Over the counter genetic tests – ethical, legal and social issues.

Hilary Newiss 26 th January 2006

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

The future market?

• Better understanding of genetic basis of disease and SNP’s • Pharmacogenetics • Improved DNA technology • Clearer clinical guidelines • Computer technology/information

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.

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

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

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

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

Genes Direct

• Inside Information • Informed consent • Testing children • offense of non consensual testing • Caution for high impact test • discrimination

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

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

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?

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.

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

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?

Public information

• HGC • Labtests online • Consumers association

conclusion

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