Position Statments on Biotechnology

Position Statements on Biotechnology

European Union

1) "Life Sciences and Biotechnology - A Strategy for Europe"

The European Commission has recently adopted a policy initiative to develop its life sciences and biotechnology. In a strategy paper entitled "Life Sciences and Biotechnology - A Strategy for Europe" the European Commission outlined a plan that recognizes the strategic and long-term importance of biotechnology in Europe's vision "to become the most competitive and dynamic knowledge-based economy in the world".

The Commission recognizes the need 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". It has realized that biotechnology is the next technological revolution after information technology. The Commission also acknowledged that Europe's biotechnology industry is lagging behind that of the US but continues to grow. By 2005, the European biotechnology market could be worth over €100 billion.

The first part of the paper discusses a Strategy that addresses questions that Europe needs to answer to develop sustainable and responsible policies. They include the following:

How can Europe best attract the human, industrial and financial resources to develop and apply biotechnology to meet society's needs and increase its competitiveness?
How can Europe deliver effective, credible and responsible policies, which enjoy the confidence and support of its citizens?
How can Europe best respond to the global challenges, develop its domestic policies with a clear international perspective and act internationally to pursue its interests?

The second part of the paper is an Action Plan composed of concrete steps, which may be taken by the Commission and the European Community. It is comprised of 30 actions with the corresponding implementer and time frame. Priorities of the biotechnology action plan include:

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, 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
A pro-active role for public authorities in monitoring the impact on competitiveness of the existing policy framework and to anticipate emerging issues and pro-actively adapt policies

Responsible governance

The public debate on life sciences and biotechnology, fundamental values affected, and the complex issues raised demonstrate the need for responsible policies to help steer these fast-moving technologies, and the need for particular attention to involvement of the general public. The debate needs to be broadened far beyond the current focus on genetically modified foods and stem cells. All key stakeholders have stressed the importance of governance, i.e. attention to the way public authorities prepare, decide, implement and explain policies and actions.

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

The EU should continue to take a leading role in developing international guidelines, standards and recommendations based on international scientific consensus.

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 the global level, in accordance with the choice of individual countries.

Implementation

To monitor progress in policy development and on the ground, and to anticipate emerging issues in this fast-developing area, the Commission will present a regular Life Science and Biotechnology Report, including a rolling work programme for related legislation. The Commission will, as part of its Life Science and Biotechnology reports, review the consistency of EU policies and legislation affecting life sciences and biotechnology and launch initiatives and proposals as appropriate.

Where different levels of competence apply, the strategy should be a reference for co-operation between the different actors. 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.

To view the Strategy Paper, go to http://europa.eu.int/
comm/biotechnology/pdf/policypaper_en.pdf

2) EC PUBLISHES REVIEW ON BIOSAFETY RESEARCH OF GMOS

Earlier in October 2001, the European Commission published a report on the results of the biosafety research it has supported over 15 years. The report, entitled EC-sponsored Research into the Safety of Genetically Modified Organisms: A Review of Results analyzed the results of 81 scientific studies on GMOs conducted by over 400 research teams at a cost of US$65 million (see Table below).

The Commission says that "research on GM plants and derived products so far developed and marketed, following usual risk assessment procedures, has not shown any new risks to human health of the environment, beyond the usual uncertainties of conventional plant breeding. Indeed the use of more precise technology and the greater regulatory scrutiny probably make them even safer than conventional plants and foods; and if there are unforeseen environmental effects - none have appeared as yet - these should be rapidly detected by our monitoring requirements."

The review includes all EC-supported projects explicitly targeting GMO safety research; it also includes a few others, which may focus on some other subject but which contain important elements of or implications for GMO safety research. Projects have been grouped for convenience into eight thematically based research areas, each with an introduction, providing an overview of the results, trends and issues, written by a scientist prominent in the field. Most reports have been written by project co-ordinators and are their author's responsibility. In a few cases, especially among the earlier projects, reports have been taken from earlier published material.

EC-sponsored research has focused on all areas of concern including plants, plant microbes, biocontrol, food, bioremediation, tools, fish, and vaccines. For a comprehensive review of the results, please go to http://europa.eu.int/comm/research/
quality-of-life/gmo/

Programme	Number of Projects
Fifth Framework Programme (1998-2000 only)
Cell Factory Key Action	5
Food, Nutrition and Health Key Action	5
Fourth Framework Programme (1994-1998)
Biotechnology (II)	18
Agriculture and Fisheries (FAIR)	2
Standards, Measurement and Testing	1
International Cooperation	5
Third Framework Programme (1990-1994)
Biotechnology (I)	9
Agriculture and Agro-Industry (AIR)	2
Second Framework Programme (1987-1991)
Biotechnology (BRIDGE)	14
Food-linked Agro-Industrial Research (FLAIR)	1
First Framework Programme (1984-1987)
Biotechnology Action Programme (BAP)	19
TOTAL Number of Projects	81