Council of Europe says tests should only be carried out under direct medical supervision

The Council of Europe (CoE) has come out against mail-order and over-the-counter genetic tests in new ethical guidelines that seek to address dilemmas faced by health services without hobbling scientific progress towards ’personalised medicine’.

The guidelines, unveiled by the Strasbourg-based human rights body at an international conference in Paris on 2 October, covers diagnostic, predictive or ’healthy carrier’ tests as well as pharmacogenetic tests but excludes tests on the human embryo and foetus - issues on which Europe is sharply divided - and tests for research purposes.

However, the guidelines also say that genetic tests may only be carried out under ’individualised medical supervision’ based on direct, face-to-face contact between patient and doctor - ruling out tests carried out by mail order or at home using kits.

The new protocol could offer a template for those European states still in the process of developing codes of bioethics. But speakers at the Paris conference suggested that states may now choose adopt a pick ’n’ mix approach to the guidelines without formally ratifying the legally binding protocol. This would repeat experience to date with the original 1997 Bioethics Convention, which has been ratified to date by only 21 of the CoE’s 47 member states.

Other provisions in the new guidelines would require states to ’take all necessary measures to safeguard human dignity and the fundamental freedoms of the person’, in particular by prohibiting discrimination against or stigmatisation of individuals or groups based on genetic characteristics, and by ensuring ’equitable access to genetic services of appropriate quality’.

The protocol also requires states to take steps to ’ensure that genetic tests meet generally accepted criteria of scientific validity and clinical validity’. Quality assurance programmes should include accreditation systems for laboratories, which should be monitored on a regular basis, and checks to ensure that ’persons providing genetic services’ - health care professionals, biologists and lab technicians - are appropriately qualified. 

One industry speaker at the conference, Klaus Lindpaintner, director of Roche Genetics and the Roche Centre for Medical Genomics in Switzerland, saw nothing conceptually new in pharmacogenetics. Lindpaintner said that the technologies simply provide new tools to support clinicians’ attempts to offer treatment in ’a more targeted, more personalised and therefore hopefully more effective way’.

For the pharmaceutical industry, improvements in molecular genetic understanding could make the difference between success or failure in Phase 2 trials if it could be shown that the efficacy of a drug will be influenced by the patient’s pharmacogenetic profile, he added.

CoE spokeswoman Henriette Girard told Chemistry World that the genetic test guidelines will be scrutinised by in the coming months by legislators at the organization’s Parliamentary Assembly. Ministers will then be asked to approve the text, clearing the way for national ratifications.

Arthur Rogers