European Parliament Pharma Watch

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

Change in the formula for Levothyrox and its consequences
Answer given by Mr Andriukaitis on 08.08.2018 on behalf of the Commission to question for written answer to the Commission by Mireille D’Ornano (EFDD) (Date : 26-06-2018 Reference :E-003511/2018)

The change to a new formulation of Levothyrox was requested by the French authorities to reduce deterioration of the active substance over time during storage of the tablets. This change also provided the opportunity to avoid lactose, unsuitable for patients with lactose intolerance, in tablets’ composition.

The marketing authorisation holder for Levothyrox has initiated a procedure to make the same formulation changes to most of its levothyroxine medicines across the EU. In this context, the German regulatory authority, Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), which is leading the procedure, sought advice from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) on any potential safety concerns with the new formulation. Based on the available information, the PRAC agreed that there is no difference in the pattern of adverse events reported before and after the switch to the new formulation.

In general, side effects associated with a switch to a new formulation of levothyroxine are expected in some patients because this medicine has a narrow therapeutic index, which means that the difference between the therapeutic dose and a dose which may trigger side effects is very small.

In January 2018, the PRAC recommended issuing specific advice to healthcare professionals on how to manage patients when switching from one formulation to another. This includes blood tests to ensure that the dose is adjusted to the individual patient situation. Particular attention should be paid to vulnerable groups, including patients with thyroid cancer and cardiovascular disease, pregnant women, children, and the elderly.

Effects of Depakine on pregnant women
Answer given by Mr Andriukaitis on 07.08.2018 on behalf of the Commission to question for written answer to the Commission by Marina Albiol Guzmán (GUE/NGL) (Date : 26-06-2018 Reference :E-003501/2018)

Medicines in the EU are subject to a post-marketing surveillance for which obligations to marketing authorisation holders and competent authorities are set by the legislation. Signals on safety risks are evaluated by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) and a regulatory action is taken, as appropriate.

A recent scientific review by the EMA recommended new measures to avoid valproate exposure in pregnancy (e.g. ban on use for migraine or bipolar disorder during pregnancy, a ban on treating epilepsy during pregnancy unless no other effective treatment available). These recommendations are reflected in the summary of product characteristics that is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively.

The Commission does not have figures on the number of people affected in the EU. However, data may be available in some Member States.

Regarding compensation, it should be stressed that health policy, as well as the organisation and delivery of healthcare, is a Member State competence under Article 168 of the Treaty on the Functioning of the EU.

Overall, the Commission takes the view that the legal framework to monitor medicines has been continuously strengthened to ensure that the medicines which are made available to patients in the EU correspond to high standards of quality, safety and efficacy.

Brexit impact assessments: medicines, pharmaceuticals and medical and healthcare products
Answer given by President Juncker on 01.08.2018 on behalf of the Commission to question for written answer to the Commission by Rory Palmer (S&D) (Date : 24-05-2018 Reference :E-002776/2018)

The Commission did not draw up an assessment of the impact of the withdrawal of the United Kingdom from the European Union in the area of medicines and healthcare products. The Commission would like to recall that the decision of the United Kingdom to withdraw from the Union was a unilateral decision of the United Kingdom. The Commission regrets, but respects, this decision. The Commission, the European Medicines Agency and EU 27 national competent authorities are taking all necessary measures to ensure preparedness of the European Union with regard to medicines and healthcare products. In particular, Commission services have published ‘preparedness notices’ to stakeholders as regards medicinal products (jointly with the European Medicines Agency) and medical devices. More information is available on the respective website of the Commission services and of the European Medicines Agency.

Pharmacovigilance and drug safety
Question for written answer to the Commission by Sophie Montel (EFDD) (Date : 27-07-2018 Reference :E-004178/2018)

Recently, several health scandals linked to medicines have unfolded in France; the latest, responsibility for which is yet to be accepted, involves Merck laboratories and the new formula for their drug Levothyrox. The placing on the market of a new formula has resulted in an as yet unexplained wave of side effects in patients on this course of treatment. Some have even gone as far as obtaining the old formula in other EU member states where it has not yet been changed.

Does the Commission believe that the EU’s current pharmacovigilance and drug safety system is effective if Member States have their own national systems? Does the Commission plan to change how its drug safety system works in order to avoid further health scandals of a similar nature? Should we not consider establishing a marketing authorisation system which goes beyond national and European levels and aims for authorisation on a global scale, under the independent supervision of the WHO?

Use of real-world data for medical research
Answer given by Mr Andriukaitis on 26.07.2018 on behalf of the Commission to question for written answer to the Commission by Roberta Metsola (PPE) (Date : 31-05-2018 Reference :E-002999/2018)

On 25 April 2018, the Commission adopted a Communication on digital health and care, which includes a key section on better data to promote research, disease prevention and personalised health and care. In the Communication, the Commission presents, as area for piloting, the use of real-world data by healthcare professionals, public authorities and industry to ensure that healthcare products, innovative technologies and therapies meet patients’ needs and lead to favourable health outcomes.

The Commission aims to take this pilot forward, by leveraging existing work and optimizing use of real-world data by researchers, healthcare professionals, health technology assessment agencies, regulatory and other public authorities. Therefore as a first step, the Commission will take into account the existing programmes and ongoing initatives in the field such as Horizon 2020 and Innovative Medicines Initiative research projects, EUnetHTA and GAPP Joint Actions, projects led by the European Medicines Agency and feedback from all relevant stakeholders. Objectives will be to improve the common understanding on how the value of real-world data can be best captured and to provide practical guidance for its use.

Online sales of medicines on prescription
Answer given by Mr Andriukaitis on 26.07.2018 on behalf of the Commission to question for written answer to the Commission by Lieve Wierinck (ALDE) (Date : 28-05-2018 Reference :E-002879/2018)

The Commission introduced stricter rules for online sales of medicines in 2011 to address the increasing concerns of falsified medicines sold to consumers in the EU via the internet. These include a common EU logo for online pharmacies, and the requirement for online pharmacies to obtain an authorisation to supply medicines at a distance and notify the Member State authorities where they are established of their intention to sell medicines online. At the same time, Member States are allowed to maintain prohibitions of online sales of prescription medicines in order to safeguard public health.

The Commission and the Member States have worked together in recent years to enable healthcare providers to exchange patient data (ePrescriptions and patient summaries) across borders by setting up an eHealth Digital Service Infrastructure (eHDSI). Thanks to this infrastructure, 22 Member States will eventually exchange patient data by 2020.

With the recently adopted Communication on enabling the digital transformation of health and care, the Commission commits to further support this infrastructure, and to expand the exchange of data to cover full electronic health records. This will give healthcare providers and patients cross-border access to medical data and increase interoperability between health systems at larger scale.

In addition, the cross-border healthcare Directive includes the recognition of medical prescriptions issued in a Member State other than the Member State where the prescriptions are dispensed.

Enforcement of Article 85d of the Falsified Medicines Directive
Question for written answer to the Commission by José Inácio Faria (PPE) (Date : 20-07-2018 Reference :E-004104/2018)

It has been three years since the common logo for online pharmacies was introduced by the Falsified Medicines Directive (2011/62/EU). Member States are still a long way from fully implementing their obligations, with an alarming lack of uptake on Article 85d.

The Commission developed a communication toolbox to help countries launch targeted national information campaigns with a consistent message across the EU. However, the usefulness of the Commission’s website as a key tool to address falsified and substandard medicines is questionable. According to ASOP EU research, the awareness rate of the common logo and its purpose is both low and highly variable, ranging from 16% to 40%.

Can the Commission provide statistics on the relevant pages of its website, such as the number of visits, time spent and pages visited? Can it also verify the statistics for the corresponding websites of the Member States, and outline its target levels for such statistics?

Given that metrics are likely to show below-target performance for public awareness, can the Commission state when it intends to send warning letters to Member States that have not yet launched public awareness campaigns or whose campaigns fall below the Commission’s targets?

Comprehensive SPC manufacturing waiver needed for European patients and SMEs
Question for written answer to the Commission by Brian Hayes (PPE) (Date : 19-07-2018 Reference :E-004041/2018)

The Commission recently published a legislative proposal to introduce an export manufacturing waiver to the Supplementary Protection Certificate (SPC) Regulation. Whilst this proposal is welcome, there are significant concerns from industry that it does not go far enough to alleviate existing barriers to enable EU patients to access medicines as soon as the SPC expires, to unlock savings for EU payers, and to allow the development of the generic and biosimilars industry in Europe.

1. Why has the Commission’s SPC waiver proposal sought to exclude EU patients from earlier access to more affordable medicines, by limiting its terms to allowing generic companies to produce in Europe only for export outside of the EU?

2. Can the Commission outline the basis for why its existing SPC waiver proposal will prevent access for European patients to more affordable medicines as a result of day one launch after an SPC expiry?

3. Why will the proposal apply only to future medicines and not existing medicines, which are to come off-patent over the coming years, thereby denying more immediate access to affordable medicines to European patients?

Funding research programmes on Down syndrome
Answer given by Mr Moedas on 13.07.2018 on behalf of the Commission to question for written answer to the Commission by Marijana Petir (PPE) (Date : 22-05-2018 Reference :E-002721/2018)

The Commission is aware of the number of people affected by Down syndrome and their plight. The prevalence of Down syndrome in Europe is monitored by the European Surveillance of Congenital Anomalies (EUROCAT), the European network of population-based registries for the epidemiologic surveillance of congenital anomalies.

The Joint Research Centre of the European Commission manages the Central Registry and European level coordination as part of the European Platform on Rare Diseases Registration.

Over the past 10 years, the EU has dedicated some EUR 70 million to research on intellectual disabilities and Down syndrome in 61 research projects. The EU will continue to support research in these areas to improve the quality of life of people with intellectual disabilities and their carers, and to eliminate stigmatisation and alleviate the social and economic burden.

In the Horizon 2020 Societal Challenge 1, most topics addressing non-communicable diseases do not specify any diseases in particular and therefore are open to less prevalent diseases, including those involving clinical trials. For instance, the 2019 Work Programme contains a topic on mental and non-mental comorbidities that could support research on the links between Down syndrome and Alzheimer’s disease or autism.

It is the intention of the Commission that the next Framework Programme — Horizon Europe, should maintain this approach of very open competitive calls for proposals. Thus, the Health cluster would not address specific diseases, but two areas of intervention would address the needs of people with disabilities, i.e. area 1 ‘Health throughout the Life Course’ and area 5 ‘Tools, Technologies and Digital Solutions for Health and Care’, while area 3 would address ‘Non-Communicable and Rare Diseases’.

The need for updated legislative provisions regarding advanced therapeutic medicinal products (ATMPs)
Question for written answer to the Commission by Norica Nicolai (ALDE), Cristian-Silviu Buşoi (PPE), Miroslav Mikolášik (PPE), Jana Žitňanská (ECR) (Date : 13-07-2018 Reference :E-003922/2018)

Over the past 50 years, rare disease patients, such as those with haemophilia, have greatly benefited from advances achieved in science, many of which have significantly improved the lives of patients and their families.

These scientific advances, in the form of breakthrough treatments, have often been the catalyst for legislative change (e.g. the 2000 Orphan Medicinal Products Regulation and the 2007 Advanced Therapeutic Medicinal Products (ATMPs) Regulation).

However, as Commissioner Andriukaitis has stated, ‘scientific developments with potential for application in healthcare are occurring at an unprecedented pace’.

Novel therapies are currently in development for many rare diseases. Yet, the latest joint European Commission and EMA action plan on ATMPs does not foresee changes to the present legal framework, despite the Commission’s own report from 2014 on the ATMPs Regulation concluding that ‘too burdensome requirements could have detrimental consequences for public health as it could prevent the appearance of valid treatments for unmet medical needs’.

To this end, could the Commission clarify the reasoning behind the decision not to establish new/updated legislative provisions for ATMPs?

The situation of the pharmacy market in Germany
Question for written answer to the Commission by Antanas Guoga (PPE) (Date : 12-07-2018 Reference :E-003882/2018)

On 19 October 2016, the Court of Justice of the European Union decided that a system of fixed prices for the sale by pharmacies of prescription-only medicinal products for human use (as applied in Germany) constitutes a measure having equivalent effect to a quantitative restriction on imports, since that legislation has a greater impact on the sale of prescription-only medicinal products by pharmacies established in other Member States than on the sale of the same medicinal products by pharmacies established within the national territory (Case C-148/15).

As a consequence, Germany would need to simplify market access for pharmacies established in other Member States, i.e. by repealing the system of fixed prices.

However, Germany intends to ban pharmacy mail order services with regard to prescription-only medicinal products in order to protect its pharmacy market from foreign competition. In the meantime, Lithuania has announced its intention to liberalise pharmacy mail order services.

What is the Commission’s assessment of the case of a protectionist ban on pharmacy mail order services in Germany?

Font size in packaging of medicinal products
Question for written answer to the Commission by Pirkko Ruohonen-Lerner (ECR) (Date : 12-07-2018 Reference :E-003852/2018)

Directive 2001/83/EC of the European Parliament and of the Council stipulates on the legibility of medicinal package labelling. The information on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging shall be easily legible, clearly comprehensible and indelible (Article 56).

Additionally, Article 63 stipulates that the package leaflet must be written in clear and understandable terms for the users and be clearly legible.

In accordance with Article 65 of the directive, the Commission shall, as necessary, publish guidelines concerning the legibility of particulars on the labelling and package leaflet.

The Commission’s Guideline on the readability of the label and package leaflet of medicinal products for human use from 2009 recommends the type size to be as large as possible to aid readers, specifying size of 9 points, as measured in font ‘Times New Roman’.

The Commission’s report in March 2017 stated that there is a need to enhance the way information is distributed to patients and healthcare personnel. As a result, the European Medicines Agency (EMA) presented an action plan to improve product information for medicines in November 2017.

The action plans concludes that the elderly and those with low literacy skills are particularly disadvantaged. Small font size, narrow line spacing and the length of the package leaflet were identified as the main issues. The EMA recommends revising the recommendations in particular concerning the guidelines on readability and package leaflets.

1. Why has the Commission not updated its guidelines on the readability of the label and package leaflet, even though its own report from March 2017 shows a need for it to be revised?

2. Why was Times New Roman, size of 9 points, considered an appropriate font size for medicinal packages in 2009, even though the elderly are known to use lots of medications and often suffer from poor eyesight?

Pharmacokinetic studies for vaccines
Answer given by Mr Andriukaitis on 11.07.2018 on behalf of the Commission to question for written answer to the Commission by Cristian-Silviu Buşoi (PPE) (Date : 29-05-2018 Reference :E-002905/2018)

Vaccines like all medicines are authorised according to EU legal requirements and only after their quality, safety and efficacy have been evaluated. Vaccines are monitored for safety and adverse reactions through their lifecycle. Signals on safety risks are reported at the EU level and evaluated by the European Medicines Agency (EMA) and regulatory actions are taken, as appropriate.

The EMA provides guidelines with the requirements on clinical evaluation of vaccines. It addresses the studies to be performed of new vaccines and may also be applicable to the further development of already licensed vaccines.

Experience with vaccine development has shown that the pharmacokinetic (PK) properties of antigens included in vaccines do not provide useful information for determining dose recommendations and this is the main purpose of doing such studies.

Vaccines are biological medicines that have different characteristics from chemical substances. Since the metabolic pathways of vaccines are generally understood (they are metabolised into small peptide and eventually to amino acids), and the action of vaccines is mediated locally at the site of injection and draining lymph nodes, PK studies are generally not required for vaccines.

However, in some cases PK evaluation is needed in particular when vaccines contain novel adjuvants/excipients or when delivered in the body using new delivery systems. This will have to be evaluated on a case-by-case basis, taking into account the expected impact on efficacy and safety and available preclinical information.

EU-Ukraine Association Agreement and access to medicines
Question for written answer to the Commission by Nessa Childers (S&D) (Date : 11-07-2018 Reference :E-003845/2018)

The Ukrainian healthcare system is undergoing sensitive reforms, including a legislative review to ensure access to medicines and medical treatment.

In a context where 95% of Ukrainian citizens have to purchase medication out of their own pockets and 15% of the population are forced either into indebtedness or into forgoing unaffordable treatment, could the Commission justify its stance in the framework of the EU-Ukraine Association Agreement, whereby it requires the Ukrainian intellectual property rights regime to continue patenting new forms of known medicines, thus artificially extending monopolies on medicines despite the fact that such minor changes to medicines deviate from the internationally recognised criteria for an inventive step and thus do not constitute an invention?

Would the Commission be willing to reconsider this stance and afford the Ukrainian authorities the flexibility foreseen under international trade law, thus enabling them to improve public health provision, as a matter of fundamental human rights and under highly challenging national circumstances?

Specifically, would the Commission be willing to accept the Ukrainian government’s draft law No 7538 amending the law on ‘Protection of Rights on Inventions and Utility Models’, which has now been submitted to the Ukrainian parliament, in its current form, which aims at safeguarding against evergreening practices, streamlining compulsory licensing and ensuring the timely marketing of generic medicines?

Fibromyalgia – authorisation of medicinal products
Question for written answer to the Commission by Takis Hadjigeorgiou (GUE/NGL) (Date : 10-07-2018 Reference :E-003801/2018)

Fibromyalgia is a chronic condition that causes symptoms such as pain in the muscles, ligaments and tendons. It also causes co-morbidities such as headaches, irritable bowel syndrome and depression.

14 million Europeans suffer from this condition.

Patients have problems with their health systems because there are no blood tests to confirm the diagnosis, so fibromyalgia is not recognised as a disability.

Neurobiological studies show that, with fMRI testing, pain treatment centres are activated in patients with fibromyalgia when they explain the pain they feel. Patients also appear to have a central nervous system which is hypersensitive to stimuli. We also know that there is a neurotransmitter imbalance (serotonin, dopamine, norepinephrine).

As far as work is concerned, only 50-55% of patients continue to work after diagnosis.

Will the Commission say:

In Europe, why has the European Medicines Agency (EMEA) not authorised the three preparations approved for fibromyalgia in the US by the equivalent agency, the Food and Drugs Administration (FDA), to relieve symptoms and thus enable sufferers to continue working?

Why is fMRI not used to diagnose the condition so as to prove the existence of a disability?

The European Medicines Agency’s ability to function during its relocation phase
Question for written answer to the Commission by Biljana Borzan (S&D), Karin Kadenbach (S&D), Kateřina Konečná (GUE/NGL), Piernicola Pedicini (EFDD) (Date : 10-07-2018 Reference :P-003774/2018)

One of the consequences of Brexit is that the European Medicines Agency (EMA) will relocate to Amsterdam, the Netherlands, where it has to commence its operations by 30 March 2019 at the latest. The EMA has developed a business continuity plan to deliver its highest priority activities and to temporarily scale back or suspend lower priority activities if required.

In the highlights of the 100th meeting of the EMA Management Board, it is stated that the Board ‘cautioned that if EMA does not receive sufficient staff resources in the face of growing workload in product-related activities, and the preparation for Brexit, the ability of the Agency to implement current and upcoming legislation may be impaired’.

The EMA is essential to the functioning of the single market for medicines in the EU and it would be regrettable if the Agency were forced to implement further cuts in its activities with an important public health impact due to having insufficient staff.

What measures is the Commission taking to address the staffing concerns of the EMA’s Management Board and to help the Agency resume functioning in full after its relocation?

Recall of Valsartan from European pharmacies
Question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 09-07-2018 Reference :E-003730/2018)

Valsartan is an active ingredient used for the treatment of high blood pressure either on its own or in combination with other active ingredients.

According to the International Agency for Cancer Research of the WHO, the presence of N‐Nitrosodimethylamine (NDMA), a substance that could cause cancer, has been detected.

The contamination with this ‘probable carcinogen’ is thought to be linked to changes to the manufacturing process for Valsartan authorised by the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe.

Some Member States have already begun to withdraw products containing Valsartan from pharmacies.

1. What measures is the Commission intending to take to withdraw this substance from circulation?

2. Why did the EDQM change the manufacturing process for Valsartan? Has this change affected other active ingredients?

3. What procedures does the EDQM intend to adopt in order to avoid such errors in future?

Combatting the sale of fake medicines online
Question for written answer to the Commission by Adam Szejnfeld (PPE) (Date : 06-07-2018 Reference :E-003721/2018)

The illegal manufacture and distribution of fake medicines pose a huge risk to public health. An estimated 1 million people die annually as a result of fake medicines. The profits made by organised criminal groups from the sale of fake medicines is very often used to support their other illegal activities.

Next year new EU rules will come into force to prevent fake medicinal products from getting into the pharmaceutical supply chain and thus into the hands of patients. These rules include a unique bar code and tamper-proof packaging that can be checked at the point of sale. These rules will no doubt increase the safety of products in the traditional medicine supply channels, but they will not solve the problem of fake medicines sold online.

The Internet is an ideal place to sell counterfeit medicines. The low prices and convenience and the discreet nature of online purchases makes the Internet an increasingly popular place for consumers to buy medicines, and so they easily fall prey to illegal Internet medicine sales websites. It is thought that half of all medicines sold online could be fake. This causes significant losses to pharmaceutical companies. What is worse, however, is that counterfeit medicines are dangerous — not only do they not treat the illness they are apparently intended for, but the substances in them could actually harm the patient.

How is the Commission planning to combat the illegal distribution of fake medicines online?

Estimated reduction of delays resulting from the Commission proposal on Health Technology Assessment
Answer given by Mr Andriukaitis on 05.07.2018 on behalf of the Commission to question for written answer to the Commission by Alfred Sant (S&D) (Date : 14-05-2018 Reference :E-002567/2018)

There are estimates of the possible reduced timeline regarding market access for health technologies as a result of a more efficient Health Technology Assessment process.

This is of course dependent on the current procedures in a given Member State. A recent study found that within a sample of 16 countries, the availability of joint clinical assessment at the time of marketing authorisation can speed up market access in 12 of them by a period ranging from 2 to 6 weeks.

The impacts of this 2-6 weeks of earlier access can have significant benefits for all relevant stakeholders. Notably, patients could receive treatment more quickly with an impact on improving their health condition.

Accessibility of content on the European Medicines Agency website for EU citizens
Answer given by First Vice-President Timmermans on 05.07.2018 on behalf of the Commission to question for written answer to the Commission by Nadine Morano (PPE) (Date : 20-03-2018 Reference :E-001679/2018)

Unless otherwise provided for in the legal bases establishing them, the general rules governing the use of languages of the European Union apply to EU decentralised agencies as regards their external communication.

Moreover, as stipulated in the Common Approach on EU Decentralised Agencies, agencies’ websites should be made as multilingual as possible. It is therefore important that agencies strive to implement, to the best of their ability, the principles of openness, transparency and good administration, while having regards to the sound financial management of their resources.

This may entail prioritisation of translation activities so as to reconcile competing demands, while reaching out to more stakeholders and citizens.

As agencies are separate legal entities, the Commission has asked those agencies mentioned by the Honourable Member 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.

Commission estimates of the costs involved in health technology assessments
Answer given by Mr Andriukaitis on 28.06.2018 on behalf of the Commission to question for written answer to the Commission by Alfred Sant (S&D) (Date : 14-05-2018 Reference :E-002569/2018)

The Impact Assessment on the Commission’s proposal on Health Technology Assessment (HTA) showed that there are important differences in the processes and definitions of health technology assessments in the Member States. Therefore, it is not appropriate to give one figure for the number or for the cost of HTAs undertaken in the EU. Nonetheless, it can be concluded that the cost of producing a single-technology HTA by Member States authorities ranged from EUR 4 000 to EUR 135 000.

1. The number of assessments carried out by national HTA bodies range from 5 HTAs per year to up to 390 HTAs per year. However, as mentioned above, they vary greatly in methodology and therefore it would not be appropriate/ adequate to provide a consolidated annual figure.

2. The costs for joint health technology assessments were modelled on the experience of the EUnetHTA Join Action, where a joint assessment on relative effectiveness assessment (REA) for pharmaceuticals has a cost of EUR 117 000. However, these are the costs in the framework of the pilot exercises and once conducted routinely the unit cost is expected to markedly decrease. In fact, a study showed that the cost savings related to the joint REA are estimated at EUR 1 560 000 to EUR 2 670 000 per year for HTA bodies. This is in line with the results of the focus group meeting with public administrations carried out in the context of the study. The participants agreed that a stronger EU cooperation would lead to a cost decrease per joint output (once the system is well established and running). The saving will of course depend on the number of joint assessments carried out.

The future of supplementary protection certificates
Answer given by Ms Bieńkowska on 28.06.2018 on behalf of the Commission to question for written answer to the Commission by Joëlle Mélin (ENF) (Date : 30-01-2018 Reference : E-000512/2018)

Further to the announcement in the 2015 Single Market Strategy, a legislative proposal to fine-tune the EU supplementary protection certificates (SPC) system was adopted by the Commission on 28 May 2018. This initiative, called for by European Parliament in its Resolution on the Single Market Strategy in May 2016, proposes a targeted adjustment to the existing SPC Regulation, through the introduction of a manufacturing waiver for export purposes. This proposal follows an inception impact assessment in February 2017, a public consultation in autumn 2017, and a series of independent studies related to SPCs.

A wider review is underway in the context of the analysis of pharmaceutical incentives called for by the Council in 2016, which the Commission is currently undertaking. This is based on various sources of evidence, including a recent study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe, conducted by Copenhagen Economics, published on 28 May 2018, and the ongoing evaluation of the EU paediatric and orphan legislations. The Commission will engage in further discussions with all stakeholders about the outcome of this analysis.

Corruption in the health sector
Answer given by First Vice-President Timmermans on 26.06.2018 on behalf of the Commission to question for written answer to the Commission by Kostas Chrysogonos (GUE/NGL) (Date : 22-02-2018 Reference : E-001096/2018)

Healthcare is a sector exposed to specific corruption risks. As noted in the Commission’s reply to E-000040/2017, the Commission has prioritised sharing of good practices in fighting corruption in this sector in its EU anti-corruption experience sharing programme and supported relevant work at the European Partners against Corruption (EPAC) — European contact-point network against corruption (EACN).

The Commission has also recently published an updated study of corruption in the healthcare sector(2) that includes, inter alia, an analysis of improper marketing practices and corruption in the procurement of medical devices and pharmaceutical products as well informal payments in healthcare.

In addition, the Commission has encouraged Member States to take steps to address the issue of corruption also in healthcare in the framework of the European semester of economic governance.

Revision of the designation of homeopathic substances as medicinal products under Directive 2001/83/EC
Answer given by Mr Andriukaitis on 21.06.2018 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 26-04-2018 Reference :E-002348/2018)

EU legislation on homeopathic medicines was introduced in 1992 with the aim of ensuring their quality and safety whilst at the same time providing a clear indication of their homeopathic nature. At the time of adoption of the legislation, it was considered that despite the differences in recognition between Member States, consumers across the EU should be adequately protected if they choose to use homeopathic medicines.

Under the current simplified registration procedure, homeopathic medicines must not mention specific therapeutic indications and be diluted to a sufficient degree to ensure their safety. Furthermore, their labelling must clearly mention that they are ‘homeopathic medicinal products’.

There are no plans to revise Directive 2001/83/EC as regards homeopathic medicinal products or change their designation to ‘homeopathic substances’.

Homeopathy is not medicine
Answer given by Mr Andriukaitis on 20.06.2018 on behalf of the Commission to question for written answer to the Commission by María Teresa Giménez Barbat (ALDE) (Date : 07-05-2018 Reference :E-002513/2018)

EU legislation on homeopathic medicines was introduced in 1992 with the aim of ensuring their quality and safety whilst at the same time providing a clear indication of their homeopathic nature. At the time of adoption of the legislation, it was considered that despite the differences in recognition between Member States, consumers across the EU should be adequately protected, if they choose to use homeopathic medicines.

Under the current simplified registration procedure, homeopathic medicines must not mention specific therapeutic indications and be diluted to a sufficient degree to ensure their safety. Furthermore, their labelling must clearly mention that they are ‘homeopathic medicinal products’.

Regarding the second question, the regulatory framework for homeopathic medicines and vaccines is different under Directive 2001/83/EC. Vaccines can only be authorised subject to an in-depth assessment of quality, safety and efficacy.

The EU in USTR Special Report 301/2018
Answer given by Ms Malmström on 15.06.2018 on behalf of the Commission to question for written answer to the Commission by Soledad Cabezón Ruiz (S&D) (Date : 12-03-2018 Reference : P-001516/2018)

The Council Conclusions of June 2016 on ‘Strengthening the balance in the pharmaceutical systems in the European Union and its Member States’ invite the Commission to perform, among other things, an analysis of the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products in the European Union. As part of this effort, a holistic, in-depth and evidence based analysis of those incentives has been carried out by an external consultant, Copenhagen Economics, contracted by the Commission. The final report of Copenhagen Economics is available on the website of the European Commission.

The Commission is aware of the submissions by Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organisation (BIO) in the context of stakeholder consultations on the 2018 Special 301 Report by the Office of the United States Trade Representative (USTR). The EU was not placed on the watch list in the report, neither does the report mention the matter brought up by PhRMA and BIO.

The Commission conducts its policy based on evidence, in consultation with the relevant stakeholders, in a transparent manner and independently of any administrative procedures carried out by third countries. It will engage in further discussions with all stakeholders about the outcomes of this study and analysis.

Depakine and other medicines containing valproate
Answer given by Mr Andriukaitis on 07.06.2018 on behalf of the Commission to question for written answer to the Commission by Lola Sánchez Caldentey (GUE/NGL) (Date : 14-03-2018 Reference :E-001561/2018)

Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine. It is known that if taken during pregnancy they can cause malformations in the baby and developmental disorders after birth.

It is therefore important to avoid exposure of babies to valproate medicines in the womb.

As with any medicinal product, the side effects (and their frequency) related to valproate used during pregnancy are clearly reflected in the summary of product characteristics and patient leaflet.

A recent scientific review by the European Medicines Agency recommended new measures to avoid valproate exposure in pregnancy (e.g. ban on use for migraine or bipolar disorder during pregnancy, a ban on treating epilepsy during pregnancy unless no other effective treatment available). These recommendations were sent to the Commission at the end of March 2018 which will be followed up with a legally binding decision.

The Commission does not have figures on the number of people affected in the EU. However, data may be available in some Member States.

Regarding compensation, it should be stressed that health policy, as well as the organisation and delivery of healthcare, is a Member State competence under Article 168 of the Treaty on the Functioning of the EU.

Overall, the Commission takes the view that the legal framework to monitor medicines has been continuously strengthened to ensure that the medicines which are made available to patients in the EU correspond to high standards of quality, safety and efficacy.

EU action on vaccination in light of the need to build public trust
Answer given by Mr Andriukaitis on 06.06.2018 on behalf of the Commission to question for written answer to the Commission by Michaela Šojdrová (PPE) (Date : 04-04-2018 Reference :E-001984/2018)

As the Commission pointed out in its reply to the Written Question E-005260/2017, the competence for vaccination policies and how they are organised lies with the EU Member States.

As the Commission pointed out in its reply to the Written Question E-003125/2017, the number of Europe-wide studies analysing the impact of mandatory vaccination on vaccination coverage is limited. Mappings conducted in the EU indicate that there are no striking differences in vaccination coverage between countries that recommend certain vaccinations and countries that make vaccinations mandatory for the general public. However, the Commission has no information on single national vaccination programmes as regards their impact on public trust.

The Commission has recently presented a policy initiative on strengthened cooperation against vaccine-preventable diseases by which it proposes to establish a European Vaccination Information Sharing system to monitor online vaccine misinformation and develop evidence-based information tools and guidance to support Member States in countering vaccine hesitancy. In addition, the Commission proposes to convene a Coalition for vaccination, including European associations of healthcare workers, to combat myths about vaccination.

Building on the existing EU pharmacovigilance system the Commission proposes with the new vaccination initiative to establish, with support of the European Medicines Agency, a European vaccination information portal to provide objective, transparent and updated evidence on vaccines, their benefit and safety, and the pharmacovigilance process.

Scientific data on aluminium in vaccine adjuvants
Answer given by Mr Moedas on 05.06.2018 on behalf of the Commission to question for written answer to the Commission by Mireille D’Ornano (EFDD) (Date : 02-03-2018 Reference : E-001327/2018)

1. Vaccines may contain small amounts of aluminium acting as adjuvants. They are authorised nationally or centrally. The European Medicine Agency (EMA) is in contact with the French National Agency for Medicines and Health Products Safety (ANMS), which financed the research referred to by the Honourable Member. In September 2017, ANMS communicated that the results of the new studies, as well as the available publication, do not change the positive benefit/risk ratio of vaccines. EMA, in collaboration with the EU Member States, continuously monitors the safety of aluminium-containing vaccines, including studies reported in the worldwide scientific literature, and will take any necessary action in case a safety issue is identified.

2. Through the Innovative Medicines Initiative (IMI), the Commission funds research on vaccine safety. The IMI projects ADVANCE and BioVacSafe work to deliver reliable data on the benefits/risks of marketed vaccines, and to improve testing and monitoring of vaccine safety, respectively.

Fixed spending and incentive system under Spanish Government agreement with Farmaindustria
Answer given by Ms Vestager on 05.06.2018 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 : 23-02-2018 Reference : E-001125/2018)

The agreement of 29 December 2016 between the pharmaceutical industry (Farmindustria) on the one hand and on the other the Spanish Ministries of Finance and Public Service and of Health, Social Services and Equality, is a state measure to control public expenditure on medicines. It caps the growth of Spanish public expenditure on originator (branded) medicines relative to the evolution of Spanish gross domestic product (GDP). This is an example of so-called ‘payback/clawback’ policies to prevent deficits in public budgets.

The agreement does not oblige the Autonomous Communities to purchase branded medicines. It only sets conditions in case sales of such medicines are higher or lower than a certain cap. In case the cap is not reached, the Monitoring Committee for the agreement (composed of representatives of the above Ministries, Farmaindustria and the Autonomous Communities adhering to the agreement) ‘may’ propose incentives under the framework of Royal Decree-Law 8/2010 (which among others envisages deductions to be applied by the industry on sales of medicines to the national health service). To date, to the Commission’s understanding, no such measures have been proposed. Thus making financing from the Spanish Government’s Autonomous Liquidity Fund contingent on acceptance of this agreement (by the Autonomous Communities) as such does not appear to create a barrier to entry for generic medicines or to raise concerns under EU competition rules.

Measures to introduce transparency in the pricing of medicines
Answer given by Ms Bieńkowska on 01.06.2018 on behalf of the Commission to question for written answer to the Commission by Nikos Androulakis (S&D) (Date : 08-03-2018 Reference :E-001467/2018)

The Commission has no current plans to submit a new proposal for the revision of Directive 89/105/EEC. It is now working to ensure the appropriate implementation of the existing Directive by the Member States.

The Commission has no current plans to develop common cost accounting and pricing methods for medicines in the European market.

However, 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 (CAPR), 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.

Member States’ legislation on the use of psychotropic drugs while driving
Answer given by Ms Bulc on 30.05.2018 on behalf of the Commission to question for written answer to the Commission by Deirdre Clune (PPE) (Date : 20-03-2018 Reference :E-001671/2018)

The Commission regrets that insufficient accident data relating to the use of psychotropic substances whilst driving, in particular for cross-border trips, is available, and that it is therefore unable to provide further details or express further views on this issue.

Water pollution and the use of Imidacloprid
Answer given by Mr Andriukaitis on 30.05.2018 on behalf of the Commission to question for written answer to the Commission by Alex Mayer (S&D) (Date : 16-01-2018 Reference : E-000231/2018)

In 2013, the use of the three neonicotinoids referred to by the Honourable Member was restricted(1) due to newly identified risks to bees. The regulation required the applicants to submit confirmatory data for the uses still allowed. The evaluation of these data identified new risks to bees. Therefore, the Commission proposed in 2017 to further restrict their use to permanent greenhouses only.

The regulation also foresaw a general review of new scientific data related to risks to bees from the three neonicotinoids. The European Food Safety Authority (EFSA) published its reports on this review on 28 February 2018. They confirmed the already identified risks to bees for outdoor uses.

On 27 April 2018, Member States represented in the Standing Committee on Plants, Animals, Food and Feed voted in favour of the Commission’s draft Regulations to further restrict the uses of the three neonicotinoids to permanent greenhouses only. The Commission will adopt the regulations in the coming weeks.

The use of imidacloprid as a veterinary medicine is restricted to pets (mainly dogs and cats) and subject to special precautions. Therefore, only very limited emissions to water are expected from that use.

Imidacloprid, clothianidin, thiamethoxam, acetamiprid and thiacloprid, are included in the surface water watch list under the Water Framework Directive. The aim of this list is to gather sufficient, high-quality monitoring data to confirm whether these substances pose a significant risk at European Union level, to or via the aquatic environment. The Commission is assessing the quality of the data collected during the first year of monitoring. A decision on the update of the watch list has not yet been taken.

Availability of Pre-exposure Prophylaxis (PrEP)
Answer given by Mr Andriukaitis on 25.05.2018 on behalf of the Commission to question for written answer to the Commission by Martina Anderson (GUE/NGL) (Date : 27-03-2018 Reference :E-001858/2018)

The Commission is aware of the Member States concerns related to HIV/AIDS, tuberculosis and hepatitis. A Commission staff working document on ‘Combatting HIV/AIDS, viral hepatitis, sexually transmittable diseases and tuberculosis’ in the EU and neighbouring countries is currently being prepared.

Pre-exposure prophylaxis as an additional prevention option has the potential to reduce HIV transmission. According to the pharmaceutical legislation a marketing authorisation is granted for a medicinal product in the applied indication only after its quality, safety and efficacy have been evaluated and a positive benefit-risk balance related to its use has been concluded. Information about a benefit-risk assessment of all EU centrally authorised products including also the product concerned is included in the European Public Assessment Reports.

However, the decision of whether to introduce pre-exposure prophylaxis, as well as its price for patients, are the competences of Member States as established in Article 168 of the Treaty on the Functioning of the European Union.

Novartis company guilty of corruption
Answer given by First Vice-President Timmermans on 25.05.2018 on behalf of the Commission to question for written answer to the Commission by Stelios Kouloglou (GUE/NGL) (Date : 07-02-2018 Reference : P-000765/2018)

Corruption in healthcare is a matter of concern for EU businesses. As noted in the Commission’s reply to Written Question E-000040/2017, the Commission has prioritised the healthcare sector in its anti-corruption experience-sharing programme which promotes the exchange of best practices, and has supported relevant work by the European Partners against Corruption (EPAC) and the European contact-point network against corruption (EACN).

The Commission has also recently published an updated study of corruption in the healthcare sector that includes an analysis of improper marketing practices and corruption in the procurement of medical devices and pharmaceutical products.

The Commission is encouraging Member States to take steps to address the issue of corruption in healthcare in the framework of the European semester of economic governance.

In addition, for the case of Greece, the economic adjustment programme monitors the implementation of the national strategy against corruption, taking into consideration particular needs in high-risk sectors such as national health services.

The Commission however has no competence to follow-up on individual allegations of corruption. When such allegations arise, unless EU funds are involved, it is for the competent national authorities to investigate, including where necessary by engaging in cross-border cooperation with relevant authorities of other Member States. Determining the extent of the financial damage is part of the national investigative activities.

Anti-cancer immunostimulating agents
Answer given by Mr Andriukaitis on 18.05.2018 on behalf of the Commission to question for written answer to the Commission by Nicola Caputo (S&D) (Date : 28-03-2018 Reference :E-001930/2018)

1. The Commission is aware of the research referred to by the Honourable Member. The Commission does not hold data specifically on the effectiveness of the combination of a CpG oligodeoxynucleotide and an antibody against OX40. However, research on similar T-cell checkpoint inhibitors is being supported through Horizon 2020, the EU Framework Programme for Research and Innovation (2014-2020), for instance in the ‘Immunostimulatory Agonist antibodies for Cancer Therapy’ (IACT) and ‘Blocking Inhibition of T-cell Co-stimulation for Anti-tumour Therapy’ (BITCAT) projects, which are examining the potential of this approach for treating cancer.

2. The Horizon 2020 2018-2020 Work Programme offers opportunities to conduct research on potential benefits and risks of immunostimulating agents. Full information on funding opportunities under Horizon 2020 is available on the Research and Innovation Participant Portal and on the ‘Access to EU Finance’ Europa website.

Biocides vs. Medicines — Reaction to a response from the Commission
Answer given by Mr Andriukaitis on 16.05.2018 on behalf of the Commission to question for written answer to the Commission by José Inácio Faria (PPE) (Date : 08-03-2018 Reference :E-001459/2018)

Regulation (EU) No 528/2012 (‘BPR’) regulates products used to protect humans against harmful organisms. In Annex V to this regulation, biocidal product-types are described.

In product-type 1 is set out the description of disinfectants for human hygiene specifying that products in this group are used for human hygiene purposes, applied on or in contact with human skin for the primary purpose of disinfecting the skin. Pursuant to Article 3(3) of the BPR the Commission may decide, at the request of a Member State, whether a specific product is a biocidal product in order to ensure a harmonised situation in the Union.

The BPR does not apply to products that fall under the scope of Directive 2001/83/EC, which provides for the basic framework for the regulation of medicinal products for human use. The applicability of legislation to a product will depend, among others, on the intended purpose, composition, its presentation and claims made for the product concerned.

Contrary to the BPR, Directive 2001/83/EC does not provide for a mechanism to decide at the EU level whether a product is a human medicinal product. Only competent national authorities may decide, on a case-by-case basis, whether a product can be classified as a medicinal product. Therefore, as Union law stands, it is indeed possible that differences exist between Member States in the classification of products as medicinal products.

The Commission notes that regardless of the applicable legislation, any product needs to be authorised by the relevant competent authorities and it has to be proven to be safe and efficacious for the intended uses. Therefore, a high level of protection is ensured under the current legal situation.

Boosting blood plasma collection in the EU
Answer given by Mr Andriukaitis on 03.05.2018 on behalf of the Commission to 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)

The Commission is aware of the discrepancy between current levels of plasma collection in the EU and the growing demand for plasma derived medicinal products and recognises their importance for the treatment of EU patients.

The evaluation of the Union legislation on blood, tissues and cells is still ongoing. Stakeholders have raised the issue of plasma supply during the stakeholder consultation and it was discussed at both the stakeholder event and during a June 2017 ad-hoc meeting between stakeholders and representatives of the EU’s blood competent authorities. The views put forward will be taken into account for the final evaluation report. On the basis of the results of this exercise, the Commission will decide on the necessity to update and strengthen existing legislation.

In the EU Research and Innovation programme, the Commission supports a range of research to develop diagnostics and new, advanced therapies for rare diseases including diseases related to blood and plasma, such as haemophilia and multiple myeloma.

It should be noted that the current legislative framework at Union level does not prevent Member States from establishing or changing their national plasma collection programmes, provided the collection and testing of blood and plasma meet the quality and safety requirements of the Union legislation.

Towards harmonisation of penalties to stamp out falsified medicines in the EU
Answer given by Mr Andriukaitis on 03.05.2018 on behalf of the Commission to question for written answer to the Commission by Alain Cadec (PPE) (Date : 16-02-2018 Reference : E-000964/2018)

The Commission has analysed the penalties in place in the Member States for the falsification of medicines and misconduct in relation to active substances and excipients. The levels of fines and prison sentences do differ between Member States, but this is a result of national circumstances and legal systems.

In the Commission Report on the Member States’ transposition of Article 118a of Directive 2001/83/EC, the Commission calls on Member States to further reinforce their penalties and ensure proper monitoring and enforcement of the penalties in place.

Health technology assessment
Answer given by Mr Andriukaitis on 27.04.2018 on behalf of the Commission to Question for written answer to the Commission by Roberta Metsola (PPE) (Date : 01-03-2018 Reference : E-001311/2018)

The Commission considers that its proposal for a regulation on Health Technology Assessment (HTA) as adopted on 31 January 2018 is an appropriate and proportionate response to the problems identified in the impact assessment report accompanying the proposal. The problems identified include both the duplication of assessments at national level across the EU-28 and the divergent outcomes of these assessments.

The proposal aims to tackle these problems in a number of ways. Firstly, it provides for a Union-level framework for carrying out joint clinical assessments on the most innovative health technologies. These assessments are not to be repeated at national level and their results are to be used by the Member States in their national HTA processes.

Secondly, under the proposed Regulation, harmonised rules will be developed on how clinical assessments are carried out. These rules are foreseen both for clinical assessments at Union level and for those assessments that have not been prioritised for assessment at Union-level and are therefore carried out at national level.

Thirdly, the proposal provides a framework for Member States to cooperate, on a voluntary basis, on the non-clinical aspects of HTA.

Shortage of medicines owing to parallel trade in Europe
Answer given by Mr Andriukaitis on 25.04.2018 on behalf of the Commission to question for written answer to the Commission by Andrey Kovatchev (PPE) (Date : 01-03-2018 Reference : P-001287/2018)

Considering that the issue of shortages has been widely discussed and studied for many years, the Commission does not intend to prepare an analysis of the reasons for shortages of medicines.

However, on 27 October 2017 the Commission launched a questionnaire on the measures implemented by the Member States for appropriate and continued supplies of medicines. The Commission is now preparing a report and will organise an expert meeting focusing on identification and sharing of best practices for ensuring continuity of supply between the Member States including measures restricting parallel exports. One reason for some of the shortages in the European Union is indeed parallel export.

The European legislation does not foresee a pan-European system for monitoring medicines.

Currently, the Commission and 22 Member States are working on setting up a Digital Service Infrastructure for the cross border exchange of electronic prescriptions and short forms of electronic health records (patient summaries).

8-9 Member States should start exchanging health data in 2018. In this first wave, the exchange possibilities are limited but in 2019 more countries will join and, due to the multilateral nature of the system, the possibilities for exchange grow with every new member.

This system will allow for medicinal prescriptions to be issued and transmitted electronically for citizens travelling inside the EU; it does not however foresee a central register for storage of ePrescriptions.

Fungicides and resistant fungi
Answer given by Mr Andriukaitis on 25.04.2018 on behalf of the Commission to question for written answer to the Commission by Jørn Dohrmann (ECR) (Date : 14-02-2018 Reference : E-000921/2018)

The European Centre for Disease Prevention and Control has published a risk assessment on the impact of environmental usage of triazoles on the development and spread of resistance to medical triazoles in Aspergillus species.

It concludes that resistance to triazole antifungals in human Aspergillus diseases appears to have been increasing in several European countries. However, the link between the environmental use of azole fungicides and the development of triazole resistance in Aspergillus species is not yet proven.

The Commission has already invested in research on antifungal resistance and continues to do so. Successful examples are the 7th Framework Programme for Research and Technological Development (FP7) project NOFUN which developed a completely new class of antifungals (patent filed) and FP7 project SYBARIS which examined antifungal resistance and identified several novel molecules with potential antifungal action.

The ongoing project FUNGITECT develops diagnostic tests for better-targeted treatment which may decrease the over use of antifungals that leads to fungal resistance.

The Commission adopted the ‘European one health action plan against antimicrobial resistance (AMR)’ in June 2017. This sets out a comprehensive framework of actions to address AMR, including multidrug resistance in fungi. The action plan has three main pillars: to make the EU a best practice region; to boost research development and innovation; and to shape the global agenda.

Clawback of the Greek pharmaceutical sector
Answer given by Mr Andriukaitis on 25.04.2018 on behalf of the Commission to question for written answer to the Commission by Eva Kaili (S&D) (Date : 29-01-2018 Reference : E-000472/2018)

According to Article 168.7 of the Treaty on the Functioning of the EU, the management of the health systems is under the control of the national authorities. The Commission supports national policy and measures aiming at improving the cost effectiveness of health expenditure. Policies such as rebates and clawbacks give the authorities a tool to control expenditures while ensuring citizens’ access to healthcare and are among the instruments at the disposal of the national governments. Typically, these should be supplemented by other structural reforms, including both demand-side and supply-side policies. Many were implemented so far, but often these measures deliver results in terms of lower excess spending later in time. The government has also committed to undertake additional measures before the end of the European Stability Support programme.

Clawback mechanisms are a temporary solution accompanied by other structural reforms such as promoting the rational use of medicines, reinforced negotiation of pharmaceutical prices, development of Health Technology Assessment, introduction of protocols and increased use of generics, reform of public procurement to increase competition and reduce prices.

The Commission believes that a constructive exchange between the Greek authorities and stakeholders could gradually lead to a more transparent and inclusive political solution acceptable to all parties.

Concerning the specific problem of shortages of medicines, the Commission is collaborating with the Member States and other stakeholders in order to facilitate sharing of best practices between the Member States with view to assuring continuous supply of medicines through effective implementation of the pharmaceutical legislation.

Rare diseases
Answer given by Mr Andriukaitis on 20.04.2018 on behalf of the Commission to question for written answer to the Commission by Merja Kyllönen (GUE/NGL) (Date : 09-02-2018 Reference : E-000831/2018)

1. The EU adopted new Regulations on medical devices and in vitro diagnostic medical devices in 2017. Although they do not contain special provisions with regard to rare diseases, they foresee harmonisation of the legal framework across the Member States, enhancement of patient safety and strengthening of cooperation between Member States, which is expected to improve the availability and quality of all medical devices, including those for rare diseases.

2. The EU introduced new legislation in 2000 with the aim of providing incentives for the research, development and marketing of medicines for rare diseases (so-called orphan medicinal products). These incentives include EU-wide authorisation, fee waivers, 10-year market exclusivity and protocol assistance. To date, the Commission has already authorised 145 orphan medicines and has designated 1 540 products as orphan medicinal products.

The setting of prices for medicines or their inclusion in the scope of national health insurance schemes falls outside the competence of the EU; it is a Member State responsibility. However, the Commission promotes the exchange of information on pricing policies between Member States in order to support them in their decision-making.

Vaccine hesitancy and the drop in vaccination rates in Europe
European Parliament resolution of 19 April 2018 on vaccine hesitancy and the drop in vaccination rates in Europe (2017/2951(RSP)) (P8_TA -PROV(2018)0188), 19-04-2018

The European Parliament

5. Points out that vaccines are rigorously tested through multiple stages of trials before being prequalified by the WHO and approved by the European Medicines Agency (EMA), and regularly reassessed; points out that researchers must declare any conflicts of interest;

14. Recalls the importance of transparency in building and maintaining public trust in medicines;

25. Is concerned at the limited budget allocated specifically to vaccination in some Member States, as well as the high prices and wide variations in price of some life-saving vaccines, which risk further exacerbating existing health inequalities; urges the Commission and the Member States to implement, as soon as possible, the measures called for in its resolution of 2 March 2017 on EU options for improving access to medicines, while stressing that vaccination is one of the most cost-effective public health interventions for healthcare systems in the long term;

Annual report on Competition policy
European Parliament resolution of 19 April 2018 on the Annual Report on Competition Policy (2017/2191(INI)) (P8_TA -PROV(2018)0187), 19-04-2018

The European Parliament,

44. Highlights the importance of ongoing investigations in the pharmaceutical sector, given the build-up of evidence of market distortions in the field, including quantity restrictions, manipulated prices and barriers to the availability of generic medicines;

Packaging and packaging waste
European Parliament legislative resolution of 18 April 2018 on the proposal for a directive of the European Parliament and of the Council amending Directive 94/62/EC on packaging and packaging waste (COM(2015)0596 – C8-0385/2015 – 2015/0276(COD)) (Ordinary legislative procedure: first reading) (P8_TA -PROV(2018)0112), 18-04-2018

(14) Article 20 is replaced by the following:

“Article 20

Specific measures

The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Directive where necessary to deal with any
difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Union, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging.”;

Petition on rules on homeopathic and naturopathic medicines
Notice to members of the Committee on Petitions in respect of Petition No 0328/2017 by A.K. (German) on behalf of the association ‘Artgerechte Tiergesundheit e.V.’, on rules on homeopathic and naturopathic medicines (18-04-2018, PE 615.329v02-00, PETI_CM(2018)615329).

Summary of petition: The petitioner states that the legal framework for veterinary medicinal products contains provisions that, in future, will hinder the use of homeopathic and naturopathic medicines. Although, according to the petitioner, the objective of curbing the use of antibiotics in animals is being pursued, naturopathic practices have been made subject to needless red tape and major restrictions, resulting in considerable increases in costs for livestock owners and seriously disadvantaging alternative veterinary practitioners and organic farmers.

Conclusions: One of the main objectives of the Commission proposal on veterinary medicines is to reduce the administrative burden and to increase the availability of medicines in the EU, including homeopathic veterinary medicines. In that regard, the Commission will do its utmost during the negotiations to take into consideration the elements that would allow the achievement of these objectives.

Life expectancy in southern Italy
Answer given by Mr Andriukaitis on 17.04.2018 on behalf of the Commission to question for written answer to the Commission by Michela Giuffrida (S&D) (Date : 20-02-2018 Reference : E-001054/2018)

Southern Italian regions have slightly worse averages than those of Italians overall in terms of mortality and life expectancy, but better than the EU overall.

Shortages of medicines are a significant problem that affect many patients. The main drivers of shortages are generally manufacturing problems or the price of medicines, which is under the competence of the Member States. Nevertheless, EU legislation obliges marketing authorisation holders and wholesalers to ensure appropriate and continued supply of the medicines concerned.

The Commission has been working over recent years with the Member States, regional authorities and other stakeholders to tap the potential of innovative solutions, such as digital technologies and data analytics. Digital health solutions have already shown many benefits and have much more to offer in Europe, both to healthcare systems and to people. This will depend to a very large extent on a better use of data and on empowered citizens who trust digital solutions. EU funding supports research and innovation in digital health and care solutions, notably through the EU Research and Innovation programme. It also supports the building of infrastructure for cross-border exchange of patient summaries and electronic prescriptions, with funds from the Connecting Europe Facility programme.

The directive on Patients’ Rights in Cross-Border Healthcare established the eHealth Network to advance the interoperability of eHealth solutions. In May 2017, the Commission adopted the Mid-Term Review of the Digital Single Market strategy. Digital health and care transformation was included and identified three priority areas for policy actions.

Rare diseases
Reply given on 16.04.2018 to question for written answer to the Commission by Merja Kyllönen (GUE/NGL) (Date : 09-02-2018 Reference : E-000830/2018)

In order to support the work done by Member States in the field of rare diseases, the Council has adopted a recommendation on an action in the field of rare diseases, in which it recommends Member States to take action with regard to such diseases.

Furthermore, in its Conclusions on Encouraging Member States-driven Voluntary Cooperation between Health Systems of 16 June 2017, the Council noted that tackling the specific characteristics and challenges arising in the healthcare market for therapeutic innovations, in particular in the field of rare diseases, may benefit from voluntary cooperation so as to ensure a balance between access, quality, affordability and sustainability of health systems.

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.

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.

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.

Kymriah: the childhood leukaemia treatment accessible only to the rich
Answer given by Mr Andriukaitis on 16.03.2018 on behalf of the Commission to 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)

Kymriah has not yet been authorised in the European Union. A decision on the marketing authorisation thereof will be taken by the Commission on the basis of the opinion of the European Medicines Agency — which is currently assessing the quality, safety and efficacy of this product — and after consultation with the Member States.

The pricing of medicines remains a national competence and the Commission has no role in the setting of prices for the medicinal products that it authorises. Specifically, it is noted that Article 168 of the Treaty on the Functioning of the European Union does not empower the Commission to take decisions on the prices of medicines. Likewise, Article 81 of Directive 2001/83/EC empowers Member States to take actions to ensure appropriate and continued supplies of medicines to pharmacies and authorised distributors under certain conditions but it does not foresee any role for the Commission in this regard.

The case law referred by the Honourable Members refers to the application of the competition rules. The Commission remains vigilant as regards potential breaches of EU competition law and will of course continue to monitor the developments in the pharmaceutical markets. It is also worth noting that the competition authorities of the Member States and the national courts are also competent to apply EU competition rules and depending on the specific circumstances, they may be well placed to tackle a given problem.

Cost of moving European Medicines Agency from London to Amsterdam
Answer given by Mr Oettinger on 16.03.2018 on behalf of the Commission to Question for written answer to the Commission by Rory Palmer (S&D) (Date : 14-12-2017 Reference : E-007748/2017)

The Commission, with input from the European Medicines Agency (EMA), is currently fine-tuning its first initial assessment of the total costs of EMA’s move from London to Amsterdam, notably by making a distinction between removal and relocation costs. This initial assessment will also show whether the Commission will need to submit a proposal to the budgetary authority to pre-finance some of the agency’s relocation costs from the EU budget.

Concerning costs for the Agency’s new permanent premises in Amsterdam, the Agency, with the Commission’s assistance, will present its building file on EMA to the Budgetary Authority in accordance with Article 88 of the Financial Regulation.

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.

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.

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’.

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.

Ineffective anti-cancer drugs have recently appeared on the market
Answer given by Mr Andriukaitis on 15.02.2018 on behalf of the Commission to question for written answer to the Commission by Daniel Buda (PPE) (Date : 13-12-2017 Reference : E-007713/2017)

The Commission is aware of the study mentioned by the Honourable Member.

The European Medicines Agency’s (EMA) evaluations of cancer medicines take into account a wide range of measures, including overall survival, quality of life, progression-free survival, response rate and duration of response. Though not all are directly linked to increased longevity, they are important indicators of how patients might benefit from treatment. EMA regularly consults its cancer experts, including patients, to make sure that these measures are meaningful for the patients concerned.

A marketing authorisation is granted to a medicinal product only after its quality, safety and efficacy have been evaluated and a positive benefit-risk balance has been concluded. A conditional marketing authorisation, which addresses an unmet medical need, though based on limited data, contains specific obligations on further studies which the marketing authorisation holder has to fulfil.

Marketing authorisation holders are obliged to submit periodically summaries of data relevant to the benefits and risks of the product and results of all studies with potential impact on the authorisation. The Commission can suspend or withdraw a marketing authorisation if the benefit-risk balance of a product is negative.

The Commission adopted on 31 January 2018 a proposal on Health Technology Assessment aiming at supporting national decision-making by providing timely and high quality joint scientific clinical assessments on innovative cancer drugs, to be complemented, depending on national requirements, by an economic assessment carried out at Member State level.

Medicines crisis in Member States
Answer given by Mr Andriukaitis on 15.02.2018 on behalf of the Commission to question for written answer to the Commission by Maria Grapini (S&D) (Date : 13-12-2017 Reference : E-007698/2017)

While the organisation of health systems and pricing of medicines are Member States’ responsibilities, the Commission supports the generation of evidence-based information and cooperation mechanisms to facilitate accessibility to medicines: for example, the EURIPID project, related work from the Organisation for Economic Cooperation and Development and the expert panel on effective ways of investing in health. Under the European Semester, the Commission encourages Member States to pursue healthcare reforms to enhance cost-effectiveness, ensure fiscal sustainability and ensure quality, affordable access.

Concerning shortages of medicines, the Commission collaborates with Member States, Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) to share best practices to assure continuous supply of medicines through effective implementation of the pharmaceutical legislation. Shortages are discussed in the Human Pharmaceutical Committee and HMA-EMA task force on availability.

In addition, as the Commission pointed out in its reply to Written Question E-001508/17, ‘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.’

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.

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.

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”.

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.

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.