The latest parliamentary questions, declarations, proposals and positions concerning industrial pharmacy from the European Parliament.
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.
It seems that the Greek Government – with the support of the institutions – will proceed with the agreed 30 % clawback reduction by just increasing the current mandatory rebates up to 50 % and not by applying the proper structural reforms. Additionally, reimbursement and a positive health technology assessment (HTA) outcome from at least six countries will be a prerequisite for the introduction of a new medicine in Greece. This will lead to an unfavorable impact for patient access to new medicines. According to a letter sent by ‘Reumazin’ – a patients’ federation for chronic rheumatic diseases – to the Greek Prime Minister, access to new medicines in Greece will be delayed up to four years. The Greek Government is incapable of delving into structural reforms, thus transferring the cost to Greek patients by restricting their access to new medicines.
1. Can the Commission guarantee that Greek patients will retain access to new medicines?
2. Is this deliberate delay compliant with the acquis communautaire and the free movement of goods, including medicines?
3. Will the Commission accept the idea of positive HTA outcomes from other countries instead of insisting on the establishment of a Greek HTA, in accordance with the 3rd Memorandum of Understanding?
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.
Because the European Medicines Agency did not include a termination clause in the lease contract for its premises in London, the EU will have to continue paying until 2039, in principle even if the EMA does not remain in London after Brexit. It is expected to cost EUR 347.6 million.
1. Has the Commission included a termination clause in the lease contracts for all the properties it rents (including the Information Offices)?
2. Why did the EMA fail to include such a clause? Brexit may well have been hard to foresee, but other unexpected events can happen during a period of 30 years.
3. What is the situation in respect of the EU agencies in this regard?
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.
Access to affordable and effective cancer treatments is a growing concern both within the EU and worldwide.
At the World Health Organisation on Monday 13 March 2017, the intersessional drafting group, counting EU representatives among its members, held a meeting to discuss the Cancer Resolution to be considered at the World Health Assembly in Geneva in May 2017.
A number of WHO Member States have proposed the addition of a new paragraph to the Resolution, with the following wording: ‘to prepare a technical report towards the end of 2018 on existing mechanisms and options for R&D for cancer medicines, including the delinkage between R&D costs and product prices, that would enhance affordability and accessibility of these products’.
1. According to reliable sources, the EU opposes this proposal. Is this true, and if so, what are its underlying motivations?
2. Could the Commission brief me on the EU’s position (represented by the Commission and the EEAS) on the above text and the institutional procedure through which it was adopted?
Consumers view medicines as unaffordable and their accessibility is also deemed problematic in a number of Member States. As a result, the debate on the affordability and accessibility of medicines has taken centre stage in the EU and its Member States.
What is the Commission doing in order to make medicines more affordable and to increase their accessibility in similar fashion in all the Member States of the European Union?
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.
At present, it is not possible to achieve SDG 3 without taking a holistic (psychosomatic) approach to patients. The psychosomatic approach to medicine began in ancient Greece, when Hippocrates drew attention to important psychic factors in the social and physical environment that need to be understood by physicians, though it was not until 1818 that the physician Heinroth introduced the term ‘psychosomatic’.
Psychosomatic medicine concerns research on and treatment of two aspects: a psychological component and a somatic component, and the study of interactions between the mind, body and social environment. Research shows that basic psychosomatic disorders include bronchial asthma, arterial hypertension, stenocardia, peptic ulcer disease, ulcerative colitis, atopic dermatitis and diabetes.
To ensure a healthy life and promote good health for people of all ages, a positive attitude towards the patient is needed, which directs all actions and measures towards the patient, not the illness, by replacing the biomedical model with a biopsychosocial model. By so doing, efforts will be focused not only on eliminating disorders, but also on finding ways to prevent them.
Would the Commission consider a holistic approach to patients, based on specific research and studies, as part of the EU’s strategies and policies for sustainable development?
The EMA’s 2015 report on the safety of Human Papillomavirus (HPV) vaccines, requested by Denmark, rejected any causal association between the use of the vaccines and certain syndromes arising as adverse reactions.
The Nordic Cochrane Centre (an independent Norwegian research centre) then raised concerns about mismanagement, at first directly with the EMA and then with the European Ombudsman, pointing out a lack of transparency in how the EMA functions.
Specifically, the criticisms concern the secrecy requirements imposed on members of the EMA’s internal committees, the numerous redactions in the official version of the report compared with the confidential version, and the margin of discretion in the selection of studies to be considered. Several researchers have emphasised the need for further research into the toxicity of HPV vaccines and for greater transparency, and the need for the EMA to consider independent studies, rather than only those from pharmaceutical companies.
Can the Commission:
Explain how the procedures and secrecy requirements imposed by the EMA are meant to protect public health and the patients’ right to complete information?
Describe what measures it intends to take to ensure that the EMA assesses studies from independent research centres along with those commissioned by the pharmaceutical industry?
In April 2007, a pharmacovigilance exercise was launched in Italy concerning attention deficit hyperactivity disorder (ADHD), through the establishment of a national register that enabled the use of methylphenidate (MPH) and atomoxetine (ATX) among growing children and adolescents to be monitored in order to ensure they are being used safely.
Thanks to the data collected by the ADHD National Register, it has been possible to estimate the risk profile of the psychotropics MPH and ATX for the treatment of children and adolescents, in addition to the prevalence of this disorder among the Italian population between the ages of 6 to 18, which has turned out to be slightly higher than 1% (considerably lower than estimated figures in other countries).
Can the Commission say:
— Whether it is aware of these facts and whether it would not be appropriate to export the Italian model to other EU countries;
— Whether it thinks that the extension of this register to other diseases, such as depression, might help to reduce the number of prescriptions and whether it knows of any similar experiences in other Member States;
— Whether there are any activities under way to monitor the worrying increase in the use of antidepressants in children and teenagers, as already highlighted in a study published in March 2016 by the European Journal of Neuropsychopharmacology?
In its report on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015, (Ayala Sender report, A8-0084/2017, paragraph 33), the European Parliament:
‘notes with concern that the Agency’s rental contract until 2039 (author’s note: in the UK) does not include an early termination clause… and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347,6 million.’
The Amsterdam region is an official candidate for the location of the EMA. The EMA is currently still based in London but will have to move from there because the UK is leaving the EU. Incidentally, the UK itself does not want the EMA to leave the country. The British Secretary of State for Exiting the European Union, David Davis, recently suggested that the Medicines Agency and the European Banking Authority might remain in London after Brexit. However, Brussels has ruled this out.
1. How many more rental contracts of this kind, without early termination clauses, are there? Please provide an overview.
2. Who is ultimately responsible for bearing these costs, and has the Commission taken account of the possible departure of other Member States in future?
3. Where or in what Treaty is it stated that an EU agency must be established in an EU Member State and that it is not possible for it to be located outside the EU?
The Commission continues to monitor the developments with respect to competition aspects surrounding the off-label use of Avastin for treatment of the age-related macular degeneration (AMD). It also remains in close contact with other National Competition Authorities that are looking into the issue, notably in the context of the regular meetings of the European Competition Network’s Pharma and Health Services Subgroup where confidential investigative work by the various competition authorities is discussed.
In addition, the Commission has lodged its observations on a preliminary ruling case before the European Court of Justice prompted by a reference from the Italian State Council in the litigation between Hoffman-La Roche and Novartis against the Italian competition authority’s decision of 27 February 2014.
However, as indicated in the Commission’s answer to written question P-002767/2014, the off-label use of pharmaceuticals is also factually and legally closely related to the respective national regulatory framework that deals with the question on how medication is ultimately used. In this respect, the Commission refers to the decision of 24 February 2017 by the highest French administrative court to uphold a policy allowing the off-label use of Avastin for treatment of AMD
According to the WHO, a counterfeit medicine is ‘a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source’. Experts estimate that 10% of medicines in the world are counterfeits.
Counterfeit medicines are a danger to individual health and public health: they contribute to an increase in infection rates, deprive not only inventors and manufacturers but also governments of financial revenue, and are therefore an obstacle to further research.
1. What steps will the Commission take to tackle that trade more effectively?
2. Is the Commission considering launching a communication campaign in order to tackle the counterfeiting of medicines and reveal the dangers of that trade?
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.
It is argued that an SPC manufacturing waiver allowing industries to produce generic and biosimilar medicines in Europe for the purpose of exporting them to countries without SPC or where it has expired earlier, would have a huge impact in terms of new investments in R&D and manufacturing, employment and economic growth within the EU.
Is the Commission aware of studies showing that the export of generic and biosimilar medicines to unprotected markets during the SPC period would stimulate investments in Europe and help increase access to high quality medicines?
Can the Commission provide evidence that either supports or does not support the purported significant positive impact generated by the introduction of an SPC manufacturing waiver?
Parliament has pushed for such a waiver on a number of occasions. In light of the new economic and social data emerging on the issue, is the Commission reconsidering its stance on the introduction of an SPC manufacturing waiver for export and does it plan to take action on this issue?
Measures regulating the prices of medicines as well as the organisation of the health systems and the delivery of care are Member States’ responsibility.
However, the Commission encourages Member States to cooperate in this area to ensure access to medicines, promote the rational use of medicines and improve the sustainability of pharmaceutical expenditure, in line with the Commission Communication on effective, accessible and resilient health systems.
The Council recently called upon the Member States to implement measures with a view to ‘strengthening the cost-effective use, availability, accessibility and affordability of medicines by implementing policies such as promoting public procurement and the role of generics and biosimilars, appropriate price-control policies and a rational use of medicines’.
To support Member States in their efforts to ensure the sustainability of their healthcare budgets, the Commission recently conducted a public consultation for an initiative to strengthen EU cooperation on health technology assessment.
In the EU, most medicine shortages are dealt with at national level. However, the European Medicines Agency can be involved in certain situations, for example when a medicine shortage is linked to a safety concern or affects several Member States.
Measures regulating prices of medicines as well as organisation of health systems and delivery of care are Member States’ responsibility.
Despite its limited competences, the Commission is promoting improved exchange of information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis; in particular through tools such as a European medicine price database (Euripid). It also facilitates the exchange of best practices and knowledge among Member States through the Network of competent authorities responsible for pricing and reimbursement.
To support Member States in their efforts to ensure sustainability of their healthcare budgets, the Commission has recently conducted a public consultation for an initiative to strengthen EU cooperation on health technology assessment.
The Council recently called upon the Member States to implement measures with a view to ‘strengthening the cost-effective use, availability, accessibility and affordability of medicines by implementing policies such as promoting public procurement and the role of generics and biosimilars, appropriate price-control policies and rational use of medicines’.
The Commission has, within the European Competition Network, supported national competition authorities when they fined companies for having abused their dominant position by means of excessive prices for medicines that lost their market exclusivity.
Greek pharmacies are facing a severe problem as, on top of the current shortage of medicines, they are also having to manage delays in the settling of overdue debts owed by the Greek National Health Service Organisation (EOPPY). As a matter of fact, the overdue debts date back to 2013. Given that Directive 2011/62/EU requires all EU Member States, to have adequate supplies of medicines, can the Commission say:
1. As they are endangering the viability of the sector and the adequacy of medicines in the Greek market, how will overdue debts to these pharmacies be addressed?
2. For the Pharmaceutical Association of Thessaloniki alone, the overdue debt is for insurance fund prescriptions and stands at EUR 2 348 655.38. How can the debt be dealt with?
3. How will pharmacy liquidity be ensured as the delay in consolidating the health sector of the insurance funds drags on and on?
According to Commission statistics, by 2025 more than 20% of Europeans will be aged 65 or older, with a clear increase in the proportion aged over 80. Efforts by the EU to help Europeans age in good health are therefore welcome.
And yet, in several Member States, overconsumption of medicine by senior citizens, especially those who live in nursing homes, has become a real health problem. For example, in Belgium, 30% of patients over 75 take at least five medicines on an ongoing basis, 43% take anti-depressants and 20% are hospitalised because of negative reactions to a medication.
1. What will the Commission do to guide public health towards the reasonable use of medicine, in particular by elderly people?
2. Can the objective set by the European Innovation Partnership on Active and Healthy Ageing to increase the average healthy lifespan in the EU by two years by 2020 still be achieved?
The Ministry of Health has proposed new measures as regards the approval of compensation for innovative medicines which would introduce new inclusion criteria for formulations included in the positive list that are compensated by the National Organisation for Healthcare Provision (EOPYY). Under the measures, compensation for a new pharmaceutical formulation would require the formulation to have been assessed and compensated at the same time in six European countries (England, Italy, Spain, Sweden, Portugal and France) through the Medical Technology Assessment (MTA) system.
Since a new medicine needs about two years to be compensated in Greece and, under the new measures, the introduction of innovation is expected to be delayed considerably further:
How will the MTA criterion be introduced in a way that avoids delays?
A medicine is rated as positive when its use is fully recommended or is recommended with limitations – whether financial or clinical – and, moreover, a particular technology may receive completely opposing recommendations from different MTA agencies, resulting in it being fully accepted in one environment, accepted with restrictions in another and rejected in a third. Given the above, how will the criterion of ‘positive decision’ apply?
Since a number of rare or serious diseases rely on innovative treatments, how will the quick and timely circulation of innovative medicines in the Greek market be ensured by applying the above criterion and without delays caused by procedural issues?
The Commission is fully aware of the recent resolution of the European Parliament on the Paediatric Medicines Regulation. When the resolution was discussed at the December 2016 plenary meeting of the European Parliament the Commission welcomed the debate, as it confirms the shared interest of both Institutions to secure the best outcomes for children.
The Commission is currently working on a second report to the European Parliament and Council on the Paediatric Regulation, which will be delivered in 2017. For this, a public consultation was conducted which has recently been closed in February 2017.
The Commission will provide the European Parliament with more detailed comments on the Resolution in due course and as per usual procedure.
Greek authorities can finance the provision of medicines and vaccines for refugees through their Asylum, Migration and Integration Fund (AMIF) and Internal Security Fund (ISF) national programmes. Their implementation is the responsibility of the competent Greek authorities, in accordance with the principle of shared management. The Commission is actively supporting the Greek authorities in their efforts to ensure an effective and efficient use of their allocation under these funds.
Substantial Emergency Assistance from both funds has also been awarded directly to Greek authorities, including the Ministry of Health (MoH). The use of emergency assistance is monitored by the Commission through reports, on-the-spot visits, and notably when assessing the final report of the action.
Healthcare activities have also been supported through the Emergency Support Instrument (ESI). Three humanitarian organisations are funded to provide basic health care, psycho-social support and referrals to hospitals to the migrant populations, including on Lesvos, for a total of EUR 15 million. These partners and other health actors have their own, facility based, pharmacies to provide drugs – purchased at Greek pharmacies/wholesalers or imported – to the migrants. While vaccines are largely provided by the MoH, the International Federation of Red Cross (IFRC), with ESI funding, has also supported the MoH in purchasing the vaccines when needed.
As concerns shortages of medecines in Greece, the Commission has limited competence to deal with specific situations in Member States as regards health policy, health care and the organisation of health services. However, the Commission supports Member States in the EU Health Security Committee with guidance on vaccination against a range of vaccine-preventable diseases, facilitating mutual assistance among Member States in case of shortages.
Following the Water Framework Directive, some progress has been noted in the way in which Member States are monitoring and reporting on the proportions of certain substances in water, e.g. phosphorus and nitrogen. A more recent problem, however, is the release of pharmaceutical waste residues into freshwater. The impact of pharmaceutical waste on health and the aquatic environment has not yet been fully investigated, and there is insufficient information on its concentration in European waters and sediment. Widely used drugs, such as analgesics, hormone medicines and antibiotics, have an adverse effect on aquatic life and thus ultimately on entire ecosystems.
Is the Commission planning to take specific measures to prevent the release of pharmaceutical waste into freshwater, as well as more concrete measures to monitor its concentration and quantify it at EU level? If so, how does it plan to implement these measures?
On 20 March 2017, the Dutch public broadcaster Nederlandse Omroep Stichting (NOS) devoted an item to the recent rises in the prices of existing medicines on the medicines market. Pharmacists in the Netherlands are warning about what they call ‘hijacked medicines’. Pharmaceutical companies take over production of existing medicines and then place them on the market at a far higher price. These are medicines which have been in existence for a long time, which are no longer under patent, but which are still in use. Examples include the laxative Norgalax, as well as Slow-K, which is a remedy for a lack of potassium. The price rises are worrying patients, because they have to pay the price difference. It is not prohibited to raise the prices of medicines. The pharmaceutical industry says that this is how the market works, while insurers only reimburse patients at the original price level. This means that patients have to foot the bill for the difference.
Is the Commission aware of such rises in prices of existing medicines on the medicines market?
Does the Commission consider this to constitute fair and honest functioning of the market?
Are such ‘hijacked medicines’ to be found all over Europe, and does the Commission see any way of combating these exorbitant price rises, together with the USA?
20% of the EU population is under the age of 18. The off-label use of drugs in children and adolescents is extremely widespread, as 50-90% of drugs have no paediatric indications because no studies have been carried out on that age group.
New EU legislation (Regulation No 1902/2006) was introduced with the aim of improving children’s health by enhancing the quality of research and the protection of ethical safeguards.
Since the Paediatric Medicines Regulation came into force, only two innovative targeted anti-cancer drugs have been authorised for a paediatric malignancy based on an agreed paediatric investigation plan (PIP).
That said, what action is the Commission taking to submit, in due course, the report referred to in Article 50 of the Paediatric Medicines Regulation and to remove the current obstacles to innovation in the paediatric medicines sector?
How does it intend to renew, in Horizon 2020, the funding provisions developed to support high-quality paediatric clinical research, following a critical review of the projects currently being funded?
The Commission is aware that an application for an orphan medicinal product containing eteplirsen (Exondys 51) was submitted to the European Medicines Agency in December 2016. The application is currently under the assessment of the Committee for Human Medicinal Product (CHMP), which has 210 days after the validation of the application to adopt an opinion, if no further questions are submitted to the applicant.
If the opinion of the CHMP concludes positively on the benefit/risk assessment of eteplirsen for the treatment of Duchenne’s Syndrome and the Committee for Orphan Medicinal Products confirms the compliance with the orphan designation criteria in line with Regulation (EC) No 141/2000, the final decision on the authorisation is taken by the Commission.
The Commission is holding regular review missions in Greece and, within the boundaries of its competences, intends to continue to raise concerns related to public health. According to the Greek health authorities, efforts are being made to provide the necessary drugs to those hospitals which provide medication to vulnerable groups.
As stated in the Commission’s reply to E-001016/2016, the EU is providing financial support to health-related actions proposed by Greece according to its national priorities through the European Structural and Investment Funds. In addition, the Structural Reform Support Services is helping with facilitating expertise in collaboration with the World Health Organization.
As the Commission pointed out in its answer to the written question E-009252/2016 raised by the Honourable Member, the Commission has limited competence to deal with specific situations in the Member States as regards health policy, health care and the organisation of health services.
Following on from previous questions on the use of diclofenac for veterinary purposes in the EU (E-009337-14 and E-003922-15), and given the recent warnings from Portuguese environmental NGOs on the threats to highly endangered vultures and large carrion-eating eagles (a species protected by national and EU legislation) and to their ecosystems, I should like some further information from the Commission on the developments to date. In particular:
1. What is the state of play with the risk-reduction steps recommended by the European Medicines Agency (Committee for Medicinal Products for Veterinary Use) in the Member States and with related action plans?
2. What evaluation has been conducted to date to gauge the suitability of each Member State’s legislation on populations of carrion-eating birds in its territory?
3. What is the state of play on the possibility of banning diclofenac for veterinary use and replacing it with the safe alternatives available, such as meloxicam?
The Commission has made clear from the start that changes to the EU’s laws on intellectual property rights for pharmaceuticals, or to pricing and reimbursement regulations, are not part of the EU’s objectives in the Transatlantic Trade and Investment Partnership (TTIP) negotiations. The EU already has a solid and comprehensive intellectual property rights system that allows innovators to thrive and to remain among the most competitive globally. So the Commission believes there is no cause for concern in relation to TTIP. For the same reasons, the Commission is not considering any new regulations related to drug pricing.
At the same time, EU Member States have some of the most efficient and inclusive public health systems in the world. Nothing in TTIP will endanger Member States’ rights to manage their health systems as they see fit. If any do choose to allow American companies to enter their public health services markets (as indeed some already do), these companies will be subject to the same regulation as any other that operates in the market. So the Commission believes there is no cause for concern on this matter either.
The Commission shares the concerns of the Honorable Member and agrees on the importance of adopting an overall policy to reduce antimicrobial resistance (AMR). AMR is a serious threat to human and animal health and there is a clear need to adopt a trans-national “one health” approach. This is why the Commission is now proposing for all new bilateral trade agreements a specific provision to increase cooperation and commitment of EU trade partners to reduce the use of antibiotics in animal production. The aim is also to foster cooperation for the development and the implementation of international guidelines, standards, recommendations and actions aiming to promote the prudent and responsible use of antibiotics.
Products of animal origin entering into the EU are checked by the veterinary services of the EU Member States at the EU border inspection posts with the aim to ensure the respect of European food safety standards and to prevent health risks for European consumers. Physical and laboratory checks are routinely carried out and the frequency of controls may be raised when there is suspicion of unsafe food. Decision 2002/994/EC concerning certain protective measures with regard to the products of animal origin imported from China also obliges Chinese authorities to provide additional sanitary guarantees, in relation to the presence of residues from medicinal products, when exporting fishery products to the EU.
The Commission intends to come forward with the strategic approach around the end of 2017.
A roadmap for the initiative should be published shortly. A study to support the development of the strategic approach is underway and will include a public consultation. The study is considering the relation between the whole lifecycle of pharmaceuticals and their presence in the environment.
On 9 April 2015, the Polish Parliament passed an act amending and supplementing the Pharmaceutical Act. The act was published in the Polish Official Journal on 11 June and entered into force on 12 July 2015 . Under this law, 187 products are banned from export, thereby affecting intra-EU trade. Article 35 of the Treaty on the Functioning of the European Union prohibits Member States from applying quantitative restrictions on exports and measures having equivalent effect.
Is the Commission aware of these measures related to the export to other Member States of medicinal products for human use?
Does it intend to launch an infringement procedure in the form of a reasoned opinion?
What is the difference between this and similar cases in Slovakia and Portugal?
It is the Commission’s task in general to monitor economic sectors, including the pharmaceutical sector, for anti-competitive practices. In line with this task, possible abuses of a dominant position by an undertaking in the pharmaceuticals sector fall within the Commission’s remit to intervene under Article 102 of the Treaty on the Functioning of the European Union (TFEU).
In particular, the Commission has been cooperating closely with national competition authorities regarding various recent national investigations into excessive prices for medicines. In this regard, the Commission has supported the decision recently taken by the Italian competition authority against Aspen Pharma.
However, any possible investigation by the Commission would necessarily have to be done on a case-by-case basis considering all relevant facts and circumstances. In addition, consideration would have to be given to the fact that pricing and reimbursement in the pharmaceutical sector are highly regulated by Member States. Moreover, public spending accounts for most of the expenditures on medicinal products in the Union. Such prima facie elements nuance the merits of a possible investigation by the Commission into the matters referred to by the Honourable Members.
1. Biomedical research requires heavy investment and long-term research, coupled with expensive clinical trials and demanding regulatory approval and post-approval procedures. Intellectual Property Rights (IPRs) provide an important incentive for pharmaceutical and biomedical research. The Commission seeks to strike the right balance between the need to promote and finance the research and development of innovative medicines through IPR protection, and to ensure that medicines are accessible to those in need and health systems remain sustainable.
Any amendment of the pharmaceutical IPR framework would need to be justified by an evidence-based analysis. As requested by the Council, the Commission will carry out, as soon as possible, and with the close involvement of the Member States, an evidence-based analysis of the impact of pharmaceutical incentives and rewards (including IPRs) on innovation, availability and accessibility of medicinal products in the EU. The timetable and methodology that the Commission intends to apply was presented at the EPSCO Council on 8 December 2016.
2. Information on funding for projects supported through Horizon 2020 is fully transparent. Beyond the costs for the projects to be implemented under an EU research grant, Horizon 2020 does not provide for the obligation of beneficiaries to disclose costs not related to the implementation of such grants.
The Commission is currently preparing a roadmap for the strategic approach to water pollution by pharmaceuticals.
The Commission report concerning chemical mixtures is expected in the second quarter of 2017.
Regarding the Cosmetics Review on endocrine disruptors, the Commission is currently preparing a report on the current regulatory framework with regard to the management of endocrine disruptors in cosmetics.
The review of the REACH legislation as regards authorisation of substances having endocrine disrupting properties has been finalised and it was published as a Commission Communication on 20 December 2016.
1. Actions that will be developed under the future EU Action Plan against antimicrobial resistance (AMR) will be co-financed under a variety of EU funding programmes managed by the Commission, such as Horizon 2020, the Innovative Medicines Initiative and the Common Financial Framework for the Food Chain and the Health Programme.
2. The evaluation of the 2011-2016 Commission Action Plan against AMR has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and created a framework to guide and coordinate activities on AMR at national and global levels. This includes actions to strengthen the promotion of appropriate use of antimicrobials in both human and veterinary medicine for example through the development of guidelines, training, exchange of good practices and research.
3. In 2017, the Commission will allocate EUR 1.7 million of the Common Financial Framework for the Food Chain to Member States for the monitoring of AMR in zoonotic bacteria in food and farmed animals. Some Member States and regions also intend to use European Regional Development Fund allocations for health related investments, mainly for research and innovation, SME competitiveness, e-health and health infrastructures.
Regarding shortages of medicines the Commission promotes improved exchange of information and best practices among Member States. The Member States are also responsible for enforcing the legislation on medicinal products which introduces an obligation of continuous supply on manufacturers and wholesale distributors to cover the needs of patients (Article 81 of Directive 2001/83/EC). The rules on retail are established by the Member States. These rules are necessary to ensure the proper distribution of medicines and protect public health and the Commission does not intend to take any action which is not under its competence.
It is important to underline that the modalities of the supply of medicinal products to the public at retail level fall under national competence. It is also up to the Member States to implement the conditions under which the nationally established retailers are authorised to sell medicinal products on line, in accordance with the Falsified Medicines Directive 2011/62/EC in order to protect public health.
The Commission does not intend to take any further action at this stage to change the authorisation process. The requirements for the granting of a marketing authorisation for medicinal products for human use are already harmonised at EU level. Medicinal products may be either authorised by the Commission or by national authorities.
As part of the third memorandum and on the basis of the OECD Toolkit, the Commission and the Greek government are jointly escalating the deregulation of the market in pharmaceutical products on the grounds that this will liberate entrepreneurial activity.
They have decided to grant pharmacy licences to non-pharmacists, thereby putting business interests even before public health. Business groups will henceforth be able to create commercial chains of pharmacies and monopolise the market, at the expense of small self-employed pharmacists who have been affected by a series of other measures such as the deregulation of pharmacy opening hours, the possibility of granting multiple licences to pharmacists and non-pharmacists, the possibility for supermarkets to sell non-prescription drugs, hikes in taxation, etc.
The prices of pharmaceutical products which are already high will soar with further monopolisation, and this will force thousands of patients to discontinue their treatment. At the same time, the sole criterion governing the prices, quality and appropriateness of medicines will be whether they generate profits for those who trade in health and pharmaceutical products rather than public health.
In view of the above, will the Commission say where it stands on the following questions:
– the fact that the granting of pharmacy licences to non-pharmacists will lead to hundreds of self-employed pharmacists being thrown out of work;
– the fact that the monopolisation of the market in the interests of business profits will pose a risk to public health?
According to Article 50 TEU, a Member State may decide to withdraw from the Union in accordance with its own constitutional requirements, and in that case shall notify the European Council of its intention. The European Council has not received such notification from the United Kingdom. The relocation of agencies currently located in the United Kingdom has not been discussed.
According to Article 168, paragraph 7 of the Treaty on the Functioning of the European Union (TFEU), Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. Hence, it is foremost for Member States to decide on how to ensure access to healthcare for their populations.
The Commission supports the intention of the Greek Ministry of Health to enhance the cost-efficiency and effectiveness of the Greek National Health System as well as the quality and accessibility of public health care in order to fully meet the health needs of the population but also to ensure sustainability. To this end, the Commission supports the authorities’ commitment to continue reforming the health care sector, including by rationalising pharmaceutical expenditure making use of the negotiating committee to develop price volume and/or risk sharing agreements, by setting up a Health Technology Assessment (HTA) centre to evaluate which products to reimburse and by managing demand for pharmaceuticals and health care through evidence-based e-prescription protocols.
In addition, through the Memorandum of Understanding the Greek authorities committed to implement structural measures focusing on improving efficiency of the health system as a means to contain expenditure to ensure the spending on pharmaceuticals, but also diagnostics and private clinics, for 2017, is reduced by at least 30 percent compared to the previous year.
The Commission will continue to monitor the implementation of the structural measures agreed in the framework of the Stability Support Programme supported by financial assistance by the European Stability Mechanism (ESM).
With regard to the specific case mentioned by the Honourable Member, it should be noted that as provided by EU legislation relating to medicinal products for human use, the Commission relies, for its decision-making process, on the scientific assessment performed by the scientific committees of the European Medicines Agency (EMA), in particular the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) in the case of the human papillomavirus (HPV) vaccines review.
The PRAC was responsible for the initial assessment. In reaching its recommendations, it also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups. The findings of the PRAC were passed on to the CHMP, which did not recommend any changes to the terms of marketing authorisation or the product information for these medicines.
The Commission is confident that the EMA and its Committees have access to the necessary expertise to be able to review the available evidence and provide robust advice regarding the safety of medicinal products.
The recommendations of the UN High Level Panel on Access to Medicines (HLP) elicited a very critical response from the EU on 14 December 2016 in the World Intellectual Property Organisation (WIPO), which stated that ‘The work conducted by the Panel started from an assumption that “there was a policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health”’. The Commission indicated in its written contribution to the Panel that it does not share this assumption.
The strong support for the HLP recommendations expressed by the European Parliament Working Group on Access to Medicines and Poverty-Related Diseases stands in stark contrast with the official EU position, calling on the EU to ‘acknowledge the usefulness of the recommendations and start a process to facilitate the implementation in order to ensure both innovation and affordable and suitable access to the needed innovative medical tools, in Europe and beyond.’
1. Could the Commission clarify at which juncture the delegation representing the Council, the European External Action Service (EEAS) and the Commission consulted with the European Parliament on the position expressed regarding the report of the UN High Level Panel on Access to Medicines?
2. Could the Commission explain how the delegation representing the Council, the EEAS and the Commission will ensure that the position adopted by the EU’s representatives at WIPO on 14 December 2016 takes into account the legitimate democratic interests and institutional viewpoints of Parliament?
3. Could the Commission explain the democratic, accountable and transparent process on the basis of which the EU’s position on the UN HLP report was formulated?
US supervisory authorities are currently investigating the activity of Novartis between 2006 and 2014 for illegal practices, including: bribery, corruption, market leverage, and money laundering through surrogates/offshore companies. The corporation has been accused repeatedly and in a number of countries around the world of such practices and has paid huge fines.
One of the primary countries in the investigation is Greece, where expenses for pharmaceutical products shot up from EUR 2.4 billion in 2004 to EUR 5.09 billion in 2009 and currently amount to approximately EUR 6 billion. American authorities have already investigated Novartis executives who are Greek nationals.
It has been revealed that for promotion purposes, Novartis bribed thousands of doctors and state officials with cash/vouchers, trips/conferences, overprescribed drugs to public insurance organisations, overpriced drugs in Europe (Greece is the reference country in determining prices of drugs at EU level, as one of the three cheapest countries in the EU) and recklessly promoted more expensive drugs and vaccines.
1. Is the Commission aware of any EU or international convictions on or current investigations into Novartis illegal practices? If so, which is it aware of?
2. Behind the revelations could lie crimes against insurance organisations, Member States and possibly the EU budget. Is the Commission investigating the reports? What means does the Commission have and what action is it taking to protect Member States against such practices?
Current Union legislation requires Member States to organise the collection of unused medicines, but this can be by way of general municipal waste collection. There is no provision in the pharmaceutical or waste management legislation for a system which keeps track of expired medicines in private households or pharmacies in the Member States.
However, the Guidelines on Good Distribution Practice of medicines impose an obligation on wholesale distributors to segregate and store expired products in a dedicated area away from other medicinal products. In addition, medicinal products that are nearing their expiry date are to be withdrawn immediately from saleable stock.
The Commission is also working with the Member States to ensure the smooth implementation of safety features (a unique identifier and an anti-tampering device) which will allow expired products which are subject to prescription to be detected in the supply chain at the time of dispensing them to the public. The safety features have to be applied from the year 2019.
Publicly funded health services are already clearly excluded from EU trade agreements. In the Joint Statement on Public services of Commissioner Malmström and Ambassador Froman of 20 March 2015 (http://europa.eu/rapid/press-release_STATEMENT-15-4646_en.htm) it was clearly stated that this approach will be followed also in the Transatlantic Trade and Investment Partnership. The EU proposal for an Annex on medicinal products has been published on the website of the Commission and provides an indication of what areas regulatory cooperation in the pharmaceuticals sector would aim at. This proposed Annex in its Article 1(4) also contains an explicit exclusion of setting of prices for medicinal products by the relevant authorities from its scope.
The Commission considers that antimicrobial resistance (AMR) is a major global challenge with serious implications for the economy and human health and agrees that a stronger push to innovation and research for the development of new drugs, rapid diagnostic tests and alternatives to antimicrobials is needed.
The evaluation of the current Action Plan against AMR adopted in 2011, has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and a framework to guide and coordinate activities on AMR at national and global levels and boosted research and innovation via a range of funding initiatives including the establishment of the ND4BB programme within the Innovative Medicines Initiative.
However, this evaluation has also demonstrated that the AMR problem is persisting and continued action is needed to address it. Therefore, the Commission will prepare a new AMR Action plan in 2017 for broader actions aimed at tackling AMR at EU and global level.
Measures to increase citizens’ awareness and sense of responsibility with regard to the use of antibiotics will be included in this new Plan, as well as measures promoting good practice for the control of hospital infections and supporting research into rapid tests. In February 2017, the Commission will award a prize for the development of such a rapid test.
Access to medicines is an important issue for the Commission. The Commission is promoting improved exchange of information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis; in particular through existing tools such as a European medicine price database (Euripid).
The Commission also facilitates the exchange of best practices, knowledge and information among Member States through the Network of Competent Authorities for Pricing and Reimbursement (CAPR) and through a structured multi-stakeholder dialogue.
The Commission works with the European Medicines Agency and the Member States to optimise the use of current regulatory mechanisms for early access to innovative medicines and to explore further possibilities to strengthen dialogue and cooperation between regulators, Health Technology Assessments (HTA) bodies and payers at EU level.
On national measures regulating prices and reimbursement, the Commission monitors the implementation of the Transparency Directive 89/105/EEC, which lays down procedural rules (e.g. time limits, motivation and judicial appeal).
A recent report calls on EU Member States to exploit possible policies to improve the access to affordable medicines, including by increasing the uptake of generics and biosimilars, when they are cheaper options.
In September 2016, the Commission published an inception impact assessment on strengthening EU coordination in the area of HTA. A public consultation is open until mid-January 2017.
The Honourable Member refers to the ongoing infringement proceedings regarding the Slovak Act on Medicinal Products and its non-conformity with the Treaty rules on free movement of goods.
To the Commission’s knowledge, the Slovak Parliament has recently adopted amendments to the Slovak law, as referred to by the Honourable Member.
The Commission continues its examination of the provisions of the Slovak law and their conformity with the rules on free movement of goods in particular.
Article 81 of Directive 2001/83/EC sets out the general obligation for the holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State, within the limits of their responsibilities, to ensure appropriate and continuous supplies of that medicinal product to pharmacies to cover the needs of patients. It clarifies that the arrangements for its implementation should be in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.
The European Parliament,
– having regard to Article 168 of the Treaty on the Functioning of the European Union,
– having regard to Rule 133 of its Rules of Procedure,
A. whereas, on 26 May 2015, a study on the latest generation of contraceptives led by researchers from the University of Nottingham showed that third- and fourth-generation contraceptive pills lead to an increased risk of thrombosis (a risk 1.5 to 1.8 times higher than that of previous pills);
B. whereas, according to a Danish study (2011) as well as a study by the French health insurance department, taking said pills could double the risk of pulmonary embolism;
C. whereas these findings show that frequent exposure to the substances contained in combined oral contraceptives carries ‘significantly higher risks’ than those in second- and third-generation pills;
D. whereas oral contraception concerns 18% of women in developed countries;
1. Notes the research already carried out, in particular by the European Medicines Agency, on third- and fourth-generation pills;
2. Encourages the Commission to issue advisory guidelines and raise awareness among European women of the risks of using third- and fourth-generation contraceptive pills.
The European Parliament,
– having regard to Article 168 of the Treaty on the Functioning of the European Union,
– having regard to Rule 133 of its Rules of Procedure,
A. whereas proton pump inhibitors (‘inhibitors’) are among the medicines most prescribed for gastroesophageal reflux worldwide;
B. whereas a team of researchers at the University of Stanford in the USA has studied the impact of inhibitors on human health and demonstrated a probable causal link with increased risk of myocardial infarction in the general population (10 June 2015);
C. whereas, according to the same study, H2 blockers are an alternative solution, as they are not associated with increased cardiovascular risk;
1. Encourages the Commission to issue advisory guidelines on H2 blockers, and encourages Member States to review their national legislation on inhibitors.
Patient access to medicines is an important issue for the Commission. The Commission promotes improved exchange of information among Member States on their pricing policies to minimise negative effects on access to medicines and strengthening Member State cooperation on a voluntary basis.
Equally important, the legality of parallel trade – whereby medicinal products are exported to other Member States which pay higher prices, is confirmed by the jurisprudence of the European Court of Justice. Nevertheless, during an informal ministerial meeting of Health Ministers held by the Slovak Presidency of the Council, Member States exchanged views, on shortages of medicines. In this context, “parallel trade” was identified by some Member States as one of the reasons for human medicines shortages and unavailability in those Member States. Member States may, therefore, adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions.
The European Union (EU) provides support for research and innovation through its Framework Programmes for research and innovation, currently Horizon 2020 (2014-2020).
Under previous Framework Programmes and the current one, the Commission has supported and continues to support – logistically and financially – veterinary research such as research on microbial diseases, their epizootic spreading, and/or their prevention via the development of tools and programmes as well as through research on reproduction, fertility, physiological conditions, networks for veterinary training, improved animal nutrition, etc. Among them, ERA-NETs have been and will be funded, in which participating Member States are fully engaged in the decision-making process. The supported research involves a large number of field veterinarians and/or researchers in Member States.
In Horizon 2020, a multi-actor horizontal approach is used to bridge research and practice by involving all actors from the beginning of the research definition and design to its final application. Thus, veterinary expertise is an integral part of the large research projects aiming at animal health, welfare, production systems, disease control, etc.
There are upcoming calls for the remaining period of Horizon 2020 on topics involving substantial veterinary research. For the 2017 calls under Societal Challenge 2 of Horizon 2020 (still open), there are at least five calls requiring veterinary expertise granting up to EUR 68 million in funding. Thus, researchers and other beneficiaries from all EU countries are invited to submit applications for research grants to be evaluated through an independent evaluation process.
Supporting the reduction of health inequalities across the EU and within countries, between regions and social groups, is an overall objective of EU health policy. Any EU activities in this respect recognise the responsibility of Member States for the definition of their health policy and the organisation and delivery of health services. This is the case also for pricing of pharmaceuticals, hence the differences the Honourable Member points out.
The reduction of health inequalities is supported via initiatives with Member States under the Health Programme, in particular in the areas of chronic and rare diseases. In the case of cancer, the Commission supports in cooperation with stakeholders prevention, early identification, screening and treatment such as raising hospitals’ awareness of new treatments and technologies (e.g. immunotherapies or genetic screening). The Commission also plans to launch a Joint Action with Member States on Health Inequalities and Migration.
Also, the State of Health in the EU-cycle and the report Health at a Glance: Europe 2016 aim to support Member States’ evidence-based policy making, boost analytical capacity and strengthen country-specific and EU-wide knowledge on health including on access to healthcare and health inequalities. The Report highlights inequalities in health in Europe, e.g. the fact that many people, in particular from vulnerable and disadvantaged groups, have difficulties in accessing health care due to costs. Poor Europeans are ten times more likely to report unmet medical needs for financial reasons than more affluent Europeans.
The Commission also implements health inequalities-related pilot projects to improve the health of those living in vulnerable situations.
A recent court case involving the pharmaceutical company Novartis focuses on investigating its unfair marketing practices and bribery, this time in Greece. Novartis ranks first for market capitalisation among pharmaceutical companies worldwide, and has been involved in similar cases in the US, China, Japan, South Korea and Turkey.
The Greek Novartis file was opened in the summer of 2016, when two Greek whistleblowers – Novartis executives – provided evidence to US authorities which allegedly revealed payments to doctors working both privately and in Greek hospitals.
It is obvious that such practices, including the overpricing of drugs currently under investigation, cause an excessive burden on national health systems.
1. What will the Commission do, at Member State and EU level, to investigate and prevent any such cases of corruption, unfair competition and leverage on the internal market?
2. How will the Commission protect whistleblowers and any citizens who may potentially reveal abusive and illegal corporate practices at EU level?
Access to medicines is an important issue for the Commission. The Commission promotes exchange of best practices, knowledge and information among Member States on their pricing policies to minimise negative effects on the accessibility of medicines and strengthening their cooperation on a voluntary basis.
In 2015, the Commission set up a Commission’s expert group on Safe and Timely Access of Medicines to Patients composed of experts from Member States and the European Medicines Agency to work together on optimising the use of existing regulatory tools to facilitate the development, timely assessment and authorisation of innovative medicines for patients with unmet medical needs.
The EU regulatory system provides incentives to support the development of innovative medicines, including data and market protection and intellectual property rules. A study will be carried out in 2017 to respond to the request made in recent Council conclusions to analyse the impact of the incentives for pharmaceutical products on innovation, the availability and accessibility of medicinal products.
In September 2016, the Commission published an inception impact assessment on strengthening EU coordination in the area of Health Technology Assessments (HTA). A public consultation is currently ongoing until mid-January 2017.
1. The evidence for this recommendation is based on scientific literature, expert discussions in different fora and recommendations given out by various national medicines evaluation boards.
2. The decisions on the interchangeability of biosimilars and innovator products rest with the Member States in the EU, and are not regulated as part of the marketing authorisation granted by the European Commission on the basis of an assessment by European Medicines Agency. The countries have the authority to introduce substitution bills. In some countries, substitution is allowed under specific conditions, such as in Cyprus, Estonia, France, Latvia, Malta, Poland, Slovenia and Slovakia. In France, a law was enacted in 2015 allowing biosimilar substitution for naïve patients, and discussions are ongoing for extending the rule for non-naïve patients. In Latvia and Slovakia, for newly diagnosed patients, the cheapest product (which generally is biosimilar) shall be provided in the pharmacy. In fact, there is no special regulation regarding biosimilars; biosimilars are evaluated by general principles applied to generics. Changes might be expected in the future; interchangeability and substitution are under discussion in some Member States (e.g.; Finland, Germany, Italy, Portugal and the Netherlands).
By common agreement, the Representatives of the Governments of the Member States, meeting at Head of State and Government level, decided in 1993 to locate the European Medicines Agency in London, UK.
Until the Treaties cease to apply to a Member State that has notified, in accordance with Article 50 TEU, the European Council of its intention to withdraw from the Union, that State remains a member of the Union with all rights and obligations of a Member State.
The Commission is not in a position to take any action in relation to the matter raised by the Honourable Member. The definition of health policy and the organisation and delivery of health service and medical care are the responsibility of the Member States, as well as the management of health insurance and the allocation of resources assigned for this purpose according to Article 168 of the Treaty on the Functioning of the European Union.
The Commission supports Member States in improving health system’s performance towards more effective, available and resilient health systems.
Giovanni La Via moved the question.
Vytenis Povilas Andriukaitis (Member of the Commission) answered the question.
The following spoke: Françoise Grossetête, on behalf of the PPE Group, Elena Gentile, on behalf of the S&D Group, Stefan Eck, on behalf of the GUE/NGL Group, Piernicola Pedicini, on behalf of the EFDD Group, Miroslav Mikolášik, Soledad Cabezón Ruiz, John Stuart Agnew, Michaela Šojdrová and Claude Rolin.
The following spoke under the catch-the-eye procedure: Notis Marias and Nicola Caputo.
The following spoke: Vytenis Povilas Andriukaitis.
Motion for a resolution to wind up the debate tabled under Rule 128(5):
— Giovanni La Via, Françoise Grossetête, Elena Gentile, Bolesław G. Piecha, Frédérique Ries, Stefan Eck and Joëlle Mélin, on behalf of the ENVI Committee, on the regulation on paediatric medicines (2016/2902(RSP)) (B8-1340/2016).
The debate closed.
The Falsified Medicines Directive (FMD) introduces stricter rules to improve the traceability of medicinal products to ensure that medicines are safe and that the trade in medicines is rigorously controlled. Nevertheless, it needs to be highlighted that the directive primarily aims at addressing the problem of falsified medicines in the legal supply chain and may indirectly help to tackle the infringement of intellectual property rights (i.e. the problem of counterfeit medicines). The new measures include:
— Obligatory safety features on the outer packaging of the medicines, to be detailed via a delegated act;
— A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
— Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients;
— Strengthened record-keeping requirements for wholesale distributors.
The Commission is working intensively with the Member States to ensure the smooth implementation of the safety features (a unique identifier and an anti-tampering device). To this end, the Commission published the Delegated Regulation on the safety features for medicines for human use on 9 February 2016. The implementation of the safety features shall be applicable as of February 2019 and will ensure a performant traceability of the medicinal products.
The Commission is aware of the concerns raised by the Honourable Member regarding the situation described. This is why within the REFIT evaluation currently undertaken on the Health Claims Regulation, and in particular with regard to the health claims made on plants and their preparations and the general regulatory framework for their use in foods, the Commission will be also looking at the potential impacts of the Regulation on the trade of herbal medicinal products bearing therapeutic indications.
The Commission is also aware of the potential effects on small and medium enterprises (SMEs) operating in both the food and the medicinal sector. Hence, in the context of the above-mentioned evaluation, an additional consultation, specifically targeting SMEs, aims at providing further evidence.
The issue of health claims on plants and their preparations used in food is complex, yet based on a fundamental principle: no misleading claim should be permitted on foods, regardless of the substance on which the claim is made. The health claims referred to by the Honourable Member, may only be used under the transitional measures provided for in Article 28(5) of the Claims Regulation under the responsibility of food business operators and provided that they comply with the general principles and conditions of the Claims Regulation and with existing national provisions applicable to them. Among these conditions is that the food, subject to the claim, has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence, in respect to the health claim made. Food business operators must be able to produce all relevant elements and data establishing compliance with this Regulation.
The Commission Communication on effective, accessible and resilient health systems points to policies and measures that Member States could use to improve and adapt their health systems. These are in line with the reform recommendations addressed to Member States in the context of the European semester and more recently, in the report prepared jointly by the Commission services and the Member States “Joint Report on Health Care and Long Term Care Systems and Fiscal Sustainability” in the EU.
To support Member States in their efforts to ensure sustainability of their healthcare budgets, the Commission published recently an inception impact assessment for an initiative to strengthen EU cooperation on health technology assessment.
The EU regulatory system provides incentives to support innovation for the development and authorisation of medicines, including data and market protection and intellectual property rules. To respond to the request made in recent Council conclusions, the Commission will analyse the impact of incentives on access to innovative medicines.
Measures regulating the prices of medicines, the organisation of the health systems and the delivery of care are Member States’ responsibility. The Commission encourages Member States to cooperate in this area and to use the results of relevant reports as mentioned above to ensure access to care and medicines and, in particular improving the sustainability of pharmaceutical expenditure by promoting policies for the cost-effective use and the affordability of medicines.
As stated in the Treaty on the Functioning of the European Union, Member States are responsible for the organisation and delivery of health services and medical care, including the availability of treatment.
As regards discrimination in the workplace, Directive 2000/78/EC prohibits discrimination on the grounds of e.g. of disability, age, sexual orientation and religion and provides for reasonable accommodation in employment for persons with disabilities. The Commission regularly monitors the effective implementation of this directive in the Member States, and when appropriate, launches infringement procedures.
The European Disability Strategy 2010-2020, as a tool for the implementation of the UN Convention on the Rights of Persons with Disabilities, recognises the right of persons with disabilities to work on an equal basis; as well as the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability.
Through the European Structural and Investment Funds, the EU supports employment and anti-discrimination. On the basis of Member States’ operational programmes, it is possible to estimate that in 2014-2020, the funds could provide around EUR 41 billion for the employment and labour market, EUR 44.4 billion for social inclusion (including anti-discrimination) and EUR 35 billion for education and training.
Antimicrobial resistance (AMR) is a major global challenge with serious implications for the economy and human health. Each year, drug resistant infections result in an estimated 25,000 patient deaths and cause EUR 1.5 billion worth of healthcare and productivity losses in the EU. The evidence suggests that these costs will increase exponentially in the absence of decisive corrective actions.
The Council conclusions, adopted in June 2016 under the Dutch Presidency, call for a reinforced EU strategy against AMR and a new and comprehensive EU Action Plan on AMR based on the One-Health approach. At global level, AMR is also high on the political agenda within G7, G20 and the United Nations (UN). The meeting on AMR held at the UN General Assembly on 21 September 2016 marked an important milestone for high-level global political commitment against AMR.
The evaluation of the current Action Plan against AMR adopted in 2011, has shown that this Plan provided the political stimulus for concrete actions within Member States, strengthened international cooperation and a framework to guide and coordinate activities on AMR at international level.
However, this evaluation published on 24 October 2016, has also shown that the AMR problem is persisting and continued action is needed to tackle it. Therefore the Commission will prepare the new AMR Action plan in the first half of 2017 in order to reinforce the One-Health approach and make the EU a ‘best-practice’ region on AMR, to give a stronger push to innovation and research for the development of rapid diagnostic tests and alternatives to antimicrobials, and to actively contribute to broader actions aimed at tackling AMR at global level.