Ever wondered where your data goes once completing an ancestry test? Should genetic testing be regulated? Do you think countries should lift bans on direct-to-consumer genetic testing?
Eline Chivot, senior policy analyst for the Center for Data Innovation, discusses why EU policymakers should call for France and Germany to lift their bans on direct-to-consumer (DTC) genetic testing (used by companies such as AncestryDNA, 23andMe, MyHeritage, FTDNA, or IGenea) and instead harmonise laws to create a single market for DTC genetic testing. Discover as Chivot explains; countries that prohibit these tests limit their populations’ ability to access information about their own genetic legacies, which could be critical to their future health. Further, a single EU market would encourage broader adoption of these sorts of tests.
The world of genetic testing
Sixteen years since the completion of the human genome project—one of the most important scientific feats in human history—people in many nations around the world can have a version of their genome analysed for a modest fee. People do this for a variety of reasons, including to better understand their ancestry and to get important insights about their health.
Unfortunately, not all European nations have embraced this health innovation. Despite its many benefits and growing adoption, a few EU member states limit direct-to-consumer (DTC) genetic testing—or in the case of France and Germany, prohibit it altogether. So, while these tests continue to improve and become more common, the lack of harmonised regulation among EU member states is holding back adoption.
But member states have made no indication that they are changing course. The French government is considering draft legislation to revise the country’s law on bioethics, following an extensive public consultation on these issues.
Modernising the rules of genetic testing
While the proposed law appears progressive because it will address issues such as expanding access to medically assisted reproductive technologies to all women and facilitating research on embryonic stem cell lines, unfortunately it is unlikely to modernise the rules on genetic testing, which the government restricts to medical research purposes, specific patients with rare diseases, criminal investigations, and those with approval from a general practitioner.
France’s reluctance to change its rules on DTC genetic testing is a good example of why EU policymakers should take the lead on calling for consistent rules.
There are three main reasons policymakers should liberalise the regulation of DTC genetic tests. First, country-level bans prevent individuals from accessing their own genetic information and exploring one of the most profound technological advances of the past decades. More than 26 million people worldwide have already bought a DTC genetic test kit, according to last year’s estimates—15 times more than in 2013.
According to a 2018 survey by Généanet, a French genealogy website, nearly three-fourths of 20,000 French respondents believe these tests should be legal. Despite the current ban and the risk of heavy penalties for consumers (possibly as much as a €15,000 fine and a year’s imprisonment), about 100,000 French citizens order these products each year from foreign consumer genetics companies such as AncestryDNA, 23andMe, MyHeritage, FTDNA, or IGenea.
Second, DTC genetic testing provides an opportunity to increase wellness and prevention efforts in healthcare by empowering individuals to take more responsibility for their health. Using simple, easy-to-use home genetic testing kits, for prices ranging from €60 to €200, consumers can gain insights into their genetic make-up, their future health, and their vulnerability to a broad diversity of the diseases.
The use of DTC genetic testing is transforming the practice of medicine by helping researchers understand diseases: Through genetic sequencing, test results can associate individuals’ genetic markers with risks of developing diseases such as type 2 diabetes, Parkinson’s and Alzheimer’s diseases, and hereditary cancers. Individuals can then use that new information to modify their behaviour or take other preventative measures, detect diseases and intervene sooner, and receive more personalised care—actions which could increase cost-efficiency and relieve some pressure on financially burdened healthcare systems.
Yet France, for one, shows reluctance to take these benefits seriously. France’s concerns are that if consumers purchase genetic tests directly, then they will not receive psychological support and medical interpretation of the results, and that it is difficult to anticipate how a patient may react when finding out he or she may be at risk of developing a serious illness.
Yet a 2011 study published in the New England Journal of Medicine suggests that the use of technologies such as genetic testing and screening does not lead to any short-term negative effects on the anxiety levels or psychological health of individuals. And France is underestimating consumers’ ability to inform themselves: 23andMe, for instance, warns its users that the results it provides do not mean they should skip the recommended medical screenings. Moreover, some of the most sensitive tests have received regulatory approval.
For example, the U.S. Food and Drugs Association has approved 23andMe’s DNA test to screen for a predisposition to colorectal cancer.
Third, countries which limit at-home genetic testing are preventing their genetics companies and labs from generating scientific advances. In countries that allow DTC testing, genetics companies now have the world’s largest collections of human DNA and can partner with pharmaceutical firms to discover new drugs. For instance, GlaxoSmithKline uses 23andMe’s database of over five million people to develop medical treatment for Parkinson’s disease. In addition, these companies create many high-paying jobs in computer science, engineering, and computational biology.
EU policymakers should call for France and Germany to lift bans on DTC genetic testing. Countries that prohibit it are limiting their populations’ ability to access information about their own genetic legacies, which could be critical to their future health. These countries will fail to harness significant economic benefits and competitive advantage over countries that have embraced societal change and technological progress. Moreover, EU policymakers should work to harmonise laws to create a single market for DTC genetic testing in the EU to unlock the potential of genetic data for all EU member states.
Senior Policy Analyst
Center for Data Innovation