European committee on human genetics issues report with guidelines on genetic engineering

Brussels 13 November 2001The European Parliament committee on human genetics has called for a public debate on genetic engineering. In a report on the social, legal, ethical, and economic implications of human genetics adopted on 6 November, the committee stated that the development and use of human genetics should be based on ethical principles. The report, prepared by the Parliament's temporary committee on human genetics and other new technologies in modern medicine, equally called for the launch of a public debate on the use of genetic engineering.


The committee added that "researchers, business circles, standard-setters and social players need to be encouraged to engage in dialogue" on new technologies in order to enable "responsible choices" to be made and supported by policy decisions. The report emphasises that although "science and research must be free", this freedom should be limited "on account of the need to protect the dignity of the individual and the fundamental rights of every human being", adding that biomedical research should aim to "benefit humankind as a whole and future generations".

In the report, the committee calls for a "harmonised regulatory framework" on new biomedical research "to be recognised in all parts of Europe", giving clear guidelines on development and scientific and technological procedures. The report calls for the Commission to make the necessary moves to establish a legal and regulatory framework on genetic testing in Europe in order to guarantee quality and safety, ensure access to information, safeguard privacy, and prevent discrimination on the basis of genetic differences. It also advocates the creation of a European laboratory network on rare diseases.

The committee emphasised that a harmonised regulatory framework needs to be established on the development, testing, and approval of new biomedicines as divergent national rules make it "difficult to develop and test new biomedicines on an EU-wide scale, although these are activities that should be encouraged". It notes that further research on biomedicines could have significant health benefits for European citizens and encourage further investment in European science and the pharmaceutical industry. Benefits, according to the report, are threatened by "rigid or overcautious public policy rules".

The report adds that patents "pose new problems when they apply to biological material and especially the human genome" and calls for clarification on the interpretation of the unpatentability of the human body as set out in Directive 98/44/EC, which forbids patenting of the human body, biological processes, and inventions contrary to morality. The report states, however, that the committee believes that the distinction between a "discovery", which is not patentable under European law but can be under the United States law, and an "invention", which is patentable in both Europe and the USA, should be maintained. It noted that a forum should be set up in order to examine the Directive and "oversee the development of a Europe-wide legal philosophy" in this area.

The committee report specifically addressed the issue of ethics under the next, Sixth EU framework programme (FP6), saying guidelines for an ethical frame of reference should be drawn up to ensure that "all research activities under the Sixth Framework programme must be conducted in keeping with fundamental ethical principles", including those set out under the Union Charter of fundamental rights and Member State laws.

The committee called for the European Union to establish a legal and regulatory frame of reference and allocate substantial funding to genomic research under FP6. The EU should endorse the "genomics and biotechnology for health" priority proposed for FP6, but called for a distinction to be made between the two fields of genomics and biotechnology, saying that each field should be identified under its own heading. It called for the Union to support public and private co-operation and prenormative research in this field. Action should be taken to invest in education and training in leading edge technologies.

The committee endorsed a European ethics group opinion on stem cell research, which states that it is too early to create embryos by therapeutic cloning in order to harvest stem cells and that the EU should draw up a budget to finance research into alternative sources of human stem cells. The committee says that research projects which use adult stem cells should be treated as the priority for Community funding. Human cloning for reproductive purposes should be banned. The report also states that while each Member State must draw up its own rules on embryo research, clear rules must be set out to prevent "arbitrary experimentation and exploitation of the human embryo".

In addition, the committee report addresses the potential social implications of genetic testing. It calls for a debate on the use of personal genetic data and argues that the use of person's genetic data to predict their health prospects should "be restricted to the utmost degree, even more severely than in the past, since assessments on that basis disregard the decisive relationship with proteins and environment and therefore produce distorted images of the person in question" which could ultimately "create new social hierarchies, in which individuals would be ranked according to their genetic aptitude".

The report says that in order to prevent such a situation, insurance companies must be prevented from requesting genetic testing and that such tests should not become a precondition to insurance contracts. Furthermore, the committee called for a ban on mass genetic testing for medical check-ups and the selection of workers on the basis of genetic criteria, calling on Member States to protect individual's rights to genetic confidentiality and to ensure that testing is used only for purposes beneficial to individuals and society as a whole.

The committee noted the increasing concentration of biotechnological research in a small number of large multinational companies, and called for national, Community, and international public authorities to monitor this concentration and safeguard the position of smaller companies and non-profit making organisations. The report says that public authorities should take measures to promote publicly funded research in areas that are currently being neglected by private industry, such as treatments for rare diseases and those which affect developing countries.

A permanent forum should be set up, the committee said, in collaboration with the European institutions, to keep track of fast-moving scientific developments and to work with the European ethics group in drawing up fundamental ethical principles to govern human genetics, to intensify public debate, and to forge closer links between national and European ethics committees. Such a forum could also work to foster public debate and understanding of new technologies. More background information is available through the Web site of the Temporary Committee on Human Genetics.

Leslie Versweyveld

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