The European Union and genetic information: time to act

Mats Engström
28 July 2003

“Seeing the results of your Genovations test is like seeing the cards you’ve been dealt by Nature. Once you know the cards, you can develop the most effective strategy to play out your hand.”

The glamorous website is promising me a route to better health. For a significant amount of dollars, Genovations, a US company, is prepared to tell me if I am in danger of getting heart disease, osteoporosis or a number of other diseases. All that I need to do is convince a doctor to make a simple test and send it to Great Smokies Diagnostic Laboratory.

The number of genetic tests has increased substantially over the last few years. A small sample of tissue is enough to map the client’s genome and analyse it for possible variations of genes, linked to a higher possibility for inherited diseases. Marketing is not limited to physicians and other professionals in healthcare. As the Genovation example shows, the general public is an important target group.

Behind this new technology are a number of scientific and technological breakthroughs. The mapping of the human genome is being followed by the linking of individual genes to certain diseases. Other applications are under way. Screening of a large part of the population is being made simple and less expensive. Genetic therapy, changing the DNA, has the potential to prevent diseases but raises difficult ethical questions. This technological revolution might be slower than heralded in some of the dramatic tabloid headlines. But it does bring both substantial benefits and risks.

Many of the medical advantages should be welcomed. But some tendencies are worrying. Still, in Europe political debate on the use of genetic information is limited. In cases such as genetic testing, marketed directly to the general public, commercial interests seem to have the upper hand when it comes to medical and bioethical recommendations. Genetic testing also brings with it the risk of discrimination in the work place and in insurance. The struggle over the ownership of genetic information is another important issue.

Why regulation is necessary

Tom Miller argues in his openDemocracy article that we should “restore and renew our commitment to competitive markets, private property rights and private contracts”, rather than rely on regulation of genetic information. Miller points at the difficulties in limiting the use of genetic data. “There is no clear line that separates genetic data from other kinds of personal health information”, he writes. Maybe not, but does that mean that it is wrong to regulate?

Making definitions is an important task of most legislation, and is not impossible in this case. For example, DNA analysis has to be differentiated from asking what diseases close relatives have. “One’s risk to privacy should not include the right to misrepresent oneself to the rest of the world”, Miller states. No, but it depends on what the question is. Take the comparable case of the employer who asks a woman if she is planning to have children, but in a similar family situation does not ask the men the same question.

When it comes to discrimination, the problem often lies in the question. Asking for genetic information places employees and people seeking insurance in a difficult and often unjustified situation. “We do not provide subsidies for other forms of bad luck in life’s genetic lottery, such as less desirable levels of traits such as intelligence, aggressiveness or physical appearance that have at least some genetic roots”, Miller also claims. That is a rather cynical way to look at the case of people with some risk for breast cancer or other inherited diseases being refused jobs or insurance, before any symptoms have appeared.

Contrary to Tom Miller’s view, there are a number of reasons why political action is needed:

  1. It is easy to use genetic information for purposes which can have negative effects for the individual, causing stigmatisation or discrimination.

  2. Genetic information can have significant effects on relatives to the individuals being tested. Their interests also have to be safeguarded, which is difficult to achieve in a private contract between an individual and the part testing or requiring information.

  3. For the individual, genetic information can be hard to deal with. There is a substantial need for genetic counselling, but resources are limited. Thus, there is a significant risk that people are left on their own to deal with information of an existential nature.

  4. Privacy of personal data is an area where most of us accept legislation. The EU, for example, has a strict directive on data protection, but the application to genetic information is unclear. Meanwhile, even a small test sample contains large amounts of sensitive data.

  5. The threat of genetic discrimination could lead individuals not to participate in health examinations, fearing that the information could be used against them. In February 2000, US President Bill Clinton signed an executive order banning the federal government from using genetic testing in employments decisions. One of his arguments was a study in Pennsylvania showing that nearly one third of women at high risk for breast cancer refused to be tested because they feared discrimination based on the results.

  6. On a larger scale, genetic information should be considered a common good, not a commercial item. The debate on this strand on gene banks illustrates this point well. Tiina Tasmuth’s, Skúli Sigurdsson’s and Helen Wallace’s articles on the Estonian, Icelandic and British cases show the risks involved if commercial interests are given too much leeway. It is necessary to protect both the integrity of the individual and the benefits for society as a whole.

Tom Miller is right in stating that genetic knowledge so far is limited. But the problem is that many could act on the simplified views currently being put forward by private companies and the media.

National action is not enough

Thus, political action is needed. In some countries, this is already happening. Norway implemented a law on genetic testing as early as 1993 (Bioteknologiloven). It bans the use of genetic tests, except in some special cases. Austria and France have similar legislation, limiting the use of genetic tests to medical, scientific and juridical applications. The US Congress is preparing legislation against genetic discrimination. Many states in the US have already enacted such laws.

National policies do not suffice when international pressures are strong. The results of genetic tests can be ordered over the internet, and reported back the same way. National legislation can be challenged within the World Trade Organisation. As pointed out by Francis Fukuyama in his recent book Our Posthuman Future, in the absence of global rules on biotechnology, the preference of the WTO in such cases would probably be to safeguard free trade. Increased transfer of medical data, for example, within multinational pharmaceutical companies, is another factor in determining the effectiveness of national legislation.

So far, efforts for international regulation have not been effective. The 1997 European Convention on Human Rights and Biomedicine includes an article prohibiting discrimination on genetic grounds, and restrictions for genetic testing. However, the practical results of the convention are limited. Only four of the present EU member states have ratified it – Spain, Portugal, Greece and Denmark. The Universal Declaration on the Human Genome and Human Rights, adopted by UNESCO in 1997, states that no-one should be subject to discrimination on genetic grounds, and that genetic information should be confidential. But the declaration is not legally binding.

What the European Union should do

The European Union has the economic and political pull to influence global rules for biotechnology. Its voice in the WTO is much stronger than conventions agreed within the Council of Europe or UNESCO declarations. This is one reason why an EU policy is urgently needed.

Another reason is the establishment of a European internal market for services. It will probably lead to a gradual harmonisation of legislation between EU member states. When insurance companies are free to operate on the whole European market, they will demand a level-playing field in much the same way that the internal market for goods has led to a harmonisation on product standards and environmental protection. In this perspective, it is necessary to formulate a coherent view among EU member states on the use of genetic information.

Thirdly, today’s information and communications technologies (ICT), give new impetus to transnational use of medical data. In July 1999, the European Commission’s Group on Ethics in Science and New Technologies stated: “ICT creates the potential for the free circulation of personal health data, across local, national and professional borders, giving such data an enhanced European dimension.”

There might be reasons to keep responsibility for many bioethical questions confined to member states. But, given the link to the internal market and world trade, the use of genetic information will necessarily have a European and an international aspect.

The Charter of Fundamental Rights, declared by the European Parliament, Council and Commission in December 2000, includes an article 21 on non-discrimination, specifically banning discrimination on genetic grounds. It also includes an article 3 on the integrity on the person, inter alia prohibiting reproductive cloning, eugenic practices and “making the human body and its parts as such a source of financial gain”.

The European Convention proposes that the Charter is included in the new Constitution. However, the result of the Convention and the forthcoming Intergovernmental Conference is likely to confirm the limited binding status of the Charter. Important principles in articles 3 and 21 will have to be implemented through secondary legislation:

  1. EU legislation should be widened to include genetic discrimination. Currently, the relevant directives cover discrimination on grounds of sex, racial and ethnic origin, religion and belief, disability, age and sexual orientation.

  2. Presently, member states are able to legislate on the information insurance companies may require for their customers. Some member states, such as Austria and Denmark, have prohibited asking for genetic information. If, as a result of the internal market in financial services, the scope of legislation on information is limited, the EU should simultaneously enact rules on a high level of protection for the individual in relation to insurance companies.

  3. The use of DNA testing rapidly increases in criminal matters, prevention of terrorism and treatment of asylum seekers. It becomes a European matter through the intensifying cooperation in justice and home affairs. It is crucial to strike a balance between the general interests of the society and personal integrity. Presently, it seems that such testing and the resulting information is used without enough consideration for the privacy aspect.

  4. The EU directive on in vitro diagnosis deals with equipment used for taking samples from an individual and analysing them for a medical diagnosis. It formally includes genetic tests. However, the directive needs revising to take account of the need for stricter demands on the quality of such methods. Even when this law has been revised, member states should have the right to introduce stricter rules for the marketing of genetic tests.

  5. The public good of genetic information has to be safeguarded. Yes, there is a need for a certain protection of intellectual property rights for medical and pharmaceutical companies. However, national rules for gene banks vary across Europe and are often unsatisfying. At the same time, joint European research and commercial cooperation is becoming even more intense. A clear protection of personal integrity and public goods must be made a prerequisite for the EU funding of gene banks and the research done in them.

  6. The genetic information revolution has many potential effects that are not clearly understood today. The EU should intensify its work on technology foresight, in cooperation with member states.

The Group on Ethics in Science and New Technologies recently called for urgent policy action on genetic testing. A special Committee in the European Parliament presented its analysis and proposals in November 2001 (the Fiori report). “It is highly likely that, following the lines of the 1995 Directive on data protection, European legislation will need to be drawn up on the use of tests at the time of taking up employment or taking out insurance”, the report said.

But this has not been followed by concrete measures. Instead, the Fiori report was rejected. In the Commission strategy on biotechnology put forward to the European Council in Barcelona last year, genetic information plays a minor role. Council conclusions and recent follow-up to the strategy have not emphasised these aspects.

In many other cases, we regard a pluralist society as an asset, and regulate to protect against discrimination. This should also be the case for genetic differences. The European Union urgently needs a policy for the use of genetic information.

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