7 April 2014
Over the past 18 months, the EU has been debating reforms to the Medical Devices and the In Vitro Diagnostic Devices directives.
One major reform is that the scope of the In Vitro Diagnostic Devices Regulation has been widened to include genetic tests. The EU’s position has been led by rapporteur of the ENVI committee, Peter Liese, who, concerned by wider threats to individual privacy, has sought to entrench a prescriptive and centralised approach to regulating genetic tests, including the nature of the counselling that patients receive before a genetic test is ordered.
This approach has been widely criticised, both by the PHG Foundation and other health and medical research organisations, on the basis that it undermines existing professional practice, is disproportionate and unworkable. These concerns have been shared by other European Member States and professional organisations such as the European Society of Human Genetics (ESHG).
In an unprecedented development, the ESHG have today released a legal opinion which suggests that by encroaching into the practice of health care, that ‘the European Union lacks the power to put [these amendments] into law’. The Opinion suggests that this is because the proposed amendments do not reflect legislative principles that are enshrined in founding Treaties, such as principles of proportionality and subsidiarity, and that the EU lacks the legal competence to legislate on bioethical matters, which should be left to individual member states.
Alison Hall (Programme Lead for the Humanities), who has led the PHG Foundation work in this area, observes: “The PHGF has been very critical of these genetic counselling amendments, on the basis that they undermine existing good practice and will lead to poorer care for patients. We therefore welcome this authoritative legal Opinion which comprehensively demonstrates that the EU lacks the power to proceed with these amendments. We hope that the European Parliament will take this Opinion into account when considering how they will take this legislation forward over the next few months”.
In addition to the legal barrier outlined, the ESHG also warns that the proposals will harm patient care and autonomy. ESHG spokesperson Dr David Barton said the proposals seek: “to dictate in detail the arrangements for every clinic where a genetic test may be ordered…We are gravely concerned that these proposals, as they stand, restrict legitimate, ethically-acceptable genetic testing activities such as the screening of new-born babies”.