EUROPEAN PARLIAMENT
1999
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2004
Committee on Industry, External Trade, Research and Energy
PRELIMINARY
◄2000/2100(INI)
13 October 2000
WORKING DOCUMENT
on the Future of the Biotechnology Industry
(2000/2100(INI))
Working Document N° 1 : "Outline of the approach"
Committee on Industry, External Trade, Research and Energy
Rapporteur: John Purvis
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THE FUTURE OF THE BIOTECHNOLOGY INDUSTRY
1. Rapporteur's introduction.
Our present prosperity, longevity and my overweight are due in part to our forefathers' skills
in applying life sciences and biotechnology to medicine and health, to food and agriculture,
and to industry.
The modern era and revolution in life sciences dates from discoveries in the mid-twentieth
century such as the structure of the DNA molecule and these developments are proceeding
apace even accelerating with the sequencing of the human genome.
As these developments come up against previous limits and frontiers of general human
experience, we enter areas of earnest public debate. Environmental and ethical issues are
raised. Often these vary substantially between different member states, between scientific and
lay persons, between the devoutly religious and the secular, between business and other
special interest groups. All these are very relevant. There are calls for legislation and
regulation and, on the other hand, for non-interference and reducing red tape. There are
comparisons with competitive regimes - how the industry is better served in the US, Japan,
China, India, or elsewhere.
So, in preparing the ideas for this report, I have put before the committee a small and short
working document to set out the lines that I am considering. Our starting point I think should
be the Lisbon Summit of last March which set the objective "to become the most competitive
and dynamic economy in the world". We all cheered. But words are cheap. The means of
achieving this was "preparing the transition to a knowledge-based economy and society,
R&D, competitiveness, innovation, and completing the internal market".
But look at the statistics. In Europe itself we have had quite a major development. Since
1995 when there were 17000 people employed in what can be described as the biotech
industry to last year when it was 54000. Revenues increased from €1.5 billion in 1995 to well
over 5 billion last year. It sounds very exciting. But then we compare ourselves with the
USA. Revenues in 1998 - €3.7 billion in Europe, €15.7 billion in America - 4.5 times as
much. R&D expense - EU 2.3 billion, US 8.4 - 3.5 times as much. Employees in the biotech
industry - Europe 45000, America 153000 - 3.3 times as many.
So, I think this report should try to define the role of biotech in achieving the Lisbon goals.
Life sciences are very prevalent in several key industries: pharmaceuticals, healthcare, agrifoods, clean-up and waste management. Biotechnology is beginning to merge with other
business areas, with information technology for example - bioinformatics. So, we will
probably attempt to measure the European biotechnology industry and its potential against a
list of criteria:
- its ability to provide products and services of benefit to people;
- its ability to contribute to achieving EU policy obligations e.g. a knowledge-based
economy;
- its relationship to international competitivity and jobs;
- safety, ethical and environmental standards;
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as an outlet for European research and research in life sciences.
I have in mind a rough timetable: working backwards from the plenary in February 2001,
committee vote second half of January 2001, major committee discussion in December, and I
would suggest an informal Roundtable in November with people from all sides.
In the meantime I will continue my Odyssey around Europe, to meet people from various
aspects of the industry, and those with a concern for it from outside the industry e.g. on the
environmental and ethical front. I am collecting information and views from as many quarters
as possible. Indeed, I would ask colleagues to refer anyone or any organisation to come
forward with their insights. They will be very welcome. Some might be potential participants
in the Roundtable discussion.
At this stage I would welcome suggestions from colleagues: whether they feel I have set out
the correct scope for the report, the objectives we aim to achieve, the range of industries to be
covered; whether or not we should get involved in the ethical and environmental issues or to
avoid these; what should government do at all levels, regarding public procurement, trade
issues, taxation, the legal environment; what should end up in the resolution; whether there
are issues of human resources and finance and investment which we should cover.
I am conscious that some of these matters arise in various other parallel reports, such as ecommerce and IT, that we are doing, or in the risk finance and venture capital reports that the
Economic Committee are doing. We should perhaps concentrate on aspects which are
specific to the future of the biotechnology industry and try to avoid too much overlap seeing
as how the length of this report and resolution is quite constrained by the EP's rules. We will
have to be selective.
This is the very first stage in its process. I would welcome colleagues' comments and
suggestions as well as any points from the Commission which they would like to raise at this
stage of the discussion.
2. The context.
The European Council meeting in Lisbon on 23-24 March 2000 set a new strategic goal for
the European Union for the first decade of the new century : ‘To become the most competitive
and dynamic knowledge-based economy in the world, capable of sustainable economic
growth with more and better jobs and greater social cohesion’. It was agreed that this required
an overall strategy, one of the principal aims of which would be ‘preparing the transition to a
knowledge-based economy and society by better policies for the information society and
R&D, as well as by stepping up the process of structural reform for competitiveness and
innovation and by completing the internal market’.
The report of the Committee on Industry, External Trade, Research and Energy on ‘The future
of the biotechnology industry in Europe’ will seek to determine the part to be played by
biotechnology in the achievement of these goals.
European enterprises are active in numerous areas where highly-developed technologies,
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based on recent advances in the life sciences, are applied. These include pharmaceuticals and
related areas of healthcare, agri-food, and other areas such as new environmental clean-up
technologies. The use of a single term ‘biotechnology’ to refer to all these activities can be
misleading, since they are disparate in character, have varying objectives, and use diverse
methods. Many of them share a common origin in the science of molecular biology, which
emerged in the middle of the twentieth century. Another important common feature, less often
recognised in public debate, is that many of the new biological sciences and technologies are
on a natural convergence course with information technology. Evidence of this can be found
in the emergence of the new science of bioinformatics and in the latest computerised
techniques of drug discovery. On balance, the term ‘biotechnology’ is perhaps too convenient
to be abandoned completely, but it should be used with a mental reserve : the awareness that it
covers a plurality of differentiated scientific and technical procedures, processes and products.
The revolution in the life sciences that began in the middle of the twentieth century with
discoveries such as that of the structure of the DNA molecule has become a major component
of the transition to a knowledge-based society which is gathering pace in Europe and other
parts of the world now.
Research and development in these areas, and the actuality or the prospect of industrial and
other practical applications of some of these technologies, have given rise to public debate.
The issues raised in this debate have ranged over a number of concerns : from health and
environmental safety issues to ethical questions. The biotechnology sector is a broad one, and
not all of these concerns are equally relevant in the case of each of the new technologies. The
overall picture of the European biotechnology sector is further diversified by differences in
public attitudes, and indeed in legislation, from one Member State to another in the European
Union.
This report will not attempt to resolve the public debate on these various issues. On the
contrary, it is assumed that the debate will continue – in various public forums, including the
European Parliament itself. The debate, proceeding at various levels at various times, will
continue to give rise to calls for legislation, both at national and at European level, on various
aspects of this sector. The report will assume this process of debate to be both natural and
desirable. However, as one may already observe, the results of the process will not be
uniform. In some instances there will be regulation, in others none. Where there is regulation,
this may take various forms : ranging from a conditionally permissive attitude towards certain
activities to a complete ban on others. Therefore the report makes a second assumption : that
there will continue to be a European biotechnology industry – or, more precisely, a palette of
industries using various technologies based on latest developments in the life-sciences.
Given these starting assumptions, the task of the report may be conceived of as that of
assessing the prospects for the European biotechnology industry against a list of relevant
criteria. At the outset of the process of preparing the report, the rapporteur offers the
following draft list of criteria to serve as a basis for debate on the biotechnology sector in the
Committee on Industry, External Trade, Research and Energy. The suggested criteria for the
sector are :
1. its ability to provide the European population with products and services of real benefit ;
2. its ability to contribute to the realisation of established goals of European Union policy,
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for example in the transition to a knowledge-based economy and society;
3. its ability to secure prosperity and employment, notably in terms of its international
competitivity ;
4. its ability to operate in conformity with health, safety, social, ethical and environmental
standards of the required high standard, including the standards of openness and
transparency necessary for risk analysis ;
5. its ability to provide an outlet for the creativity and knowledge of the European research
community in the life sciences.
3. Planning and outline of the report.
It is planned to have the report debated by the European Parliament at the plenary session in
February 2001. This implies adoption in ITRE in January 2001.
In November 2000 the rapporteur intends to hold an informal round-table in Brussels to which
a small number of experts will be invited. Although this event will not be held as part of an
official meeting of the Committee, Members of the Committee will be welcome to attend.
Meanwhile the rapporteur has drafted the following outline for the report. Both the outline
and the content may be adapted to take account of the views expressed by Members during
discussions in the Committee or of ideas generated at the round-table
SCOPE OF THE REPORT
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Industry and industrial branches
Ethics and environmental issues
Intellectual property
Science and research
OBJECTIVES
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Best conditions for a successful future for the industry
Ethical and environmental constraints defined
Intellectual property rules
EU research support
Contribute to public debate
INDUSTRY
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Europe’s competitive position (Comparative table)
Medical
Agriculture and food
Industrial
Geographic dispersal
Constraints and red tape
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ETHICS AND ENVIRONMENTAL ISSUES
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Human cloning/human embryos
Animal testing
Religious attitudes
Medical potential/food supply, etc.
Ecological impact
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