The year is 2035, and every embryo has its DNA sequenced, informing parents about their offsprings potential risk of cancer, diabetes or even its future level of intelligence. Criminals no longer roam the streets, as police use DNA databases to identify suspects. And everyone knows what potentially harmful genetic mutations they carry, with free sequencing available through the health care system.
Is this science fiction — or is it just around the corner, perhaps a vision in the daydreams of Boris Johnsons top adviser, Dominic Cummings?
It depends on whom you talk to. But dystopian predictions aside, its clear that Europe is moving toward a world where the power of the genome is being realized.
In two years, EU regulation will become more harmonized as member countries move toward a deadline for the application of new regulations on genetic testing. Meanwhile, policymakers and researchers are working to develop guidelines and codes that can be adopted across countries and sectors.
This year, for example, a major international EU-funded research project is finalizing its investigations into genomics, potentially publishing recommendations for better legislation. The global organization for genomic data-sharing will also be rolling out its new strategic roadmap in October. At the same time, the U.K. is bracing for talks over whether it wants to align with EU regulations on genomics and genetic testing, or go its own way after Brexit.
Who makes the rules?
The year is 2020, and genetic testing is booming, with nations across Europe pushing the science further than ever. The U.K. is embedding genetic testing into the National Health Service with its Genomic Medicine Service. Similarly, the Danes are working toward a vision of personalized medicine for the masses through their National Genome Center. And in France, Genomic Medicine 2025 aims to link the health system with the research sector and industry.
However, in these examples, most private consumers dont meet the threshold to receive genetic testing within the health system. Instead, the only way they can know anything is to enter the Wild West of online direct-to-consumer (DTC) genetic testing.
What began as DNA testing to trace ancestry in the early 2000s has morphed into a multibillion dollar industry. After you spit into a tube and send it to a lab thousands of miles away, you might learn something as benign as whether youre more likely to develop wrinkles, or as potentially life-changing as predictions of disease risk.
The question now for governments across Europe: How to regulate these tests offered by the private sector?
DNA testing at the Genetic Institute Nantes-Atlantique in France | Georges Gobet/AFP via Getty Images
In France, where such tests are prohibited, a 2019 review kept the ban intact, disappointing activists who wanted commercial genetic testing to be legalized. In the U.K., where theyre permitted, the issue prompted lawmakers to start an inquiry, but it was shut down once parliament was dissolved ahead of the national election in December.
The challenge across the EU is that regulations are a “patchwork,” said Pascal Borry, professor of bioethics at the University of Leuvens Centre for Biomedical Ethics and Law. Some general laws at the EU level — such as consumer protection laws — apply to genetic tests, as do some specific ones, such those regulating in vitro diagnostic medical devices. But by and large, member countries have maintained authority over regulations.
In France, for example, national laws include tests being covered under biomedical regulation, while Austria has laws specific to genetics. Then there are countries that dont have specific laws but can regulate these tests by considering them as health services.
“Theres a lack of EU legislation specifically on this, but also at national level, it isnt clear how member states are addressing this,” said Eline Chivot, senior policy analyst at the think tank Centre for Data Innovation.
Others are concerned about what this means for standards of testing.
“At the moment, the European landscape is not sufficiently taking care of the quality of genetic testing,” said Martina Cornel, professor of community genetics and public health genomics at Amsterdam University Medical Center.
New era, new regs
Facing this patchwork landscape, policymakers and scientists are working to harmonize regulations at the international, EU and member country level.
This year, for example, the EU-funded SIENNA project will finalize work on genetics and genomics. It aims to develop tools such as ethical frameworks and codes of conduct for these areas, and is also specifically looking at the advertising of DTC tests.
Penalties in France have actually never been enforced, and consumers remain largely free to purchase the tests from companies outside the country.
SIENNA, which includes researchers in the Netherlands, the U.K., Sweden, Poland, Germany, Spain, Greece and France, officially ends in March 2021. But some of the guidelines could already be released later this year.
Another set of rules that member countries can sign up to, if they choose, is the Council of Europes protocol on genetic testing. But so far, only four have ratified the text: the Czech Republic, Norway, Portugal and Slovenia.
This could all change in 2022, when member countries may no longer opt out. By then, a new EU regulation on in vitro diagnostic medical devices must be applied. Cornel is optimistic this change will improve the regulation of genetic testing.“In a few years time, it will be much better,” she said.
Santa Slokenberga, a postdoctoral researcher at Lund University and a researcher at the University of Uppsalas Centre for Research Ethics and Bioethics, said that under the old regulations, many DTC tests fell outside the legislations scope or were exempt. By contrast, the updated regulations are “a great step forward,” in her view.
A regulator with teeth
Some of the toughest regulations on DTC tests, on paper, are in France, where you can face a fine of up to €3,750. But the penalty has actually never been enforced, and consumers remain largely free to purchase the tests from companies outside the country.
“One can question what the point of the prohibition is, whether it still upholds the values it intended to protect, and if youre not diminishing the importance of the law if the norm isnt enforced when violations occur,” said Slokenberga.
In the U.K., where DTC testing is allowed, there are guidelines and recommendations around genetic testing. But as Anna Middleton, chair of the Association of Genetic Nurses and Counsellors, told the parliamentary inquiry last year, theres no real consequence for not abiding by themRead More – Source