Biotechnology - the EU and USA compared
With biotechnology research due to take a front row seat in Europe in the forthcoming Sixth Framework programme, a recent article by authors Patrice Laget and Mark Cantley, writing in Issues in Science and Technology, indicates that the ethical and economic challenges thrown up by biotechnology's rapid pace of change continue to create barriers between researchers in the US and the EU. While progress in biotechnology research is forging ahead on both sides of the Atlantic, there are huge differences in the public reception of recent scientific developments in this area. These differing political contexts have created huge divergences in approach to regulation. Greater public awareness and transatlantic dialogue can help to reverse this trend, opening the door to greater policy convergence and laying the foundation for increased co-operation. One such barrier is the perception by some Americans that Europe is 'anti-science' according to the authors, an impression fuelled by heated public debate over the safety of some biotechnology applications. New findings from a recent Eurobarometer survey show that the majority of Europeans are sceptical of bioengineered foods - two-thirds said they would not buy GM products even if they tasted better. Patrice Laget and Mark Cantley say this could be because Europeans have traditionally been spoilt for choice: Few Europeans have been offered GM foods that have enhanced appeal to consumers. The Europeans have very good food and plenty of it. The first major GM products have been modified in ways beneficial to the agrichemical companies, the seed suppliers, or the farmers, but not to the consumer.' Yet despite the perceived scepticism of European consumers, EU investment in biotechnology research is on a par with USA levels - over $2 million per year. The fourth EU RTD Framework Programme saw member state governments pump $10 billion into biotechnology research, topped up by $0.6 billion from the European Commission. This was divided roughly equally between human and veterinary medicine and food and agriculture. The allocation of Framework Programme budgets has also seen a shift in emphasis, with the percentage given to life sciences expanding steadily to its current level of 20 per cent. This has been accompanied by a sharp increase in Framework programme funding since the first FP was set up in the 1980s - from $3.5 billion to the $14 billion of funds behind the fifth FP currently in place. The private sector is also adding its support, with heavy investment in biotechnology from Europe's large corporations. Europe has also seen the creation of over a thousand biotech SMEs. The number of biotechnology companies in Europe is comparable to that in the USA, although the European enterprises employ only a third of the people working for similar companies in the USA. Approaches to the regulation of biotechnology research also differ widely between the USA and the EU, with the divergence becoming more marked in recent years in the face of increasing public concern over the safety of genetic engineering. Regulatory policy is now clearly split between the American approach, which entrusts the monitoring of new food and drug developments to existing laws and regulatory bodies, and the European approach, which, driven by public concern, has created specific statutory regulations for the products of biotechnology research. This split has arisen not from a division in expert opinion, but from public pressure for an independent guarantee of the safety of new developments, brought about by events such as the BSE crisis and the increasing influence of 'green' political parties in Europe. Despite the adoption in 1997 of a novel-food regulation requiring the authorisation of GM foods and ingredients, concerns over food safety have escalated. In 1999, the European Council of Ministers approved a de facto moratorium on the commercial authorisation of GM crops. The final revised text of the field release directive known as 90/220, which will bring about an end to the moratorium, is currently awaiting final approval. The Commission hopes to address the problem of risk assessment in biotechnology with the creation of an independent Food Safety Authority, a proposal launched in 2000 with the backing of the European Parliament. The new body, independent of the EC and individual governments, would be responsible for ensuring the integrity and impartiality of food safety judgements while leaving regulatory power in the hands of member states. The Commission's formal adoption target is set for 2002. The Commission has also published a draft communication on the precautionary principle, which states that in cases of uncertainty or where there is a risk of danger, the Commission must err on the side of caution in authorising scientific developments. Although this may seem inefficient to those who favour the American approach to regulation, the principle aims to combine rigorous safety standards with a minimum of barriers to innovation. This is an essential ingredient in the process of rebuilding public trust in biotechnology developments and accelerating safe innovation. However, despite the wide and apparently growing gap between American and European approaches to biotechnology applications, there does exist a historical basis for the development of a common approach. An EU/USA taskforce has been working on ways to bring together approaches to risk assessment policy for the last 10 years. And in May 2000, European Commission President Romano Prodi and American President Bill Clinton set up a Biotechnology consultative forum where a wide range of professionals from both the USA and the EU meet to try to come to a common viewpoint on the issue, helping to foster an atmosphere of co-operation on both sides of the Atlantic.