European Responses to Biotechnology: Research, Regulation, and Dialogue

Modern biotechnology is the fruit of a massive surge of knowledge about the structure and functioning of living entities that has taken place over the past few decades. The surge continues unabated with the sequencing of human and other genomes at ever-increasing speed and declining cost. The knowledge spreads around the globe–available, irreversible, pervasive, and subversive–its accessibility and influence amplified by the tools of informatics that have also advanced rapidly during this period. It presents opportunities to scientists, and it poses challenges to policymakers. It arrives, often uninvited, in the in-boxes of the ministries of research, industry, agriculture, environment, education, health, trade, and patents in countries rich or poor and makes its way onto the agendas of the international agencies.

That multifaceted set of challenges has elicited various responses in national capitals and in the institutions of the European Union (EU). Maintaining some degree of coherence or coordination among the numerous responses has been a persistent concern of the European Commission (EC) for almost two decades. The price of sugar, the patentability of genes, and the ethics of stem cell research are among the many issues related in some way to biotechnology but typically addressed by different parts of the machinery of government.

In spite of the proliferation of international exchanges and communication in recent years, most intensely across the North Atlantic, the responses to the challenges raised by biotechnology seem to have diverged. With respect to research, the EU and the United States are following similar paths; but in the regulatory arena, the differences in approach are large and, in the view of some observers, increasing. This need not be so. Increased dialogue across the Atlantic that builds on the agreement among scientists and includes a broader mix of representatives from both sides can close this gap.

A positive attitude

Europe is not against science. As the debate over biotechnology has heated up in recent years, particularly in Europe, some Americans have begun to view the Europeans as antiscience because of their sometimes vociferous questioning of the safety of biotech techniques and products. The reality is that European investment in biotechnology research is comparable to that in the United States: over $2 billion per year. Although there has been determined opposition to some biotech applications, Europeans are in general very supportive of science and appreciative of its benefits. In fact, Europeans have expressed no objection to the use of biotechnology to produce new medicines, and some early genetically engineered food products were popular in Europe. Besides, attitudes change.

For example, opposition to biotechnology had become so intense in Switzerland that a national referendum to severely limit genetic engineering activity was scheduled for 1998. In the two years leading up to the referendum, the scientific community conducted an ambitious education campaign with extensive public discussion. The result was that two-thirds of the voters rejected the restrictions. Ten years ago, Germany faced serious opposition to biotechnology, but it is now a technology leader. Similar controversies have broken out in many countries, including the United States. Although they have not blocked the development and application of the technology, they have served to underline the need for public trust and credible regulations.

Americans and Europeans do disagree on some issues pertaining to the exploitation of science, and the European system of performing research and some aspects of European regulatory approaches differ from those of the United States in significant ways. For example, European regulation of food extends throughout the entire food production system from farm to table. The U.S. system focuses primarily on the end product. In international discussions of biotech regulation, the United States perceives it to be essentially a trade issue, whereas the Europeans see trade as only one part of a larger complex of related issues.

Nevertheless, there is no denying that at present many Europeans are reluctant to consume bioengineered foods. In the latest Eurobarometer survey, two-thirds of Europeans stated that they would not buy genetically modified (GM) fruits even if they had better taste. One reason may be that 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. The available evidence, within Europe and elsewhere, indicates that when producers begin offering GM foods with clear advantages over traditional foods, consumers will buy. It will not be an overnight change in the market, but there will be change.

European research

The structure of research funding in Europe has changed significantly in the past two decades. Research organized through the EC began in the early 1980s. The EC has not only stimulated multinational programs, but it has increased collaboration between university and industry researchers. Recently it has also opened the door to participation by U.S. laboratories.

Research activities are organized in the context of five-year plans and budget envelopes called Framework Programs (FPs). The money has grown steadily from about $3.5 billion for the first FP in the mid-1980s to the $14 billion budget of the fifth FP, launched in 1999. The rate of growth has been rapid, but the total still amounts to only about five percent of public-sector nonmilitary research spending in Europe. Within the growing budgets, there have also been major shifts in priorities: Energy was the favored field of research in the early years, but the percentage going to life sciences has been growing steadily to its current share of about 20 percent.

In biotechnology, Europe has done quite well. For the period of the fourth FP, 1994-1998, national governments spent $10 billion and the EC about $0.6 billion. On top of that, Europe’s large corporations have invested heavily in biotechnology research, with roughly half going to human and veterinary medicine, and half to food and agriculture. In addition, Europeans have launched more than a thousand small and mid-sized biotech companies. In fact, Europe has about the same number of biotech companies as the United States, though the European companies employ only about 30 percent as many people.

Competition for EC research support is intense, and only one in five proposals is funded. Those selected must offer not only first-class science but also relevance to EC policy objectives, including industrial competitiveness, food safety, and environmental protection. For example, funded projects have been looking at biosafety assessment of GM microorganisms or plants for use in the environment and examining issues such as horizontal gene flow, effects on microbial populations in the soil, and interbreeding between cultivated plants and wild relatives. Years of biosafety research have not given cause for serious concern, but it is also clear that we still have much to learn about how these organisms will behave in the environment.

Many projects aim to refine our methods of measurement and control. As Sydney Brenner, former director of the Laboratory of Molecular Biology in Cambridge, England (where Crick and Watson discovered the double helix structure of DNA), has expressed it, we are still at the stage of genetic “tinkering” rather than genetic engineering. For example, we want greater control over where and when the inserted gene is expressed. The EC has supported work on genetic engineering of plant metabolism to enhance control of expression, which can identify novel routes to development of vitamins, colors, and aromas. Research in this area contributed to the development of “golden rice,” which is rich in vitamin A and is now being bred into local rice lines in China, India, and other developing countries.

The current research program reflects a political push toward practical objectives reflected in support for large-scale projects addressing major socioeconomic problems of relevance to Europe. In the $2.3 billion “Quality of Life” program, historically separate efforts in agricultural, biomedical, and biotech research have been fused into a single program, then reorganized into key action areas (such as control of infectious diseases, aging, and environment and health), cross-cutting generic activities (such as bioethics and socioeconomic factors), and infrastructure. The EC has already contributed substantially to public facilities such as the DNA sequence library at the European Molecular Biology Lab, which shares with GenBank in the United States and the DNA Database of Japan the global work of collecting, checking, annotating, and distributing sequences, and to the European Mutant Mouse Archive (EMMA) at Monterotondo, near Rome. EMMA, which works in collaboration with the Jackson Laboratory in Maine, is the main node of a European network of nonprofit facilities receiving and distributing transgenic mouse lines essential for basic biomedical research and as models for research into complex diseases.

Under the Quality of Life program, the EC has recently launched a supplementary effort to strengthen European capabilities and promote collaboration among the several national programs in genomics. Among the success stories of Europe’s research in the life sciences has been the initiation of large-scale, multilaboratory, collaborative genome sequencing projects. These started in the 1980s with an effort to sequence the smallest chromosome of the yeast Saccharomyces cerevisiae and progressed to the completion of the entire sequence in a collaboration with North American and Japanese laboratories. A similar pattern of collaboration has led to the completion last year of the first plant genome, Arabidopsis thaliana, thus opening up a vast range of new research possibilities in plant genetics and agricultural research.

How to regulate

Debate over the regulation of biotechnology started in the 1970s and has barely slackened since. Initial concerns about accidentally creating Frankenstein monsters or uncontrollable epidemics soon diminished as researchers in molecular biology and genetics engaged in discussions with biomedical and clinical experts. Still, public uncertainty about the dangers of genetic engineering persisted. During the 1980s, the Paris-based Organization for Economic Cooperation and Development (OECD) provided a useful forum for exchange of international experience, and expert consensus on safety rules for genetic engineering work was fairly easily obtained.

In principle, that provided a common basis for regulatory policies, but a fundamental split developed between those, including the Americans, who felt that products of the new technology could be handled under current statutes and existing agencies responsible for the safety of food, drugs, and other products, and those, including many Europeans, who felt that the level of public concern necessitated the creation of specific legislation for products derived through biotechnology. Faced with incipient national legislation in its member states, the EC decided in 1991 that although existing EC rules governing pharmaceuticals could handle the new technology and its products, technology-specific regulations would be necessary in the food and agriculture sectors.

Although differences in opinion between EC and U.S. experts were not great, public attitudes in Europe took a separate path. The growing influence of “green” political parties in the 1990s and the perceived failure of several governments to anticipate or respond effectively to a series of food-safety crises (of which “mad cow disease” is perhaps the best known but by no means the only example) resulted in diminished trust in government and popular campaigns for regulatory stringency to guarantee “100 percent safety.”

The EC responded with high-profile legislation on the contained use and field release of GM organisms. The initial legislation has been significantly modified in the light of experience and the advance of scientific knowledge, including the EC’s own extensive biosafety research programs, which invested $60 million in more than 400 laboratories over the past 12 years. The necessary learning process has been wider than the scientific and legislative communities. It has been necessary to carry public opinion, which has not always been a straightforward process, given the combination of green campaigning, public distrust of government, and the inevitable uncertainties that accompany any significant innovations. Critical and apprehensive spectators can generate “what if?” questions faster than any finite research budget or scientific effort can answer them.

We have been in this business of regulatory directives since 1990. Under the field release directive (the so-called “90/220”), we have authorized 18 GM crops for import or culture, in addition to approving thousands of research field trials. The system was starting to work, and approval was granted to some products such as GM soya, which was used widely in animal feed and as a constituent of many foods. But opposition to GM food mounted, and national authorities became reluctant to approve further authorizations. Some countries announced bans on imported GM foods; large retailers started announcing that they would go “GM-free”; and in July 1999 at a meeting of the European Council of Ministers, a de facto moratorium on further commercial authorizations was approved. The moratorium will continue until agreement is reached on new provisions for traceability and labeling of GM products, in the context of the revision of 90/220. An agreed text now awaits final approval, and applicant companies have indicated that although the revised text would come into effect only 18 months later, they will voluntarily commit themselves to observing its requirements with immediate effect, if authorization can recommence.

The revised text of the directive introduces a series of new articles, especially the famous (or, in the United States, infamous) precautionary principle. A carefully phrased communication on this has made it clear that it is not an excuse for protectionism but a provisional measure to be used in carefully defined cases, where adverse consequences are a possibility and scientific information is insufficient. It should, among other things, be “proportionate” to the need, and the precautionary action should be reviewed as research and/or experience reduce the uncertainty. It is not very different from possibilities envisaged under World Trade Organization agreements such as the Agreement on the Application of Sanitary and Phytosanitary Measures, which states that “In cases where relevant scientific evidence is insufficient, a member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information.” The revised 90/220 text provides for traceability and monitoring of newly authorized materials. Authorizations will be time-limited for 10 years.

Creating or revising legislation for the EU is not quick or easy. We have to have the agreement of the 15 member countries and their parliaments. In matters concerning biotechnology, that may involve ministers of health, agriculture, environment, and trade in each of these countries. With 5 of Europe’s 15 environment ministers coming from green parties, it is easy to see how difficult it will be to reach consensus in these areas, in spite of the growing evidence that the more precise genetic technologies can diminish the harmful effects of agriculture and industry on the environment.

The EU also adopted in 1997 a novel-food regulation, requiring authorization for GM foods or ingredients. But concerns about food safety have intensified. The EC, with strong support from the European Parliament, has proposed the establishment of a European Food Safety Authority, independent of the administration. If approved, it will operate on the basis of high standards of scientific excellence and transparency and will be responsible for overseeing risk assessments. It will not have any regulatory power, which will remain in the hands of the individual countries, but by its independence from the EC and from national governments, it will be expected to have high intellectual authority and to command public trust in its judgments.

The Food Safety Authority and the EC will be faced with new products of economic significance. Authorization decisions to place new products on the market must be based on a high standard of safety for human health and the environment. The risks and uncertainties associated with innovations will have to be adequately addressed in the supporting dossiers. And when decisions have been made, the EC will have to communicate to the public the rationale for its decisions. This pattern of greater transparency is already practiced in publishing the reports and opinions of the EC’s scientific advisory committees. As with existing legislation, member state experts will participate on the committees voting on authorization. The proposal was launched in 2000 and is now being discussed. We will receive feedback from the member states and then aim for formal adoption perhaps in 2002.

We have also published a carefully drafted communication on the precautionary principle. This principle, or similar language, has been used increasingly in recent years at the United Nations, in world trade agreements, and in the Biodiversity Convention. Its application is currently the topic of much discussion within Europe and also with our overseas trading partners such as the United States. It has been misused on occasion, when member states have sought to refuse authorization, claiming alleged new scientific evidence. The EC has successfully challenged such misuse before the European Court of Justice. We hope that international consensus will gradually develop on what the principle is and how to use it; the limits can be determined when necessary by judgments in appropriate fora such as the European Court or the Disputes Panel of the World Trade Organization. But the bottom line for us is that where there is scientific uncertainty and risk of significant hazard, we cannot simply give a “go-ahead” decision. Although the initial effect is delay, the uncertainty should be addressed by corresponding research efforts, as we have done for the past 20 years in biotechnology, and the general result will be to ensure a higher standard of safety without blocking innovation. The new product or service might be an improvement on current practice, in which case the logic of the principle could argue for accelerated innovation.

Our public opinion survey suggested that half or more of Europeans are willing to pay more for non-GM food. People do not necessarily always seek cheap foods. They want something they like and trust, and regulators must take that into account. The precautionary principle is one of the elements in building trust in the decisionmaking process.

In the end, the message is quite clear. The GM food problem is not a trade problem; EU legislation and regulatory actions are nondiscriminatory, science-based, and reflective of the judgments made by elected bodies regarding desirable levels of safety and environmental protection. It is true that a trade issue arises when some farmers find that they cannot sell their products in Europe, but the EC and member states cannot command the consumers regarding their choices. By developing a strong and transparent regulatory framework, the EC authorities are seeking to create a market in which continued safe innovation is encouraged.

In this context, it is important to remember that scientists have been working together to develop a common international framework for understanding these issues. Since the early 1980s, the OECD Group of National Experts on Safety in Biotechnology and other later groups have provided meeting places for hammering out broad expert consensus across the developed world on common approaches to assessing the safety of work with recombinant DNA. The resulting reports provide a common basis of reference for legislators and regulators throughout the world. An EU/U.S. task force on biotechnology research has been trying during the past 10 years to develop a common method of doing risk assessment. On the political side, Presidents Bill Clinton and Romano Prodi established in May 2000 a Biotechnology Consultative Forum that brings together from both sides of the Atlantic a diverse working group, including lawyers, consumer representatives, farmers, environmentalists, scientists, industrialists, and ethicists to work out a common understanding of the definition of risk and how to regulate risk. Their first report was published in December 2000.

Such activities do not interact formally with the legislative and regulatory processes but can contribute to the popular climate of debate and counter the unfortunate demonization of GM products that has tended to win more prominence in the popular media. This has influenced perceptions and delayed the growth of market opportunities in Europe. It has also tended to overemphasize differences between the two continents, which at the scientific level are minimal. Greater dialogue should promote convergence of policy, with benefits to industry and consumers in both areas.