The latest parliamentary questions, declarations, proposals and positions concerning industrial pharmacy from the European Parliament.
The European Parliament, ….
28. Commends the Ombudsman’s work in dealing with issues of general public interest, such as fundamental rights, the safety and efficiency of medicine, the protection of the environment and health, and safeguarding against environmental risks; calls on the Ombudsman to follow up on her proposals to the European Chemicals Agency on disincentives relating to animal testing when new cosmetic products are registered on the market, and to the EPSO on the application of the principle of force majeure and the transparency of EPSO competitions;
30. Supports the Ombudsman’s role in shaping a proactive and transparent policy on the clinical trials carried out by the European Medicines Agency (EMA) and in particular the Ombudsman’s recommendations on the approval of Humira, one of the world’s best-selling drugs, which is used to treat Crohn’s disease; urges the Ombudsman to continue monitoring the EMA to ensure that it meets the highest standards of transparency and access to information on clinical trials, namely standards that are in the public interest and of value to doctors, patients and researchers;
Paragraph 15 of the Guidelines for Brexit negotiations of the European Council of 29 April 2017 states that “while the future location of the seats of EU agencies and facilities located in the United Kingdom is a matter for the 27 Member States to settle rapidly, arrangements should be found to facilitate their transfer”.
Furthermore, in the margins of the European Council of 22 June 2017, the Heads of State or Government of 27 Member States endorsed the procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union.
This procedure sets out six criteria which the interested Member States should address in their offer to host one or both of the Agencies. One of these criteria is the geographical spread of agencies’ seats. The deadline for submitting offers expired on 31 July 2017. The Commission has been invited to examine the submitted offers based on the six criteria agreed by the 27 Member States and to submit an assessment of the offers by 30 September 2017. On 30 September 2017, the Commission submitted its assessment of the offers to the Secretary-General of the Council.
On the basis of this assessment, it is for the 27 Member States to decide on the new locations for the two Agencies. A political discussion based on the Commission’s assessment took place in the margins of the General Affairs Council (Article 50) meeting of 17 October 2017. The 27 Member States will take a decision by vote in the margins of the General Affairs Council (Article 50) meeting of 20 November 2017. The Commission does not take part in this vote, nor does it have any other formal role in the decision-making process regarding the new locations for the two Agencies.
The Commission is aware of the risk that some medicinal products imported from third countries contain insufficient or falsified active ingredients. In 2011, to address this concern, strengthened rules on the importation of active substances were introduced in the EU.
According to EU legislation, active substances imported from third countries need to be accompanied by a written confirmation from the competent authority of the exporting third country confirming that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU.
Member States regularly inspect EU and non-EU manufacturing sites of finished medicinal products and their ingredients to check whether those sites meet EU standards of quality and safety. If an inspection by an EU Member State finds that an active substance manufacturing site does not comply with EU Good Manufacturing Practice (GMP) for active substances, a statement of non-compliance is issued and entered in the publicly available EudraGMDP database.
These measures, complemented with the obligation to test each production batch at import, should ensure the quality of all medicinal products (including generics) to be placed on the EU market.
Based on the above, the Commission does not foresee the need to introduce additional measures to strengthen the controls of medicinal products imported from third countries.
In Belgium recently, around 15 of the country’s 100 or so hospitals have sold their patients’ confidential data to the American medical data processing multinational, Quintiles IMS. The data in question concern the patients’ treatment (course of treatment, pathology, medical examinations, consultants) and the sums invoiced by the hospitals to mutual benefit insurance companies. For Quintiles IMS, this is a deal that offers plenty of potential advantages as it could sell this data on to the highest bidder, and in particular pharmaceutical companies seeking to fine-tune their marketing strategy.
I am opposed to all commercialisation of health. Patients do not know that their data has been recorded and may be passed on for mercenary purposes. Patients’ data should only be used for their benefit and within an ethical framework. Health data are of inestimable value for those who wish to profit from them. Transactions of this kind must be strictly regulated, with the data involved rendered strictly anonymous.
Will the Commission speak out against practices of this kind? What will it propose to combat the issue of patients’ medical data being used as merchandise, without their permission? Does the Commission have other figures available or know of similar cases at EU level?
The specific criteria and conditions referred to by the Honourable Member are set out in document XT 21045/17 on the procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union, endorsed on 22 June 2017 by the Heads of State or Government of 27 Member States.
All these specific criteria and conditions have to be taken into account when taking the final decision on the host countries.
On the basis of the Commission Communication of 4 April 2014 on effective, accessible and resilient health systems and in response Council Conclusions on the economic crisis and healthcare, the Commission developed several initiatives.
For example, in 2014 the Commission has supported the Member States in setting up an expert group on Health Systems Performance Assessment which has produced reports on quality of care and integrated care. The Commission is also supporting a European medicine price data base (EURIPID), and is working on an initiative for EU cooperation on health technology assessment. In addition, the European Pillar of Social Rights, adopted on 26 April 2017, underlines the right of everyone to access affordable healthcare.
As regards health systems’ capacities to deal with crises, the Joint Economic Policy Committee-Commission report of 2016 states that expenditure on health care and long-term care accounts for 8.5% of GDP in the EU and may increase by an additional 2 to 4 percentage points of GDP by 2060. As pointed out repeatedly in the Commission’s Annual Growth Surveys, reforms are needed to enhance the cost-effectiveness of national health systems and ensure adequate access to healthcare, thus improving national health systems’ resilience.
The directive on the mutual recognition of professional qualifications, which introduced the mutual evaluation of regulated professions between Member States, was revised in 2013. Member States are to use the directive to examine whether the requirements of their legal systems, that restrict access to or pursuit of a profession, are consistent with the principles of non-discrimination, which are justified on the grounds of public interest and proportionality.
An evaluation process has shown that regulatory decisions are not always based on a rational and objective analysis. The introduction of new restrictive measures has not been prevented, despite Member States’ national plans and Commission guidelines.
Recommendation COM(2016)820 and the proposal for a directive on a proportionality test COM(2016)822 aim to improve Member States’ approach to regulating professions by ensuring better regulatory procedures to ensure proportionate regulation and avoid negative economic consequences.
1. Can the Commission say, if proportionality and justification due to the public interest are common principles for accessing services and regulated professions, why has the Commission not proposed that the proportionality test is also applicable to accessing services?
2. The guidelines in COM(2016)820 set out examples of reforms for Member States. Has the Commission acted in all cases to enforce Union law through infringement proceedings?
3. Will the Commission initiate infringement proceedings in each case where it is aware of a breach of the rules on restricting access to professions or, if not, how will it choose the cases in which it will initiate infringement proceedings?
Summary of petition: The petitioner is forwarding to the European Parliament a petition written on the online platform Avaaz.org bearing her own signature denouncing the practice of extracting blood from horses for pharmaceutical purposes. The petition claims that the European pharmaceutical industry is engaged in wide scale “industrial horse torture” and calls upon the European institutions to put a stop to this practice, also as regards the import of products derived from such practices (e.g. hormones).
Conclusion: The Commission does not currently plan to ban the import of pregnant mare serum gonadotropin. While the Commission will continue raising awareness of this issue among the stakeholders concerned and Member States, it should be noted that the EU cannot impose its animal welfare standards on non-EU countries. For imports into the EU, EU trade policy shall respect the rules of the World Trade Organization. The Commission will however continue promoting, within its remits, the development and implementation of animal welfare standards globally.
The rules contained in the EU General Data Protection Regulation (GDPR) for processing personal data, including genetic data, biometric data and data concerning health, will be directly applicable to controllers and processors as from 25 May 2018.
The GDPR provides in particular for the right of the individual to be informed by the controller about the purposes of the processing and about other relevant aspects such as the existence of automated decision-making, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject; the data subject is also entitled to receive information about the intention to further process personal data for other purposes than the initial ones (Articles 13 and 14 GDPR). The individual is also entitled not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her (Article 22 GDPR). Depending on the purposes of the processing and the risks for the rights of individuals, controllers must have in place appropriate technical and organisational measures to ensure that the processing is GDPR-compliant.
The Commission is working closely with Member States to achieve uniform application of the GDPR to achieve a high level of personal data protection across the EU.
Directive FMD 2011/62/EU introduces harmonised, Europe-wide safety and control measures for the detection of counterfeit medicines. Furthermore, in accordance with Regulation DR 2016/61, Member States are creating a repository system at national level where a database will be kept with all the serial numbers of boxes of medicines available to the public.
The illegal medicines detection rate is soaring at 12% for Greece, and counterfeit medicines even end up in pharmacies and are sold without any problems.
Since the date of entry into force of the regulation on 9/2/2019, Greece is among the countries that have secured deferral for 6 years from that date, can the Commission say:
1. What steps are being taken to ensure compliance with the FMD Directive 2011/62/EU on harmonised, Europe-wide safety and control measures?
2. What steps will be taken to raise awareness among EU citizens to prevent the purchase of counterfeit medicines?
3. What measures will the European Medicines Agency take?
By Presidential Decree (Greek Government Journal 148/A/9.10.2017), the National Organisation for the Provision of Health Services (EOPYY) has been stripped of its administrative and financial autonomy. The new EOPYY will be directed and supervised by the Health Minister as regards spending, budgets, contracts, e-prescriptions, procurement and pharmaceutical expenses.
Although health is a matter for subsidiarity, Article 168(1) TFEU requires that a high level of human health protection be ensured in determining and implementing all Union policies and activities.
In view of the above, will the Commission say:
Does the new Presidential Decree safeguard the independence of the Agency and the proper and safe provision of health services to Greek citizens, but also to EU citizens who need medical assistance in Greece?
Is this transfer of responsibilities, while reducing the administrative and financial responsibility of the EOPYY, in line with the EU guidelines for the operation of health insurance funds?
The Commission has indeed granted marketing authorisations to several new medicines to be taken orally rather than by injection, including a dimethyl fumarate-containing medicinal product for the treatment of psoriasis.
The scientific evaluation of marketing authorisation applications for EU centrally authorised medicinal products is performed by the European Medicines Agency (EMA). EMA’s opinions are based on assessment of all available evidence and approval is recommended when the desired effects or ‘benefits’ of a medicine outweigh its undesired effects or ‘risks’. This is the case for the above mentioned product. The European public assessment reports, which contain all the information about the evaluated scientific evidence, are published on the web site of the EMA.
With regard to the dimethyl fumarate-containing product to treat psoriasis and possible occurrence of hepatotoxicity, Skilarence’s Summary of product characteristics (SmPC) notes that the medicinal product must not be used in patients who have severe problems of the digestive system, liver or kidneys. The SmPC of Tecfidera states the product “has not been studied in patients with severe renal or severe hepatic impairment and caution should, therefore, be used in these patients”; Tecfidera’s Package Leaflet warns patients to talk to their doctor before taking it if they have severe liver disease. Aubagio’s SmPC and Package Leaflet state that it must not be used in patients with severe liver disease.
The organisation of health systems and delivery of care is the responsibility of Member States. The Commission can therefore not harmonize national legislation on access to medicines. However, the Commission recognises the importance of timely access to innovative medicines for patients and facilitates EU cooperation in different areas concerning access to medicines.
One of the initiatives is Health Technology Assessment (HTA), which assesses the added value of given health technology over and above existing ones, helping Member States to allocate national resources to effective health interventions. HTA can speed up process of market access and thus improve patient access to innovative technologies The Commission is currently preparing an initiative on strengthening EU cooperation on HTA.
The Commission supports improved exchange of information among Member States and promotes voluntary cooperation for example through the Network of competent authorities responsible for pricing and reimbursement, and through a European medicine price data base. It also supports an Organisation for Economic Co-operation and Development project on Sustainable Access to Innovative Therapies.
The Commission has mandated the Expert Panel on Effective Ways of Investing in Health to develop an Opinion on “Innovative payment models for high-cost innovative medicines”, which would assist Member States to develop policies on cost-effective use of medicines.
Synthetic biology is a newly emerging and fast-growing field. As with many emerging technologies, the applications and products associated with it can be used as a vehicle for positive change and innovation, such as in the fields of medicine, materials and biofuels. However, these new applications also bring with them potential risks, and should therefore be evaluated from a legal, social, economic and ethical perspective. Key to mitigating such uncertainty is updating existing risk management frameworks developed for the related fields, such as genetic engineering.
Additional institutional oversight is also needed in order to fully assess the bioethical implications and potential ramifications of this emerging field.
In 2015, the Commission received a set of Opinions on synthetic biology from its Scientific Committees on Emerging and Newly Identified Health Risks (SCENIHR), Health and Environmental Risks (SCHER) and Consumer Safety (SCCS).
1. How has the Commission taken these Opinions into consideration?
2. Has it updated risk assessment frameworks to mitigate the potential risks that synthetic biology could pose?
3. How will it address the broader need for institutional oversight regarding the development of synthetic life?
As a result of Operation Pangea X, in which 123 countries were involved in an action coordinated by INTERPOL, together with the World Customs Organisation (WCO), the Permanent Forum on International Pharmaceutical Crime (PFIPC), the Heads of Medicines Agencies’ Working Group of Enforcement Officers (WGEO), and the Portuguese national medicines agency, Infarmed, about 400 people were arrested and 25 million potentially lethal fake medicines were seized.
Following a total of 1 058 investigations, more than 3 000 advertisements for illicit pharmaceuticals posted on social media platforms were suspended, and 3 584 websites were also taken offline.
The most notable examples of illegal counterfeit medicines include dietary supplements, painkillers, epilepsy medication, erectile dysfunction pills, and antipsychotics; the operation also extended to nutritional products, illicit medical devices – dental devices and implants, for instance – and condoms.
Is the Commission keeping the findings of the investigation under review, bearing in mind that the sale of illegal medicines and medical devices endangers public health?
According to the Venezuelan Pharmaceutical Federation (Fefarven), painkillers, antibiotics, contraceptives, and antihypertensive drugs have disappeared from pharmacy shelves, and more than 80% of essential medicines are out of stock.
The federation figures show that there is one pharmacy for every 7 000 inhabitants, and at least 70 pharmacies have gone out of business within the last year.
1. Is the High Representative aware of this serious problem?
2. What steps has she taken or will she take to relieve Venezuela’s plight?
3. What forms of support or help has she been providing for European citizens living in Venezuela?
The Commission has made a technical assessment of where to relocate the European Medicines Agency (EMA) and the European Banking Authority, in line with the procedure agreed by the EU-27. At the same time, independently of that process, the EMA conducted its own assessment, which it then published.
On what criteria were the studies conducted by the EMA based, and how does the Commission view those studies, which have repercussions for the image of certain Member States?
What steps does the Commission plan to take to compensate for the adverse effects of the EMA’s actions, given that these could have a negative impact on the assessment process and on the decision on where to relocate the European Medicines Agency?
In Europe, cancer remains the primary cause of death by disease in children, killing 6 000 a year. Parliament’s resolution of 15 December 2016 acknowledges the substantial impact of the Paediatric Medicines Regulation on paediatric medicine development.
The resolution affirms that the regulation has fostered multi-stakeholder cooperation on paediatric medicine development, and multi-stakeholder cooperation is indeed critical for advancing care for children. In France, VIK-e and U-Link are two examples of collaborative paediatric oncology projects. Through collaboration between IHOPe: a paediatric oncology institute, APPEL: a parents association, Awabot: a robotic solutions company, and Bristol-Myers Squibb: a pharmaceutical company, VIK-e has provided telepresence robots to those child cancer patients in intensive care or undergoing long periods of isolation to help them maintain social links. For its part, U-Link has facilitated children’s access to clinical trials through collaboration between UNAPECLE: a union of parents’ associations, the SFCE: a children’s cancer society, and Bristol-Myers Squibb.
1. Given that collaboration on paediatric oncology projects such as VIK-e and U-Link is essential, in the Commission’s view, what kind of projects and practices can yield the best outcomes for paediatric patients?
2. How can the Commission encourage the dissemination of best practices, so exemplified by VIK-e and U-Link, across the Member States?
In the light of the call made to it at the June 2016 Health Council meeting to assess the system of incentives in the pharmaceutical sector (such as patent exclusivity, supplementary protection certificates and legislation on orphan medicinal products), the March 2017 European Parliament report on options for improving access to medicines and the report on the impact of pharmaceutical incentives which it is due to publish in late 2017, does the Commission intend to put forward specific legislative proposals to revise the laws on orphan medicinal products?
In the recent European Action Plan on resistance to antimicrobial agents, the Commission referred to the need to offer pharmaceutical companies incentives. Is the Commission thinking of introducing incentives similar to those in force for orphan medicinal products in the area of resistance to antimicrobial agents, taking account of the misgivings which this system is prompting as regards access to medicines, prices and the quality of innovations?
Could it provide more information on the supplementary protection certificate, the manufacturing waiver in connection with the export of generics and biosimilars and the broadening of the scope of the restrictions on patent rights and supplementary protection certificates, all of which are options under consideration?
As the Commission pointed out in its answer to written question E-003863/2017, while vaccination policies are the competence of Member States, the Commission supports Member States in this area, for example by sharing information on vaccination policies within the Health Security Committee and by coordinating preparedness, assessment and outbreak management of vaccine-preventable diseases.
On 31 May 2017, the Commission held a workshop with Member States, civil society, industry and academia on vaccination which provided input for improving cooperation at EU level to counter vaccine hesitancy, address shortages and strengthen routine immunisation. Discussions also addressed issues related to the evidence-base and communication of vaccination programmes.
On the basis of Council conclusions on vaccination as an effective tool in public health and of this workshop, the Commission and Member States are currently developing a Joint Action on vaccination co-funded by the Health Programme to share best practices on national vaccination policies.
In cooperation with the European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO), the Commission is supporting Member States in the course of the European Immunisation Week, raising awareness on the importance of vaccination. In this context, the ECDC supports Member States with guidance on planning and implementing communication activities in relation to immunisation programmes to help to improve the training and education of healthcare professionals by providing them with tools for tailored communication with their patients.
The Commission has submitted a proposal for a directive which would enable it to carry out a proportionality test before the adoption of a new regulation of a profession by a Member State. The Commission’s main argument for gaining the right to veto the regulation of professions by Member States is that this would create 700 000 jobs.
The conclusion of the study cited by the Commission is as follows:
‘Our findings in relation to the effect of licensing on employment are less conclusive. Although we estimate that licensing is associated with a loss of about 705 000 jobs, our cross-sectional analysis did not yield any clear results either way. We are inclined to attribute this to the characteristics of our dataset and we urge policy makers not to interpret our inability to reach a robust conclusion […]’.
How can the Commission legislate for a total of 500 million people on the basis of such weak data: a single, non-independent study which does not provide a robust conclusion?
In January 2017, the Commission submitted a proposal for a directive which would allow it to carry out proportionality tests before the adoption of any new regulations of professions by Member States.
The proposal states that 700 000 jobs would be created across the EU.
The French, Austrian and German parliaments objected to this proposal for a directive.
On 4 August, the Commission stated that it had responded to the various parliaments.
Why were the Commission responses not sent to the MEPs responsible for amending this new directive(2) before the deadline for submitting amendments, 7 September 2017?
Article 59 of the Professional Qualifications Directive introduced the mutual evaluation exercise under which Member States were asked to evaluate their existing regulations. The Commission supported Member States during this exercise by issuing a Communication, analytical grids and by providing guidance, organising workshops etc. The uneven and often insufficient outcome of this exercise made clear that a more structured and transparent approach as to how such assessments need to be made would be beneficial, especially considering the obligation imposed on Member States under Article 59 of Directive 2005/36. The newly proposed Directive is therefore a consequence of Article 59(9) of the Professional Qualifications Directive, which foresees the possibility for the Commission to make proposals for further initiatives depending on the outcome of the mutual evaluation exercise.
The newly proposed Directive on a proportionality test not only provides for clear criteria based on which a proportionality test should be performed, but also includes procedural issues, stakeholder involvement and transparency. These elements were deemed necessary to be introduced for the proper conduct of such assessments. Consequently, it was considered more appropriate to introduce these through a separate legal act. Furthermore, the Directive 2005/36/EC has been amended only recently by Directive 2013/55/EU, for which an implementation report is due in January 2019.
The Committee on the Environment, Public Health and Food Safety calls on the Committee on Budgets, as the committee responsible, to incorporate the following suggestions into its motion for a resolution:
(12) Strongly disapproves of staff reductions in EEA (-3 posts), ECHA (-2), ECDC (-2), EFSA (-4) and EMA (-5), which, given that the tasks and duties of those agencies are growing, will almost inevitably negatively impact their work; demands that they should receive adequate human and financial resources; furthermore, is concerned that in the case of fee-funded agencies, like EMA, the staff cuts imposed in recent years have meant a reduction in staff working on tasks that are actually funded by applicants’ fees and not by the Union budget; such cuts have been carried out without taking into consideration either the additional workload created by increasing numbers of applications, or the corresponding increase in income from fees paid by applicants for the services provided which could have allowed staff increases while avoiding any impact on the Union budget
(14) Notes in particular that EMA will be facing an increased workload and further budgetary needs in 2018 as a consequence of the decision of the UK to withdraw from the Union; calls on the Commission to make available additional staff and budget resources in 2018 so as to ensure that this agency can both continue to carry out its tasks effectively and launch all required activities in preparation for its relocation in 2019; proposes therefore that EMA, in the spirit of sound financial management, be authorised to maintain a budgetary reserve to respond to unforeseen costs that may be incurred in 2018 or beyond, such as a result of unfavourable exchange rate fluctuations.
The Commission is aware that Asia is the world’s main producer and supplier of active pharmaceutical ingredients including antibiotics, and shares the growing concern about the development and spread of antimicrobial resistance (AMR) in the environment due to discharges of antimicrobials and their metabolites from various sources including pharmaceutical production plants. As a consequence, the Commission has launched several initiatives aimed at addressing these issues.
The Commission recently adopted its second AMR Action Plan which includes specific actions to improve knowledge about the contribution of the environment to AMR, and to explore possibilities for taking appropriate measures. This includes developing a Strategic Approach to address the risks from pharmaceuticals in the environment. The Action Plan also promotes actions and collaboration at global level. The synopsis report accompanying the Action Plan mentions that some options could relate to manufacturing effluents and to the collection of unused antimicrobials.
The existing Guidelines on Good Manufacturing Practice for active substances require that sewage, refuse, and other waste in and from factory buildings and the immediate surrounding area should be disposed of in a safe, timely and sanitary manner. Although not specifically mentioned in those guidelines, manufacturing facilities have to comply with local regulations to minimise the risk of contaminating the environment.
The Commission proposal on a Directive for a proportionality test to be carried out before adoption of new regulation or introduction of amendments to any existing one, covers all requirements for access and pursuit of a regulated profession in the Member States, including also health professions.
The regulatory criteria and requirements listed in Article 6 of the proposed Directive are neutral and aim at guiding Member States in the assessment of the proportionality in the light of the case law of the Court of Justice (e.g. Case C-570/07 Blanco Perez). Such an assessment should take into account both the specificities of each profession and the public interests to be protected, such as public health.
In that respect, it is not necessary for the Commission to ring-fence specifically health professions or any other profession. The specificities of each and every profession can always be taken into account by the Member States, including the professions referred to by the Honourable Member, when regulating in a justified and proportionate manner.
The EU pharmaceutical legislation includes derogatory provisions when it comes to contraceptives and abortifacients, namely Article 4(4) of Directive 2001/83/EC. Under those derogations, Member States may prohibit or restrict the use of such products in their territory. In accordance with Article 13(1) of Regulation (EC) 726/2004 this derogation can also be invoked for products, which have been authorised by the Commission on the basis of a scientific opinion of the European Medicines Agency.
Poland recently notified the Commission of its intention to make use of the derogation in accordance with Article 4(4) of Directive 2001/83/EC.
Diabetes research has been a priority for the Commission for many years. Most recently, Horizon 2020, the EU Framework Programme for Research and Innovation (2014-2020), has allocated over EUR 286.5 million to 160 projects in this area. Their aim is to gain a better understanding of the very complex pathophysiology of diabetes and its complications and to deliver personalised health and care.
Regarding complications of diabetes affecting the eye, the EU is supporting nine projects with an overall budget of EUR 11.7 million addressing retinopathy and age-related macular degeneration. These projects cover the whole healthcare continuum from aetiology to diagnosis and treatment, to public health and prevention.
Horizon 2020 will provide further opportunities for funding research on diabetes through the remaining calls for proposals. Information regarding these opportunities will be made available on the Research and Innovation Participant Portal.
The Commission is aware of the risks of falsified medicines through internet sales. Since 1 July 2015, a common EU-wide logo is mandatory for all online pharmacies or retailers legally operating in the EU. This makes it easier to distinguish between legal and illegal online pharmacies throughout the EU. The Commission led a proactive communication campaign for the introduction of the EU common logo to identify legal online pharmacies. This included a Commission toolbox in all EU languages that was shared with Member States in order to ensure that a consistent message is given to EU citizens.
The communication material explains the legal framework for online sales in the EU. It clarifies that Member States may impose certain conditions and limitations, e.g. by not allowing online sale of prescription medicines. It warns that a legally operating EU online retailer, if authorised or entitled to supply a prescription medicine, will always require a prescription. It stresses that compliance with this legal requirement is one of the guarantees that the medicine bought online is authentic and safe.
The Commission website remains a key tool to keep citizens informed of the ongoing work to address counterfeit and falsified medicines.
The Commission does not propose any additional measures at this time to combat the sale of falsified medicines over the internet.
The final report on the off-label use of medicinal products published on 28 February 2017 provides a description of practices across Member States, of the positions of all parties, and it investigates the balance between benefits and risks of off-label use for patients.
The report was discussed at the Commission Expert Group on Safe and Timely Access to Medicines for patients (STAMP) on 14 March 2017. Given that off-label prescribing of authorised medicinal products is not regulated by EU law and remains in most Member States the responsibility of the prescribing physician, the Expert Group considered that the options identified in the report relevant to collaborative action could be directly led by Member States. The Expert Group will continue exploring with relevant stakeholders the possibilities for repurposing, one of the options identified in the report to move from “off” to “on” label of medicinal products.
The Commission has no information on investigations by Member States on possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labelled for single use. Nevertheless, Regulation 2017/745 on Medical Devices sets up strict conditions under which reprocessing of single use devices can take place.
As of 1 July 2015, in line with Directive 2001/83/EC and Implementing Regulation (EU) 699/2014, any legally operating on-line retailer, authorised in a Member State of its establishment to sell medicinal products on the internet, should display the logo on every webpage offering medicinal products to sell. The Commission is gathering information on the progress of implementation of these requirements and on the national information campaigns on the logo and danger of falsified medicines.
1. The Commission takes the subsidiarity concerns that have been expressed in the reasoned opinions of the French Sénat and Assemblée Nationale on the proposal for a Directive of the European Parliament and of the Council on a proportionality test before adoption of new regulation of professions seriously and has provided written replies.
2. In the view of the Commission, the proposal fully respects the principle of subsidiarity. The legal bases (Articles 46, 53(1) and 62 of the Treaty on the Functioning of the EU) allow for coordinating measures to reach a certain degree of harmonisation of national regulation regarding access to or exercise of professions. In respect of some professions, this has been achieved already at EU level. The current proposal does not aim at such a harmonisation of rules, but merely coordinates how Member States should assess whether requirements that are to be adopted are in line with the principle of proportionality. It does not in any way prejudge the outcome of the national legislative process. The objective of the proposed Directive is not to regulate or deregulate professions in the health, tourism or other sectors of the economy – this remains a national prerogative. It rather aims at ensuring coherent and consistent compliance by all Member States with existing obligations under EU law that national professional requirements are justified, suitable and necessary.
The Commission supports the transition to a modern, clean and fair economy, with a comprehensive and results-oriented approach across different policy areas, providing sector-specific solutions when needed.
With regard to the pharmaceutical industry, the Commission is currently conducting a number of initiatives aiming to improve the competitiveness and innovation framework, for example in respect of activities related to the Transparency Directive and the committee established under that directive.
The Commission has acknowledged the importance of intellectual property protection for the pharmaceutical sector and included a package of dedicated measures in the 2015 Single Market Strategy. In that context, the Commission has launched a study analysing the impact of pharmaceutical incentives on innovation, availability and accessibility of medicinal products, in response to the call by the Council in 2016. The study is being carried out in the course of 2017.
Finally, the Commission will organise another multi-stakeholder workshop as a follow-up to the Process on Corporate Responsibility in the Field of Pharmaceuticals, bringing together Member States, healthcare professionals, patients, and industry to discuss matters such as pricing and reimbursement.
1. The rental contracts of the EU agencies vary across agencies and over time, depending on local real estate markets, national applicable rules and related costs (including for break out clauses). In addition, the conditions in which agencies operate differ greatly not only from one Member State to another, but sometimes within the same host State. As long as the seat agreements are negotiated on a case-by-case basis in bilateral discussions, it is difficult to ensure that agencies benefit from a common and most favourable set of conditions.
2. As regards the bearing of the costs, point 26 of the negotiation directives adopted by the Council states that ‘the United Kingdom should fully cover the specific costs related to the withdrawal process such as the relocation of the agencies or other Union bodies’. The final budgetary implications of the withdrawal agreement under Article 50 of the TFEU will be clarified in the course of the Brexit negotiations.
3. By virtue of Article 341 TFEU, the seat of EU institutions shall be determined by agreement of the governments of the Member States. Similar rules apply for the determination of the seats of EU Agencies. As it is the case in the Member States, where even without specific reference in their Constitutions or laws, national agencies and bodies are established in the territory of the concerned Member States, EU agencies and bodies have to have their seat in the European Union.
Moreover, the common agreement of the governments of the Member States which determine the seats of EU Agencies refer to concerned Member States, which indicates that the seat of EU Agencies can only be located in the Member States.
According to Article 341 of the Treaty on the Functioning of the European Union, the seat of the institutions of the Union shall be determined by common accord of the governments of the Member States. The same principle applies by analogy to the seat of EU decentralised agencies.
On 29 April 2017, the European Council (Article 50) adopted guidelines following the United Kingdom’s notification under Article 50 of the Treaty on European Union, which confirm that the seats of EU agencies and facilities located in the United Kingdom should be relocated and that this is a matter for the 27 Member States to settle rapidly.
On 22 June 2017, in the margins of the European Council (Article 50) meeting, the Heads of State or Government of 27 Member States endorsed the Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority in the context of the United Kingdom’s withdrawal from the Union.
According to Article 168(7) of the Treaty on the Functioning of the European Union, it is foremost for Member States to decide on how to ensure access to healthcare for their populations and the Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care.
The Commission supports the efforts of the Greek Ministry of Health to enhance the efficiency and effectiveness of the Greek National Health System as well as the quality and accessibility of public health care in order to fully meet the health needs of the population but also to ensure sustainability.
Amongst structural measures specific to the health care sector, the Commission supports the authorities in the broader goal of elimination of arrears and formulation of strategies to manage operations in compliance with the provisions of the Late Payment Directive. The authorities committed to both of these goals, which feature in the Memorandum of Understanding under the stability support programme as per the Council Implementing Decision (EU) 2015/1182 under Regulation 472/2013.
This includes ensuring a regular flow of payments for current expenditure, implementing procedures to monitor average payment delays,while at the same time working to reduce and eliminate the back log accumulated from the past, prior to the merger of social security funds into the current single insurer EOPYY.
The Commission has limited competence to deal with specific situations in the Member States as regards health policy, health care and the organisation of health services.
As the Commission pointed out in its answer to the written question E-003237/2017, which also dealt with the provisions of the Law in question and was raised by the Honorable Member, “As medicinal products have different benefits and costs, the Health authorities of Member States need to carefully decide on reimbursement to ensure good value to the health system in general and to patients. To support the rationalisation of pharmaceutical expenditure, while guaranteeing full access, the Greek authorities revised the criteria to introduce innovative drugs into the list of publicly reimbursed ones.
New criteria have been designed to improve on the shortcomings of the previous method and allow for internal capacity building in the area of Health Technology Assessment (HTA). The Commission through the Structural Reform Support Service together with the World Health Organisation are assisting Greece to build this capacity. In the meantime, the institutions, as part of the MoU implementation agreed with the Greek authorities that these would take an informed decision based on the judgements reached following HTA processes in six Member States. The choice of six Member States was the result of a sensitivity analysis and ensures objectivity. Although this may prolong slightly the time for a decision to be taken in Greece, it will ensure the right balance between supporting patients’ access whilst ensuring sustainability of the health system.”
For collaborative projects focused on pharmaceutical research under the EU Framework Programme for Research and Innovation Horizon 2020 Societal Challenge n°1 (Health, Demographic Change and Wellbeing), after a preliminary ad-hoc analysis, Greece currently holds the 16th rank among the EU Member States. For the projects funded under the 2nd Innovative Medicines Initiative (IMI2), Greece currently holds the 19th rank (it held the 13th rank under the previous partnership, IMI1).
Regulation (EU) No 536/2014 on Clinical Trials, which sets streamlined procedures and strict timelines for the assessment of clinical trials applications, will be directly applicable in all Member States of the EU and will replace current national legislation adopted in order to transpose Directive 2001/20/EC. The entry into application of the Clinical Trials Regulation is linked to the full functionality of the EU Clinical Trials Portal and Database, developed by the European Medicines Agency. The Commission has not assessed the compliance of Article 78 of the Greek law No 4472/2017 with the Clinical Trials Regulation since a Regulation is directly applicable in Member States. In any case, the Clinical Trials Regulation does not set the timelines and the procedures for the authorisation to place a new medicine on the market.
1+2. The Commission would refer the Honourable Member to the Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority, endorsed by the Heads of State or Government of 27 Member States in the margins of the European Council (Article 50) held on 22 June 2017.
3. As regards the bearing of the costs of the relocation, point III.2 of the Directives for the negotiation of an agreement with the United Kingdom states that “the United Kingdom should fully cover the specific costs related to the withdrawal process such as the relocation of the agencies or other Union bodies”. No relevant estimate of the cost of the relocation can be made at this time because essential factors remain to be established.
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.
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.
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.
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.
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 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.
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.
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.