ConseilUE Councilofthe EuropeanUnion Brussels,28October 2014 (OR.en) PUBLIC 14793/14 LIMITE PHARM81 SAN405 MI817 COMPET590 NOTE From: To: Subject: GeneralSecretariatoftheCouncil Delegations DraftCouncilconclusionsoninnovationforthebenefitofthepatients -Examinationofthetext Inviewofthemeetingof WorkingPartyonPharmaceuticalsand MedicalDeviceson3November 2014,delegationswilfindinAnnexdraftCouncilconclusionsreferedtointhesubject. 14793/14 JS/pm 1 DGB4B LIMITE EN
ANNEX Draft Council conclusions on innovation for the benefit of the patients THE COUNCIL OF THE EUROPEAN UNION 1. RECALLS that under Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities, and that Union action which is to complement national policies shall be directed towards improving public health, and also to encourage cooperation between the Member States in the field of public health and, if necessary, lend support to their action, and fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care; 2. RECALLS the Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; 3. TAKES NOTE that in order to stimulate development, there is need to facilitate the translation of scientific advances into innovative medicinal products that meet adequate regulatory standards, accelerate patients access to promising therapies and are affordable to the EU healthcare systems; 4. TAKES NOTE that the EU pharmaceutical legislation provides already regulatory tools for the earlier authorisation of medicinal products under certain circumstances, in the interest of making these medicines available to patients with unmet medical need. Such mechanisms include conditional marketing authorisation, authorisation under exceptional circumstances, accelerated scientific review and compassionate-use programs; 14793/14 JS/pm 2
5. RECOGNISES that the development of new medicinal products is costly and timeconsuming, with a high attrition rate. As a result there is active dis-investment from research and development, which makes it particularly difficult for smaller companies to bring innovative products to the market; 6. RECOGNISES that support to early development activities, and collaboration and dialogue between the key actors involved in the regulatory approval of medicinal products would promote innovation quicker access to medicines and affordable prices, to the benefit of patients; 7. RECALLS that Regulation (EC) No 1394/2007 on advanced therapy medicinal products was intended to ensure the free movement of advanced therapies, the effective operation of the internal market in the biotechnology sector, and the protection of public health; 8. TAKES NOTE of the Report from the Commission to the European Parliament and the Council in accordance with Article 25 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 1 ; 9. CONSIDERS that the regulation of advanced therapy medicinal products must be innovation-friendly, proportionate and adapted to scientific progress, while continuing to ensure a high level of public health protection; 10. RECALLS the Council Conclusions on the reflection process on modern, responsive and sustainable health systems, adopted on 10 December 2013 2, and the Council Conclusions on the economic crisis ad healthcare, adopted on 20 June 2014 3, which advocate the need for cooperation, while fully respecting areas of Member States' competence, and for sharing information in view of managing pharmaceutical expenditure, while taking equitable access to medicinal care into account. 1 2 3 7310/14 - COM(2014) 188 final OJ C 376, 21.12.2013, p.3 + Corrigendum OJ C 36, 7.2. 2014, p. 6 OJ C 2017, 14793/14 JS/pm 3
11. NOTES WITH CONCERN that patients have to wait to get access to new treatments and the prices of many new innovative medicines are very high in relation to the public health expenditure capacities of most Member States; 12. WELCOMES the proposal to hold a debate on the European pharmaceutical industry, which should involve decision-makers from public bodies in charge of industrial competitiveness, health, pricing and reimbursement, research and innovation, patients, healthcare professionals, trade unions and industry representatives. 13. TAKES NOTE that the European Union has supported HTA cooperation since the late 1990s by funding projects and Joint Actions. The EUnetHTA cooperation first focused on the development of common assessment methodologies and information tools, then entered a new phase by promoting joint assessment work where HTA bodies voluntarily produce and compile clinical evidence to inform the national decision makers; 14. RECALLS that European cooperation on Health Technology Assessment (HTA) enables a better evidence base for optimal use of new technologies and RECOGNISES that it consequently leads to faster decisions on access to innovative technologies for European patients throughout the European Union; 15. RECALLS that the enhanced cooperation of national authorities or bodies in the HTA Network 4 aims to: i) support Member States in providing timely, objective, reliable, and transferable information on the relative efficacy and effectiveness of health technologies; ii) support the analysis of the information to be exchanged, and iii) avoid duplication of assessments; 4 COMMISSION IMPLEMENTING DECISION of 26 June 2013 providing the rules for the establishment, management and transparent functioning of the Network of national authorities or bodies responsible for health technology assessment (2013/329/EU). OJ L 175/71, 27.6.2013. 14793/14 JS/pm 4
16. RECOGNISES that the enhanced cooperation in the HTA Network contributes to sustainability of healthcare systems of EU Member States; 17. [UNDERLINES the importance of the strategy endorsed by the HTA Network on 29 October 2014 5 ;] 18. RECALLS the discussion at the Informal Meeting of Ministers of Health in Milan on 22-23 September 2014 on innovation in health care for the benefit of patients, which highlighted the need to support innovation for the benefit of patients. 5 http://ec.europa.eu/health/technology_assessment/policy/network/index_en.htm 14793/14 JS/pm 5
INVITES THE MEMBER STATES TO: 19. Make better use of the existing flexibility in the regulatory framework for marketing authorisation, while ensuring the highest possible safeguard of patient safety; 20. Explore common ground for uptake of a life cycle approach for regulatory, HTA and payer purposes, based on: (a) (b) (c) (d) Early dialogue and scientific advice, Conditional reimbursement and managed entry agreements, Monitoring registries, Re-assessment and sharing of information; 21. Implement the HTA strategy adopted by the HTA Network, by: (a) (b) (c) promoting the broad scope of EU cooperation on HTA, covering the whole range of technologies, providing support to a wide range of decision-makers in healthcare, and throughout the life cycle of health technologies, from early developments to established use and until decisions on disinvestments, increasing voluntary joint work at European level and its uptake in national activities, without interfering with the Member States competences in deciding on the implementation of HTA conclusions, integrating HTA needs into regulatory and other processes; 22. Increase the effective sharing of information on prices of medical devices and medicinal products, including innovative medicines; 14793/14 JS/pm 6
INVITES THE MEMBER STATES AND THE COMMISSION TO: 23. Explore ways to maximise the effective use of the existing EU regulatory tools of accelerated assessment, conditional marketing authorisation and authorisation in exceptional circumstances and exchange information on the effectiveness and impact of these tools, taking into account the European Medicines Agency s pilot project on adaptive licensing; 24. Discuss national initiatives for early patient access to innovative medicines and the possibility of using a common approach to compassionate use to maximise the opportunities of patients across the EU to be supplied with innovative medicines; 25. Further enhance joint work on HTA, including common reports focusing on clinical evidence; 26. Support collaboration between regulators, HTA bodies, and the European Medicines Agency that enables assessment of the benefit/risk profile and added therapeutic value all along the life cycle of the products, without compromising the independence and respective prerogatives of regulatory and HTA processes; 27. Use existing fora to reflects on the possible developments that could be made in current pricing policy and systems which would results in increased availability and accessibility of innovative medicines to patients; 28. Explore the full potential of the joint procurement agreement to procure medical countermeasures, not limited to vaccines for cross-border health threats, but also extended to medicines to treat non-communicable diseases. 14793/14 JS/pm 7
INVITES THE COMMISSION TO: 29. Consider possible changes to the Regulation (EC) No 1394/2007 with a view to reduce regulatory burdens and increase incentives for SMEs and academia, while maintaining the principle of marketing authorisation based on quality, efficacy and safety; 30. Support the cooperation between Member States to implement the HTA strategy through a joint Action under the third Programme for the Union's action in the field of health (2014-2020), while exploring options for continued and sustainable financing; 31. Propose measures to ensure sustainability of work on HTA, making the best use of existing bodies such as the European Medicines Agency 32. Support the exchange of information between Member States on prices, economic factors determining the availability and on pricing policies of medicinal products and medical devices, with particular attention being paid to small markets; 33. Continue to support research and information tools that aim to provide a better understanding of how pharmaceutical pricing approaches may be applied to minimise possible unintended negative effects on patient access, to the extent these can be mitigated through better cross-border cooperation. 14793/14 JS/pm 8