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EuroGentest Project Aims to Standardize Genetic Rights Across EU Member States

Two reports recently released by EuroGentest outlining patients’ genetic rights in Denmark and the Czech Republic are the first in what will be series of such explorations that aim to create universal patient rights across the European Union’s 27 member states.
With the “Patient Rights in the EU” series of reports, EuroGentest is attempting to standardize the quality of genetic testing among member states, not just in terms of quality and technical requirements, but also the legal and ethical aspects of the healthcare provider/patient relationship.  
The €10 million ($13.6 million) EU-funded project is an effort to “embed the rights of users of genetic [testing] services in the more general European legal protection of patient rights,” EuroGentest member Herman Nys told Pharmacogenomics Reporter last week in an email.
“Equality of treatment, which is one of the pillars of European law, does not allow that EU citizens are treated differently as patients,” said Nys.
The project aims to establish a network of excellence in genetic testing. According to Nys, EuroGentest plans to map all 27 EU member states, a process that promises to be time consuming due to language barriers and changing legislation in the individual countries.
Such a project has never before been attempted, Nys said. According to Nys, past efforts to establish healthcare rights of patients in EU states have not been comprehensive enough.
Although EuroGentest’s reports would not be legally binding to the member nations, the documents will have the ability to influence policy decisions and possibly encourage changes in established regulations of member states.
“There is no legal weight of these documents,” EuroGentest member Milan Macek wrote to Pharmacogenomics Reporter last week. “However, they will be used as role models at major law schools and schools of medicine in [Czech Republic cities] Brno and Prague. Moreover, the Czech Society for Medical Genetics has endorsed the document.”
Any effort to align genetic rights across all 27 member states promises to be challenging, given the diversity among EU member nations. “Due to cultural, religious, and other reasons there will always be differences in the protection of patient rights,” Nys acknowledged.
The scope of work that lies ahead for EuroGentest is evident in the vast difference between the Czech Republic and Denmark reports, which were issued on the 10th anniversary of the European Convention on Human Rights on Biomedicine.
“Despite the two countries ratifying the Convention, the authors discovered significant differences between patient rights on issues such as informed consent, confidentiality, access to records, insurance and employment,” EuroGentest said in a statement.
Eastern Block
According to Nys, a comprehensive legislative framework of patient rights does not exist at the moment in the Czech Republic.
“Despite the fact that [it has been] 17 years [since the] so-called Velvet Revolution, the legislative process is painfully slow and many norms are lacking,” Macek said.
Macek heads the National Center for Cystic Fibrosis in Prague, which provides diagnostic services to 75 percent of the Czech population for mutation analysis in the CFTR gene.
While genetic rights of patients in the Czech Republic are “sketched” in the legal framework of the country, they are dated and do “not correspond to the actual needs of protection” for patients, EuroGentest’s report states.
There are provisions under current Czech law requiring geneticists to for example, respect a patient’s right to informed consent and to medical confidentiality.
Yet, implemented by individual judges and the so-called Czech Public Defender of Rights, these regulations are “incorporated fragmentally and incompletely into the legislation,” Nys said.
The report’s authors pointed out the need for the Czech Republic to specify its genetic antidiscrimination laws and confine genetic testing to health purposes only.
Article 3, Section 1 of the Czech Charter of Fundamental Rights and Freedoms guarantees fundamental human rights and freedoms to people, but does not spell out the status of genetic discrimination. However, the EuroGentest report suggests that article 11 of the EU’s Biomedicine Convention, which states that “any form of discrimination against a person on grounds of his or her genetic heritage is prohibited,” should be applied to the Czech Republic.
Similarly, in the Czech Republic there is no law relegating the use of diagnostic tests for health purposes only. However, article 12 of the Biomedicine Convention does spell out such a restriction and advises that such testing should be performed with appropriate genetic counseling. “Like article 11 of the Biomedicine Convention, this article is directly applicable to the Czech Republic,” the report states.
Great Dane
As of this year, Denmark implemented a new patient rights act delineating provisions for privacy, insurance and employment. However, “there are still gaps in certain areas such as rights of minors,” Nys said.

“Equality of treatment, which is one of the pillars of European law, does not allow that EU citizens are treated differently as patients.”

Under Danish law, children 15 years and older can provide informed consent, but parents must be informed and involved in any decisions. Under the age of 15, children must acquiesce to their parents’ decisions.

Similar to the Czech Republic, Denmark doesn’t have non-discrimination rules specific to genetic testing. However, the non-discrimination rule in the European Convention on Human Rights was incorporated into Danish law and serves as a “general non-discrimination clause.”
The more modern protections under Danish law provide a level of protection against abuses based on genetic information. The report highlights the case of a woman who was not accepted as an adoptive mother because her family had a genetic predisposition to cancer. The woman had refused the adoption authorities’ demands to take a genetic test.
However, the Danish legal system offered this woman opportunities to challenge this decision. She appealed the case citing Articles 11 and 12 of the Biomedicine Convention, the EuroGenetest report states. Ultimately, Denmark's Patient Complaints Board found that the adoption authorities did not have the authority to demand a genetic test.
According to Nys, EuroGentest’s efforts may not be received favorably by all geneticists in Europe. However, establishing people’s genetic rights is an inevitability given advances in therapeutic and diagnostic treatments.  
Currently, there are 1,500 genetic testing centers in Europe testing more than 1,000 disease conditions. Standardization of genetic testing services and establishing people’s genetic rights in member states are critical since 30 million people in the EU are suffering from a genetic disease, costing the health sector €500 million each year.
Although geneticists in Europe “are well aware of their obligations toward users of genetic services,” EuroGentest’s efforts may “give the impression”  that the relationship between the geneticist and the patient will become mired in regulations, standards, and codes, Nys said.

“However, legally and ethically there is no way back,” he said. “Genetic services are health services and users of genetic services have to be treated as users of health services in general.”

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