insights: eu healthcare policy march 2013

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March 2013

SPECIAL EDITION EU HEALTHCARE POLICY DEVELOPMENTS


Brussels, 22nd March 2013

In this policy alert we provide an overview of the latest EU policy and regulatory developments in relation to healthcare. Although the organisation and delivery of healthcare is the responsibility of each EU Member State, the role of the EU is to complement and adds value to the national policies by addressing common challenges and by establishing a level-playing field in terms of market access for the industry. In its mission, the EU is assisted by ad hoc agencies such as the European Medicine Agency (EMA) and the European Food and Safety Agency (EFSA). The technical investigation and scientific opinions provided by these agencies underpin the policy orientations and decisions taken by the EU institutions, notably the European Commission, the Council and the European Parliament. The EU priorities in the 2013 health work plan include active and healthy ageing, patients' rights and safety, and effective ways to make health systems more sustainable. Key regulatory changes on the table of the EU institutions for the months ahead include a number of revisions, namely:

- the Directive for clinical trials, with parliamentary and Council work expected to last also in 2014;

- the Directives for medical devices, with a view to reach final agreement in November this year;

- the Directive for prices of medicines, with negotiations expected to last until mid-2014; - the Tobacco Products Directive, with the objective of finalising a compromise before the

next European Parliament’s elections in 2014; - the Directives on occupational health and safety, with a view to reach final agreement at

the end of this year. New legislative proposals planned in the 2013 working programme and expected in the coming months include:

- proposals for new Regulations on the production and marketing of Plant Reproductive Material, Plant Health and national and EU controls, seeking to reduce administrative burdens by introducing plant passports and quarantine measures;

- a simplified framework on Animal Health, due to replace 40 different Directives, and legislation on veterinary medicines where pro- and post- marketing authorisation will be facilitated.

I hope that you will find this overview useful for your work and remain available for any assistance you may require in relation to policy intelligence and strategy, advocacy, communication and stakeholders outreach campaigns. Leonardo Sforza Managing Director



EU healthcare agenda for 2013

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1. MEPs disagree on clinical trials ....................................................................................................3

2. New rules on medical devices and in vitro diagnostic medical devices to be adopted ..................3

3. Pricing and reimbursement of medicines: new move from the European Parliament ..................4

4. On-going discussions on the revision of the Tobacco Directive ....................................................4

5. Pharmaceuticals: new symbol identifies medicines undergoing additional monitoring ................5

6. European Commission wants to improve labelling of hazardous products ...................................5

7. Cosmetic products: full ban on animal testing enters into force ..................................................6

8. European Commission provides €144 million funding for rare diseases research .........................6



1. MEPs disagree on clinical trials The European Commission’s proposal for a new Regulation on clinical trials, which was presented on 17 July and repeals the current Directive 2001/20/EC, is currently being debated in the European Parliamentary Environment, Public Health and Food Safety (ENVI) Committee. The current Directive, which was implemented in 2004 with a view to improving research standards, protecting patients and notably enhancing the competitiveness of clinical research, has been criticised by researchers for imposing an overly heavily regulatory framework, thus increasing costs and red tape without bringing any major benefit to patients. Hence, the new Regulation aims at breathing new life into clinical research in Europe by simplifying procedures. The new rules are supposed to make it easier for drug companies and researchers to carry out cross-border clinical trials by introducing a harmonised EU submission system. The discussions in the ENVI Committee, however, have unveiled substantial disagreements among MEPs, particular when it comes to the issue of transparency in clinical trial results. NGOs have called for total transparency in clinical results, which would bring to light what laboratories are eager to hide and avoid redundant research. Pharmaceutical companies, by contrast, argue that they have to protect their commercial data and the patients’ private data. Rapporteur Glenis Willmott (S&D, UK) spoke of the need to quickly find a compromise solution. With more than 700 amendments to go over, she has only a month to find compromise amendments with the other political groups. The vote is scheduled for 24 April and, if the European Parliament wants to close this dossier by the end of its mandate in June 2014, it would be well advised not to postpone the vote. 2. New rules on medical devices and in vitro diagnostic medical devices to be

adopted Following the adoption in June 2012 of a Resolution on defective silicone gel breast implants, the European Parliament has called for the revision of the current regulatory framework related to the safety of medical technology. Hence, the European Commission presented in September 2012 two proposals replacing the existing Directives on active implantable medical devices and on in vitro medical devices. The aim of both proposals is to address inconsistencies in Member States’ interpretation of the current rules, to increase the protection of public health and safety, to remove obstacles in the internal market, to improve transparency with regard to information to patients, and to strengthen the rules on traceability. The draft Regulations also propose to strengthen the powers and obligations of assessment bodies, which authorise the placing on the market of devices qualifying for the CE label, through evaluations before and after market release, regular checks on manufacturers, including announced factory inspections and sample testing. In addition, the draft reinforces the supervision powers of these independent assessment bodies by national authorities (Member States can freely manage these bodies), while introducing controls carried out jointly by national experts and the European Commission.



On 21 March 2013, members of the European Parliamentary Environment, Public Health and Food Safety Committe had their first exchange of views on the European Commission’s proposal, before the reports drafted by the rapporteurs Dagmar Roth-Behrendt (S&D, Germany) and Peter Liese (EPP, Germany) will be presented next months. The rapporteurs agreed that the proposal will improve the safety of patients, but they also stressed the need to reinforce the aspects related to the information provided to the patient, with particular emphasis on the question of informed consent. Discussions on these draft Regulations will continue within the European Parliament and the EU Council with the view to adopt the new provisions in November this year. 3. Pricing and reimbursement of medicines: new move from the

European Parliament In February, MEPs adopted a report by Bulgarian liberal MEP Antonyia Parvanova on the medicine prices transparency Directive. Through its proposal unveiled in March 2012, the European Commission wants to address the question of medicine prices to further improve the transparency of measures regulating the prices of medicinal products and reimbursements, dating back from 1989. Key issues include shorter time limits for pricing and reimbursement, as well as faster introduction of generic drugs on the market. In this sense, the proposal aims at reducing the deadline to 120 days (60 for the decision on the price and 60 for reimbursement), while MEPs call for 180 days (90 and 90). Concerning generics, while the Commission proposed 30 days (15 and 15), parliamentarians have opted for 60 days (30 plus 30). European Commissioner for Industry, Antonio Tajani, has shared with MEPs its willingness to accept this compromise text, because strong disparities have emerged during the discussions, both in the European Parliament and in the EU Council, where Member States are concerned by by the opportunity for the European Commission to intervene in this area and by the changes that the new law would make to national price-setting systems. Tough negotiations lie ahead. 4. On-going discussions on the revision of the Tobacco Directive Around three months after the European Commission presented its proposal, debates on the revision of the 2001 Tobacco Products Directive are accelerating. At the end of March, the topic had already been discussed four times in the EU Council, with the Irish Presidency planning another nine meetings, and the European Parliament’s report, prepared by rapporteur Linda McAvan (S&D, UK), is expected at the end of this month. During an exchange of views between members of the European Parliamentary Environment, Public Health and Food Safety (ENVI) Committee on 21 March, McAvan already made clear that she fully supports the European Commission’s proposal, which introduces new and strengthened rules on tobacco products, such as large pictorial health warnings. Moreover, McAvan emphasised she is determined to defend the well-being of European citizens, instead of flinching before the arguments put forward by the tobacco industry.



On the whole, however, positions on the proposal vary widely. Some MEPs, such as Satu Hassi (Greens, Finland) and Martina Anderson (United Left, UK) are in favour of a more robust text than that proposed by the European Commission, supporting compulsory neutral packaging and a ban on all added aromas and flavourings without exceptions. Other MEPs, next to several Member States and the tobacco industry, draw attention to the proposal’s potential negative impact on the economy, expressing concerns that the new Directive could damage a multibillion Euro industry and destroy jobs at a time when the EU has to grapple with the economic crisis. Proponents of the proposal would like to see it adopted before the parliamentary elections in 2014, which means that the EU institutions are now racing against time. 5. Pharmaceuticals: new symbol identifies medicines undergoing

additional monitoring Following a Regulation adopted by the European Commission on 7 March, an inverted black triangle will soon appear on the inside leaflet of certain medicinal products on the EU market. The purpose of the symbol is to allow patients and healthcare professionals to easily identify medicinal products that are undergoing additional monitoring. The accompanying text is aimed at encouraging people to report unexpected adverse reactions through national reporting systems. The new symbol will be required to be part of pharmaceutical product labels from September 2013. The medicines that are part of this requirement are the following: all medicinal products authorised after 1 January 2011 that contain a new active substance; biological medicinal products, such as vaccines or plasma derived products, authorised after 1 January 2011; and products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions on their safe and effective use. Through the EU pharmacovigilance system, the safety of an authorised medicinal product is monitored throughout its entire lifespan to ensure that, in case of adverse reactions that present an unacceptable level of risk under normal conditions of use, it is rapidly withdrawn from the market. This system underwent a major review leading to the adoption of new legislation in 2010 to strengthen and rationalise the system for pharmaceutical product safety. The new Regulation is an Implementing Act of this legislation. 6. European Commission wants to improve labelling of hazardous

products The European Commission aims at better protecting workers from the dangers of exposure to chemical substances at their workplace. On 26 February, it presented a legislative proposal for a Directive amending five existing Directives on occupational health and safety to align them with Regulation (EC) 1272/2008 on the classification, labelling and packaging of chemicals. The new Directive would require manufacturers and suppliers of chemical substances to provide harmonised labelling information on hazard classification. Thus, users would be alerted to the presence of hazardous chemicals, the need to avoid exposure and the associated risks.



The proposal has been the subject of two rounds of consultation of employer and trade union representatives at EU level as well as debates in the Advisory Committee on Safety and Health at Work (ACSHW). It now goes to the EU Council and the European Parliament for further elaboration. 7. Cosmetic products: full ban on animal testing enters into force The European Commission decided that the final deadline of 11 March for phasing out animal testing for cosmetic products has to be observed by the cosmetics industry if they wish to market their products in the EU. Pursuant to Directive 2003/15/EC, animal testing has been prohibited since 2004 for cosmetic products and since 2009 for cosmetic ingredients (testing ban). Since 2009, this prohibition has also applied to the marketing of products that have been subject to animal testing (marketing ban). However, a derogation existed for tests related to complex human health effects, such as the toxicity of repeated doses. As of 11 March, the marketing ban is total. In a Communication published on 11 March, the European Commission informed the EU Council and the European Parliament of its decision and outlines its policy priorities in this area: ensuring a coherent implementation of the marketing ban and monitoring its impact, continuing the support for research on alternative testing methods; and making alternative testing methods an integral part of the EU’s trade agenda and international cooperation. 8. European Commission provides €144 million funding for rare

diseases research On Rare Disease Day 2013 (28 February), the European Commission announced €144 million of new funding for 26 research projects on rare diseases in order to help improve the lives of some of the 30 million Europeans suffering from them. The selected projects, which cover a broad spectrum of diseases, bring together more than 300 participants from 29 countries in Europe and beyond. The aim is to pool resources and to work beyond borders to get a better understanding or rare diseases and to find adequate treatment.



For further information please contact: Leonardo Sforza ([email protected]) Romain Seignovert ([email protected]) Klas Landelius ([email protected]) Andrea Oechsler ([email protected]) MSLGROUP – JKL Group Brussels, Avenue des Gaulois, 18 – B 1040 Bruxelles Follow us on twitter : @MSL_Brussels

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