Life sciences and biotechnology – a strategy for Europe, January 2002

Speaking on 23 January 2002, at the launch of the European Commission's strategy and action plan for the development of life sciences and biotechnology in Europe, Commission President Romano Prodi said:

'Life sciences and biotechnology are widely recognised to be, after information technology, the next wave of technological revolution in the knowledge-based economy, creating new opportunities for our societies and economies.'

The Commission's initiative is intended to promote the development of these 'frontier technologies' which it is hoped will help make the EU 'the most competitive and dynamic knowledge-based economy in the world' - an aim established by the Lisbon European Summit in March 2000.

Although identified as key industries, there is currently no overall framework for developing biotechnology and life sciences in the EU. Responsibility for a range of relevant policies is shared between EU, international, national and local organisations.

The Commission's strategy addresses how potential can be exploited, the issue of governance, and the international dimension. The section on governance is linked to public concern over the role of science in society, and echoes sentiments expressed in the Commission's Science and Society Action Plan, published on 4 December 2001.

Background

According to an article in European Voice it was in 1993 that 'former Commission President Jacques Delors singled out biotechnology as one of the jewels of EU enterprise, a massive money-spinner and a potential generator of jobs'. More recently, the Union's Sixth Framework Programme has identified 'Genomics and biotechnology for health' as one of seven priority areas for research.

Biotechnology is, however, a contentious technology, and developments in the field have been accompanied by heated debates about the ethics of such research. It seems to be widely accepted that people generally have little understanding of science - although a Eurobarometer survey undertaken for the Commission's Research DG shows that almost half of respondents are interested in science and technology, even though two thirds think they are badly informed about them. The survey also revealed concern over the misuse of scientific discoveries.

Rightly or wrongly people appear to be concerned about biotechnology. Their concerns appear to be fuelled partly by arguments over issues such as cloning or the use of genetically modified organisms, and partly by incidents such as BSE (where biotechnology was not involved, but science was seen to have been in some way responsible for the problem and/or to have failed to solve it).

As the strategy document says:

There is a general need to enhance public trust in the role of science in our societies. The Commission has proposed an action plan on Science & Society to promote scientific culture, to better take into account public needs in setting the scientific agenda, and to place science at the heart of European policies.

The Commission is well aware of public concern and uncertainty. Announcing its latest initiative, Commission President Romano Prodi said:

Life sciences and biotechnology are developing rapidly and globally and have given rise to intense public debate. Europe needs to address the challenges of biotech by developing responsible policies to exploit these new opportunities in a manner that is consistent with European values and standards. Commitment to fundamental ethical values will be crucial to build confidence and foster public acceptance of new biotechnology.'

The point is emphasised in the Communication ... Life sciences and biotechnology - A Strategy for Europe:

The Uncertainty about societal acceptance has contributed to detract attention in Europe for the factors that determine our capacity for innovation and technology development and uptake. This has stifled our competitive position, weakened our research capability and could limit our policy options in the longer term.

Improving the relationship between science and society is the aim of the 38-point Science and Society Action Plan (COM(2001)714) published in December 2001. A range of initiatives are proposed under three main headings: promoting education and science culture in Europe; bringing science policy closer to citizens; responsible science for policy-making.

Legislation is also a difficult area, with a range of relevant issues currently regulated under an ad hoc system which has evolved over some 25 years. Aspect covered include patenting of biotechnological inventions, the authorisation of pharmaceutical products, contained use of genetically modified microorganisms, and release and marketing of products consisting of or derived from GMOs, including foods, feeds and seeds.

The legislative situation is currently complicated by disagreements between EU Member States over rules governing genetically modified foods. Six Member States (Austria, Denmark, France, Greece, Italy, Luxembourg) are currently maintaining an unofficial ban on the approval of new foodstuffs. No new genetically modified crops have been approved in the EU for more than three years.

The European Parliament has decided that the EU should be allowed to fund research into the use of human stem cells, but that money should not go towards human cloning for reproductive purposes or the creation of embryos for research. However, Parliament has rejected attempts to establish much more restrictive criteria for genomic research under the Sixth Framework Programme.

The projected economic impact of biotechnology is significant. Areas in which biotechnology has potential include healthcare, food and agriculture, industry, and the environment. Estimates in Life sciences and biotechnology - A Strategy for Europe

suggest that, in 2010, the direct and indirect market potential of life sciences and biotechnology could amount to: agricultural €2,000 billion; industrial €1,500 billion; pharmaceutical €818 billion. (The Commission has proposed spending €2,150 billion on biotechnology in the Sixth Framework Programme).

The employment picture is not as bright for the EU as for the US. Although there are more biotechnology companies in Europe, they are relatively small; total employment in the industry amounts to 61,000 in Europe, compared to 162,000 in the US. Most European biotechnology firms are very small. They tend to organise themselves in regional clusters, based on centres of scientific excellence. Research co-operation among regions of member states is still quite weak.

The threat of competition from the US and elsewhere is one of the forces driving the Commission to seek a common policy on life sciences and biotechnology. Speaking on 23 January Mr Erkki Liikanen, European Commissioner responsible for Enterprise and the Information Society said: 'The time is ripe and we have no time to loose if we are to catch up with other regions of the world.'

In a similar vein, President Prodi stated in a speech that:

Europe is faced with a major policy choice: either we accept a passive role, and bear the implications of the development of these technologies elsewhere, or we develop pro-active policies to exploit them in a responsible manner.

He also said that part of the problem is that Europe has no single policy for life sciences and biotechnology, but has instead developed:

a patchwork of many sector-specific and overall policies at international, EU, Member State and local levels. In Europe, relevant responsibilities are spread across a broad range of policies and actors. In the absence of a shared vision of what is at stake and without common objectives, Europe has therefore only slowly and with difficulty addressed the challenges and opportunities of these new technologies.'

The strategy and action plan

The Commission's plans for a strategy for life sciences and biotechnology were endorsed

At the European Council's first Annual Spring Meeting on economic and social issues, held in Stockholm on 23-24 March 2001, biotechnology was one of four topics added to the Lisbon strategy. The intention is now for the Commission's life sciences and biotechnology strategy and action plan to be endorsed at the Barcelona Spring European Council in March 2002.

The Commission's strategy seeks to address key issues by developing 'responsible, science-based, and people-centred policies on an ethical basis.' The strategy and accompanying 30-point action plan focus on four main areas:

Harvesting the potential

• Reinforcing the resource base (enhancing education in life sciences; promoting the mobility of, and retaining, Europe's scientists; fostering entrepreneurial management skills; ensuring access to risk capital and intellectual property right protection);
• Networking Europe's biotechnology communities and operators to facilitate open access to knowledge, skills and best practices;
• Developing a pro-active role for public authorities in monitoring the impact on competitiveness of the existing policy framework and in anticipating emerging issues and pro-actively adapting policies.

Responsible governance

• Societal dialogue and scrutiny should accompany and guide the development of life sciences and biotechnology;
• Life sciences and biotechnology should be developed in a responsible way in harmony with societal values;
• Informed choice should facilitate demand-driven applications;
• Science-based regulatory oversight should enjoy public confidence;
• Fundamental regulatory principles and legal obligations should be respected to safeguard the EU Internal Market and international obligations.

International dimension

• Europe has a particular responsibility to support developing countries in dealing with the risks, challenges and opportunities, and to facilitate the safe and orderly development of these new technologies at a global level, in accordance with the choice of individual countries.

Implementation

• The Commission will present a regular Life Science and Biotechnology Report, including a rolling work programme for related legislation;
• To facilitate transparency and dialogue on the further development and implementation of the proposed strategy for life sciences and biotechnology, the Commission will organise a broadly-based Stakeholders' Forum

Further information within European Sources Online:

European Sources Online: Topic Guide:

• The Research and Development Policy of the European Union

European Sources Online: In Focus:

• Europe Commission proposes a new framework programme for research and innovation in Europe, 2002-2006 (Sixth Framework Programme), 21 February 2001
• Genetically modified organisms: Replacement of Directive 90/220 and new proposals on the traceability and labelling of food containing GMOs
• The precautionary principle, April 2000
• European Council, Stockholm, 23-24 March 2001

European Sources Online: European Voice
	11.01.96:	Biotech firms call for single market rules
	27.06.96:	Biotechnology patents set for renewed debate
	12.09.96:	MEPs put ethics under microscope
	27.02.97:	Consumers wary of genetic changes
	29.05.97:	EU in a pickle over biotechnology
	29.05.97:	Stirring up a fine mess
	03.07.97:	In the eye of the biotechnology storm
	17.07.97:	MEPs support legal protection in EU for biotechnology inventions
	26.11.98:	Ethical debate key to industry's future
	17.12.98:	Biotech rules hit genetically modified minefield
	18.03.99:	Science fights for hearts and minds
	15.03.01:	Ban on GMOs widens biotech industry divide
European Sources Online: Financial Times
	23.07.01:	Brussels set to propose new labelling of GM crops
	26.07.01:	Genes, greens and global trade disputes
	27.07.01:	Food labels
	28.08.01:	Brussels firm on plans for biotech food
	04.09.01:	Brussels urges rapid boost for biotech sector
	10.10.01:	EU biotechnology law stays
	10.11.01:	Biotech groups despair at EU attitudes
	15.11.01:	Vote allows EU to fund stem cell research
	18.12.01:	US steps up pressure on Brussels over modified crops

Further information can be seen in these external links:
(long-term access cannot be guaranteed)

European Commission
	Communication...Life sciences and biotechnology - A Strategy for Europe
	Communication...Towards a strategic vision of life sciences and biotechnology: consultation document
	Life sciences and biotechnology a strategic vision
	European Group on Ethics in Science and New Technologies

DG Press and Communication:
	Press Releases:
		06.11.01:	Erkki Liikanen: 'Towards a European Strategic Vision for Biotechnology'
		23.01.02:	Barcelona European Council: Commission launches proposal for comprehensive biotechnology policy
		24.01.02:	Erkki Liikanen: 'Commission proposal for comprehensive biotechnology policy'

DG Research
	Science and society in Europe: How to bridge the gaps?
	European Bio-entrepreneurs: examples of start-up companies in the biotech sector
	The Commission's proposal for a Sixth Framework Programme (2002-2006)
DG Enterprise
	Enterprise Papers No 7, 2002. Innovation and competitiveness in European biotechnology
	European competitiveness report 2001
CORDIS
	European Science and Technology Week 4 - 10 November 2002
	EuropaBio - the European Association for Bioindustries

Further and subsequent information on the subject of this week's In Focus can be found by an 'Advanced Search' in European Sources Online by inserting 'biotechnology' in the search box.

Eric Davies
KnowEurope Researcher
Compiled: 25-27 January 2002

The European Commission launched its strategy and action plan for the development of life sciences and biotechnology in Europe on 23 January 2002. The Commission's initiative is intended to promote the development of these 'frontier technologies' which it is hoped will help make the EU 'the most competitive and dynamic knowledge-based economy in the world' - an aim established by the Lisbon European Summit in March 2000.