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The Biotechnology Market
in the United Kingdom

June 2002


© Department of Foreign Affairs and International Trade
FaxLink #42582

Report prepared by the Market Research Centre
Market Support Division (TCM)
Department of Foreign Affairs and International Trade
125 Sussex Drive, Ottawa K1A 0G2
Fax: (613) 943-1103
E-mail: mrc@dfait-maeci.gc.ca


The Market Research Centre produces a wide range of market reports by region and sector for Canadian exporters. These reports are available from:
- DFAIT's InfoExport Internet site (http://www.infoexport.gc.ca).

The Government of Canada has prepared this report based on primary and secondary sources of information. Readers should take note that the Government of Canada does not guarantee the accuracy of any of the information contained in this report, nor does it necessarily endorse the organizations listed herein. Readers should independently verify the accuracy and reliability of the information.




Quick Facts

Market Highlights 

  • The biotechnology industry in the United Kingdom is one of the largest in the world, with annual sales of over $9.7 billion. There are approximately 460 companies active in the market, including some of the world's largest multinational pharmaceutical companies.
  • The primary strengths of the industry are therapeutics and human health applications. There is an emphasis on genomics and gene therapy, stem cell research and drug discovery. 
  • In February 2002, the U.K. parliament voted to allow therapeutic cloning and end a ban on stem cell research using human embryos. As a result, additional funding to support research is expected from both government and private sources. The United Kingdom is now positioned to lead the world in stem cell research.

Opportunities

  • The most significant opportunities for Canadian biotechnology firms are in collaborative research partnerships, technology transfer agreements, and licensing ventures.
  • Companies with expertise in genomics and stem cell research will find opportunities in this market.

Key Players 

  • The U.K. biotechnology industry is dominated by multinational corporations, although there is a vibrant small and medium-sized enterprise sector.
  • The industry is also characterized by clusters. The clusters are located around academic centres of excellence and are the main focal points for biotechnology.

Export Checklist

  • As a member of the European Union, biotechnology drugs and human health products seeking access to the U.K. market must be approved by the European Medicines Evaluation Agency. The United Kingdom is also bound by EU regulations on the approval and release of genetically modified (GM) crops.

Market Summary

  • With annual sales of over $9.7 billion,1 the biotechnology industry in the United Kingdom is second in size only to the United States. Along with some of the world's largest pharmaceutical multinational corporations, there are approximately 460 biotechnology companies, including consultant and service companies, working in this sector. An estimated 270 are dedicated biotechnology firms and 48 are publicly traded. Small and medium-sized biotechnology companies drive the industry as key sources of innovation.
  • Biopharmaceuticals are the primary strength of the U.K. biotechnology industry, with an emphasis on genomics and gene therapy, combinatorial chemistry, regulation of cells, and development of transgenic animals. The entire market is characterized by partnerships, mergers and licensing agreements. In fact, very few biotechnology firms are completely integrated from initial research through development, testing, manufacturing and marketing. As much as 70% of all biotechnology companies in the United Kingdom focus on health care products.
  • The U.K. biotechnology industry is also characterized by clusters. Established to assist start-up companies and combine expertise to strengthen the industry, biotechnology clusters have become essential to industry growth. The clusters are located around academic centres of excellence, which contribute spin-off companies as well as valuable preliminary research and trained scientists to the business community. The main focal points for biotechnology are London, southeast England (around Oxford), East Anglia (including Cambridge) and Scotland.
  • The United Kingdom may well be one of the best places in the world for cuttingedge research and biotechnology development because of the strong regulatory system, investor confidence in the industry as well as government support for basic and applied research.
  • While government support for biotechnology is strong in the United Kingdom, particularly at the university level, the industry relies on venture capital and partnerships for growth and development. Despite an economic downturn in other industries and few initial public offerings, the biotechnology industry has still managed to attract the attention of both foreign and domestic investors. Venture capital for biotechnology remains strong in the United Kingdom and companies continue to form alliances to strengthen their individual positions with collaborative work. In the first half of 2001, more than $360 million in private equity was invested in U.K. biotechnology companies.
  • One reason for the continued success of biotechnology companies in the United Kingdom is the long pipeline of products under development. British companies have more products (130) at various clinical stages than any other country in Europe. The industry is maturing rapidly and more and more companies are expected to become profitable in the short to medium term.
  • As the science behind biotechnology develops, many traditional pharmaceutical companies are turning their attention to the potential of biopharmaceuticals, resulting in mergers, partnerships and increased convergence between the two industries. The British pharmaceutical industry is the fourth largest in the world, accounting for 12% of the world market. There are over 600 pharmaceutical manufacturers and research organizations in the United Kingdom, including British and U.S. multinationals, which dominate production.
  • Key sectors of excellence in the United Kingdom, and sectors that continue to receive substantial research funding, include stem cell research, genomics, infectious disease research, mental health, cancer and ageing.

Stem Cell Research

  • After two years of consultation the Human Fertilisation and Embryology Authority (HFEA)2 announced in November 2001 that couples at risk of having a baby with a serious genetic disorder should be allowed to use procedures to select healthy embryos. The guidelines have also been extended to allow parents to choose embryos that are a tissue match for an existing child to enable blood from the umbilical cord to be used in medical treatments. The procedure, known as pre-implantation genetics diagnosis (PGD) is generally approved of by the public, although there are some concerns about wider applications of this sort of genetic analysis.
  • In February 2002, Parliament voted to end a ban on stem cell research using human embryos and to allow therapeutic cloning. After a judicial decision in November 2001 exposed a legal loophole in human reproduction and cloning legislation, the government moved quickly to define its position and put solid regulations into place.
  •  A special committee convened by the House of Lords to study the ethical and moral issues decided that the potential of stem cells outweighs ethical concerns, particularly in light of restrictions and monitoring to be imposed under the new regulations. The House of Lords articulated that embryos left over from in-vitro fertilization treatments were the preferred source of embryonic stem cells and cloned embryos would only be permitted in unique and specific circumstances.3
  • The HFEA governs clinics offering in-vitro fertilization, donor insemination and egg, sperm or embryo storage. HFEA also licenses and monitors all human embryo research and will have authority over the new regulations governing human embryonic stem cell research.
  • As a result of the decisions and debate surrounding stem cells, additional funding to support research is expected from both government and private sources, including the Wellcome Trust. The United Kingdom is now positioned to lead the world in stem cell research and will likely see top researchers from countries with more restrictive rules relocating to pursue their work.
  • The Medical Research Council (MRC) has been charged with establishing a stem cell bank to facilitate research and ensure ethical standards are met when harvesting the cells. The Chief Executive of the MRC will also chair a Coordinating Committee for Stem Cell Research to co-ordinate research on a national level and look for joint funding and research opportunities.
  • The U.K.'s decision to allow stem cell research and therapeutic cloning may have a negative impact on funding from the EU's research support program. EU officials feel that the moral issues surrounding embryonic stem cell research should exclude companies from potential funding. As of May 2002, the European Union looked ready to approve research on those human embryos, up to 14 days old, that are considered to be surplus from in-vitro fertilization treatments.

Agricultural Biotechnology

  • The U.K. government has stated publicly that despite protests against genetically modified organisms (GMOs), the country can not afford to give up its position on the cutting edge of agricultural biotechnology research.
  • The challenge that GM food has faced in the United Kingdom and much of Europe is, in part, a problem of public perception and lack of scientific understanding. Added to these challenges is the series of food scares that have swept Europe in recent years including BSE or "mad cow" disease; the scandal over carcinogenic dioxins in Belgian poultry and dairy products; and the use in France of sewage slurry for animal feed. All this has made Europeans, and U.K. citizens in particular, very concerned about the source and safety of their food supply. Food scandals may also have made the people of the U.K. especially resentful of the power of large multinational corporations and their influence over what people eat.
  • The U.K. press has widely publicized objections from private citizens and special interest groups to agricultural biotechnology and GM crops. Although small in number, protesters have succeeded in causing extensive physical damage to field trials throughout the country. The have threatened to continue their protests if the government continues to encourage agricultural biotechnology research.
  • In January 2002, the Rural Affairs Secretary announced that three years of field trails on GM foods would not be enough to justify lifting the current moratorium on commercial planting. The decision calls for additional testing to ensure GM crops have no adverse effects on the environment or human health, and stresses the need for a full public debate on the issue before planting is allowed.
  • The government has also announced that any further field testing will require larger separation distances between GM crops and non-GM varieties.
  • For the 2002 growing season, there will be 57 sites planted with oilseed rape (canola) and sugar beet throughout the United Kingdom.
  • The Royal Society has also stepped into the discussion on GMOs and released an updated report in February 2002 calling for improved safety assessments and tighter regulations for approvals of all novel foods. The Royal Society is particularly concerned with allergy testing procedures and the nutritional content of infant formula.
  • Government and industry are also pursuing research into non-food uses for agricultural biotechnology crops including biomaterials and biofuels. If public resistance to GM food crops continues, these sectors may become increasingly important to the agricultural biotechnology industry.


Government Support for Biotechnology

  • The U.K. government is highly supportive of biotechnology as a growth industry, both in terms of competitiveness and innovation. Through a series of funding initiatives, councils, commissions and departments, the government encourages research and development, commercialization and innovation in all areas of biotechnology.
  • In May 1999, the government announced the creation of two strategic advisory commissions to take a broader, long-term view of the implications of biotechnology. The Human Genetics Commission advises the government on genetic technologies and the Agriculture and Environmental Biotechnology Commission advises the government on all other aspects of biotechnology, except food. The commissions examine ethical issues related to biotechnology, identify gaps in the regulatory framework, and advise the government on new technologies.
  • The Human Genetics Commission is expected to submit a package of laws in the spring of 2002 to protect personal genetic information. As genetic research rapidly advances, the legal structure to protect personal privacy and rights has fallen behind. The Commission is expected to ask the government to make it illegal to submit a person's DNA for testing without first obtaining their informed consent.
  • The Agriculture and Environmental Biotechnology Commission released their first report in September 2001. Crops on Trial reviews the issue of GM crops and considers scientific, ethical and social issues in its evaluation. The Commission recommended that the current trials be completed and form the beginning of an additional evaluation phase that encourages public input and a wider view of overall agricultural policy for the United Kingdom. The Commission will continue to monitor developments in agricultural biotechnology and report to the government on two additional areas: animals in biotechnology and environmental liability.
  • The Food Standards Agency (FSA) was established in 2000 to provide advice and information to the public and the government on food safety, nutrition and diet. The Agency is also responsible for enforcement and monitoring of food legislation. Relevant divisions for agricultural biotechnology and GM food include the Novel Foods Division of the Food Safety Policy Group and the Food Labeling and Standards and Consumer Protection Division within the Enforcement and Food Standards Group. The Novel Food Division is responsible for implementing the government's policies on GM foods, as well as novel foods, functional foods and irradiated foods. Research from this division also supports the FSA's role in safety assessments for all GM foods.
  • The Food Labelling and Standards and Consumer Protection Division is responsible for developing policy on food labelling and authenticity. The FSA supports labelling provisions for GM food products, as well as consumer education about the benefits and possible risks.
  • The FSA also works directly with a number of advisory committees including the Advisory Committee on Novel Foods and Processes (ACNFP). The ACNFP is an independent advisory group of scientists who carry out safety assessments on GM food products and advise the FSA and the government on all matters related to novel foods.
  • The Biotechnology Directorate within the Department of Trade and Industry (DTI) has the lead role for biotechnology promotion and development within the United Kingdom. The directorate focuses on four key areas: research and development policy and technology transfer; regulatory environments and intellectual property rights; financing and developing small companies; and competitiveness within key biotechnology subsectors.
  • Research investment by the DTI for all areas of the economy is focussed on the Office of Science and Technology and seven research councils-two of which have a particular emphasis on biotechnology.
  • The Biotechnology and Biological Sciences Resource Council (BBSRC) is one of two government-funded research councils with a primary emphasis on biotechnology. The Council supports basic, strategic and applied research at universities and research institutes located throughout the country in seven key areas:
    • agri-food;
    • animal sciences;
    • biochemistry and cell biology;
    • biomolecular sciences;
    • engineering and biological systems;
    • genes and developmental biology; and
    • plant and microbial sciences.
  • The BBSRC's mandate includes supporting research and development, training and international co-operation that will benefit society and economic competitiveness in the United Kingdom. The Council also has a role in public education, to disseminate knowledge and promote public understanding in biotechnology and biological sciences.
  • The BBSRC works collaboratively with the Department of Environment, Fisheries and Food as well as with other research councils, including the Natural Environment Research Council and the MRC.
  • The BBSRC also supports biotechnology research at eight institutes (see Table 1).
Table 1. Institutes Supported by the BBSRC
Institute 2000 Research Grants
Babraham Institute $1.4 million
Institute for Animal Health $6.0 million
Institute of Arable Crop Research $3.7 million
Institute of Food Research $1.6 million
Institute of Grassland and Environmental Research $1.1 million
John Innes Centre $5.2 million
Roslin Institute $2.5 million
Silsoe Research Institute $1.3 million

Source: BBSRC, 2002.

  • Over 5000 scientists and students receive funding from the BBSRC. Beyond providing academic funding and supporting the eight key research institutes, the BBSRC has established six Structural Biology Centres throughout the country to provide access to the latest equipment, research, expertise and training to the entire research community.
  • In February 2001, the BBSRC announced Exploiting Genomics, its largest single research initiative to date. The program will capitalize on $450 million invested in genomics over the past 10 years and will see an additional investment of almost $70 million over the next 3-5 years. Exploiting Genomics will ensure the United Kingdom remains at the forefront of genetic research and will explore ways to benefit from plant, animal and microbic genetic information. Research proposals are expected to bring together the latest technologies in genetics, informatics and engineering, and to also address pressing industrial and policy needs including improved food safety technology, new treatments for disease and overcoming bacterial resistance to antibiotics.
  • Finally, the BBSRC also provides funding and support to smaller research groups at various universities in the United Kingdom. More details on individual research institutes and other funding programs offered by the Council are available on line at http://www.bbsrc.ac.uk.
  • The Medical Research Council is the second research council in the United Kingdom with a primary emphasis on biotechnology research. The MRC's six research areas are:
    • people and population studies;
    • neurosciences and mental health;
    • immunology and infection;
    • genetics, molecular structure and dynamics;
    • cell biology, development and growth; and
    • medical physiology and disease processes.
  • The MRC provides funding through a series of grants to university researchers, and also supports research and development at a variety of research centres. There are over 40 institutions and research centres throughout the United Kingdom that receive MRC funding and support.
  • The MRC supports basic, applied and clinical research and trials through an application process and by seeking out promising research opportunities. The MRC also has a view toward ensuring research discoveries are developed effectively to benefit the economy and are translated into new health-care products. Like other research councils, the MRC promotes inter-disciplinary cooperation, fosters the development of research skills, and co-ordinates international co-operation. Complete program details are available at http://www.mrc.ac.uk.
  • In January 2002, the Secretary of State for Health announced a plan for six Genetic Knowledge Parks to further support the growth of genetic research and technology in the United Kingdom. The Genetic Knowledge Challenge Fund of almost $23 million and DTI funding of $11 million will be distributed among the programs in Oxford, Cambridge, London, Newcastle, the Northwest and Wales. The program announcement also included the establishment of two National Genetics Reference Laboratories, in Salisbury and Manchester.
  • The Genetic Knowledge Parks will support collaboration among clinicians, scientists, academics and industrial researchers. These parks will be centres of excellence and will look to improve diagnosis, treatment and counselling of patients with genetic diseases.
  • The National Genetics Reference Laboratories will specialize in assessing and developing new genetic tests for use by the National Health Services and will receive $1.1 million in annual funding.
  • In March 2002, the U.K. government announced a new research and development tax credit for larger companies to match a similar program already in place for smaller firms. The new tax credit is designed to encourage collaborative research with universities and allows companies to claim research and development as a write-off against their taxes. While the program for large companies does not offer a cash-back system in the same way as the program for small companies, the 20% credit will still benefit companies and encourage research collaboration.
  • The DTI encourages manufacturing and service companies to explore biotechnology applications for their business through the BIO-WISE Program. In April 2002, five new projects, including the use of micro-organisms to treat waste in the textile industry, and diagnostic kits to detect harmful bacteria in sewage sludge, were awarded a total of $2.3 million in government funding. The government funding will be matched by industry contributions to bring the total investment to almost $7 million. The BIO-WISE Program also runs workshops and conferences to raise awareness of industrial biotechnology applications.
  • The U.K. Biotechnology Finance Advisory Service (UKBFAS) is a governmentfunded consultancy service designed to help start-up biotechnology companies. Since 1997, the UKBFAS has helped establish 40 companies and responded to information requests from many others. The service helps companies by assessing business plans and identifying potential funding sources, including private-sector sources and government grants.
  • The University Challenge Fund (UCF) was established in 1998 in collaboration with government and private funding sources (including the Wellcome Trust and Gatsby Charitable Foundation) to help move viable ideas from university laboratories into spin-off or start-up companies. UCF funding is used to hire management personal, secure intellectual property protection, prepare business plans and fund legal costs.


Opportunities

  • The most significant opportunities for Canadian biotechnology firms are in collaborative research partnerships, technology transfer agreements, licensing ventures, production facilities, and services. The U.K. industry is seeking greater emphasis on the role of biomanufacturing for long-term industry development, and the market is also strong for preclinical research studies and other research services for clinical trials.
  • Given the current state of public opinion on issues of agricultural biotechnology and public opinion surveys indicating support for additional research in health care and pharmaceuticals, the most significant opportunities for Canadian firms in the United Kingdom are in drug discovery and development. Canadian companies should target British firms working in similar areas and initiate collaborative discussions. Attending trade shows is a good way to meet with companies directly and determine appropriate partners in this market.
  • One of the challenges facing this academically oriented industry is the lack of entrepreneurial expertise and management talent. Canadian firms with expertise in both biotechnology and management consulting will find a ready market in the United Kingdom.
  • British biopharmaceutical companies will have over 80 products ready for market by 2005. In the interim, the market is strong for preclinical research studies and other research services for clinical trials. Other areas of opportunity in the research and development sector include sequencing, the production of proteins and enzymes, and chemical synthesis.


Key Players

  • Biotechnology in the United Kingdom is characterized by strong multinational corporations and a vibrant SME sector reliant on mergers and partnerships. There are numerous world-renowned research institutions and academic training facilities throughout the country, as well as technology parks to cluster the industry and encourage collaboration. Key clusters are detailed below. Emerging clusters for biotechnology include Newcastle (One North East), Manchester (Bionow) and York (York BioScience).
  • Key multinationals active in the market include GlaxoSmithKline (U.K.), AstraZeneca (U.K.), Pfizer (U.S.), Novartis (Switzerland), Merck & Co. (U.S.), Aventis (France) and Bayer (Germany). London
  • London has emerged as a significant cluster of biotechnology activity. There are more than 60 biotechnology companies located in the area, attracted by London's teaching hospitals and science-based academic institutions. There are also large pharmaceutical and contract research industries in London that are increasingly integrated with the biotechnology sector.
  • Spending on biotechnology-related research in London is estimated at more than $675 million annually. London is also the financial centre of Europe with several venture capital companies located in the city to support biotechnology growth.
  • Shortage of manufacturing and office space and high costs may limit industry growth here, despite the efforts of various industry associations and economic development agencies. For additional information on the biotechnology cluster in London, consult the London Biotechnology Network at http://www.londonbiotechnology.co.uk.
Table 2. Key Players Active in London's Biotechnology Cluster
Ark Therapeutics http://www.arktherapeutics.com
Arrow Therapeutics http://www.arrowt.co.uk
Biogeny http://www.biogeny.co.uk
BioVex http://www.biovex.com
Genemedix http://www.genemedix.com
MedPharm Ltd. http://www.medpharm.co.uk
ReGen Therapeutics http://www.regentherapeutics.com/regen


Cambridge

  • Cambridge has a vibrant biotechnology community. The region is home to worldclass medical and genetic research with specialists in other areas including monoclonal antibodies and bio-informatics. There are approximately 175 biotechnology companies of all sizes located in the region as well as a strong network of service and support companies with biotechnology expertise. The region has 30 research institutions and universities. As many as 20 multinational corporations in the pharmaceutical and biotechnology industries are located here.
  • The recently established Babraham bio-incubator has added further support to the growth and development of spin-off and small biotechnology companies in the region. The Cambridge Science Park has the highest concentration of biotechnology and pharmaceutical companies in the United Kingdom.
  • In a recent announcement, the Wellcome Trust Sanger Institute announced a five-year plan to spend almost $700 million on human genetic research to follow up the Institute's role in the initial publication of the human genome. The plan will include studies on gene function, development of informatics tools and comparisons between the human genome and other organisms.
  • The biotechnology industry in Cambridge is focussed on human therapeutics, including pharmaceuticals and biopharmaceuticals, followed by biomedical  devices and instruments for biotechnology applications. The two subsectors complement one another and further add to the strength of the local biotechnology industry.
  • Companies in this cluster have built strong partnerships with research centres and universities and have also established international collaborations. As the industry matures in the region, more strategic partnerships are developing and international players have become more active in the market.
  • Because of the stellar growth in the region's biotechnology industry, Cambridge is facing some infrastructure challenges. There is increased pressure on space and highways in the region and some companies are beginning to expand beyond the original cluster into nearby areas.
  • Additional information on the biotechnology industry in Cambridge may be obtained from Eastern Region Biotechnology Initiative (ERBI) at http://www.erbi.co.uk.
Table 3. Key Players in the Cambridge Biotechnology Cluster
AdProTech Ltd. http://www.adprotech.co.uk
Acambis http://www.acambis.com
Alizyme http://www.alizyme.co.uk
Arakis http://www.arakis.com
Astex Technology http://www.astex-technology.com
Biowisdom http://www.biowisdom.com
Cambridge Antibody Technology http://www.cambridgeantibody.com
Celltech http://www.medeva.co.uk
De Novo Pharmaceuticals http://www.denovopharma.com
GlaxoSmithKline http://www.gsk.com
Incenta http://www.incenta.co.uk
Lorantis http://www.lorantis.co.uk
Ribotargets http://www.ribotargets.com
Syngenix http://www.syngenix.com
Visible Genetics Inc. http://www.visgen.com


Oxford

  • The Oxford biotechnology cluster is home to almost 100 biotechnology companies and more than 200 support companies. The region has worldrenowned research institutions including the University of Oxford and Oxford Brookes University, as well as a growing number of science parks and biotechnology incubators to encourage industry development.
  • The Wellcome Trust Centre for Human Genetics (WTCHG) is a focal point for the industry in this cluster. The Centre was established in 1994 and focuses on research into the genetic basis of common diseases.
  • To further add to the infrastructure available to biotechnology companies in the region, a $560-million diamond synchroton light source is being constructed at the CLRC Rutherfod Appleton Laboratory with an expected completion date of 2006.
  • Additional information on the Oxford biotechnology cluster may be obtained from Oxfordshire Bioscience Network at http://www.oxfordshirebioscience.net.
Table 4. Key Players in the Oxford Biotechnology Cluster
British Biotech http://www.britishbiotech.com
Evotec OAI http://www.evotecoai.com
Genzyme Therapeutics http://www.genzyme.com
Oxagen http://www.oxagen.com
Oxford Bio-Innovation Ltd. http://www.oxbio.co.uk
Oxford Glycosciences http://www.ogs.com
Powderject Pharmaceuticals http://www.powderject.com
Prolysis http://www.prolysis.com


Scotland

  • Scotland is one of the most concentrated biotechnology clusters in Europe with more than 400 organizations participating in the industry. As of September 2001, there were 86 biotechnology companies, 99 medical devices companies, 192 support and supply companies, and 51 academic and research institutes. The industry here is growing at approximately 40% per year and currently employs approximately 24 000 people. Bio Glen, which features world-class research institutions and biotechnology parks in Dundee, Edinburgh and Glasgow is the focus of the Scottish industry.
  • Commercialization is recognized as a key element to having a successful biotechnology industry. A series of initiatives from the U.K. government, the Scottish Executive and Scottish Enterprise support commercialization efforts through funding for proof of concept research, business development advisors, as well as business development and incubation programs.
  • Additional information on the cluster of biotechnology activity in Scotland may be found at http://www.biotech-scotland.org.
Table 5. Key Players in the Scottish Biotechnology Cluster
Aortech http://www.aortech.com
Ardana Bioscience http://www.ardana.co.uk
Axis-Shield http://www.axis-shield.com
Biovation (part of Merck Group) http://www.biovation.co.uk
Cyclacel http://www.cyclacel.com
Inveresk Research http://www.inveresk.com
Pantherix http://www.pantherix.com
PPL Therapeutics http://www.ppl-therapeutics.com
Strakan http://www.strakan.com
Viragen http://www.viragen.com



Export Checklist

Medical Biotechnology

  • The European Medicines Evaluation Agency (EMEA) is responsible for the administration of common rules relating to the approval, quality and safety of prescription drugs, including all biotechnology-derived products, in the European Union, as well as monitoring compliance with the guidelines. The EMEA's endorsement of a new drug is binding in all EU member states. The application and approval process takes between 300 and 500 days, and costs approximately $250 000.
  • Pharmaceuticals that cannot be registered through the EMEA-including established (non-innovative drugs) and products requiring re-registration due to changes in format or packaging-follow national procedures. The national body responsible for drug approvals and monitoring in the United Kingdom is the Medicines Control Agency (MCA), under the authority of the Department of Health.
  • The MCA is responsible for licensing all pharmaceutical products for the domestic market as well as licensing clinical trials and monitoring drug safety. The Inspection and Enforcement Division is responsible for ensuring compliance with good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP).

Agricultural Biotechnology

  • Prior to the 1998 moratorium on approvals of GM food products, the European Union had approved 18 GM products for sale and a further 14 were awaiting approval.
  • On January 21, 2002, the European Union established the European Food Safety Authority (EFSA) as well as a new regulatory framework for EU food law. The regulation sets out guiding principles for the traceability of all foodstuffs, animal feed and food ingredients, including all GMOs from the store shelf straight back to the farm or field. The regulation also places responsibility for food safety on companies that put items on the market and includes procedures for developing food law and dealing with food emergencies.
  • The European Commission has determined that once the moratorium on GM food approvals is lifted (perhaps by mid-to-late 2002), strict labelling requirements will be put into place to ensure consumers know which food contain modified products and which do not. The labelling regulations will include a 1% tolerance level.
  • All GM food products currently approved for sale in the United Kingdom must be labelled. However, highly processed foods, including vegetable oils, that no longer contain proteins (and therefore cannot be analyzed) do not need to be labelled. Unlike the proposed EU regulations, catering companies and restaurants in the United Kingdom must also indicate to their customers which products are made from GM ingredients, either in the menu, at the counter, or verbally by staff. The U.K. labelling regulations also include a 1% tolerance level.
  • The Department for Environment, Food and Rural Affairs' Chemical and Biotechnology Division is responsible for the control and deliberate release of GMOs into the environment and is also responsible for national, EU and international policy on the environmental safety of GMOs. If commercialization procedures are approved, the Advisory Committee on Releases to the Environment (ACRE), an independent scientific committee, will advise the government on any potential implications of wide release. Products involving food or animal feed will also be assessed by the Advisory Committee on Novel Foods and Processes and the Advisory Committee on Animal Feedingstuffs (ACAF). Consent will ultimately be issued by the Department for Environment, Food and Rural Affairs.



Key Contacts

Canadian Government Contacts

Canadian High Commission in the United Kingdom
Macdonald House
1 Grosvenor Square
London, UK W1K 4AB
Tel.: (44-20) 7258-6600
Fax: (44-20) 7258-6384
Contact: Caroline Martin, Science and Technology Officer
E-mail: caroline.martin@dfait-maeci.gc.ca
Janet Farmer, Business Development Officer
E-mail: janet.farmer@dfait-maeci.gc.ca
Internet: http://www.dfait-maeci.gc.ca/london

Agriculture and Agri-Food Canada
Market and Industry Services Branch
Sir John Carling Building
930 Carling Ave.
Ottawa, ON K1A 0C5
Tel.: (613) 759-7744
Fax: (613) 759-7499
Internet: http://www.agr.gc.ca

Canadian Food Inspection Agency
Office of Biotechnology
59 Camelot Dr.
Nepean, ON K1A 0Y9
Tel.: (613) 225-2342
Fax: (613) 228-6653
E-mail: cfiamaster@agr.gc.ca
Internet: http://www.inspection.gc.ca

Export Development Canada (EDC)
151 O'Connor St.
Ottawa, ON K1A 1K3
Tel.: 1-888-332-3320 or (613) 598-2500
Fax: (613) 237-2690
E-mail: export@edc-see.ca
Internet: http://www.edc-see.ca

Department of Foreign Affairs and International Trade (DFAIT)
125 Sussex Dr.
Ottawa, ON K1A 0G2
Internet: http://www.dfait-maeci.gc.ca

Market Research Centre (TCM)
Contact: Michelle Van Dyk, International Market Research Officer
Tel.: (613) 996-3535
Fax: (613) 943-1103
E-mail: michelle.van-dyk@dfait-maeci.gc.ca
Internet: http://www.infoexport.gc.ca

Market Support Division (TCM)
Tel.: (613) 996-1431
Fax: (613) 944-0050
Contact: Patricia Filteau, Trade Commissioner
E-mail: patricia.filteau@dfait-maeci.gc.ca
Internet: http://www.infoexport.gc.ca

Northern Europe Division (REN)
Contact: Graham Gleddie, Desk Officer
Tel.: (613) 995-9766
Fax: (613) 995-6319
E-mail: graham.gleddie@dfait-maeci.gc.ca

Health Canada
International Affairs Directorate
Brooke Claxton Building, Room 814A
Postal Locator 0908A
Tunney's Pasture
Ottawa, ON K1A 0K9
Tel.: (613) 941-3136
Fax: (613) 952-7417
Internet: http://www.hc-sc.gc.ca

Industry Canada
Life Sciences Branch
PO Box 940, Station M
1505 Barrington St.
Halifax, NS B3J 2V9
Contact: Mark Craig, Sector Officer
Tel.: (902) 426-9958
Fax: (902) 426-2624
E-mail: craig.mark@ic.gc.ca
Internet: http://strategis.ic.gc.ca

Canadian Industry Associations

Ag-West Biotech
101 - 111 Research Dr.
Saskatoon, SK S7N 3R2
Tel.: (306) 975-1939
Fax: (306) 975-1966
E-mail: agwest@agwest.sk.ca
Internet: http://www.agwest.sk.ca

Alberta Biotechnology Association
1150, 10180 - 101 St.
Edmonton, AB T5J 3S4
Contact: Myka Osinchuk, Executive Director
Tel.: (780) 425-3815
Fax: (780) 423-3893
E-mail: myka@bioalberta.com
Internet: http://www.bioalberta.com

BioAtlantech
PO Box 636, Station A
Fredericton, NB E3B 5A6
Tel.: (506) 444-2444
Fax: (506) 444-5662
Internet: http://www.bioatlantech.nb.ca

BioEast
2 nd Floor, Spencer Hall
220 Prince Philip Dr.
St. John's, NF A1B 3X5
Contact: Margaret Miller, Managing Director
Tel.: (709) 737-2682
Fax: (709) 737-4029
Internet: http://www.bioeast.ca

BIONova
c/o Innovacorp
101 Research Dr.
PO Box 790
Dartmouth, NS B2Y 3Z7
Contact: Bill Mills, Executive Director
Tel.: (902) 424-8670
Fax: (902) 424-4679
E-mail: bmills@innovacorp.ns.ca
Internet: http://www.bionova.ns.ca

Bio Quebec
6100 Mount Royal Ave.
Montreal, QC H4P 2R2
Tel.: (514) 733-8411
Fax: (514) 733-8272
E-mail: info@bioquebec.com
Internet: http://www.bioquebec.com

BIOTECanada
130 Albert St., Suite 420
Ottawa, ON K1P 5G2
Tel.: (613) 230-5585
Fax: (613) 563-8850
E-mail: info@biotech.ca
Internet: http://www.biotech.ca

British Columbia Biotechnology Alliance
3250 East Mall, Suite 225
Vancouver, BC V6T 1W5
Contact: Paul Stinson, Executive Director
Tel.: (604) 221-3020
Fax: (604) 221-3027
Internet: http://www.bcbiotech.ca

Canada's Research-Based Pharmaceutical Companies
302-1111 Prince of Wales Dr.
Ottawa, ON K2C 3T2
Tel.: (613) 727-1380
Fax: (613) 727-1407
Internet: http://www.canadapharma.org

Toronto Biotechnology Initiative
PO Box 446, Station A
Toronto, ON M5W 1C2
Tel.: (416) 392-4780
Fax: (416) 397-0906
Internet: http://www.torontobiotech.org

Ottawa Life Sciences Council
600 Peter Morand Dr., Suite 100
Ottawa, ON K1G 5Z3
Tel.: (613) 521-1008
Fax: (613) 521-3065
Internet: http://olsc.ca

British Government Contacts in Canada  

British High Commission
80 Elgin St.
Ottawa, ON K1P 5K7
Tel.: (613) 237-1542
Contact: Julia Hinde
Internet: http://www.britainincanada.org

British Consulate General in Montreal
1000 de la Gauchetiere W, Suite 4200
Montreal, QC H3B 4W5
Tel.: (514) 866-5863
Fax: (514) 866-0202
Contact: Stephanie Murphy

British Consulate General in Toronto
777 Bay St., Suite 2800
Toronto, ON M5G 2G2
Tel.: (416) 593-1290
Fax: (416) 593-1229
Contact: Carla Taverniti
Internet: http://www.uk-canada-trade.org

British Consulate General in Vancouver
1111 Melville St.
Vancouver, BC V6E 3V6
Tel.: (604) 683-4421
Fax: (604) 681-0693
Contact: Dianne Coleman

British Trade Office in Calgary
1500 Bow Valley Square IV
250-6th Ave. SW
Calgary, AB T2P 3H7
Tel.: (403) 705-1755
Fax: (403) 538-0121

British Government Contacts

Agriculture and Environmental Biotechnology Commission
Bay 479
1 Victoria Street
London, UK SW1H 0ET
Tel.: (44-20) 7215-6508
Fax: (44-20) 7215-0313
E-mail: aebc@dti.gsi.gov.uk
Internet: http://www.aebc.gov.uk

Department for Environment, Food and Rural Affairs
Nobel House, 17 Smith Square
London, UK SW1P 3JR
Tel.: (44-20) 7238-6000
Fax: (44-20) 7238-6591
Internet: http://www.defra.gov.uk

Department of Health
Richmond House, 79 Whitehall
London, UK SW1A 2NS
Tel.: (44-20) 7210-4850
Fax: (44-20) 7210-5433
Internet: http://www.doh.gov.uk

Department of Trade and Industry
1 Victoria Street
London, UK SW1H 0ET
Tel.: (44-20) 7215 5000
Internet: http://www.dti.gov.uk
Biotechnology Directorate
151 Buckingham Palace Road
London, UK SW1W 9SS
Tel.: (44-20) 7215-5000
Fax: (44-20) 7215-1379

Food Standards Agency
Aviation House, 125 Kingsway
London, UK WC2B 6NH
Tel.: (44-20) 7276-8000
Internet: http://www.foodstandards.gov.uk
Committee on Novel Foods and Processes (ACNFP)
Internet: http://www.foodstandards.gov.uk/science/
ouradvisors/novelfood/43153

Human Fertilisation and Embryology Authority (HFEA)
Paxton House, 30 Artillery Lane
London, UK E1 7LS
Tel.: (44-20) 7377-5077
Fax: (44-20) 7377-1871
E-Mail: admin@hfea.gov.uk
Internet: http://www.hfea.gov.uk

Human Genetics Commission
Department of Health
Area 652C, Skipton House
80 London Road
London, UK SE1 6LH
Tel.: (44-20) 7972-1518
Fax: (44-20) 7972-1717
E-mail: hgc@doh.gsi.gov.uk
Internet: http://www.hgc.gov.uk

British Industry Associations

Association of the British Pharmaceutical Industry (ABPI)
12 Whitehall
London, UK SW1A 2DY
Tel.: (44-20) 7930-3477
Fax: (44-20) 7747-1414
Internet: http://www.abpi.org.uk

BioIndustry Association (BIA)
14/15 Belgrave Square
London, UK SW1X 8PS
Tel.: (44-20) 7565-7190
Fax: (44-20) 7565-7191
Internet: http://www.bioindustry.org

BIA Scotland
Festival Business Centre
Unit 17, Brand Street
Glasgow, UK GS1 1DH
Tel.: (44-141) 427-9977
Fax: (44-141) 427-0744

British Medical Association
BMA House
Tavistock Square
London, UK WC1H 9JP
Tel.: (44-20) 7387-4499
Fax: (44-20) 7383-6400
Internet: http://www.bma.org.uk

British Generic Manufacturers Association
26 Grosvenor Gardens
London, UK SW1W 0GT
Tel.: (44-20) 7838-4800
Fax: (44-20) 7838-4801
E-mail: info@britishgenerics.co.uk
Internet: http://www.britishgenerics.co.uk

BiopartnerUK Internet site:
http://www.biopartneruk.com

British Universities and Research Institutions

Biotechnology and Biological Sciences Research Council (BBSRC)
Polaris House, North Star Avenue
Swindon, UK SN2 1UH
Tel.: (44-17) 9341-3200
Fax: (44-17) 9341-3201
Internet: http://www.bbsrc.ac.uk

BBSRC funds the following eight research centres:

The Babraham Institute
Babraham
Cambridge, UK CB2 4AT
Tel.: (44-12) 2349-6000
Fax: (44-12) 2349-6020
E-mail: babraham.contact@bbsrc.ac.uk
Internet: http://www.bi.bbsrc.ac.uk

Institute of Arable Crops Research
Rothamsted, Harpenden
Hertfordshire, UK AL5 2JQ
Tel.: (44-15) 8276-3133
Fax: (44-15) 8276-0981
Internet: http://www.iacr.bbsrc.ac.uk

Institute for Animal Health
Compton Laboratory
Compton, Newbury
Berks, UK RG20 7NN
Tel.: (44-16) 3557-8411
Fax: (44-16) 3557-7237
E-mail: animal.health@bbsrc.ac.uk
Internet: http://www.iah.bbsrc.ac.uk

Institute of Food Research
Norwich Research Park
Colney, Norwich UK NR4 7UA
Tel.: (44-160) 325-5000
Fax: (44-160) 350-7723
Internet: http://www.ifrn.bbsrc.ac.uk

Institute of Grassland and Environmental Research
Aberystwyth, UK SY23 3EB
Tel.: (44-19) 7082-3000
Fax: (44-19) 7082-8357
Internet: http://www.iger.bbsrc.ac.uk/igerweb

John Innes Centre Norwich Research Park
Colney Norwich, UK NR4 7UH
Tel.: (44-160) 345-0000
Fax: (44-160) 345-0045
Internet: http://www.jic.bbsrc.ac.uk

Silsoe Research Institute
Wrest Park, Silsoe
Bedford, UK MK45 4HS
Tel.: (44-15) 2586-0000
Fax: (44-15) 2586-0156
Internet: http://www.sri.bbsrc.ac.uk

Roslin Institute
Roslin BioCentre
Midlothian, UK EH25 9PS
Tel.: (44-13) 1527-4200
Fax: (44-13) 1440-0434
Internet: http://www.roslin.ac.uk

Medical Research Council (MRC)
20 Park Crescent
London, UK W1B 1AL
Tel.: (44-20) 7636-5422
Fax: (44-20) 7436-6179
Internet: http://www.mrc.ac.uk

MRC Human Genome Mapping Project Resource Centre
Hinxton Hall, Hinxton
Cambridge, UK CB10 1SB
Tel.: (44-12) 2349-4500
Fax: (44-12) 2349-4512
Internet: http://www.hgmp.mrc.ac.uk

MRC National Institute for Medical Research
The Ridgeway, Mill Hill
London, UK NW7 1AA
Tel.: (44-20) 8959-3666
Fax: (44-20) 8906-4477
Internet: http://www.nimr.mrc.ac.uk

European Union Contacts

EuropaBio
Avenue de l'Armée 6
1040 Brussels, Belgium
Tel.: (32-2) 735-0313
Fax: (32-2) 735-4960
E-mail: mail@europabio.org
Internet: http://www.europabio.org

European Agency for the Evaluation of Medicinal Products (EMEA)
7 West Ferry Circus
Canary Wharf
London, UK E14 4HB
Tel.: (44-20) 7418-8400
Fax: (44-20) 7418-8416
Internet: http://www.emea.eu.int

European Federation of Pharmaceutical Industries Association (EFPIA)
Rue du Trône 108
B-1050 Brussels, Belgium
Tel.: (32-2) 626-2555
Fax: (32-2) 626-2566
E-mail: info@efpia.org
Internet: http://www.efpia.org

European Generic Medicines Association
P.O. Box 193
B-1040 Brussels 4, Belgium
Tel.: (32-2) 736-8411
Fax: (32-2) 736-7438
Internet: http://www.egagenerics.com

European Union Office of Patents
Office Européen des Brevets
Erhardtstrasse 27
D-80331 Munich, Germany
Tel.: (49-89) 239 90
Fax: (49-89) 239 94465
Internet: http://www.european-patent-office.org


References

Print

Agra Europe. "New Body to Boost GM Debate in UK," February 2002.

Asia Intelligence Wire. "London Calling-Biotechnology Startups Boom in London and UK," April 2002.

Blades, Vicky. "UK Biotech Initiatives," BioVenture View, February 2002.

The Business. "Britain at Cutting-Edge of the Biotech Boom," April 2002.

Cookson, Clive. "Britain-Immortal Human Brain Cells go on Sale to Labs," Financial Times, April 2002.

Curtis, Polly. "Higher Education-Research-A Good Time for Life Sciences," The Guardian, February 2002.

Durman, Paul. "Biotechs-Taking a Walk on the Wild Side," The Sunday Times, March 2002.

EIU Viewswire. "UK Industry-Biotechnology on a High," November 2001.

Elliott, Valerie. "Beckett Tightens Rules on GM Crop Trials," The Times, January 2002.

Firn, David. "Biotech Industry Plays Down UK Cloning Rules," Financial Times, November 2001.

----. "PPL Therapeutics Licks Wounds over Pig Cloning Accusation," Financial Times, January 2002.

Food Chemical News. "UK Government Issues a Statement January 17 (Possible Delay of Biotech Crops)," January 2002.

----. "A New Group of UK Companies Found that more than Two-Thirds of British Consumers Believe they do not know enough about Biotech Foods," February 2002.

Gledhill, Dan. "New GM Crop Trials to Start in 50 Fields," The Independent, January 2002.

The Grocer. "Seed Giants Create Arena for GM Clarity," February 2002.

M2 Presswire. "Innovative Biotechnology Projects Secure Share of GBP1m DTI Funding Stream," April 2002.

McElderry, Kevin. "Britain Aims to Close Human Cloning Loophole," Agence France-Presse, November 2001.

McCoy, David. "Commission's First Report," Belfast News Letter, November 2001.

Marketletter. "UK Biotech's Prospects Bright, Despite Market Downturn, says E&Y," November 2001.

Nicholson, Stuart. "Stem Cell Work Puts EU Funding at Risk for Scots Biotech Firms," Business A.M., April 2002.

Pfeifer, Sylvia. "UK Leaps to Forefront of Cloning Research," The Business, March 2002.

Reuters News. "UK Increases Lead in European Biotechnology Race," November 2001.

Reynolds, Toby. "Britain to Continue GM Trails, Calls for Debate," Reuters News, January 2002.

Sunday Business. "Britain Provides Hospitable Climate for Cutting-Edge Biotechnology Research," April 2002.

Tobin, Edward and Ben Hirschler. "Biotech Paves Way for Drugmaker Consolidation," Reuters News, December 2001.

Ward, Sharon. "Biotech Industry Set to Double by 2003," Scotland on Sunday, November 2001.

United Kingdom. Department of Health. Press Release: "Britain Must be at the Leading Edge of Genetics," January 2002.

Yorkshire Insider. "Clusters-Biotechnology is Big Business," November 2001.


Electronic

Biotech Scotland. "Framework for Action, 2001-2002," November 2001. Downloaded on April 18, 2002 from http://www.biotech-scotland.org/doclibrary/Framework%20
For%20Action%202001-02L.pdf
.

Canada. Department of Foreign Affairs and International Trade. "The Biotechnology Market in the United Kingdom," 2000. Available on line at http://www.infoexport.gc.ca.

Nature Publishing Group. "Spotlight on Scotland," March 2001. Downloaded on April 25, 2002 from http://www.nature.com/naturejobs/spotlight/
scotland/index.html
.

----. "Cambridge: Driving Biotechnology in Europe," November 2001. Downloaded on April 25, 2002 from http://www.nature.com/naturejobs/spotlight/
cambridge/index.html

----. "Oxfordshire Bioscience-Pulling Together," April 2002. Downloaded on April 25, 2002 from http://www.nature.com/naturejobs/spotlight/
oxfordshire/index.html
.

United Kingdom. Agriculture and Environment Biotechnology Commission. "Crops on Trial," September 2001. Downloaded on April 29, 2002 from http://www.aebc.gov.uk/aebc/crops.pdf.

United Kingdom. Department of Trade and Industry. "BioGuide", 2001. Downloaded on April 18, 2002 from
http://164.36.253.20/bioguide
.


Useful Internet Sites

BioGuide: http://164.36.253.20/bioguide. A complete PDF guide to biotechnology support and regulations in the United Kingdom, available from the Department of Trade and Industry. Last updated February 2001.

British Chambers of Commerce: http://www.chamberonline.co.uk

Canadian Business Service Centres: http://www.cbsc.org. Western Canadian-based companies should see particularly the Agricultural Biotechnology and Biotechnology Loan Program established by Western Economic Diversification Canada.

Canada Europa (Canada and the European Union): http://www.canadaeuropa.gc.ca/menu-e.asp

ExportSource: http://exportsource.gc.ca

InfoExport: http://www.infoexport.gc.ca

Invest UK-Research and Development: http://www.ukresearchanddevelopment.com


1 All monetary amounts are expressed in Canadian dollars, unless otherwise indicated. The conversion rate to Canadian dollars is based on IDD Information Services, Tradeline, April 2002.

2 For contact information regarding key organizations mentioned in this report, see KeyContacts and Support Services.

3 Readers will not that this position on stem cell research differs from that taken by the United States, which places no legal restrictions of privately funded research but does prohibit federally funded researchers from working with embryonic stem cells. Canada has not yet finalized legislation on this issue, but is likely to adopt measures that fall between the positions taken by the U.S. and the U.K.


Date Modified: 2002 07 16 Important Notices