The latest parliamentary questions, declarations, proposals and positions concerning industrial pharmacy from the European Parliament.
Proposal COM(2016) 0822 sets out clear criteria to be used by Member States when assessing the proportionality of draft national legislation that regulates professions and falls within the scope of the directive on the Recognition of Professional Qualifications.
Some of the requirements set out in national regulations on professions fall within the scope of the Professional Qualifications Directive and the Services Directive. Article 59(3) of Directive 2005/36/EC refers to the basic criteria to be followed by Member States when adopting new regulations on professions. Directive 2013/55/EU, amending Directive 2005/36/EC, introduced, among other requirements, an obligation for Member States to assess the proportionality of their professional regulations.
Why does the Commission propose the creation of new legislation rather than making additions or adjustments to Directive 2005/36/EC?
With reference to the Honourable Members’ question, it should be noted that in accordance with the pharmaceutical legislation, a marketing authorisation for a medicinal product granted either by the Commission for the entire EU or by a Member State for its own territory, also includes the assessment and approval of its proposed packaging.
The Commission is aware of the problem encountered by older patients in opening medicines’ containers or removing pills from blister packs. The European Medicine’s Agency (EMA) has a Geriatric Medicines Strategy in place since 2011, and one of the first areas of action within that strategy is the suitability of packaging and formulations of medicines to be used by the older population.
The EMA Quality Working Party’s paper concerning quality aspects of medicines for elderly patients looks at different strategies to help the elderly, e.g. using adapted container closure systems with a requirement to test ease of opening, providing additional instructions on the product label and specific and dedicated dose dispensers to avoid medication errors to older people. In May 2017, the EMA’s Committee for Medicinal Products for Human Use adopted this document and it will soon be published for public consultation. Further information can be found on the EMA webpage on Medicines for older people.
As medicinal products have different benefits and costs, the Health authorities of Member States need to carefully decide on reimbursement to ensure good value to the health system in general and to patients. To support the rationalisation of pharmaceutical expenditure, while guaranteeing full access, the Greek authorities revised the criteria to introduce innovative drugs into the list of publicly reimbursed ones.
New criteria have been designed to improve on the shortcomings of the previous method and allow for internal capacity building in the area of Health Technology Assessment (HTA). The Commission through the Structural Reform Support Service together with the World Health Organisation are assisting Greece to build this capacity.
In the meantime, it was agreed that the Greek authorities would take an informed decision based on the judgments reached following HTA processes in six Member States. The choice of six Member States was the result of a sensitivity analysis and ensures objectivity. Although this may prolong slightly the time for a decision to be taken in Greece, it will ensure the right balance between supporting patients’ access whilst ensuring sustainability of the health system.
In addition, the authorities are taking measures to reduce pharmaceutical prices and incentivising generics penetration, such as incentives to pharmacists to dispense cost-effective generics.
Together with this they revised the rebates system, simplifying it and rendering it transparent. Merging the previous components into one single formula increases efficiency of collection and facilitates providers with more predictable net profits.
The benefit/risk profile of Infanrix Hexa for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b is considered to be favourable by the European Medicines Agency (EMA).
The Commission is not aware of any recent meta-analysis. It should be noted that any reports received by the Italian Medicines Agency are also transmitted to an EU safety database called EudraVigilance (the system for managing and analysing information on suspected adverse reaction to medicines). EMA performs regular signal detection activities using this data. Moreover, risk-benefit evaluation is conducted during periodic safety assessments of authorised products. The latest evaluation of Infanrix Hexa ended in June 2015 and concluded that the data are globally reassuring with no clear indication of a signal for sudden deaths. In addition to the routine pharmacovigilance activities performed by the marketing authorisation holder (MAH), the Pharmacovigilance Risk Assessment Committee of EMA requested the MAH to continue monitoring sudden death cases and to update the literature review and the observed versus expected analyses (including sensitivity analyses). The next periodic assessment is due in January 2018. So far, no valid signal was identified; therefore further research (such as e.g. a meta-analysis) has not been required.
The Commission Communication of October 2015 on the Single Market Strategy announced a package of possible measures in relation to Supplementary Protection Certificates (SPCs), including a possible initiative on an SPC manufacturing waiver. The Commission believes that this package of measures would result in an important modernisation of SPC rules and facilitate further investment in research and innovation in the fields concerned.
In line with the Commission’s better regulation rules, the preparatory work regarding the evaluation and the optimisation of SPC legislation has started. An inception impact assessment was published on 16 February 2017. A number of studies are now under development and an online public consultation will soon be launched.
The Commission is very conscious of the position of the European Parliament regarding the SPC manufacturing waiver, which is referenced in the above-mentioned inception impact assessment. It has analysed several studies related to the SPC waiver and commissioned an economic study on the potential impact of a SPC manufacturing waiver in the EU, which has now been concluded. The Commission intends to publish this study together with the launch of the online public consultation.
Against this background, the Commission is still analysing the functioning of the SPC system, and it is thus too early at this stage to prejudge whether EU legislation will be revised.
The EU and its Member States did not oppose the proposal made during informal consultations to have an additional paragraph addressing Research and Development and access to medicines aspects in the draft resolution on cancer prevention and control, to be adopted by the 70th World Health Assembly. In these informal consultations, the EU and its Member States took a constructive approach aiming at finding a consensus on this paragraph, taking into account the various views expressed by World Health Organization Member States and supported the final agreement found on this paragraph.
The World Health Assembly resolution was agreed by the EU and the Member States representatives in Geneva, and is in line with agreed EU policies relevant to this resolution, including the EU global health policy, the specific programme implementing Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020) and the Communication from the Commission on action against cancer: European partnership.
Following the answer E-008541/2016 of the European Council, and given the changed circumstances in the Council’s answer, I repeat my interpellation E-008541/16:
The European Medicines Agency (EMA) and the European Banking Authority (EBA) are preparing to leave London following the Brexit vote and are now seeking new host countries.
Croatia, the newest Member State, is one of the few countries — along with Bulgaria, Romania, Slovakia, and Cyprus — without a single EU body or agency. When the European Council decides on the new host countries for the above two agencies, will it take into account the EU’s hitherto extremely discriminatory practice on that point?
I am a Member representing Croatia — the Member State with the third highest unemployment rate in the EU, immediately after Greece and Spain — and these agencies currently provide permanent employment for more than a thousand highly qualified people from several Member States. That being the case, I should like to know whether the European Council also intends to factor unemployment into its decision.
Are there specific criteria and conditions that a Member State has to meet and which the European Council will observe when taking its final decision on the host countries?
The website Euractiv has published the results of an investigation by researchers from Leipzig, which shows that some antibiotics sold in Germany are produced in India in what are described as alarming conditions likely to contribute to the development of pathogens resistant to most forms of treatment, and hence the risk of an epidemic. Pharmaceutical firms are contributing to the development of killer bacteria because they are not purifying drains in their immediate surroundings.
Water samples taken near factories in November 2016 showed a high concentration of antibiotics and fungicides. In fact, the greater the contact bacteria and pathogens have with the medicines designed to fight them, the more quickly they can adapt and become resistant. Ninety-five per cent of the samples collected by the research team, at 28 different sites in India, contained multi-resistant pathogens. It should be noted that the vast majority of German pharmaceutical firms have their antibiotics and fungicides manufactured in India under these conditions.
Does the Commission know about these practices and what does it plan to do to ensure adherence to standards required in the European Union?
1. The rental contracts for the Brussels buildings usually do not foresee early termination clauses, as this allows obtaining better contractual conditions. In Luxembourg, lease contracts with private landlords usually do contain a termination clause, when the lessee is obliged to leave by virtue of a decision taken on the basis of Article 341 of the Treaty on the Functioning of the European Union (TFEU). Otherwise, both in Brussels and Luxembourg it is possible to transfer the lease to another EU body or agency without the Landlord’s consent or to transfer the lease to third parties subject to the agreement of the lessor.
Eleven of the buildings hosting the Commission Representations are owned by the EU; in most cases, the rental contracts of the Representations in the Member States allow for early termination.
2,3. The rental contracts of the EU agencies are concluded between the agencies and the host states on a case by case basis in bilateral discussions. They vary therefore across agencies and over time. For more information on individual contracts, the Honourable Member may therefore wish to contact the agencies directly.
At present, it is estimated that more than one medicine in ten worldwide is false. In Europe, the percentage of falsified medicines is close to 1%.
On the Internet, the risk of buying a falsified medicine is particularly high, as, according to the World Health Organisation, a patient runs a risk of around 50% that a medicine bought over the Internet will be falsified.
In 2011, the European Union adopted a directive on falsified medicines. Among other aspects, it regulates the sale of medicines over the Internet, and provides for awareness-raising and prevention campaigns. However, it seems that so far few campaigns have been carried out.
In view of the extent of the phenomenon, therefore, will the Commission launch a number of large-scale awareness-raising campaigns concerning the dangers of falsified medicines on the Internet?
In view of the rapid development of the Internet since 2011, what adjustments does the Commission intend to make in order to combat the sale of falsified medicines over the Internet?
The initial effects of the new pharmaceuticals agreement are now being felt in Greece following the adoption of Law 4472/17 under the terms of the new memorandum, stipulating that, before next-generation medicines can be administered to Greek cancer sufferers, they must have been previously approved in nine European countries, be reimbursed in six and have undergone health technology assessment, which is not currently available in Greece, in three countries.
The provisions of this recent law are effectively denying Greek patients access to new medicines that might offer a cure or increase their life expectancy, thereby depriving them of the same treatment as other European patients.
In view of this:
1. Is the Commission aware of the agreement and its implications for the health of patients and possibly their chances of survival?
2. Does it consider it admissible for individuals to be literally sacrificed to the economic adjustment programme and does it approve of the restrictions being imposed?
3. If not, will it propose alternative solutions to ensure that economic measures do not affect public health?
Measures regulating the prices of medicines and the organisation of the health systems as well as the delivery of care fall under the responsibility of Member States (in line with Article 168 of the Treaty on the Functioning of the European Union).
Given the Commission’s limited role in this field, it encourages Member States to cooperate so as to ensure access to medicines and improve the sustainability of pharmaceutical expenditure, in line with the Commission Communication on effective, accessible and resilient health systems.
The only EU legislation dealing with pricing/reimbursement of medicinal products is the Transparency Directive on the processing of a Member State’s decision regarding the pricing/reimbursement of a medicine, but not the actual price or reimbursement level. With regard to the recording of prices set by Member States, the Commission only supports the “Euripid database project” which is a voluntary and Member States’ driven initiative.
The Council recently called on the Member States to strengthen cost-effective use, availability, accessibility and affordability of medicines by, inter alia, promoting public procurement and the role of generics and biosimilars, appropriate price-control policies, and a rational use of medicines.
1. As the Commission pointed out in its answer to written question E-008233/2016, the Falsified Medicines Directive introduces stricter rules to improve the traceability of medicinal products to ensure that medicines are safe and that the trade in medicines is rigorously controlled. The Directive primarily aims at addressing the problem of falsified medicines in the legal supply chain, and may indirectly help to tackle the infringement of Intellectual Property Rights (IPR), i.e. the problem of counterfeit medicines. The new measures include:
– Obligatory safety features on the outer packaging of the medicines;
– A common, EU-wide logo to identify legal online pharmacies, to make it easier to distinguish between legal and illegal online pharmacies throughout the EU.
The Commission is working intensively with the Member States through an expert group to ensure the smooth implementation of the safety features as of February 2019. The Commission will also continue to work with customs authorities, international partners and industry to ensure a high level of protection for IPRs in the EU. International cooperation is also an essential component of the EU’s strategy for the effective enforcement of IPR. Furthermore, the Commission is finalising an evaluation of the intellectual property rights (IPR) Enforcement Directive which is also looking at the functioning of the enforcement framework for IPR for medicines.
2. The Commission maintains its website as a tool to keep citizens informed of the ongoing work to continue to address counterfeit and falsified medicines and led a proactive communication campaign for the introduction of the EU common logo to identify legal online pharmacies.
The organisation of health systems and delivery of care as well as the cost containment measures in the area of medicine are the responsibility of Member States.
The Commission is supporting improved exchange of information among Member States and promoting their cooperation on a voluntary basis for example through the Network of competent authorities responsible for pricing and reimbursement, by supporting a European medicine price data base focusing on the appropriate use of current data sets of product prices and implementing effective application of reference pricing to participating Member States and by supporting a Project on Sustainable Access to Innovative Therapies.
To respond to a call by the Council in 2016, the Commission has commissioned a study to analyse the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products. The study will be carried out in the course of 2017.
The Commission is working on an initiative to strengthen EU cooperation on health technology assessment. Finally, the Commission has also mandated the Expert Panel on Effective Ways of Investing in Health to develop an Opinion on “Innovative payment models for high-cost innovative medicines”, which would assist Member States to develop policies on cost-effective use of medicines.
EU legislation relating to medicinal products for human use relies on the scientific assessment performed by the scientific committees of the European Medicines Agency (EMA) for its decision making process. In the case of the Human papillomavirus (HPV) vaccines review, in particular the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) were involved. Patients’ representatives were also extensively involved during the evaluation so that scientific experts could understand the views of those affected by the two conditions under assessment. Extensive measures are in place, including rules on handling potential conflicts of interests of scientific committee members, to ensure that the committees reach their scientific conclusions in an impartial way without any undue outside pressure particularly while the procedure is ongoing. Once the procedure is completed, a summary of the scientific recommendation enters the public domain. This published assessment report (European public assessment reports) contains a comprehensive summary of the data assessed.
Further explanation regarding the EMA review process is publicly available in the EMA’s response to the questions raised by the Nordic Cochrane Centre.
After a marketing authorisation is granted, medicines in the EU, including the HPV vaccines, are subject to a post-marketing surveillance. New emerging safety information including pharmacovigilance reports and published studies, regardless of their origin, are appropriately considered. The pharmacovigilance reports on suspected adverse drug reactions of all centrally authorised medicines are collected in the EU centralised database.
In accordance with Article 168(7) of the Treaty of the Functioning of the European Union Member States are responsible for the organisation and delivery of health services and medical care, including prescriptions for medicinal products.
The Commission supports Member States through the governmental expert group on mental health and well-being as a forum to exchange information and best practices on mental health, where issues such as the use of medicinal products could be discussed.
There are no activities under way or planned to monitor specific treatment for children or teenagers.
More generally, the Commission supports Member States in their efforts to review their mental health policies and share experiences in improving policy efficiency and effectiveness on the basis of the European Framework for Action on Mental Health and Wellbeing.
In addition, the EU-Compass for Action on Mental Health and Well-being provides a forum to report progress and exchange good practices in areas such as prevention of depression and suicide, mental health at work and in schools, e-health and access to mental health care.
The Commission is aware of the legislation mentioned by the Honourable Member and has been in dialogue with the Polish authorities on this issue. As mentioned in the replies to written questions E-007113/2016 and P-002868/2016, the Commission also follows developments in other Member States and has engaged in relevant dialogues. Given the confidential nature of such dialogues, the Commission cannot comment on the cases under assessment.
As stated in the replies to written questions P-002868/2016 and P-008962/2016, Member States are entitled to take restrictive measures to address these shortages, provided that the measures are necessary for the protection of health and life of humans. Such restrictions must be appropriate for securing the attainment of the objective pursued and must not go beyond what is necessary in order to attain it. A proportionality assessment is always undertaken in respect of the situation in a particular Member State and in the light of the justification provided.
1. It is for Member States to investigate specific allegations of bribery of doctors by pharmaceutical companies. The Commission has prioritised the healthcare sector in its anti-corruption experience sharing programme, including a workshop for national experts held in Rome in November 2015. In addition, the Commission will publish in 2017 an update of a research study first carried out in 2013 on corruption in the healthcare sector, including risks in relations between doctors and pharmaceutical companies. The Commission also supports relevant work at the European Partners against Corruption (EPAC) – European contact-point network against corruption (EACN).
The fight against corruption is part of structural reforms envisaged in Greece’s economic adjustment programme. The programme monitors the implementation of a national strategy against corruption, taking into consideration particular needs in high risk sectors such as national health services. For these sectors, specific strategies are designed with technical assistance from the Organisation for Economic Co-operation and Development (OECD).
2. The Commission fully supports the objective of protecting whistleblowers against retaliation and has taken steps to protect whistleblowers in EU sector-specific legislation, ranging from audit and money laundering to trade secrets protection, market abuse, and other instruments regulating financial services. With a view to strengthening the protection of whistleblowers, the Commission is assessing the need, legal feasibility and scope for horizontal or further sector-specific action at EU level, while respecting the principle of subsidiarity. An impact assessment study is being carried out and a public consultation was launched in March 2017.
3. The European Anti-Fraud Office (OLAF) has competence to investigate alleged misuse of, or damage to the EU budget. Any suspicion of misuse of EU funds by pharmaceutical or medical companies should therefore be referred to the Office. OLAF does not generally comment on cases it may or may not be investigating, to protect the confidentiality of investigations and to ensure respect for personal data and procedural rights.
The Euro Summit conclusions of 12 July 2015 confirmed that the Greek authorities had offered to abolish the provision that the ownership of a pharmacy should be limited to pharmacists only. This measure follows a recommendation by the Organization for Economic Cooperation and Development (OECD) and is intended to enhance competition and improve efficiency. However, the Greek authorities are still free to regulate pharmacy services in a way that takes into account public health considerations, as is the case in other Member States where the ownership of pharmacies is not restricted.
In 2016 the Greek legislator adopted the Joint Ministerial Decision No 36277 which carries out the commitment made in 2015 and which states that pharmacy licenses can be granted to non-pharmacists. According to the Decision, pharmacies owned by non-pharmacists are required to take the legal form of a Limited Liability Company (LLC). However, such pharmacies owned by non-pharmacists have to be operated by qualified pharmacists who should participate in the shareholder structure of the above-mentioned LLC as a partner with at least a 20 % share in the capital.
The Commission does not have any evidence that the new law has led to massive unemployment under pharmacists nor that the measure has endangered public health.
According to Article 168 of the Treaty on the Functioning of the European Union, the definition of the health policy and the organisation and delivery of health service and medical care are the responsibility of the Member States, including pricing and reimbursement decisions. However the Commission recognises the importance of timely access to innovative medicines for patients and facilitates EU cooperation in different areas concerning access to medicines.
One of the initiatives is Health Technology Assessment (HTA), which assesses the added value of given health technology over and above existing ones, helping Member States to allocate national resources to effective health interventions. The Commission launched an initiative on strengthening EU cooperation on HTA which aims at reducing discrepancies of procedures and duplication of efforts for HTA bodies and industry, discrepancies in HTA methodologies, and ensuring uptake of work jointly produced into national HTA activities.
The Commission supports the Greek authorities, in the context of the dialogue within the Memorandum of Understanding to cooperate and exchange information, experience and best practices with other Member States that carry out these assessments in order to increase the cost-effectiveness of public expenditure for health care. Increased cooperation will help Greek authorities in making decisions for their health system that are evidence based and contribute to the development of an effective, efficient, resilient and sustainable health sector.
The Commission supports the implementation of all the United Nations Sustainable Development Goals. Goal 3 to “ensure healthy lifes and promote well-being for all” includes a target on promoting mental health and well being.
The following are examples of some key Commission activity strands which mainstream a holistic approach to patients:
– Support through the 3rd Health Programme for a project “Supporting Member States in mainstreaming health promotion and disease prevention in health and educational settings”;
– Collection of good practices in the field of health promotion by the joint action on chronic diseases and healthy ageing (CHRODIS);
– Two pilot projects, funded by the European Parliament, are promoting patient empowerment and self-care;
– The European Framework for Action on Mental Health and Well-being, which was the result of a cooperation of 25 Member States, underlines the need for a mental health in all policies approach and addresses mental health in schools, at work, prevention of depression and suicide and access to mental health care in a holistic way;
– The European Guidelines on Quality Improvement in Comprehensive cancer control contains recommendations in person centered approach and psychosocial rehabilitation.
Through the Horizon 2020 programme, the Commission supports health research based on a holistic, patient-centred approach that includes research on mental health and on its impact on physical disorders. Horizon 2020 also supports public health research on effective promotion of mental well-being and resilience.
The organisation of health systems and delivery of care are Member States’ responsibility, including the measures in the area of use of medicines by patients.
The Commission is co-financing the project ‘Simpathy’ which aims at developing ways to improve the rational use of medicines in the context of multiple treatments (polypharmacy) and an action group under the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) is focusing on adherence to treatment.
Regarding safe use of medicines, the Commission has also funded several projects through its research programme. For example the ‘Monitoring Medicines’ project in the area of medicine-related patient harm and consumer reporting of adverse events of medicines resulted in practical guidelines available at the World Health Organization website. There is currently a specific focus on projects developing and validating new digital solutions which can contribute to healthy ageing, including on the issue of medications use.
EIP on AHA partners remain committed to the goal of increasing average healthy life years in Europe given the decline in the healthy life years expectancy registered between 2010 and 2014. Further measures to harness the potential of digital innovation to support better treatment, diagnosis and prevention of diseases, notably chronic diseases have been announced by the Commission in the context of the Digital Single Market mid-term review.
Parliament’s resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance incorporates a number of significant amendments.
These are reflected in the following paragraphs: ‘Urges the Member States to implement or develop the following measures: […] ensure that medical professionals inform patients when a medicine is used off-label and provide patients with information on the potential risks in order to enable them to give informed consent; […] Calls on Member States to investigate possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labelled for single use; […] Calls on the European Medicines Agency (EMA) to develop guidelines on the off-label/unlicensed use of medicines based on medical need, as well as to compile a list of off-label medicines in use despite licensed alternatives; […] Calls on the Commission and the Member States to promote the introduction of the European logo provided for by Implementing Regulation (EU) No 699/2014 in order to identify clearly online pharmacies which offer medicines for sale to the public remotely while safeguarding consumers against the purchase of fake medicines, which are often a health hazard […]’.
Can the Commission say what progress has been made in addressing these important amendments?
In its conclusions on a ‘future EU industrial policy strategy’ published on 29 May 2017, the Council called on the Commission to ‘provide a holistic EU industrial policy strategy for the future in time for the European Council meeting in spring 2018’.
Against that background, does the Commission intend to:
— Include the European pharmaceutical sector, which plays an important role in generating jobs, growth, innovation and exports in Europe, in its future recommendations for industrial policy and to implement the action plan for the industry, as suggested by the Commission in its communication ‘A Stronger European Industry for Growth and Economic Recovery’, as soon as possible?
— Relaunch a high-level dialogue, along the lines of the G10 in 2001-2002 and the Pharmaceutical Forum in 2005-2008, involving representatives of the Commission itself, the European Parliament and the Member States as well as key stakeholders from the health sector?
Cyprus has been a Member State since 2004, and its ties with the EU and its membership of the Customs Union go back decades.
During its European path, Cyprus has demonstrated that it is steadily and consistently in line with the European ideal, and its presence in the EU is synonymous with its positive contribution at all European levels. Cyprus has been successfully meeting all its European obligations in both economic and political terms and coped well with the Council Presidency.
I firmly believe that Cyprus meets all the requirements for hosting a European agency. I think it can host one of the two agencies which will be released by Great Britain after Brexit, i.e. either the European Medicines Agency or the European Banking Union.
1. What steps will the Commission take to support small countries like Cyprus with hosting a European agency as part of the equal treatment of Member States? 2. Does the Commission consider that it is fair and objective for some Member States to have more than one European agency while some others do not have any? 3. How does it ensure equitable geographical distribution of European agencies?
The Standing Committee on the Law of Patents (SCP) of the World Intellectual Property Organization (WIPO) is a committee of WIPO Member States’ experts that meets twice per year to discuss patent related issues. There are several issues on the agenda of the SCP.
The nature of the discussions remains at the level of an exchange of views and best practices. The Commission does not have an authorisation to open negotiations on any of the issues under discussion at the SCP and there is no consensus amongst the WIPO members as to the desirability to engage in such negotiations at this stage. If any of the current discussions were to turn into negotiations and the Commission received an authorisation from the Council to engage in them, the Commission would ensure full information of the European Parliament in accordance with the Framework Agreement on relations between the European Parliament and the Commission.
The Commission is in contact with stakeholders on a regular basis, also prior to SCP discussions, and coordinates with Member States interventions at the SCP in view of the fact that the current discussions consist of an exchange of views and best practices.
In this context, the Commission welcomes the view on the High Level Panel report taken by the European Parliament in paragraph 53 of its own-initiative Resolution of 2 March 2017 on EU options for improving access to medicines.
Following the UK Government’s decision to trigger Article 50 of the Treaty on European Union, the European Medicines Agency (EMA) will be relocated to a country in which EC law applies. The relocation will also affect the 2018 budget, a draft of which was published by the Commission on 30 May 2017, as well as the Multiannual Financial Framework (MFF).
1. What is the expected procedure for relocation of the EMA? Can the Commission outline the legal basis for the procedure and the formal criteria that it deems crucial for choosing a new host country?
2. Is the Commission considering to propose relocating the EMA to a country that does not currently host any agencies, such as Bulgaria, Romania, Croatia, etc.?
3. How much is the relocation expected to cost? Does the Commission take the view that, on account of its decision to leave the EU, the UK should bear the cost of relocation?
The Commission is currently working on a second report to the European Parliament and Council on the Paediatric Regulation, which will be delivered in 2017. A public consultation to gather feedback and a study with a specific focus on the reward system provided by the regulation and its economic impact will inform the report.
The Commission is confident that this will lead to a comprehensive picture about the strengths and weaknesses of the regulation.
The questions raised by the Honourable Member mirror the calls of a recent Resolution of the European Parliament on paediatric medicines. In this regard, several obstacles to innovation are already being addressed; the new legal provisions on clinical trials will facilitate the conduct of cross-border trials in the field of paediatric medicines; and under the ‘Innovative Medicines Initiative 2’ (IMI2), the creation of a large pan-European paediatric network should facilitate the development and availability of new medicinal products and other therapies.
In the area of rare diseases, of which many are of genetic nature and become clinically evident during childhood, several calls have been carried out or are ongoing.
Additional opportunities for research will be created by future European Reference Networks, which aim at concentrating resources and expertise, including in rare or low-prevalence complex diseases or conditions.
The Commission has already provided dedicated funding for paediatric research under the EU Framework Programme for Research and Innovation Horizon 2020.
The Commission has adopted a proposal for a directive (COM(2016) 822 final) that is intended to benefit access to regulated professions. The general idea behind the proposal is to improve scrutiny of regulations on access to certain professions, as the Commission considers that in far too many cases, criteria set by Member States for setting up businesses or practices are unjustified.
The regulations in France, however, have a beneficial effect. Pharmacists are a regulated profession in France, meaning that every area of the country has at least one. Doctors, however, for whom there are no specific regulations, can set up practice wherever they want, even though many areas in France are suffering from a lack of healthcare.
Hence, thanks to the restrictions imposed on pharmacists, as a profession they are spread fairly across the whole of France’s territory for the good of the public’s health.
Is the Commission considering ring-fencing specific regulations in certain fields, most notably health, so that Member States can continue to regulate health professions where there are specific essential needs?
In January 2017, the Commission presented a proposal for a directive on the need for a proportionality test before adoption of new regulation of professions. The proposal seeks to establish a legal framework for the use of the proportionality test in Europe, in order to put an end to disproportionate restrictions on regulated professions and to address the fragmentation of the internal market in this regard.
In France, this proposal has been the subject of two reasoned opinions, by the Senate and the National Assembly, concerning non-compliance with the subsidiarity principle. The French Parliament believes that, as it stands, the directive undermines the Member States’ competence in the areas of health and tourism, where, according to the treaties, the EU can only complement the action of the national authorities.
1. Is the Commission aware of the reasoned opinions? Does it plan to adapt its proposal to bring it into line with the subsidiarity principle?
2. If not, can the Commission assure the Member States and stakeholders in the relevant sectors of the economy that the directive will not undermine national competence in the areas of tourism and health?
The Commission is aware that certain pharmaceuticals may count among the ‘emerging pollutants’ on which attention is increasingly being focused in the aquatic environment.
In 2015, six pharmaceutical substances were included in the first watch list of substances to be monitored by Member States temporarily in surface waters to determine whether they pose a risk to the environment or to human health via the environment, and thus whether their concentrations in surface waters need to be controlled under the Water Framework Directive.
The results from the first year of monitoring are being analysed. Furthermore, data have also been gathered by Member States on the concentrations of pharmaceuticals in groundwater in the context of the establishment of a voluntary watch list under the Groundwater Directive.
In addition, the Commission is supporting a study on the risks from pharmaceuticals in the environment to inform the development of its strategic approach to pharmaceuticals in the environment. Adoption of the approach will be followed, as appropriate, by proposals for measures. The Commission recently published a roadmap(4) for the initiative, on which feedback may be given.
Article 87 of Law 4472/2017 on the Reimbursement for Medicines Dispensed under Prescription Protocols lays down a particularly time-consuming bureaucratic procedure for the authorisation of new medicines. This procedure can cause significant delays, often doubling the time needed to sign a contract for the authorisation of a clinical study — where such authorisation is granted — thereby further delaying the introduction of new medicines on the Greek market.
According to the official data of the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than EUR 75 billion are invested worldwide and more than EUR 30 billion across Europe every year in pharmaceutical research, of which Greece accounts for less than EUR 80 million.
In view of the above, can the Commission say:
What position does Greece occupy in the take-up of Community funds for pharmaceutical research in Greece?
Is Law 4472/2017 compatible with the guidelines of Regulation 536/14 on the avoidance of administrative delays for the initiation of clinical trials?
The Commission is fully aware of the priority pathogens list recently published by the World Health Organisation (WHO).
It supports research on Anti-Microbial Resistance (AMR) since 1999 with an investment of over EUR 1.3 billion. Research is currently ongoing in the areas of health, veterinary sciences, food and environment. The focus is on antimicrobials, vaccines and alternative therapies to treat infections caused by the pathogenic bacteria on the WHO list and also other relevant bacteria like Mycobacterium tuberculosis.
The Commission is using different instruments to support the development of new antimicrobials, such as Innovative Medicines Initiative (IMI), which is the world’s biggest public–private partnership in the field of AMR. IMI’s new drugs for bad bugs programme has already invested over EUR 650 million, created a drug discovery platform for testing and optimising new antibiotics, and established a Pan-European network of more than 700 hospitals and 500 laboratories in 39 countries.
Through calls-for-research specifically targeted at Small and Medium-sized Enterprises (SMEs), the Commission has strengthened European SMEs involved in AMR research.
Furthermore, the Commission and the European Investment Bank launched InnovFin ID that provides loans to help develop new solutions for infectious diseases such as a HIV monitoring device, a diagnostic tool, and clinical trials of treatments for hepatitis B, human papilloma virus-induced cancers, and tuberculosis.
Efforts are being further stepped up with the preparation of a second EU Action Plan planned to be finalised by summer 2017 to support Member States in the fight against AMR. A public consultation collecting the views and input of citizens, administrations, associations and other organisations on possible activities to include in the new Action Plan closed on 28 April 2017.
The Commission is not aware of any recommendation to Member States, currently under consideration in the European Medicines Agency (EMA) for the use of cannabidiol through compassionate use programmes for the treatment of Dravet Syndrome.
Compassionate use means making a medicinal product available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product. It falls under the competence of Member States, which notify EMA and may request opinions on the conditions for use, the conditions for distribution and the patients targeted. Therefore, it is not the role of the Commission to propose a roadmap.
In addition, according to Article 5 of Directive 2001/83/EC(1), a Member State, in accordance with its legislation in force and to fulfil special needs, may allow supply of a medicinal product without marketing authorisation in response to a bona fide unsolicited order formulated in accordance with the specifications of a healthcare professional and for use by an individual named patient under the direct responsibility of the healthcare professional.
The organisation of health systems as well as measures regulating the price of medicines, the distribution of medicinal products to the public and the handling of unused medicines are Member States’ responsibility.
The Commission is not in a position to establish and fund permanent structures for donation and distribution of pharmaceuticals on a non-profit basis.
The organisation of health systems and delivery of care are Member States’ responsibility as well as the cost containment measures in the area of medicines.
The Commission is supporting improved exchange of information among Member States on pricing and promoting their cooperation on a voluntary basis; such as the Network of competent authorities responsible for pricing and reimbursement, a European medicine price data base and an Organisation for Economic Co-operation and Development Project. The Commission is also working on an initiative to strengthen EU cooperation on health technology assessment.
The Cypriot healthcare sector remains characterised by lack of universal coverage and various levels of inefficiency (i.e. improving competitive public procurement and stronger governance and coordination of the pharmaceutical market). Legislation aiming to create a National Health System and providing public hospitals with greater autonomy are key to improve the capacity and cost-effectiveness of the healthcare sector, but is still pending parliamentary adoption.
The Commission is ready to support Member States and the European Medicines Agency to tackle the problem of shortages of medicines which can have serious consequences on the health of patients. Some work is already being undertaken by the national authorities, who meet regularly through the Heads of Medicines Agencies network. On 27 March 2017, the Commission also raised the issue of shortages within the Commission’s expert Committee on Pharmaceuticals and some Member States expressed interest to follow-up on the recommendations laid down in the recent own initiative report of the European Parliament on access to medicines.
The Commission has no further means to help with the treatments of patients in Romania, as measures regulating the organisation of the health systems and the delivery of care are Member States’ responsibility. The Member States are also responsible for ensuring the marketing authorisation holders and wholesale distributors’ obligations of continuous supply of medicines to cover the needs of patients. Moreover, a Member State can authorise the placing on the market of a medicine from another Member State or use an unauthorised medicine for the treatment of patients.
In addition, Member States may adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions. It should be noted that some Member States have already taken national measures to prevent shortages of medicines arising from parallel trade.
1. As highlighted in the European Food Safety Authority opinion, a multi-faceted approach is needed to reduce the use of antimicrobials (AM) in animal husbandry including the development of national strategies; harmonised systems for monitoring AM use; prudent use of AM by veterinarians and farmers and increasing the availability of rapid and reliable diagnostics. The Commission is currently examining how to follow-up to the 2011 Action Plan against Antimicrobial Resistance (AMR) in order to address properly these issues.
2. Since 1999, the Commission has invested more than EUR 1.3 billion in AMR research, including alternatives to AM such as vaccines, phages, phytotherapy or probiotics. Under the most recent EU Programmes for research and innovation, several projects on AMR have been funded. For instance, the currently running project EFFORT aims at providing knowledge on the ecology and transfer of antimicrobial resistant bacteria throughout the food chain but also studies strategies to reduce the use of AM in farming systems.
The Commission continues to support research on AMR under Horizon 2020, with for instance two topics open in the 2017 call, respectively on a European Joint Programme “Co-Fund on “One Health” (zoonoses – emerging threats)” that will have an important component on AMR, and on “Alternative production system to address AM drug usage, animal welfare and the impact on health”.
3. In most cases, antibiotics in humans are used for acute infections for less than two weeks. Exceptions however exist such as the treatment of difficult infections (e.g. endocarditis) and chronic treatment for cystic fibrosis patients. The Commission has not assigned studies on the long-term use of antibiotics in humans.
The European Union has adopted a number of measures to fight against falsified medicines including the introduction of safety features.
The safety features consist of a unique identifier (a 2-dimension barcode containing a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product) and an anti-tampering device.
The principle of unique identifier across Europe is for prescription medicinal products. Nevertheless, Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier to any medicinal product subject to prescription or subject to reimbursement.
Moreover, all reimbursable medicinal products placed on the French market will have to bear the unique identifier, regardless of the country of origin of the manufacturing authorisation holder.
Consequently, the Commission would like to confirm that the Member States can go beyond the scope of prescription medicines and that the French obligation to extend the scope is compatible with the European legislation.
In the light of the growing challenge of antimicrobial resistance (AMR), the Commission is actively encouraging the development of alternatives to antibiotics.
The Commission is aware of the potential merits of bacteriophage therapy. However, studies in livestock have not always been positive. Lately, the EU funded project Camcon did not show consistent reduction of Campylobacter in broiler chicken. The Commission is currently funding the PHAGOBURN project that aims to evaluate the efficacy and safety of phage therapy to treat bacterial infections of burn wounds in a clinical trial. The clinical trial is now running, and results will be available within the coming months. For all latest results, the project website can be consulted.
It should be emphasised that a veterinary medicine cannot be authorised before its safety and efficacy have been appropriately demonstrated. This is not currently the case for bacteriophage therapies, for which very few randomised controlled clinical trials have been conducted to date. Therefore, more robust evidence on bacteriophage treatments and further discussion of the scientific aspects are needed.
In its Proposal for a regulation on veterinary medicinal products, as adopted in 2014, the Commission has not included any specific provisions for the authorisation or use of bacteriophages as veterinary medicines.
Nonetheless, the Commission could, based on an actual application dossier, analyse if a specific product would fall under the scope of Regulation (EC) No 1831/2003 on additives for use in animal nutrition.
EU legislation on medicinal products for human and veterinary use requires the Member States to ensure that appropriate collection systems are in place for medicinal products that are unused or have expired. In addition, this legislation requires that, where appropriate, the packaging of medicinal products contains information on specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, as well as a reference to any appropriate collection system in place. The detail of how collection systems should operate is for the Member States to decide. Several have opted for separate collection by pharmacies, free of charge, with subsequent transfer to specialised treatment facilities.
The Commission is aware of the issue of unused medicines and its economic impact on national health systems and of the recent report of the European Parliament on access to medicines. Measures regulating the organisation of the health systems and the delivery of care are a responsibility of the Member States.
As indicated by the Honourable Member, the Member States were requested to carry out an analysis of the risk mitigation measures recommended by the European Medicines Agency (EMA) in its opinion of 11 December 2014 and to indicate in an action plan the measures that have been already implemented or that they would consider to put in place in the future.
At the meeting of the Veterinary Pharmaceutical Committee that took place on 15 June 2015, it was agreed that the mitigation measures implemented by the Member States should guarantee that, where diclofenac is used and vultures (or other relevant necrophagous birds) are present on the territory, they would be able to contain the risk effectively.
Given the Commission’s commitment to follow up on the effectiveness of the risk mitigation measures introduced in the Member States and on any new information with regard to the death of vultures, the Member States were invited during the Veterinary Pharmaceutical Committee that took place on 4 July 2016 to provide an update of the situation in their territories.
Most Member States indicated that they had still not authorised diclofenac. Those that have authorised products indicated that appropriate safety warnings were included in the product literature and that appropriate measures are in place for the safe disposal of fallen stock and the feeding of carrion to birds of prey.
None of the Member States reported deaths of vultures in their territories and no request was made for the initiation of a referral where the withdrawal of the marketing authorisations of products containing diclofenac would be considered.
In its report on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015, (Ayala Sender report, A8-0084/2017, paragraph 33), the European Parliament:
‘notes with concern that the Agency’s rental contract until 2039 (author’s note: in the UK) does not include an early termination clause… and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347,6 million.’
The Amsterdam region is an official candidate for the location of the EMA. The EMA is currently still based in London but will have to move from there because the UK is leaving the EU. Incidentally, the UK itself does not want the EMA to leave the country. The British Secretary of State for Exiting the European Union, David Davis, recently suggested that the Medicines Agency and the European Banking Authority might remain in London after Brexit. However, Brussels has ruled this out.
1. How many more rental contracts of this kind, without early termination clauses, are there? Please provide an overview.
2. Who is ultimately responsible for bearing these costs, and has the Commission taken account of the possible departure of other Member States in future?
3. Where or in what Treaty is it stated that an EU agency must be established in an EU Member State and that it is not possible for it to be located outside the EU?
The Commission continues to monitor the developments with respect to competition aspects surrounding the off-label use of Avastin for treatment of the age-related macular degeneration (AMD). It also remains in close contact with other National Competition Authorities that are looking into the issue, notably in the context of the regular meetings of the European Competition Network’s Pharma and Health Services Subgroup where confidential investigative work by the various competition authorities is discussed.
In addition, the Commission has lodged its observations on a preliminary ruling case before the European Court of Justice prompted by a reference from the Italian State Council in the litigation between Hoffman-La Roche and Novartis against the Italian competition authority’s decision of 27 February 2014.
However, as indicated in the Commission’s answer to written question P-002767/2014, the off-label use of pharmaceuticals is also factually and legally closely related to the respective national regulatory framework that deals with the question on how medication is ultimately used. In this respect, the Commission refers to the decision of 24 February 2017 by the highest French administrative court to uphold a policy allowing the off-label use of Avastin for treatment of AMD
The Commission is examining the compatibility of the Slovak Law on Medicinal Products with Union law, and in particular with Articles 35 and 36 of the Treaty on the Functioning of the EU (TFEU). Should the legal assessment reveal non-conformity of Union law, the Commission in its role as Guardian of the Treaties may take the necessary action, as appropriate.
As a general rule, during an ongoing assessment the Commission cannot pronounce on the compatibility of any individual elements of the laws under analysis. The elements the Honourable Member draws the attention to will be taken into account in the Commission’s examination.
Measures regulating the prices of medicines as well as the organisation of the health systems and the delivery of care are Member States’ responsibility.
However, the Commission encourages Member States to cooperate in this area to ensure access to medicines, promote the rational use of medicines and improve the sustainability of pharmaceutical expenditure, in line with the Commission Communication on effective, accessible and resilient health systems.
The Council recently called upon the Member States to implement measures with a view to ‘strengthening the cost-effective use, availability, accessibility and affordability of medicines by implementing policies such as promoting public procurement and the role of generics and biosimilars, appropriate price-control policies and a rational use of medicines’.
To support Member States in their efforts to ensure the sustainability of their healthcare budgets, the Commission recently conducted a public consultation for an initiative to strengthen EU cooperation on health technology assessment.
In the EU, most medicine shortages are dealt with at national level. However, the European Medicines Agency can be involved in certain situations, for example when a medicine shortage is linked to a safety concern or affects several Member States.
Measures regulating prices of medicines as well as organisation of health systems and delivery of care are Member States’ responsibility.
Despite its limited competences, the Commission is promoting improved exchange of information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis; in particular through tools such as a European medicine price database (Euripid). It also facilitates the exchange of best practices and knowledge among Member States through the Network of competent authorities responsible for pricing and reimbursement.
To support Member States in their efforts to ensure sustainability of their healthcare budgets, the Commission has recently conducted a public consultation for an initiative to strengthen EU cooperation on health technology assessment.
The Council recently called upon the Member States to implement measures with a view to ‘strengthening the cost-effective use, availability, accessibility and affordability of medicines by implementing policies such as promoting public procurement and the role of generics and biosimilars, appropriate price-control policies and rational use of medicines’.
The Commission has, within the European Competition Network, supported national competition authorities when they fined companies for having abused their dominant position by means of excessive prices for medicines that lost their market exclusivity.
Greek pharmacies are facing a severe problem as, on top of the current shortage of medicines, they are also having to manage delays in the settling of overdue debts owed by the Greek National Health Service Organisation (EOPPY). As a matter of fact, the overdue debts date back to 2013. Given that Directive 2011/62/EU requires all EU Member States, to have adequate supplies of medicines, can the Commission say:
1. As they are endangering the viability of the sector and the adequacy of medicines in the Greek market, how will overdue debts to these pharmacies be addressed?
2. For the Pharmaceutical Association of Thessaloniki alone, the overdue debt is for insurance fund prescriptions and stands at EUR 2 348 655.38. How can the debt be dealt with?
3. How will pharmacy liquidity be ensured as the delay in consolidating the health sector of the insurance funds drags on and on?
The Commission is fully aware of the recent resolution of the European Parliament on the Paediatric Medicines Regulation. When the resolution was discussed at the December 2016 plenary meeting of the European Parliament the Commission welcomed the debate, as it confirms the shared interest of both Institutions to secure the best outcomes for children.
The Commission is currently working on a second report to the European Parliament and Council on the Paediatric Regulation, which will be delivered in 2017. For this, a public consultation was conducted which has recently been closed in February 2017.
The Commission will provide the European Parliament with more detailed comments on the Resolution in due course and as per usual procedure.
Greek authorities can finance the provision of medicines and vaccines for refugees through their Asylum, Migration and Integration Fund (AMIF) and Internal Security Fund (ISF) national programmes. Their implementation is the responsibility of the competent Greek authorities, in accordance with the principle of shared management. The Commission is actively supporting the Greek authorities in their efforts to ensure an effective and efficient use of their allocation under these funds.
Substantial Emergency Assistance from both funds has also been awarded directly to Greek authorities, including the Ministry of Health (MoH). The use of emergency assistance is monitored by the Commission through reports, on-the-spot visits, and notably when assessing the final report of the action.
Healthcare activities have also been supported through the Emergency Support Instrument (ESI). Three humanitarian organisations are funded to provide basic health care, psycho-social support and referrals to hospitals to the migrant populations, including on Lesvos, for a total of EUR 15 million. These partners and other health actors have their own, facility based, pharmacies to provide drugs – purchased at Greek pharmacies/wholesalers or imported – to the migrants. While vaccines are largely provided by the MoH, the International Federation of Red Cross (IFRC), with ESI funding, has also supported the MoH in purchasing the vaccines when needed.
As concerns shortages of medecines in Greece, the Commission has limited competence to deal with specific situations in Member States as regards health policy, health care and the organisation of health services. However, the Commission supports Member States in the EU Health Security Committee with guidance on vaccination against a range of vaccine-preventable diseases, facilitating mutual assistance among Member States in case of shortages.
The Commission is aware that an application for an orphan medicinal product containing eteplirsen (Exondys 51) was submitted to the European Medicines Agency in December 2016. The application is currently under the assessment of the Committee for Human Medicinal Product (CHMP), which has 210 days after the validation of the application to adopt an opinion, if no further questions are submitted to the applicant.
If the opinion of the CHMP concludes positively on the benefit/risk assessment of eteplirsen for the treatment of Duchenne’s Syndrome and the Committee for Orphan Medicinal Products confirms the compliance with the orphan designation criteria in line with Regulation (EC) No 141/2000, the final decision on the authorisation is taken by the Commission.
The Commission is holding regular review missions in Greece and, within the boundaries of its competences, intends to continue to raise concerns related to public health. According to the Greek health authorities, efforts are being made to provide the necessary drugs to those hospitals which provide medication to vulnerable groups.
As stated in the Commission’s reply to E-001016/2016, the EU is providing financial support to health-related actions proposed by Greece according to its national priorities through the European Structural and Investment Funds. In addition, the Structural Reform Support Services is helping with facilitating expertise in collaboration with the World Health Organization.
As the Commission pointed out in its answer to the written question E-009252/2016 raised by the Honourable Member, the Commission has limited competence to deal with specific situations in the Member States as regards health policy, health care and the organisation of health services.
Following on from previous questions on the use of diclofenac for veterinary purposes in the EU (E-009337-14 and E-003922-15), and given the recent warnings from Portuguese environmental NGOs on the threats to highly endangered vultures and large carrion-eating eagles (a species protected by national and EU legislation) and to their ecosystems, I should like some further information from the Commission on the developments to date. In particular:
1. What is the state of play with the risk-reduction steps recommended by the European Medicines Agency (Committee for Medicinal Products for Veterinary Use) in the Member States and with related action plans?
2. What evaluation has been conducted to date to gauge the suitability of each Member State’s legislation on populations of carrion-eating birds in its territory?
3. What is the state of play on the possibility of banning diclofenac for veterinary use and replacing it with the safe alternatives available, such as meloxicam?
The Commission has made clear from the start that changes to the EU’s laws on intellectual property rights for pharmaceuticals, or to pricing and reimbursement regulations, are not part of the EU’s objectives in the Transatlantic Trade and Investment Partnership (TTIP) negotiations. The EU already has a solid and comprehensive intellectual property rights system that allows innovators to thrive and to remain among the most competitive globally. So the Commission believes there is no cause for concern in relation to TTIP. For the same reasons, the Commission is not considering any new regulations related to drug pricing.
At the same time, EU Member States have some of the most efficient and inclusive public health systems in the world. Nothing in TTIP will endanger Member States’ rights to manage their health systems as they see fit. If any do choose to allow American companies to enter their public health services markets (as indeed some already do), these companies will be subject to the same regulation as any other that operates in the market. So the Commission believes there is no cause for concern on this matter either.
The Commission shares the concerns of the Honorable Member and agrees on the importance of adopting an overall policy to reduce antimicrobial resistance (AMR). AMR is a serious threat to human and animal health and there is a clear need to adopt a trans-national “one health” approach. This is why the Commission is now proposing for all new bilateral trade agreements a specific provision to increase cooperation and commitment of EU trade partners to reduce the use of antibiotics in animal production. The aim is also to foster cooperation for the development and the implementation of international guidelines, standards, recommendations and actions aiming to promote the prudent and responsible use of antibiotics.
Products of animal origin entering into the EU are checked by the veterinary services of the EU Member States at the EU border inspection posts with the aim to ensure the respect of European food safety standards and to prevent health risks for European consumers. Physical and laboratory checks are routinely carried out and the frequency of controls may be raised when there is suspicion of unsafe food. Decision 2002/994/EC concerning certain protective measures with regard to the products of animal origin imported from China also obliges Chinese authorities to provide additional sanitary guarantees, in relation to the presence of residues from medicinal products, when exporting fishery products to the EU.
The Commission intends to come forward with the strategic approach around the end of 2017.
A roadmap for the initiative should be published shortly. A study to support the development of the strategic approach is underway and will include a public consultation. The study is considering the relation between the whole lifecycle of pharmaceuticals and their presence in the environment.
It is the Commission’s task in general to monitor economic sectors, including the pharmaceutical sector, for anti-competitive practices. In line with this task, possible abuses of a dominant position by an undertaking in the pharmaceuticals sector fall within the Commission’s remit to intervene under Article 102 of the Treaty on the Functioning of the European Union (TFEU).
In particular, the Commission has been cooperating closely with national competition authorities regarding various recent national investigations into excessive prices for medicines. In this regard, the Commission has supported the decision recently taken by the Italian competition authority against Aspen Pharma.
However, any possible investigation by the Commission would necessarily have to be done on a case-by-case basis considering all relevant facts and circumstances. In addition, consideration would have to be given to the fact that pricing and reimbursement in the pharmaceutical sector are highly regulated by Member States. Moreover, public spending accounts for most of the expenditures on medicinal products in the Union. Such prima facie elements nuance the merits of a possible investigation by the Commission into the matters referred to by the Honourable Members.
1. Biomedical research requires heavy investment and long-term research, coupled with expensive clinical trials and demanding regulatory approval and post-approval procedures. Intellectual Property Rights (IPRs) provide an important incentive for pharmaceutical and biomedical research. The Commission seeks to strike the right balance between the need to promote and finance the research and development of innovative medicines through IPR protection, and to ensure that medicines are accessible to those in need and health systems remain sustainable.
Any amendment of the pharmaceutical IPR framework would need to be justified by an evidence-based analysis. As requested by the Council, the Commission will carry out, as soon as possible, and with the close involvement of the Member States, an evidence-based analysis of the impact of pharmaceutical incentives and rewards (including IPRs) on innovation, availability and accessibility of medicinal products in the EU. The timetable and methodology that the Commission intends to apply was presented at the EPSCO Council on 8 December 2016.
2. Information on funding for projects supported through Horizon 2020 is fully transparent. Beyond the costs for the projects to be implemented under an EU research grant, Horizon 2020 does not provide for the obligation of beneficiaries to disclose costs not related to the implementation of such grants.
The Commission is currently preparing a roadmap for the strategic approach to water pollution by pharmaceuticals.
The Commission report concerning chemical mixtures is expected in the second quarter of 2017.
Regarding the Cosmetics Review on endocrine disruptors, the Commission is currently preparing a report on the current regulatory framework with regard to the management of endocrine disruptors in cosmetics.
The review of the REACH legislation as regards authorisation of substances having endocrine disrupting properties has been finalised and it was published as a Commission Communication on 20 December 2016.
1. Actions that will be developed under the future EU Action Plan against antimicrobial resistance (AMR) will be co-financed under a variety of EU funding programmes managed by the Commission, such as Horizon 2020, the Innovative Medicines Initiative and the Common Financial Framework for the Food Chain and the Health Programme.
2. The evaluation of the 2011-2016 Commission Action Plan against AMR has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and created a framework to guide and coordinate activities on AMR at national and global levels. This includes actions to strengthen the promotion of appropriate use of antimicrobials in both human and veterinary medicine for example through the development of guidelines, training, exchange of good practices and research.
3. In 2017, the Commission will allocate EUR 1.7 million of the Common Financial Framework for the Food Chain to Member States for the monitoring of AMR in zoonotic bacteria in food and farmed animals. Some Member States and regions also intend to use European Regional Development Fund allocations for health related investments, mainly for research and innovation, SME competitiveness, e-health and health infrastructures.
Regarding shortages of medicines the Commission promotes improved exchange of information and best practices among Member States. The Member States are also responsible for enforcing the legislation on medicinal products which introduces an obligation of continuous supply on manufacturers and wholesale distributors to cover the needs of patients (Article 81 of Directive 2001/83/EC). The rules on retail are established by the Member States. These rules are necessary to ensure the proper distribution of medicines and protect public health and the Commission does not intend to take any action which is not under its competence.
It is important to underline that the modalities of the supply of medicinal products to the public at retail level fall under national competence. It is also up to the Member States to implement the conditions under which the nationally established retailers are authorised to sell medicinal products on line, in accordance with the Falsified Medicines Directive 2011/62/EC in order to protect public health.
The Commission does not intend to take any further action at this stage to change the authorisation process. The requirements for the granting of a marketing authorisation for medicinal products for human use are already harmonised at EU level. Medicinal products may be either authorised by the Commission or by national authorities.
According to Article 50 TEU, a Member State may decide to withdraw from the Union in accordance with its own constitutional requirements, and in that case shall notify the European Council of its intention. The European Council has not received such notification from the United Kingdom. The relocation of agencies currently located in the United Kingdom has not been discussed.
According to Article 168, paragraph 7 of the Treaty on the Functioning of the European Union (TFEU), Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. Hence, it is foremost for Member States to decide on how to ensure access to healthcare for their populations.
The Commission supports the intention of the Greek Ministry of Health to enhance the cost-efficiency and effectiveness of the Greek National Health System as well as the quality and accessibility of public health care in order to fully meet the health needs of the population but also to ensure sustainability. To this end, the Commission supports the authorities’ commitment to continue reforming the health care sector, including by rationalising pharmaceutical expenditure making use of the negotiating committee to develop price volume and/or risk sharing agreements, by setting up a Health Technology Assessment (HTA) centre to evaluate which products to reimburse and by managing demand for pharmaceuticals and health care through evidence-based e-prescription protocols.
In addition, through the Memorandum of Understanding the Greek authorities committed to implement structural measures focusing on improving efficiency of the health system as a means to contain expenditure to ensure the spending on pharmaceuticals, but also diagnostics and private clinics, for 2017, is reduced by at least 30 percent compared to the previous year.
The Commission will continue to monitor the implementation of the structural measures agreed in the framework of the Stability Support Programme supported by financial assistance by the European Stability Mechanism (ESM).
With regard to the specific case mentioned by the Honourable Member, it should be noted that as provided by EU legislation relating to medicinal products for human use, the Commission relies, for its decision-making process, on the scientific assessment performed by the scientific committees of the European Medicines Agency (EMA), in particular the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) in the case of the human papillomavirus (HPV) vaccines review.
The PRAC was responsible for the initial assessment. In reaching its recommendations, it also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups. The findings of the PRAC were passed on to the CHMP, which did not recommend any changes to the terms of marketing authorisation or the product information for these medicines.
The Commission is confident that the EMA and its Committees have access to the necessary expertise to be able to review the available evidence and provide robust advice regarding the safety of medicinal products.
Current Union legislation requires Member States to organise the collection of unused medicines, but this can be by way of general municipal waste collection. There is no provision in the pharmaceutical or waste management legislation for a system which keeps track of expired medicines in private households or pharmacies in the Member States.
However, the Guidelines on Good Distribution Practice of medicines impose an obligation on wholesale distributors to segregate and store expired products in a dedicated area away from other medicinal products. In addition, medicinal products that are nearing their expiry date are to be withdrawn immediately from saleable stock.
The Commission is also working with the Member States to ensure the smooth implementation of safety features (a unique identifier and an anti-tampering device) which will allow expired products which are subject to prescription to be detected in the supply chain at the time of dispensing them to the public. The safety features have to be applied from the year 2019.
Publicly funded health services are already clearly excluded from EU trade agreements. In the Joint Statement on Public services of Commissioner Malmström and Ambassador Froman of 20 March 2015 (http://europa.eu/rapid/press-release_STATEMENT-15-4646_en.htm) it was clearly stated that this approach will be followed also in the Transatlantic Trade and Investment Partnership. The EU proposal for an Annex on medicinal products has been published on the website of the Commission and provides an indication of what areas regulatory cooperation in the pharmaceuticals sector would aim at. This proposed Annex in its Article 1(4) also contains an explicit exclusion of setting of prices for medicinal products by the relevant authorities from its scope.
The Commission considers that antimicrobial resistance (AMR) is a major global challenge with serious implications for the economy and human health and agrees that a stronger push to innovation and research for the development of new drugs, rapid diagnostic tests and alternatives to antimicrobials is needed.
The evaluation of the current Action Plan against AMR adopted in 2011, has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and a framework to guide and coordinate activities on AMR at national and global levels and boosted research and innovation via a range of funding initiatives including the establishment of the ND4BB programme within the Innovative Medicines Initiative.
However, this evaluation has also demonstrated that the AMR problem is persisting and continued action is needed to address it. Therefore, the Commission will prepare a new AMR Action plan in 2017 for broader actions aimed at tackling AMR at EU and global level.
Measures to increase citizens’ awareness and sense of responsibility with regard to the use of antibiotics will be included in this new Plan, as well as measures promoting good practice for the control of hospital infections and supporting research into rapid tests. In February 2017, the Commission will award a prize for the development of such a rapid test.
Access to medicines is an important issue for the Commission. The Commission is promoting improved exchange of information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis; in particular through existing tools such as a European medicine price database (Euripid).
The Commission also facilitates the exchange of best practices, knowledge and information among Member States through the Network of Competent Authorities for Pricing and Reimbursement (CAPR) and through a structured multi-stakeholder dialogue.
The Commission works with the European Medicines Agency and the Member States to optimise the use of current regulatory mechanisms for early access to innovative medicines and to explore further possibilities to strengthen dialogue and cooperation between regulators, Health Technology Assessments (HTA) bodies and payers at EU level.
On national measures regulating prices and reimbursement, the Commission monitors the implementation of the Transparency Directive 89/105/EEC, which lays down procedural rules (e.g. time limits, motivation and judicial appeal).
A recent report calls on EU Member States to exploit possible policies to improve the access to affordable medicines, including by increasing the uptake of generics and biosimilars, when they are cheaper options.
In September 2016, the Commission published an inception impact assessment on strengthening EU coordination in the area of HTA. A public consultation is open until mid-January 2017.
The Honourable Member refers to the ongoing infringement proceedings regarding the Slovak Act on Medicinal Products and its non-conformity with the Treaty rules on free movement of goods.
To the Commission’s knowledge, the Slovak Parliament has recently adopted amendments to the Slovak law, as referred to by the Honourable Member.
The Commission continues its examination of the provisions of the Slovak law and their conformity with the rules on free movement of goods in particular.
Article 81 of Directive 2001/83/EC sets out the general obligation for the holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State, within the limits of their responsibilities, to ensure appropriate and continuous supplies of that medicinal product to pharmacies to cover the needs of patients. It clarifies that the arrangements for its implementation should be in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.
The European Parliament,
– having regard to Article 168 of the Treaty on the Functioning of the European Union,
– having regard to Rule 133 of its Rules of Procedure,
A. whereas, on 26 May 2015, a study on the latest generation of contraceptives led by researchers from the University of Nottingham showed that third- and fourth-generation contraceptive pills lead to an increased risk of thrombosis (a risk 1.5 to 1.8 times higher than that of previous pills);
B. whereas, according to a Danish study (2011) as well as a study by the French health insurance department, taking said pills could double the risk of pulmonary embolism;
C. whereas these findings show that frequent exposure to the substances contained in combined oral contraceptives carries ‘significantly higher risks’ than those in second- and third-generation pills;
D. whereas oral contraception concerns 18% of women in developed countries;
1. Notes the research already carried out, in particular by the European Medicines Agency, on third- and fourth-generation pills;
2. Encourages the Commission to issue advisory guidelines and raise awareness among European women of the risks of using third- and fourth-generation contraceptive pills.
The European Parliament,
– having regard to Article 168 of the Treaty on the Functioning of the European Union,
– having regard to Rule 133 of its Rules of Procedure,
A. whereas proton pump inhibitors (‘inhibitors’) are among the medicines most prescribed for gastroesophageal reflux worldwide;
B. whereas a team of researchers at the University of Stanford in the USA has studied the impact of inhibitors on human health and demonstrated a probable causal link with increased risk of myocardial infarction in the general population (10 June 2015);
C. whereas, according to the same study, H2 blockers are an alternative solution, as they are not associated with increased cardiovascular risk;
1. Encourages the Commission to issue advisory guidelines on H2 blockers, and encourages Member States to review their national legislation on inhibitors.
Patient access to medicines is an important issue for the Commission. The Commission promotes improved exchange of information among Member States on their pricing policies to minimise negative effects on access to medicines and strengthening Member State cooperation on a voluntary basis.
Equally important, the legality of parallel trade – whereby medicinal products are exported to other Member States which pay higher prices, is confirmed by the jurisprudence of the European Court of Justice. Nevertheless, during an informal ministerial meeting of Health Ministers held by the Slovak Presidency of the Council, Member States exchanged views, on shortages of medicines. In this context, “parallel trade” was identified by some Member States as one of the reasons for human medicines shortages and unavailability in those Member States. Member States may, therefore, adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions.
The European Union (EU) provides support for research and innovation through its Framework Programmes for research and innovation, currently Horizon 2020 (2014-2020).
Under previous Framework Programmes and the current one, the Commission has supported and continues to support – logistically and financially – veterinary research such as research on microbial diseases, their epizootic spreading, and/or their prevention via the development of tools and programmes as well as through research on reproduction, fertility, physiological conditions, networks for veterinary training, improved animal nutrition, etc. Among them, ERA-NETs have been and will be funded, in which participating Member States are fully engaged in the decision-making process. The supported research involves a large number of field veterinarians and/or researchers in Member States.
In Horizon 2020, a multi-actor horizontal approach is used to bridge research and practice by involving all actors from the beginning of the research definition and design to its final application. Thus, veterinary expertise is an integral part of the large research projects aiming at animal health, welfare, production systems, disease control, etc.
There are upcoming calls for the remaining period of Horizon 2020 on topics involving substantial veterinary research. For the 2017 calls under Societal Challenge 2 of Horizon 2020 (still open), there are at least five calls requiring veterinary expertise granting up to EUR 68 million in funding. Thus, researchers and other beneficiaries from all EU countries are invited to submit applications for research grants to be evaluated through an independent evaluation process.
Supporting the reduction of health inequalities across the EU and within countries, between regions and social groups, is an overall objective of EU health policy. Any EU activities in this respect recognise the responsibility of Member States for the definition of their health policy and the organisation and delivery of health services. This is the case also for pricing of pharmaceuticals, hence the differences the Honourable Member points out.
The reduction of health inequalities is supported via initiatives with Member States under the Health Programme, in particular in the areas of chronic and rare diseases. In the case of cancer, the Commission supports in cooperation with stakeholders prevention, early identification, screening and treatment such as raising hospitals’ awareness of new treatments and technologies (e.g. immunotherapies or genetic screening). The Commission also plans to launch a Joint Action with Member States on Health Inequalities and Migration.
Also, the State of Health in the EU-cycle and the report Health at a Glance: Europe 2016 aim to support Member States’ evidence-based policy making, boost analytical capacity and strengthen country-specific and EU-wide knowledge on health including on access to healthcare and health inequalities. The Report highlights inequalities in health in Europe, e.g. the fact that many people, in particular from vulnerable and disadvantaged groups, have difficulties in accessing health care due to costs. Poor Europeans are ten times more likely to report unmet medical needs for financial reasons than more affluent Europeans.
The Commission also implements health inequalities-related pilot projects to improve the health of those living in vulnerable situations.
Access to medicines is an important issue for the Commission. The Commission promotes exchange of best practices, knowledge and information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis.
In 2015, the Commission set up a Commission’s expert group on Safe and Timely Access of Medicines to Patients composed of experts from Member States and the European Medicines Agency to work together on optimising the use of existing regulatory tools to facilitate the development, timely assessment and authorisation of innovative medicines for patients with unmet medical needs.
The EU regulatory system provides incentives to support the development of innovative medicines, including data and market protection and intellectual property rules. A study will be carried out in 2017 to respond to the request made in recent Council conclusions to analyse the impact of the incentives for pharmaceutical products on innovation, the availability and accessibility of medicinal products.
In September 2016, the Commission published an inception impact assessment on strengthening EU coordination in the area of Health Technology Assessments (HTA). A public consultation is currently ongoing until mid-January 2017.
1. The evidence for this recommendation is based on scientific literature, expert discussions in different fora and recommendations given out by various national medicines evaluation boards.
2. The decisions on the interchangeability of biosimilars and innovator products rest with the Member States in the EU, and are not regulated as part of the marketing authorisation granted by the European Commission on the basis of an assessment by European Medicines Agency. The countries have the authority to introduce substitution bills. In some countries, substitution is allowed under specific conditions, such as in Cyprus, Estonia, France, Latvia, Malta, Poland, Slovenia and Slovakia. In France, a law was enacted in 2015 allowing biosimilar substitution for naïve patients, and discussions are ongoing for extending the rule for non-naïve patients. In Latvia and Slovakia, for newly diagnosed patients, the cheapest product (which generally is biosimilar) shall be provided in the pharmacy. In fact, there is no special regulation regarding biosimilars; biosimilars are evaluated by general principles applied to generics. Changes might be expected in the future; interchangeability and substitution are under discussion in some Member States (e.g.; Finland, Germany, Italy, Portugal and the Netherlands).
By common agreement, the Representatives of the Governments of the Member States, meeting at Head of State and Government level, decided in 1993 to locate the European Medicines Agency in London, UK.
Until the Treaties cease to apply to a Member State that has notified, in accordance with Article 50 TEU, the European Council of its intention to withdraw from the Union, that State remains a member of the Union with all rights and obligations of a Member State.