International Declaration on Human Genetic Data

In view of the complexity and scale of research in genetics, the Director-General of UNESCO in 2001 asked the IBC to examine the possibility of drafting an international instrument on human

495 _{Ibid., Article 12.} 496 Ibid., Article 13. 497 _{Ibid., Article 14.} 498 _{Ibid., Article 15.} 499 _{Ibid., Articles 16-17.} 500

Ibid., Article 18 para 1.

501 _{Ibid., Article 18 para 2.} 502 _{Ibid., Article 19.} 503 _{Ibid., Article 21.} 504

H. ten Have, "The Activities of UNESCO in the Area of Ethics", 16 Kennedy Institute of Ethics Journal, 2006, 331, 339, and, similarly, A. Asai/S. Oe, "A Valuable Up-to-Date Compendium of Bioethical Knowledge", 5 Developing World Bioethics, 2005, 216 et seq.

genetic data.505 _{In 2002 a first draft was sent to Member States of UNESCO, intergovernmental}

organizations, non-governmental organizations, specialists, professional research associations and many other organizations. As part of this consultation, a Public Hearings Day was held on 28 February 2003 in Monaco, and associations and institutions representing aboriginal groups, the handicapped, doctors and the private sector expressed their views.506 _{A revised version was}

subsequently adopted unanimously and by acclamation as the International Declaration on Human Genetic Data at UNESCO's 32nd General Conference on 16 October 2003.507 _{The adoption of the}

Declaration by UNESCO by acclamation should, however, not be confused with universal acceptance. States, such as the United States of America which in 2001 were not a member of UNESCO, have hence also not adopted and are not bound, morally or politically, by the provisions of the Declaration. As the other UNESCO standards the Declaration is legally non-binding and non-enforceable.508

The Declaration has 5 parts. In the first section, entitled general provisions, it specifies the

Declaration's aims, which are in particular “to ensure the respect of human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data, human proteomic data and of the biological samples from which they are

derived…[]…in keeping with the requirements of equality, justice and solidarity, while giving due consideration to freedom of thought and expression, including freedom of research.509 _{It thereby}

undertakes to define the principles that should guide States in formulating their legislation and their policies on these issues.510

Building on the premise that human genetic data are special and that such data deserves to be treated special,511 _{the Declaration sets forth a number of limitations and obligations for the}

collection, processing, use and storage of such data. Art 5 defines that such data may be collected, treated, used and stored for various purposes, including diagnosis and health care, research,

505

UNESCO, Webpage of the International Declaration on Human Genetic Data, note 4, at:

http://portal.unesco.org/shs/en/ev.php-URL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html (last visisted 16.10.10).

506 _{See IBC Report on the Public Hearings Day of 28 February, SHS/EST/CIB-Gred5/03/01, 2003. On public}

deliberations in bioethical processes see E. Blacksher/A. Diebel/P. Forest/S. Dorr Goold/J. Abelson, "What Is Public Deliberation?", 42 Hastings Center Report, 2012, 14 et seq. and K. O'Doherty/F. Gauvin/C. Grogan/W. Friedman, "Implementing a Public Deliberative Forum", 42 Hastings Center Report, 2012, 20 et seq.

507 _{Declaration on Human Genetic Data, note 4.} 508

See discussion under Chapter V 1.2. and 2.

509 _{Article 1 of the Declaration on Human Genetic Data, note 4.}

510 _{See UNESCO Press Release No. 2003-81, October 2003.}

511 _{Ibid., Article 3, defining human genetic data as "information about heritable characteristics of individuals}

obtained by analysis of nucleic acids or by other scientific analysis." 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."

forensic medicine and criminal proceedings or “any other purpose consistent with Human Rights principles.”512

With regard to procedures the Declaration calls for collecting, treating, using and storing data on the basis of transparent and ethically acceptable procedures.513 _{It proposes that independent,}

multidisciplinary and pluralist ethics committees should be promoted and established at national, regional, local or institutional levels.514 _{It also recommends that states should endeavour to foster}

all forms of ethics education and training as well as encourage information and knowledge dissemination programmes about human genetic data.515 _{Every effort should be made to ensure}

that human genetic data are not used in any discriminate way or in any way that infringes human rights of the individual.516

In section B the Declaration sets forth more specific limitations and obligations for the collection of genetic data. Informed and free consent should be obtained for the collection of such data.517 _A

person not able to consent should as far as possible take part in the authorization procedure of the collection of such data. Persons concerned have the right to decide whether or not to be informed of results.518 _{Appropriate genetic counselling should be provided.}519

Part C defines limits of the admissible processing of such data. The privacy and confidentiality of individuals and their genetic data should thereby be protected.520 _{They, for example, should not be}

disclosed to third parties, in particular, employers, insurance companies, educational institutions and the family.521 _{The accuracy, reliability, quality and security of these data should also be}

ensured.522

The permissible uses of human genetic data is regulated in section D. It limits the purposes of use to those stipulated for in Article 5. Any changes to that should be compatible with the prior, free, informed and express consent of the person concerned or must correspond to an important public

512 _{Ibid., specifying that human genetic data and human proteomic data may be collected, processed, used and stored}

only for the purposes of: (i) diagnosis and health care, including screening and predictive testing; (ii) medical and other scientific research, including epidemiological, especially population-based genetic studies, as well as anthropological or archaeological studies, collectively referred to hereinafter as "medical and scientific research"; (iii) forensic medicine and civil, criminal and other legal proceedings...; (iv) or any other purpose consistent with the Universal Declaration on the Human Genome, note 4, and the international law of human rights. On ethical analysis of some of these topics see Irrgang, note 131, 539.

513 _{Ibid., Article 6 clause a.} 514 _{Ibid., Article 6 clause b.} 515 _{Ibid., Article 6 clause c.} 516 Ibid., Article 7. 517 _{Ibid., Article 8.} 518 _{Ibid., Article 10.} 519 _{Ibid., Article 11.} 520

Ibid., Article 14 clause a.

521 _{Ibid., Article 14 clause b.} 522 _{Ibid., Article 14 clause c.}

interest reason and be consistent with the international human rights law.523 _{The cross-border}

flow of human genetic data should be supported to foster international medical and scientific cooperation and to ensure fair access to these data.524 _{Scientific and cultural cooperation, in}

particularly between industrialized and developing countries.525

Section E deals with the storage of human genetic data. Such data should be monitored and stored within a framework that is based on the principles of independence, multidisciplinarity, pluralism, non-discrimination, and transparency as well as the other principles set out in the Declaration.526

In the final sections the Declaration recommends that states should endeavour to provide ethics education, training and information.527 _{Again it relies on UNESCO, the IBC and the IGBC to}

contribute to the implementation of the Declaration and the dissemination of the principles set out therein.528

Overall the Declaration is important as it provides one of the few international points of reference in the area of collection and use of human genetic data.529 _{However, it has also been noted that the}

subject of genetics has regularly been subject to dramatic changes instigated by new findings in the natural sciences.530 _{As such the Declaration will be in need of frequent adaptations to}

accommodate the new realities.