confidential investigative work by the various competition authorities is discussed.

In addition, the Commission has lodged its observations on a preliminary ruling case before the European Court of Justice prompted by a reference from the Italian State Council in the litigation between Hoffman-La Roche and Novartis against the Italian competition authority’s decision of 27 February 2014.

However, as indicated in the Commission’s answer to written question P-002767/2014, the off-label use of pharmaceuticals is also factually and legally closely related to the respective national regulatory framework that deals with the question on how medication is ultimately used. In this respect, the Commission refers to the decision of 24 February 2017 by the highest French administrative court to uphold a policy allowing the off-label use of Avastin for treatment of AMD

Restriction of the free movement of goods in Slovakia – distribution of medicinal products – unanswered question E-007113-16
Answer given by Ms Bieńkowska on 11.04.2017 on behalf of the Commission to question for written answer to the Commission by Richard Sulík (ECR) (Date : 30-01-2017 Reference : E-000534/2017)

The Commission is examining the compatibility of the Slovak Law on Medicinal Products with Union law, and in particular with Articles 35 and 36 of the Treaty on the Functioning of the EU (TFEU). Should the legal assessment reveal non-conformity of Union law, the Commission in its role as Guardian of the Treaties may take the necessary action, as appropriate.

As a general rule, during an ongoing assessment the Commission cannot pronounce on the compatibility of any individual elements of the laws under analysis. The elements the Honourable Member draws the attention to will be taken into account in the Commission’s examination.

Shortage of medicinal products in Romania
Answer given by Mr Andriukaitis on 07.04.2017 on behalf of the Commission to question for written answer to the Commission by Maria Grapini (S&D) (Date : 14-02-2017 Reference : E-000998/2017)

Measures regulating the prices of medicines as well as the organisation of the health systems and the delivery of care are Member States’ responsibility.

However, the Commission encourages Member States to cooperate in this area to ensure access to medicines, promote the rational use of medicines and improve the sustainability of pharmaceutical expenditure, in line with the Commission Communication on effective, accessible and resilient health systems.

The Council recently called upon the Member States to implement measures with a view to ‘strengthening the cost-effective use, availability, accessibility and affordability of medicines by implementing policies such as promoting public procurement and the role of generics and biosimilars, appropriate price-control policies and a rational use of medicines’.

To support Member States in their efforts to ensure the sustainability of their healthcare budgets, the Commission recently conducted a public consultation for an initiative to strengthen EU cooperation on health technology assessment.

In the EU, most medicine shortages are dealt with at national level. However, the European Medicines Agency can be involved in certain situations, for example when a medicine shortage is linked to a safety concern or affects several Member States.

Cost of cancer treatment
Answer given by Mr Andriukaitis on 07.04.2017 on behalf of the Commission to question for written answer to the Commission by Martina Anderson (GUE/NGL) (Date : 03-02-2017 Reference : E-000822/2017)

Measures regulating prices of medicines as well as organisation of health systems and delivery of care are Member States’ responsibility.

Despite its limited competences, the Commission is promoting improved exchange of information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis; in particular through tools such as a European medicine price database (Euripid). It also facilitates the exchange of best practices and knowledge among Member States through the Network of competent authorities responsible for pricing and reimbursement.

To support Member States in their efforts to ensure sustainability of their healthcare budgets, the Commission has recently conducted a public consultation for an initiative to strengthen EU cooperation on health technology assessment.

The Council recently called upon the Member States to implement measures with a view to ‘strengthening the cost-effective use, availability, accessibility and affordability of medicines by implementing policies such as promoting public procurement and the role of generics and biosimilars, appropriate price-control policies and rational use of medicines’.

The Commission has, within the European Competition Network, supported national competition authorities when they fined companies for having abused their dominant position by means of excessive prices for medicines that lost their market exclusivity.