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Council of Europe Protocol on Genetic Testing Could Serve as Blueprint for New Laws

NEW YORK (GenomeWeb) – The Council of Europe's new protocol on genetic testing recently came into force, roughly a decade after members of the 47-member organization created the rules as an addition to the Convention on Human Rights and Biomedicine.

The governments of five countries Norway, Montenegro, Moldova, Slovenia, and Portugalhave now ratified the protocol, meaning that, according to the rules of the Council of Europe, it is now considered to be in force.

In addition, five other countries the Czech Republic, Finland, France, Iceland, and Luxembourg have signed the protocol, signifying their intent to eventually ratify it.

The Council of Europe's protocol, available here, outlines specific rules for genetic testing for health purposes, including rules that could impact consumer genomics test providers. According to experts, the protocol could lead to greater regulatory harmonization in Europe, where every country has its own national legislation covering genetic testing. It could also provide guidance for countries that have not yet enacted their own legislation covering genetic tests.

"The impact of this work is not limited to those countries that are bound by [ratifying] the text," noted Laurence Lwoff, head of the bioethics unit at the Strasbourg, France-based Council of Europe. Lwoff, who has written previously about the protocol, noted that German legislators, for instance, "took on board certain provisions" in the protocol directly into the German law covering genetic testing, the German Genetic Diagnostics Act, which the country adopted in 2010.

"There is a formal impact on those who are ratifying the protocol, and it is five at the moment," said Lwoff. But it has "been a source of inspiration for other countries in the development or revision of their national laws."

"We still have countries that have absolutely no legal provisions on genetic testing," she added. "The idea was that the protocol would enable those countries to have a basis for developing their own national legislation."

The protocol was originally drawn up in 2008 as an addition to the Convention on Human Rights and Biomedicine, commonly called the Oviedo Convention. Twenty-nine Council of Europe member states have ratified the convention, yet only 10 have signed the additional protocol on genetic testing, and it has taken a decade for five of those countries to ratify it. Only after five countries ratify the protocol is it considered by the Council of Europe to have come into force.

The stated purpose of the protocol is to "protect the dignity and identity" of people being tested for health purposes, but it does not apply to prenatal testing or to testing for research purposes.

The tests discussed in the protocol include chromosomal analysis, as well as analysis of DNA and RNA. The protocol provides measures for ensuring quality control of genetic testing services, including quality assurance programs, and supervision of testing by certified individuals.

The protocol further addresses a need for informed consent prior to testing, genetic counseling of individuals undergoing testing, and rules governing authorization of testing for individuals who have not yet reached adulthood. Lwoff noted that this aspect of the protocol specifically suggests that genetic testing on children should be postponed until adulthood except if it is shown to benefit the health of the child before he or she reaches maturity.

"That is important when you think about testing at birth and so forth and is especially important in the context of whole-genome sequencing," said Lwoff. "This is to the best of my knowledge the only legally-binding instrument setting up a principle like this at the European level," she added. "There is always the right not to know, and if there is no benefit for the child, it should be postponed."

The protocol also discusses principles related to individuals' right to access information collected about themselves. Any conclusions drawn from a test should be accessible to the person concerned in a comprehensible form, it states, and any biological sample should be stored in a way that protects the confidentiality of the individual.

While it does not explicitly discuss tests offered by consumer genomics firms, Lwoff said that the aspects of the protocol governing privacy, as well as counseling, should inform the ways in which companies offering such tests interact with customers.

"When it comes to direct-to-consumer tests, there was a lot of concern expressed in terms of the conditions under which those tests are offered, plus the fact that there is a limited ability to enforce national legislation on tests that are sold via internet by [entities in] other countries," Lwoff said.

"They decided to focus on the essential criteria that needs to be met for those tests to be considered acceptable," she said. "I think the issues of genetic counseling and individual assessment were extremely important and are conditions that are not currently met by some companies offering DTC testing."

Currently, in France and Germany national legislation more or less prohibits the sale of direct-to-consumer tests.

"I think those companies are offering consumer tests rather than healthcare, and they do not take into account the particular situation of the person concerned, which obviously has implications on how you interpret the outcome of the test results," commented Lwoff.

"It leaves the person without necessary support to clearly understand what their results mean," she said. "That is where the concern is, hence, the approach taken by the provisions in the protocol."

Of the 10 countries that have signed the protocol, France, with a population of 67 million, is by far the largest. Anne Cambon-Thomsen, head of research for epidemiology and public health at the French National Center for Scientific Research (CNRS), said that she does not believe France will ratify the protocol until it revisits its own legislation covering genetic tests.

"Ratifying the protocol is giving it legal power in your country," Cambon-Thomsen noted. "That means not only do you refer to it as a reference for guiding principles, but it is a legal obligation to apply it," she said. French authorities will likely make sure their own legislation covers the principles laid out in the protocol before formally adopting it. "It sounds logical to me," she said.

Cambon-Thomsen said the other signatories to the protocol that have not yet ratified it are likely revisiting their national legislation covering genetic testing. And, she noted, other countries that have not yet signed or ratified it might look to adopt it in lieu of drawing up their own national regulations.

"In some countries there is no precise legislation on genetic tests," said Cambon-Thomsen. "These texts provide a legal framework that has been discussed at many levels involving different countries," she said. "It is quite a strong document with different aspects."

In general, Cambon-Thomsen said that French regulations are not very different from the principles laid out in the protocol. "I think the French regulations are even more restrictive," she said. "For instance, French genetic testing regulations apply to clinical application but also research," she noted.

As such, countries that ratify the protocol are free to add even more restrictions on testing should they deem it necessary. "This does not prevent any country signing and ratifying it to add changes," Cambon-Thomsen pointed out. "They cannot do less or contradictory regulations, but they can do additional ones."

According to Lwoff, other countries that have signed the protocol are in the process of adopting it. She said that the Czech Republic is one of the signatories that is getting closer to ratifying the protocol.

In addition, in line with the protocol, the bioethics unit at the Council of Europe has developed an 11-page document concerning genetic testing for health purposes, including the variety of tests available, such as pharmacogenomic or consumer genomic tests. Lwoff said the leaflet, available in 20 European languages, is aimed at providing the public with general information about genetic testing.