The European Community has been directing research funds into biotechnology since the beginning of its First Framework Research programme in 1984. Most has gone on agricultural biotech, with the emphasis being on the ‘safety’ of GMOs. From 1985 to 1999, 81 projects involving 400 research teams spent around €70 million in public money on trying to fi nd out whether various GMOs were safe to grow and to place on the market. Other projects part-funded by the EU during that period included an investigation into the potential of genetically modifi ed algae, engineering tomatoes to produce antioxidant carotenoids, and several which aimed at genetically modifying micro-organisms to produce new antibiotics. As well as research per se, the Commission gave fi nancial support to attempts to develop a network of clinical centres working on umbilical cord blood stem cells, and to information-gathering exercises such as surveys of public attitudes to various aspects of biotechnology and studies of ethical and social aspects of biotechnology.82
The Commission’s view is, however, that the commitment it has shown has not always been matched by the member states, and that this has had consequences for the private sector. In the Communication sent to the member states at Barcelona, it laments the fact that investment in research and development (R&D) in general lags behind that of the United States, a problem compounded by ‘fragmentation of public…support, and…the low level of interregional cooperation’. This analysis guided the design of the EU’s Sixth Community Framework Programme for research, technological development and demonstration activities, a fi ve-year programme (2002–06) in which biotechnology would fi gure highly. The Communication mentioned ‘Genomics and technology for health’ as one of the Sixth Programme’s ‘thematic priorities’, adding that the Commission would co-operate with the member states and the European Investment Fund (EIF) to ‘develop a competitive bioinformatics infrastructure in support of biotechnology research and focus support for the development of research in computational biology and biomedical informatics’. Other initiatives would seek, amongst other things, to stimulate capacity for research: a ‘strong, harmonised and affordable intellectual property protection system’ would function ‘as an incentive to R&D and innovation’; this would require member states urgently to transpose into their national laws ‘Directive 98/44/EC on the legal protection of biotechnological
inventions’ and the adoption by the Council of an EU-wide ‘Community Patent Regulation’. The Communication also outlines measures to improve the industry’s capitalisation and its access to fi nance, to stimulate networks of businesses, scientists in public and private sectors and the universities, and regions, and encourage the adoption of good practices.83
Controversy over use of human embryonic stem cells
One area of controversy dogged the design of the programme and featured repeatedly in debates in the European Parliament and Council of Ministers. This concerned the use of human embryonic stem cells (ESCs). In some member states – the Republic of Ireland, France and Spain – this is wholly illegal. In most of the rest it is not prohibited, but researchers may use only ‘supernumerary’ embryos, embryos created as part of fertility treatment programmes which turn out to be surplus to requirements and, if not put to this use, would in any case be destroyed. In Denmark, Austria and Germany, these must be imported. Belgium, Italy, Luxembourg and Portugal have no legislation on their use. Only the UK specifi cally allows the creation of embryos for research.84 Moreover, the law is in a state
of fl ux, with Belgium, Denmark, France, Italy, Portugal, Spain and Sweden all considering new measures, while enlargement further complicates the matter. As the expert body responsible for advising the Commission on ethical aspects of scientifi c issues observed, ‘the challenge of stem cell research’ has meant that many countries have felt the need to introduce new legislation, and many are still in the process of doing so. Under these circumstances, during the period that the implementing provisions of the programme were being debated, the Commission agreed informally not to grant funds to any project involving human embryos or ESCs, unless these were already stored in banks or isolated in cultures. Although bitter differences of opinion, culture and tradition emerged during the debate,85 the controversy revolved not only around the ethical issues, but also more general principles of EU law. Those who favoured allowing such research argued that, if something were legal in a certain member state, then it would be overstepping the Community’s competence to exclude it from the possibility of funding. Those who opposed the use of human ESCs countered that the money for the programme came from all 15 member states and only if a procedure were legal in all member states should it be eligible. With Britain’s industry benefi ting from the uncertainties surrounding the use of human ESCs in the US,
the UK was particularly concerned to defend what it saw as the rights of its scientists. The issue was resolved, though far from defi nitively, in November 2003 when the European Parliament failed to back moves to deny funding to research using human embryos, just as it had done when the Sixth Programme had been approved.86
National and private research programmes
Notwithstanding the Commission’s complaints about the paucity of private sector and national funding, the EU’s own research budget represents only a tiny fraction of the overall publicly funded effort, which is itself dwarfed by investment by private industry. In 2003, the UK committed £55.5 million to proteomics and post-genomics research alone,87 an increase of 40 per cent over the previous year
described by Nature Biotechnology as ‘part of a fi ve-year, UKP246 million structural biology research program that will focus on protein structure and function modelling, bioinformatics, and regulation modifi cation and expression analysis’. Other parts of the programme focused, signifi cantly, on ‘training…science PhDs for careers in industry by teaching them management and project planning skills’, investigation of gene function in relation to neuroscience, and ‘UKP40 million into funding stem cell research…in an attempt to take a world lead in commercial exploitation of the technology’.88