IVTIP Bulletin 13
August 2001

In this issue

Central to this month’s bulletin is business news: ranging from new labeling rules for cosmetics, CEFIC’s comments on the White Paper on Chemicals and press releases of BIO2001 to the biopharmaceutical pipeline. We continue with public opinion, which seems to be slowly swinging to a more favorable attitude. News from the USA deals with the Up-and-Down procedure, while News from the Commission deals with calls currently open and various other items. Much space this time for Company and Research News, with spotlights on cloning and on stem cells. Good reading over the summer months, and do send me items of interest for next bulletins.


Tougher labeling rules for cosmetics

 The European Commission plans tougher rules for the labeling of cosmetics in response to warnings from scientists about the risk of allergic reactions triggered by chemicals in products such as hair dye and perfume. The new rules would force firms to clearly label ingredients which are known to cause serious allergies or other side effects. At the same time, some of the ingredients known to cause contact allergies – such as lithium hydroxide and calcium hydroxide – will be banned from perfumes or products containing them. The new rules, to be unveiled before August, are based on the findings of scientific experts on cosmetic and non-food products for consumers. The committee says fragrance ingredients are one of the most prevalent causes of contact allergy. However, the draft will not cover use of peanut and other nut oils in products, claimed by UK researchers to be potentially fatal in some cases.

Source: European Voice, July 4, 2001

Your feedback please

ECVAM online

ECVAM has announced that online access via the Internet is now provided to a first set of selected databases, established for the dissemination of information on advanced alternative methods in the field of biomedical sciences: the ECVAM Scientific Information Service (SIS). The main aim of this first set is to provoke constructive comments on the proposed structure, content and planning. Therefore, the first Internet access will be limited to the potentially most interested people.
Dr. Annett Janusch-Roi asks your help in providing feedback.
To join SIS, connect to: http://ecvam-sis.jrc.it

Alternatives to animal use in education

Despite a widespread availability of alternatives, animal use for educational purposes still continues at a low but still significant level. One possible reason for this is a lack of effective dissemination of information about alternatives. Although databases listing such information exist, teachers need hands-on experience with the alternative and information about their practical applicability.

The European Resource Centre for Alternatives in Higher Education (EURCA) is a new and exciting project co-ordinated by Dr. Jan van der Valk of the Netherlands Centre for Alternatives to Animal Use (NCA) at the University of Utrecht, The Netherlands, and Dr. David Dewhurst of the University of Edinburgh, UK. The main aims of EURCA are (1) to provide a mechanisms for the dissemination of useful information to teachers about alternatives to the use of animals in education and (2) actively encourage the use of alternatives by taking the Resource Centre with examples of alternatives to international conferences of science teachers.

In order to realise the goals mentioned above, the organisers need to collect detailed information about alternatives that are already available. They therefore kindly request manufacturers and users of alternatives to fill in an information form, available upon request from EURCA or the IVTIP Secretariat.

For more information, please visit: http://www.eurca.org
or contact:
J.deBoo@vet.uu.nl or
d.dewhusrt@ed.ac.uk

Poland rethinks animal laws

A Polish law allowing stray cats and dogs to be used for scientific experiments is being redrafted because of concerns it would incur the wrath of the European Commission when the country joins the Union. Poland’s president has refused to sign the so-called animal protection act because its controversial provisions run counter to a 1986 EU vivisection directive which lays down that animals used in laboratories must be bred for that purpose. His refusal put him at loggerheads with the country’s lower house of Parliament, the Sejm, which recently approved the legislation.

Source: European Voice, June 7-13, 2001

Business News from Bio 2001

Europe a favourable location for biotech start ups

At the BIO 2001 meeting, six company founders described that Europe has significant advantages as a location for biotechnology companies. One of them, antibody company Genmab AB, stated that the European location has been key to success. They went from inception to listing in 20 months, raised 263 million Euro and are one of the best funded biotechnology companies in Europe. Reason: in the US, a lot of antibody companies are chasing the same financing, while in Europe there are only a few antibody companies. In addition, it was found that it is easier to set up networks of clinical trial sites in Europe, and there is less competition.

Source: Bio2001 Press release, June 27, 2001

Genomics will fragment industry

A specific ‘partnering for life’ event at the BIO 2001 conference had to do with how biotechnology companies find and keep the pharmaceutical collaborators that often become drivers of their success. One participant sounded a note quite different from the usual talk of increased mergers, acquisitions and overall consolidation of the industry.

According to Papadopoulos, deconsolidation is what the future will be about. Papadopoulos, who is managing director of a New York Securities firm, said Wall Street’s unreasonable pressures for constant earnings growth will force companies to act in new ways. Weaker aspects from a firm’s efforts will be separated from the main enterprise, increasing average profit for the main. The sold/chopped off pieces will be the subject of major venture capital investment, boosting innovations.
Also Ravi Kiron of Pfizer predicted further fragmentation, this time for the already fragmented genomics industry.

Source: Bio2001 Press release, June 27, 2001

Shortcomings of the patent system

Several speakers at a session during BIO2001 addressed shortcomings with patent systems in relation to the biotechnology industry.

The U.S. Patent and Trademark Office (PTO) is struggling to keep up with the pace of developments in biotechnology, with 300 biotech examiners to deal with an expected 40,000 applications in 2002.
There are issues of money and resources.
The patent office will see an 84 percent increase in applications by 2006, and between then and now there will be a 400 percent increase in the number of applications awaiting action. The PTO also needs funding for infrastructure.
However, things are starting to happen to address the shortcomings.

The protection of intellectual property of biotechnology companies also is under challenge on the international front. In prior years, we could recount improvements in developing countries and international forums, but in the past year, very few countries have improved their Intellectual Property protection laws, and developing countries are coalescing in international forums to reduce the level of IP protection. One of the main drivers of this is the catastrophic AIDS crisis in Africa. African leaders say they need access to non-expensive drugs to save lives. What is surprising is that many African leaders focus on patents as a problem. In fact, most companies have not got patents in Africa, apart from South Africa. Nevertheless, there is a battle cry that the patent system is part of the problem.
Developing countries don't think they get a fair share of the pie. They supply raw materials and genetic materials, and don't think they get the economic benefits. They believe the patent system has failed them and needs to be overhauled.

Source: Press release BIO2001, June 27, 2001

The biopharmaceutical pipeline

 In the April issue of Nature, an interesting article dealt with 'Growing pains for biopharmaceuticals'.

By the beginning of the year 2000, 77 biopharmaceuticals were available in the global marketplace. During 1998-1999, they contributed to over 20% of the annual output of new drugs (although the percentage seems to be falling).

At the beginning of the year 2000, 369 biotechnology-derived medicines were in clinical development in the US. Currently, biopharmaceuticals make up 11% of new molecular entities in development.

Impact of biopharmaceuticals

The greatest impact of biopharmaceuticals has been in the treatment of orphan diseases: 56% of biotechnology products launched between 1982-2000 were first approved for orphan drug indications, compared with only 14% of novel chemical entities (NCEs).

Another notable feature is their innovative mode of action. Clinical success rate for biopharmaceuticals and gene therapy was 35% compared to 23% for NCEs.

Much favoured by companies was the shorter development time of biopharmaceuticals compared to the one for NCEs: between 1982-1989, 5.9 years for a biopharmaceutical and 11.0 years for an NCE. However, in the 1990s the mean development time has risen dramatically, converging to the development time of NCEs: 9.8 years now for biopharmaceuticals and 10.1 years for an NCE, reflecting that the 'easy' drug targets of established therapeutic profile have been covered by now.

The future

The article concludes that the nature of biopharmaceuticals is evolving and the industry can no longer assume that the biopharmaceuticals of the future will have short development times ands high success rates. Genomics will inevitably aid in the discovery of therapeutically relevant proteins, but it will also provide an even greater wealth of targets for the development of chemically synthesised drugs.

Source: Nature, April 2001, Vol. 19, pp 307-311

Public opinion and biotechnology

 UK public opinion swings towards GM foodsA national survey conducted by the UKs NOP reveals that support for GM foods amongst the British public has increased over the last 12 months. NOP conducted a telephone survey of 999 adults aged 15+ years, on 23-25thFebruary 2001.
Key findings include:Half the nation would eat GM food;
A 10 per cent decrease in those who believe GM foods are unsafe;· Two out of three people don't feel they know enough about GM foods;Contrary to claims that there is no demand for GM food in the UK, and major campaigns against it, 48 per cent of people questioned said that they would eat food they knew was genetically modified. 44 per cent of people questioned said they would not.
Comparisons with an identical poll in 2000demonstrate an increase in consumer acceptance. Then, 46 per cent said they would and 50 per cent said they would not eat it. The greatest levelof support resided in the north east of England, where 60 per cent ofrespondents expressed a willingness to eat GM products: broadly the divideis between willing young men in the north east and reluctant middle agedwomen in the west country and Wales.Source: NOP Press Release, April 3, 2001For a full breakdown of the survey results, please contact Peter Johonnett, Michael Brannan or Penny Hawley on 020 7853 2393 or 07720 277143. Website: www.cropgen.org Public discussion on the web
A new public discussion board has opened on the web. Based on a very plain and simple web interface, scientists canengage in discussions around gene synthesis, molecular biology problems, and life science issues in general.The board is expected to foster the discussions around the emerging applications of synthetic genes in an open and easy-to-access environment.You can access the discussion board at www.entelechon.com/genetalk/index.php3

On the web

Research online

European Research Gateways On-Line. National Information on R&D projects, co-ordinated by:
www.cordis.lu/ergo

EU research results
Apollo.cordis.lu/cordis/EN_RESU1_search.html
or
Europa.eu/int/comm/dg12/success/en/success_en.html

Research timeline, USDA scientific and other achievements:
www.ars.usda/gov/is/pr/2001-07-10

European Life Sciences Forum ELSF:
www.elsf.org

Ethics

www.theo.uu.nl/Eursafe

To post, search, view and/or respond to over 125,000 international trade opportunity notices classified under 23 industry categories, please go to:
http://www.eceurope.com/

Updated statistics on BSE can be found at:
http://www.euractiv.com/dossiers/ld_bse.htm

News from the USA

Up and Down Procedure

New documents

A Federal Register Notice was published announcing the availability of a revised draft Up-and-Down Procedure for assessing acute oral toxicity and solicitation of public comment. This notice isavailable on the ICCVAM web site in PDF at http://iccvam.niehs.nih.gov/6633550.pdf or in HTML at http://iccvam.niehs.nih.gov/6633550.htm. Documents available at http://iccvam.niehs.nih.gov/methods/udpdocs/udprpt/udp_ciprop.htm include: 1) A revised draft Up-and-Down Procedure (UDP) test guideline; 2) A procedure incorporated into the revised draft UDP forcalculating the confidence interval for the estimated median lethaldose (LD50); and 3) A software program for use in establishing test doses,determining when to stop the test, and estimating the LD50 and theconfidence interval for the estimated LD50Documents 1 and 2 and the User's Manual can be downloaded in PDF.Please send requests for the software program (item 3 above) to brenzel@niehs.nih.gov. A copy of the program will be sent by returnemail.You can also access these documents from the ICCVAM home page at http://iccvam.niehs.nih.gov by visiting the link in the Announcementsbox.

Public Teleconference meeting

On Tuesday, August 2001, a public teleconference meeting of the Up-and-Down Procedure (UDP) independent scientific peer review will be held.
To attend this meeting, please contact Ms. Loretta Frye, NTP Interagency Centre for the Evalkuation of Alternative Toxicological methods (NICEATM), NIEHS, 79 Alexander Drive, Bldg. 4401, P.O. Box 12233, EC-17, Research Triangle Park, NC 27709; telephone (919) 541-3138; fax (919) 541-0947; or email frye@niehs.nih.gov.Additional information about the teleconference meeting and details onsubmitting comments to NICEATM are contained in the Federal Registernotice (Vol. 66, No. 133, pp. 36294-36295, published on July 11, 2001), which is available on the Internet at: http://iccvam.niehs.nih.gov/docs/FR/6636294.htm in HTML or at http://iccvam.niehs.nih.gov/docs/FR/6636294.pdf in PDF. This Federal Register notice can also be accessed from the ICCVAM home page at http://iccvam.niehs.nih.gov/
or the Up-and-Down Procedure page at http://iccvam.niehs.nih.gov/methods/udp.htm.

News from the Commission

Personal priorities Busquin

When speaking at the inauguration of the 'European Neuroscience Institute' in Göttingen recently, Research Commissioner Philippe Busquin outlined three personal priorities for future EU research policy: the participation of the regions, the creation of networks of excellence and researcher mobility.

Referring to the participation of the regions in EU research, Mr Busquin said that he is convinced that 'the regional dimension in research should be deepened and better exploited.' He added that the Commission will present a communication on this issue at the beginning of the autumn.

Source: CORDIS RTD News, June 29, 2001, record 17011

Open calls

New calls for proposals have been published recently, and can be downloaded from the following website:
http://www.cordis.lu/life/calls/calls.htm.

The following calls for proposals are still open:

Joint dedicated call for proposals for RTD actions on the health and environmental implications of endocrine disruptors
Closing date: September 14, 2001

Dedicated Call for proposals for RTD actions on Transmissable Spongiform Encephalopathies
Closing date: October 18, 2001

Dedicated Call for proposals to extend existing contracts under the specific programme for research, technological development and demonstration on Quality of Life Programme to include partners from the ‘Newly Associated States’.
Closing date: February 15, 2002

Dedicated Call for proposals for RTD actions on ‘Genomics and Human Health
Closing date: October 18, 2001

IRCs for technology transfer

Sixty-eight Innovation Relay Centres (IRCs), created by the Innovation and SME Programme network, spans 30 countries. Each IRC is its region’s window on European innovation, helping companies and research organisations to transfer technologies to and from the rest of Europe. In addition, under FP5, a series of innovation cells have been set up. Every FP5 project must produce a Technology Implementation Plan (TIP). The innovation cells are responsible for monitoring these plans and for supporting transfer of technologies with potential for exploitation. A forthcoming pilot action will try to link selected Technology Implementation Plans to the closes IRC, which will visit the company concerned, and disseminate its technology offer to the network’s members.

Source: Innovation & technology Transfer, Vol. 2, March 2001, pp 21-22. A copy is available upon request from the ACTIP Secretariat.
See also:
www.cordis.lu/irc/home.html

Example of ‘Networks of Excellence’

Part of FP6 will be networks of excellence. They should put together research capacities present in the various European regions. An example is E-core, a network involving 66 partners from 20 countries, 14 of them EU member states. There will be one entry point for stakeholders seeking the latest technological advances in construction research. E-core will function as a reference group for developing future R&D strategies, and a forum for exchange of information. It will also set-up research co-operation beyond national borders.

Source: www.cordis.lu/growth

Intellectual Property’s Rights Helpdesk

The Intellectual Property Rights Helpdesk (IPR-Helpdesk), a project funded by the European Commission Innovation Programme of Enterprise DG, offers help with intellectual property (IP) issues to all persons engaged in EU-funded Research. It provides free advice with research contracts, consortium agreements, and more general IP information.

The legal Helpline (info@ipr-helpdesk.org) enables anyone to have specific IP questions answered in detail.

The IPR-Helpdesk website is a major source of IP and innovation information for every EU member state. Tutorials and guides in at least three EU languages to help understand complex IPR issues that confront scientists when undertaking EU-funded R&D activities. A free monthly electronic newsletter IP-Wire (ip-wire@ipr-helpdesk.org) keeps one abreast of the latest news in the IPR and innovation fields.

The IPR-Helpdesk has produced an extensive multimedia tutorial for the esp@cenet service of the European Patent Organisation. This tutorial helps laypersons to use the esp@cenet database - which contains more than 30 million patent documents - effectively and is available in English, French, German, Italian and Spanish.

The IPR-Helpdesk has also produced a CD-ROM "It all starts with an idea" this is available free to all current and potential EU-RTD contractors.

If you would like to order a copy then either send an e-mail to
promo@ipr-helpdesk.org or telephone +352 47 11 11 1 or fax your request to +352 47 11 11 60.

A better future for Europe?

A comment on the FP 6 proposal by R. J. van Duinen

Let's face it: The proposal for the sixth European R&D Framework Program by research Commissioner Philippe Busquin could have been a lot worse. In fact, if it survives the scrutiny of the Council of Ministers and sails through the European Parliament without too much damage, it will offer substantial benefit for science policy in Europe. These are big ifs, admittedly. For one thing, industry and the business sector do not seem overenthusiastic because they see too much emphasis on basic research. The constituency in the science and engineering community that has become dependent on previous framework programs may feel left out in the cold, and the traditional peddlers of national interest may feel deprived of power to guide the commission in the "right direction." If the history of the previous programs is any guide, all this may lead to substantial changes in the present proposal during the upcoming wrestling matches between special interest groups. But as it stands, the proposal delivers on the promise of Busquin's vision of a European Research Area (ERA).

The existing science system in Europe is a collection of jealously guarded national systems, resulting in a lot of waste and undue fragmentation. Europe should spend more public money on science to compete, but it must also use the available financial resources and talent much more effectively than it does now. In formulating the ERA, Busquin demonstrated the urgency of the problem and presented an outline for a solution.
The new framework proposal aims to bring this ERA closer to reality. For example, collaboration between national R&D organisations is to be strengthened to overcome the competitive disadvantages of the science system in Europe. The objectives of the Framework Program will thus be reoriented from promoting collaboration among individual scientists to promoting collaboration among research organisations. The ideas are still vague and lack operational specificity, but the opportunity to build on these modest beginnings should be taken up.

Collaboration between research councils can take various forms. For example, the European Science Foundation has introduced the EUROCORES mechanism, directed at joint planning and execution of bottom-up research programs. Such concepts should be expanded to include joint planning and investment in research infrastructure. The new plan offers European Union (EU) support for such activities. In doing so, it recognises the limited ability of the EU's bureaucracy to micromanage programs. Such courageous recognition is a necessary condition for improvement.

Industry and commerce should welcome the plan because it is directed at improving the European science system, which will lead to better science and better scientists and engineers. Europe's competitiveness depends on the effective transfer of ideas from generation to commercial application and exploitation in new and existing companies; this transfer in turn depends entirely on the quality of the people we educate and train in our higher education system. Especially in fast-moving areas of science, where the rate of discovery cannot be transmitted in the traditional education chain, it is vital that scientists and engineers have firsthand experience at these new frontiers.

Creative and effective application of technology in new products and services must be supported by entrepreneurial skills in recognising opportunities and marketing products. Science and technology policy, whether at the national or European level, should be directed at creating the conditions to achieve and sustain this dynamic. The present proposal shows that this has been recognised, as it emphasises the need and promises to support collaboration between science and industry.
At the Lisbon summit in March 2000, the EU government leaders requested from the European Commission a proposal for a program that can assist and stimulate the emergence of a creative and entrepreneurial spirit in the European research and innovation system. To achieve that, issues of mobility, patenting, taxation, competition, and collaboration will have to be tackled. Most of these issues are outside the responsibilities of the Commissioner for Research, but the present Framework Program proposal is a step in the right direction.

The fate of the proposal in the coming months will be an interesting test of the political commitment to a change in European R&D policy. Let us see what remains by the end of this year.

Source: A Better Future for European Science? May 4, 2001. By Reinder J. van Duinen, president of the European Science Foundation,
1 Quay Lezay-Marnesia,
67080 Strasbourg, France,
and president of the Nederlanse Organisatie voor Wetenschappelijk Onderzoek,
131 Laan van Nieuw Oost Indie, The Hague, Netherlands.
E-mail: president@esf.org and
duinen@nwo.nl

Company News

Update SkinEthic

Per June 1, 2001, SkinEthic has updated their website with new data on their different in vitro tissue models. Please visit:
http://www.skinethic.com

New Release DEREK for Windows and METEOR

At the Paris meeting, IVTIP members received a very enlightening talk about the software systems DEREK for Windows and METEOR of Lhasa Ltd to assess predictive toxicity and structure-metabolism relationships. The new releases of LHASAs DEREK for Windows and METEOR contain many new and improved features requested by the users. For example, with this release, reasoning rules are used for the first time in DEREK for Windows; for all toxicological endpoints, the system reports a higher level of confidence in the predictions. Also, skin permeability of the query structure is now estimated so that it can give predictions about skin sensitization or photoallergenicity.

For more information please contact:
LHASA Ltd
Tel 00 44 113 233 6531

CEFIC on the White Paper on Chemicals

A group of technical experts from across the CEFIC membership has examined the long-awaited White Paper on the EUs Chemicals Policy Review.
The industry wants to see effective legislation put into place that is based on risk assessment and sound science. Initial examination, however, shows that the White paper falls short at the practical level, with further clarification needed and shortcomings to be addressed before the new policy can be implemented properly. The introduction of more bureaucracy, more testing on more chemicals using more animals (an estimated 13 million!) and costing an estimated 7-10 billion USD will inevitably slow down progress which runs counter to the stated objectives. Of particular concerns is the introduction of an ''authorisation'' process that is based on the intrinsic properties of chemicals rather than on the real risks that they may pose. Furthermore, industry fears it will be unable to meet the deadlines.

Socialist MEP David Bowe is drafting the European Parliament's Socialists position, and thinks: " the implementation of the White Paper is going to produce lots of data that's not much use to anybody". It will take so long and be so expensive that it's not going to get to what we really want, which is to eliminate chemicals that are a serious concern’.

Source: European Voice, July 5-11, 2001
Source: CEFIC, see also CEFIC chemicals policy review website at:
www.chemicalspolicyreview.org/index2.html

HyCult Biotech

HyCult biotechnology b.v. is a small biotechnology company which is involved in the development of antibodies and new detection systems for research purposes.
One of their aims is to provide new methods for in vitro toxicology assessments. These are based on assays for the detection of Fatty Acid Binding Proteins (FABP).. Fatty Acid Binding proteins have proven to be excellent markers for cell and tissue damage.
An example is an assay for the detection of liver damage by toxic compounds. In this assay cell damage can be detected in culture supernatant by measuring L-FABP. Antibodies and assays are available for the detection of heart, liver and intestinal FABP of various species.

For more information visit:
www.hbt.nl

Research news

New Long Range Research Initiative research projects

Seven new projects have started this year under the Long Range Research Initiative. One of particular interest to our members might be:
The role of irritancy and irritant-induced inflammation in the elicitation of respiratory hypersensitivity reactions., coordinated by Dr. Josje Arts, Target Organ Toxicology Department, TNO Voeding, Zeist (NL). The project will run from Jan 2001-December 2003. More information from the IVTIP Secretariat.

Limitless supply transformed neurons

Cells isolated from the embryonic, neonatal and adult rodent central nervous system divide in response to epidermal growth factor (EGF) and fibroblast growth factor 2 (FGF-2), while retaining their ability to differentiate into neurons and glia. These cultures can be grown in aggregates termed neurospheres, which contain a heterogeneous mix of both multipotent stem cells and more restricted progenitor populations. Neurospheres can also be generated from the embryonic human brain.
Recently, a group of researchers demonstrated that maintaining cell-cell contact during the differentiation stage in combination with growth factor administration can increase the number of neurons generated under serum-free conditions from 8% to more than 60%.The current experimental system provides a practically limitless supply of enriched, non-genetically transformed neurons. These should be useful for both neuroactive drug screening in vitro and possibly cell therapy for neurodegenerative diseases.

Source: Nature Biotechnology Vol. 19, May 2001, pp 475-479

How many genes do we have?

Rival scientists and companies have been challenged to a 'gene count' showdown. In February, draft sequences of the entire human genome were published by the publicly funded human genome project (HGP) and Celera Genomics, both estimating the total number of genes to be between 30,000 and 40,000.
But some biotech companies have challenged these figures. William Haseltine, the head of Human Genome Sciences, Maryland, claims that his company has found more than 90,000 genes. Other companies estimate the number to be above 60,000, and sell gene chips based on this higher number.
A group at Ohio State University says that gene prediction programs tend to miss large amounts of genes. It has analysed the same information that the HGP did and believes there may be about 80,000 genes. Craig Venter of Celera is defending the lower estimates.
It is not the accuracy of the draft sequences that is in question, but how specific genes are identified. All parties involved claim that their technique is accurate.

Source: NewScientist 12/5/2001 'So what's the score?'

Spotlight on cloning

Call for worldwide ban on reproductive cloning

In a report to the House of Lords select committee on stem cell research, the Royal Society has called for a world wide moratorium on human reproductive cloning. The Society believes that this would be the only way to prevent 'rogue' experimental attempts at cloning babies in other countries where the law is unclear. The report follows recent claims by Severino Antinori, an Italian fertility doctor, that he will produce a cloned humanbaby in an unnamed Mediterranean country.
The report says that cloning humans would be 'unethical' and that 'responsible scientists across the world should not ignore the public's well-founded opposition to such research'. It is believed that a ban on reproductive cloning would have public support and is justified on scientific grounds.
The report did however warn that research into potential therapeutic uses of cloning, including embryo stem cell research, must not be jeopardised by any action taken on reproductive cloning: 'in our view, therewould be no merit in banning therapeutic cloning research for fear that it might give some benefit for reproductive cloning'.

Meanwhile, the German and French Foreign Ministers, Joschka Fischer andHubert Vedrine, said that they would jointly back a United Nations resolution to ban human reproductive cloning. Fischer's ministry issued a statement saying that 'with the joint initiative, the ministers seek to establish in a legal instrument valid worldwide that reproductive cloning ofhumans is unacceptable and incompatible with human dignity'.

Source: The Independent 20/6/2001 'Global ban demanded on cloning of humans' http://www.independent.co.uk/story.jsp?story=79131

France plans cloning regulation

A draft law banning human cloning in medical research but allowing limitedresearch on leftover or donated embryos was adopted in France last week.Under the new law, human reproductive cloning would remain illegal and be punishable with prison sentences of up to 20 years.Current President Jacques Chirac, a known opponent of embryo research,welcomed the move, saying that priority should be given to other ways ofadvancing cell therapy.

Source: Yahoo Daily News 20/6/2001 'France drafts new genetics law as cloningdebate continues'
http://sg.news.yahoo.com/010620/1/13jv1.html

US proposals to ban reproductive cloning

The Bush administration indicated its support last week for the more prohibitive of two proposed bills on cloning: the 'Human Cloning Prohibition Act 2001' and the 'Cloning Prohibition Act of 2001'. The intention of both bills is to ban human cloning, but they differ in the extent of theirprovisions. The first is said to propose a ban on 'virtually all uses of human somatic cell nuclear transfer', and would make doing so a federal crime. The second would allow embryos to be produced by cloning techniques, but not allow them to develop into foetuses - in other words, it would ban only reproductive cloning.
Meanwhile, in the ongoing discussions on stem cell research in America,it has been reported that several Republican senators have urged PresidentBush to allow the use of federal funds in embryo stem cell research. One ofthe senators, Orrin G Hatch, is an opponent of abortion, but believes thatembryo research raises 'fundamentally different' questions. He said researchwith embryonic stem cells is 'consistent with bedrock pro-life, pro-familyvalues'.

Source: The Washington Post 21/6/2001 'Bush backs broad ban on human cloning'
http://www.washingtonpost.com/ac2/wp-dyn/A23750-2001Jun20
The New York Times 19/6/2001 'Several G.O.P. senators back money forstem cell research'
http://www.nytimes.com/2001/06/19/health/19RESE.html?

Spotlight on Stem Cells

Stem cells for heart patients

Researchers at the US Baylor College of Medicine have found that stem cells taken from the bone marrow of adult mice are able to develop into blood vessel and cardiac cells when injected into the bloodstream of another adult mouse that had suffered a heart attack.

The stem cells were extracted from the bone marrow of the mice and 'tagged' with a blue marker. They were then injected into the bone marrow of some mice which had been induced to have heart attacks and some which had not, and these mice were observed. When the hearts were later examined, 'tagged' cells were not found in the hearts of the healthy mice, but were present in the blood vessels and cardiac tissue of the other mice.

Source: ScienceDaily 1/6/2001 'Stem cells help regenerate tissue damaged from heart attack'
http://www.sciencedaily.com/print/2001/06/010601082914.htm

US in favour of stem cell research

A report from the US National Institutes of Health (NIH) says that stem cell research - both embryo and adult - promises a 'dazzling array' of potential treatments for disease. But the report, published last week, says that in some cases, embryonic stem cells are 'clearly superior'.
The study was ordered as part of the review of federal policy on embryonic stem cells by the Bush administration. It says 'all avenues of research should be exhaustively investigated, including both adult and embryonic sources of tissue'. The report confirms the view of scientists,but has yet to convince the Bush administration, which remains divided overthe ethical issues involved in embryo stem cell research.
Similarly, a poll of 1,022 randomly selected adults has been conducted by the US ABC News network in conjunction with Beliefnet. The results show that twice the amount of Americans favour stem cell research as those that do not. The poll, which also breaks down supporters and opponents of the research into ethnic, religious, class and gender groups, also shows thatmost Americans believe that there should be federal funding of all stem cell research. Among all groups identified, opposition was highest amongst those who believed abortion should be illegal in all cases.

Source: The New York Times 27/6/2001 'US study hails stem cells' promise'
http://www.nytimes.com/2001/06/27/politics/27RESE.html

In Europe: ESF policy briefing

'Human stem cell research: scientific uncertainties and ethical dilemmas' European Science Foundation policy briefing.The policy paper recommends the permission of studies of stem cells fromembryos and adults, that reproductive cloning should not be permitted, butthat therapeutic cloning should be allowed.Full text of the document can be downloaded from
http://www.esf.org/update/news/01/cells.htm

New German embryo research guidelines

New embryo research guidelines were issued last week by the main research funding agency in Germany, the Deutsche Forschungsgemeinschaft (DFG).
The guidelines would allow German researchers to use imported human Embryonic stem cells. Currently, Germany law allows scientists to work on foetal Stem cells but not those derived from embryos. The DFG has also recommended That the German Parliament pass new legislation that would allow researchers there to derive stem cell lines from leftover IVF embryos if imports cannot meet demand. Creating embryos specifically for research and research into therapeutic cloning would remain illegal.

But the Social Democrat Party, opposition politicians and church officials strongly oppose the new guidelines. In response, the German government's Research Ministry has asked the DFG to postpone funding for the one research proposal that has so far been submitted and called for a general moratorium on funding to allow time for discussion of the ethical and moral issues.

Sources:
Nature 10/5/2001 'An end to procrastination?'
Nature 10/5/2001 'Stem-cell research in doubt as funders clash with government'
Science 11/5/2001 'DFG gives embryo research a boost'

Stem cell policies revisited

With the above proposal, Germany took one step closer to permitting at least some form of embryo stem cell research to take place within its national boundaries.
In so doing, Germany joins a number of countries with rather restrictive rules on the use of human embryos in research which are now rethinking their position in the light of stem cells. France, the United States, some Australian states and the Netherlands, not forgetting the UK, have all Felt compelled to reconsider existing rules on embryo research in the face of The great promise of embryo stem cells.
But politicians have been slow to respond. Most would probably rather the issue went away in order to avoid controversy. But the difficulty with embryo stem cell research, as far as politicians are concerned, is that the people who might benefit from it cannot be ignored, in the same way that those benefiting from embryo research have been (as unfair as that might seem).
Embryo stem cell research might not be an election issue, but it certainly is an issue that politicians know they must take seriously. By sheer force of numbers, those who might benefit command real political power.

Source: Juliet Tizzard, director, Progress Educational Trust

Important changes in European patent system

On November 29, 2000, agreement was reached on a number of important amendments to the European Patent Convention. All are expected to enter into force within the next four years.

The amendments to the EPC relate primarily to the streamlining of granting procedure, in particular the language system:
  1. once effective, applicants will be able to file a patent application in any of the languages of the designated countries and, if this is not onr of the thre offical EPC languages (English, German and French), a translation into one of these need only take place at a later stage. This will reduce costs by some 50%
  2. In the grant procedure, search (novelty) and examination (inventiveness) will be combined, with one examiner in principle carrying out both;
  3. computer programmes remain unpatentable, but computer-implemented inventions can be patented if they involve a new and inventive technical contribution to the state of the art.

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.

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