16 October 2015
The PHG Foundation has been working with the Wellcome Trust and the ESHG (European Society of Human Genetics) to highlight the potential impact of proposed reforms to genetic testing within Europe. These proposals are contained in revised EU Regulations on in vitro diagnostic medical devices (IVDD) and on medical devices. IVDD’s include tests that are used within health services or for self-testing, for predicting future or current disease (prediction and prognosis) and for treatment and management of existing disease.
Key concerns are that the proposed reforms will restrict access to clinically useful genetic tests and restrict their wider uptake, thus having a potentially detrimental impact on health. A Position Statement elaborating on these concerns was published on 13 October 2015 with the aim of informing MEP’s and Member States as they work to agree final consolidated versions, timed to coincide with the reforms entering the critical trilogue process (i.e. the process of negotiation between the European Parliament, The Council of Europe and the European Commission).
The Position Statement calls on the European Parliament, the Council of Ministers and the European Commission to demonstrate their support for genetic testing technologies as an increasingly vital element in current and future healthcare; to allow Member States to regulate genetic tests in ways that take account of the needs of specific healthcare systems; and for devices intended to be used for “indirect medical purposes” to be excluded from the scope of both the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation.
The PHG Foundation would support proposals that regulate genetic tests in an appropriate and proportionate manner allowing Member States to retain discretion over detailed provisions relating to the offer and delivery of genetic tests, possibly within a framework of EU minimum standards. These could include that genetic tests should be offered by any appropriately qualified health professional and that any applicable regulatory requirements are commensurate with the potential risks and benefits of testing.
For more details contact Alison Hall