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,
8. SYNTHESIS AND
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
"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 Delorsat 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
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 marketfor 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 controlwhatever the disputes
about detailsessentially 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 changefor 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 trendsthe move towards knowledge-based
economics, the natural internationalism of science, its perceived
relevance to economic competitiveness, the increasingly expensive
and specialised character of researchled 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 XIIIresponsible for the large R and D
programmes in information technology and telecommunicationswas
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 populismand
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
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 rapporteuror,
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
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 scopea central issue in the US debateswere 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
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 mutandisand
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
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 debatesand voteson
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 playfor example, through EC-US
bilateral, OECD, or UN agenciesthe 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.