The meeting will be hosted by Johnson & Johnson Pharmaceutical Research. The programme features genotoxicity testing, the REACH proposal and endocrine disruptor testing. Have you sent in the reply form?
In the months of August and September, the IVTIP website still had a large number of visitors. There were respectively 4,727 (Aug) and 6,684 (Sept) requests for access, resulting in 2,505 (Aug) and 3,618 (Sept) downloaded pages. Of the visitors, 18% came from industry in August and 36.6% in September, as seen by their .com ending. The most popular pages were protocols, the secure page and research.
The Commission's proposals for the new chemical policy (REACH) have been the battleground for fierce lobbying from the chemicals industry and NGOs. The intensity of the debate was shown by the number of responses to the 8-week Internet consultation organized by the Commission. More than 6,000 contributions were received. 42 per cent of them were sent by industry. 142 NGOs participated. Five Member State governments and 10 public authorities as well as lots of important international trading partners (such as Canada, Japan, the USA and others) sent their comments and position papers.
In short: industry fears that the proposed new chemicals policy will undermine the competitiveness of the European chemicals industry and will cost many thousands of jobs. For the industry and some governments (especially the German government), the outcome of this chemicals review will determine how serious the EU is in its Lisbon ambitions to become the world's most competitive knowledge society by 2010. NGOs claim that the revision will be good for the environment and public health and see the chemicals review as the ultimate test for the sustainable development strategy of the Union.
Below we summarize some of the activities and positions.
The US chemical industry and the Bush administration have also lobbied hard against the Commission's plans. The US administration stated that "the European Commission's draft chemicals regulation appears to adopt a particularly costly, burdensome, and complex approach, which could prove unworkable in its implementation, adversely impact innovation and disrupt global trade."
In a report released on 9 September, 70 health and environmental NGOs in the United States accuse their government of "intervening in the regulatory process of sovereign nations at the behest of the industry". In a letter to the Bush administration, the NGOs urge their government "to recognize the potential benefits (of REACH) to American consumers and businesses and cease all efforts to undermine EU chemicals policy reforms" and request "that the Administration solicit public comments from the American people to formulate a forward-looking position on chemicals policy to prepare for new economic realities of the 21st century".
Source: EurActiv News, September 12, 2003
The German industry has opposed the REACH proposals from the start. It has asked corporate consultants Arthur D. Little for a second economic assessment of the Commission's proposals. The results of the new study indicate that the current proposals in the Commission's consultation paper would lead to a gross value added loss of 4.7 per cent. More than 1.7 million jobs would be at risk if the proposals were to become law. In its press conference in Brussels on 16 September, the German industry federation BDI called for "a new REACH", which should consist of three elements:
The French government has also been warning that the Commission proposals would undermine the competitiveness of the European chemicals industry and lead to job losses
In the UK, Trade and Industry Secretary Patricia Hewitt announced on 16 September that her country is ready for a showdown with the Commission on this legislation as it would "destroy the European chemicals industry".
Environment NGOs have repeatedly questioned these economic impact assessments, accusing the industry of scaremongering over job losses and forgetting about positive effects for health and the environment. For the NGOs, the chemicals debate has also become a test case, but then on the commitments of the EU concerning its sustainable development strategy. In a reaction to the new Arthur D. Little report presented by the BDI, the Greens in the European Parliament accused the report of being "detached from economic reality". They criticised the methodology of the study.
Source: EurActiv, September 18, 2003
The revised proposal drafted by the Commission demonstrates that the participants in the stakeholder consultation had a real impact on the final outcome of the future legislation. The Consultation Document from May 2003 was revised in several areas. The most important changes are the following:
Scope of the system:
The following documents related to the revised proposal are available:
* Commission draft document: www.euractiv.com/ndbtext/environ/reach1.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume I
Commission draft document: www.euractiv.com/ndbtext/environ/reach2.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume II
Commission draft document: www.euractiv.com/ndbtext/environ/reach3.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume III
Commission draft document: www.euractiv.com/ndbtext/environ/reach4.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume IV
Commission draft document: www.euractiv.com/ndbtext/environ/reach5.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume V
Commission draft document: www.euractiv.com/ndbtext/environ/reach6.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume VI
Commission: www.euractiv.com/cgi-bin/cgint.exe/1345839-646?714&1015=8&1014=EUROPAEUINTKSHPACTIONGETTXTGTDOCMEMO032020RAPIDLGENDISPLAY" \t "OTHR" Impact assessment of the chemicals proposal [ www.euractiv.com/cgi-bin/cgint.exe/1345839-646?714&1015=8&1014=EUROPAEUINTKSHPACTIONGETTXTGTDOCMEMO032020RAPIDLGFRDISPLAY" \t "OTHR" FR ] [www.euractiv.com/cgi-bin/cgint.exe/1345839-646?714&1015=8&1014=EUROPAEUINTKSHPACTIONGETTXTGTDOCMEMO032020RAPIDLGDEDISPLAY" \t "OTHR" DE ] (16 Oct. 2003)
Environment Commissioner Wallström confirmed on 27 October that the Commission would go ahead with the presentation of legislative proposals for a complete overhaul of the EU's chemical substances policy.
Source: EurActiv, September 25, 2003
In a press conference on 8 October, CEFIC, the European chemicals industry lobby, admitted that the revised draft on the REACH proposal contains several improvements for industry.
However, Eggert Voscherau, President of CEFIC, and Mathieu Vrijsen, President of DuPont Europe, stated that more changes to the current draft are needed to make it workable:
UNICE, the European employers federation, supported CEFIC's demands in a letter sent to all Directors Generals of the Commission on 8 October. It urges the Commission to change the REACH proposals from a hazard-based approach to a risk-based approach and to carry out a full and extended impact assessment.
The environmental NGOs are even less satisfied with the Commission's revised draft proposals. In a press conference on 25 September, BEUC, the European consumers organisation, the European Environmental Bureau (EEB), Friends of the Earth, Greenpeace and WWF accused the Commission of giving in to industry lobbying.
Source: EurActiv News, October 9, 2003
On Wednesday 29 October 2003, the Commission endorsed the revised draft regulation on REACH, which will now have to be approved by the European Parliament and the Council. The proposal replaces over 40 existing directives and regulations. Under the new system, companies that produce and import chemicals will need to assess the risks arising from their use and take the necessary measures to manage any risk they identify. This will shift the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.
In the latest phase of the policy-defining process, the Commission undertook an independent impact assessment, estimating the overall costs of REACH to the chemicals industry at 2.3 billion euro over a period of 11 years. The costs for the downstream users (manufacturers who use chemical substances in their products, eg in cars or textiles) would be between 2.8 to 3.6 billion euro over a period of 11 to 15 years. The Commission will organize another open workshop on the extended impact assessment and its methodology
Environment Commissioner Margot Wallström and Enterprise Commissioner Erkii Liikanen underlined that the right balance had been found between the economic, environmental and social aspects of this radical overhaul of the rules for the chemical industry.
The chemical industry reiterated its support for the broad objectives of new chemicals legislation. CEFIC, the voice of the chemical industry in Brussels stated that the industry will co-operate constructively with the stakeholders to ensure an efficient, workable and cost-efficient system. It welcomed the Commission's initiative to hold a workshop on the methodology of the impact assessment and stated that it is looking forward to a strategic alliance and discussion with the Commission, European Parliament and Council.
Environmental NGOs and consumers organizations expressed their disappointment with the Commission's proposals. In a press release the European Environmental Bureau (EEB), Friends of the Earth and Greenpeace stated that the "slimmed-down REACH needs healthy supplements". They urged the European Parliament and the Council "to strengthen the EU chemical policy proposal". Tony Long, Director of WWF's European Policy Office welcomed the draft law but also called for a strenghtening of the proposals. He stated that "too many concessions [were given] to the chemical industry, who have been promoting exaggerated studies of the costs of REACH. If improvements are made, REACH will provide an opportunity to create an innovative and forward-looking chemical industry in Europe, and will assist 'downstream' users of chemicals in their quest to produce safer and greener products."
Next Steps:
The proposal will now start its legislative process (under co-decision procedure) through the Parliament and the Council; no final decision is expected before the next European Parliament elections. A frantic new round of lobbying can be expected when these proposals are discussed by MEPs and Member States. The first battle has already started on the question as to whether the Competitiveness Council or the Environment Council should take the lead.
Source: EurActiv, October 30
The following news items were taken from the ECVAM Newsletter, July/August 2003 (see also http://ecvam.jrc.it)
ECVAM has established a number of new Task Forces (in brackets the names of the chairpersons):
The use of fish cells in ecotoxicology, ECVAM Workshop Report 47, ATLA 31, 317-351
Biostatistical methods and the development, validation and acceptance of in vitro toxicity tests. ECVAM studies, ATLA 31, Supplement 1
The European Pharmacopeia Commission has adopted two serological methods for the potency testing of human tetanus vaccines. The methods had previously successfully been validated in a joint ECVAM/EDQM study.
As a result of another ECVAM study, the European Pharmacopeia has revised its general monograph on veterinary vaccines with respect to the use of the target animal safety test to the quality control of veterinary vaccines.
Finally, the European Pharmacopeia Commission has adopted an in vitro method for the potency testing of swine erysipelas vaccines. ECVAM was a participating laboratory in the study on the in vitro method.
France has launched a legal action aimed at killing off a historic EU ban on animal-tested cosmetics, said Newspaper the Guardian.
The EU measure, agreed this year after 13 years of negotiations, will phase in a near-total ban on the sale of animal-tested cosmetic products throughout the EU from 2009 and put a stop to all animal testing. It has been hailed as one of the most significant pieces of EU legislation on animal welfare.
France has lodged a case at the European court of justice in Luxembourg demanding that the ban be quashed on legal and technical grounds. France argues that the ban is too severe and is incompatible with world trade rules, that its wording is ambiguous and that it will damage European business interests. It also contends that the resulting improvement in animal welfare would be "extremely small" and that "it is likely to result in the circulation of products presenting significant risks to human health".
Animal rights campaigners said they were appalled by the French move. "It has taken animal campaigners and the European parliament a frustrating 13-year struggle to finally secure legislation to outlaw the suffering of lab animals to produce trivial products like lipstick and perfume," said Wendy Higgins of the British Union for the Abolition of Vivisection (BUAV). "It is shameful enough that it has taken this long, impeded as we have been at every stage by aggressive industry lobbying. It is even more shameful that a challenge to actually reverse the EU cosmetics animal testing ban has been brought forward." Campaigners said they were confident the European courts would throw out both legal challenges.
The ban, it emerged yesterday, is also under attack from another front. A coalition of companies which manufacture cosmetics ingredients has launched a separate but equally discreet challenge - this time in Europe's court of first instance - that is also designed to kill off the EU ban. That action is being undertaken by an organisation called the European Federation for Cosmetics Ingredients, which represents 70 companies in Switzerland, Belgium, France, Germany and Italy.
Around 38,000 animals are used and killed in developing cosmetics in the EU every year.
Source: The Guardian, August 19, 2003
Meeting in May this year, the Competitiveness Council (with among others Commissioner Erkki Liikanen), adopted conclusions from a communication on ìStrengthening European Innovation Policyî. The Council recognized that innovative activity is a key factor stimulating productivity growth and competitiveness, as well as a key factor in achieving sustainable development. Ministers also noted that ìa better understanding of the drivers of innovation in the European contextî is required. The key message was that ìinnovation goes beyond technological means and can take many formsî. Furthermore, the ìspeed and efficiency of spreading innovation through the economy is critical to productivity, economic growth and job creation. It was also noted that enterprises must be considered as central to innovation in Europe.
With regard to actions, the Council calls on both member states and acceding countries to:
Source: OJ no C 149 of 26-6-2003, p 4. See also:
europa.eu.int/eur-lex/pri/en/oj/dat/2003/c_149/c_149200326en00040006.pdf
Europe needs to spend more on R&D and technological innovation if its economy is to be as strong as, or stronger than, that of its main competitors. In March 2002, EU leaders endorsed a target of 3% of GDP for overall R&D spending in Europe. This means that Europe must spend substantially more on R&D, because the average level is 1.9% of GDP, compared to 2.7% for the US and 3% for Japan. This means that the research expenditures in Europe will need to grow at an average annual rate of 8%, shared between a 6% growth rate in public expenditure and a 9% growth rate for private investment. Meeting the objectives is expected to increase GDP by 0.5% per annum after 2010, as well as creating 400,000 new jobs each year.
The Commission is currently pressing hard to get implementation of an action plan up and running. Among the measures envisioned are fiscal incentives, availability of risk capital and IPR guidelines for public research institutions.
Source: Investing in research ñ an action plan for Europe. COM(2003)226
europa.eu.int/comm/research/era/3pct/index_en.html
While preparations for the next calls for proposals for the Sixth Framework Programme are already underway at the Commission, the first calls remain a topic for fervent discussion among stakeholders.
One group, the national contact points (NCPs), are particularly concerned by the outcome of the first calls. CORDIS news spoke to three coordinators, from Germany, France and Poland, to find out more about the lessons learned from the results of the first calls, and their thoughts on areas that can be improved for future calls.
Paul Jamet is the coordinator the NCP network in France. He told CORDIS News that the results from the first call were better than initially expected with respect to French participation. Around 25 per cent of projects involving French partners were retained, a figure well above the global average. Also, 14 per cent of the projects retained are being coordinated by French consortia.
However, despite such encouraging statistics, Mr Jamet explained that there remains a significant amount of confusion regarding Integrated Projects and Network of Excellence, which has led to rejection of high quality projects. In some priorities the success rate is about five per cent. This is really frustrating.'
Andre Schlochtermeier, coordinator of the German NCP system, also believes that one of the main problems in the first calls was the misunderstanding by applicants of the objective of Network of Excellences. 'Not only was it not understood by applicants, I think there were different concepts of the instrument in the Commission depending on the thematic area,' he said. 'There has also been a reluctance from industry to participate in NoEs because the main aim is not to create results but to overcome the fragmentation of research,' explained Dr. Schlochtermeier. 'It is impossible to expect industry to coordinate all their research with 20 to 30 partners - they will gain nothing.' Some people at the Commission have also warned that these networks are too large and have suggested that to ensure industry participation, the networks should start with a smaller number of partners,' said Dr. Schlochtermeier.
In addition, there has been a general problem of over-subscription. 'Overall, 12,000 proposals were submitted for the first calls, out of which, less than one in five projects could be supported.
The difficulties encountered due to over-subscription, particularly with regard to the projects deploying the new FP6 instruments, are most visible in candidate countries. 'Candidate counties are immediately in a weaker position than Member States,' said Andrzej Siemaszko, head of Poland's NCP system. He told CORDIS News that the success rate is as low as five per cent in some cases, with candidate counties coordinating only a handful of projects overall.
The fact that so many high quality projects have not been retained for budgetary reasons, Mr Siemaszko says, will have a knock-on affect on the second round of calls. 'It's clear that proposers will be reluctant to invest their time and money just to have their project rejected.'
However, despite the negative feedback received by some NCPs, they feel that their concerns are not falling on deaf ears. 'The Commission is generally aware of all the problems and that is very positive,' explained Dr Schlochtermeier. 'They are listening to NCPs and Member States and they will make some necessary adjustments.'
The Commission had already proposed a number of measures to turn the situation around. These include:
Asked to pinpoint the most important lesson learned from the results of the first calls, the three coordinators agreed that there should be more emphasis on funding smaller projects and the older instruments, such as specific targeted research projects (STREPs) . 'In research as in life, it is wise not put all your eggs in the same basket,' said Mr Jamet. 'While big research networks and projects will achieve their objectives, they will not really innovate.'
Source: CORDIS News
The European Commission has announced the eight projects short listed for the Descartes Prize. The one million euro prize will be awarded at a ceremony in Rome on 20 November, following a decision by the Grand Jury. While deciding between eight such diverse and high caliber projects will be no easy task, the list of finalists has already been whittled down from applications involving 900 scientists in 230 research teams. The Commission is keen to highlight the fact that two of this year's short listed projects are coordinated by women. This follows an increased number of entries from projects coordinated by women.
The short listed projects are the following:
Source: Source: CORDIS News, October 1, 2003 , see also www.cordis.lu/descartes
EU Research Commissioner Philippe Busquin has spoken of a new idea within the Commission with regard to funding for interesting projects proposed for the Sixth Framework Programme (FP6) that were not selected for EU support.
"We have to make it known that these projects are not receiving finance, not because they're not good, but because we don't have the (financial) capacity," said the Commissioner.
While there is as yet no concrete proposal, Mr Busquin suggested that "if this could allow Member States to finance these projects, that would be very good."
Source: CORDIS News, October 1, 2003
On May this year, the Japanese group of Norio Nakatsuji in Kyoto announced that they had successfully derived Japan's first line of human embryonic stem cells. These were cultured from donated human embryos left over from fertility treatments. As a result, Japanese scientists will no longer need to pay licensing fees to the patent owner of foreign cell lines. It is expected that 40-50 Japanese groups and companies will want to avail of this cell line. The scientists plans to develop another 3-4 cell lines over the coming months.
Source: Nature Biotechnology, vol 21, 7, 2003
Increasingly, zebrafish are found to be very good model systems for the study of the effects of small drug molecules on vertebrate development and disease. Zebrafish are permeable to small molecules, are amenable to visualization of embryogenesis, have large clutch sizes and can be maintained at high population densities. Recently, Australian scientists (Love et al) described how the combination of gene expression with zebrafish screens complemented existing whole organism studies currently used in drug discovery projects.
Source: Nature Biotechnology, vol 21; 8, August 2003, pp 879-883
New Scientist reports that scientists at Stanford University in California are developing genetically modified bacteria able to excrete an anti-HIV protein. Following insertion into the vagina, these bacteria are supposed to colonise the vagina and effectively form a living condom against HIV. The used bacterium, Lactobacillus jensenii, excretes the human protein CD4, a protein capable of binding to HIV viruses. In the laboratory, these genetically modified bacteria were successful in preventing infection of human cells by HIV viruses. Currently, the scientists are investigating whether a non-genetically modified strain of these bacteria is capable of colonising the vagina of rhesus monkeys.
Source: 'Living condom could block HIV', New Scientist 90-09-03, www.newscientist.com/news/news.jsp?id=ns99994141
During 2000-2003, regulators in North America and Europe approved a total of 64 biopharmaceuticals for human use. The approved drugs include hormones, blood factors, thrombolytics, vaccines, interferons, mAbs and therapeutic enzymes. All of these are protein-based drugs. In total, four humanized mAb products were approved, including Humera, the first human monoclonal antibody created using phage display technology. In total, there are now 24 therapeutic antibodies on the market.
An increasing number of the newly approved products have undergone some form of genetic engineering. To date, no gene therapy drug has gained marketing approval. Neither has a new antisense-based product gained approval since 1998. During the same period, an estimated 50 new chemical entities (NCEs) were approved in the EU and 64 in the US. However, excluding duplicates, only 80 genuinely different NCEs have come to market. These data suggest that during the past three years over a quarter of all new drug approvals were biopharmaceuticals.
Notable target indications for newly approved medicines include diabetes, hemophilia, myocardial infarction and various cancers, largely reflecting the major killers of Western society. Hepatitis remains the most frequently targeted indication of newly approved medicines, reflecting its global significance with 2 billion perople affected worldwide.
A complete table, containing all biopharmaceuticals approved in the US and the EU, is available as a fold-out with the benchmark review.
Source: Nature Biotechnology, vol 21, August 2003, 8, pp 865-870
A team of internet specialists has analyzed 57 biotech websites for design consistency, organization and information delivery. Overall, new scientific companies scored poorly. Of the studied companies, 54% allowed poor design to undermine their work and repouations. Here some advice distilled from the study on how to avoid common pitfalls:
Source: The homepage report: a study of the latest crop of Biotechs. Mark.williams@jwt.com
Information: www.eatb.de/html/events
Information: www.patinnova.org
Or www.european-patent-office.org/epidos/conf/eac2003/
Information: ivtip@planet.nl
Information: clare.king@reedexpo.co.uk
http://www.cordiaconvention.com
Information: www.chi-peptalk.com
Information: info@biovalleybasel.com
Organization:blhata@uta.fi
Information: www.esof2004.org