BIO-PARTNERING EUROPE EVENT SPEECH PAOLA TESTORI COGGI DIRECTOR GENERAL FOR HEALTH AND CONSUMERS EUROPEAN COMMISSION

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1 EUROPABIO BIO-PARTNERING EUROPE EVENT TUESDAY 9 OCTOBER HRS SPEECH BY PAOLA TESTORI COGGI DIRECTOR GENERAL FOR HEALTH AND CONSUMERS EUROPEAN COMMISSION I am pleased to have the opportunity to take part in this BioPartnering event. Introduction The Commission is very much aware of the contribution the biotech industry makes to health and other sectors, and of the huge promise it holds for the future. 1

2 Innovation in all its forms will be a crucial component in helping Europe to break free from the current economic crisis, and towards achieving the Europe 2020 goal set out by President Barroso of smart sustainable and inclusive growth for the European economy. Biotechnology certainly has a key role to play in Europe's future success a role for which the Commission is keen to support. The Commission is also aware of the challenges the Biotech industry has to face, especially when it comes to financing innovation and research activities. We also know how tough the global competition in this field can be. I see that you debated yesterday already on the regulatory track and perceived hurdles to market access for biotechnology products. I would be interested to know what main conclusions you drew from these discussions. Let me repeat that the Commission's basic standpoint is to maintain an enabling regulatory environment: for the development of biotech medicines that are safe and efficacious; which provides legal certainty for developers; 2

3 offers incentives for innovation; and therefore enables industry to compete and win on the world stage. I want to use this opportunity to focus on some current developments regarding issues relevant to biotech innovation in the healthcare sector. In keeping with this morning's agenda, I will first address personalised medicines, then medical devices with particular reference to companion diagnostics, clinical trials and finally a word on biosimilars. Personalised medicines Personalised medicine is as you are well aware an area of increasing importance in the field of health. Naturally there is great excitement given the potential to provide medical solutions that are far better tailored to the individual patient than with traditional "one-size-fits-all" medicinal products. But although a few of such personalised medicines are already authorised in the European Union, clearly there is a long road ahead to exploit their potential to the maximum. 3

4 Indeed, a great deal of further research and development is called for from the pharmaceutical and the medical devices industries. Collaborations and partnerships between academia and industry have to be enhanced in Europe. But while personalised medicine may hold great promise for the future and has even been described as a "revolution in modern medicine", we need to keep our feet firmly on the ground. Expectations are high maybe unrealistically so or at least somewhat premature. Another important aspect is the uptake of new medicinal products by healthcare systems. New products depend on more than just a market authorisation. They also need a positive uptake decision by healthcare decision makers, be they at national, regional or local level. Innovations in medical technology are, in fact, the primary driver of healthcare spending. Estimates suggest that medical technology accounts for around 50% of observed healthcare budget increases. 4

5 Whilst we hope that the potentially high costs of personalised medicine could be compensated by efficiency gains for public health budgets, we recognise that such hopes might not be enough. In future, we will need to ask more pertinently how we can optimise public resources. The drive towards demonstrated cost-effectiveness will become ever more important. This is where Health Technology Assessment (HTA) can play an important role, by identifying the most effective treatment or technology. Here we need to develop and maintain an efficient cooperation between Member States. Through European HTA co-operation we want to facilitate the effective re-use of information from one Member State to another, thereby reducing duplication of work both for the Member States and the European health industry. We are currently preparing for setting up a permanent HTA network in Europe before the end of 2013, in line with the provisions of the Cross-border healthcare Directive. 5

6 This network should serve as a platform for sharing of HTA information and developing common methods and approaches to undertaking HTA which in turn should also provide industry with a more level playing field. We must not forget that the Commission strives for healthcare for all and is always keen to advance opportunities to reduce health inequalities not only between Member States, but also between and even within regions. With costs of personalised medicines predicted by some to be prohibitively high for many, the possibility of a widening impact on health inequalities is of great concern and something that should be constantly kept in mind. Our goal is, and will remain, to ensure as far as possible that the maximum number of people can reap the full benefits of medical progress. 6

7 Companion Diagnostics Personalised medicine relies on close inter-linkage between pharmaceutical and medical device aspects, with the prescription of such medicines depending on the results of screening of the patient's genomic or other 'omic' - information, usually done by in vitro diagnostic medical devices (companion diagnostics). It is therefore essential to ensure that only safe and wellperforming companion diagnostics are placed on the EU market. In this context, the Commission adopted, on 26 September, a proposal to revise the European regulatory framework of in vitro diagnostic medical devices. This proposal is of key importance for the development of personalised medicine. Firstly, the proposal brings clarity and legal certainty. In particular, companion diagnostics are now clearly referred to in the scope of the legislation, and a definition has been included. 7

8 Secondly, the proposal strengthens the safety and performance requirements applicable to companion diagnostics. It ensures that a notified body is systematically involved in the conformity assessement procedure before a companion diagnostic is placed on the EU market. Thirdly, the proposal seeks to foster better collaboration between the pharmaceutical and the device sectors. In particular, it is proposed that the pharmaceutical authorities are systematically consulted by the notified bodies as part of the conformity assessment procedure for companion diagnostics. This will ensure a second look at the suitability of the device in relation to the medicinal product concerned. Clinical Trials Another key initiative of relevance to your sector is a Commission proposal, which was tabled in July, to revise the Clinical Trials Directive. Again this is equally applicable to personalised medicines as it is to traditional medicines. The key objective of the proposed revision is to strengthen knowledge and innovation in clinical research, thereby ensuring that the EU remains an attractive place for medical research. 8

9 The proposed revision aims to respond to the decline of clinical trials in the EU in recent years by seeking to remove unnecessary bureaucracy for industry and academia, and to facilitate multi-national clinical trials. Clinical trials are, of course, crucial for the development of new medicines and equally to improve and refine treatments with existing medicines. They are also a key contributor to growth and jobs in the area of public health. Clinical trials mean research and investment, including inward investment from outside the EU. It is therefore essential to provide the right regulatory framework. The main issues under consideration relate to the authorisation process, where we want to simplify and streamline procedures and facilitate the application for multinational trials. This last point is particularly critical for personalised medicines which because of small patient populations often require cross-border clinical trials. Only multinational clinical trials can reach recruitment targets and thus produce robust and reliable results. 9

10 Our proposal would introduce a risk-adapted procedure, in order to avoid unnecessary regulatory burdens. Furthermore, it would increase transparency for clinical trials conducted in Europe as well as in third countries. The negotiations on the proposal have started in Council. Some parties fear that the proposal could challenge the work of ethics committees in the assessment of a clinical trial application. This is absolutely not the case, our proposal does not aim to reduce or limit the competences of ethics committees; it aims instead at ensuring a clear timeline for the assessment of an application. What we want to achieve is to have a single decision on the authorisation of a clinical trial application per Member State, including all aspects, scientific and ethical, and within a defined timeline. I am confident that we will get your full support on this proposal, in order to restore Europe's reputation as an attractive place for clinical trials, while ensuring both the reliability of data generated in trials and the protection of the health, safety, rights and well-being of patients. 10

11 Biosimilars Finally a word on the Commissions efforts to facilitate the global development of similar biological medicinal products (biosimilars). Europe was the first to set up a comprehensive regulatory framework for biosimilars in 2005, which was followed by many countries world-wide. We are working towards acceptance that a biosimilar application could contain clinical data with reference products not sourced from the EU, when certain scientific conditions are met. This would avoid the unnecessary repetition of clinical trials. In this respect, a close cooperation with the United States Food and Drug Administration (FDA) is foreseen to ensure harmonisation of requirements on both sides of the Atlantic Ocean. However, the procedure to adopt US guidance is very long. 11

12 Conclusion Before I close, may I once again express the Commission's support and very strong interest in what the biotechnology sector has to offer in terms of current and future benefits to citizens and to the economy. Be sure that the Commission will do its best to accompany its development. Thank you. End 1571 words 12