There are certainly differences in the applicable law of different countries, including the US and UK. For example, the recent legislation enacted in Germany (see: http://www.genomicslawreport.com/index.php/2009/09/02/genetic-exceptionalism-and-paternalism-themes-in-new-german-legislation/) which appears to outlaw DTC genetic testing might suggest that 23andMe’s strategy of targeting doctors with discounted products might be one of its only viable options for actively growing its customer base in that country. With respect to the US/UK, there are substantial differences in the reimbursement of medical testing in general that I would imagine 23andMe is cognizant of in determining which doctors should be targeted with discounted products. However, I’m not familiar enough with those differences off the top of my head to analyze whether or why 23andMe would prefer primary care doctors in one country over the other.

It’s a great question and I apologize for my tardy response. The high-level answer is that the precise line that separates clinical from non-clinical activity with respect to the conduct and interpretation of genetic testing or genomic sequencing is difficult if not impossible to define.

On the clinical side of the line exist more extensive duties, greater liabilities and (typically) a higher price tag. The converse is generally true of non-clinical activity. But not only is the line fuzzy generally – due to a complex mix of competing principles, risks and benefits that attend any effort to define the line more precisely – where the line is drawn in any particular instance depends substantially on the specific set of facts. Where 23andMe or any other DTC provider falls with respect to the clinical/non-clinical line in any given instance is almost certainly too fact-specific (including facts that may not be public knowledge) and subjective to render anything more than an educated guess as to how a legislative, regulatory or judicial authority might conceivably rule.

I know that is in some ways an unsatisfactory answer to what is, indeed, a tremendously important question, but it does reflect the considerable uncertainty surrounding this portion of the law. I will consider whether or not this issue can be expanded into a complete post and provided with a more thorough treatment.

Thanks.

- Dan

Are there differences with the UK legal system and laws compared to the USA, related to genetic testing that would bias the selection of doctors, doctors who will be offered a discounted test? I am curious about why go the GBs in the UK with a discount as opposed to offering a discount to the USA primary care doctors? Are there legal advantages/differences that might influence location of companies performing genetic tests (Iceland/USA/UK)?

-Steve
http://www.thegenesherpa.blogspot.com