UK BIOTECHNOLOGY ADVISORY & REGULATORY BODIES BACKGROUND PAPER Office of Science and Technology - December 1998 SIMIC INDEX Page Introduction 3 List A - Biotechnology Specific Committees 5 List B - Associated Committees with a Major Role in Biotechnology 7 List of Acronyms Used ? Diagram of UK Biotechnology Committee System 10 eWAnI T CeOeR ESa eeT eQesH OT INEARRAAmTs ION GCDVICE pWCLLOUNIC TRUST INFORMATION SERVICE <= pee7 : ae: . pe 4ae KsP 7 o : = e + f be? a) — tt a — — =, AU TEUACTee a a) eep ae k: ard, ive’ oe CeO aF WAL Of ¢ vi Cor mo. > ~~ #2 seeee Om ~~L O<Ea. - se 3 + «, wy ey ’ be. > cous ve > Pep ne _e é INTRODUCTION The Ministerial Group on Biotechnology and Genetic Modification was established in October to take a strategic view of biotechnology policy. Given the fast pace of recent advances in the technology, the Group decided that it would be helpful to review the current system which is in place to advise Government on biotechnology, in order that Ministers can be confident that the system is robust enough to meet current and future needs. This document aims to give a factual overview of the current system. This system is based upon a number of regulatory and advisory committees which address issues raised by advances in modern biotechnology. List A contains committees established to deal specifically with questions arising from biotechnology. List B details other committees, originally established to oversee areas broader than just biotechnology, which now play an important role in advising Ministers on the technology (e.g. the Committee on Safety of Medicines advises on biotechnology- based medicines alongside its other work). Website addresses of committees have been included. Consultees should be aware that the framework for biotechnology fits into a wider regulatory framework which advises Ministers on broader aspects of health, medicines, environment, food, agriculture, animal welfare etc. Some of the committees in this wider system may occasionally undertake limited amounts of biotechnology-based work in the course of their wider duties (e.g. the National Screening Committee (NSC), which advises Ministers on population screening programs). Committees throughout the Government system do not operate in isolation. Some products may be looked at by a number of committees, and different committees may work together on specific issues. In addition, there is a degree of cross committee membership, as well as contact/meetings between Chairmen, Members and Secretariats. Furthermore, the UK system fits into a broader framework of European regulation of biotechnology. ri, = - >aaa ¢ | rece is att tarlelfdarns dia otro libel st lesyost Yo Sot taelt se civic) (eb aaa isthe * panka re | (i waiver of [helad of blidw 9 tet babiosh qos sal xt ot til! waite al wyolentlasiond ae insevea smaiv bn ot ek i irL ea ae i ‘noNit bere Haver teed: at dyads taudesta c areye oa tectS abino 24 a mice wttengs sei to wobrge inure 6 ovig a! eaelme ab i 4 r ia tidy conn Wiedivis bas erodalitges to tadieatt 6 nog boaradi im ~w~ ie rreites A tet .veolondaniniti mphor Mi eoonenbs «eb out aauread eb cor niiioatos mere yuiaite 2coitesup ittiw yllsoftinecs Inab shes tg net hwnd arse sonsve ot budeidutes ylisnigno soonimmes witoa is Ae 2A HO kein! gmzrybe mn los Inehodnd on yeiy won doidw seasoned sia (udoudseltud no es2ivby eonivibol to viSted wo ssttiontio® oft 3) vetoed Sart POSI ie to asaerthby atladeW Aros toe to ei Sar ag eonioibom baat’ Bebclonl nod). : — 24 tebiv 6 ater ait ygoloasototd vot Ara vodmit cel tet ruven edb ce deta. sattiotbon Abad Jo gosqer wbeoe au aye ssulvbe ronhwr Fewweostiett een ait oj esshinimce aii Yo orn? ote o'milowe lacie vauttuoings Dod) ? o7R Uy hoved-veoluarzaroid lo anin-omne' bolted emebobin Siintacoa secede Sciam) yninvans? MenotieVt anf 9.5) esitub rabive tied? Lo aii eohinnne) (ainergong aninssros maith (16e rolaiaiM agaiv bed fg tw, ie Yon etgubany setoe npinwhoat ti eee tt vor s119 tatitogel Anew \yeen esorriemetees necaiien aa i ms 6 bod 84. qisesorterare; =i a mii a8s i 228 Metter cate) we 1992.h ee exodenaE ee f Gy - cEa t Angoluncioevotet io neattal gst msqonh Yo 2ko we This review will focus primarily on the operation of the committees named in the attached lists, which are the most directly involved in advising Government. This should not stop consultees making comments on the broader aspects if they feel these would be helpful. a eo == ca 7 ie wy : D> Ae i 7 i 7 a) 7 ; 7 Pr ea ea shold leat vat ie toores Yoho sell ioa dite PS . 7 List A oat The following bodies were established specifically to address issues arising from developments in modern biotechnology. (i) Advisory Committee on Genetic Modification (ACGM) - is a non-statutory advisory body which advises the Health and Safety Commission/Executive and Ministers on all aspects of human and environmental safety of the contained use of genetically modified organisms under the GMO (Contained Use) Regulations 1992 (based on EC Directive 90/219), as amended. ACGM focuses on safety questions in the laboratory and industrial installations. It is not involved in product approval. Website (http:// www.open.gov.uk/hse/openacgm.htm) (11) Advisory Committee on Genetic Testing (ACGT) - is a non-statutory advisory body which advises Health Ministers on developments in genetic testing, taking account of ethical, social and scientific aspects. It establishes requirements, especially in respect of efficacy and product information, to be met by manufacturers and suppliers of genetic tests. Website (http:/www.open.gov.uk/doh/genetics/htm) (iii) | Advisory Committee on Releases into the Environment (ACRE) - is a statutory body under the Environmental Protection Act 1990 (EP Act 1990), which advises Environment, Agriculture and Northern Ireland Ministers, and the Health and Safety Commission/ Executive, and other bodies as appropriate on the release of genetically modified organisms into the environment. In particular, it advises on the exercise of powers regarding the release of GMOs under EP Act 1990, the Wildlife and Countryside Act 1981, and the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 1993. It also advises on research needs. Website (http://www. environment.detr.gov.uk/acre) (iv) | Gene Therapy Advisory Committee (GTAC) - is a non-statutory advisory body which advises UK Health Ministers on developments in gene therapy research and their implications. It reviews and if appropriate approves individual protocols for gene therapy research. It works closely with the statutory body for medical products, the Medicines Control Agency (MCA), and with research ethics committees. Website (http:/www.open.gov.uk/doh/genetics/htm) (v) | Human Genetics Advisory Commission (HGAC) - is a non-statutory advisory body which reports to Industry and Health Ministers on issues arising from new developments in human genetics that can be expected to have wider social, ethical, and/or economic consequences, for example in relation to insurance, patents, employment and public health. It keeps under review scientific progress at the frontiers of human genetics and related fields, and advises on ways to build public confidence in, and understanding of, the new genetics. It works closely with (and has a significant degree of shared membership with) other advisory committees in the human genetics area. 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