IVTIP Bulletin 12
April 2001

In this issue

Summary proposal FP 6

Recently, the European Commission presented its proposal for a next Framework Programme (FP 6). In this issues of the IVTIP Bulletin we review this proposal, both with respect to the background as with the proposed content. We start on page 4.

We start with other, equally important news:

IVTIP website popular

 During the month of March, the IVTIP website proved a success, with 5,474 requests and 1,390 visits. The number of unique visitors was 899, and the repeat visitors numbered 151, visiting the site 2-4 times at least. Most visitors are from US commercial organisations. The most visited pages are the protocols of alternatives to animal testing (479 requests), followed by the home page (282 requests), the network page, the members page and the interesting links page. A good number of visitors homes in on the research and projects pages, while also the newsbulletin and agenda are popular.

Animal testing for cosmetics should end

 The marketing of cosmetic ingredients tested on animals is supposed to have been prohibited since 1998. This was decided when the 6th amendment to the relevant directive was adopted. However, so far the ban has not come into effect. The main reasons cited are the lack of alternative testing methods (only 3 validated and accepted so far), and the problem of WTO compliance.

The European Commission has now drafted the 7th amendment to the cosmetics directive, in which it proposes to ban the performance of tests on animals but not the marketing of products which have been tested on animals. The ban on testing will cover both finished products and ingredients.

The proposal has been discussed in the European Parliament and several amendments have been adopted. The amendments adopted in the EP plenary call for not only the proposed testing ban, but also to preserve the ban on marketing. The ban should come into force immediately for ingredients where other validated testing methods exist, and in any case 5 years after the adoption of the directive. To ensure WTO compliance, producers in third countries would have to be treated in a way equivalent to Community producers, with no discriminatory treatment. Another amendment asks for manufacturers who have carried out animal tests after the date of implementation to labelling the packaging 'tested on animals' in easily legible lettering covering at least 20% of the total surface area. Parliament also wants the ingredients of cosmetic products to be listed in full, and fragrance allergans to be labelled with their name.

Furthermore, Parliament calls for funding from the 6th Framework Research pogramme for the development of new non-animal teting methods.

Moral standards and dogs and cats

As for those who say that adoption of this directive would violate WTO regulations, the rapporteur, mrs. Roth-Behrendt, referred to the recently adopted "US dog and cat fur act", a law prohibiting the production and the importing of fur products from dogs and cats because "such products are detrimental to public moral standards and to animal protection (official justification)". Mrs. Roth Behrendt argued that the same moral standards should apply to testing on animals.


Source: EP Press Release, 03-04-2001, and the EP report on the 7th amendment (FINAL A5-0095/2001). For the 7th amendment, see COM(2000)189-C5-0244/2000-2000/0077(COD)

Chemical Industry judged by its actions

 With the White Paper on EU Chemicals Policy Review just published, the chemical industry is, more than ever, judged by its actions, in particular its voluntary actions. Both the Long-Range Research Initiative and the ICCA HPV initiative are therefore crucial for the credibility of the industry. The latter involves assembling all available knowledge about high volume production chemicals. Its target is harmonised, internationally agreed data on the intrinsic hazards and initial hazard assessments of approximately 1,000 HPV chemicals by the end of 2004.

However, progress on the ICCA HPV initiative has been slower than expected, which is not surprising since it is the first initiative of its kind at a global scale with complex coordination.

The initiative, launched in October 1998 by the ICCA Board and covering Europe, Northern America and Japan, has three major milestones:
The first milestone was recently passed, and the second is in sight.

It is foreseen that the EU will consider those substances which reach the conclusion "candidate for further work" at the OECD SIAM meeting as possible candidates for an EU Priority List.

Greenpeace is less happy with the initiative, viewing that "industry has neither the moral nor actual authority to place demands on regulation in return for efforts at meeting responsibilities it has ignored for decades".

Source: CEFIC Confidence in Chemicals, Newsletter, Issue 3, January 2001,
tel + 32 2 676 73 09. A copy is available from the IVTIP Secretariat as well.

News from the Commission

Deadlines for FP5 proposals

First half 2001

In the first few months of the year 2001, 6 deadlines for proposals had been scheduled. The following had been submitted: In addition, 71 expression of interest for topics in functional genomics relating to human health were received.

Second half 2001

The following programmes are open for proposals:

Accompanying measures: deadlines June 12, 2001 and October 11, 2001

Marie Curie Individual Fellowships: deadlines October 10, 2001


SME Cooperative Research Awards: deadline September 19, 2001


Mechanism for the submission of joint projects under the 'Partner for Life': available until April 2002. Intended for SMEs, to support their participation in European Research Projects.
See also: www.bit.ac.at/partners_for_life.htm

Workshop on ethics and animal experimentation

The Quality of Life Programme - Generic Activities organized on November 9, 2000, a workshop on Ethics, Laws and Animal Experimentation.

The focus of the discussion of the workshop was to specifically pinpoint areas of research and topics where specific work is required in order to further the protection of animals used for research purposes.

Proposed were:
A full copy of the report, as well as a list of participants, can be requested from the IVTIP Secretariat. You may also consult the Bioethics part of the Quality of Life Programme on www.cordis.lu/life

One shop for ethic documents

Furthermore, the Commission aims at promoting responsible research in Europe and keeping the rapidly advancing progress in science in harmony with the ethical values of all Europeans. It has therefore created a page that guides researchers towards the most important reference texts in the area of ethics in research. The page provides access to key documents in the area of ethics in research, such as directives of the European Union, Conventions of the Council of Europe, Opinions from the European Group on Ethics in Sciences, examples of Codes of Conduct etc.
Visit: www.cordis.lu/rtd2002/science-society/ethics.htm

Commission adopts communication on Precautionary Principle

On February 2, 2000, the European Commision has adopted a Communication on the Use of the Precautionary Principle.

The Communication underlines that the precautionary principle forms part of a structured approach to the analysis of risk, as well as being relevant to risk management. It covers cases where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU.

The Communication makes it clear that the precautionary principle is neither a politicisation of science or the acceptance of zero-risk but that it provides a basis for actiob when science is unable to give a clear answer.

A copy of the press release and the Communication itself is available on request from the IVTIP Secretariat.

Short News

Pharmaceutical firms attacked

On February 11 last, animal rights activists in the UK mounted demonstrations against pharmaceutical companies which they claimed support testing of drugs on animals at Huntingdon Life Sciences.

Hundreds of protesters were involved in a coordinated series of break-ins or demonstrations at the laboratories, offices and at the homes of directors of five leading companies: Bayer, Eli Lilly, Novartis Pharmaceuticals, Roche and Pharmacia Corporation.

Shac hopes to persuade the companies to withdraw their support from Huntingdon's laboratories in Cambridgeshire and in Occold, Suffolk.

Pharmaceutical companies condemned the attacks, which caused tens of thousands of pounds of damage, and warned that a threat of violence against them was "not conducive to medical research in the UK".

Campaigners from Stop Huntingdon Animal Cruelty (Shac) said the demonstrations marked the start of a new era in its protests against the company. In the past its campaign has targeted the firm's financial backers.

Source: The Guardian, February 12

Patients challenge animal rights protestors

Sources: The Times 15/3/2001
http://www.thetimes.co.uk/article/0,,11-99393,00.htm http://www.telegraph.co.uk:80/et?pg=/et/01/3/15/npar15.html#go2

On the web

Quality of Life Bulletin only on web

DG Research used to send us the Quality of Life Bulletin, but as of recently it is only available via the web.
Visit: www.cordis.lu/life

All about genetic research

If you do not want to miss anything concerning genes and genome research, visit the freely available GeneLetter, full of interesting articles and easy to navigate links: www.geneletter.com

Documents on ethics

A recently established page provides access to key documents in the area of ethics in research.
Visit: www.cordis.lu/rtd2002/science-society/ethics.htm

ICCA HPV initiative

Full information on the ICCA HPV initiative can be found at:
www.icca-chem.org/hpv
or
www.iccahpv.com/hpvchallenge/about.asp

Minutes ACATM on web

The summary minutes of the 5th meeting of the National Toxicology Program Advisory Committee on Alternative Toxicological Methods (ACATM), held on November 28, 2000 at Bethesda, USA, have been placed on the ICCVAM website. Previous minutes are also still available:
http://iccvam.niehs.nih.gov/acatm.htm, follow section Meeting Minutes

Meeting on FETAX

Below is the web address where you can find the minutes from the public meeting of an Expert Panel on the Frog Embryo
http://iccvam.niehs.nih.gov/fetaxMin.doc
or viewed in Adobe Portable
http://iccvam.niehs.nih.gov/fetaxMin.pdf.

Revised Up and Down Procedure (UPD)

Minutes of the public meeting of an independent peer review panel,
http://iccvam.niehs.nih.gov/UDP_Min.doc
The purpose of this meeting was to evaluate the validation status of the UDP as a replacement for the conventional

Protocol on Murine Local Lymph Node Assay

The protocol on the Murine Local Lymph Node Assay (LLNA), based on an independent expert peer review panel evaluation of the LLNA and
http://iccvam.niehs.nih.gov/LLNAProt.doc
or viewed in Adobe Portable
http://iccvam.niehs.nih.gov/LLNAProt.pdf.

ICCVAM autorization act 2000

The ICCVAM Authorization Act of 2000 was signed into law on December
http://iccvam.niehs.nih.gov/auth_act.pdf
The law will be published on the Government Printing Office (GPO) website under the Catalog of Public Laws for the 106th Congress at
http://www.access.gpo.gov/nara/publaw/106publ.html.

The document will be made available in text and PDF formats.

4th World Congress

As you may already know, the 4th World Congress on Alternatives and Animal Use in the Life Sciences will be held in New Orleans, USA on August 10-15, 2002. All information is now available at http://www.worldcongress.net

Partners for Life

Partners for Life is a new project that provides economic and technological intellginece to SMEs. The aim is to offer SMEs with targeted information on technological and market trends in the field of life sciences and to support their participation in European research projects, in particular in biomedicine, biotechnology and agro-industry. Groups of SMEs preparing innovative projects can receive up to 1 million EURO for research. Submission of joint projects is possible until April 2002.
www.bit.ac.at/partners_for_life.htm

Publications

 Individual subscribers to one of the many Nature publications received from the publisher a commemorative copy of The Human Genome. Beautifully printed, but if you didn't receive one: the entire content plus additional features and commentary is available without restriction on: www.nature.com/genomics

Proposal FP 6

Goal: to implement European Research Area

Recently, the European Commission presented its proposal for a "multiannual Framework Programme 2002-2006 of the European Community for Research, Technological Development and demonstration activities aimed at contributing towards the creation of the European Research Area". In short, a proposal for a 6th Framework Programme (FP 6). As the title shows, FP6 is meant to implement the European Research Area. It is designed to:
  1. step up its (ERAs) contribution to the development of scientific and technical excellence in Europe, in EU countries and non-EU countries, both in universities and in industry.
  2. increase its impact on the innovation process in Europe;
  3. reinforce its contribution to the efforts to integrate European Research.
Maximum budget proposed is 16.270 million EURO.

Various institutions will be consulted regarding this proposal. Proposals for specific programmes will follow later. It is the intention that the Council and the European Parliament will adopt FP 6 not later than the first half of 2002.


Why the European Research Area?

The European Research Area (ERA) has become the reference framework for research policy issues in Europe. It is seen as a central component to promote innovation, competitiveness and employment, sustainable economic growth and social cohesion in Europe.
The necessity of ERA is evidenced by:
  1. the EU's major technological rivals are stepping up their efforts (US public spending on research will grow by 9% in 2001);
  2. prospects in life sciences and technologies are promising; the challenge is to capitalize on the human genome;
  3. there is a growing role for information and communication sciences;
  4. science holds to a large extent the key to solving societal problems (i.e. BSE);
  5. sustainable development is a major political objective on the EU agenda.

Principle of Framework Programme 6

The new FP will be based on the following main principles:
  1. concentrating on a selected number of priority research areas in which EU action can add the greatest possible value;
  2. defining the various activities in such a way as to enable them to exert a more structuring effect on the research activities conducted in Europe thanks to a stronger link with national, regional and other European initiatives;
  3. simplifying and streamlining the implementation arrangements, on the basis of the intervention methods defined and the centralised management procedures envisaged: networks of excellence and integrated projects will be administered to a large extent autonomously by participants: to involve other partners, define small-scale projects, adapt their programme of research to meet changing needs. Certain aspects of the specific research activities and support for researcher mobility will be entrusted to external organisations operating under the Commission's responsibility.

Special efforts:
A special effort will be made to maximise the dissemination of results and to express them in terms that are readily understandable to decision makers, so as to help them implement public policies.


Another special effort will be made to increase the participation of women in all activities of the programme.
All research activities carried out under the FP 6 must be carried out in compliance with fundamental ethical principles.

Two fundamental new aspects are (1) the full participation of candidate countries and (2) the opening up of EU research activities to the rest of the world.The regional dimension of European research will be fully taken into account.

Concentrating (focusing) efforts

To ensure the focusing of efforts, FP6 will be integrated around three targets:
  1. Integrating European research;
  2. Structuring the European Research Area;
  3. Strengthening the foundations of the European Research Area.

Target 1.

Integrating European Research
(12.770 million EURO)

The bulk of FP6 efforts are intended to strengthen the scientific and technological bases of Community industry. These activities will be carried out:
1. In a limited number of priority areas by means of networks of excellence, integrated projects and EU participation in national research programmes. Participation of SMEs in networks of excellence and integrated projects should be significant. Two new instruments will be introduced: a collective research scheme and extension of 'cooperative research activities'. International cooperation will be important.

2. In areas related to the anticipation of EU science and technology needs (help to anticipate emerging needs, react rapidly to new scientific and technological developments and be present at the frontiers of knowledge (annual decisions following calls for proposals, choice of topics by the Commission)

3. In the field of science and technology as a whole in the case of complementary research activities for SMEs.

As a fundamental general principle, competitive calls for proposals and evaluation by means of peer review will be used to implement the bulk of the activities.

Instruments to integrate research are:
a. Networks of excellence, characterised by a joint programme of activities, precise research themes and topics, and activities to manage, transfer and exploit the knowledge produced. Selection will be on the basis of calls for proposals. A network of excellence will involve several million EURO.

b. Integrated projects will involve consortia with intense university/industry collaboration. They should concern risky research and have clearly defined objectives. Participation will be through calls for proposals. Max support will be 50% of the proposed budget. A project may involve tens of millions of EUROs.

c. Participation in national programmes. The EU may contribute to national programmes. Max support will be 50% of the proposed budget. This new element will require a lot of consultation.

1.1. Priority thematic areas of research

Seven thematic areas have been selected. These have, within each of them, a number of subjects linked to economic and societal issues that are especially important to the EU and where its action adds specific value for reasons which may vary according to the themes in question. Some activities, particularly those intended to help structure the European Research Area, will be opened up to all themes and areas.

Activities are intended to assemble a critical mass of resources and support a high level of integration of research capacities in Europe in areas in which this is especially necessary for the competitiveness of European industry or the major political and social implications of the issues in question. The seven priority thematic areas are:
1. Genomics and biotechnology for health (2 000 million EURO);
2. Information Society Technologies (3,600 million EURO);
3. Nanotechnologies, intelligent materials and new production processes (1,300 million EURO);
4. Aeronautics and space (1,000 million EURO);
5. Food safety and health risks (600 million EURO);
6. Sustainable development and global change (1,700 million EURO);
7. Citizens and governance in the European knowledge-based society (225 million EURO);

Genomics and biotechnology for health

With respect to genomics and biotechnology for health, the objectives are to help Europe exploit, by means of an integrated research effort, breakthroughs achieved in decoding the genomes of living organisms, Ö.for the benefit of public health and citizens and to increase the competitiveness of the European biotechnology industry.

Community activities will address the following aspects:
1. fundamental knowledge and basic tools for functional genomics: gene expression and proteomics; structural genomics; comparative genomics and population genetics; bioinformatics;

2. application of knowledge and technologies in the field of genomics and biotechnology for health: technological platforms for the development of new diagnostic, prevention and therapeutic tools; support for innovative research in genomics start-up companies;

3. application of medical genomics knowledge and technologies in the following fields: combating cancer, degenerative diseases of the nervous system, cardiovascular diseases and rare diseases; combating resistance to drugs; studying human development, the brains and the ageing process.

A broader approach will be pursued with regard to combating the three poverty-linked infectious diseases (AIDS, malaria and tuberculosis), which have priority in terms of disease control at EU and international level.

Other themes of interest
Other priority themes with topics of interest are:
Nanotechnologies, which aim to achieve a critical mass of capacities needed to develop and exploit, especially for greater eco-efficiency, leading-edge technologies for the knowledge and intelligence-based products, services and manufacturing processes of the years to come.

Actions envisaged include applications of nanobiotechnologies in areas such as health, chemistry, energy, optics and the environment.

Food safety and health risks include, among others, methods of analysis and detection of chemical contaminants and pathogenic microorganisms (incl. prions)

The final theme, citizens and governance, includes such a wide variety of topics as improving the production, transmission and utilisation of knowledge in Europe; transnational research and comparative studies; interdisciplinary research in support of public policies; and the establishment and exploitation on a European scale of research infrastructures and data and knowledge bases.

1.2. Anticipating the EUs scientific and technological needs (2,345 million EURO)

Objective: respond to the scientific and technological needs of the policies of the Community;

Respond more flexibly and rapidly to emerging scientific and technological needs and major unforeseeable developments, as well as needs appearing at the frontiers of knowledge.

The activities will address the following themes:

1. Activities carried out on the basis of calls for proposals

a. In particular research in support of common policies, EU objectives

b. Research that responds to needs in new areas at the leading edge of knowledge.

Activities will essentially take the form of:

1. Specific targeted projects generally of a limited scale;

2. The networking of research activities carried out at national level

The choice of research topics will be made by the Commission on the basis of assessment by an internal group of users

These activities will also comprise, in particular, specific research activities for SMEs:
(i). Collective research activities (by technical research centres of industrial associations or industry groupings in entire sectors of industry dominated by SMEs at the European level;

(ii). Cooperative research activities by research centres for a number of SMEs on themes of common interest

2. Joint Research Centre Activities

Target 2.

Structuring the European Research Area (3,050 million EURO)

a. Research and innovation: stepping up economic and technological intelligence activities, utilisation of research results, transfer of knowledge, setting up of technology businesses in Europe. (300 million EURO)

b. Human resources and mobility. More funding, making Europe more attractive to third-country researchers, and support schemes for excellent EU research teams. (1,800 million EURO)

c. Research infrastructures of the highest level in Europe and promote their optimal use on a European scale. Broadband communication infrastructures, transnational access, networking. (900 million EURO)

d. Science/society: activities to encourage harmonious relations between science and society and the opening up of innovation in Europe as a result of the establishment on new relations and an informed dialogue between researchers, industrialists, political decision makers and citizens (50 million EURO)

Target 3.

Strengthening the foundations of the European Research Area (450 million EURO)

The activities are intended to step up the coordination and support the coherent development of research and innovation-stimulation policies and activities in Europe. The activities will take the following form:

a. Strengthening coordination of research: mutual opening up of research programmes, networking of research activities conducted at national level, scientific and technological cooperation activities, collaboration and joint initiatives of CERN, EMBL, ESO and ESA;

b. Supporting the development of coherent research and innovation policies: analyses and studies, specialised working groups, forums for concertation and political debate, benchmarking of research and innovation policies, mapping of scientific and technological excellence.

References:

The full text of the proposal can be downloaded from the CORDIS website (http://www.cordis.lu)or you can request a copy from the IVTIP Secretariat.

Reference: COM (2001) 94 final, Brussels, 21.2.2001 for explanatory memorandum, reference 2001/0053 (COD) for RTD proposal itself.

AGENDA

A number of interesting conferences and workshops is coming up. Of all the events mentioned here, the detailed programmes and registration/application forms are available from the IVTIP secretariat.

Early drug target validation
May 21-22, 2001 Geneva, Switzerland

Organization: Vision in Business Ltd. Tel + 44 20 7256 5188

Technology Commercialisation: Developing Biotech Start-ups
May 23, 2001, London UK

Organization: SMI Pharmaceutical Conferences. Tel + 44 207 252 22 22

2nd International Joint Meeting
In vitro models and toxicity mechanisms
May 30-June 1, 2001, Verona, Italy

Organization: Glaxo Welcome, Verona, Italy. tel + 39 45 9218 590; fax: + 39 45 9218 174. Email; gdn9073@glaxowellcome.co.uk

Crucial issues in inhalation research & Drug research and
clinical inhalation
June 6-9, 2001, Hannover, Germany

Organization: Fraunhofer Institute fur Toxicologie, Tel + 49 511 5350 151; fax: + 49 511 5350 132; email: teicke@ita.fhg.de or pavel@ita.fhg.de

8th International Inhalation Symposium
Drug research and clinical inhalation
June 6-9, 2001 Hannover, Germany

Organization: fraunhofer Institute of Toxicology. www.ita.fhg.de.
Tel + 49 511/53 50 121

17th ESACT meeting
From target to market
June 10-14, 2001, Tylösand, Sweden

Organization: ESACT Secretariat, fax + 46 8 730 06 99; email: www.esact.org

ICLAS-CCAC International Symposium on regulatory testing
and animal welfare
June 21-23, 2001, Quebec City, Canada

Organization: ICLAS and the Canadian Council on Animal Care.
Tel + 1 (418) 656 41 41; fax; + 1 (418) 654 2761

International Symposium on Regulatory Testing and Animal Welfare

Organization: The International Council on Laboratory Animal Science (ICLAS) and
http://www.crchul.ulaval.ca/ICLAS2001

10th European Congress on Biotechnology (ECB 10)
July 8-11, 2001, Madrid, Spain

Organization: EFB, Dechema

9th International congres of Toxicology
July 8-13, 2001, Brisbane, Australia

Organization: ASCEPT Secretariat, tel + 61 225 654 56

EUROTOX 2001, 39th congress of the European Societies of
Toxicology
September 12-15, 2001, Istanbul, Turkey

Organization: Mumtaz Iscan, Ankara University. Tel + 90 3122 12 68 05. www.eurotx2001.org. Email: iscan@pharmacy.ankara.edu.tr

9th Intenational Conference on human-animal interaction
Sept 13-15, 2001, Rio de Janeiro, Brasil

Organization: www.iahaio.org email: rio2001@i-et-e.fr

Cell Interactions and Cellular Complexity
Sept 30-October 3, 2001, Granada, Spain

Organization: European Tissue Culture Society.
web: www.san.gva.es/centros/lafe/ETCS/ETCS_ESP-granada-2001-00.html

Vaccines of the future: from rational design to clinical development
October 17-19, 2001, Paris, France

Organization: Institut Pasteur Euroconferences. Fax: + 33 1 40 61 34 05.
www.pasteur.fr/applications/euroconf

Pharmaceutical products and viral safety
March 14-15, 2002, Paris, France

Organization: Institut Pasteur Euroconferences. Fax: + 33 1 40 61 34 05. www.pasteur.fr/applications/euroconf

4th World Congress on Alternatives and Animal Use in the Life Sciences
August 4-6, 2002, Boston, MA, USA

Organization: HSUS, ZEBET. Contact: email dpease@hsus.org