THE BETTER REGULATION TASK FORCE (BRTF) REPORT 

`Scientific Research:

Innovation With Controls

’, JANUARY 2003

THE GOVERNMENT’S RESPONSE

Introduction

The Government thanks the Task Force for its report, 

“Scientific Research: Innovation with

Controls”

, and has considered its recommendations carefully.

The Report rightly acknowledges the unrivalled position of the UK for research.  Although the
UK has only 1 per cent of the world’s population, it carries out 4.5 per cent of world science and
produces 8 per cent of science papers.  These papers receive 9 per cent of citations

1

.  UK

researchers are among the most prolific in the world, producing 16 research papers per $1
million of research funding, compared to 9.2 in the USA and 3.6 in Japan. For medical research,
England ranks 2

nd

 behind the United States of America

2

.  Furthermore, on average, UK scientists

receive about 10 per cent of internationally recognised science prizes.

As a result of our excellent record of scientific discovery, the UK is home to strong science-
based industries such as aerospace and pharmaceuticals.  It is a remarkable tribute to the
creativity of British science that 15 out of the world’s top 75 medicines were discovered and
developed in the UK.

Transparent and proportionate regulation is essential in allowing that research to flourish.  The
Government’s strategy for science, engineering and technology 

“Investing in Innovation”

,

published in July 2002, recognised that effective and proportionate regulation can encourage
rather than deter innovation in the UK by creating confidence for organisations to undertake
scientific research, but at the same time address legitimate public concerns on ethical, safety, or
environmental grounds.

The Government also welcomes the very positive comments made in the Report about the
operation of the Human Fertilisation and Embryology Act 1990 Act and the success the UK
Government has had in influencing the agenda in the rest of Europe, particularly in the area of
funding embryonic stem cell research.

So far as the general proposals are concerned, the Report sets out a model for a system of
variable regulation based on stages of scientific research.  In the Government’s view, the
objective should not be to regulate intellectual activities such as scientific research 

per se.

Rather, regulation should be applied to all activities that could have unacceptable ethical,
environmental or safety implications, whether they are carried out in the name of scientific
research or for any other purpose.  For example, there are regulations governing not only
research into, but also the development of new medicines.  Similarly, there are regulations

                                                

1

 “Excellence and opportunity: a science and innovation policy for the 21

st

 century”, DTI (2000)

2

 “Benchmarking of the International standing of research in England” Centre for Policy Studies in Education,

University of Lees, Institute for Scientific Information, Philadelphia, November 1997

governing the storage or use of particular hazardous materials which are commonly used for
research purposes but may equally be used for other non-research purposes such as full-scale
production activity.  And in areas such as nuclear, “research” activities may well be on an
industrial scale.

Thus, the Government’s approach is that the need for regulation needs to be determined by the
risk or danger, the environmental impact, or the ethical undesirability of the activity in question,
not by the stage of the innovation chain which the research concerned has reached, or indeed
whether or not it is labelled as research.

The report makes seven recommendations. The remainder of this response considers each of
these in turn.

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

Government Response

Not accepted.

  As outlined above, the Government’s general approach is to regulate all activities

that might have unacceptable ethical, environmental or safety implications.  It does not accept
that essentially different considerations apply at different stages of the innovation chain.  For
example, the handling of radioactive materials needs to be regulated, irrespective of whether it
falls under the heading of research, development or production/operations.  While the
Government is always happy to discuss with the scientific community general issues in relation
to the regulation of scientific research, it would not wish to open a debate that took the model
proposed in the Task Force’s report as its starting point.

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 the progress of the above by the end of July 2003
and January 2004.

Government Response

Value for cultivation and use (VCU)

The Task Force report rightly recognises that National Listing operates as a UK function.
DEFRA cannot act unilaterally to seek changes to the EC Directive to remove the requirement
for VCU.   Responsibility for the policy is shared jointly between the Secretary of State and
Ministers of the devolved administrations in Scotland, Northern Ireland and Wales. Any changes
to UK policy require agreement between the four Ministers.   Policy changes must also be
discussed and formulated taking account of all interested parties (e.g. seed producers, seed users,
and environmental groups). This part of the recommendation is therefore 

not accepted

.

However, government accepts the Task Force’s recommendation that the requirement for
establishing VCU should be implemented in a light touch way.  It is already agreed UK policy
that the arrangements for trialling new varieties should be the minimum at the same time
consistent with proper implementation of the Directive. A working group comprising of
technical representatives of DEFRA and the devolved administrations was established in August
2002 to consider how the official costs of the National List system could be reduced.  The
group’s remit includes VCU trials, where it is considering how cost efficiency could be
improved, whilst preserving the integrity of the system in a way consistent with proper
implementation of the Directive.   The aim is to report the outcome of the review to Ministers by
August 2003.

Higher Voluntary Standards (HVS)

Not accepted.

  Once a variety is entered on a National List or the EC Common Catalogue, the

variety can be marketed throughout the UK.  In other words, the variety – that is, the “product” -
is approved for marketing.   Seed certification is about the minimum quality standards which
individual consignments (called seed lots) of seed of a listed variety must meet.  These quality
standards also include standards, which must be met by the crops from which seed lots are
obtained.  This assures a farmer that an individual bag of seed has been produced to a certain
standard and meets specific requirements for, e.g. varietal purity, germination, and analytical
purity.

HVS is part of the seed certification system. England Regulations offer seed producers the option
to verify that individual seed lots of wheat, barley, oats and some grass species meet prescribed
quality standards which are higher than the minimum required by the EC cereal seed directive
and the EC fodder plant seed directive.   The devolved administrations also offer HVS in their
separate seeds marketing regulations.  HVS is entirely voluntary.  There is nothing to prevent
seed, which meets lower, minimum, standards from being marketed.   Nor is there anything to
prevent imported seed from being verified at HVS, provided confirmation that standards were
met is provided by the authorities in the exporting country.

DEFRA has consulted on options for HVS in England as part of a wider review of seeds
marketing regulations.  These included removing it from regulations, retaining it with
modifications and retaining it unchanged.  Three separate consultations took place between
February 2001 and July 2002.   Those asked to comment included representatives of all sectors
of the seeds industry – plant breeders, seed producers, seed growers and seed users.  There was
no consensus on what should be done.  But the majority view from those representing seed
producers, seed growers and seed users was that some form of HVS should be retained,
particularly for wheat, oats and barley.

Given the demand for HVS, particularly from seed producers, growers and users, DEFRA
retained it in new seeds regulations which came into effect on 31 January 2003.  We have,
however, identified changes to the way HVS is verified, which will save some £70,000 of the
estimated £100,000 official costs of administering HVS.

Progress report

Accepted in part.

    Government will report progress on the VCU aspects of the review of

National Listing after reporting  to Ministers (report due by  August 2003) and again in January
2004, if the review is not completed by that time.

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.

Government response

Accepted

. The Government agrees that all HFEA consultation documents should follow current

Cabinet Office guidelines and include a regulatory impact assessment where appropriate. The
HFEA has confirmed that this recommendation will be adopted with immediate effect.

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.

Government Response

Accepted in principle.

  The Government accepts all parts of this recommendation in principle.

The implementation of Directive 2001/20/EC of the European Parliament and of the Council on
the approximation of the laws, regulations and administrative provisions of the Member States
relating to the implementation of good clinical practice in the conduct of clinical trials on
medicinal products for human use will require by May 2004 a system of ethical approval for
clinical trials involving medicines that provides for a single ethical opinion valid across the
United Kingdom. This means important changes for MRECs and LRECs in advance of the
recommended review date.

A standard electronic application form will be piloted by MRECs from February 2003, and used
throughout the UK (MRECs and LRECs) from October 2003.  (The work has to take account of
EU guidance on the format and content of application forms for RECs, which the EU
Commission is expected to finalise in 2003.  The electronic form will be downloadable from the
Internet, can be completed on screen, and transmitted electronically to those managing the
business of the relevant REC.  A true “on-line” version may be developed at a later stage, after
changes in the law relating to ethical opinions on clinical trials of medicines take effect in 2004.

The Department of Health funds a Central Office of Research Ethics Committees (COREC),
which supports MRECs and LRECs, facilitating training and other activities to encourage a
consistent approach. The process and correspondence related to approval will certainly be more
consistent, but the report itself recognises the independence of REC review.  It would be
inappropriate to make any promises on consistency of the content of REC opinions. The final
phrase of the recommendation  " as far as is compatible with the independent nature of ethical
review” is very welcome.

Recommendation 5 – Research license applications
The Task Force recommends that, with immediate effect, the HFEA ensure that its License
Committees always have a majority of lay members.

Government Response

Accepted in principle.

 The importance of the involvement of lay members in the HFEA’s

work is well-recognised and accepted, starting with the requirement in the Human
Fertilisation and Embryology Act 1990 that a majority of the members of the Authority must
be lay. The legislation also requires that licence committees must be made up solely of
members of the Authority. However, it does not require licence committees to have a
majority of lay members.

The Government understands the argument that all research licence committees established
by the Authority should have a majority of lay members – as does the HFEA. However, there
may be occasions when, in practice, it is simply not possible to achieve a majority of lay
members given that there are only eight lay members of the Authority and there are
considerable other demands on their time. However, the HFEA has undertaken to ensure that
all research licence committees will be chaired by a lay member.

The complex technical nature of research licence applications submitted to the
HFEA requires committees to have considerable scientific input from members. The

Authority already has protocols in place that require conflicts of interest to be
declared, and any member of a licence committee who has such a conflict of interest
is required to stand down

.

Recommendation 6
Review of the 2001 amendments to the Human Fertilisation and Embryology Act 1990.

The Government accepts the need to keep the Human Fertilisation and
Embryology (Research Purposes) Regulations 2001 under review. We will
continue to monitor scientific developments in the field of assisted
reproduction and embryo research to ensure that the legislation covers them
effectively. This monitoring and review is a continuous process and we do not
believe it would be helpful to limit it to three yearly intervals.

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 develop two-way communication channels; and

•

 

take a strong lead over the handling of any risk issues, particularly information provision and
policy implementation.

Government Response

Accepted in principle.  

The Government agrees that securing public confidence in new

technologies will involve dialogue between the Government, scientists and the public about
science, and the issues that it raises for society.

So far as the general use of scientific advice in policy-making is concerned, the Office of Science
and Technology (OST) has issued Guidelines 2000, which sets out best practice for government
departments, and published a Code of Practice for Scientific Advisory Committees in December
2001.  Both these documents promote openness, transparency and an acknowledgement of
uncertainties in decision-making processes.  They also emphasise the need to involve stakeholder
groups in the debate about the benefits, risks and values of science as well as the science itself.

OST works with departments and their scientific advisory committees to secure implementation
of the guidance.  The Chief Scientific Adviser has produced regular implementation reports on
the Government’s use of scientific advice in policy making.  Over eighty advisory committees

across Whitehall have agreed to follow the Code of Practice.  OST will produce its first
implementation report on the Code this year. It will include examples

 

of how committees have

used the Code, including public engagement activity.

As regards nanotechnology, the Government agrees with the Task Force that - as for any
other area of science and technology – the Government should be open about its approach,
acknowledge uncertainties, and ensure that the public and other stakeholders are engaged in
the decision making process.  The research and research user communities are already
considering the issues raised by nanotechnologies, not just in terms of the science but also the
social and ethical aspects.  The Royal Institution  hosted such an event at the end of March
2003.

There is, however, no obvious focus for an informed public debate of the type suggested by the
Task Force.  The Government is, therefore, currently looking at how to initiate work which will
examine whether there are any areas of nanotechnology which raise or will raise specific safety,
environmental or ethical issues, and which would, therefore, warrant more detailed study now or
in the future.