DNA quest: genetic research data will be banned from being transferred abroad
The genetic data of Russians can no longer be simply sent abroad. The Russian Federation is preparing to introduce a complete ban on the transfer of information obtained during population and immunological research, as well as a special procedure for international scientific cooperation. The authorities motivate the decision by the danger of blackmail and discrimination. After all, unlike passwords or card numbers, the DNA profile cannot be changed, which means that the risks increase. Scientists worry that the restrictions will complicate bone marrow transplantation and hinder research that is important for creating new treatments. How to find a balance is in the Izvestia article.
Why do I need a ban?
Amendments to the draft law on tightening the rules for the transfer of genetic information abroad were approved by the government commission on legislative activity on Monday, February 16. This was reported to Izvestia by sources in the Cabinet of Ministers. In January of this year, the bill was adopted in the first reading.
In the current legislation, genetic data is subject to the regulation of the law on personal data, said Sofya Lukinova, head of the Legal Department of VMT Consult.
"Cross—border transfer is formally permissible if the established conditions are met: the informed consent of the data subject and the provision of an adequate level of protection by the receiving party," she recalled.
Any Russian citizen has the right to take a test in a foreign laboratory, send his DNA kit to a foreign company, or upload his genetic data to a foreign service, if the consent requirements are met.
The Russian government is currently creating a comprehensive legal regime for a new category of objects — human genetic data, Vladimir Gruzdev, Chairman of the Board of the Russian Bar Association, told Izvestia. The existing law on genetic engineering, adopted in 1996, is adapting to modern realities, where genetic information plays an important role in scientific research and digitalization.
— The project concept is aimed at three key objectives, — he said. — First, to subordinate the circulation of human genetic data to the general rules of state regulation in the biotechnological field.
Secondly, the amendments are aimed at legalizing the digital form of providing such information. This is critically important for integration with modern medical information systems and biobanks.
Thirdly, it is supposed to establish sovereign control over the cross—border flows of this data, introducing a permissive procedure for their transfer abroad and establishing an absolute ban on the transfer of data obtained during population and immunological research," explained Vladimir Gruzdev.
Any actions leading to foreigners' access to forwarding, distribution, publication on the Web and providing access to databases will be subject to restrictions.
It will be possible to transfer data only for medical care to a patient, the development and manufacture of medicines for a specific person, as well as within the framework of international cooperation in the field of health protection and biosafety. The transfer procedure will be set by the government.
"At the current stage of the development of science and technology, the collection, processing, storage, use and transfer of human genetic data is of exceptional importance for the security of the state and citizens," the explanatory note says.
It notes that the legal regulation of the exchange of genetic data should ensure a balance between the use of the results of scientific and technological development, the biological security of the state and the protection of data confidentiality.
"The amendments proposed by the bill will ensure the protection of the genetic data of Russian citizens," the document says.
The amendments to the approved bill introduce clear legal definitions, Vladimir Gruzdev added: "human genetic data" and "population genetic and (or) immunological studies."
Who will be able to collect the data
First of all, Russian companies will come under increased control, says Sofya Lukinova.
— They may be prohibited from transferring genetic data abroad, posting it on foreign servers and cooperating with foreign biobanks without special permission. Technically, such restrictions are implemented through Roskomnadzor's mechanisms, licensing, and localization requirements," the lawyer clarified.
For Russian genetic services, it is most likely that data storage requirements will be introduced in Russia, banning or severely restricting the cross-border transfer of genomic information, Sofya Lukinova believes.
It is legally and technically extremely difficult to completely block the leakage of genetic data abroad, the lawyer believes.
— Russian law cannot effectively prohibit a citizen from taking a DNA test abroad. And then it's impossible to track the self—shipment of samples to foreign laboratories," the expert said.
The leakage of genetic data carries certain risks, since the DNA profile cannot be changed, she pointed out. This data can be used for targeted blackmail, discrimination based on predisposition to diseases, or the creation of biological profiles of specific individuals or groups.
What risks will the restriction cause?
There are a number of myths in the field of genetic data, recalled Sergey Kharitonov, a molecular biologist and researcher at Lomonosov Moscow State University.
— For example, there is a legend that knowing the genotype of a person or a group of people, you can create a biological weapon aimed at them, — he said. — But this is fiction, in this sense, there is no biological danger.
The second aspect is legal. The genetic data obtained as a result of the tests is personal medical data protected by law.
— Their distribution is prohibited, — the expert emphasized. — We are talking, for example, about predisposition to certain diseases. Disclosure of such information may affect a person's reputation and personal life. Therefore, such data requires protection.
Also, research on the genetic data of different ethnic groups is mostly specific and transparent. They are aimed at studying the origin of the ethnic group and the ways of its migration.
"This information helps to better interpret archaeological finds," says Sergey Kharitonov. — Understanding the patterns of migration of peoples and the evolution of genotypes is essential for effective healthcare organization and the development of personalized treatment methods.
Yaroslav Sidorov, a geneticist, expressed hope that the new regulatory restrictions would not affect the work of national bone marrow donor registries.
"This aspect must be spelled out, as it is literally a matter of life and death," he said. — This can probably be done by maximizing the anonymization of data and a special clause that falls under the definition of "providing medical care."
Maria Posadkova, Associate Professor of the Department of Interdisciplinary Programs and Research in Law at the Higher School of Law of the Presidential Academy (RANEPA), said that an excessive ban on the cross-border transfer of genetic data may be disproportionate.
— For example, in their practice, doctors regularly face the search for donors of bone marrow and hematopoietic stem cells. An international donor bank is urgently needed for this, as the domestic registry is often insufficient. This situation is typical not only for Russia, but also for other countries," the teacher noted.
Companies that are engaged in the field of genetic research and processing of such data will have to rebuild, Yaroslav Sidorov believes. They will be forced to limit Russia's participation in population studies.
"This will affect international cooperation, as well as make it difficult to access the latest technologies in this area," he fears. — We will have to change some of the internal processes related to the processing and storage of genetic information of Russians.
Sergey Kharitonov called for a clear distinction between the two types of information. According to him, anonymous scientific information about the genetic diversity of populations in a certain territory should be highlighted.
"States should share such information as openly as possible, as it helps to study the human genome as a whole and accelerates drug development," the expert noted. — The second type is personal data obtained during medical examination or genetic testing. To transfer them, you need good reasons and the voluntary consent of the person to whom they belong. For example, with his participation in donor programs.
Since large amounts of personal genetic data began to accumulate relatively recently, states should respond to such challenges of the time and take measures to protect sensitive information about their citizens, experts say.
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