Rebecca Taylor, on behalf of the ALDE Group. – Mr President, I welcome Dr Liese’s report on IVD devices, which is being voted on later today. I believe that the considerable efforts made by the rapporteur and shadows, both on this and on the Roth-Behrendt report on medical devices, have resulted in legislation that will meet the needs of patients, healthcare professionals and device manufacturers.

In relation to high-risk devices, I am pleased that we have now reached a workable and more streamlined procedure than was adopted in committee. Authorising high-risk IVD devices to a scientific committee of the Medical Device Coordination Group will lead to safer devices and greater transparency without being overly bureaucratic. I hope Parliament will adopt these provisions.

Unfortunately, there remain elements in the IVD text which are of concern for the Liberal Group. We cannot support amendments 72 or 271, which restrict genetic medicine unnecessarily. Genetic tests range from those informing you of an increased risk of diabetes through to tests diagnosing an incurable, life-threatening illness such as Huntington’s disease. I believe the rapporteur has created a framework that responds to the problems stemming from genetic tests for life-threatening conditions but has applied this framework to all genetic tests, which risks damaging current routine medical practice.

Genetic testing is not just about diagnosing serious inherited disorders. In cancer, for example, genetic screening can ascertain sensitivity to treatments, thus producing test results that are risk based rather than deterministic. For these reasons, as well as the fact that the EU has no legal power to regulate national medical practice, we oppose those amendments and support instead amendments 255 and 256, which seek solutions to the problem identified by the rapporteur without damaging developments in the field of genetic medicine.

We also cannot accept amendments 42, 68 and 205, which could have a severe impact on public health – primarily sexual health – in Europe by making all high-risk devices, including HIV tests, prescription only. This threatens public health policies in France and the UK which seek to make HIV tests easily available to high-risk groups. Amendments 268 and 205 will do the same in various different ways. The ALDE Group would like to support this report, but the concerns I have outlined may prevent us from doing so.