Conclusion
The preceding paragraphs have highlighted that the regulation of aspects of DTC genetic testing is fragmented and jurisdiction-specific: different rules (and varying levels of enforcement) in particular countries.[656] Regulators in each nation are concerned with the protection of consumers within that nation through rules that cover the operation of test providers and/or other parties such as medical practitioners that are located within the specific jurisdiction, but limited in terms of regulating the activities of off-shore providers of those tests who market their services via the internet.
There is an indifference to and even non-recognition of marketing across borders to consumers within other jurisdictions. That indifference about regulation of the “export market” is reflected in the scholarly literature. Both regulators and academic commentators continue to conceptualise DTC genetic testing as a national problem with a national solution, ignoring the emergence of a global market that is addressed by service providers with global ambitions and global marketing opportunities, ie through use of the internet.Inconsistencies and incapacity in national policy-making and enforcement regarding DTC genetic testing encourage regulatory arbitrage. At this time it is unclear whether such arbitrage will be a substantive problem. We can hypothesise that testing costs will continue to decline, that the FDA is likely to authorise some DTC testing, that bodies such as the US National Geographic Society and insurers will continue to be attracted to promotion of DTC testing, and that enterprises in light-touch (or no-touch) jurisdictions such as India, South Korea and Iceland will emphasise marketing across borders. Policymakers in India and South Korea, for example, may well encourage an export-oriented DTC sector as a way of strengthening their life-sciences industries and building human capital.[657]
There is thus a need for co-operation between consumer protection agencies and health regulators in the advanced economies regarding development of a coherent global framework regarding DTC genetic testing.
A model for that framework is provided by the 2008 Protocol (CETS No 203) to the 1997 Council of Europe Convention on Human Rights and Biomedicine (ETS No 164).In the absence of an effective global framework, what might be done to restrict the operation in Australia of DTC genetic testing services that are based offshore?
One response might simply be that there is no need for restriction, with the national government (supported by medical practitioner organisations) instead concentrating on measures that increase the genetic literacy of consumers. Such a public education program would respect individual autonomy. It would result in benefits such as the reduction of stigma associated with particular genetic attributes and the reduction of unnecessary testing (and thence lower overall health costs) highlighted by economists such as Baumol.[658]
There is no express reference to genetics or health testing in the Australian Constitution; that statute indeed is silent regarding both health and consumer protection. It does, however, provide scope for the regulation of DTC genetic testing by enterprises that are located within Australia or that market from outside the national border. At a basic level sections 51(i) and 86 deal with international trade and commerce and with customs respectively. Section 51(v) encompasses the internet under the posts, telegraph and like services head of power. Section 51(xx) encompasses the regulation of corporations.
In principle an activist national government could therefore shape the Australian DTC genetic testing market through an outright prohibition on DTC test provision by Australian enterprises that is independent of medical practitioners, through interdiction of test kits and samples passing into/from Australia, and through directions to payment processors (banks and credit card services) not to handle transactions relating to offshore test service providers. There might even be attempts to restrict online advertising of offshore test services.
In practice, the Australian Customs Service is much more likely to focus its capabilities on the interdiction of illicit drug shipments and, with less vigour, on unauthorised imports of pharmaceuticals and herbal medicines.A far more comprehensive solution would be establishment of an international regulatory agreement, whereby each participating nation agreed to regulate the activities of DTC genetic testing providers within its borders at the supply end, rather than the demand end. This would see regulators cracking down on the online presence and marketing outreach of service providers within their jurisdiction, in exchange for similar activity being undertaken by regulators in other jurisdictions hosting DTC service providers marketing into their jurisdiction. As mentioned before, a difficulty in achieving such a framework is the potential for commercial exploitation offered by development of this market in some light-touch regulatory jurisdictions. Nonetheless, as many of the light-touch jurisdictions are dependent on regulatory approvals for marketing and exporting pharmaceuticals and other biological products into jurisdictions with an interest in regulating DTC genetic testing, and they are also interested in the results of further scientific and clinical research performed in these countries, there are options for negotiation that should be explored in the interests of establishing an international framework.
Sequencing the human genome was a monumental achievement in the timeline of human endeavour, made possible only by international collaboration and co-operation. It would be fitting if a global framework for the regulation of some of the derivative activities of this landmark could be established in the same spirit.
Authors note: It was announced on 10 December 2012 that life sciences company Amgen had purchased deCODE for $415 million. On 12 December 2012, Amgen confirmed that it would not be offering DTC genetic testing services after acquiring the company. Concerns about control of all the Icelandic DNA samples held by the company the time of sale passing to an American company have been raised, however no formal resolution on the issue has been reached as of December 2012.