Volume 1

Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology.

  • Great Britain. Parliament. House of Lords. Science and Technology Committee.
Date:
1993
Catalogue details

Licence: Open Government Licence

Credit: Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology. Source: Wellcome Collection.

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    Products manufactured using biotechnology processes usually fall within existing regulatory frameworks that have been developed for the target industry. The techniques of biotechnology are unlikely to raise regulatory issues which have not already been addressed in part by other experience and regulation. In particular the risks from organisms modified by biotechnology are of a similar nature to those risks from the use of unmodified organisms. The BioIndustry Association fully supports the OECD Council Recommendation of July 1986 which states: “There is no scientific basis for legislation specific to recombinant DNA organisms”’. This recommendation continues to be supported by accumulating experience and scientific evidence. Gene technology has been developing for the past twenty years and laboratories have always carried out adequate risk assessments, and are now increasingly required to do so by regulation. The early fears surrounding the growth of modern biotechnology have proved, over this period of development, to be without foundation. The biotechnology industry has an unblemished safety record, having had over 1,500 experimental releases of genetically modified organisms and several products in the marketplace with the total absence of adverse consequences. This record is in no small part due to the co-operation and contact between scientists and public authorities, who have worked closely together on a scientific basis to identify possible risks (see Appendix 4). The experience gained from past and future field trials must be used to evolve appropriate guidelines, rather than keeping to rigid interpretations which may be outdated. 5. Should biotechnology be regulated by an industry-specific regime? The regulation of biotechnology should be commensurate with the scientific indications of potential risk and uncertainty. Biotechnology should not be regulated by an industry-specific regime, but the products of biotechnology should be so regulated on the basis of safety, efficacy and quality in those industries whose products, services or activities require regulation. Industry will thereby benefit from the application of relevant knowledge and experience to tackle the many applications of biotechnology processes. A model of this approach can be seen in the USA where novel products are being brought rapidly, safely and cost- effectively to the market. The Commission of the European Communities clearly advocated a similar approach of sectoral legislation in its April 1991 communication, “Promoting the Competitive Environment for the Industrial Activities Based on Biotechnology within the Community”, SEC(91)629; subsequently re-published (without annexes) as one of the three communications in the Bulletin of the European Communities, Supplement 3/91, “European Industrial Policy for the 1990s”. In the Commission’s original proposal for the contained use and deliberate release directives this was also the case. Unfortunately, the approach towards sectoral legislation was changed during the process of negotiation in the European Parliament and Council of (Environment) Ministers. Academic and industrial interests at European and national level were systematically excluded from this debate. 6. From a technical point of view, is horizontal regulation (where a product is judged through the process by which it is derived) better than vertical regulation (where a product is judged by its characteristics)? Vertical regulation is certainly to be preferred, for the reasons indicated above. The industries where biotechnology is likely to have the greatest impact are already regulated through extensive existing product legislation. It is essential to avoid discriminatory regulatory requirements for biotechnology processes and products which would constitute a systematic and in-built discrimination against innovation, in particular against inherently safer technology (see Appendix 5). It is important to firstly consider the nature of the products or effects of the activities. ““Horizontal”’ legislation is valid for cross-cutting concerns such as worker safety, animal welfare, patent laws, taxation rules etc. In many cases satisfactory mechanisms are already in place to protect man and the environment within current legislation, and there may not be a need for further horizontal regulation. 7. Should regulation evolve from a horizontal to a vertical approach in each industrial or environmental application? In general, horizontal regulation may be appropriate in the research and development stages, but having established the consistency and characteristics of the product, regulation should be vertical, in those cases where the product (or services or activities) require regulation. It is important for a single regulatory agency in any given sector to manage the evaluation of safety, efficacy, purity and impact on the environment in the approval pathway for marketing new products in that sector. If these review processes are separated, and become the responsibility of different regulatory agencies, the impact may be to delay delivery of the benefit of the product and would, in the longer term, militate against innovation in these types of technology.