The Royal Society of Edinburgh is pleased to respond to the Office of Science and Technology’s Review of the Framework for Overseeing Developments in Biotechnology. The RSE is Scotland’s premier learned society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled with the assistance of a number of Fellows with many years experience in biotechnology.

Biotechnology is extremely important both for the UK, and for Scotland, and represents a burgeoning field in which we have a potentially world leading position. However, there are also challenges in that the new technologies face major issues of adverse public concern and reaction. It is, therefore, crucial that we seek to have national systems that provide fully satisfactory controls over the proper development of the technology, and reassure the general public, but do not stultify the scientific advances or block their conversion to useful technologies.

The specific questions identified in the consultation document are addressed below:

What gaps exist in coverage of biotechnology by the existing committees and how might these be remedied?

Gaps in the existing List B committee structure are now being addressed in part through the establishment of the Advisory Committee on Animal Feeding stuffs (ACAF). This committee should be put in place immediately, as this is an area in which politics and vested interests, rather than science and animal welfare, are setting the agenda. It should be noted that Genetically Modified Organisms (GMOs) are as important an issue in the feeding of animals as in the feeding of people.

The further establishment of a body similar to the Human Fertilisation and Embryology Authority (HFEA) to give prior approval for experimental manipulations to be carried out on the embryos of farm animals, as recommended by the Banner Committee, would also be worthwhile. This would prevent the unacceptable violation of an animal’s form and function, but ensure that potential benefits of novel biotechnology in animal reproduction are not lost through the influence of uninformed pressure groups.

There should also be some interaction between the committee regulatory process and the science funding activity. It can be envisaged that active developments in agriculture will impinge on others in medicine, and vice-versa, and specific research or development might be needed to harmonise the work in these disciplines.

What overlaps exist and are they justified? If not, how might they be remedied?

While there are no unnecessary scientific overlaps in the areas covered by the various committees the system is relatively complex. However, the boundaries between the Home Office Animal Scientific Procedures Committee (ASPC), Advisory Committee on Genetic Modification (ACGM), Advisory Committee on Genetic Testing (ACGT), Advisory Committee on Releases into the Environment (ACRE), Gene Therapy Advisory Committee (GTAC), Human Genetics Advisory Commission (HGAC), UK Xenotransplantation Interim Regulatory Authority (UKXIRA), Advisory Committee on Dangerous Pathogens (ACDP), Advisory Committee on Novel Foods and Processes (ACNFP), Farm Animal Welfare Council (FAWC) and HFEA, which all deal with issues of genetics and biotechnology in humans and/or animals, could be clarified.

Could the current system be structured in a more simple way?

The List B Committees would provide an appropriate range and balance of advisory input if developed as noted above. There is, however, a case for simplifying the List A structure by considering the establishment of three committees covering respectively: non-human areas of genetic technology; human areas of genetic technology; and environmental protection. The remits of these committees would derive effectively from the existing committees and each issue would be evaluated on a case-by-case basis by a committee of scientists and lay people (ethicists, lawyers, consumer organisations etc.), as at present.

It is important that there should also be a central or top committee to discuss and co-ordinate the work of the other committees. If we cannot get the safety issues right without delaying all potential developments, the UK is likely to loose out in the biotechnology stakes, yet in the longer term will not be able to resist the pervasiveness of the ultimate products, as genetically modified soya has demonstrated.

How could the system for providing advice to Government be made more transparent?

There is a perception that the work of advisory committees is not sufficiently in the public view. However, increasingly a variety of committee material is published on the internet, and we suggest this could be done on a more consistent and regular basis. There are, however, genuine difficulties with the committees that deal with aspects of approval of commercial products. Here commercial confidentiality is crucial and cannot be breached by a more public release of information.

Are ethical and other wider issues addressed fully and properly within the current system?

At present, none of the committees has a specific remit for ethics in isolation but by and large all take ethical matters into consideration. It is, therefore, important that committees include lay people (ethicists, lawyers, and consumer organisations) to provide a rounded view.

In this context, one area where the creation of a new Standing Committee would be worthwhile, is in reviewing the ethical (as opposed to the welfare) issues arising from new technology in farm animals.

Are stakeholders given the appropriate opportunities to make their views known? For example, would an environmental stakeholder forum be a valuable addition to the current framework?

In relation to the aquatic environment, there is a distinct need for an environmental stakeholder forum in relation to GMOs, pesticides and medicines, operating on a balanced and rational basis, dealing in science, logic and truth rather than invective. There is also a need for much closer liaison between the ACRE, Advisory Committee on Pesticides (ACP), FAWC and Veterinary Products Committee (VPC), and with the Environmental Agencies.

There is an initial attraction to bringing members of pressure groups within the official framework. However, past experience has shown that individuals belonging to long-established pressure groups have used their privileged positions within government advisory groups to pursue their own agenda through the media (and courts).

Is the framework flexible enough to cope with the rapid development of this technology which is likely in the future?

In terms of the flexibility of the present framework it should be recognised that the UK approach fits into a European regulatory framework that has a much more overt recognition that factors other than science must be considered. The need for public reassurance is therefore ensuring that the precautionary principles should apply where proof positive is not available.

Does the public have confidence in the system currently in place?

The public in the UK undoubtedly has some residual concerns. However, this is all part of a wider trend to be suspicious of science, which reflects a real need for efforts to improve the public understanding of science. It is notable that public attitudes to science are different in the USA, for example, and more needs to be done to understand why this is, and how we can encourage changes in UK attitudes.

One area where this is particularly pertinent relates to the use of GMOs and the environment. The public are currently very poorly served by the media in terms of rational argument in this area, and there seems to be a general view that controls are lax and the public is at danger. There is need for fully informed debate on the issues involved and for greater understanding of the present legislative framework. While the ACRE is a statutory body, its input to the argument is rarely heard outside Whitehall.

Conclusion
Biotechnology is currently widely pervasive. It clearly has great potential for enhancing the UK economy and for increasing the range of human benefits that are already beginning to appear. The potential risks and the ethical concerns have to remain foremost at all times in terms of extending the technologies, but in general the UK system for overseeing such developments, from the technical and scientific viewpoint, is more than adequate.

Further information is available from the Research Officer, Dr Marc Rands