European law has a significant influence on many aspects of national law in the UK and other member states, including research. One aspect that is currently of concern to the Wellcome Trust lies within new rules on medical devices, which have the potential to restrict genetic testing in the EU. Policy officer Will Greenacre explains why one size does not necessarily fit all.
The European Union is currently redrawing the rules governing the manufacture and sale of medical devices, including in vitro diagnostic devices. These devices range from blood glucose monitoring kits for diabetics and home pregnancy tests, right through to complex hospital assays.
These rules, which will be directly binding in national law for all EU member states, also apply to genetic tests, and an amendment proposed by the European Parliament to the draft regulations has the potential to limit the availability of genetic tests by placing very specific requirements on their use.
The field of genetics has the potential to transform medicine and healthcare, both through the development of novel treatments, and enhancing our understanding of health and disease states. We are already seeing genetic testing embedded in some aspects of healthcare, with initiatives like Mainstreaming Cancer Genetics supporting easier access to genetic testing for cancer patients – making it a routine part of their treatment. Knowledge of a person's genetic makeup – and that of their tumour – can help doctors to understand the cause of their disease and plan the most effective, 'targeted' treatments.
It's not limited to cancer genetics. Genetic testing is becoming more prevalent in other areas of medicine, including for conditions like cardiovascular disease and dementia. As technology advances, it has the potential to benefit many areas of healthcare by providing greater insights into our genetic susceptibility to disease, and how our genes can inform the best approaches to treatment.
The new regulations currently being discussed in the European Union could hinder these developments. The suggested amendment proposes that genetic tests can only be conducted by a qualified medical professional, and only after mandatory genetic counselling has been given and full consent provided. While this is appropriate for some types of tests, where the results could have profound implications for the patient and their family, to apply it to genetic tests where consent may be implicit would risk restricting the availability of tests for other conditions.
This raises concerns due to the wide scope of genetic testing, with new tests and diagnostics being developed all the time. As testing becomes a more common and integrated part of healthcare it might be that in hospitals, for example, tests would be carried out by nurses or laboratory staff without the patient present. To require genetic counselling before and after tests in all circumstances would be unworkable. While we support the role of genetic counsellors, requirements for consent and counselling have to be proportionate, taking into account the nature of the test and the implications of the information for the patient and their family.
We will be taking forward discussions with European Commission officials and key MEPs involved in the negotiations in the coming weeks and months, ahead of final negotiations between the European Parliament, the Commission and the Council of Ministers which are expected to begin in the autumn. Regulation of this area is a complex issue, but it must aim to strike the right balance between protecting patients and encouraging innovation for their benefit.