Legal framework needed for human genetics
At a conference on the implications of human genetics research on 6 and 7 May, participants insisted on the need for a regulatory framework at European level, combining competitiveness and solidarity through socially sustainable innovation. Participants also insisted on the need to address the perceptions and fears of the general public, and the need to foster education in genetics for professionals as well as patients. The conference, which took place in Brussels, was organised by the European Commission to discuss the 25 recommendations published by the EU expert group on the ethical, legal and social aspects of genetic testing. Many speakers spoke of their fear that unless a regulatory framework is put in place, Europe runs the risk of developing a genetic underclass. 'The human genome project is a potential gold mine,' said Bernadette Moran from the Huntingdon Disease Association and Genetic Inherited Disorder Organisation (GIDO). 'There is a lot of money to be made and lots of vulnerable people that can potentially be exploited.' Heinrich Schulte from Endokrinologicum in Hamburg agreed, stating: 'We should not hamper future development of research and development [R&D], but have to make sure we give protection to minority groups. It is also very important that we develop quality assessment schemes and regulation on data processing,' he explained. Judit Sandor from the University of Budapest explained that there are disadvantages to regulation, including 'the lack of flexibility, the fact that regulation would lag behind science and the high level of coercion.' Most believe, however, that it is vital to legislate in an area such as access to genetic data, how it should be collected, used and stored. 'Without a regulatory framework,' said Dr Jean-Jacques Cassemain from the University of Leuven, 'it not possible to discuss what is legal and what isn't.' At present, he explained, networking is limited because of different legislation in different Member States. There is a lack of centralised and standardised external quality assessment schemes, a lack of harmonised standards and a lack of reference materials. It is therefore important that the EU takes the lead and provides a framework at European level so as to avoid problems of harmonising national legislation at a later stage. All speakers insisted, however, that regulation should not stand in the way of innovation and technological progress. Ségolène Aymé from the European Society of Human Genetics explained that people expect to be offered relevant and accessible genetic tests, as well as quality of service. However, at the moment 'correct interpretation of the tests is a problem as the tests tend to be carried out by biologists who are not fully trained in genetics. Test results are therefore limited as no-one can interpret them correctly.' Dr Aymé called for the training of professionals and for the specialisation to be recognised in the Member States. 'It is unethical not to have proper training,' she said. 'We, in Europe, need formal training with minimum standards.' She called for an agency at European level to assess the validity and utility of the tests. 'This agency should be independent from industry,' she explained and 'should draw the line between research and services.' The call for an independent body was also taken up by Elletra Ronchi from the OECD, who emphasised the need to regulate the development of tests, and to make sure they conform to international standards. 'Laboratories must be accredited and we need to decrease the number of technological errors and poor reporting.' Like Dr Aymé, Ms Ronchi was of the opinion that priority setting in the development of genetic testing must be guided by the degree of unmet medical need, and not by disease prevalence, in order to avoid the risk of tests only being developed for common diseases. 'The EU must start developing strategies to enhance counselling services, genetic training and public information,' she said. Ms Ronchi also expressed the view that a 'broader consultation on the report is needed.' She insisted on the need for generating a climate of user trust, stating also that the regulatory environment should be favourable to innovation and promote international cooperation and trade. Alex Capron from the World Health Organisation (WHO) insisted on the need to make information readily available. Genetic testing should not be taken without counselling. Dialogue between professionals and patients should be encouraged and accompanied by evaluation, as well as research on ethical and social perceptions. Per Sørup from the Joint Research Council in Seville agreed, stating that there is a need for professional training in an area which is constantly evolving. He also insisted on the need for educating the general public, including patients so that they can better understand the potential benefits and problems.