vida, ciencia y biotecnología

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Life sciences

andbiotechnology

A strategy

for Europe

EUROPEAN COMMISSION


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Life sciencesand biotechnology

A strategy for Euro

Communication from the Commisthe European Parliament, the Co

the Economic and Social Committthe Committee of the Region

COM(2002) 27


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A great deal of additional information on the European Union is availaIt can be accessed through the Europa server (http://europa.eu.int).


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Contents

Part I: A strategy for Europe . . . . . . . . . . . . . . . . . . . . . . . . .

1. The strategic challenges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.1. Technology revolution and policy response . . . . . . . . . . .

1.2. A European strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. The potential of life sciences and biotechnology . . . . . . . . . . . .

3. Harvesting the potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1. The knowledge base . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.2. Europes capacity to offer scientific and technological solu

4. A key element for responsible policy: governing life sciences and

4.1. Societal scrutiny and dialogue . . . . . . . . . . . . . . . . . . . . .

4.2. Developing life sciences and biotechnology in harmony wi

and societal goals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.3. Demand-driven applications through informed choice . .4.4. Confidence in science-based regulatory oversight . . . . . .

4.5. Regulatory principles . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. Europe in the world responding to global challenges. . . . . .

5.1. A European agenda for international collaboration . . . . .

5.2. Europes responsibilities towards the developing world . .

6. Implementation and coherence across policies, sectors and acto

7. A framework for dialogue and action . . . . . . . . . . . . . . . . . . . .


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PART I

A STRATEGY FOR EUROP


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1. The strategic challenges

Life sciences and biotechnology are widely recognised to be, after infmation technology, the next wave of the knowledge-based economcreating new opportunities for our societies and economies.

They also raise important policy and societal issues and have given rto a broad public debate, as confirmed in the comprehensive public csultation carried out by the European Commission during autu2001 (1). These issues must be addressed with great care and sensitivIn Europe, however, the relevant responsibilities fall across a broad ranof policies and actors. In the absence of a shared vision of what is at stand without common objectives and effective coordination, Europe htherefore only slowly and with difficulty addressed the challenges a

opportunities of these new technologies.

Our democratic societies should offer the necessary safeguards achannels of dialogue to ensure that the development and applicationlife sciences and biotechnology take place respecting the fundamenvalues recognised by the European Union in the Charter of FundamenRights.

Europe is faced with a major policy choice: either accept a passive areactive role, and bear the implications of the development of these tenologies elsewhere, or develop proactive policies to exploit thema responsible manner, consistent with European values and standarThe longer Europe hesitates, the less realistic this second option will

The Community is competent on important policy aspects of relevanand the Commission therefore has a particular responsibility to assistfinding ways forward. The present initiative proposes a framework for th

A STRATEGY FOR EUROPE


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8

Europe seems to be

hesitating

applications, such as gene testing and regenerati

tissues. These in turn offer the prospect of applimpacts throughout our societies and economies,genetically modified plant crops.

The expansion of the knowledge base is accocedented speed in transformation of frontier scpractical use and products and thus also represe

wealth creation: old industries are being regeneraare emerging, offering the kind of skill-baknowledge-based economies. As probably the frontier technologies, life sciences and biotechmajor contribution to achieving the EuropeanSummits objective of becoming a leading knowThe European Council in Stockholm in March 2invited the Commission, together with the Coun

examine measures required to utilise the full poand strengthen the European biotechnology secorder to match leading competitors while ensurments occur in a manner which is healthy and safe

environment, and consistent with common fuethical principles.

Europes current performance in life sciences anfacilitating the achievement of that objective.

In Europe and elsewhere, intensive public deba

the public debate has contributed to awareness ments on important issues, it has also focused nmodified organisms (GMOs) and specific ethicpublic opinion has become polarised. In the Coregions and countries, the scientific and technol


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but how to deal with the challenges posed by the new knowledge and

applications.

1.2. A European strategy

The European Commission wishes to contribute actively to the refltion on these issues and to address the challenges. In September 2001

launched a broad public consultation on the wide range of issues at stake These issues can only in part be addressed by the Community mdepend on many other public and private actors. In some areas suchproduct approvals, safeguarding the internal market, agricultural atrade policies, the Community has exclusive competence. On othaspects, the Community has no competence or shares it with MembStates. The ultimate responsibility for success or failure is thereforshared one.

But respecting the subsidiarity principle should not prevent Europefrom working together towards common goals. Within a shared visionthe long-term and global opportunities and challenges, we can deveclear strategic objectives and coherent and holistic approaches, rely

also on new forms of collaboration and monitoring, in particular throuopen coordination and benchmarking which underpins the Lisbon strate

With the present initiative, the European Commission proposes a stratefor Europe to develop sustainable and responsible policies to address following three broad questions:

Life sciences and biotechnology offer opportunities to address manythe global needs relating to health, ageing, food and the environmeand to sustainable development. How can Europe best attract human, industrial and financial resources to develop and apply thtechnologies to meet societys needs and increase its competitivenes


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New solutions to realproblems

develop its domestic policies with a clear intern

act internationally to pursue its interests?

The Commission proposes a strategy to respond wbased, and people-centred policies on an ethical bto allow Europe to benefit from the positive potebiotechnology (Sections 2 and 3), to ensure properand to meet Europes global responsibilities (Se

posal for an integrated strategy its differedependent and mutually reinforcing.

Implementing this strategy requires an open, collprocess to develop coherent and credible poCommission also proposes an action plan for coCommission and the Community, as well as recopublic and private actors, respecting the subsidia

2. The potential of life scbiotechnology

Life sciences and biotechnology are widely regarpromising frontier technologies for the comingand biotechnology are enabling technologies nology, they may be applied for a wide range of ppublic benefits. On the basis of scientific breakththe explosion in the knowledge on living systemtinuous stream of new applications.

There is a huge need in global healthcare forapproaches to meet the needs of ageing populatiThere are still no known cures for half of the woexisting cures such as antibiotics are becomin

A strategy and anaction plan


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prospect of replacement tissues and organs to treat degenerative disea

and injury resulting from strokes, Alzheimers and Parkinsons diseasburns and spinal-cord injuries.

In the agro-food area, biotechnology has the potential to deliimproved food quality and environmental benefits through agronomally improved crops. Since 1998, the area cultivated with geneticamodified (GM) crops worldwide has nearly doubled to reach so

50million hectares in 2001 (in comparison with about 12 000 hectareEurope). Food and feed quality may be linked to disease prevention areduced health risks. Foods with enhanced qualities (functional foodare likely to become increasingly important as part of lifestyle and nutional benefits. Plant genome analysis, supported by a FAIR reseaproject, has already led to the genetic improvement of a traditioEuropean cereal crop (called spelt) with an increased protein yi(18%) which may be used as an alternative source of protein for animfeed (3). Considerable reductions in pesticide use have been recordedcrops with modified resistance. The enhancement of natural resistancedisease or stress in plants and animals can lead to reduced use of cheical pesticides, fertilisers and drugs, and increased use of conservattillage and hence more sustainable agricultural practices, reduc

soil erosion and benefiting the environment. Life sciences and biotenology are likely to be one of the important tools in fighting hunger amalnutrition and feeding an increasing human population on currently cultivated land area, with reduced environmental impact.

Biotechnology also has the potential to improve non-food uses of croas sources of industrial feedstocks or new materials such as biodegr

able plastics. Plant-based materials can provide both molecular buildblocks and more complex molecules for the manufacturing, energy apharmaceutical industries. Modifications under development inclualterations to carbohydrates, oils, fats and proteins, fibre and new pomer production. Under the appropriate economic and fiscal conditio


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3. Harvesting the po

The potential of life sciences and biotechnology accelerating rate and is likely to engender a ncreation of wealth and skilled jobs. Less certand orientations of this development and wheparticipate.

Some estimates suggest that by the year 2005 theogy market could be worth over EUR 100 billdecade, global markets, including sectors whbiotechnology constitute a major portion of the ncould amount to over EUR 2 000 billion.

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The economicdimension

Direct and indirect market potential of life sciences andIndustrial: EUR 1500 billion market globally in 2010 in sustainable imental technology (only partly biotech) with environmental techEUR 90120 billion (2).

Pharmaceutical: EUR 506 billion world market in 2004 (EUR 818 billconstant increase) (3).

Agricultural: Although there is a steady increase in the area sown witseeds, the future market value is difficult to predict, as it would dedevelopment of a non-GM feed market.

Million hectares worldwide (4):

1998 1999 2000

28 40 44

Allowing for the uncertainty of estimates from different sources, the ain 2010 there would be a total world market (excluding agriculture) olion in sectors where a major portion of the new technology and a substechnology comes from biotechnology companies.


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emerging economy, Europe should also command the knowledge base a

its transformation into new products, processes and services.

3.1. The knowledge base

The life sciences revolution was born in, and is fed and nurtured research. Public research laboratories and institutions of higher edu

tion are at the core of the science base interacting also with enterpribased research and that of other private bodies.

The success of any knowledge-based economy rests upon the generatidiffusion and application of new knowledge. Investments in researand development, education and training and new managerial approaes are therefore of key importance in meeting the challenges posed by

sciences and biotechnology.

One of Europes main strengths is its science base; centres of scientexcellence in specific technologies exist and are at the core of regioclusters of biotechnology development. However, total European invement in R & D is lagging behind the United States. Moreover, Euro

suffers from fragmentation of public research support, and from the llevel of interregional cooperation in R & D, among companies and intutions from different regions of several States.

The Commission aims to restore European leadership in life sciences abiotechnology research. The sixth Community framework programfor research, technological development and demonstration activit

(200206) proposes this area as the first priority and will provide a soplatform for constructing, in collaboration with the Member StatesEuropean research area. This should reinforce R & D capacity and hovercome existing fragmentation of research policies and efforts. WhEuropeans work together, maximising collaboration and minimis



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interface where biotechnology is yielding innovat

ments of human and animal diseases.

Europes research agenda for life sciences should

of its citizens and attuned to our particular requ

an approach which actively identifies the needs

sented by European societies and seeks to addr

vative research. We need to strengthen furth

research and other Community policies, includin

health and safety regulations. Within the same lo

importance to involve scientists and researchers

societal consensus-building. New research partn

encouraged amongst developed and developin

advantage of promising technologies and biodive

for future progress.

3.2. Europes capacity to offer

technological solutions

The potential for applications of life sciences and to be a growing source of wealth creation in th

creation of jobs, many of which will be highly sk

nities for investment in further research.

If Europe is to benefit from this, excellence in

enough: it is essential to have the capacity to tr

new products, processes and services, that in turto society, skilled jobs and prosperity. The devel

involves the encouragement of the entire re

process to attract and train researchers, to a

resources and to provide a balanced and respo

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... research to meetsocietys needs

Transforming scienceinto applications


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NB: European data for 2000 and 2001 are adjusted by the inclusion of the Swiss biot

company Serono.

However, the European SMEs are relatively small companies, wherthe US biotechnology industry started earlier, produces more than thtimes the revenues of the European industry, employs many more peo(162 000 against around 60 000), is much more strongly capitalised anin particular, has many more products in the pipeline.


Biotechnology industry in Europe compared

with the United States

0

200

400

600

800

1 000

1 200

1 400

1 600

1 800

1997 1998 1999 2000 2001

Companies

0

5

10

15

20

25

30

Billion

EUR

Number of companies, Unit

Number of companies, Euro

Revenue, United States

Revenue, Europe

Revenue Europe (adjusted)

Comparison of employment

160 000

180000

200 000


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The Commissions 2001 report on competitivene

in detail why commercial development of EU behind that of the United States in the biotechnoproperty rights were identified as a relevant faccount.

Structurally, biotechnology SMEs are very capitments have long payback periods. Risk capital fu

ingly available, but does not appear to be sufficlong company development process. Insufficiensonnel may develop into a major constraint for in

Eliminating such bottlenecks is as important asneurial Europe with sufficient incentives for innrisk-taking to create the necessary dynamics. Eushould be enhanced through three main pillars base, networks and a proactive role for public au

Reinforcing the resource base is of primeknowledge-based industry; this calls first of alences education (lifelong learning for scientist

the public). We also need training across discipincluding the potential for take-up of informattechnologies in biotechnology; new ideas tendtion of specialisation. Scientific and engineerinmatched with entrepreneurial management skpany operation. This action pillar contributes dcation (4) and employment (5) objectives. Com

and publicly and freely available bioinformaticadvances in biotechnology. In order to flourishto high-quality public and private databases taining strong public research, public support arules should encourage collaborations especia

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Action for Europesbiotechnology sector


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European Community (EC) will provide innovative firms in the va

ous industries using biotechnology with an incentive to continueeven increase their investments in research. In addition, the adoptof the Community patent would promote the competitiveness of EC companies.

We need to network Europes biotechnology communities to facilitopen access to knowledge, skills and best practices, and to creat

close community of actors and institutions involved in biotechnoloEurope-wide intellectual property protection must be completedprovide an affordable basis for technology transfer and cooperatiLinks between the university and the industry spheres need to strengthened. Research cooperation and technology transfer amoregions and Member States must be enhanced. There is a need to pmote and facilitate different forms of networking and linking-upovercome current fragmentation. Benchmarking allows the sharingknowledge of good practices (e.g. on business clusters and incubatoAn intelligent management of diversity may exploit the network befits of regional clusters that are specialised in specific technologies.

The fast development of biotechnology and the broad range of pot

tial applications require a proactive role for public authorities to moitor the impact on competitiveness of the existing policy framewoand to anticipate emerging issues and proactively adapt policies. Twill need a pooling of the knowledge available to public decision-makthrough information exchange and networking.

4. A key element for responsible policygoverning life sciences and

biotechnology



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life sciences and biotechnology should be dev

way in harmony with ethical values and societa

informed choice should facilitate demand-driv

science-based regulatory oversight should enha

basic regulatory principles and legal obligation

safeguard the Community single market and in

4.1. Societal scrutiny and dialo

Life sciences and biotechnology have given ris

attention and debate. The Commission welcome

sign of civic responsibility and involvement. Lif

nology should continue to be accompanied a

dialogue.

Dialogue in our democratic societies should be in

well informed and structured. Constructive di

respect between participants, innovative approacbe structured in agreement with stakeholders

example in the provision of better information and

Experience also shows how important it is that

the local and national levels, as well as in

Commission invites Member States and local

initiatives.

Dialogue should be open for all stakeholders. Pu

help to ensure participation by stakeholders w

Economic operators industry and users who hav

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... inclusive,informed and

structured dialogue


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4.2. Developing life sciences and

biotechnology in harmony withethical values and societal goals

Without broad public acceptance and support, the development and of life sciences and biotechnology in Europe will be contentious, befits will be delayed and competitiveness will be likely to suffer.

The debate and the public consultation carried out by the Commissionindicate that the European public is quite prepared and capable to eninto complex weighting of benefits against disadvantages, guided by fudamental values. Although sometimes polarised, the public debdemonstrates many points of converging views.

Public opinion depends crucially on the perceived benefits of life ences and biotechnology. Eurobarometer surveys reveal that pubexpectations of biotechnology, apart from medical advances, are moderThere is also considerable public uncertainty about some applicatioand aversion towards their distributional impacts and the risks involv

There is broad support for many guiding values and goals. Somethese, such as the freedom of research, intrinsic value of new knowledand the moral obligations to help alleviate illness or hunger, tendfavour the development and application of these new technologiOthers help to clarify the criteria and conditions for the developmand applications of life sciences and biotechnology, in particular need to take into account the ethical and societal implications, and

importance of transparency and accountability in decision-making, mimising risk, and freedom of choice.

It is therefore of key importance to support information and dialoguehelp the public and stakeholders better understand and appreciate th

l d d l h d d f b



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the Franco-German initiative, addressed to the

convention on the prohibition of human reproissues such as stem cell research clearly requir

debate. Europe has also taken clear positions on

dom of choice for consumers as well as for ec

respect to GM foods, and we have established b

on the need to safeguard European agricultural p

However, scientific and technological progress w

to new ethical or societal implications. The Com

these issues should be addressed proactively and

tive, taking into account the moral obligation

future generations and the rest of the world. W

ourselves with acting defensively only when ou

transgressed.

These issues cannot be adequately addressed wit

of regulatory product approvals but require mor

looking approaches. Europe needs an active an

logue, accompanied by focused fact-finding on b

vantages to allow the public to contribute to the ting priorities. In the context of its science and

Commission has already proposed a series o

strengthen the ethical dimension in sciences and

To be at the front of developments, Europe shou

foresight/prospective analysis and the necessary

the often complex issues for policy-makers and tthem in their scientific and socioeconomic con

welcomes the key role played by the Europea

Science and New Technologies since its creation

f h

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4.3. Demand-driven applications through

informed choice

The regulatory oversight applied to the development and use of sciences and biotechnology is the expression of societal choic

Regulation and other public policy measures set the rules and conditio

under which life sciences and biotechnology may be developed a

applied. Regulation should therefore ensure that market mechanisfunction effectively to obtain the stated objectives. This is the purpose

Europes policy of mandatory labelling which aims to ensure that co

sumers preferences are translated into incentives for producers to ad

supply.

As far back as 1990 and after lengthy discussions, the Community op

for a science-based regulatory approach that subjects all commercial uof genetically modified organisms to ex ante public scrutiny and safapproval on a case-by-case basis, prior to any application, release into

environment or marketing. As a result of this approach, a revised fram

work legislation on GMOs has been adopted and will enter into force

October 2002. The new legislation provides a sound basis to overco

the present standstill in authorising new products.

Under the Communitys regulatory approach in sectors where p

marketing authorisation is required, authorisation is granted aftescientific evaluation of the risks which the product may present

human and animal health or to the environment, taking into accou

other factors legitimate to the matter under consideration. In the loof this approach, it is for the markets to determine whether produ

survive. But it is essential to ensure that the market mechanisms woeffectively so that consumers can exercise choice and thus send cl

signals to suppliers. Over the last five years, Europe has pionee



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4.4. Confidence in science-base

oversight

Where safety is an issue, Community legislation application with respect to specific decisions wilthe precautionary principle (9). The European Agof Medicinal Products (EMEA) is a successful estandards of scientific advice and effective risk cocreation of the European Food Safety Authorihigh standards of excellence, independence andtific advice in that field will be taken further andplaced on risk communication. EFSA will be reassessments of environmental, human and anGMOs and GM food and feed, and will have a f

sibility for identifying emerging risks, includingfrom the application of biotechnology in agri-fooessential contributions to public trust in the scienoversight for the safety of existing foods and mapplications. Building public confidence and unpermanent concern.

There is a general need to enhance public trustour societies. The Commission has proposed anand society to promote scientific culture, to bpublic needs in setting the scientific agenda, anheart of European policies. Public authorities, ethe scientific community should actively presand facilitate understanding on key issues, in

knowledge is always advancing and therefore reference points. Moreover, it is an essential partunderstanding and policy formulation to alsnot taking action, for example against the evoresistant diseases and in areas where current a

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... fostering publicconfidence inscience andregulation



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to be monitored very closely. Regular assessments need to be made

whether the patent regime satisfies the needs of researchers and copanies. In this respect, the EC and its Member States should ensuthat the interpretation of the essential criteria of novelty, invention autility in the field of life sciences is not left exclusively to courts apatent offices. As regards the international context, there is a needwork towards a level playing field in patent protection in industrialicountries. Steps need to be taken with a view to promoting intern

tional dialogue on this issue.

The basis for Community regulation of these new technologies shobe more transparent and better communicated. For example, we shobe clearer about how regulators deal with risk potential risk, scitific uncertainty (e.g. the absence of zero risk, the application of the p

cautionary principle), weighing of comparative risks, the role of the dferent stages of risk analysis, the role of risk management measures suas monitoring and safeguards, and their proportionality with risk.addition, whilst underlining the importance of legal certainty and pdictability, we need to stress the reversibility of regulatory decisiowhen justified and highlight the ongoing work on international convgence of risk analysis methodologies and development of anticipat

risk analysis methodologies. Publicly funded research in supportregulatory oversight is of particular importance for public confiden

Specific initiatives proposed in the Commissions White Paper European governance are particularly relevant for enhancing pubconfidence, in particular the planned improvements for openness a

accountability in risk governance and in use of expertise.

Confidence in our regulatory oversight is a responsibility of pubauthorities but also requires the responsible participation of othstakeholders such as the biotechnology industry, other economic op


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In order to improve the coherence, transpar

Community regulation, the Commission suggestslatory activity should respect the following princ

Risk governance and product authorisation: Pr

should, in accordance with the established re

frameworks, be authorised on the basis of a c

risk assessment if found to be safe for human,

health and the environment. In cases where scie

ficient, inconclusive or uncertain, and where p

to be unacceptable, risk management measures

precautionary principle. Risk management sh

the results of risk assessment and other factors

under consideration in order to achieve the cho

Procedures for authorisation should be transpments should be published and made available

part of the authorisation procedures. Commun

integral part of risk assessment and risk manag

Safeguarding the internal market: To secure

internal market and legal certainty, Communidrafted and periodically reviewed to ensure co

including with regard to its practical feasibi

Implementation of and compliance with Com

carefully monitored, and any problem of

addressed and resolved among the parties c

existing procedures in a transparent and predic

Proportionality and consumer choice: Commu

ments should be proportionate to the degree

should conform with the Communitys intern

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5. Europe in the world responding

to global challenges

The revolution in life sciences and biotechnology is global. Researchfundamentally international knowledge and experts circulthroughout the world. A growing number of countries are activpursuing biotechnologies, and the resulting products and services w

increasingly be traded on global markets, with a premium for fiinnovators.

It is also clear that great diversity exists between countries and regiowith respect to their capacities to develop, regulate and apply the nproducts and services. Even greater diversity may emerge with respectthe priorities and societal values that will shape the approaches a

choices to developing and using these new technologies.

European policies should not be developed in isolation. We needembrace the wider international context which shapes both challenges aopportunities for Europe, and we must respond with responsible aproactive policies at the global level. A main objective must be to ensuthat the EU maintains competitiveness vis--vis major industrialised coutries such as the United States and Japan. Moreover, whatever policEurope will decide regarding life sciences and biotechnology, they whave important international impacts, in particular for developing cotries. The interests of these countries must also be taken into account. Wmust integrate the international dimension into all relevant policies, awe need to develop an international agenda, based on our fundamental v

ues and long-term objectives, to actively promote balanced and responsipolicies globally, in particular towards the developing world.

5.1. A European agenda for


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The Community is committed to open, multi

trading systems. We should therefore promote tation of existing international agreements. Givraised by life sciences and biotechnology, the Comsolutions and dialogue at international level that

ensure mutual supportiveness between relevaments and, in particular, between the WTO

Biosafety Protocol;

support a coherent, comprehensive, effective,sive approach to biotechnology across the forums in order to avoid overlaps and makerespective expertise (including the FAO, UNEand Unctad (10)). Europe should continue to pular in the OECD and the Codex Alimentariusintergovernmental task force on biotechnolothese organisations the development and pmonised guidelines with respect to the risk anthe traceability of products derived from modrole and efficiency of EU participation in in

should be enhanced, including through discuand developing countries. Dialogue should pstanding of concerns and objectives of differensuch as the EU/US Biotechnology Forum wreport in December 2000(11). Early policy dialolegislation may reduce the potential for interna

5.2. Europes responsibilities todeveloping world

Life sciences and biotechnolog hold the promise

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Potential to meet the



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Life sciences and biotechnology are not a panacea and will not reso

the distributional problems of the developing world but they willone of the important tools. New capacities should help developing coutries reconcile yield increases, sustainable use of natural resources, enomic efficiency and social acceptability. Potential applications mustadequately researched and assessed, taking full account of both the enronmental safety issues and the needs expressed by the populations ccerned to reduce poverty and strengthen food security and nutritio

quality.

As a major actor in life sciences and technologies, Europe has a particuresponsibility to help the developing world deal with the risks, chlenges and opportunities, and to facilitate the safe and orderly develoment of these technologies at the global level. Europe already holds

influential position in international deliberations on life sciences abiotechnology. This needs to be taken forward with responsible policto achieve our strategic objectives and to allow the safe and efficient uof life sciences and biotechnology in developing countries.

Europe should continue to promote protection of biodiversity and implementation of the Biosafety Protocol for international trade in

ing modified organisms. Moreover, Europe should continue to suppnegotiated multilateral frameworks such as the Convention Biological Diversity and the FAO international undertaking on plgenetic resources. These international instruments regulate accessgenetic resources and the sharing of the benefits arising from their uwith a view to providing compensation to the centres of origingenetic resources and the holders of traditional knowledge usedbiotechnological inventions. The EC should contribute to ensure tthe benefits generated by biotechnological inventions, includintellectual property income, are properly shared with the providersgenetic resources or traditional knowledge.


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Domestic European policies with regard to lif

nology are bound to have major impacts onWhilst not compromising EU food safety reqinformation policies, we should provide tecapacity-building to ensure that our policies dvent developing countries from harvesting desular, we should guard against regulatory reqmanageable only in the industrial world but are

oping countries, thereby either upsetting existblocking developing countries from developbiotechnology at their own wish and pace.

6. Implementation and

across policies, sectors aEurope does not have a single policy for life sciebut a patchwork of specific regulation, overlaidhorizontal policies at international, Community, levels. If, with so many actors and policies invocessfully manage life sciences and biotechnolog

for society, we should proceed on the basis of a serative approach and with effective implementinpensate for absence of overall responsibility andmechanisms, life sciences and biotechnology riindecision or short-sighted and local solutions.

The Commission proposes to structure and supthe present strategy and the enclosed action planmeasures.

To monitor progress in policy development an

Overcomingdispersedresponsibilitiesthroughcollaboration

Implementationthrough

... monitoring



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sciences and biotechnology adequately integrates our internatioobjectives and facilitates innovation and international competitivenethat Community research contributes coherently and effectivelyCommunity objectives, and that other Community policies and objtives (e.g. in environment, public health and consumer protectieducation, employment, agriculture, trade and development policiadequately reflect the long-term and global importance of life scienand biotechnology. The Commission will evaluate whether exist

international forums and bilateral dialogues are sufficiently effectand provide an adequate flow of information, and whether the domtic coordination mechanisms can be improved.

Where different levels of competence apply, the strategy should breference for collaboration between different actors (Communnational and local public authorities, economic operators, the scient

community, etc.). As part of the Lisbon strategy, coherent action life sciences and biotechnology should be pursued through the estlished methods of coordination and benchmarking. In addition, nforms of collaboration and partnerships between stakeholders shoube encouraged. Together with Member States, the Commission walso assess whether current patterns of competence and mechanismscooperation allow the effective achievement of the strategic objectivincluding to reassess whether there is a need for reinforcCommunity competence in accordance with the EC Treaty.

The Commission invites all institutions and public actors to strive better coherence in their action. For its own part, it will seek to provthe vigilance and political impetus to keep momentum in implement

the present strategy, through its own action or through recommentions and invitations to other parties. The Commission intends to hmore regular orientation debates, coinciding with the adoption of abovementioned Commission life sciences and biotechnology repor


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PART II

ACTION PLAN


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ACTION PLAN


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1. Harvesting the potentia

The resource base

Investing in people

Action 1

The Commission will, together with competent authorities in Membeeducation needs in life sciences within the Ten-year objectives for leasociety (2) and:

(a) strengthen a broad education and understanding of life sciences

(b) develop and train a skilled workforce in life sciences;

by issuing recommendations for curricula and teacher training. Com

provided under the Comenius and Erasmus programmes.

As set out in its communication on the European area of lifelong learnwill work with Member States, industry, academia and others to identcontinuing education and refresh the current competence of thCommunity support can be provided under the Leonardo programm

The Commission and Member States should support discussion forumwith the objective of stimulating an exchange across disciplines. Vithappen at the point where disciplines intersect. Community supportthe Erasmus programme.

Implementer: Member States, Commission, private sectorTimeframe: 200310

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Action 2

The Commission will explore with Member States:

(a) the opportunity and best way to establish efficient methods to mawith job opportunities, involving effective communication of opetion with established companies and a labour force aware of options;

(b) possible measures to attract and retain scientists and avoid brain dspecific reference will be paid to the initiatives launched undeA mobility strategy for the research area(4), which aims at imprronment of researchers and their families in the EU. Due attention increased mobility opportunities offered by the forthcoming sixth f(200206), and more particularly to the measures aimed at attractand supporting the return of EU researchers established in other p

Implementer: Member States, CommissionTimeframe: 2003 onwards

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Generating and exploiting knowledge

Research

Management and legal services

Action 3

The Commission will enhance its support for life sciences and biotecnological development, demonstration and training activities under tgramme 200206 aimed at contributing towards the creation of the

Biotechnology research will be supported under the thematic prioriti

1. Genomics and biotechnology for health

3. Nanotechnologies

5. Food quality and safety

6. Sustainable development

7. Citizens and governance.

Specific measures will be provided to encourage SME participation, inand mobility and training of researchers.

The new instruments of networks of excellence and integrated probjectives of Europe-wide collaborations, attaining critical mass and istrative procedures.

The Commission and the Member States should also in collabora

Investment Fund (EIF) develop a competitive bioinformatics infrabiotechnology research and focus support for the development of rebiology and biomedical informatics.

Implementer: Member States, EIF, CommissionTimeframe: 200206

Action 4

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Exploitation of intellectual property

Capital base

Action 5

A strong, harmonised and affordable European intellectual property prtioning as an incentive to R & D and innovation will be finalised by:

(a) Member States urgently transposing into national laws Directive protection of biotechnological inventions;

(b) the Council adopting the Community patent regulation;

(c) Member States and the Commission clarifying rules on ownership stemming from public research and monitoring the effect of implegislation on research and innovation;

(d) encouraging awareness training in the strategic use of IPR during tinnovation process and raising awareness among academics of theof their research, encouraging entrepreneurship and movement b

companies;(e) taking steps to promote international dialogue and cooperation w

towards a level playing field with industrialised countries on patent nology inventions, ensuring an effective level of protection for inno

Implementer: Member States, Council, CommissionTimeframe: 2002 onwards

Action 6

The Commission should, together with the European Investment Bank Investment Fund (EIF), strengthen the capital base for the biotechnolo

(a) seeking to stimulate investments in research and technological imentary financing on the basis of the cooperation agreement, between the Commission and the EIB group;

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Networking Europes biotechnology commu

Networks in Europe

Action 7

The Commission will strengthen the work of the Biotechnology andinclusion of relevant major stakeholders to provide advice in policy dof capital supply.

Implementer: CommissionTimeframe: 2002

Action 8The Commission will:

(a) support the creation of a commercial biotechnology web portal free access to information and networking of available Internet psuch a portal will have to be defined based on the requirement osustained demand;

(b) develop its newly created Commission web site to provide a brthe Commissions work on biotechnology.


Action 9

Member States, their regions, the Commission and the EIB should su

(a) stronger interregional cooperation, for example, through a neregions. Cross-border and interregional cooperation can rec

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A proactive role for public authorities

Action 10

The Commission will establish:

(a) a competitiveness monitoring function and a contact network witistries with responsibility for competitiveness in biotechnologyinclude the impact on European competitiveness of legislation and

(b) a competitiveness in biotechnology advisory group with industry in identification of issues affecting European competitiveness. Tinput into the Commissions regular reports on life sciences and b

Implementer: Member States, CommissionTimeframe: 2002

Action 11

Transparency in the administrative process:

(a) The Commission and Member States, as regulatory authorities, especially from start-up companies and SMEs, requesting approval process.

(b) The Commission will issue a guide to Community regulation for neurs who have limited staff and expertise in the regulatory and legshould also benefit non-EU (e.g. developing world) applicants and

Implementer: (a) Member States, Commission; (b) CommissioTimeframe: 2003 onwards

Action 12

In collaboration with the involved actors, the Commission will benchml b h l d h k f b b

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2. A key element for responsible

governing life sciences and biote

Societal scrutiny and dialogue

Action 13

The Commission, Member States, organisations, institutions and othin a structured dialogue at various levels to develop an understaexchange on life sciences and biotechnology. The Commission wmobilise all key actors in the public debate and facilitate participation ited resources.

In particular:

(a) the Commission will propose a framework for a process of dialostakeholders as a result of the European strategy for life sciences framework will notably include a broadly based stakeholders forCommission will take the initiative to explain better Europes regulathe application of the precautionary principle, the role of risk masafeguards and reversibility of regulatory decisions);

(b) the Commission will take initiatives, and invites the scientific com

holders to assist, to promote awareness of key scientific paradigry oversight such as scientific uncertainty, absence of zero risk, coence is continuously evolving and therefore continuously improvand the articulation between the steps in the risk analysis processfields, the European Food Safety Authority and the European Agof Medicinal Products will play an important role in general risk ing the scientific background for their conclusions on risk assessm

(c) beyond these two specific initiatives, the Commission will also enon biotechnology between scientists, industry and civil society, ingroups, such as patients groups, farmers and consumers, focuslogical developments, to raise public interest in such developmemation on potential benefits and risks. Developers in the scieni d t h ifi ibilit i ti l l i i th b

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Developing life sciences and biotechnology i

with ethical values and societal goals

Action 14

The Commission will strengthen and focus Community support foeconomic and ethical issues and dissemination of results, including crbenefits of using biotechnology in agri-food production, to facilitate

to provide a good basis for societal decisions on the applicationbiotechnology. The Commission will programme research support mapping of benefits and disadvantages/risks which should include a dissemination of information and debate.

The Commission will ensure that ethical, legal and social implications at the earliest possible stages of Community-supported research bioethics research and of providing an ethical review of research propo


Action 15

The Commission proposes to enhance the role of the European Grou

and New Technologies. In addition, the Commission will launch a separother Community institutions on possible structural improvements. Thpromote collaboration between Community, national and local networking of national and local ethical bodies and elected representawill organise a network of academic and professional experts for ad socioeconomic aspects.

Implementer: ethical bodies, legislatures, CommissionTimeframe: 2002

Action 16

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Demand-driven applications through inform

Confidence in science-based regulatory over

Pharmaceutical legislation

Action 17

The Commission will take the initiative to develop, in partnership witers and other private operators, research and pilot projects to clarifyoptions, for agronomic and other measures to ensure the viability of cfarming and their sustainable coexistence with genetically modifieCommission recognises the importance of safeguarding the existing g

culture. It will launch a new action programme for the conservation, tion and utilisation of genetic resources in agriculture in the Commun

Implementer: Member States, professional associations, other oTimeframe: 2002 onwards

Action 18

The Parliament and the Council are invited to speed up the adoptionproposals, revising the Community pharmaceutical legislation, includ

(a) to develop and reinforce the system of giving scientific advice anof the European Agency for the Evaluation of Medicinal Producto high-level expertise through the creation of expert panels agroups. The increased level of expertise will also help the revof European guidelines on the quality, safety and efficacy aspemedicinal products;

(b) to introduce an accelerated procedure for products with a majothat will allow the assessment and authorisation of a medicinal ened timescale;

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Genetically modified organisms (GMO) legislation

Short-term regulatory actions

Implementation and enforcement activities

Action 19

The Parliament and the Council are invited to speed up the adoptionlegislative proposals:

(a) proposal for a European Parliament and Council regulation on traof genetically modified organisms and traceability of food and genetically modified organisms;

(b) proposal for a European Parliament and Council regulation on genand feed.

Implementer: European Parliament, Council

Timeframe: 2002

Action 20

The Commission will continue its work with a view to finalising the legishave already been announced, such as initiatives concerning GM plant

environmental liability and the implementation of the Biosafety Protoc

Implementer: European Parliament, Council, CommissionTimeframe: 200203

Action 21

The Commission will ensure that legislation is enforced in a uniform an

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Specific long-term regulatory actions

3. Europe in the world respondinchallenges

A European agenda for international collab

Action 22

The Commission will report on the feasibility of options to improve and efficiency of the framework for authorising GMOs for deliberate ment, including a centralised Community authorisation procedure.

Implementer: Commission

Timeframe: 2003

Action 23

The Commission will support the development of methodologies flong-term environmental impacts of GMOs as compared with c

methodologies for the monitoring of effects of genetically modifiedpared with conventional food and feed. With the establishment of thAuthority, the work on the early identification of emerging risks will be r

Implementer: CommissionTimeframe: 2002 onwards

Action 24

The Commission should continue to play a leading role in developing

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Europes responsibilities towards the develop

Agriculture

Genetic resources

Action 25

The Commission will in cooperation with Member States support:

(a) the redefining of national research towards an appropriate mix of

and new technologies, based on priorities developed with local fa(b) the establishment of effective research partnerships between publ

organisations in developing countries and in the EU, and the adequstructure for developing countries to enter into such partnershipinternational commitments under the conventions;

(c) sub-regional, regional and international organisations, in particulacultural research centres.


Action 26

The Commission and the Member States will support the conservation genetic resources in developing countries and their equitable sharing otheir use by:

(a) supporting the development and enforcement of effective measusustainably and to provide access to genetic resources and traditio

as to share equitably the benefits arising from them, including incolectual property protection. Support for local communities is vital tknowledge and genetic resources;

(b) supporting the participation of delegates from developing countrof relevant international conventions;

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Health

Responsible and careful use

Action 27

The Commission and the Member States should work with the inteconcretise the commitment to research to combat HIV/AIDS, malapoverty-related diseases and also to identify effective measures to sutries in establishing the structures needed to deploy a health policy.


Action 28

The Commission should support:

(a) the safe and effective use of modern biotechnologies in developtheir autonomous choice and on their national development stra

(b) measures to increase the capacity of developing countries to assman and the environment, under conditions prevailing in the co

(c) the development of appropriate administrative, legislative and redeveloping countries, for the proper implementation of the Cart

(d) that international research on social, economic and environmenadapted to take into account conditions prevailing in developingfindings are subsequently disseminated to them in an appropriat

(e) that the international regulatory requirements remain manageabtries, so as not to impede their trade and production prospects.


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4. Implementation and coherence acr

sectors and actors

Action 29

The Commission will enhance:

(a) the general foresight function across Commission services, and, itechnology foresight through its Institute for Prospective Technolo

early identification of newly emerging issues and of elements of a (b) its monitoring and review function to assess:

the relevance, coherence and effectiveness of legislation and po

the extent to which policy objectives are achieved and legislatio

the societal and economic impact of legislation and policy meas

In pursuit of these objectives and to further strengthen policy coheren

(a) will reinforce continuous coordination between its services and calto provide also enhanced foresight/review functions and a coordinlogue on these issues.

Implementer: Commission, Member StatesTimeframe: 2002 onwards

Action 30

The Commission will present a regular report on life sciences and biotprogress and indicate possible specific proposals to ensure policy andThe report will draw on the conclusions under Actions 10 and 29.



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