The latest parliamentary questions, declarations, proposals and positions concerning industrial pharmacy from the European Parliament.
The problem of stock shortages in the European Union has become considerably more acute in recent years, increasing twenty-fold in France between 2008 and 2018, placing patients in considerable danger and undermining health services at both national and European level.
In July 2019, the European Medicines Agency published two studies analysing the underlying causes of the problem (distribution bottlenecks, differences between national standards, lack of raw materials, etc.), but failing to put forward any specific solutions.
In view of this, what measures are being envisaged by the Commission and could a European health forum be set up to bring together all stakeholders (Member States, pharmaceutical industry, distributors, patients, etc.), in order to analyse the causes of these shortages and make recommendations?
Today, 80% of active ingredients, such as ibuprofen or paracetamol, are manufactured in Asia, compared to only 20% thirty years ago. Given the need for Europe to end its dependence on external production chains, what measures does the Commission intend to take to remedy matters? How does it intend to promote European production?
The Commission is currently evaluating the functioning of the EU Orphan and Paediatric Regulations, including an assessment of the impact of incentives introduced for research, development and marketing of medicines for rare diseases and for children and on accessibility of orphan medicines in Member States. This evaluation will be finalised with a Staff Working Document to be published in spring 2020.
Once the evaluation is finalised, the Commission will consider whether further steps may be needed.
An orientation paper on Horizon Europe, the next research and innovation framework programme, was released in June 2019 and subject to public consultation. The document aimed to stimulate a co-design process by setting the foundations to prepare the first four years of the Horizon Europe Strategic Plan (2021-2024). The document following public consultation refers to research on rare diseases and a future possible Rare diseases partnership building on the lessons learnt from the European Joint Programme on Rare Diseases, and to implement the objectives of International Rare Diseases Research Consortium.
As the Commission noted in its reply to Written Question E-001439/2018 as regards the Novartis case, when allegations of corruption arise, competent national authorities are responsible for investigating them. The Commission cannot intervene in these investigations.
The Commission took note of the European Court of Auditors special report and acknowledges the need to strengthen strategies for boosting Antimicrobial Resistance (AMR) research in the EU. The Commission is working towards the full implementation of the EU One Health Action Plan against AMR, highlighted as a priority in the mission letter of the Commissioner for Health and Food Safety. In this context, it is important to boost the global dimension by advocating for a global agreement on the use of and access to antimicrobials.
As part of its actions against AMR, the Commission co-funds the development of new classes of antimicrobials via the Innovative Medicines Initiative’s ‘New Drugs 4 Bad Bugs’ and ‘AMR accelerator’ programmes. These partnerships between industry, academia and biotech organisations have invested more than EUR 950 million to bring new treatments and research incentives closer to patients.
The Commission together with the European Medicines Agency (EMA) has taken several actions to facilitate development of new antibiotics such as the EMA PRIME scheme or an early engagement initiative with medicine developers through the EMA Innovation Task Force.
Moreover, the Commission supports global activities on AMR including the launch of a Global Antimicrobial Resistance Research and Development Hub in May 2018 after a call by G20 Leaders.
The Commission is exploring which further measures may be needed to boost development of new antimicrobials. In November 2019, a reflection on how to address market failures was started with Member States in the Commission’s Pharmaceutical Committee.
It is clear that significant progress in developing new classes of antimicrobials relies on the active involvement of all stakeholders.
The Commission was provided by the Secretary-General of the Council of the European Union with both the public and the confidential versions of Member States’ offers to host the European Medicines Agency (EMA).
The offer from the Netherlands for the EMA can be found on the website of the Council of the European Union, including the part of the offer which initially the Netherlands had wished to keep confidential but in the meantime decided to make publicly available.
The Dutch authorities handed over the EMA’s permanent building in Amsterdam Zuidas to the EMA on 15 November 2019.
The EMA finalised the staff relocation to this new building during the week of 20 January 2020 and the first committee meetings have already taken place in the new building.
EU medicines legislation requires companies to ensure continuous supply of marketed medicines and to notify competent authorities two months before any temporary or permanent interruption of supply. EU legislation does not, however, oblige companies to maintain medicines on the market should they decide to withdraw. Member States are responsible for the enforcement of the legislation.
The Commission addresses issues of availability through the Pharmaceutical Committee, the Expert Group on Safe and Timely Access to Medicines for Patients and will launch a study on shortages under the EU Health Programme. The Commission also analyses the effectiveness, accessibility and resilience of health systems, including spending on medicines, as part of the European Semester. Also, a study was launched with support of the EU Health Programme on the “Accessibility of pharmaceutical care and trends in pharmaceutical spending”. This study will – amongst others – look into patterns of market withdrawals. In addition, the Commission follows the Heads of Medicines Agencies/European Medicines Agency Task Force work to address shortages of medicines and improve coordination between Member States.
The Commission will also launch a Pharmaceutical Strategy to ensure Europe’s supply of affordable medicines to meet patients’ needs. The Strategy will aim to deliver a future-proof pharmaceutical policy to address all levels of the value chain, from research and development to authorisation and access of patients to medicines. The Strategy will also be addressing the issue of dependency of the pharmaceutical industry on the manufacturing capacities of, and the supply of starting materials and active pharmaceutical ingredients from third countries.
The Commission takes the safety of medicines and the protection of patients very seriously. The unexpected presence of N-nitrosamines in certain medicines led the Commission to request the European Medicines Agency (EMA) to review the available evidence and assess the potential impact on the safe use of these medicines. The outcome of the review of the sartan-containing medicines was that there was a very low risk that N-nitrosamine impurities at the levels found could cause cancer in humans. The ongoing EMA review of ranitidine-containing medicines is expected to be completed by February 2020.
EMA has also started developing guidance for marketing authorisation holders on avoiding presence of nitrosamines in human medicines containing chemically synthesised active substances. EMA’s Committee for Medicinal Products for Human Use is gathering and consolidating the knowledge and expertise on this subject and is expected to provide additional advice in early 2020.
In addition, a lesson learnt exercise has been initiated. The Commission will work with the national competent authorities and EMA to follow up this exercise.
The supply of medicine has been identified as a priority for the new Commission. In this context, consideration will be given to the problem of shortages of medicines in the EU as well as enhancing the oversight of the global manufacturing chain to address the quality of active substances.
Novartis’ Zolgensma has received a marketing authorisation in the United States, but the product has not yet been authorised in the EU. The marketing policies and possible price for the product, which the company would apply in the EU, have therefore not been communicated.
A “lottery”, making the medicine available free of charge to a limited number of children, is not a viable model. The health of patients cannot become dependent on a game of chance. Instead, it is for companies to develop a sustainable model that meets societal needs.
The Commission is committed to improving the supply of affordable medicines to meet Europe’s needs and at the same time maintaining the status of a world leader in innovation for the European pharmaceutical industry. To pursue and achieve these objectives, the Commission will launch a Pharmaceutical Strategy for Europe.
It may be noted that EU Member States’ patent laws do include compulsory licensing provisions.
Measures regulating the prices and reimbursement of medicines within the EU are a national competence. The Commission, however, is committed to support Member States in constantly improving the quality and sustainability of their health systems and address the challenges linked to affordable medicines. The 2019 EU State of Health report highlights ways that EU can help decisions at national and local level, such as sharing experiences on pricing and payment methods at EU level.
On Monday, 10 February, hospitals in the Netherlands called for the introduction of a requirement for factories to notify the authorities of any impending shortages of medical devices. They fear that care may be acutely endangered due to the requirement for medical devices to comply with more stringent European rules from 26 May onwards. The European Medical Devices Regulation makes it compulsory to demonstrate by means of various tests that a product is safe and effective.
1 What is the Commission’s assessment of the above-mentioned news, and is it aware of any impending shortages in other Member States because manufacturers may not have medical devices approved (or reapproved) in time?
2 What impact does the Commission expect that Brexit will have on the number of approved EU inspection bodies that assess the safety of medical devices, as it has already fallen from 55 to 9 in recent years? And if the current number of approved inspection bodies is too small: how does the Commission intend to ensure that medical devices are certified in good time?
3 In what concrete ways does the Commission intend to avert impending shortages of medical devices, and does it agree that a European requirement for manufacturers to notify impending shortages is one of the options?
According to the settled jurisprudence of the Court of Justice, parallel trade of medicinal products is a lawful form of trade within the internal market, subject to Articles 34 – 36 of the Treaty on the Functioning of the European Union. At the same time, Directive 2001/83/EC on the Community Code relating to medicinal products for human use foresees an obligation of appropriate and continuous supply so that the needs of patients in each Member State can be covered.
The Commission has not received any complaints about the possible incompatibility of Article 129 of the Sozialgesetzbuch (SGB V) with the internal market rules. Currently, the Commission has no indication that this provision would infringe EU law.
Already today, Member States may take measures to prevent or address shortages of medicines, by restricting their free movement from, to and within their territory in order to protect human life and ensure adequate supply of medicinal products on their territory. Such measures need to be justifiable as appropriate, necessary and proportionate to the objectives pursued.
Asthma is a chronic and long-term illness, but is not classified as a long-term illness in Ireland under the Long-Term Illness Scheme which would provide free medication for asthma sufferers. Consequently, asthma sufferers are burdened with a comparatively high recurring cost for asthma inhalers, especially when compared to the cost of the same drugs in tablet form. The introduction of generic alternatives has not driven down prices commensurate with the introduction of generic alternatives to other drugs.
1 Does the Commission intend to work towards standardising pharmaceutical pricing and reimbursement across the Union, especially with regard to chronic and long-term illnesses such as asthma?
2 What mechanisms are in place at EU level to investigate and prevent pharmaceutical companies setting artificially high prices for medications required to treat chronic and long-term illnesses such as asthma?
3 What mechanisms exist for assessing the effectiveness of pharmaceutical competitiveness (including the introduction of generic medicines) in driving down the prices of medication for consumers within captive markets, such as those suffering from long-term illnesses like asthma?
The Hellenic Cancer Federation (ELOC) has complained that hospitals across the country are unable to supply cancer patients with the indispensable drugs they need on a regular basis. Shortages of medicines mean that treatment is being postponed, which is a cause of further anxiety for patients, detrimentally affecting their health.
According to public complaints, these shortages are purely technical in nature and intended either to exert inflationary pressure to raise prices or to force people to choose other more expensive medicines which are available. The Director of the Oncology Department of Venizelos Hospital in Crete has gone on public record stating that the medicines in question are older, cheap medicines which are not imported into Greece by the pharmaceutical companies and as a result very often cancer patients and the doctors are ‘left in the lurch’. More specifically, for the last month Venizelos Hospital has been unable to meet the needs of cancer patients.
In view of the above, will the Commission say:
1 How does the EU protect European citizens who are fighting for their lives against cancer?
2 What steps is it taking to ensure the necessary availability of medicines and to combat market leverage by pharmaceutical companies?
3 To what extent have drugs shortages become an EU-wide issue? Is this situation being centrally managed and monitored in the EU?
According to the World Health Organisation (WHO), cancer causes almost 20% of deaths in Europe. More than 3 million cases of cancer are reported each year, and approximately 1.7 million people die each year of cancer. After various cardiovascular diseases, cancer is the second largest cause of death and illness in Europe.
Regardless of the resources available to them, all states can apply the basic elements of dealing with cancer, which are: prevention, early detection, diagnosis and treatment so that various cancers can be prevented and cured. Cancer is avoidable in many cases, and the early detection process greatly increases the chance of successful treatment. It is therefore important to keep in mind that investing in cancer control is an investment in the future and in the health of society.
1 How does the Commission intend to promote efficiency and ensure uniform standards in health systems throughout the EU?
2 Does the Commission plan to allocate more funding to healthcare (innovative medicines and treatments) in the new MFF, especially with regard to Southeast European Member States, which are financially lagging behind the European standard?
In a position paper, AIM (Association of Mutual Benefit Societies), the umbrella organisation representing mutual benefit societies in the health sector and health insurance funds, criticises the opaque nature of the pricing system for pharmaceuticals. The cost of cancer treatment, which the paper claims increased tenfold between 1995 and 2010, is cited as one example. AIM calls for greater transparency, in order to ensure that fair prices are set for medicines and make medicines affordable for everyone. It also criticises the failure on the part of pharmaceutical companies to invest sufficiently in key areas. New approaches are needed to make innovative medicines more readily available. AIM proposes, for example, a European model for calculating fair prices which takes account of investment in research and development. It also calls on the Commission to set up a high-level working party on a fair pricing policy on which all stakeholders are represented.
Has the Commission noted the proposals made in AIM’s position paper and does it plan to put them into practice?
Over the last few years, patients in a number of Member States have experienced medicines shortages. In many of those places, unfortunately, the shortages affect medicines for thyroid disease, diabetes and even cancer. An effective health policy cannot be achieved if the medicines supply chain is disrupted.
The issue seems to lie, at least partly, in the intersection between health policy and economic policy. In particular, over-reliance on imports of active substances from third countries – covering 80% of demand in some cases – has brought to light policy flaws, including at EU level. In connection with the above, can the Commission say:
1 Has it undertaken studies into the EU’s medicine shortages, and in particular the reasons behind those shortages?
2 Is it planning to give the European Medicines Agency funds to help it monitor the situation on the medicines market more closely and warn Member States in advance of any possible supply restrictions?
3 Is it in regular contact with Member State partners, and is it gathering the information needed to create a system that could prevent medicines shortages in future?
In October 2019, Parliament’s Committee on the Environment, Public Health and Food Safety approved the appointment of Ms Kyriakides as European Commissioner for Health. During her hearing, she said she would work with the industry and the Member States to reduce shortages in medicinal products in Europe. This is a very real problem and injurious to the public health goal of guaranteeing access to top quality, affordable medicines for patients.
1 What possible solutions does the Commission have in mind to end these shortfalls in medicine stocks which pose a significant risk to patients’ health?
2 Will the Commission be able, in particular, to resolve those problems that stand in the way of access to essential medicines, such as high price erosion, cumbersome statutory processes in some Member States, and the fact that the manufacture of active pharmaceutical ingredients (APIs) is left to countries outside the EU?
3 Would the Commission be prepared to set up a high-level pharmaceutical forum where the industry, patients, political decision-makers and other stakeholders could come together to define strategic recommendations on how to ensure sustainable access to medicinal products, while at the same time enhancing the competitiveness of the European pharmaceutical industry?
Europe has recently been struggling with a lack of access to medicines. This problem is not limited to specialist or complex medicinal products: the most basic medical supplies can also be hard to come by, not only in the countries in the east of the EU, but also in highly developed countries with top-quality healthcare.
There is no question that one of the main reasons for poor access to medicines is that the active substances required are mostly produced in factories in Asia, namely China and India.
It has been clear for years now that the best solution would be to bring in regulatory measures to encourage manufacturers to return to Europe.
1 What action is the Commission intending to take to help ensure that the European pharmaceutical industry is given the right incentives to return to Europe, thereby guaranteeing the continent’s safety in terms of access to medicines?
2 Is the Commission intending to carry out a public consultation to meet the expectations of the European pharmaceutical industry and persuade it to return its operations to Europe, so as to ensure that patients once again have free and equal access to the medicines they need?
The Commission acknowledges that meeting the compliance deadlines of 26 May 2020 for the full applicability of the new Regulation on medical devices (MDR) is a challenging task for the whole sector. The availability of notified bodies is one of the most significant issues in this context.
The nine notified bodies already designated hold a very significant share of the existing certificates and are reported to have increased resources significantly (up to 50 per cent), which means that notified bodies are expected to be much better equipped and resourced than in the past. It is expected that more notified bodies will be available in the first quarter of 2020.
In addition, thanks to the extension of the validity of old certificates under certain conditions, it is expected that until May 2024 devices will be placed on the marked by virtue of either certificates issued in accordance with the MDR or certificates issued in accordance with the currently applicable Directives.
Regarding clinical evaluation, the MDR does not specifically establish provisions related to the adoption of Common Specifications on the subject. However, a number of guidance documents are currently under development in the area of clinical investigations and evaluation, to be published in the coming months.
As for the quality of the certification, the stricter rules foreseen by the MDR will ensure a higher level of protection of public health. In fact, such rules will provide the Commission and the Member States with a number of new monitoring tools, including stricter ex-ante control of high-risk devices, reinforced criteria for notified bodies, strengthening of postmarket surveillance and improved coordination mechanism between Member States.
In Germany, hospitals and pharmacies have for some time been complaining about shortages in the supply of medicines, some of which are important and relevant to hospitals. The Federal Institute for Drugs and Medical Devices maintains a list of them on its website, which is updated daily.
Germany’s federation of pharmaceutical wholesalers (PHAGRO) believes that the main reasons for the shortage of supplies are relocation of production outside Europe, which is concentrated in a small number of production sites, and the ever-increasing demand for pharmaceuticals worldwide.
1 Is the Commission aware of such supply shortages in other Member States, i.e. can this be defined as an EU-wide problem?
2 Has the Commission devised a single European strategy to address this problem and if so, what is the nature of this strategy?
3 What strategies has the Commission formulated to ensure the health of citizens in the event of a worst-case scenario (long-term shortages of essential medicines)?
Measures regulating the prices and reimbursement of medicines within the EU are a national competence. The Commission however has a clear task and is committed to support Member States in constantly improving the quality and sustainability of their health systems and address the challenges linked to affordable medicines.
The 2019 EU State of Health underlines the challenges on access to pharmaceuticals and highlights a number of cross-country collaborations, such as Health Technology Assessment (HTA) or horizon scanning. EU tools can indeed help decisions at national and local level and a way forward is to step up efforts to share experiences and pool expertise. The Commission will continue to develop and support initiatives that promote cooperation among Member States.
The Commission proposal on HTA creates an EU legal framework for Member States to work together on clinical elements and on emerging health technologies (horizon scanning). The EU Health Programme also supports evidence based information and cooperation mechanisms, including the work of the Organisation for Economic Cooperation and Development on improving capacity and sustainable access to medicines which offers the opportunity for experts to discuss pricing negotiation methodologies and good practices. Further, a recently launched study is analysing pharmaceutical market data and various trends, including pricing.
At the end of 2019, the BUKO Pharma Campaign and TranspariMED organisations reported that German university hospitals had entered the results of only 32 clinical trials out of the 477 undertaken (6.7%) into the EudraCT database. Under EU law, results must be entered within 12 months. The Paul Ehrlich Institute, which is the responsible body in Germany, is said to have told a university that, in accordance with Section 13(9) of the GCP Regulation, there is no obligation on sponsors to publish the results of trials in the EudraCT database in Germany.
1 Are German universities, as public law bodies, currently required, under EU law, to enter summaries of results and/or the full data sets of paediatric and non-paediatric clinical trials which they have sponsored into EudraCT within 12 months? If so, what is the legal basis for this?
2 Does the Federal Republic of Germany check whether the results of clinical trials are submitted to the EMA, in accordance with Section 4.7 of Guideline 2012/C 302/03? Does Section 13(9) of the GCP Regulation comply with EU law?
3 Has the Commission initiated an infringement procedure against the Federal Republic of Germany for possible breaches of EU law in connection with either of the above questions, or does it intend to seek a remedy by other means (please give justification)?
Regulation (EU) 2017/745 on medical devices will apply from May 2020. However, the implementation of the new rules is proving to be a real challenge.
Among other things, the lack of notified bodies is creating problems. So far, only nine bodies have been recognised, leading to huge delays in processing applications. Furthermore, the notified bodies are said only to be considering certificates from existing customers. This being so, it is virtually impossible for businesses to place new products on the European market, which is disastrous and leads to very high costs for businesses.
The establishment of the Eudamed database has also been delayed, and it is not expected to be operational until 2022. In addition, a corrigendum will apparently provide for a transitional arrangement for Class I products with or without a certificate that are already on the market.
In this context:
1 Does the Commission acknowledge the difficulties in implementation?
2 What solutions will the Commission devise to ensure that applications for new products can be processed in a cost-effective way and without delays?
The Regulation provides for an alternative plan for the exchange of information in the absence of the Eudamed database (Article 123). Will this alternative plan be activated?
The Commission is aware of the problem of shortages of essential medicinal products and its negative impact on the European patients. The Commission is following closely the issue and Member States’ and European Medicines Agency initiatives addressing this problem. The reasons of the shortages are diverse, and vary from the manufacturing issues to the commercial decisions of pharmaceutical industry.
The current Commission is not in a position to answer questions related to the mandate of its successor and invites the Honourable Member of the European Parliament to address the question to the next Commission once it takes office.
The Commission is aware of the growing concerns regarding shortages of medicines and patient care.
However, the current Commission is not in a position to answer questions related to the mandate of its successor and invites the Honourable Member of Parliament to address the question to the next Commission once it takes office.
The evaluation of studies reviewed in a marketing authorisation or in the post-marketing setting is managed by the authorities in charge of the assessment for the medicinal product concerned (for fluoroquinolones they were mostly national competent authorities). The outcome of such review is public (e.g. publication of the assessment report). Although the medicines have been evaluated by different national agencies, the criteria for granting a marketing authorisation are identical across the EU.
In this context, authorities have to take into account the well-known effects of (fluoro)quinolones on the tendons. Over the past years, product warnings have been strengthened, especially on the use of these medicines for patients more prone to tendon damage. The product summary advises that the medicine should be discontinued at the first sign of tendon swelling or pain. Similarly, such summary includes warnings about effects on the nervous system. This being said, before prescribing a medicine, a physician has to always consider whether the proposed therapy is adequate in view of the benefits and risks it involves and in view of the specific patient the doctor is treating.
Whilst these side effects of fluoroquinolones were known, new data emerged on the characteristics of these side effects, i.e. that some of these effects could be disabling, long-lasting and potentially permanent. In view of this new information, an EU review on the matter, a so-called Article 31 referral, was initiated in February 2017. The review was finalised in 2018 and its outcome is reflected for each (fluoro)quinolones in the annexes to the Commission Decision. Products subject to suspension are mentioned in Annex IA.
The Commission supports EU citizens’ access to innovative medicines along the supply chain.
The pharmaceutical legislation provides mechanisms for earlier access to promising medicines. A marketing authorisation can be granted to fulfil an unmet medical need based on limited evidence and medicines of major interest for public health and therapeutic innovation may undergo an accelerated assessment.
The European Medicines Agency (EMA) offers developers opportunities for an early dialogue through scientific advice or the PRIority MEdicines (PRIME) scheme.
Pricing policies for medicinal products fall under the Member States’ competence. However, the Commission promotes the exchange of information among Member States on their pricing policies. This can enhance price competition and help minimise potential negative effect on the accessibility of medicines.
The Commission also supports the strengthening of Member States’ 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 authorities responsible for pricing and reimbursement.
The EU Regulation on medicines for rare diseases (orphan medicines) provides incentives for research, development and placing on the market of orphan medicines. The Commission is currently evaluating the functioning of this regulation, including an assessment of measures at national and EU level ensuring accessibility to affordable medicines.
The public has been involved in this evaluation and many patients and healthcare professionals directly contributed to the work. The final report is expected in the beginning of 2020.
The Commission is aware of the study referred to by the Honourable Member.
Public scrutiny of decisions taken by regulatory authorities to authorise medicinal products is an important element to create and maintain trust in the system of authorising medicines in the EU.
The Commission as the authority responsible for the authorisation of centrally authorised medicines is in contact with the European Medicines Agency and the Member States for the centralised authorisation procedures as well as policy and implementation issues related to the authorisation of medicines.
The authorisation of a new medicine is based on an assessment of its quality, safety and efficacy. Only when the benefit/risk balance of the product is positive, the product will be authorised.
The Commission relies on the scientific expertise of the European Medicines Agency and its committees for the evaluation of medicines on the basis of the evidence submitted by the applicant. EU legislation however does not require that new medicines be superior to medicines already on the market.
Once a medicine is authorised, the decision as regards to its use is taken by healthcare professionals in Member States who take into account national guidelines and conclusions of health technology assessment bodies.
According to EU legislation, marketing authorisation holders must inform Member State authorities at least two months before temporary or permanent market withdrawals. They are also obliged to ensure continuous supply for medicines placed on a specific EU market.
Following a meeting in 2018, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages.
The Commission addresses issues of access and availability through the Pharmaceutical Committee, the Expert Group on Safe and Timely Access to Medicines for Patients and by supporting relevantprojects and initiatives via the EU Health Programme. The Commission also analyses the effectiveness, accessibility and resilience of health systems as part of the European Semester.
In addition, Heads of Medicines Agencies/European Medicines Agency Task Force is working to address shortages and availability of medicines. Shortages with an impact on public health are being shared between Member States in order to increase awareness and facilitate action.
The Commission is currently reflecting on possible additional ways to address shortages of medicines.
The Commission acknowledges that meeting the compliance deadlines of May 2020 for medical devices and May 2022 for in-vitro diagnostic medical devices is a challenging task for the whole sector and all concerned stakeholders. The availability of Notified Bodies is one of the most significant issues in this context.
At the same time, the stricter rules foreseen by the new Regulations must be introduced with no further delay, to ensure a higher level of patient safety. The importance of this has been confirmed in recent discussions in both the European Parliament and the Council. The Commission has been working relentlessly, together with Member States, to ensure that the transition can occur timely and smoothly. In this respect, significant progress has been made.
Up to date, four Notified Bodies have been designated, covering over one third of existing certificates. While progress of the applications depends very much on the level of preparedness of Notified Body applicants, it can be reasonably estimated that a substantially higher number of Notified Bodies will be available before the end of 2019.
The Innovative Medicines Initiative (IMI) has invested EUR 46 million in the pain area referred to by the Honourable Member.
EuropaIN, one of the funded projects, has carried out translational research that aims at understanding pain mechanisms, and at helping to develop novel analgesics and better biomarkers for pain. EuropaIN researchers demonstrated that antidepressants, such as amitriptyline, may relieve fibromyalgia syndrome (FMS) symptoms. However, a remarkable number of patients presents intolerable adverse effects or experience only a small relief of symptoms.
Horizon Europe will be the next Framework Programme investing in Research and Innovation for the period 2021 ‐2027. The implementation of Horizon Europe’s programme-level objectives will be ensured by a multiannual Strategic Planning. This process will set out key strategic orientations for the implementation of Horizon Europe in a transparent and inclusive manner for the period 2021‐2024. Based on the Strategic Planning, a Work Programme will be developed during 2020 that will cover the needs for Research & Innovation for the period 2021‐2022. The Orientation Paper towards the Strategic Planning indicated a possible partnership candidate Innovative Health Initiative (IHI) building upon IMI2.
The Strategic Planning will promote strong engagement with citizens and civil society and include extensive consultations with various stakeholders about research priorities. In the same context, a public consultation is ongoing, which together with the opportunity of participation in the Research & Innovation Days in September 2019 and contributing to the upcoming public consultation on potential future partnerships, represent excellent opportunities also for FMS patients to share their perspectives and expectations.
The Commission recognises the burden of Alzheimer’s disease.
Horizon 2020 is funding brain research with EUR 3.2 billion. The Commission also supports the efforts to coordinate Alzheimer’s research of the Joint Programming Initiative on Neurodegenerative Diseases, and the Innovative Medicines Initiative, a public-private partnership that established a platform where companies and academia collaborate.
In addition the Commission supports Member States and stakeholders in implementing best practices on mental health, including on Alzheimer’s, at national and regional levels. The EU Framework on mental health and well-being and the EU-Compass for action on mental health and well-being provide examples of good practices and policy approaches that Member States may use to complement their national initiatives.
The expert group on dementia, as well as other existing expert groups such as the cancer expert group, are now replaced by the Member States’ Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases that is a high-level group providing guidance and selecting best practices for transfer between countries with the view to support Member States to reach the United Nations Development Goals as well as to pursue a horizontal approach to non-communicable diseases.
The Steering Group agreed that mental health will be a priority area for the selection of best practices in 2019. In May 2019, mental health best practices and implementable research results (including projects funded by the Health Programme and Horizon 2020) were presented to the Member States.
Countries will now be able to select from that group their preferred initiatives for implementation with possible EU funding.
Since 2007, the outermost regions have benefitted from a specific additional allocation implemented in the framework of the European Regional Development Fund, which objectives are to offset additional costs linked to handicaps listed in Article 349 of the Treaty on the Functioning of the European Union.
This allocation may finance operating aid and expenditure covering freight transport services, start-up aid for transport services, operations linked to storage constraints, the excessive size and maintenance of production tools, as well as public service obligations, including those in the transport sector.
The specific transport needs of the outermost regions are fully recognised by the Commission in the strategy adopted in October 2017. The Commission proposed to keep the specific additional allocation at the same level of funding for the programming period 2021-2027.
The Commission is aware of the growing concerns regarding shortages of medicines and patient care. The reasons for shortages include manufacturing problems, industry quotas, legal parallel trade, or economic reasons such as the price of medicines, which falls under Member States competence.
According to EU legislation, marketing authorisation holders must, other than in exceptional circumstances, inform Member State authorities at least two months before they withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal. There is also an obligation of continuous supply to cover the needs of patients for medicines placed on a specific EU market.
Following a meeting with Member States in 2018, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages. A paper on the obligation of continuous supply to tackle shortages was also agreed with Member States. The Commission is currently reflecting on possible additional ways to address shortages of medicines.
Furthermore, in specific circumstances, the deliberate creation of medicines shortages, for example in the sense of a refusal to supply, may constitute an infringement of both European and national competition rules.
The Commission and/or national authorities are closely following this issue and can further investigate and take enforcement measures in individual cases.
According to Article 168(7) of the Treaty on the Functioning of the EU, the organisation and delivery of health services and medical care is a national competence.
Notwithstanding the above, the EU supports fostering accessible healthcare in Member States. Article 35 of the EU Charter of Fundamental Rights enshrines people’s right of access to treatment and care.
The European Pillar of Social Rights affirms everyone’s right to timely access to affordable, preventive and curative healthcare of good quality. The Commission’s contribution to the future of Europe, stresses that the EU should support Member States to make their healthcare systems effective, accessible and resilient.
The Commission has supported various relevant initiatives through the EU Health programme.
In the Romanian Country Report, published under the most recent European Semester cycle, the Commission has drawn attention to the comparatively low level of spending on healthcare in Romania, notably impacting the coverage of novel medicines.
Under the 2019 European Semester, a Country Specific Recommendation was adopted, that underlines the need for Romania to improve access to healthcare.
Moreover, the Commission engages through different fora with Member States, including its Pharmaceutical Committee, on issues related to the early availability of centrally authorised medicines, for which the marketing authorisation is granted by the Commission.
The Commission is aware of the growing concerns regarding shortages of medicines and the dependence on active substances manufactured in non-EU countries.
To address the security of supply, the Commission, together with the Member States and the European Medicines Agency, is strengthening enforcement and control activities and stimulating the alignment of non-EU countries’ regulatory frameworks with international standards.
The Commission is currently reflecting on possible ways to address these challenges to health security by enhancing oversight of the global manufacturing and supply chain and boosting industrial policy.
In addition, the Heads of Medicines Agencies/European Medicines Agency Task Force is working to develop and coordinate actions to address shortages and availability of medicines. It is currently piloting a system for internal cooperation and information sharing between national authorities. Shortages with an impact on public health are being shared through this system in order to increase awareness and facilitate Member State actions.
As the Honourable Member rightly states, Directive 2001/83/EC obliges that the labelling and the package leaflet of medicinal products placed on the market shall be in an official language (or languages) of the Member State where the medicinal product is placed on the market.
Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product; or in case of certain medicinal products for rare diseases, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant a full or partial exemption to the abovementioned obligation. This may be the case in Member States with smaller markets where there is an issue of availability of the medicinal product.
The enforcement of the directive is the primary responsibility of the Member States’ competent authorities. These authorities check marketing authorisation holders’ compliance with the terms of the marketing authorisation, for instance by conducting inspections and imposing applicable sanctions. If consumers believe companies do not comply with the terms of a marketing authorisation they can contact their respective national medicine regulator.
The role of the Commission consists of monitoring the Member States’ implementation of EC law and ensuring that national legislations and practices comply with EC law, in line with the communication from the Commission ‘EC law: Better results through better application’. In its communication, the Commission explains its strategic approach to enforcement and the important role that the national authorities play in securing the rights of individuals when EC law is breached.
The relocation costs of the European Medicines Agency are part of the total costs to the Agency’s budget related to the United Kingdom’s withdrawal from the EU.
These costs will be incurred during the years 2018 to 2020 and, at this time, can only be estimated by the Agency.
The Commission has therefore sent to the European Medicines Agency the request of the Honourable Member on costs related to its move from London to Amsterdam. The Commission will transmit the reply as soon as it is available.
The Commission is aware of the shortages of the nationally authorised medicines Sinemet and Sinemet Plus. The company announced the shortage in September 2018 and recommendations to healthcare professionals and patients on suitable alternatives were issued in individual Member States.
According to EU legislation, marketing authorisation holders must, other than in exceptional circumstances, inform Member States’ authorities at least two months before they withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal. As correctly stated by the Honourable Members, there is also an obligation of continuous supply to cover the needs of patients once a medicine is placed on a specific EU market.
The Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages, following a meeting with Member States on 25 May 2018. A paper on the obligation of continuous supply to tackle shortages was also agreed with Member States in this meeting.
In addition, Heads of Medicines Agencies/European Medicines Agency Task Force is working to develop and coordinate actions to address shortages and availability of medicines. It is currently piloting a system for internal cooperation and information sharing between national authorities. Shortages with an impact on public health are being shared through this system in order to increase awareness and facilitate Member State actions.
EU legislation on homeopathic medicines was introduced in 1992 with the aim of ensuring their quality and safety whilst at the same time providing a clear indication of their homeopathic nature.
At the time of adoption of the legislation, it was considered that despite the differences in recognition between Member States, consumers across the EU should be adequately protected if they choose to use homeopathic medicines.
Under the current simplified registration procedure, homeopathic medicines must not mention specific therapeutic indications and must be diluted to a sufficient degree to ensure their safety. Furthermore, their labelling must clearly mention that they are ‘homeopathic medicinal products without approved therapeutic indications’ and shall bear a warning advising to consult a doctor if symptoms persist.
There are currently no plans to revise Directive 2001/83/EC as regards homeopathic medicinal products or change their designation to ‘homeopathic substances’.
Protecting people exposed to low quality medical products requires a holistic approach that strengthens pharmaceutical systems both globally and locally, tackling issues such as adequately resourced health systems, the regulatory framework and its enforcement, quality manufacturing and distribution, and the availability of qualified health workers.
The EU promotes access to medicines in developing countries through a health-in-all-policies approach and various initiatives, programmes and financial support. The Renewed Partnership on Strengthening pharmaceutical systems aimed to improve the quality and availability of pharmaceutical supplies including safety and quality of medicines. In particular the EU MEDISAFE project supports the fight against the production and trafficking of falsified medicines and pharmaceuticals in Eastern and Central Africa. The EU also provides support to the World Health Organization (WHO) to work on access to medicines that includes the prevention, detection and response to sub-standard and falsified products.
Furthermore, the EU contributes to global initiatives that provide quality assured medicines such as the Global Fund to fight Aids, Tuberculosis and Malaria, Gavi, the Vaccine Alliance, the United Nations Population Fund, and supports partner countries’ bilateral health programmes on medical product quality. The EU and Member States also play an active role in the WHO Member State mechanism on substandard and falsified medicines, with WHO supporting countries through its activities on medicines quality assurance.
In order to help fight the dissemination of counterfeit medicines, the EU prepares a biannual Report on the protection and enforcement of intellectual property rights in third countries and the Counterfeit and Piracy Watch List. The EU also has cooperation programmes with China, South-East Asia and Latin America among others to reduce the import of such medicines.
Genome-editing technologies can cure or treat patients affected by life-threatening diseases. In order to support these technologies, the EU has already invested more than EUR 450 million in research projects, including more than EUR 166 million since the start of Horizon 2020.
Examples include the projects Cell-PID and UPGRADE, always complying with our framework’s ethical principles and relevant national and international legislation. Remaining calls in Horizon 2020 further support genome editing approaches and support will continue in Horizon Europe through the ‘Health’ Cluster of Pillar II, paving the way for their swift uptake into health systems.
Regulation No 1394/2007 governs the use of genome editing techniques in medicinal products for human use. The regulation provides for strict controls of quality, safety and efficacy and a centralised assessment by the Committee for Advanced Therapies.
Recognising the potential of gene therapy medicinal products — including genome-editing approaches, the Commission is working with the Committee and Member States to support developers while ensuring a high level of public health protection.
Examples are the recent Guidelines on Good Manufacturing Practices (GMP) for Advanced Therapy Medicinal Products and the ongoing development of scientific guidelines for gene therapy medicinal products, including genome editing approaches.
The Commission is exploring different activities to stimulate and inform the scientific and social debate on the applications of genome editing technologies for healthcare. A public survey such as Eurobarometer could be considered.
The Commission supports proactively EU citizens’ access to innovative cancer medicines along the steps from product discovery to a patient.
The EU plays an important role in supporting cancer research, including funds for the development of innovative cancer drugs. Overall, EU’s long-term investment in cancer research totals more than EUR 2.8 billion since the beginning of the 7th Framework Programme in 2007.
The pharmaceutical legislation provides mechanisms for earlier access to promising medicines, including treatments for cancer. A marketing authorisation can be granted to fulfil an unmet medical need based on more limited evidence and medicines of major interest for public health and therapeutic innovation may undergo an accelerated assessment.
The European Medicines Agency (EMA) offers developers opportunities for an early dialogue through scientific advice or the PRIority MEdicines (PRIME) scheme, under which 14 oncology products have been granted access.
The pricing and reimbursement of medicines are competency of the Member States. However, the Commission has adopted a proposal for a Regulation on cooperation on Health Technology Assessment, which is being negotiated in the European Parliament and Council. The proposal provides for joint clinical assessments of new health technologies, including innovative cancer medicines. High quality, timely joint clinical assessments would support Member States in taking timely and evidence-based decisions on patient access, and contribute to improving patient access to innovative health technologies across the EU.
The relocation of EMA was handled efficiently and will not impact the high quality and safety of medicines that patients in the EU expect.
The Commission has been in frequent contact with the European Medicines Agency (EMA) over the Agency’s efforts to find a new tenant for the London building and to keep the related costs under control.
EMA signed its rent contract in 2011 without a break clause, bearing in mind that negotiating such a break clause would have increased the rental costs considerably. The absence of a break clause in the rent contract was a conscious choice to achieve savings, at a time when a potential United Kingdom withdrawal was not under discussion. On this basis the European Parliament and the Council (“the budgetary authority”) approved EMA’s building file in 2011.
Following the submission of its request to the budgetary authority on 4 March 2019, the EMA obtained the European Parliament’s approval on 18 March 2019 and Council approval on 2 April 2019, to enter into a sub-lease contract for the London building. Negotiations with the landlord and the sub-tenant are currently ongoing.
Shortages of pharmaceutical products are a serious problem that can affect many patients across the EU. The Commission is aware of the concerns regarding shortages of pharmaceutical products for human use. The reasons for shortages include manufacturing problems, quotas from industry, legal parallel trade, or economic reasons such as the price of medicines, which falls under the competence of the Member States.
As a response to calls from the co-legislators to monitor the obligation of continuous supply laid down in EU legislation), the Commission held a meeting with experts from EU countries on 25 May 2018.
After the meeting, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages. At the meeting, a document was also agreed to assist Member States to implement and enforce the obligation of continuous supply.
The European Medicines Agency and Heads of Medicines Agencies network are working on measures to address this problem, including agreeing a definition of a shortage and improving the reporting of shortages of medicines.
The Commission also addresses issues of access and availability through the Pharmaceutical Committee, the Expert Group on Safe and Timely Access to Medicines for Patients and by supporting relevant projects and initiatives via the EU Health Programme.
Generally speaking, the organisation and delivery of health services and medical care and the pricing and reimbursement decisions that closely influence access to medicines are a Member State competence. The Commission, however, closely follows this issue and analyses the effectiveness, accessibility and resilience of health systems as part of the European Semester.
The Commission is aware of the matter at hand. The Dutch and the Belgian competition authorities, which, as part of the European Competition Network, also enforce EU competition rules, are analysing the situation as a follow up to complaints.
Therefore, the Commission is at this stage not in a position to provide further information with regard to the questions raised. The Commission will however continue to monitor the pharmaceutical sector in close cooperation with the national competition authorities, and take action, if necessary.
The Commission notes that although medicines authorised at EU level can be placed on the market in all Member States, this is not always the case, as placing on the market depends on the decision of companies and on pricing and reimbursement decisions.
Pricing policies for medicinal products are Member States’ competence. However, the Commission promotes the exchange of information among Member States on their pricing policies, for example through the European medicine price database (EURIPID) and projects by the Organization for Economic Co-operation and Development (OECD). The Commission also facilitates the exchange of best practices and knowledge among Member States through a network of competent authorities.
As part of its competition policy, the Commission monitors pharmaceutical markets and investigates, where appropriate, possible breaches of EU competition rules. In addition, the Commission supports national competition authorities in Europe that can investigate possible breaches of EU competition rules, including as regards excessive pricing.
The Commission started in May 2017 with Brexit preparedness activities in the pharmaceutical sector to ensure continued and safe access to medicinal products for patients, including in case of a disorderly withdrawal of the United Kingdom from the European Union. While no legislative preparedness proposals were necessary, the Commission worked closely together with Member States and the European Medicines Agency (EMA) to minimise any potential risk concerning supply of medicines in a no-deal scenario.
For example, with regard to the batch control testing, the Commission has informed the authorities and stakeholders that, for a specific period of time and in justified cases, competent authorities may allow justified cases controls of imported medicines to be carried out by third parties in the United Kingdom, provided that the batch is released by a qualified person established in the EU. This is based on the applicable legislation given the particular circumstances of Brexit.
Subject to these conditions, a temporary exemption may be given to the concerned companies by the national competent authorities or EMA.
As regards Brexit preparedness at the Union’s borders, the Commission has published a wealth of information on customs procedures, including links to relevant websites and additional information from national authorities. On 10 April 2019, the Commission published additional practical guidance for a no-deal scenario, including with regard to medicines and medical devices.
As a response to calls from the co-legislators to monitor the obligation of continuous supply laid down in EU legislation, the Commission held a meeting with experts from EU countries on 25 May 2018. After the meeting, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages. A document on the obligation of continuous supply to tackle shortages, including the general principles to be considered by Member States planning to introduce restrictions on the supply of medicines at risk of shortage, was also published in order to improve enforcement by national authorities. The European Medicines Agency and Heads of Medicines Agencies network are also working on various measures to address this problem, including improving the reporting of shortages of medicines.
The enforcement of EU medicines legislation is the responsibility of the Member States. An overview of Member State penalties in relation to shortages is included in the summary report of Member States’ measures to ensure continuous supply mentioned above.
EU legislation requires an authorisation to manufacture or import medicines and active ingredients. There is no requirement in the marketing authorisation regarding the number of manufacturing sites or production capacity.
The compatibility of national legislation banning the mail order sale of prescription medicines for human use with the relevant EU legislation (in particular Articles 34 and 36 of the Treaty on the Functioning of the EU and Directive 2001/83/EC of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use), would have to be assessed on a case-by-case basis.
This assessment would consider the modalities of the national legislation and would include an appreciation of whether such legislation is necessary to pursue legitimate objectives of public health protection, and appropriate for securing the attainment of the objective pursued.
The assessment would also examine whether the legislation is not going beyond what is necessary to attain the legitimate objectives of public health protection.
According to EU medicines legislation, a marketing authorisation is required to place a medicine on the market in the EU, including online. In 2011, stricter rules for online sales of medicines were introduced in the EU to address increasing concerns with falsified medicines being sold online to citizens.
EU legislation requires online pharmacies to obtain an authorisation to supply medicines at a distance and to notify the national authorities where they are established of their intention to sell medicines online. Member States are responsible for enforcing the legislation and ensuring that only legal economic operators are offering medicines for sale in the EU.
In addition, Member States cooperate with other jurisdictions around the world to tackle illegal online sales. In 2018, the INTERPOL operation Pangea shut down 3 671 websites with illegal online offerings. The operation led to the seizure of ten million units of medicines and 859 arrests around the world.
Since 1 July 2015, a common EU-wide logo is mandatory for all online pharmacies legally operating in the EU(5). The logo makes it easier for EU citizens to identify legal online pharmacies.
The main objective of the EU Regulation on orphan medicinal products is to provide incentives for research, development and placing on the market of orphan medicines to ensure that patients suffering from rare conditions have the same quality of treatment.
The Commission is currently evaluating the functioning of the EU Orphan Regulation, which will provide insight in how the various incentives (including market exclusivity) have been used in practice and the financial consequences this has resulted in.
Pricing policies for medicinal products are outside the EU remit and fall under the Member States’ competences. However, the Commission is promoting the exchange of information among Member States on their pricing policies. This can enhance price competition for medicines and help minimise potential negative effects on accessibility. The Commission also facilitates the exchange of best practices and knowledge and supports the strengthening of cooperation on a voluntary basis, in particular through tools such as a European medicine price database.
As part of its competition policy, the Commission also monitors pharmaceutical markets and investigates, where appropriate, possible breaches of EU competition rules that may entail high prices. Article 102 of the Treaty on the Functioning of the EU also applies to abusive practices in the context of medicines benefitting from patent protection and regulatory exclusivity. That said, competition law enforcement has to take due account of the efforts and incentives to innovate. The Commission supports national competition authorities in Europe that can investigate possible breaches of EU competition rules, including excessive pricing.
1. The Commission has taken note of the report of France Assos Santé. The reasons for shortages include manufacturing problems, quotas from industry, legal parallel trade, or economic reasons such as the price of medicines, which falls under the competence of the Member States.
According to EU medicines legislation, there is an obligation for companies to ensure continuous supply of medicines to cover the needs of patients once a product is placed on a specific EU market. Furthermore, in specific circumstances, the deliberate creation of medicines shortages, for example in the sense of a refusal to supply, may constitute an infringement of both European and national competition rules. The Commission and/or national authorities are closely following this issue and can further investigate and take enforcement measures in individual cases.
2. Marketing authorisation holders must, other than in exceptional circumstances, inform Member States’ authorities at least two months in advance if they plan to withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal. There is also an obligation of continuous supply to cover the needs of patients once a medicine product is placed on a specific EU market and an obligation to comply with competition rules. The sudden withdrawal of marketing authorisations should, therefore, not be a common occurrence. There is, however, no obligation to market medicines in a particular or all Member State(s) by pharmaceutical companies.
As mentioned above, EU legislation requires an authorisation to manufacture or import medicines and active ingredients. There is no requirement in the marketing authorisation regarding the number of manufacturing sites.
The European Parliament,
– having regard to Rule 133 of its Rules of Procedure,
A. whereas, in its resolution of 2 March 2017 on EU options for improving access to medicines, Parliament states that ensuring patient access to essential medicines is one of the core objectives of the EU and the WHO;
B. whereas the agenda of the WHO plenary meeting to be held in Geneva from 20 to 28 May 2019 lists, among the strategic priority matters to be discussed, item 11.7 ‘Addressing the global shortage of, and access to, medicines and vaccines’; whereas the Italian Government has tabled a comprehensive resolution on this topic;
C. whereas it is of the utmost importance to address properly the global shortage of, and access to, medicines and vaccines;
1. Calls on the EU and all Member States to agree on a common position supporting, at the upcoming 72nd WHO plenary meeting, the resolution entitled ‘Improving the transparency of markets for drugs, vaccines and other health-related technologies’, which sets out a number of measures designed to achieve this objective.
The main objective of the EU Regulation on orphan medicinal products is to provide incentives for research, development and placing on the market of orphan medicines to ensure that patients suffering from rare conditions have the same quality of treatment.
The Commission is currently evaluating the functioning of this regulation. The evaluation will include an assessment of measures at national and EU level ensuring accessibility to affordable medicines and will provide insight into the use of various incentives in practice and its financial consequences.
Pricing policies for medicinal products are Member States’ competence. However, the Commission promotes the exchange of information among Member States on their pricing policies, for example through the Euripid database. It also facilitates the exchange of best practices and knowledge among Member States through a network of competent authorities.
As part of its competition policy, the Commission monitors pharmaceutical markets and investigates, where appropriate, possible breaches of EU competition rules that may entail high prices. Article 102 of the Treaty on the Functioning of the EU also applies to abusive practices in the context of medicines benefitting from exclusivity, like the one resulting from patent law and orphan medicines regulation.
That said, competition law enforcement has to take due account of the efforts and incentives to innovate. The Commission supports national competition authorities in Europe that can investigate possible breaches of EU competition rules, including as regards excessive pricing.
The Commission is aware of the concerns regarding shortages of pharmaceutical products for human use. Shortages are a serious problem that can affect many patients across the EU. The main reasons for shortages include manufacturing problems, quotas from industry, legal parallel trade, or economic reasons such as the price of medicines, which falls under the competence of the Member States.
The Commission has not carried out an impact assessment on shortages but held a meeting with experts from EU countries on 25 May 2018. The meeting was a response to calls from the co-legislators to monitor the obligation of marketing authorisation holders to ensure continuous supply of medicines as laid down in EU legislation.
The Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages. A meeting document on the obligation of continuous supply to tackle shortages, including the general principles to be considered by Member States planning to introduce restrictions on the supply of medicines at risk of shortage, was agreed at the meeting. The European Medicines Agency and Heads of Medicines Agencies network are also working on various measures to address this problem, including improving the reporting of shortages of medicines.
On 25 January 2019 the Commission asked the European Medicines Agency (EMA) to review as soon as possible the available evidence on the safety and efficacy of the use of Lartruvo (olaratumab) in combination with doxorubicin. In this review the EMA is seeking clarification of the discrepancy between the results of the phase II and III trials. The outcome of the full review will be published on the EMA website. Any regulatory action if necessary will be based on the outcome of the review and will be in the interest of patients.
Regarding clinical trials, the marketing authorisation holder informed the EMA that they stopped enrolling new patients into clinical trials where the active substance olaratumab is used in combination with doxorubicin, and that patients already treated in such a clinical trial are asked to confirm their consent. Research is continuing in those clinical trials of olaratumab where it is used in combination with other agents, in patients with a soft tissue sarcoma or in other cancers.
Soft tissue sarcoma may require surgery, radiation therapy and/or systemic anti-cancer medicines (“chemotherapy”) for treatment. Each patient’s situation is evaluated with respect to best option(s) as part of the patient’s treatment. Public information on treatment options is readily available through healthcare professional guidelines.
Patients with a soft tissue tumour are closely and regularly followed for evaluations and treatment by healthcare professionals. Recommendations for systematically monitoring of patients are also included in the information accompanying the medicine.
Summary of petition: The petitioner argues that Spanish Law 29/2006 of 26 July on guarantees and the rational use of medicines and health products (as amended by Royal Legislative Decree 1/2015 of 24 July) subjects official formulas or preparations to an additional and more restrictive requirement not provided for in Directive 2001/83/EC. This Directive concerns the Community code relating to medicinal products for human use. This additional requirement means that official preparations must be listed and described in the National Formulary, which is a different resource to the pharmacopoeia. For this reason, the petitioner states that Spain is failing to comply with Directive 2001/83/EC.
Conclusion: As the EU legislation clearly leaves to the Member States the competence to decide on the requirements to be applied on officinal preparations, the Commission is not in a position to intervene in favour of the petitioner.
The Commission would like to inform the Honourable Member that there is a pending assessment of a marketing authorisation application via the EU centralised procedure for a medicinal product containing an active substance lifitegrast for use in ophthalmology.
The assessment by the European Medicines Agency’s (EMA) scientific Committee for Medicinal Products for Human Use (CHMP) is expected to be finalised in 2019. In case of a positive CHMP opinion the next standard step is a decision-making process at the Commission level, with involvement of the Member States, potentially leading to a marketing authorisation valid across the whole EU. As the procedure is in its early stage, more precise estimation of timelines of the process in question cannot be provided.
In response to the Honourable Member, we can confirm that the European Medicines Agency (EMA) is currently evaluating an extension of indication for Lynparza in the first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.
This procedure (for a variation of the marketing authorisation of Lynparza) is expected to be finalised later this year. In view of the pending scientific assessment, a more precise timing is not possible.
EMA’s Business Continuity Plan has been put in place to ensure that any activities directly related to authorisation, maintenance and supervision of medicines are not affected by EMA’s relocation to the Netherlands. As a result of this policy, this authorisation procedure is following the foreseen timetable and there have been no unexpected delays.