“Every effort should be made to ensure that human genetic data and human proteomic data are not used for purposes that discriminate in a way that is intended to infringe, or has the effect of infringing human rights, fundamental freedoms or human dignity of an individual or for purposes that lead to the stigmatization of an individual, a family, or a group or communities,” reads one of the provisions of the International Declaration on Human Genetic Data, which has just been adopted by the UNESCO General Conference meeting in Paris for its 32nd Session.
With the Declaration, human genetic data now have their own standard-setting instrument, laying down the ethical principles that should govern their collection, processing, storage and use. Collected from biological samples (blood, tissue, saliva, sperm, etc.), human genetic data play an increasingly important role in our lives. They are allowing scientists to identify, in advance, the diseases that threaten us, and they hold the promise of new cures. Genetic data banks, furthermore, are multiplying and expanding all over the world. And certain countries are undertaking a genetic census of their population. Such data are also providing answers to a number of questions - concerning paternity, for instance, or the identity of law-breakers - posed by judges or police.
In view of this rapid and not always orderly development, common ethical guidelines needed to be defined. UNESCO Director-General Koïchiro Matsuura stressed the urgency for this in his speech to the General Conference on September 30: “I could never overstate the urgency with which we must adopt such a declaration, because every day brings more new experiments and initiatives, some of which could have irreversible consequences.”
UNESCO - which had previously developed the Universal Declaration on the Human Genome and Human Rights, adopted in 1997 - began an examination of human genetic data issues through its International Bioethics Committee (IBC). The Declaration now adopted is the result of the committee’s deliberations, but also of an extensive international consultation, which included, notably, a governmental experts’ meeting last June. Discussions on the Declaration’s content continued up until its adoption, to take into account the widest possible range of situations (including unequal scientific development, but also more or less developed legislation in this domain).
A declaration, which is not a legally binding instrument, was chosen instead of a convention to facilitate consensus and allow for adaptations in a domain where the variety of situations covered, and the complexity of the subject, is constantly evolving with new scientific discoveries.
The Declaration’s objective is clearly stated - to ensure the respect of human dignity and the protection of human rights and fundamental freedoms, in keeping with the requirements of equality, justice and solidarity, while giving due consideration to freedom of thought and expression, including freedom of research. It undertakes to define the principles that should guide States in formulating their legislation and their policies on these issues.
According to the Declaration, “Each individual has a characteristic genetic makeup. Nevertheless, a person's identity should not be reduced to genetic characteristics, since it involves complex educational, environmental and personal factors and emotional, social, spiritual and cultural bonds with others and implies a dimension of freedom.”
The respect of international laws protecting human rights is the principal safeguard established by the instrument. It is a recurring theme, evoked in each instance that the Declaration allows exceptions or restrictions to the major principles it sets out.
The specific nature of genetic data and the purposes for which they should be collected, treated, used and stored are also defined. Concerning procedures, the Declaration calls for collecting, treating, using and storing data on the basis of transparent and ethically acceptable procedures. It proposes that independent, multidisciplinary and pluralist ethics committees should be promoted and established at national, regional, local or institutional levels.
At the collection stage, the Declaration emphasizes “prior, free, informed and express consent, without inducement by financial or other personal gain” of the person providing the data. Limitations are possible but “should only be prescribed for compelling reasons by domestic law, consistent with the international law of human rights.” The right to withdraw consent is affirmed, “unless such data are irretrievably unlinked to an identifiable person.” The right to decide whether or not to be informed of research results is also considered and the Declaration recommends that genetic counselling – non-directive, culturally adapted and consistent with the person’s best interest - be made available when genetic testing that may have significant implications for a person’s health is being considered.
The key issue at the processing stage is confidentiality. The Declaration stipulates that genetic data linked to an identifiable person not be disclosed nor made accessible to third parties, in particular employers, insurance companies, educational institutions and families, except for an important public interest reason in cases restrictively provided for by domestic law that is consistent with the international law of human rights. “The privacy of an individual participating in a study using human genetic data, proteomic data or biological samples should be protected and the data should be treated as confidential,” adds the text.
Change of purpose is the main topic discussed at the use stage. The Declaration considers that data collected for one purpose should not be used for a different purpose that is incompatible with the original consent. Concerning sharing benefits, the text affirms, “In accordance with domestic law or policy and international agreements, benefits resulting from the use of human genetic data, proteomic data or biological samples collected for medical and scientific research should be shared with the society as a whole and the international community.”
At the storage stage, the problem of cross-matching is anticipated: “Consent should be essential for cross-matching human genetic data, proteomic data or biological samples stored for diagnostic or and health care purposes and for medical and other scientific research purposes, unless otherwise provided for by domestic law for compelling reasons and consistent with the international law of human rights.”
The final articles of the Declaration cover its promotion and implementation. Action in the sphere of education, training and public information is recommended. The text also calls for entering into bilateral and multilateral agreements enabling developing countries to build up their capacity to participate in generating and sharing of scientific knowledge concerning human genetic data and related know-how. UNESCO’s International Bioethics Committee (IBC) and Intergovernmental Bioethics Committee (IGBC) are called upon to contribute to the implementation of the Declaration and the dissemination of the principles it sets out.