European Parliament Pharma Watch

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

Approval of Exondys 51 for use in the European Union
Answer given by Mr Andriukaitis on 21.03.2017 on behalf of the Commission to question for written answer to the Commission by Marina Albiol Guzmán (GUE/NGL) (Date : 30-01-2017 Reference : E-000525/2017)

The Commission is aware that an application for an orphan medicinal product containing eteplirsen (Exondys 51) was submitted to the European Medicines Agency in December 2016. The application is currently under the assessment of the Committee for Human Medicinal Product (CHMP), which has 210 days after the validation of the application to adopt an opinion, if no further questions are submitted to the applicant.

If the opinion of the CHMP concludes positively on the benefit/risk assessment of eteplirsen for the treatment of Duchenne’s Syndrome and the Committee for Orphan Medicinal Products confirms the compliance with the orphan designation criteria in line with Regulation (EC) No 141/2000, the final decision on the authorisation is taken by the Commission.

Shortages in Greek public hospitals and postponement of scheduled treatments
Answer given by Mr Andriukaitis on 13.03.2017 on behalf of the Commission to question for written answer to the Commission by Eleftherios Synadinos (NI) (Date : 19-01-2017 Reference : E-000264/2017)

The Commission is holding regular review missions in Greece and, within the boundaries of its competences, intends to continue to raise concerns related to public health. According to the Greek health authorities, efforts are being made to provide the necessary drugs to those hospitals which provide medication to vulnerable groups.

As stated in the Commission’s reply to E-001016/2016, the EU is providing financial support to health-related actions proposed by Greece according to its national priorities through the European Structural and Investment Funds. In addition, the Structural Reform Support Services is helping with facilitating expertise in collaboration with the World Health Organization.

As the Commission pointed out in its answer to the written question E-009252/2016 raised by the Honourable Member, 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.

Petition on disproportionate administrative costs of health insurance when buying medication abroad

Impact of TTIP’s general clauses on the public health sector
Answer given by Ms Malmström on 08.03.2017 on behalf of the Commission to question for written answer to the Commission by Izaskun Bilbao Barandica (ALDE) (Date : 09-11-2016 Reference : E-008447/2016)

The Commission has made clear from the start that changes to the EU’s laws on intellectual property rights for pharmaceuticals, or to pricing and reimbursement regulations, are not part of the EU’s objectives in the Transatlantic Trade and Investment Partnership (TTIP) negotiations. The EU already has a solid and comprehensive intellectual property rights system that allows innovators to thrive and to remain among the most competitive globally. So the Commission believes there is no cause for concern in relation to TTIP. For the same reasons, the Commission is not considering any new regulations related to drug pricing.

At the same time, EU Member States have some of the most efficient and inclusive public health systems in the world. Nothing in TTIP will endanger Member States’ rights to manage their health systems as they see fit. If any do choose to allow American companies to enter their public health services markets (as indeed some already do), these companies will be subject to the same regulation as any other that operates in the market. So the Commission believes there is no cause for concern on this matter either.

Antibiotic resistance and international trade
Answer given by Mr Andriukaitis on 07.03.2017 on behalf of the Commission to question for written answer to the Commission by Mireille D’Ornano (ENF) (Date : 17-01-2017 Reference : E-000200/2017)

The Commission shares the concerns of the Honorable Member and agrees on the importance of adopting an overall policy to reduce antimicrobial resistance (AMR). AMR is a serious threat to human and animal health and there is a clear need to adopt a trans-national “one health” approach. This is why the Commission is now proposing for all new bilateral trade agreements a specific provision to increase cooperation and commitment of EU trade partners to reduce the use of antibiotics in animal production. The aim is also to foster cooperation for the development and the implementation of international guidelines, standards, recommendations and actions aiming to promote the prudent and responsible use of antibiotics.

Products of animal origin entering into the EU are checked by the veterinary services of the EU Member States at the EU border inspection posts with the aim to ensure the respect of European food safety standards and to prevent health risks for European consumers. Physical and laboratory checks are routinely carried out and the frequency of controls may be raised when there is suspicion of unsafe food. Decision 2002/994/EC concerning certain protective measures with regard to the products of animal origin imported from China also obliges Chinese authorities to provide additional sanitary guarantees, in relation to the presence of residues from medicinal products, when exporting fishery products to the EU.

The Commission’s strategic approach to the contamination of water by pharmaceutical substances
Answer given by Mr Vella on 06.03.2017 on behalf of the Commission to question for written answer to the Commission by Fredrick Federley (ALDE) (Date : 12-01-2017 Reference : E-000149/2017)

The Commission intends to come forward with the strategic approach around the end of 2017.

A roadmap for the initiative should be published shortly. A study to support the development of the strategic approach is underway and will include a public consultation. The study is considering the relation between the whole lifecycle of pharmaceuticals and their presence in the environment.

Twelve new bacteria
Question for written answer to the Commission by Dubravka Šuica (PPE) (Date : 02-03-2017 Reference : E-001460/2017)

The World Health Organisation (WHO) has published its first list of 12 pathogenic bacteria that pose a significant threat to human health. As they are becoming resistant to most antibiotics, these 12 bacteria pose the greatest threat to humanity. WHO experts warn that in the near future these bacteria could pose a greater threat to mankind than all cancers combined.

In cases where antibiotics are losing their effectiveness, efficiency and power, surgical procedures such as caesarean sections, organ transplants, and even chemotherapy can become dangerous, risky and deadly medical interventions.

Currently, about 700 000 people a year worldwide die of consequences of infections caused by these bacteria, and it is estimated that by 2050, this number could reach 10 million.

The objective of this WHO publication is to encourage scientists and the pharmaceutical industry to start new research to find antibiotics capable of destroying those bacteria.

What does the Commission plan to do about the 12 new bacteria and encouraging research to find new antibiotics?

Measures to recover useful medicines not yet past their sell-by date
Question for written answer to the Commission by Damiano Zoffoli (S&D) (Date : 01-03-2017 Reference : E-001405/2017)

Throughout Europe, tonnes of still-valuable drugs are regularly being thrown away, causing not only environmental damage but also economic damage to national health systems.

In addition, millions of poor people in Europe cannot afford to buy the drugs necessary for their health.

Given the above, and in view also of Parliament’s own-initiative report on ‘EU options for improving access to medicines’ (2016/2057(INI)) and some successful experiences at Member State level, such as the campaign to recover useful medicines conducted by the Italian ‘Pharmaceutical Bank’ non-profit organisation, can the Commission say whether it is aware of the great waste of medicines taking place every day in Europe? Should it not make representations to the EU and the Member States to promote measures to counter such waste, also with a view to recovering effective medicines that have not yet expired?

Pharmaceutical law in Poland
Question for written answer to the Commission by Alexander Graf Lambsdorff (ALDE) (Date : 01-03-2017 Reference : P-001382/2017)

On 9 April 2015, the Polish Parliament passed an act amending and supplementing the Pharmaceutical Act. The act was published in the Polish Official Journal on 11 June and entered into force on 12 July 2015 . Under this law, 187 products are banned from export, thereby affecting intra-EU trade. Article 35 of the Treaty on the Functioning of the European Union prohibits Member States from applying quantitative restrictions on exports and measures having equivalent effect.

Is the Commission aware of these measures related to the export to other Member States of medicinal products for human use?

Does it intend to launch an infringement procedure in the form of a reasoned opinion?

What is the difference between this and similar cases in Slovakia and Portugal?

Aspen Pharma’s anticompetitive practices
Answer given by Ms Vestager on 24.02.2017 on behalf of the Commission to question for written answer to the Commission by Piernicola Pedicini (EFDD), Eleonora Evi (EFDD) (Date : 14-11-2016 Reference : E-008535/2016)

It is the Commission’s task in general to monitor economic sectors, including the pharmaceutical sector, for anti-competitive practices. In line with this task, possible abuses of a dominant position by an undertaking in the pharmaceuticals sector fall within the Commission’s remit to intervene under Article 102 of the Treaty on the Functioning of the European Union (TFEU).

In particular, the Commission has been cooperating closely with national competition authorities regarding various recent national investigations into excessive prices for medicines. In this regard, the Commission has supported the decision recently taken by the Italian competition authority against Aspen Pharma.

However, any possible investigation by the Commission would necessarily have to be done on a case-by-case basis considering all relevant facts and circumstances. In addition, consideration would have to be given to the fact that pricing and reimbursement in the pharmaceutical sector are highly regulated by Member States. Moreover, public spending accounts for most of the expenditures on medicinal products in the Union. Such prima facie elements nuance the merits of a possible investigation by the Commission into the matters referred to by the Honourable Members.

Access to medicines
Answer given by Ms Bieńkowska on 23.02.2017 on behalf of the Commission to question for written answer to the Commission by Jiří Maštálka (GUE/NGL) (Date : 04-10-2016 Reference : E-007539/2016)

1. Biomedical research requires heavy investment and long-term research, coupled with expensive clinical trials and demanding regulatory approval and post-approval procedures. Intellectual Property Rights (IPRs) provide an important incentive for pharmaceutical and biomedical research. The Commission seeks to strike the right balance between the need to promote and finance the research and development of innovative medicines through IPR protection, and to ensure that medicines are accessible to those in need and health systems remain sustainable.

Any amendment of the pharmaceutical IPR framework would need to be justified by an evidence-based analysis. As requested by the Council, the Commission will carry out, as soon as possible, and with the close involvement of the Member States, an evidence-based analysis of the impact of pharmaceutical incentives and rewards (including IPRs) on innovation, availability and accessibility of medicinal products in the EU. The timetable and methodology that the Commission intends to apply was presented at the EPSCO Council on 8 December 2016.

2. Information on funding for projects supported through Horizon 2020 is fully transparent. Beyond the costs for the projects to be implemented under an EU research grant, Horizon 2020 does not provide for the obligation of beneficiaries to disclose costs not related to the implementation of such grants.

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

Directive 2011/62/EU on Falsified Medicinal Products introduces the requirement to establish a system of serial numbers for medicinal products manufactured in the EU so as to make these easier to trace and prevent counterfeiting. This mechanism ensures there can be no tampering with the packaging of any prescription medicines.

The EU Directive only requires that the mechanism be established for prescription medicines. However, France has chosen to apply the rules more strictly by requiring that it apply to all medicines reimbursed through the social security system. This means that rather than applying to a minority (around 20%) of medicines, it should apply to almost 80% of all medicines produced in France.

While the aim of protecting the public against counterfeiting is laudable, the misapplication of the directive is particularly disadvantageous to the French pharmaceutical industry. It clearly clashes with the fair competition that the EU wishes to establish across all Member States.

Given these circumstances, does the Commission plan to:

1. Remind the French authorities of the compelling obligation to apply the letter of EC law?

2. Review its criteria in respect of control requirements so as to bring these into line with those applied by the French authorities and hence maintain fair competition between all EU operators, while also protecting the European public against counterfeit medicines?

Public health initiatives that the Commission must present
Answer given by Mr Vella on 22.02.2017 on behalf of the Commission to question for written answer to the Commission by Claude Rolin (PPE) (Date : 21-12-2016 Reference : E-009717/2016)

The Commission is currently preparing a roadmap for the strategic approach to water pollution by pharmaceuticals.

The Commission report concerning chemical mixtures is expected in the second quarter of 2017.

Regarding the Cosmetics Review on endocrine disruptors, the Commission is currently preparing a report on the current regulatory framework with regard to the management of endocrine disruptors in cosmetics.

The review of the REACH legislation as regards authorisation of substances having endocrine disrupting properties has been finalised and it was published as a Commission Communication on 20 December 2016.

Antimicrobial resistance
Answer given by Mr Andriukaitis on 20.02.2017 on behalf of the Commission to question for written answer to the Commission by Karol Karski (ECR) (Date : 01-12-2016 Reference : E-009119/2016)

1. Actions that will be developed under the future EU Action Plan against antimicrobial resistance (AMR) will be co-financed under a variety of EU funding programmes managed by the Commission, such as Horizon 2020, the Innovative Medicines Initiative and the Common Financial Framework for the Food Chain and the Health Programme.

2. The evaluation of the 2011-2016 Commission Action Plan against AMR has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and created a framework to guide and coordinate activities on AMR at national and global levels. This includes actions to strengthen the promotion of appropriate use of antimicrobials in both human and veterinary medicine for example through the development of guidelines, training, exchange of good practices and research.

3. In 2017, the Commission will allocate EUR 1.7 million of the Common Financial Framework for the Food Chain to Member States for the monitoring of AMR in zoonotic bacteria in food and farmed animals. Some Member States and regions also intend to use European Regional Development Fund allocations for health related investments, mainly for research and innovation, SME competitiveness, e-health and health infrastructures.

Parallel market in medicines — monitoring and penalties
Answer given by Mr Andriukaitis on 20.02.2017 on behalf of the Commission to question for written answer to the Commission by Massimo Paolucci (S&D) (Date : 01-12-2016 Reference : E-009158/2016)

Regarding shortages of medicines the Commission promotes improved exchange of information and best practices among Member States. The Member States are also responsible for enforcing the legislation on medicinal products which introduces an obligation of continuous supply on manufacturers and wholesale distributors to cover the needs of patients (Article 81 of Directive 2001/83/EC). The rules on retail are established by the Member States. These rules are necessary to ensure the proper distribution of medicines and protect public health and the Commission does not intend to take any action which is not under its competence.

It is important to underline that the modalities of the supply of medicinal products to the public at retail level fall under national competence. It is also up to the Member States to implement the conditions under which the nationally established retailers are authorised to sell medicinal products on line, in accordance with the Falsified Medicines Directive 2011/62/EC in order to protect public health.

The Commission does not intend to take any further action at this stage to change the authorisation process. The requirements for the granting of a marketing authorisation for medicinal products for human use are already harmonised at EU level. Medicinal products may be either authorised by the Commission or by national authorities.

Petition on Croatia’s failure to abide by EU directives on medicines

Resolution of 15 December 2016 on the regulation on paediatric medicines (P8_TA(2016)0511)
Question for written answer to the Commission by Michał Marusik (ENF) (Date : 15-02-2017 Reference : E-001020/2017)

On 15 December 2016, the European Parliament adopted a resolution on the regulation on paediatric medicines (P8_TA(2016)0511).

In paragraph 11 the European Parliament calls on the Commission ‘(…) to ensure that Member States enact measures to support research into and the development and availability of medicinal products for paediatric use.’

Further to this resolution, what actions to support Member States on this matter has the Commission taken or will it take soon?

Medicinal products
Question for written answer to the Commission by Michał Marusik (ENF) (Date : 15-02-2017 Reference : E-001016/2017)

On 15 December 2016, the European Parliament adopted a resolution on the regulation on paediatric medicines (P8_TA(2016)0511).

In paragraph 9 of the resolution, Parliament calls on the Commission ‘to work as a matter of urgency on any possible regulatory changes that could […] in the meantime’ help improve the situation with regard to paediatric clinical research and accelerate paediatric drug development, in particular drugs for neonatology and childhood cancers.

In the light of the above: what steps have already been taken, or what steps does the Commission intend to take in the near future, in response to the resolution?

Shortage of medicinal products in Romania
Question for written answer to the Commission by Maria Grapini (S&D) (Date : 14-02-2017 Reference : E-000998/2017)

As of 1 July 2017, Article 8(1) will come into force in Romania. It was introduced by Order No 703/2015, according to which the prices of innovative medicines should drop to those of generic medicines. Up to that date, the prices of innovative (original) medicines were higher, as the production costs for those medicines are significantly higher. At present, the cost of a generic medicine (which contains the active ingredient and has the same effect) can be a maximum of 65% higher than the value of the original product. As the prices will be reduced by up to 35%, 123 medicines will disappear from the market starting on 1 July and, in Romania alone, this will affect 800,000 patients suffering from cardiovascular and neurological diseases or cancer, in addition to other diseases. It will be the large pharmaceutical companies that will benefit from this situation. At present, medicines in Romania have the lowest price in the EU, and this price is state-regulated.

What measures does the Commission plan to take to avoid a medicine crisis in Romania?

Escalation in the deregulation of the market in pharmaceutical products
Question for written answer to the Commission by Sotirios Zarianopoulos (NI) (Date : 14-02-2017 Reference : E-000991/2017)

As part of the third memorandum and on the basis of the OECD Toolkit, the Commission and the Greek government are jointly escalating the deregulation of the market in pharmaceutical products on the grounds that this will liberate entrepreneurial activity.

They have decided to grant pharmacy licences to non-pharmacists, thereby putting business interests even before public health. Business groups will henceforth be able to create commercial chains of pharmacies and monopolise the market, at the expense of small self-employed pharmacists who have been affected by a series of other measures such as the deregulation of pharmacy opening hours, the possibility of granting multiple licences to pharmacists and non-pharmacists, the possibility for supermarkets to sell non-prescription drugs, hikes in taxation, etc.

The prices of pharmaceutical products which are already high will soar with further monopolisation, and this will force thousands of patients to discontinue their treatment. At the same time, the sole criterion governing the prices, quality and appropriateness of medicines will be whether they generate profits for those who trade in health and pharmaceutical products rather than public health.

In view of the above, will the Commission say where it stands on the following questions:
– the fact that the granting of pharmacy licences to non-pharmacists will lead to hundreds of self-employed pharmacists being thrown out of work;
– the fact that the monopolisation of the market in the interests of business profits will pose a risk to public health?

New headquarters for the European Banking Authority and the European Medicines Agency
Answer given on 13.02.2017 to question for written answer to the Council by Ruža Tomašić (ECR) (Date : 14-11-2016 Reference : E-008541/2016)

According to Article 50 TEU, a Member State may decide to withdraw from the Union in accordance with its own constitutional requirements, and in that case shall notify the European Council of its intention. The European Council has not received such notification from the United Kingdom. The relocation of agencies currently located in the United Kingdom has not been discussed.

Clawback regarding the Greek Pharmaceutical expenditure
Answer given by Mr Moscovici on 09.02.2017 on behalf of the Commission to question for written answer to the Commission by Eva Kaili (S&D) (Date : 15-11-2016 Reference : E-008556/2016)

According to Article 168, paragraph 7 of the Treaty on the Functioning of the European Union (TFEU), 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. Hence, it is foremost for Member States to decide on how to ensure access to healthcare for their populations.

The Commission supports the intention of the Greek Ministry of Health to enhance the cost-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. To this end, the Commission supports the authorities’ commitment to continue reforming the health care sector, including by rationalising pharmaceutical expenditure making use of the negotiating committee to develop price volume and/or risk sharing agreements, by setting up a Health Technology Assessment (HTA) centre to evaluate which products to reimburse and by managing demand for pharmaceuticals and health care through evidence-based e-prescription protocols.

In addition, through the Memorandum of Understanding the Greek authorities committed to implement structural measures focusing on improving efficiency of the health system as a means to contain expenditure to ensure the spending on pharmaceuticals, but also diagnostics and private clinics, for 2017, is reduced by at least 30 percent compared to the previous year.

The Commission will continue to monitor the implementation of the structural measures agreed in the framework of the Stability Support Programme supported by financial assistance by the European Stability Mechanism (ESM).

Complaint against the European Medicines Agency concerning the papillomavirus vaccine
Answer given by Mr Andriukaitis on 08.02.2017 on behalf of the Commission to question for written answer to the Commission by Jean-François Jalkh (ENF) (Date : 16-12-2016 Reference : E-009532/2016)

With regard to the specific case mentioned by the Honourable Member, it should be noted that as provided by EU legislation relating to medicinal products for human use, the Commission relies, for its decision-making process, on the scientific assessment performed by the scientific committees of the European Medicines Agency (EMA), in particular the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) in the case of the human papillomavirus (HPV) vaccines review.

The PRAC was responsible for the initial assessment. In reaching its recommendations, it also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups. The findings of the PRAC were passed on to the CHMP, which did not recommend any changes to the terms of marketing authorisation or the product information for these medicines.

The Commission is confident that the EMA and its Committees have access to the necessary expertise to be able to review the available evidence and provide robust advice regarding the safety of medicinal products.

Macular degeneration – Illegal practices of pharmaceutical companies
Question for written answer to the Commission by Nikolaos Chountis (GUE/NGL) (Date : 06-02-2017 Reference : E-000841/2017)

The recommendations of the UN High Level Panel on Access to Medicines (HLP) elicited a very critical response from the EU on 14 December 2016 in the World Intellectual Property Organisation (WIPO), which stated that ‘The work conducted by the Panel started from an assumption that “there was a policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health”’. The Commission indicated in its written contribution to the Panel that it does not share this assumption.

The strong support for the HLP recommendations expressed by the European Parliament Working Group on Access to Medicines and Poverty-Related Diseases stands in stark contrast with the official EU position, calling on the EU to ‘acknowledge the usefulness of the recommendations and start a process to facilitate the implementation in order to ensure both innovation and affordable and suitable access to the needed innovative medical tools, in Europe and beyond.’

1. Could the Commission clarify at which juncture the delegation representing the Council, the European External Action Service (EEAS) and the Commission consulted with the European Parliament on the position expressed regarding the report of the UN High Level Panel on Access to Medicines?

2. Could the Commission explain how the delegation representing the Council, the EEAS and the Commission will ensure that the position adopted by the EU’s representatives at WIPO on 14 December 2016 takes into account the legitimate democratic interests and institutional viewpoints of Parliament?

3. Could the Commission explain the democratic, accountable and transparent process on the basis of which the EU’s position on the UN HLP report was formulated?

Cost of cancer treatment
Question for written answer to the Commission by Martina Anderson (GUE/NGL) (Date : 03-02-2017 Reference : E-000822/2017)

The cost of generic drugs is the cost of research and development, a cost already paid, with governments paying close to the production cost. However, overcharging by global pharmaceutical companies is putting millions of lives at risk.

The costs of many cancer treatments have soared by more than 1,000 % in the last 5 years.

For example, during this period the price in GBP of Busulfan (for leukaemia) shot up from 21 pence to GBP 2.61 – a 1,142 % rise. Tamoxifen (for breast cancer) went up from 10 pence to GBP 1.21 – an increase of 1,100 %.

The UK Competition and Market Authority found last year that drug maker Actavis broke competition law by increasing the cost of hydrocortisone tablets from GBP 1.07 a pack to GBP 102.74 – a rise of 9,500 %.

EU Member States need to take protective action against these scandalous price rises and ensure that cancer patients’ health is not jeopardised by a desire for profit.

While the UK Government is introducing a Health Service Medical Supplies (Costs) Bill to regulate prices in the future, authorities at all levels need to do more.

What is the Commission doing to help prevent global pharmaceutical corporations robbing health department budgets by preying on the suffering of cancer patients?

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

The recommendations of the UN High Level Panel on Access to Medicines (HLP) elicited a very critical response from the EU on 14 December 2016 in the World Intellectual Property Organisation (WIPO), which stated that ‘The work conducted by the Panel started from an assumption that “there was a policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health”’. The Commission indicated in its written contribution to the Panel that it does not share this assumption.

The strong support for the HLP recommendations expressed by the European Parliament Working Group on Access to Medicines and Poverty-Related Diseases stands in stark contrast with the official EU position, calling on the EU to ‘acknowledge the usefulness of the recommendations and start a process to facilitate the implementation in order to ensure both innovation and affordable and suitable access to the needed innovative medical tools, in Europe and beyond.’

1. Could the Commission clarify at which juncture the delegation representing the Council, the European External Action Service (EEAS) and the Commission consulted with the European Parliament on the position expressed regarding the report of the UN High Level Panel on Access to Medicines?

2. Could the Commission explain how the delegation representing the Council, the EEAS and the Commission will ensure that the position adopted by the EU’s representatives at WIPO on 14 December 2016 takes into account the legitimate democratic interests and institutional viewpoints of Parliament?

3. Could the Commission explain the democratic, accountable and transparent process on the basis of which the EU’s position on the UN HLP report was formulated?

Investigations into multinational Novartis’s illegal practices
Question for written answer to the Commission by Nikolaos Chountis (GUE/NGL) (Date : 02-02-2017 Reference : E-000767/2017)

US supervisory authorities are currently investigating the activity of Novartis between 2006 and 2014 for illegal practices, including: bribery, corruption, market leverage, and money laundering through surrogates/offshore companies. The corporation has been accused repeatedly and in a number of countries around the world of such practices and has paid huge fines.

One of the primary countries in the investigation is Greece, where expenses for pharmaceutical products shot up from EUR 2.4 billion in 2004 to EUR 5.09 billion in 2009 and currently amount to approximately EUR 6 billion. American authorities have already investigated Novartis executives who are Greek nationals.

It has been revealed that for promotion purposes, Novartis bribed thousands of doctors and state officials with cash/vouchers, trips/conferences, overprescribed drugs to public insurance organisations, overpriced drugs in Europe (Greece is the reference country in determining prices of drugs at EU level, as one of the three cheapest countries in the EU) and recklessly promoted more expensive drugs and vaccines.

1. Is the Commission aware of any EU or international convictions on or current investigations into Novartis illegal practices? If so, which is it aware of?

2. Behind the revelations could lie crimes against insurance organisations, Member States and possibly the EU budget. Is the Commission investigating the reports? What means does the Commission have and what action is it taking to protect Member States against such practices?

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

Given that the Commission in its answer to my parliamentary written question No E-007113-16 failed to answer any of the questions which I put to it, I would like to ask these questions again and request concrete answers to them.

In the case of the Slovak Law on Medicinal Products, in force since 2012, the Commission has had an infringement procedure against Slovakia running for two years. Under an amendment effective from 2017, the previous 30-day general notification obligation for exports of medicinal products, which was the subject of the infringement, is to be removed and replaced by the obligation to notify the Slovak institution concerned of the export of medicinal products within seven days of their export. This obligation applies only to distributors of medicinal products covered by public health insurance.

The change in the law will permit manufacturers and those distributors authorised by them (licence holders) to export medicines. Such a rule will, among other things, create a conflict of interests for manufacturers with a dominant position in that they must protect public health, but at the same time operate for profit.

Is it possible under EU legislation to delegate the protection of public interests to private producers that have commercial and private interests?

Are the proposed changes compatible with the internal market, in the Commission’s view?

Expired medicines
Answer given by Mr Andriukaitis on 24.01.2017 on behalf of the Commission to question for written answer to the Commission by Claudiu Ciprian Tănăsescu (S&D) (Date : 17-11-2016 Reference : E-008651/2016)

Current Union legislation requires Member States to organise the collection of unused medicines, but this can be by way of general municipal waste collection. There is no provision in the pharmaceutical or waste management legislation for a system which keeps track of expired medicines in private households or pharmacies in the Member States.

However, the Guidelines on Good Distribution Practice of medicines impose an obligation on wholesale distributors to segregate and store expired products in a dedicated area away from other medicinal products. In addition, medicinal products that are nearing their expiry date are to be withdrawn immediately from saleable stock.

The Commission is also working with the Member States to ensure the smooth implementation of safety features (a unique identifier and an anti-tampering device) which will allow expired products which are subject to prescription to be detected in the supply chain at the time of dispensing them to the public. The safety features have to be applied from the year 2019.

Guaranteed right of universal access to medicines in the negotiation of the Transatlantic Trade and Investment Partnership (TTIP)
Answer given by Ms Malmström on 20.01.2017 on behalf of the Commission to question for written answer to the Commission by Inmaculada Rodríguez-Piñero Fernández (S&D) (Date : 28-10-2016 Reference : E-008171/2016)

Publicly funded health services are already clearly excluded from EU trade agreements. In the Joint Statement on Public services of Commissioner Malmström and Ambassador Froman of 20 March 2015 (http://europa.eu/rapid/press-release_STATEMENT-15-4646_en.htm) it was clearly stated that this approach will be followed also in the Transatlantic Trade and Investment Partnership. The EU proposal for an Annex on medicinal products has been published on the website of the Commission and provides an indication of what areas regulatory cooperation in the pharmaceuticals sector would aim at. This proposed Annex in its Article 1(4) also contains an explicit exclusion of setting of prices for medicinal products by the relevant authorities from its scope.

Antibiotic resistance
Answer given by Mr Andriukaitis on 18.01.2017 on behalf of the Commission to question for written answer to the Commission by Nicola Caputo (S&D), Monica Macovei (ECR) (Date : 16-11-2016 Reference : E-008598/2016)

The Commission considers that antimicrobial resistance (AMR) is a major global challenge with serious implications for the economy and human health and agrees that a stronger push to innovation and research for the development of new drugs, rapid diagnostic tests and alternatives to antimicrobials is needed.

The evaluation of the current Action Plan against AMR adopted in 2011, has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and a framework to guide and coordinate activities on AMR at national and global levels and boosted research and innovation via a range of funding initiatives including the establishment of the ND4BB programme within the Innovative Medicines Initiative.

However, this evaluation has also demonstrated that the AMR problem is persisting and continued action is needed to address it. Therefore, the Commission will prepare a new AMR Action plan in 2017 for broader actions aimed at tackling AMR at EU and global level.

Measures to increase citizens’ awareness and sense of responsibility with regard to the use of antibiotics will be included in this new Plan, as well as measures promoting good practice for the control of hospital infections and supporting research into rapid tests. In February 2017, the Commission will award a prize for the development of such a rapid test.

Inflammatory bowel diseases – EU action
Answer given by Mr Andriukaitis on 12.01.2017 on behalf of the Commission to question for written answer to the Commission by Biljana Borzan (S&D) (Date : 08-11-2016 Reference : E-008423/2016)

Access to medicines is an important issue for the Commission. 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 existing tools such as a European medicine price database (Euripid).

The Commission also facilitates the exchange of best practices, knowledge and information among Member States through the Network of Competent Authorities for Pricing and Reimbursement (CAPR) and through a structured multi-stakeholder dialogue.

The Commission works with the European Medicines Agency and the Member States to optimise the use of current regulatory mechanisms for early access to innovative medicines and to explore further possibilities to strengthen dialogue and cooperation between regulators, Health Technology Assessments (HTA) bodies and payers at EU level.

On national measures regulating prices and reimbursement, the Commission monitors the implementation of the Transparency Directive 89/105/EEC, which lays down procedural rules (e.g. time limits, motivation and judicial appeal).

A recent report calls on EU Member States to exploit possible policies to improve the access to affordable medicines, including by increasing the uptake of generics and biosimilars, when they are cheaper options.

In September 2016, the Commission published an inception impact assessment on strengthening EU coordination in the area of HTA. A public consultation is open until mid-January 2017.

Restriction of the free movement of goods in Slovakia – distribution of medicinal products
Answer given by Ms Bieńkowska on 10.01.2017 on behalf of the Commission to question for written answer to the Commission by Richard Sulík (ECR) (Date : 27-09-2016 Reference : E-007113/2016)

The Honourable Member refers to the ongoing infringement proceedings regarding the Slovak Act on Medicinal Products and its non-conformity with the Treaty rules on free movement of goods.

To the Commission’s knowledge, the Slovak Parliament has recently adopted amendments to the Slovak law, as referred to by the Honourable Member.

The Commission continues its examination of the provisions of the Slovak law and their conformity with the rules on free movement of goods in particular.

Article 81 of Directive 2001/83/EC sets out the general obligation for the holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State, within the limits of their responsibilities, to ensure appropriate and continuous supplies of that medicinal product to pharmacies to cover the needs of patients. It clarifies that the arrangements for its implementation should be in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.

Health risks related to the latest generation of contraceptives
Motion for a European Parliament resolution on the health risks related to the latest generation of contraceptives by Mireille D’Ornano (Date : 09-01-2017 Reference : B8-0117/2017)

The European Parliament,

– having regard to Article 168 of the Treaty on the Functioning of the European Union,

– having regard to Rule 133 of its Rules of Procedure,

A. whereas, on 26 May 2015, a study on the latest generation of contraceptives led by researchers from the University of Nottingham showed that third- and fourth-generation contraceptive pills lead to an increased risk of thrombosis (a risk 1.5 to 1.8 times higher than that of previous pills);

B. whereas, according to a Danish study (2011) as well as a study by the French health insurance department, taking said pills could double the risk of pulmonary embolism;

C. whereas these findings show that frequent exposure to the substances contained in combined oral contraceptives carries ‘significantly higher risks’ than those in second- and third-generation pills;

D. whereas oral contraception concerns 18% of women in developed countries;

1. Notes the research already carried out, in particular by the European Medicines Agency, on third- and fourth-generation pills;

2. Encourages the Commission to issue advisory guidelines and raise awareness among European women of the risks of using third- and fourth-generation contraceptive pills.

Health risks associated with proton pump inhibitors
Motion for a resolution on health risks associated with proton pump inhibitors by Mireille D’Ornano (Date : 09-01-2017 Reference : B8-0101/2017)

The European Parliament,

– having regard to Article 168 of the Treaty on the Functioning of the European Union,

– having regard to Rule 133 of its Rules of Procedure,

A. whereas proton pump inhibitors (‘inhibitors’) are among the medicines most prescribed for gastroesophageal reflux worldwide;

B. whereas a team of researchers at the University of Stanford in the USA has studied the impact of inhibitors on human health and demonstrated a probable causal link with increased risk of myocardial infarction in the general population (10 June 2015);

C. whereas, according to the same study, H2 blockers are an alternative solution, as they are not associated with increased cardiovascular risk;

1. Encourages the Commission to issue advisory guidelines on H2 blockers, and encourages Member States to review their national legislation on inhibitors.

Pricing of medicines
Answer given by Mr Andriukaitis on 09.01.2017 on behalf of the Commission to question for written answer to the Commission by Marian Harkin (ALDE) (Date : 30-11-2016 Reference : P-008962/2016)

Patient access to medicines is an important issue for the Commission. The Commission promotes improved exchange of information among Member States on their pricing policies to minimise negative effects on access to medicines and strengthening Member State cooperation on a voluntary basis.

Equally important, the legality of parallel trade – whereby medicinal products are exported to other Member States which pay higher prices, is confirmed by the jurisprudence of the European Court of Justice. Nevertheless, during an informal ministerial meeting of Health Ministers held by the Slovak Presidency of the Council, Member States exchanged views, on shortages of medicines. In this context, “parallel trade” was identified by some Member States as one of the reasons for human medicines shortages and unavailability in those Member States. Member States may, therefore, adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions.

Research in the field of veterinary medicine
Answer given by Mr Moedas on 06.01.2017 on behalf of the Commission to question for written answer to the Commission by Daniel Buda (PPE) (Date : 17-11-2016 Reference : E-008635/2016)

The European Union (EU) provides support for research and innovation through its Framework Programmes for research and innovation, currently Horizon 2020 (2014-2020).

Under previous Framework Programmes and the current one, the Commission has supported and continues to support – logistically and financially – veterinary research such as research on microbial diseases, their epizootic spreading, and/or their prevention via the development of tools and programmes as well as through research on reproduction, fertility, physiological conditions, networks for veterinary training, improved animal nutrition, etc. Among them, ERA-NETs have been and will be funded, in which participating Member States are fully engaged in the decision-making process. The supported research involves a large number of field veterinarians and/or researchers in Member States.

In Horizon 2020, a multi-actor horizontal approach is used to bridge research and practice by involving all actors from the beginning of the research definition and design to its final application. Thus, veterinary expertise is an integral part of the large research projects aiming at animal health, welfare, production systems, disease control, etc.

There are upcoming calls for the remaining period of Horizon 2020 on topics involving substantial veterinary research. For the 2017 calls under Societal Challenge 2 of Horizon 2020 (still open), there are at least five calls requiring veterinary expertise granting up to EUR 68 million in funding. Thus, researchers and other beneficiaries from all EU countries are invited to submit applications for research grants to be evaluated through an independent evaluation process.

Health inequalities between EU Member States
Answer given by Mr Andriukaitis on 06.01.2017 on behalf of the Commission to question for written answer to the Commission by Monica Macovei (ECR), Patricija Šulin (PPE), Elisabetta Gardini (PPE), Tomáš Zdechovský (PPE), Miroslav Poche (S&D) (Date : 31-10-2016 Reference : E-008271/2016)

Supporting the reduction of health inequalities across the EU and within countries, between regions and social groups, is an overall objective of EU health policy. Any EU activities in this respect recognise the responsibility of Member States for the definition of their health policy and the organisation and delivery of health services. This is the case also for pricing of pharmaceuticals, hence the differences the Honourable Member points out.

The reduction of health inequalities is supported via initiatives with Member States under the Health Programme, in particular in the areas of chronic and rare diseases. In the case of cancer, the Commission supports in cooperation with stakeholders prevention, early identification, screening and treatment such as raising hospitals’ awareness of new treatments and technologies (e.g. immunotherapies or genetic screening). The Commission also plans to launch a Joint Action with Member States on Health Inequalities and Migration.

Also, the State of Health in the EU-cycle and the report Health at a Glance: Europe 2016 aim to support Member States’ evidence-based policy making, boost analytical capacity and strengthen country-specific and EU-wide knowledge on health including on access to healthcare and health inequalities. The Report highlights inequalities in health in Europe, e.g. the fact that many people, in particular from vulnerable and disadvantaged groups, have difficulties in accessing health care due to costs. Poor Europeans are ten times more likely to report unmet medical needs for financial reasons than more affluent Europeans.

The Commission also implements health inequalities-related pilot projects to improve the health of those living in vulnerable situations.

Unfair competition and illegal practices by multinationals
Question for written answer to the Commission by Stelios Kouloglou (GUE/NGL) (Date : 05-01-2017 Reference : E-000040/2017)

A recent court case involving the pharmaceutical company Novartis focuses on investigating its unfair marketing practices and bribery, this time in Greece. Novartis ranks first for market capitalisation among pharmaceutical companies worldwide, and has been involved in similar cases in the US, China, Japan, South Korea and Turkey.

The Greek Novartis file was opened in the summer of 2016, when two Greek whistleblowers – Novartis executives – provided evidence to US authorities which allegedly revealed payments to doctors working both privately and in Greek hospitals.

It is obvious that such practices, including the overpricing of drugs currently under investigation, cause an excessive burden on national health systems.

1. What will the Commission do, at Member State and EU level, to investigate and prevent any such cases of corruption, unfair competition and leverage on the internal market?

2. How will the Commission protect whistleblowers and any citizens who may potentially reveal abusive and illegal corporate practices at EU level?

Access to medicines
Answer given by Mr Andriukaitis on 05.01.2017 on behalf of the Commission to question for written answer to the Commission by Joëlle Mélin (ENF) (Date : 07-11-2016 Reference : E-008378/2016)

Access to medicines is an important issue for the Commission. The Commission promotes exchange of best practices, knowledge and 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 2015, the Commission set up a Commission’s expert group on Safe and Timely Access of Medicines to Patients composed of experts from Member States and the European Medicines Agency to work together on optimising the use of existing regulatory tools to facilitate the development, timely assessment and authorisation of innovative medicines for patients with unmet medical needs.

The EU regulatory system provides incentives to support the development of innovative medicines, including data and market protection and intellectual property rules. A study will be carried out in 2017 to respond to the request made in recent Council conclusions to analyse the impact of the incentives for pharmaceutical products on innovation, the availability and accessibility of medicinal products.

In September 2016, the Commission published an inception impact assessment on strengthening EU coordination in the area of Health Technology Assessments (HTA). A public consultation is currently ongoing until mid-January 2017.

Biotechnologically-produced drugs
Answer given by Mr Moscovici on 23.12.2016 on behalf of the Commission to question for written answer to the Commission by Birgit Collin-Langen (PPE) (Date : 31-10-2016 Reference : E-008202/2016)

1. The evidence for this recommendation is based on scientific literature, expert discussions in different fora and recommendations given out by various national medicines evaluation boards.

2. The decisions on the interchangeability of biosimilars and innovator products rest with the Member States in the EU, and are not regulated as part of the marketing authorisation granted by the European Commission on the basis of an assessment by European Medicines Agency. The countries have the authority to introduce substitution bills. In some countries, substitution is allowed under specific conditions, such as in Cyprus, Estonia, France, Latvia, Malta, Poland, Slovenia and Slovakia. In France, a law was enacted in 2015 allowing biosimilar substitution for naïve patients, and discussions are ongoing for extending the rule for non-naïve patients. In Latvia and Slovakia, for newly diagnosed patients, the cheapest product (which generally is biosimilar) shall be provided in the pharmacy. In fact, there is no special regulation regarding biosimilars; biosimilars are evaluated by general principles applied to generics. Changes might be expected in the future; interchangeability and substitution are under discussion in some Member States (e.g.; Finland, Germany, Italy, Portugal and the Netherlands).

Increase in number of refugees in Lesvos and shortage of medicines and children’s vaccines on the island
Question for written answer to the Commission by Notis Marias (ECR) (Date : 21-12-2016 Reference : E-009700/2016)

In Greece, shortages of children’s medicines and vaccines are severe in view of the increased needs in the country resulting from the refugee crisis.

According to the Pan-Hellenic Pharmaceutical Association, the shortage of vaccines for children, such as hepatitis B vaccine, and of medicines used for neuro-psychiatric conditions in areas with a high number of refugees is expected to result in serious public health problems.

Moreover, there is a major shortage of influenza vaccines, while often a mismatch can be seen between the quantities ordered and the availability of medicines, as is the case in Lesvos. The Pharmaceutical Association of Lesvos has already condemned the massive shortage of medicines on the island, and is expected to lodge a complaint against the firm responsible for the provision of medicines to Lesvos.

In view of this:

1. What measures will the Commission take to ensure that the subsidies from the EU and from the Asylum, Migration and Integration Fund for the provision of medicines and children’s vaccines to the children on the island of Lesvos are actually used?

2. What measures will it take to immediately cover the current medicine shortages in Greece?

Relocation of the European Medicines Agency
Answer given by Vice-President Katainen on 20.12.2016 on behalf of the Commission to question for written answer to the Commission by Brian Hayes (PPE) (Date : 29-09-2016 Reference : E-007270/2016)

By common agreement, the Representatives of the Governments of the Member States, meeting at Head of State and Government level, decided in 1993 to locate the European Medicines Agency in London, UK.

Until the Treaties cease to apply to a Member State that has notified, in accordance with Article 50 TEU, the European Council of its intention to withdraw from the Union, that State remains a member of the Union with all rights and obligations of a Member State.

Reactionary proposals for ‘self-diagnosis, self-medication and self-care’
Answer given by Mr Andriukaitis on 15.12.2016 on behalf of the Commission to question for written answer to the Commission by Sotirios Zarianopoulos (NI) (Date : 31-10-2016 Reference : E-008189/2016)

The Commission is not in a position to take any action in relation to the matter raised by the Honourable Member. The definition of health policy and the organisation and delivery of health service and medical care are the responsibility of the Member States, as well as the management of health insurance and the allocation of resources assigned for this purpose according to Article 168 of the Treaty on the Functioning of the European Union.

The Commission supports Member States in improving health system’s performance towards more effective, available and resilient health systems.

Review of the regulation on paediatric medicines
Answer given by Mr Andriukaitis on 14.12.2016 on behalf of the Commission to question for oral answer to the Commission by Giovanni La Via, Françoise Grossetête, Elena Gentile, Bolesław G. Piecha, Frédérique Ries, Stefan Eck, Joëlle Mélin, on behalf of the Committee on the Environment, Public Health and Food Safety (Date : 09-11-2016 Reference : O-000135/2016)

Giovanni La Via moved the question.

Vytenis Povilas Andriukaitis (Member of the Commission) answered the question.

The following spoke: Françoise Grossetête, on behalf of the PPE Group, Elena Gentile, on behalf of the S&D Group, Stefan Eck, on behalf of the GUE/NGL Group, Piernicola Pedicini, on behalf of the EFDD Group, Miroslav Mikolášik, Soledad Cabezón Ruiz, John Stuart Agnew, Michaela Šojdrová and Claude Rolin.

The following spoke under the catch-the-eye procedure: Notis Marias and Nicola Caputo.

The following spoke: Vytenis Povilas Andriukaitis.

Motion for a resolution to wind up the debate tabled under Rule 128(5):

— Giovanni La Via, Françoise Grossetête, Elena Gentile, Bolesław G. Piecha, Frédérique Ries, Stefan Eck and Joëlle Mélin, on behalf of the ENVI Committee, on the regulation on paediatric medicines (2016/2902(RSP)) (B8-1340/2016).

The debate closed.

Impact of counterfeit medicines
Answer given by Mr Andriukaitis on 14.12.2016 on behalf of the Commission to question for written answer to the Commission by Daniel Buda (PPE) (Date : 19-10-2016 Reference : E-007894/2016)

The Falsified Medicines Directive (FMD) 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. Nevertheless, it needs to be highlighted that 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 (i.e. the problem of counterfeit medicines). The new measures include:

— Obligatory safety features on the outer packaging of the medicines, to be detailed via a delegated act;
— A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
— Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients;
— Strengthened record-keeping requirements for wholesale distributors.

The Commission is working intensively with the Member States to ensure the smooth implementation of the safety features (a unique identifier and an anti-tampering device). To this end, the Commission published the Delegated Regulation on the safety features for medicines for human use on 9 February 2016. The implementation of the safety features shall be applicable as of February 2019 and will ensure a performant traceability of the medicinal products.

Provisions banning discounts for medicines supplied to patients in Germany

Evaluation of the Health Claims Regulation: Avoiding Unfair Competition
Answer given by Mr Andriukaitis on 01.12.2016 on behalf of the Commission to question for written answer to the Commission by Jens Gieseke (PPE) (Date : 28-10-2016 Reference : P-008126/2016)

The Commission is aware of the concerns raised by the Honourable Member regarding the situation described. This is why within the REFIT evaluation currently undertaken on the Health Claims Regulation, and in particular with regard to the health claims made on plants and their preparations and the general regulatory framework for their use in foods, the Commission will be also looking at the potential impacts of the Regulation on the trade of herbal medicinal products bearing therapeutic indications.

The Commission is also aware of the potential effects on small and medium enterprises (SMEs) operating in both the food and the medicinal sector. Hence, in the context of the above-mentioned evaluation, an additional consultation, specifically targeting SMEs, aims at providing further evidence.

The issue of health claims on plants and their preparations used in food is complex, yet based on a fundamental principle: no misleading claim should be permitted on foods, regardless of the substance on which the claim is made. The health claims referred to by the Honourable Member, may only be used under the transitional measures provided for in Article 28(5) of the Claims Regulation under the responsibility of food business operators and provided that they comply with the general principles and conditions of the Claims Regulation and with existing national provisions applicable to them. Among these conditions is that the food, subject to the claim, has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence, in respect to the health claim made. Food business operators must be able to produce all relevant elements and data establishing compliance with this Regulation.

Development of European healthcare systems
Answer given by Mr Andriukaitis on 28.11.2016 on behalf of the Commission to question for written answer to the Commission by Jérôme Lavrilleux (PPE) (Date : 30-09-2016 Reference : E-007335/2016)

The Commission Communication on effective, accessible and resilient health systems points to policies and measures that Member States could use to improve and adapt their health systems. These are in line with the reform recommendations addressed to Member States in the context of the European semester and more recently, in the report prepared jointly by the Commission services and the Member States “Joint Report on Health Care and Long Term Care Systems and Fiscal Sustainability” in the EU.

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

The EU regulatory system provides incentives to support innovation for the development and authorisation of medicines, including data and market protection and intellectual property rules. To respond to the request made in recent Council conclusions, the Commission will analyse the impact of incentives on access to innovative medicines.

Measures regulating the prices of medicines, the organisation of the health systems and the delivery of care are Member States’ responsibility. The Commission encourages Member States to cooperate in this area and to use the results of relevant reports as mentioned above to ensure access to care and medicines and, in particular improving the sustainability of pharmaceutical expenditure by promoting policies for the cost-effective use and the affordability of medicines.

Unequal treatment of Parkinson’s sufferers
Answer given by Mr Andriukaitis on 25.11.2016 on behalf of the Commission to question for written answer to the Commission by Daciana Octavia Sârbu (S&D) (Date : 24-10-2016 Reference : P-007974/2016)

As stated in the Treaty on the Functioning of the European Union, Member States are responsible for the organisation and delivery of health services and medical care, including the availability of treatment.

As regards discrimination in the workplace, Directive 2000/78/EC prohibits discrimination on the grounds of e.g. of disability, age, sexual orientation and religion and provides for reasonable accommodation in employment for persons with disabilities. The Commission regularly monitors the effective implementation of this directive in the Member States, and when appropriate, launches infringement procedures.

The European Disability Strategy 2010-2020, as a tool for the implementation of the UN Convention on the Rights of Persons with Disabilities, recognises the right of persons with disabilities to work on an equal basis; as well as the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability.

Through the European Structural and Investment Funds, the EU supports employment and anti-discrimination. On the basis of Member States’ operational programmes, it is possible to estimate that in 2014-2020, the funds could provide around EUR 41 billion for the employment and labour market, EUR 44.4 billion for social inclusion (including anti-discrimination) and EUR 35 billion for education and training.

Antimicrobial resistance action
Answer given by Mr Andriukaitis on 24.11.2016 on behalf of the Commission to question for written answer to the Commission by Miriam Dalli (S&D) (Date : 30-09-2016 Reference : E-007386/2016)

Antimicrobial resistance (AMR) is a major global challenge with serious implications for the economy and human health. Each year, drug resistant infections result in an estimated 25,000 patient deaths and cause EUR 1.5 billion worth of healthcare and productivity losses in the EU. The evidence suggests that these costs will increase exponentially in the absence of decisive corrective actions.

The Council conclusions, adopted in June 2016 under the Dutch Presidency, call for a reinforced EU strategy against AMR and a new and comprehensive EU Action Plan on AMR based on the One-Health approach. At global level, AMR is also high on the political agenda within G7, G20 and the United Nations (UN). The meeting on AMR held at the UN General Assembly on 21 September 2016 marked an important milestone for high-level global political commitment against AMR.

The evaluation of the current Action Plan against AMR adopted in 2011, has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and a framework to guide and coordinate activities on AMR at international level.

However, this evaluation published on 24 October 2016, has also shown that the AMR problem is persisting and continued action is needed to tackle it. Therefore the Commission will prepare the new AMR Action plan in the first half of 2017 in order to reinforce the One-Health approach and make the EU a ‘best-practice’ region on AMR, to give a stronger push to innovation and research for the development of rapid diagnostic tests and alternatives to antimicrobials, and to actively contribute to broader actions aimed at tackling AMR at global level.

Regulation of paediatric medicines in the EU – further action
Answer given by Mr Andriukaitis on 14.11.2016 on behalf of the Commission to question for written answer to the Commission by Vilija Blinkevičiūtė (S&D) (Date : 15-09-2016 Reference : E-006905/2016)

In 2013, the Commission published a first progress report on the Paediatric Regulation, which pointed to improvements in the paediatric medicines landscape.

The Commission is currently preparing a second report on the impact and the functioning of the Paediatric Regulation, to be published in 2017. According to Article 50(3) of the regulation, this report should also discuss to what extent amendments to the current provisions might be appropriate. The Commission will therefore focus on this second report, before considering further necessary steps.

Antibiotic resistance
Motion for a resolution on antibiotic resistance by Mireille D’Ornano, Sylvie Goddyn, Jean-François Jalkh (Date : 09-11-2016 Reference : B8-1218/2016)

The European Parliament,

– having regard to Article 168 of the Treaty on the Functioning of the European Union,

– having regard to the Council recommendations of 15 November 2001, 10 June 2008, 1 December 2009 and 17 June 2016,

– having regard to the Commission Communication of 15 November 2011,

– having regard to the World Health Organisation global action plan of 25 May 2015,

– having regard to Rule 133 of its Rules of Procedure,

A. pointing out that, according to OECD data, antibiotic resistance causes 700 000 deaths per year;

B. deploring the fact that private investment into pharmaceutical research into antibiotic treatments is on the decline;

C. welcoming national initiatives, in particular the creation of the ‘Fleming Fund’ by the UK for pharmaceutical research into antibiotic resistance;

D. taking note of European initiatives in this area, in particular the Joint Programming Initiative and the European Innovative Medicine Initiative;

1. Calls on the Commission to support pharmaceutical research into the development of new antibiotics or rapid diagnostic tools from existing European scientific research funds;

2 Calls on the Commission to take part in the World Health Organisation’s surveillance programme.

Late introduction of system for the serialisation of medicines
Answer given by Mr Andriukaitis on 04.11.2016 on behalf of the Commission to question for written answer to the Commission by Davor Škrlec (Verts/ALE) (Date : 04-10-2016 Reference : P-007508/2016)

1. The legislation does not require the Commission to adopt the delegated act setting up the detailed rules for the safety features of medicinal products for human use within a specific legal deadline. Nevertheless, the Commission confirms that more time than initially expected was needed to adopt the provisions due to the impact assessment, the involvement of stakeholders and the complexity and technical nature of measures to be put in place.

2. The legislation does not provide an obligation for the European Medicines Verification Organisation to share its contacts with the national medicines verification organisations.

3. Until the Treaties cease to apply to a Member State that has notified, in accordance with Article 50 of the Treaty on European Union (TEU), the European Council of its intention to withdraw from the Union, that State remains a member of the Union with all rights and obligations of a Member State. In line with the Statement of 29 June 2016 of the Heads of State or Government of 27 Member States, as well as the Presidents of the European Council and the European Commission, there can be no negotiations of any kind before a notification under Article 50 TEU has taken place. At this stage, it is therefore not possible to give a more precise answer to the questions of the Honourable Member.

Value-added medicines
Answer given by Mr Andriukaitis on 04.11.2016 on behalf of the Commission to question for written answer to the Commission by Roberta Metsola (PPE) (Date : 31-08-2016 Reference : E-006571/2016)

‘Value added medicines’ is a term used by some stakeholders generally for new medicines based on known substances. EU legislation already provides for the authorisation of such medicines. It includes specific provisions for new indications of well‐established substances as well as for medicinal products that have been in well-established medicinal use.

Following authorisation, in accordance with Member States legislation, medicinal products undergo health technology assessments (HTA) performed by designated HTA bodies. HTA assesses the added value of given health technologies, including medicinal products, over and above existing ones, helping Member States to allocate national resources to effective health interventions.

Therefore, as for any medicinal products receiving a marketing authorisation, medicines which fall within the concept of ‘value added medicine’ would undergo HTA, in accordance with national provisions.

The Commission is also supporting Member States in their efforts to ensure sustainability of their healthcare budgets. In this regard, the Commission recently published an inception impact assessment for an initiative to strengthen EU cooperation on HTA.

Antimicrobial resistance
Answer given by Mr Andriukaitis on 21.10.2016 on behalf of the Commission to question for written answer to the Commission by DAME Glenis Willmott (S&D), Judith Sargentini (Verts/ALE), Beatriz Becerra Basterrechea (ALDE) (Date : 02-09-2016 Reference : E-006648/2016)

The Commission considers antimicrobial resistance (AMR) to be a big and urgent global risk requiring international and national attention, and is willing to cooperate in all suitable forms, including as regards a global AMR development and stewardship framework under the auspices of the World Health Organization.

DRIVE-AB, a three year project started in 2014, conducts research on AMR, engages stakeholders, creates and tests new business models and will disseminate its findings by the end of 2017. In June 2016 DRIVE AB organised a conference on “Stimulating innovation, sustainable use and global access to antibiotics”, to present the preliminary results of its research and sought feedback from stakeholders regarding the feasibility of incentive policies and reward models.

A key objective of the TRANSLOCATION project is sharing data and knowledge on the development of both failed and successful drug candidates to provide companies and the public sector access to key information that can accelerate novel antimicrobials’ development. A key outcome of the COMBACTE project is an accessible pan-European network of hospitals and laboratories prepared for and experienced in performing high-quality multinational trials at all stages of antibiotic development. Both projects together with DRIVE-AB are collaborating and sharing data within the overarching New Drugs for Bad Bugs programme, where stewardship aspects are addressed by the latter. As regards access to the medicines that would benefit from the research developed under such projects, it should be noted that pricing and reimbursement, which ultimately determine the availability of medicines are under the sole authority of Member States.

Depakine
Answer given by Mr Andriukaitis on 20.10.2016 on behalf of the Commission to question for written answer to the Commission by Dominique Bilde (ENF) (Date : 24-08-2016 Reference : E-006304/2016)

The “Agence Nationale de Sécurité du Médicament et des Produits de Santé” has published a report on the risks associated with Valproate medicines including Depakine. Valproate-containing medicines have been authorised nationally.

Medicines safety is of paramount importance to the EU. After marketing authorisation, medicines are subject to a post-marketing surveillance. This includes the analysis of new emerging safety information. Reports on suspected adverse drug reactions are collected in the EU centralised database. Signals on safety risks are evaluated by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee and a regulatory action is taken, as appropriate.

Regulatory action on valproate and the risks of birth defects and developmental problems in children was taken at EU level in 2014 by the Coordination Group for Mutual Recognition and Decentralised Procedure. It recommended strengthened warnings related to the risk in the product information and the introduction of educational materials to healthcare professionals and patients. Doctors in the EU are advised not to prescribe valproate for epilepsy or bipolar disorder in pregnant women, in women who can become pregnant or in girls unless other treatments are ineffective or not tolerated.

Since the 2014 review, valproate medicines are under continuous monitoring by the EMA and Member States. In 2016, the EMA approved the design of a study to assess the effectiveness of risk minimisation measures and to chart prescribing patterns with valproate. This study should provide useful information to guide risk minimisation in the future.

Prices of medicines and EU-funded medical research and development
Answer given by by Mr Moedas on 17.10.2016 on behalf of the Commission to question for written answer to the Commission by Marian-Jean Marinescu (PPE) (Date : 16-09-2016 Reference : P-006918/2016)

Projects funded under Horizon 2020 are not intended to support the direct market introduction of new products. The applicable rules do not foresee conditions being attached to EU-funded research projects on pricing of products that may come out of such projects.

Projects funded in the area of health research and innovation address the specific objective to improve the lifelong health and well-being of all. These projects contribute to the objectives of Horizon 2020 and the priorities of the Commission, in particular regarding Jobs, Growth and Investment. Return on investment from such EU-funded health research consists in creating jobs and economic growth, maintaining leadership of EU health research and innovation, supporting academic research institutions and SMEs, and increasing competitiveness of industry with the pharmaceutical industry being one of the EU’s key industries.

Information on funding for projects supported through Horizon 2020 is fully transparent. Beyond the costs for the projects to be implemented under an EU research grant, Horizon 2020 does not provide for the obligation of beneficiaries to disclose costs not related to the implementation of such grants.

According to Article 168(7) of the Treaty on the Functioning of the European Union, Member States are responsible for the definition of their health policies and for the organisation and delivery of health services. This includes measures regulating the prices of medicines and their inclusion in health insurance systems.

Access to medicines
Answer given by Mr Andriukaitis on 05.10.2016 on behalf of the Commission to question for written answer to the Commission by Piernicola Pedicini (EFDD) (Date : 05-08-2016 Reference : E-006218/2016)

As stated by the Honourable Member, on 17 June 2016 European Health Ministers adopted Council Conclusions inviting the Commission to analyse the impact of the incentives for pharmaceutical products on innovation, the availability and accessibility of medicinal products. Among those, particular attention should be paid to supplementary protection certificates, to the use of the “Bolar” patent exemption and to data exclusivity and market exclusivity. To this end, the Commission is invited to prepare by the end of 2016 a timetable and methodology for conducting the analysis.

The Commission has taken due note of the request from the Council and will follow the standard procedures associated with the commissioning of relevant studies. The Commission had already announced its intention to evaluate the Regulation on supplementary protection certificates in its Single Market Strategy.

It is envisaged to present the timetable and methodology to the Member States towards the end 2016. The Commission intends to keep the European Parliament informed and updated on this issue.