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By giving bioethics a human face, UNESCO's much-maligned Universal Declaration on Bioethics is a triumph for the developing world, says Mônica C. Serra.

The 21st century has already witnessed radical changes — new possibilities in medicine and the life sciences, as well as environmental and social problems — that all point to the need for ethical debate at both the national and international levels. In this context, the guidelines for ethical conduct drawn up by the United Nations Educational, Scientific and Cultural Organization (UNESCO) are a laudable effort.

UNESCO has been concerned with bioethics for more than a decade. It created the International Bioethics Committee in 1993, and announced that bioethics was one of its priorities in 2000. The organisation has underlined its commitment to work on bioethics through the recent Universal Declaration on the Human Genome (1997) and International Declaration on Human Genetic Data (2003).

In October 2005, UNESCO's 33rd general conference adopted the Universal Declaration on Bioethics and Human Rights (UDBHR), which aims to set universal standards in bioethics, with "due regard for human dignity, human rights and freedoms".

UNESCO's member states, many organisations and experts were involved in drawing up this declaration, including the general public, through an online consultation. This is the first international bioethics text adopted by governments, that also commits governments. And, while the text has some specific shortcomings, its strengths are many and outweigh its weaknesses.

The weaknesses, in fact, are few. Declarations cannot, by their nature, exhaustively cover all needs and possibilities, but in the UDBHR the absence of norms concerning research on animals is noticeable. At certain points, such as the articles on protecting future generations and on risk assessment, the declaration is unclear, and at others it seems to repeat the content of existing international documents, particularly those concerning research involving people.

Making new progress

The UDBHR's statement that transnational research must undergo ethical review in both countries involved is very important, however. This obligation is also established, for example, in a resolution of Brazil's National Health Council concerning research funded by other countries and developed in Brazil. Bioethics education is another important concern of the declaration.

A new point, raised by developing countries and included in the UDBHR, is the notion of social responsibility — fostering human wellbeing. The declaration states that progress in science and technology should improve access "to quality health care and essential medicines, to adequate nutrition and water, improvement of living conditions and environment".

This might help to set a different agenda of bioethics, that considers not only the interests of developed countries — such as cloning, nanotechnology and other issues — but also poverty, food and clean water, for instance.

The declaration also urges a holistic interpretation of its principles, stating that they are to be understood "as complementary and interrelated". In the same way, all of UNESCO's three bioethics-related declarations should be read systematically, and not interpreted separately.

Consistent with international human rights, the UDBHR also sets limits on the application of its principles, in relation to public safety, the protection of public health, and the rights and freedoms of others.

So far, seven developed countries — Belgium, Canada, Germany, Japan, the Netherlands, the United Kingdom and the United States — have expressed support for the declaration. They have also presented, during the 33rd General Conference, their interpretations of several articles of the UDBHR, including those on human rights, medical intervention and research involving people (see the UNESCO conference draft report).

Belgium, Germany and the United Kingdom noted the article on protecting people without legal capacity to give consent. The United Kingdom, along with Canada and Germany, also particularly noted the article on privacy and confidentiality.

In this, Germany commented that "a change of purpose for the use of personal data requires a new consent by the person concerned", while the United Kingdom presented an exception to this principle, affirming that "confidential personal information should not be used or disclosed in a form that may identify the person concerned, but there are separate issues in the use of anonymous and non-confidential information".

Meanwhile, the United States expressed its understanding that the declaration is to be "understood in a manner consistent with their domestic law". And in the context of intellectual property, it affirmed that "the right to own property is a basic right, on which so many others depend, and everyone has the right to the protection of the moral and material interests resulting from their scientific, literary or artistic production".

A developing victory?

During discussions on the text of the declaration, representatives of developing countries succeeded in extending its scope beyond the biomedical and biotechnological to social and environmental bioethics.

Article 1, for instance, says that the declaration "addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions".

Other articles meanwhile aim to shorten the knowledge and other gaps between developed and developing countries. Article 2(vi) seeks to promote equal access to "medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge" from those developments, as well as the sharing of benefits.

Article 15(a) reflects this by stating that any benefits arising from research and its application should be shared with "society as a whole and within the international community, in particular with developing countries". And Article 24(a-b) says that states should "encourage the free flow and sharing of scientific and technological knowledge", and enter into agreements that allow developing countries to build capacity to participate in generating and sharing scientific knowledge and the benefits from it.

All this is significant. In fact, the Brazilian Bioethics Society stated that the final text of the UDBHR could be considered a great victory for developing countries. Representatives of other Latin American countries endorsed this view during the sixth Brazilian Congress of Bioethics in August and September 2005.

The Brazilian Ministry of Science and Technology advised the Brazilian delegation that participated in UNESCO's discussions about the UDBHR. According to the ministry, the UDBHR text was extended to cover issues concerning human life, social inclusion, access to health and medicines and environmental questions. Brazil and other Latin American countries played an important role in this advance.

Developed nations' interpretation of specific provisions of the UDBHR, and developing countries' expectations, can be very different because their needs and conditions are different. However, the declaration's principles and statements can help both developed and developing countries to formulate their national policies, legislation or other instruments according to their own realities.

The time is right for a declaration on bioethics and human rights. Despite its flaws, the UDBHR will help people contemplate ethical issues, and help nations establish bioethics and human rights guidelines. Ultimately, this declaration may help humanity forge a more ethical era.

Mônica C. Serra is post-doctor in bioethics and professor of bioethics at the Araraquara Faculty of Dentistry, São Paulo State University, Brazil.

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