Brussels, 28 February 2013 – On Tuesday, 26 February, European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) held a public workshop to exchange views on the in vitro diagnostics medical devices proposal in Europe. Policymakers, industry leaders, medical professionals and healthcare stakeholders unanimously highlighted the role of in vitro diagnostics as the “parent” of healthcare.
The primary topic on the agenda was the necessary overhaul of the in vitro diagnostics regulatory system, refocusing the regulation to address the concerns of patients, society and healthcare systems. The session also focused on informed consent, highlighting the concerns of patients and users towards genetic information. There was recognition from panelists including Sabine Lecrenier, Head of Unit Health Technology & Cosmetics, DG SANCO, European Commission, Sine Jensen, Senior Health Adviser, Danish Consumer Council and Serge Bernasconi, CEO, European Diagnostic Manufacturers Association (EDMA) on the value of in vitro diagnostics (IVDs) overall.
Serge Bernasconi emphasised the four important areas that require enormous efforts from the industry – enhanced role of notified bodies, systematic clinical evidence, a new classification system and setup of reference laboratories. He added, “The proposed regulation completely overhauls the system for IVDs, resulting in much more stringent requirements across the board. The IVD industry supports the proposed measures because they will result in a more controlled and transparent system which is better accepted within Europe and beyond.”
A big part of the discussion also surrounded the ethical aspects of the medical data that in vitro diagnostic tests provide, which were highlighted by Dr Laurence Lwoff, Secretary at the Committee on Bioethics, Bioethics Department of the Council of Europe. The session’s chair and Rapporteur on the proposal for a Regulation on in vitro diagnostics, Dr Peter Liese, underlined in his final remarks the potential and hope for future developments in healthcare due to in vitro diagnostics.
About In Vitro Diagnostics
In vitro diagnostics (IVDs) are non-invasive tests performed on biological samples (for example blood, urine or tissues) to diagnose or exclude a disease. IVDs provide valuable information about how the body is functioning and the state of health. They are used for diagnosis, screening and therapeutic monitoring of diseases. IVDs have a broad scope ranging from sophisticated technologies performed in clinical laboratories to simple self-tests, such as those for pregnancy and glucose monitoring.
EDMA, the European Diagnostic Manufacturers Association, advocates for the interests of the in vitro diagnostic industry and its enormous contribution to transforming healthcare systems by improving healthcare efficiency and reducing costs. EDMA’s strength lies in its close co-operation with European institutions, patients groups, trade associations, health professionals, and academia, working together to shape the EU policy that will have the most impact on the lives of Europeans and reinforce the European IVD industry’s voice globally. From small businesses to major corporations, the European in vitro diagnostic industry is a market worth around 11 billion euro. Driven by research and development, 95% of the industry is comprised of small and medium size enterprises and approximately 1 billion euros per year is reinvested in R&D. EDMA is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information, visit www.edma-ivd.eu.
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Ingmar de Gooijer
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