June 28,2007

EBRA Bulletin

Produced by the European Biomedical Research Association 

June 2007

Articles
  Revision of 86/609 delayed again
-   Campaigns against primate research
-  
EU adopts new housing and welfare guidelines
-   New booklet from UK group
-   REACH is now in action
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Revision of 86/609 delayed again
Although it was expected to be adopted by the Commission and published in June, it is now clear that the revision of Directive 86/609 will take longer.

 

It was widely expected that the Commission would adopt their proposal for the new directive on animal experimentation during the German Presidency, which lasts until the end of June 2007.   Once adopted, it would be published and sent to the Council of Ministers and the European Parliament to begin its first reading.
 
However, we have recently learned that technical issues with the legal drafting are taking longer than expected to resolve and the adoption may be not be until September or October.  It is worth remembering that almost every stage in the lengthy process involved in developing the proposal has taken significantly longer than expected, so it is quite possible that it may take even longer.
 
In addition, Commissioner Dimas (Environment) has had an operation and is still sick in the US.   So, given the forthcoming summer break, it looks as though even the inter-service consultation, where the different DGs discuss the draft among themselves, is unlikely to start before October.
 
 
 

 

Campaigns against primate research
 

 

Some of the most active animal rights groups in Europe are campaigning in the European Parliament against the use of non-human primates in research.

 

 
A second Written Declaration calling for an end to the use of primates in research has been put down in the European Parliament. Although Written Declarations are not part of the legislative process, they are a method that MEPs can use to express an opinion on a subject.
 
In 2006, several MEPs put down a Written Declaration on behalf of the National Anti-Vivisection Society, a UK animal rights group operating under the name of Animal Defenders International.  This called for all primate experiments in the EU to be phased out over the next six years.  By the time this declaration lapsed, in January 2007, it had been signed by 88 MEPs.  If an Written Declaration gets the signatures of over half of all MEP's - ie 393 of them - it is written into the minutes of a plenary session of the Parliament. 
 
The same animal rights group had another Written Declaration on primate experiments put down in April.   It currently has 174 signatures and will remain open until September.
 
Another animal rights group, the European Coalition to End Animal Experiments, recently held a press photo opportunity on the steps of the Euroepan Parliament in which a number of MEPs released activists in monkey suits from cages, to to launch the groups campaign for a ban on the use of primates in EU research.
 

 

 EU adopts new housing and welfare guidelines
The revised Council of Europe guidelines have now been adopted by the EU.
 

On the 18th June, the European Commission adopted new guidelines for the accomodation and care of laboratory animals.  These guidelines are the revised Appendix A of the Council of Europe Convention ETS123. 
 
The original EU guidelines were set out in a 12-page annexe to Directive 86/609.  Starting in 1998, the Council of Europe revised their equivalent guilines, eventually adopting a 109-page document containing much greater detail, higher welfare standards and significanrtly larger enclosure sizes for all the main species of laboratory animals.
 
During the revision process, the EU took the unusual step of ratifying the Convention, thus binding itself to adopting the new guidlelines.  It completed this process by adopting a Recommendation on the revised guidelines in June.  Although Recommendations are a type of EU legislation that is not binding on Member States, they do have a significant political impact.  Since their adoption involves negotiation and a defined legislative proecedure, there is a substantive expectation that Member States will conform with them.
 
The full text of the new guidelines can be found at http://conventions.coe.int/Treaty/EN/Treaties/PDF/123-Arev.pdf.
 
 
 

 

New booklet from the Coalition for Medical Progress
 

 

A UK group has produced a new booklet aimed at patients which could also be useful for lobbying

 

 
The Coalition for Medical Progress (CMP) have followed-up their 2006 opinion poll that showed that almost 9 in 10 British general medical practitioners agree that safety tests should be carried out on animals before human trials of new medicines are conducted. The CMP has now produced a glossy booklet – “Where do medicines come from?” – intended for distribution to patients via their doctor’s waiting room.   The leaflet, which is supported by the British government, sets out in simple language how new medicines are developed from understanding the mechanism of disease through animal studies to human trials.
 
The CMP is an alliance of organisations that share the common aim to ensure the UK continues to lead advances in human and animal medicine. The role of CMP is to help explain the case for medical progress and the benefits brought about by animal research.    Members include scientific and veterinary organisations, medical charities, pharmaceutical companies, research funding agencies, medical organisations, patient groups, and trade unions.

Copies of the leaflet, which could also be suitable for use in lobbying politicians, are available from www.medicalprogress.org.  
 
 
 
 

 

REACH is now in action
 

 

The new European Chemcials Regulations now apply across all EU Member States

 

 
The new European Chemicals Regulation, REACH, came into effect across Europe on 1 June.   Because it is a regulation and not a directive, national legislation is not necessary for its implementation.   REACH will replace 40 older laws on EU chemicals, and will be overseen by a new EU Chemicals Agency based in Helsinki.
 
One of the goals of REACH is to reduce animal testing, particularly in vertebrates.   Such testing should only be undertaken “as a last resort”, says the regulation.   But with some 30 000 chemicals involved, including the 3 000 considered to be the most dangerous and subject to special authorisation, it seems likely that animal testing will increase rather than decrease.   Most of these dangerous chemicals are known as persistent, bio-accumulative and toxic (PBTs) or very persistent and very bio-accumulative (vPvBs).   Permission to use these chemicals in Europe will only be given if no alternative exists and the benefits of using them outweigh the risks.   In this case, permission to use them will be granted for a limited period while the manufacturer pays for research to be carried out to identify an alternative.
 
While environmentalists say this is not strict enough to protect human health, animal rights groups are claiming that REACH will lead to hugely increased animal use in fulfilling the strict testing requirements.   In a letter to the Brussels weekly paper European voice, Sandra Hannen, from the European Coalition to End Animal Experiments said:    “Like most sensible Europeans, the European Coalition to End Animal Experiments fully supports the REACH aims to protect our citizens and the environment from exposure to harmful chemicals.  But like many Europeans we do not believe that aim should be achieved via tens of millions of new tests on animals.”
REACH has been considerably toned down during its passage through the European legislative process, and the testing requirements considerably relaxed.   But the problem of balancing human health and animal welfare seems set to cause difficulties for many years to come.
 
More information about REACH can be obtained on the European Commission website at:
http://ec.europa.eu/environment/chemicals/reach/reach_in_brief04_09_15.pdf
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