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Scientific Research: Innovation with Controls

 
   
 

 
15 January 2003

Government has a difficult job in ensuring that scientific research can flourish, whilst at the same time confirming to the public that research being carried out is both ethical and safe.

Launching "Scientific Research: Innovation with Controls", David Arculus, Chairman of the Better Regulation Task Force, said: "The UK has an unrivalled position in the world for scientific research and innovation. Regulations play an important part in scientific research. They set the boundaries for what scientists may and may not do – in line with society’s moral, ethical and safety concerns. But if not properly designed they will hamper scientific research and innovation."

"The Government and others put a great deal of money into scientific research. It is important that the money is used in the most effective way possible, with the aim of making the UK the best place to do scientific research."

"This report looks at how the Government balances the desire to encourage scientific advancement with the unease often felt about the direction of some scientific research."

"We look in detail at three controversial areas of research: seed and plant breeding, embryonic stem cell research and nanotechnology. The UK is a world leader in embryonic stem cell research and has attracted millions of pounds of investment to this country and some top quality researchers from around the world. They benefit from a regulatory environment that is clear and precise. We would like to see the same precision adopted for the emerging science of nanotechnology."

"Unfortunately the situation is less satisfactory for seed and plant breeding. Regulations around since the 1960s do not reflect the 21st century. We recommend the removal of some outdated legislation, which would not reduce the safety of products coming on to the market."

The Task Force proposes a four-stage model for the regulation of research. Moral, ethical and safety concerns need to be taken into account at all stages of the research process, but other regulations need to be proportionate to the risks involved.

For embryonic stem cell research, the Task Force recommends that the Department of Health and the Human Fertilisation and Embryology Authority review some of the processes surrounding the awarding of research licences, to make sure they are subject to regulatory scrutiny.

In the area of seed and plant breeding, the Task Force recommends removing two pieces of outdated legislation on Higher Voluntary Standards and value for cultivation and use. The Task Force does not believe these are issues with which the Government should be concerned. Removing them would free up resources to concentrate on more important issues, such as the regulation of genetically modified plants.

David Arculus said "The Prime Minister rightly wants the UK to be the best place to do scientific research. This report should help the Government meet that aim."

Lord Hunt at the Department of Health has agreed to respond to the report on behalf of the Government, within 60 days of publication.

 

Notes to editors

  1. Key facts
    • There have been more scientific discoveries in the last ten years than in the whole of human history and the rate at which discoveries are being made continues to increase
    • UK is currently a world leader in life sciences, with over ¾ of biotechnology pharmaceuticals in late stage clinical trials in Europe originate in the Britain
    • The European Biotech market is expected to be worth over $100 billion by 2005, with as many as 3 million employees working in the industry

In this year’s Comprehensive Spending Review the science budget annual average was raised in real terms by 10 per cent per year between 2002/03 and 2005/06

  2.   Full list of recommendations

Regulating scientific research

Recommendation 1: Regulating scientific research – innovation with proportionate controls. The Task Force recommends that the Office of Science and Technology use the Task Force’s outline for the regulation of scientific research to initiate a debate with the scientific community and other stakeholders on how scientific research should be regulated.

The Office of Science and Technology should report on progress with this debate by January 2004.

Better regulation of seed and plant breeding

Recommendation 2: Remove outdated legislation

  1. DEFRA, should, at the earliest opportunity, negotiate to have the value for cultivation and use requirements removed from the EC seed and plant breeding directives. Until negotiations are complete, DEFRA should implement the requirements in a light-touch way; 
  2. DEFRA should, at the earliest opportunity, remove the Higher Voluntary Standards from the seed certification regulations. The Task Force invites the devolved administrations to follow suit. 
  3. DEFRA should report to the Task Force on progress on (i) and (ii) by the end of July 2003 and January 2004.

Better regulation of stem cell research

Recommendation 3:HFEA consultation. The Task Force recommends that all HFEA consultation documents should follow the Cabinet Office guidelines, and include a regulatory impact assessment.

Recommendation 4: Research Ethics Committees. The Task Force recommends that:

  1. the Multi-site Research Ethics Committee (MREC) system should be reviewed in October 2005; 
  2. by the end of 2003, it should be possible to complete all Local Research Ethics Committees (LREC) and MREC forms online; and
  3. approvals granted by Research Ethics Committees should be consistent across committees, as far as is compatible with the independent nature of ethical review.

Recommendation 5: Research licence applications. 

The Task Force recommends that, with immediate effect, the HFEA ensure that its Licence Committees always have a majority of lay members.

Recommendation 6: Review the 2001 amendments to the Human Fertilisation and Embryology Act 1990. The Task Force recommends that the Department of Health should review, in 2004, the 2001 amendments to the Human Fertilisation and Embryology Act 1990, to make sure the Act keeps pace with the developments in embryonic stem cell research and public opinion. Thereafter the legislation should be reviewed every three years.

Nanotechnology

Recommendation 7: Nanotechnology. The Task Force recommends that, in the area of nanotechnology, the Government should:

  1. enable, through an informed debate, the public to consider the risks for themselves, and help them to make their own decisions by providing suitable information;
  2. be open about how it makes decisions, and acknowledge where there are uncertainties;
  3. communicate with, and involve as far as possible, the public in the decision making process;
  4. ensure it develops two-way communication channels; and
  5. take a strong lead over the handling of any risk issues, particularly information provision and policy implementation.

   3.    The Better Regulation Task Force

The Better Regulation Task Force was established in September 1997. It is an independent advisory body. All members are unpaid. Its terms of reference are to advise the Government on action to ensure that regulation, and its enforcement, accord with the five principles of good regulation: transparency, accountability, proportionality, consistency and targeting.

The Task Force is currently conducting reviews into the following regulatory issues: independent regulators; alternatives approaches to implementing policy; producer responsibility; and the problems small firms face doing business with the public sector.

 

     
   4.    Task Force reports and further information

Flagship deal with media enquiries and press issues regarding the Task Force.

Media copies of the Better Regulation principles leaflet and Task Force reviews are available from:
Susanna Collins and Barnaby Fry
Flagship Group
tel: 020 7886 8449/8459
Mobile 07767 793895 / 07768 475452
email: firstname.surname@flagshipgroup.co.uk

Others can obtain copies from: 

Better Regulation Task Force Secretariat
Regulatory Impact Unit
5th Floor
22 Whitehall
London
SW1A 2WH

Tel: 0207 276 2141.

Click here for a background briefing note