Select Committee on European Communities Second Report - Written Evidence


  1. Final section of "The Regulation of Modern Biotechnology: A Historical and European Perspective. A Case Study in How Societies Cope with New Knowledge in the Last Quarter of the Twentieth Century"; Mark F Cantley. Chapter 18 (pp 505-681) of Volume 12: Legal, Economic and Ethical Dimensions (edited by D Brauer), of the Multi-Volume Comprehensive Treatise Biotechnology (Second, completely revised edition), edited by H J Rehm and G Reed in co-operation with A Puhler and P Stadler. Pub: VCH, Weinheim, 1995. For references cited, see the original, full text.


  2. In 1981, the Nobel prize-winning American, James Watson, and the Secretary of the European Molecular Biology Organisation, John Tooze, published "The DNA Story: A Documentary History of Gene Cloning". With their narrative, they interspersed the principal documents associated with the pre- and post-Asolomar discussions, from 1973 through to the end of the 1970s, documents which illustrate the rise of the once-threatening tide of Congressional legislation, and of the widespread public concern and criticism which drove it. A few of the same elements are briefly reviewed in the first Chapter of this review; the Watson and Tooze compendium fills over six hundred pages. In the closing paragraph of their final section, "Epilogue", the authors conclude with evident relief:

    "Politics and politicking preoccupied the first years of the recombinant DNA story, but that phase, fortunately, is fast becoming history. This book is our epitaph to that extraordinary episode in the story of modern biology".

  3. More than a decade later, no such facile conclusion can be offered in a history of biotechnology regulation; one thinks rather of a contemporary historian in Europe's Thirty Years' War, or in the Anglo-French 100-year conflict, invited at year 10 or year 20 to give an overview and prediction of outcomes . . ..

  4. For the "politicking", although it paused in the early 1980s, picked up momentum thereafter and has increased ever since, pari passu with the progress of the science and the diffusion of biotechnology. In Europe, the politicking was more intense, and the initial outcome less happy than in the US; for the surge of knowledge and innovations coincided with two other historic processes. The mid-80s saw a surge of political support for environmental movements, which in parts of Europe tapped into older romantic traditions, containing strong anti-intellectual and anti-technological elements. LoÏnngren (1992) speaks of "the politicisation of chemicals control". At the same time, the political will and leadership in Europe, at both Community and national levels, was ready to drive forward the processes of constitutional change and development. The potential for such development had always been present in the founding EC Treaty, but the drive was accelerated from the mid-1980s by an impatience with slow progress, and by a will to "build Europe". These were given concrete expression by the 1992 target date for completing the common internal market, and by the Single European Act (adopted 1987, effective 1989) as the instrument for its completion. Majority voting for proposals under Article 100A (the legal basis for harmonising legislation), and for specific R and D programmes within a (still unanimity-requiring) multi-year Framework Programme, were among the several significant innovations of this Act.

  5. The momentum was maintained, through the three successive Commissions during the ten-year presidency of Jacques Delors—at least to its penultimate year, 1993, which saw the ratification of the Treaty on European Union, signed at Maastricht in December 1992. By 1993, however, it was "a damn close-run thing" (as Wellington remarked at an earlier defining moment in European history), with a second plebiscite required in Denmark, a wafer-thin assent even in France, and the ruling British Conservative party almost mortally split. The continued decline in numbers voting in European Parliamentary elections (in June 1994), and the divisive political arguments accompanying the 1994 plebiscites in Austria, Finland, Sweden and Norway, on accession to the European Union, underlined the slackening of political will.

  6. This political backdrop interacted repeatedly, and often unnecessarily and unhelpfully, with the development of biotechnology in Europe. The politicking hindered, where it should have facilitated, the effective integration of the new knowledge into the activities and sectors that needed it. Conversely, the history of Community strategy for biotechnology in Europe, and the history of biotechnology regulation to which for some years it seemed to be reduced, illuminated structural weaknesses within the Commission, and within the Community's institutional structure. These structures were ill-adapted to managing the challenges and complexities of biotechnology; for even when these were clearly identified and described, in good time, the communication to the political level was generally ineffectual; and political action was blocked or diverted into irrelevant and unhelpful actions by the weight of other interests.

  7. Many factors render obscure the legislative and other actions of the Community institutions, shielding them from effective democratic scrutiny, and limiting their transparency: the multi-institutional complexity (Commission, Parliament, Council, etc.) of the machinery; the distance from national politics (where "Brussels bureaucracy" is a convenient scapegoat for nationally unpopular measures), and from citizens and local communities; and the inescapable diversity of Europe's languages and cultures, at once its glory and a permanent political constraint.

  8. This lack of transparency means that on complex subjects, only a sustained and determined effort of communication can ensure that all parties with relevant interests and knowledge have the opportunity to participate in preparing proposals and decisions; and when the mass of information and opinions is effectively elicited, there has to be a radical condensation and filtering to summarise the debate into the drafting or amending of a legislative text, or to enable the elected parliamentarian to cast his vote. Both in the communication, and in the condensation, the opportunities for distortion, accidental or wilful, are legion.

  9. Complexity without transparency allows, even encourages, the pursuit of individual and institutional self-interest. Key individuals involved in the biotechnology regulatory agenda differed widely in their interests, their style of operation, and their attitudes to science, innovation and industry.

  10. Within the Commission, each Directorate-General has its "déformation professionelle", and the linguistic barriers are trivial in comparison to those between DGs. The Commission as a whole is by constitution naturally activist, and that constitution reflects the political aims of the founding Treaties: there was much to be done. This maps down to the level of the individual, particularly in the Directorates-General concerned with legislation: success tends to be equated with the adoption of a new Directive or Regulation, however flawed.

  11. Thus in DG III, legislation was essential to creating a common market—for food products, pharmaceuticals, etc., and ultimately to achieve new structures such as the European Medicines Evaluation Agency. Similarly for DG XI, the control of chemical products for the protection of human health and the environment, was a major challenge, the legislation a major achievement, and the basic need for such control—whatever the disputes about details—essentially an unquestionable imperative, world-wide. DG V's responsibilities for promoting uniform high standards of worker safety similarly demanded and brought forth a constructive and successful framework of Community law.

  12. The Commission embraces other aims and their corresponding cultures. The Common Agricultural Policy was the creation of the Community institutions, its management and defence the burden of DG VI; who had simultaneously to respond to world-wide pressures for change—for the liberalisation of agricultural trade under GATT, for protecting rural interests under the pain of "rationalisation", and for reconciling the diverse European interests represented by the Ministers of Agriculture. Biotechnology, uninvited, came insistently onto the DG VI agenda via agricultural research and agricultural legislation, offering productivity increases in sectors plagued by excess production.

  13. The culture of DG XII, especially in its earlier decades, was scientific in its sympathies and roots. They were reluctant legislators in 1978, glad to retire from such matters in the mid-80s. Global trends—the move towards knowledge-based economics, the natural internationalism of science, its perceived relevance to economic competitiveness, the increasingly expensive and specialised character of research—led to rapidly expanding biotechnology R&D programmes at European level in the late 1980s and 1990s. The pressures of managing these increasing resources with a static or declining complement of staff forced DG XII to focus on the politics of winning these heavier research budgets, and on managing efficiently the selection and administration of vast numbers of projects. These pressures further diminished the appetite for inter-DG arguments over legislation; but paradoxically increased the need for such interaction, as the expending R and D activities, and the global trend to more knowledge-based economies, were inexorably increasing the scientific content in the agenda of other DGs. DG XIII—responsible for the large R and D programmes in information technology and telecommunications—was from the mid-80s closely involved in the full range of research, industrial policy, and related legislative activities. For biotechnology obtruded across the range of DG interests, and no single DG could pretend to a monopoly of scientific wisdom, even within the life sciences and technologies.

  14. The first FAST programme, and the Commission's 1983-84 responses, establishing the Biotechnology Steering Committee, reflected an adequate perception and analysis of the challenges, followed by apparently appropriate action. The "need for an integrated approach" was similarly endorsed by Parliament, in the 1987 Viehoff report and the resolution adopted.

  15. The subsequent fading of the Biotechnology Steering Committee has been described. As the new techniques of genetic engineering were emerging from the laboratory to cross the road to the market-place, the bus of environmentalism was accelerating; and although the new techniques could fairly claim a place on the bus, as "Clean Technologies", the interaction in Europe was more a collision than an accommodation or a welcome.

  16. The self-confidence of success led to an uncritical and inappropriate transfer of the culture of chemicals control to legislation focussed on, and by inescapable implication stigmatising, a technology. Many factors reinforced this strategic blunder: widespread scientific illiteracy, sensationalism in the media, bureaucratic and political opportunism, agricultural protectionism, mistrust of industry, an anti-industrial, anti-intellectual populism—and the usual scientific uncertainties and caution.

  17. Oversight in the form of notification and monitoring is a rational response to uncertainty, and enables uncertainties to be diminished by the accumulation of experience, and resources for risk assessment and management to be rationally deployed. This was the approach adopted by the Community in the 1982 Council Recommendation; and it worked satisfactorily, not least because there was no attempt by DG XII, the service chef-de-file, to exploit the opportunity to build up a permanent bureaucracy.

  18. In the United States, the effective dialogue between scientific and political communities headed off the threat of technology-specific legislation, and even those who (unsuccessfully) advocated and prepared such legislation in the 1970s and 1980s, typically incorporated in their Bills a "sunset clause", which would automatically terminate the legislation after a set period, if there was no further Congressional action taken to renew or amend it.

  19. Such a "provisional" or "learning" approach was a rational and scientific response to uncertainties about a new phenomenon, such as a new technology. But for new chemical substances, or pharmaceutical products, there is the practical certainty of a continuing stream of new entities requiring testing and oversight; and the corresponding administrative structures are therefore conceived on permanent lines, give or take some future adaptation.

  20. The imposition of this "permanent" character on novel technologies both stigmatised them, and built a bureaucratic structure at Community and national levels with an in-built tendency to justify and defend its continued existence.

  21. Within the European Parliament, the active members, coping with a flood of documentation, and a complex and exhausting life-style (between home, committee work in Brussels, and plenary sessions in Strasbourg), could in general devote little time to understanding complex dossiers such as biotechnology.

  22. While there could be real concerns about ethical aspects of the use and abuse of new technologies (e.g., in relation to human genetics or animal welfare), and popular suspicions of "mad scientists" and mistrust of industry, in general the esoteric character of genetic engineering meant that practically all MEPs would leave such a dossier to the rapporteur—or, if the rapporteur was not of their political group, would designate a member of their group to follow the dossier. The basis for formulating the parliamentary opinion on legislation relating to biotechnology was therefore typically a very narrow one; in an area which shared (with nuclear energy) the most concentrated attention of the "Green" fraction in the Parliament. Moreover, even MEPs not of this fraction, were in many countries acutely conscious in the late 1980s that the major political parties were losing ground to the Green movements; and to recapture these votes, were anxious to demonstrate their own "Green" credentials. A severely restrictive approach to the highly publicised new gene technology appeared to be a painless and popular way of doing so.

  23. Against this coincidence of popular fears, political self-interest and bureaucratic opportunism, the voices of scientific protest were few, feeble and disregarded. DG XII lost the arguments inside the Commission, and had at the critical moments no interested allies. The protests to Parliament by Nobel prize-winners did not represent a politically significant constituency. The OECD report on rDNA safety, indicating no scientific basis for legislation specific to recombinant DNA, was quoted for its prestige and authority, in support of precisely such legislation. The advice of the safety specialists of the European Federation of Biotechnology was aggressively rejected by the Director-General of DG XI. The House of Lords Committee's report noted that in drafting the legislation, the Commission had been "impervious to scientific advice"; in fact the efforts of DG XII to offer such advice, as they were (by the Council Decisions on BAP and BRIDGE programmes) required to do, were vigorously repulsed and successfully counter-attacked.

  24. A similar "knee-jerk" reaction greeted the suggestion (in the Biotechnology Regulation Inter-service Committee, around 1987) that the details of a fast-changing and complex field might best be addressed by technical experts in standards committees. DG XI was Chef-de-File for biotechnology legislation, but not for standards. As a result, technical details of scope—a central issue in the US debates—were defined in Annex I of each "biotechnology" Directive, 90/219 (contained use), and 90/220 (field release), in terms specific to the legislators' understanding of the science of the 1980s, as modified by the experts chosen by the Environment Ministers, who then removed these defining Annexes from the scope of the committee procedure for adaptation to technical progress. The consequences in costs, delays and controversies would dominate the regulatory debate throughout the 1990s.

  25. The silencing of Galileo no doubt seemed to contemporaries a matter of limited significance, beyond the scientific and theological communities; but by 1990, biotechnology was beginning to matter, and countervailing forces were coming into play, to correct the strategic error. Industry in Europe, following the widely publicised meeting with Davignon of December 1984, had established a communication network for the expression of bio-industrial interests, but failed to endow this with muscle. By continuing to devote their main energies to sectoral channels, they confirmed a similar conservatism within the Commission.

  26. The change of perspective from 1989 was attributable to the significance accorded to biotechnology in less constrained environments (such as the USA), or in those where long-term strategic vision was taken seriously (as in Japan). Multi-national companies operating in several continents could most readily compare the differences of approach, and their implications for regulation. Although they could to some extent re-locate their activities and investments to adapt to circumstances, this had costs and discomforts, particularly for those whose base operations and major investments were in Europe; and for all firms, wherever based, the European market was a major element of the global total.

  27. The loss of investment (actual and threatened), and the loss of R and D activities and personnel, the seed corn for future industries, inevitably attracted political concern, particularly once linked with the rising political concerns about employment. The constitution of the SAGB at European level, the various national bio-industry associations, and the US examples, ensured an attentive hearing for industry once it started to express itself vigorously at political level, from 1990 onwards; but their intervention was late, and did not have enough momentum to divert the legislative juggernaut in that year.

  28. Within the European Commission, the consequences of the failure of inter-service co-ordination were gradually recognised at the highest level; and in 1990 the Secretary-General at the request of President Delors initiated the Biotechnology Co-ordination Committee. More importantly, he maintained and developed the central role of the BCC within the Commission services; thus acting as a brake on the autonomous behaviour of individual DGs, and enforcing a greater degree of horizontal transparency within the house. Also during the early 1990s, the Commission was responding to the need and political demands for greater external transparency (European Commission, 1993); and within the BCC framework, "Round Tables" with industry and with a wide range of non-governmental interests became a regular feature of its activities. The 1991 communication similarly announced that CEN (the European Standards Committee) would be charged with a mandate to develop standards in biotechnology.

  These developments were neither trivial nor obvious: the suspicions and hostility vis-á-vis biotechnology which had driven, and been reinforced by, the 1990 legislation were far from dissipated. If a Directorate-General was disgruntled at BCC, a "phone call or a fax could quickly trigger a forceful letter from a sympathetic MEP to the Secretary-General, and there would not be lacking groups and activist organisations to carry the argument to the public domain, mutatis mutandis—and the mutations could be remarkable.

  30. Moreover, the "public domain" for argument was dramatically enlarged as the UN agencies progressively recognised the need or opportunity for each of them to engage with biotechnology. Particularly damaging were the renewed and amplified opportunities for stigmatisation offered by Article 19.3 of the Convention Biological Diversity, with its invitation to consider the need for an international "bio-safety" protocol. Using these international fora to reinforce one's local position was an instinct as natural to the conflicts in Brussels as in Bosnia.

  31 The prominence of biotechnology regulatory matters in the Commission's December 1993 White Paper on "Growth, Competitiveness and Employment" has been noted in the previous section, along with the follow-up action in the communication at the Corfu Summit, and in the regulatory proposals submitted during the German and French Council presidencies of 1994-95.

  32. These developments clearly display the capacity of the European Commission, of industry, and of national political leaders to be responsive, and to limit and reverse the past mistakes. But as Heraclitus observed, one cannot step twice in the same river. The waters of public opinion have been muddied by misrepresentation, and there remains enough continuing uncertainty and concern to slow the work of reorienting policies and of adapting or dismantling the legal and administrative structures whose foundations are now questioned.

  33. The European Parliament has yet to re-address the central issues of biotechnology regulation. As the renewed European Parliament (after the June 1994 election) struggles for increased power in the Union's inter-institutional debate of the mid-1990s, it is difficult for it to acknowledge that it goofed in earlier years. Institutional face-saving is no less endemic in the national Ministries concerned, and within the Directorates-General of the Commission. However, bureaucratic drafting skills, changes of government, and internal reorganisation are all instruments through which such changes can be respectably managed, and all will have their role.

  34. Parliamentary debates—and votes—on specific challenges such as the Directive on the Protection of Biotechnological Inventions, or the Novel Foods Regulation, continue to give cause for concern to those focusing on Europe's economic competitiveness. Biotechnology is not yet recognised as integral to the future competitiveness of agriculture and of major sectors of industry, as well as to the effective improvement of public health and the protection of the environment. Ethical issues, such as those highlighted in the Council of Europe's draft Convention on Bioethics (1994), will continue to attract greater prominence in Europe; with the risk of consequent relative neglect and damage to the bases of Europe's economic (and consequent political) weight in the 21st century.

  35. To paraphrase the Watson and Tooze "Epilogue" quoted at the start of this section: politics and politicking preoccupied the first years of the recombinant DNA story, and that phrase, in Europe and more than a decade later, became, unfortunately, not "history", but a story of arrested development. The internal conflicts within the Commission are for the moment better controlled, but much energy in Brussels is still devoted to inter-institutional and Community-national conflicts, on constitutional matters which the USA settled 13 decades ago; and to the geographical expansion of the Community.

  36. Insofar as wider international relations and activities come into play—for example, through EC-US bilateral, OECD, or UN agencies—the tendency is for the contending interests, within the Community institutions and at national level, to use such wider dimensions to reinforce their position in domestic conflicts,

  37. As Europe's political leaders and public servants battle for control on the bridge of their Ship of State, and prepare for the Inter-Governmental Conference of 1996-97, they must remember there's ocean out there (and rocks)—not just more and more ship. On the swelling and stormy oceans of knowledge, not least, of the life sciences and technologies, forecasting and navigational skills, and institutional and political structures capable of using them intelligently, will be more than ever essential.

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