A blood test can reveal important information about your risk of breast cancer — but the law hasn’t fully caught up with its consequences. BRCA1 and BRCA2 – short for BReast CAncer gene – are the two genes associated with an elevated risk of especially breast and ovarian cancer. People assigned female at birth with a BRCA1 mutation have an approximately 80% risk of breast cancer, and 60% risk of ovarian cancer, compared with 10% and 1%, respectively, in the general population. Approximately 1 in 400 people is a BRCA mutation carrier. Within 4-6 weeks after taking a blood test, a healthy individual could learn that they may need to enrol in an early monitoring cancer programme, involving frequent and multiple health screenings and preventive surgeries.

The current legal framework in Europe

There is no common European approach to BRCA testing, and the eligibility requirements for the tests differ among the countries. At EU level, the main legal provision is Art. 3 of the Charter of Fundamental Rights, which provides for the integrity of a person, and especially in the fields of medicine and biology requires a “free and informed consent”. Art. 21 of the charter prohibits discrimination, based amongst other things on “genetic features”.

The Council of Europe (CoE) 1997 Convention on Human Rights and Biomedicine is the only legal act at European level, aimed at the protection of human rights specifically in the area of biomedicine, and draws on the values of the European Convention on Human Rights. Especially relevant in the context of BRCA testing is the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, which deals with the procedures for conducting the genetic testing, the rights of the patients before, during and after the procedure. However, only a small number of the CoE countries signed and ratified the Convention on biomedicine, even less countries signed and ratified the Protocol, which means that both these legal acts remain unenforceable in the majority of the CoE member states. Czech Republic, Portugal and Slovenia are the only EU countries where the Protocol is in force. A positive BRCA test result is just a prelude to many questions to which the law in Europe does not have a clear answer. These questions may cover the issues of procreation, privacy or getting an insurance.

Procreation

There is a 50% chance of passing a BRCA mutation on to one’s offspring – regardless of their gender. Studies prove that knowledge of being a carrier impacts the decisions on having biological children. How could the law help, though? Should access to pre-natal diagnostics (PND) be offered? Or an in vitro fertilisation, which would allow to screen the embryo for the mutation? PND is possible, but controversial: BRCA mutation is not related to a fatal illness, ‘only’ to a probability, however high, of such an illness. Equally, in some countries abortion is permitted in cases of severe or fatal foetal illness. This raises the question whether a confirmed BRCA mutation would also qualify as sufficient grounds.

Privacy

Genetic test results may be relevant to other family members, who might be carriers as well. To what extent is it justified to place the obligation on the carrier to inform their family about the test result? This raises concerns about the carrier’s right to privacy (Art. 8 ECHR). Would this interference be justified by the rights and freedoms of other people, especially given that the risk of developing cancer for healthy individuals, while high, remains hypothetical?

There are no laws or other guidelines at European level, except for the above-mentioned protocol on genetic testing, which in principle considers the individual patients as “”. In Germany, for instance, an individual informed of their genetic test result is notified in the same letter that they are under no legal obligation to disclose the results to anybody. Prior to testing, they are asked to sign an informed consent form for the test results to be accessed by first and second grade relatives – which they are free to decline. The right to privacy is the main value protected and takes precedence over the rights to know medical information of biological family members. In France, however, there is an obligation to inform other family members who could also be mutation carriers.

Insurance

Learning about carrying the BRCA genetic mutation may be linked to financial consequences, and lead to so-called “”. Insurance providers informed of genetic mutation might limit the options available or increase the cost of the insurance. By virtue of the Genetic Information Nondiscrimination Act 2008 (GINA), US patients are protected better than their European counterparts. In accordance with GINA, insurance companies may not take into account genetic conditions during risk assessments, including the results of BRCA testing. Hence, carriers are not at risk of paying higher contributions or being denied certain services altogether.

In the EU, according to a , only Belgium, Croatia, France and Portugal explicitly prohibit discrimination based on genetic features/heritage. In Germany, one is informed by the medical personnel that the insurers may ask about genetic test results in life insurance contracts exceeding 300.000 Euros. There are fears that protection from genetic discrimination may be , due to the lack of a legal definition of “genetic data” and its clear distinction from non-genetic data. Some people already undergoing BRCA testing for fear of genetic discrimination from insurers and employers.

Conclusion: need for more legal protection

Depending on where they live in Europe, people who receive a positive BRCA test result may have access to in vitro fertilisation and pre-natal diagnostics, or not. In some cases, they might have to balance their interest in getting tested against their insurance needs. There appears to be a gap in the law, which should be preferably rectified at a European level, in order to offer the BRCA mutation carriers more protection and legal certainty.

 

Kaja Kaźmierska is a research fellow at the Institute of Social Sciences  at Humboldt-Universität zu Berlin since March 2021. She works on the research project “Judicial autonomy under authoritarian attack” and on her PhD examining the challenges to the independence of the CJEU and the ECtHR. Before joining the HU, Kaja worked for over four years as a legal analyst in the area of EU law in a consulting company, Spark Legal Network, in London. She also underwent internships in the European Commission, the Council of Europe and various Polish embassies. Kaja studied English, German and European law at King’s College London and Humboldt University. She has a M.A. in EU International Relations from the College of Europe, Bruges. She speaks Polish, English and German fluently and has an advanced knowledge of French and Italian.