Prostate Cancer Screening in Europe – A Four Month Follow-Up
Four months on from the lively dinner debate on prostate cancer organised by the International Centre for Parliamentary Studies, I would like to put forward my reflections on the points raised. The comments and questions received from the participants related mainly to improved regulatory frameworks and accelerated approval processes and also Health Technology Assessment.
On the first point, I would like to make a few clarifications about the Clinical Trials Directive. This piece of legislation provides for a broad regulatory framework that sets out how clinical trials should be performed to ensure the safety and rights of subjects and the quality of data. It does not, however, address specific diseases.
I am very concerned about a steady decline of clinical trials in the EU since 2007. The primary responsibility for such research lies with industry and academia. But obviously the regulatory environment plays an important role, too. The 2001 Clinical Trials Directive has been the subject of repeated criticism. Indeed, the Directive is not applied uniformly by the Member States. Furthermore, it is criticised for neglecting the increasingly global scale of clinical trials and for causing a high administrative burden of clinical trials by not taking account of practical needs and constraints.
I am committed to addressing these issues. My services have launched a public consultation on the revision of the Clinical Trials Directive earlier this year. The responses received from stakeholders, including those from the International Centre for Parliamentary Studies, were carefully analysed by the Commission’s services. The resulting consultation report, which includes individual comments, as well as a summary of all responses, is now available on the Commission’s website.
Following the public consultation, I intend to put forward a proposal for a thorough revision of the Clinical Trials Directive next year. My ambition is to improve the regulatory framework by introducing a smart and quick approval process for clinical trials, which at the same time respects the primary responsibility of Member States for ethical issues.
Another important topic of discussion during our previous dinner was health technology assessment (HTA). This tool has become increasingly important for European countries, helping them to assess the consequences of introducing new health technologies in public health services. However, the use of HTA currently differs from country to country, both in methodology and scope. While some Member States focus on relative effectiveness and/or efficiency, others prefer more complex analyses including organisational, societal and ethical aspects. This means that a treatment introduced in one country may not necessarily be considered or selected by another. And it renders the incentives and perspectives for valuable innovation in healthcare more difficult.
I am convinced that establishing common approaches to assessing new health technologies will benefit national health systems, European patients and innovation in health care. The European Commission has supported projects for EU cooperation on HTA for several years. Now, we are in the process of reinforcing this co-operation by creating a regular voluntary network under the 2011 Directive on Patients’ Rights in Cross-border Healthcare.
It is important to ensure that EU actions on HTA are transparent and based on the widest possible consultation of European patients, health professionals, health industries and other interested parties.
The final point I would like to make on HTA is that, although there is consensus on its benefits, it is not the only element in the national decision-making process when it comes to introducing new treatment methods. It is therefore necessary to explore better ways of working together – regulators, HTA agencies, health insurers/payers, as well as patient organisations and other stakeholders – to prevent any delays to the introduction of new, effective treatments to European patients.
I take this opportunity to stress once again that the European Commission is committed to working with all partners, using all means at its disposal, to reducing the burden of cancer and the suffering it causes. Action against cancer, regardless of the type, lies at the heart of European health policy.