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removal of some outdated legislation, which would not reduce the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Force recommends removing two pieces of outdated legislation on Higher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
- 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
- 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;
- 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.
- 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:
- the Multi-site Research Ethics Committee (MREC)
system should be reviewed in October 2005;
- by the end of 2003, it should be possible to
complete all Local Research Ethics Committees (LREC) and MREC
forms online; and
- 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:
- 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;
- be open about how it makes decisions, and
acknowledge where there are uncertainties;
- communicate with, and involve as far as possible,
the public in the decision making process;
- ensure it develops two-way communication
channels; and
- 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.