European Union: Life Sciences and Biotechnology - the European Commission´s Strategy for Europe

Last Updated: 12 July 2004
Article by Sarah Turner

Originally published June 2004

Last month, the European Commission (the "Commission") produced its second report on the implementation of its 2002-2010 Strategy for Europe on Life Sciences and Biotechnology. The 2002-2010 Strategy for Europe set out a road map to 2010, recommending actions from the European Union institutions and well as other public and private stakeholders. The latest report highlights the progress that has been made on the Commission's plan to transform policy into action and indicates those areas where improvement is still necessary in order to strengthen the competitive position of the European biotechnology sector.

COMPETITIVENESS OF THE EUROPEAN BIOTECH SECTOR

Life sciences and biotechnology are amongst the key growth technologies for a more innovative and competitive Europe. Although the performance of small and medium-sized European biotechnology companies is comparable to their US counterparts, there are far fewer medium- sized biotech companies in Europe compared to the US. This is thought to be partly attributable to difficulties with financing in Europe.

Different Member States have adopted different measures in order to address this problem. Some have introduced fiscal benefits, some are encouraging inward investment, while others are promoting technology transfer. Tax breaks and better research conditions are also being introduced in other Member States to encourage "brain gain" by making the European Research Area more attractive for scientists.

Three main areas have been identified for attention by the Commission at national level in order to improve European competitiveness:

  • Protecting intellectual property rights;
  • Boosting finance, liquidity and capital markets in Europe; and
  • Research funding through public/private partnerships.

INTELLECTUAL PROPERTY PROTECTION

Of the EU-15 Member States, eight still have not implemented the Biotechnology Patent Directive into their national legal systems. This leaves companies uncertain as to what rights they have in relation to biotechnology research. The Commission feels that this, together with the lack of a Community Patent and a centralised Community Patents Court, discourages both inventors and potential investors from the European market. Member States have been encouraged in the Report to adopt the Community Patent Regulation1 and to agree on the creation of the centralised Community Patents Court, as well as to implement the Biotechnology Patent Directive.

BOOSTING FINANCE

The biotech industry with its long lead times and high costs is more dependent than most on effective access to investment. As well as encouraging investors by a coherent legal and regulatory regime, the Commission also recommends the establishment of funds to cover the period between venture capital financing and IPOs (Initial Public Offers) to encourage companies to expand. Given the boom in 2000, the European industry has a large number of companies requiring this stage of finance. It is encouraging to see that in October 2003, the European Investment Bank invested E0.5 billion for the European Investment Fund to invest in high technology companies, most of which is expected to benefit the biotechnology sector.

EU FUNDED RESEARCH

Under the 6th Framework Programme for Research more than E810 million has been allocated to research in the areas of "life sciences, genetics and biotechnology for health" and "food quality and safety". Funding has been concentrated on a few selected priorities so that top researchers are provided with resources and skills in order to stay at the leading edge of scientific and technological research.

The following areas are being promoted:

Genomics research, in particular bioinformatics; Biotechnology for health; Plant genomics and biotechnology; and Industrial biotechnology.

FUTURE RESEARCH POLICY INITIATIVES

The Commission has highlighted as a priority its presentation of a Communication regarding future research policy initiatives later this month. This is intended to initiate a debate amongst all stakeholders in the biotech industry and is seen as vital in order to maintain momentum towards an effective knowledge-based economy.

PUBLIC CONFIDENCE

The Commission is aware that the public's acceptance of biotechnology is important to strengthen the EU's capacity for innovation. Therefore the Commission is continuing efforts to explain the benefits of biotechnology in all its fields of application, whilst being aware of the public's concern about the possible use of biotechnology in bioweapons and bioterrorism.

GMOs LEGISLATION

The Commission reports that it expects active cooperation from all Member States in ensuring implementation of legislation governing GMOs (genetically modified organisms). To date, only seven Member States have communicated their implementation measures for Directive 2001/18/EC, which provides a more complete authorisation procedure for GMOs. The Commission has referred the other eight Member States to the European Court of Justice.

As well as requiring implementation of GMO legislation, Member States have been asked to exchange information on their approaches and best practices concerning co-existence of GM crops with conventional and organic crops. The Commission for its part aims to enhance its co-ordination role in order to smooth out any potential problems associated with the development of Member States' co-existence strategies. The Commission will also report to the Council and the European Parliament on Member States' experiences of implementation of co-existence measures.

NEW TECHNOLOGIES

The Commission also looks ahead in its Report to ensure long-term competitiveness in emerging technologies, such as tissue engineering, genetic testing and animal biotechnology. For example, it aims to prepare legislation to harmonise the regulatory framework for marketing products and processes obtained from human tissue engineering. Genetic testing is another field in which the Commission feels the need for a co-ordinated approach. It plans an EU-wide co-ordinated effort to ensure high quality genetic testing throughout the EU and to establish a networking centre to exchange information on certain genetic testing issues. Cloning technology in animals is another recognised emerging field which may raise ethical, social and safety concern. The Commission plans to launch initiatives on the potential benefits and risks and possible new policy issues associated with animal cloning.

CONCLUSION

Since last year's Report further progress has been made on the implementation of the EU's Strategy on Life Sciences and Biotechnology. However, the Commission recognises that much still needs to be done in order for European competitiveness to improve. A major example is the need for a harmonised regulatory framework. This will only be achieved when all Member States have implemented the Biotechnology Patent Directive and GMO legislation. Greater co-ordination and cooperation between all parties interested in the sector are also vital to ensure that the European biotechnology sector remains competitive. These actions are particularly important given the current anxiety about the apparent inability of European biotechnology companies to achieve global leadership. Unless more is done at a national and European level to encourage growth, European biotechnology firms risk becoming simply the research divisions of US multinationals.

Footnote

1 Since the Report was published, the Competitiveness Council has failed to reach agreement on the last few points still at issue regarding the Community Patent, most of which relate to translation requirements. The Commission is now said to be considering whether to withdraw plans for the Community Patent.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions