BRUSSELS, Belgium ¿ The European Parliament¿s temporary committee on human genetics held discussions here Monday over the first draft of a report on how to regulate appropriately at the European level in this rapidly developing field.
Much of the input to the debate displayed a strong pro-industry tendency, in contrast to the critical tone about the risks of biotechnology that often is heard in the European Parliament.
The EU should create rules that are more helpful to the development, testing and approval of new biotechnology-based medicines. And it should promote innovation in the genomics sector, according to one of the principal contributions to the debate ¿ the first working document from the committee member drafting the report, Italian Euro-MP Francesco Fiori. He said he could see a major role for the EU in backing research, in assisting contacts between researchers and financiers, and in ensuring effective exchange of information between teams working in different countries.
Fiori¿s working document makes some initial recommendations, and raises some questions that still need exploration. It says that there should be greater efforts to take account of the ethical dimension in genetics, and closer coordination with bodies such as the EU¿s advisory committee on ethics and the work now under way in the Council of Europe on a new agreement on human genetics. It urges reinforced public debate so that the opinion of citizens, patients and their families are taken into account alongside the views of industry, investors and ethics experts.
Fiori spelled out his views to a roundtable session with representatives of the relevant committees of the parliaments of the 15 EU member states and the 13 EU candidate countries. The participants reviewed the regulatory situation in each country across Europe, with a focus on the key issues covered by the committee¿s mandate: research involving embryos, patentability of human genetics, the use of genetic information and data protection, and the role for the EU in human genetics, including possible funding of genetics research. Their discussions revealed wide divergences of approach, ranging from the highly restrictive regulation in some Mediterranean countries to the more liberal regimes in northern Europe.
The committee, set up by the Parliament in January to examine recent developments in the field of human genetics, has been asked to deliver an assessment of the problems and opportunities offered in the area and other new technologies of modern medicine. It has already held a series of expert hearings, and is conducting an extensive program of visits to various locations.
¿The U.S. is definitely the most important point of reference and comparison in the field of human genetic research and the application of its results,¿ said the committee chairman, Luxembourg Euro-MP Robert Goebbels. Based on its examination of the scientific, medical, ethical, legal, economic and social risks and opportunities in human genetics, it will prepare a report aimed at providing political guidance to EU lawmakers.
The next stage in the committee¿s work will be a major conference in Brussels July 9-10. Then in late August and early September it will examine and refine the text of a draft report, which it hopes to finalize at committee level during October and early November so that it can be adopted by the Parliament as a whole in the plenary session in Brussels on Nov. 28-29.