Est. 2min 30-05-2008 (updated: 28-05-2012 ) labor.jpg Euractiv is part of the Trust Project >>> Languages: Français | DeutschPrint Email Facebook X LinkedIn WhatsApp Telegram The pan-EU biobanking initiative hopes to solve a number of ethical and legal issues connected with the storage of DNA and other human samples in order to boost new drug discovery, personalised medicines and therapies. The pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) is one of the projects identified by the EU as a future large-scale European research infrastructure. A seminar held on 28 May in the European Parliament took stock of the progress made so far and discussed future challenges for completing BBMRI. Biobanks are collections of biological material, such as DNA, tissue, cells, blood or other bodily fluids. They also include the medical, environmental and lifestyle data linked with each sample. Such a major infrastructure could allow the identification of disease genes and help understand relationships between genes, the environment, lifestyle and diseases. Crucially, it could also allow people to realise their potential to develop specific diseases, opening the door to personalised prevention programmes and treatments. Biobanks are considered as a key resource in the study of the molecular basis of disease subtypes, the identification of new targets for therapy and speeding up drug discovery and development. They are also expected to help develop more precise diagnostic tools and study the environmental and genetic factors causing disease. Currently, “nobody knows what [samples] are already available in which country,” said Kurt Zatloukal from the Medical University of Graz, Austria, deploring “the significant duplication of efforts” at EU level as well as the fragmentation of the scientific community and lack of sustainable funding. Currently, over 50 partners and around 150 associated partners are taking part in the BBMRI project. Pharmaceutical or other medical companies, who also have their own collections of samples, are also waiting for the infrastructure to be put in place in order to guarantee access to large collections of well-characterised samples, a pre-requisite for the speedy development of new drugs and personalised medicine. However, before establishing a true pan-European biobank, major ethical and legal questions need to be overcome and a legal framework needs to be found. The privacy and confidentiality of the donors, the use of genetic technologies, commercialisation of genetic products and intellectual property rights are also issues to be dealt with before the final structure can start working. Read more with Euractiv EU in search of technology transfer area A change of mindset regarding academia-industry collaboration is key to successful tech transfer, argued stakeholders debating the conditions for turning research results into economic growth and competitiveness yesterday (28 May). Subscribe now to our newsletter EU Elections Decoded Email Address * Politics Newsletters Positions Hervé Pero, the head of the research infrastructure unit at the Research Directorate General said BBMRI now needed to try to get member states on board, even though it might be difficult for them to trust the organisation, which remains very fragmented. However, for the success of the initiative, as for that of the other planned 34 European infrastructures, the participation of the whole EU 27 in all of them is not necessary, he added. "We are talking about an average annual operational budget of some €300,000 to €1 billion" once the BBMRI is in place, added Georges Dagher, director for clinical research infrastructures at the French national health and medical research institute (INSERM). Christian Bréchot, vice-president for medical and scientific affairs at Merieux Alliance , a biomedical industry group, agreed with Pero and said the initiative was doomed unless the member states decided to invest in it now to create a "leveraging effect" with some seed money. In addition, he said that industry's willingness to support the project will depend on its complexity, IPR regulation and legal and ethical framework. "Industry needs a guaranteed access to collections of well-characterised samples that are collected ethically and in accordance with IPR," added Bréchot. Eero Vuorio, chancellor of the University of Turku, Finland, said the project was very complicated, as it is about people's samples and therefore potentially a source of huge ethical debate. "It is about trusting those to whom you give your sample to use it at your best interest and not against you," he said. The European Science Foundation's (ESF) recent report on biobankings states that if Europe wants "to stay at the forefront and to take full advantage of the huge research potential in its human biobanks, there is an urgent need for coordination and harmonisation of the biobanking and biomolecular resource infrastructure". It argues that "the practical regulatory formats have become unnecessarily diverse due to the multitude of independent national legislative processes in the member states," seriously hampering progress in this field. BackgroundThe European Strategy Forum on Research Infrastructures (ESFRI) published, in October 2006, its first road map for new European research infrastructures. It identified 35 large-scale infrastructure projects, which a sufficient number of member states were ready to support (see EURACTIV 19/10/06). European research infrastructures are major instruments, installations and facilities that provide top-class research services to support the work of scientists in different areas (materials science, astronomy, biomedical applications and protection of cultural heritage). They combine scientific equipment, software (digital databases) and technical support and can be single sited, distributed or 'virtual'. Examples of current research infrastructures include CERN, the world's largest particle physics laboratory and Géant, the pan-European data communications network for research and education. The 35 ESFRI projects range from icebreaker vessels for marine research to next-generation radio telescopes and European social surveys. Timeline 30 May 2008: Council adopted conclusions on European research infrastructures and their regional dimension. July 2008: The Commission will present a Communication proposing a legal framework to allow the creation of appropriate partnerships for the establishment of pan-European research infrastructures. This is the first legal proposal on the area of research by the Commission since a long time. 2 Dec. 2008: Adoption on the legal framework expected by the Council. Further ReadingEuropean Union Biobanking and Biomolecular Resources Research Infrastructure European Science Foundation news:Europe's biobanks need urgent coordination, scientists say(27 May 2008) European Science Foundation science policy briefing:Population Surveys and Biobanking(26 May 2008) Cordis:European Strategy Forum on Research Infrastructures (ESFRI) European Strategy Forum on Research Infrastructures (ESFRI):European roadmap for research Infrastructures(19 October 2006)
