1. Over the counter genetic tests – ethical, legal and social issues. Hilary Newiss 26 th January 2006

2. Over the counter genetic tests What are we talking about? Direct to public Direct to consumer Outside normal medical referral Read out from device at home Send back to lab Possible pre/post counselling

3. The future market? Better understanding of genetic basis of disease and SNP’s Pharmacogenetics Improved DNA technology Clearer clinical guidelines Computer technology/information

4. Genes Direct – public consultation (2002/3) Some demand – speed/convenience/ confidentiality- genetic discrimination 80+% would consult doctor for serious disorders/carrier testing. Varies with seriousness of disorder. 60% said not interested 81% would use if recommended by doctor The majority would still access ‘lifestyle tests through a GP. No-one, except Genewatch and Consumers Association wanted all out regulation.

5. The market demand Future – personal responsibility. Cf pregnancy testing – 40% women have used. United States. Germany. Not much of a UK market yet. Nicotest/Sciona/Roche Amplichip/Medichecks/Internet

9. Regulation history in the UK ACGT – in response to CF testing ACGT code – notification procedure Establishment of HGC Sciona – new code? Genes Direct EU IVD Directive – MHRA Nicotest HGC reconvene Genetic Services subgroup/briefing paper HIV, Cancer, paternity genealogy

10. GENES DIRECT March 2003 Human Rights Act 1998 – right to private life. Must justify denial of access From paternalism towards self determination But state can intervene if potential harm – eg controls advertising and supply of prescription drugs. Protect vulnerable from misleading claims Genetic rights v NHS resources

11. Genes Direct –genetic exceptionalism? Other tests – osteoporosis, PSA, sperm counts, pregnancy tests Small samples – consent issues Immediate action v long term consequences Genes and disease/environment – complex relationships Impact family members Invulnerability/false reassurance

12. Genes Direct Inside Information Informed consent Testing children offense of non consensual testing Caution for high impact test discrimination

13. Genes Direct - conclusions Accepted that some form of regulation required Presumption that tests predictive of medical condition generally unsuitable for “direct to public” supply Independent mechanism to consider the scientific and clinical validity and utility of any genetic testing service No evidence of harm at present Parliamentary time Regulatory ethos Adequate NHS provision

14. Genes Direct - conclusions Pragmatic conclusion Complex array of regulatory mechanisms Consumer protection key Information Regulatory regime in flux – MHRA/OFT/BIVDA/UK Genetic testing network/role of pharmacists Public information and education – role of MHRA,FSA,NICE, professional bodies, consumer bodies Ongoing debate – dyslexia, IQ? International co-operation/internet Government response

15. IVD directive and MHRA Risk-based consumer legislation Level of regulation commensurate with risk of harm All genetic tests save for PKU are deemed low risk and subject to self certification Higher risk lists include HIV,HTLV hepatitis, rubella, glucose Can add to higher risk lists but will take time and European agreement. Special self reporting vigilance procedures for new products – Roche amplichip?

16. IVD Directive All products must meet essential requirements – 6 Safety, quality and performance Must not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons. Performance criteria may include analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity – analytical and clinical validity.

17. IVD directive CE mark Uncertain interpretation – early days. Nutrigenomics – concerns a physiological state? Companies – independent evaluation – risk assessment Directive enabling free trade? MHRA information Role of UKGTN Directives under review

18. advertising ASA – legal decent honest and truthful - genetic hair Trading Standards Genewatch – Nicotest OFT – if it looks too good to be true, it probably is. Codes of practice. Consumer legislation under review Regulation by media?

21. Public information HGC Labtests online Consumers association

23. conclusion Controlled inaction Informal regulation Public perception International co-operation Crystal ball gazing in genetics Prompt intervention.