• What this atlas is about
  
  
• The regulatory architecture of biotechnology
  
  
• How to use this atlas
  
  
• Treatment of devolved, European, foreign and international regulation
  
  
• Acknowledgements
  

Other useful information:

• Other regulatory atlases
  
  
• Other help for those starting up or running a business

What this atlas is about

Article 2 of the UN Convention on Biological Diversity defines biotechnology as ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.’

Genetic modification is the subject of an intense debate throughout society, and nearly all of the groups likely to use this atlas will have an interest. Therefore laws on the application of genetic modification and the control of genetically modified organisms are given a central place. However, the definition of biotechnology goes much wider. Other areas covered here include:

• overarching laws, such as the Health and Safety at Work Act, that have a special impact on biotechnology
  
  
• use of biomolecules, micro-organisms, biological cells or other biological components in industrial production, or directly for the common good in health care or environmental applications.

Given this broad regulatory and scientific scope, care has been taken to optimise the amount of detail to meet the expectations and needs of most users of such a high level atlas. Summaries, explanations, or guides to compliance action are given where this is considered helpful. In other cases, Web links are included to provide rapid access to the relevant regulations and supporting information.

The regulatory architecture of biotechnology

Regulation aims to protect health and the environment, and to respect ethical and social norms, while maximising the benefits obtainable from biotechnology. It evolves with the concerns and priorities of the real world, and does not slot precisely into any theoretical framework. European biotechnology regulation was founded in the circumspection and self-control of the academic pioneers of the 1970s. It was then steered for a time by ambitions to realise the expected industrial and consumer benefits; but it has since been reinforced as a result of public concerns over safety and ethics.

The architecture of biotechnology and its regulation has been variously outlined according to regulatory authority (e.g. BioGuide, DTI, 2000), technology/professional discipline (e.g. Biotechnology in the Public Sphere: A European Sourcebook, J Durant et al, Science Museum, London, 1998; ISBN 190074709X), or end use (as in some of the ongoing work of SPRU. However, there is general agreement that the regulated area includes research and development, industrial bioprocessing, agri-food and human health applications.

The structure chosen for this atlas enables a logical progression to be made through the requirements which biotechnology researchers, producers and practitioners have to meet whilst delivering their outputs as effectively as possible.

Of the nine main subject area maps in the Atlas, Maps A-E form a ‘Primary Route’, presenting cross-sectoral or ‘horizontal’ regulations and regulatory issues in an order in which they might most usefully be considered. These maps include the ‘default’ rules applying to those working in any sector not covered by specific regulations.

Maps A-C apply across all technologies as well as across sectors developing specialised products and services, whereas Maps D and E are mostly of interest to those intending to work with GMOs. The Primary Route crosses a roundabout between these two groups of maps. The roundabout offers further exits to those needing to explore the sector-specific or ‘vertical’ regulation after examining some or all of Maps A-E. The specialised sectors defined for the purposes of this Atlas are:

• Medicinal products and medical devices
  
  
• Human genetics and novel therapies
  
  
• Environmental services such as reduced chemical pollution, and related optimisation of production processes
  
  
• Food chain and similar agricultural applications.
  

These are represented by Maps F-I respectively. The breadth of the sector-specific maps allows the interdependencies of individual products, regulatory and compliance processes to be shown. For instance, in the health care maps, legislation such as the Medicines Act 1968 and the Human Fertilisation and Embryology Act 1990 is of broad scope; while in the Food and Agriculture map, there is a logical progression down the food chain from seed, through animal feed, to food for human consumption.

Most of the maps describe statutory or advisory bodies as well as laws, because such bodies are involved in developing regulations and ensuring compliance with them. These bodies may also offer official guidance, standards, or codes of practice.

Bear in mind that biotechnology regulation is changing rapidly, and is likely to continue to do so for the foreseeable future. For instance, European Union Directive 2001/18/EC reinforced controls on the deliberate release of GMOs late in 2002, and in 2003-4 there are likely to be major changes to the regulation of novel food and animal feed, together with developments in the arrangements for clinical trials. The online Atlas is designed to track the development of new regulation by means of quarterly updates. However, it should not be relied upon as the sole source of information as to which legislation and regulatory procedures are currently in force. Official databases, reference works and specialist legal advice should also be used.

How to use this atlas

The atlas attempts to highlight laws and regulatory compliance tasks which may require significant resource or forward planning, and is intended to benefit

• biotechnology innovators, production companies and practitioners who are working primarily to UK law, in the context of EU regulation
  
  
• any group or person who wants to find out how the potential benefits and risks of biotechnology are kept in balance by precautions written into the law, with its compliance and enforcement procedures
  

Like most other web sites, the online atlas can be navigated efficiently by simple point and click:

• You can view the Route Planner by clicking on this icon
  
  

• You can click to any map from the Route Planner,
  or using the navigation letters at the top
  
  

• The Map Overviews appear below each map (you will need to scroll down to read these)
  
  
• You can click to any checkpoint (text box) from its parent map
  
  
• Checkpoints are often supported by detailed annexes; you can click to the annex from its parent checkpoint. The annex page is subdivided '(a), (b), (c)...' if several subjects are treated
  
  
• You can click on this arrow icon to return to the top of the page
  

Treatment of devolved, European, foreign and international regulation

This atlas covers English law unless otherwise stated. Similar but separate legislation frequently applies to some or all of Wales, Scotland and Northern Ireland. An effort has been made to state whether individual legislative areas and regulatory responsibilities apply across the wider national entities of England and Wales, Great Britain, or the whole of the United Kingdom.

European Union directives and regulatory instruments underlie many of the national provisions, and are mentioned where this is considered to be helpful or to provide context - particularly if they are directly applicable (e.g. EU Regulations), or if the national regulation which will implement EU law has yet to be finalised.

Since the biotechnology industry needs to set UK regulation in its international context when making strategic and operational decisions, an effort has been made to outline salient US and other international regulation at the most appropriate points in the Atlas. There is scope for the inclusion of further international links in later issues.

The main repositories of consolidated US law are the United States Code and the Code of Federal Regulations. European and US laws on genetic modification have tended to differ in that Europe has taken a more precautionary approach and required activities to be positively justified. The US has relied more on interagency co-ordination under the auspices of the Office of Science and Technology Policy (OSTP). OSTP’s Director serves as the President’s Science Adviser. The US regulatory strategy for biotechnology was laid out in Co-ordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment (51 Federal Register 23302, 1986).

World Trade Organization (WTO) rules and other international obligations tend to affect the biotechnologist indirectly through EU and UK legislation. EU Member States are bound to legislate in the context of WTO rules, under which all products imported from Most Favoured Nations must be treated equally and, once imported, treated as if home produced. National legislation would have to be amended if successfully challenged under WTO’s Dispute Settlement procedures.

Acknowledgements

The author of this atlas greatly appreciates the oversight given by the Biotechnology Industry Government Regulatory Advisory Group (BIGRAG) to the development of the Route Planner and map structure. He would like to thank the many officials of the Scottish Executive, Defra, DH, DTI, FSA, HSE, and the Home Office - together with their executive agencies - who have co-ordinated and provided advice on content. Other stakeholders, representing the Atlas’s intended user base, have made a valuable contribution to its scope and style, or have made helpful comments on the online prototype. Finally, several colleagues at LGC deserve to be acknowledged for their respective roles in drafting and review of the Atlas. However, decisions on the regulatory scope and the adoption of proposed amendments remain the responsibility of the author.

• Web site design by Clinic (www.clinic.co.uk)

Other regulatory atlases

The following regulatory atlases are already available:

• LGC, UK Chemicals Regulatory Atlas. DTI, 1998
  
  
• LGC, DTI, and FSA, Food Regulatory Atlas: a Guide to Regulatory Compliance. LGC, 2002, ISBN 0948926171
  
  
• DTI and LGC, Medical Device Material Atlas. LGC, 2002, ISBN 0948926163.

Other help for those starting up or running a business

Business Link offers information and facilities covering all aspects of running a small business, including obtaining finance and identifying relevant regulation. Business Link is overseen by the Small Business Service (SBS), an executive agency of DTI. The SBS guide Setting up in Business outlines the main regulations applicable, and how to comply with them.

The Inland Revenue's Starting up in Business web page focuses on the main tax and National Insurance issues that businesses need to be aware of from the outset, and provides pointers to wider legal issues for new companies.

For specialist help with money matters, the UK Biotechnology Finance Advisory Service is provided free of charge by an experienced partnership comprising a chartered accountant and a science and business consultant, and fully funded by DTI. The partnership has helped 55 biotechnology companies through the early stages when cash flow and business planning are so crucial, and continues to provide support as a business matures. In addition to identifying realistic sources of finance it offers technology brokerage so that skills and resources can be outsourced as necessary to underpin start-up businesses.