23 October 2013
Proposed revisions to European laws relating to data protection and diagnostic devices have moved closer to adoption, with potentially very serious implications for biomedical research and genomic medicine.
The European Parliamentary Committee on Civil Liberties, Justice and Home Affairs (LIBE) is leading the reform of the current data protection laws, which are currently enforced at national level by member states. On 21 October the LIBE voted in favour of the proposed General Data Protection Regulation and Data Protection Directive, which will now go before the European Council in spring 2014.
The PHG Foundation has serious concerns about the limited breadth of permitted exemptions from otherwise mandatory consent processes for the use of personal data, which in the proposed form could significantly inhibit medical research including many large scale genomic projects. As set out, the exemption from consent for health research purposes would only apply to anonymised (as opposed to identifiable) data and only if it had 'high public interests, if that research cannot possibly be carried out otherwise'.
Meanwhile, the European Parliamentary Committee on the Environment, Public Health and Food Safety (ENVI) has proposed amendments to a new Regulation to replace the current In Vitro Diagnostic Medical Devices Directive. On 22 October the Directive was approved by a large majority, although key elements of some of the amendments were defeated.
The PHG Foundation remains concerned that some of the proposed amendments would have a seriously detrimental impact on healthcare in the UK and Europe. This is partly because the proposed Regulation utilises a very broad definition of ‘device for genetic testing’ as ‘an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development’ together with overly restrictive criteria for offering genetic testing, including supervision and administration solely by medical professionals, mandatory genetic counselling and requirements for explicit and written consent. The proposed IVDD Regulation, like the Data Protection Regulation, will be directly enforceable on Member States.
Whilst these may be appropriate measures for some forms of genetic testing – for example, testing for the presence of mutations that indicate a high probability of developing a serious inherited disorder – they are greatly excessive for others, such as identifying the most appropriate treatment option for a tumour, or evaluating genetic influences that may impact on overall risk of cardiovascular disease. The practice of personalised medicine, currently in rapid expansion and with enormous potential to deliver improved healthcare, would be seriously impeded by such disproportionate requirements for wider forms of genetic testing.
The PHG Foundation joined with the Wellcome Trust, European Alliance for Personalised Medicine and the European Genetic Alliances’ Network in a joint statement to oppose these regulations and briefed MEPs and other key stakeholders to this effect. The proposed new Regulation will now be reviewed by the European Council next year.
PHG Foundation Programme Lead for the Humanities Alison Hall, who has led legal work on these issues, commented: “Those promoting these changes fail to understand the complexity and breadth of genetics and genomics in healthcare and in research. As a result, these EU reforms threaten to undermine existing medical research, the development of evidence based healthcare and to compromise future development of genomic technologies: in short, if implemented in their current form, they threaten the health and wealth of all European citizens”.