Biotechnology - United Kingdom.


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Biotechnology - United Kingdom.

  1. 1. Biotechnology - United Kingdom. Trends and opportunities The market The United Kingdom’s biotechnology industry is the largest in Europe, and has the attributes of a mature sector. Government support for the sector, R&D and venture capital funding are all available. The British Government has supported biotechnology since the 1990s with funding and collaboration programs. Programs include BioWise a mentoring program for biotechnology companies and a research collaboration program. Biotechnology clusters in the UK includes Cambridge, Oxford, London, Central Scotland, South East England and North West England. These clusters are supported and encouraged by regional development organisations and academic institutions. Opportunities The UK biotechnology industry offers foreign companies opportunities for forming alliances and export markets because: • The biotechnology market offers a critical mass and well established international networks. • The market is less competitive than the USA. • The market is open for international collaborations and offers easy access to its biotechnology industry through government supported biotechnology clusters. • Access to funding from public and private funds. • Investors remain optimistic about the fundamentals and longer-term prospects of the industry.
  2. 2. Because of the size and scope of the biotechnology industry, there are many large and small opportunities in many different sectors. However, some of the key opportunities are: human health, environmental remediation and agricultural biotechnology. Characteristics A snapshot of the UK biotech industry (2003): • Over 450 biotech companies (behind Germany) • 22,400 people employed – first in Europe • € 5,041 million Revenue – first in Europe • € 1,757 million R&D spend • € 247 million Venture Capital • second highest number of biotech start-ups (behind Germany) • 70 per cent of drugs in the European pipeline originate from the UK Tariffs, regulations and customs All European Union (EU) countries are covered by a harmonised trade system. Common Customs Tariff (CCT) is applicable to goods from non-EU countries. Goods travelling between EU member states are free of customs duty. Value Added Tax is payable at varying levels in each member state. Import licenses may be required and you may need an export certificate. Certain products will need to comply with pan-European legislation for medical devices, medicines, foods and ingredients. There are also local variations in legislation, packaging and labelling that need careful consideration before shipping samples or final products. Industry standards
  3. 3. Biotechnology cuts across many legislative areas, and there is no single pan-European law covering the sector. Laws and voluntary standards vary from country to country. Tariff The UK is part of the harmonised trade system of the European Union and gives preference to associate members of the Union, developing countries and European Free Trade Association (EFTA) members. Most duties are ad valorem (%), based on the GATT Valuation Code (approximately CIF value (Incoterms 2000)). Common External Tariff (CET) is applicable to other countries. Before shipping any goods to the UK, you should obtain a written customs duty ruling from the customs service in the destination country. These rulings are called Binding Tariff Information (BTI). Getting a BTI is free and will prevent any conflict over customs or excise duty. HM Customs & Excise (VAT) Alexander House 21 Victoria Avenue Southend-on-Sea SS99 1AA Tel: 44 (0) 1702 366 077 Fax: 44 (0) 1702 367 342 HM Customs & Excise (International Development) 7th Floor, New King’s Beam House 22 Upper Ground London, SE1 9PJ Tel: 44 (0 20) 7620 1313 Marketing your products and services Market entry The main methods of market entry for biotechnology companies looking at the United Kingdom are:
  4. 4. • Supply of products or raw materials • Collaboration with European company/institution • Investment into Europe • Running clinical trials in Europe Supplying a European company The traditional market entry strategy, and a good option to consider for companies with products that can be easily combined by European end-users. Pharmaceutical companies are likely to be a major end-user. You can develop relationships with these companies via: • Licensing • Sales • Contracting • R&D services Collaboration Working with European biotechnology/pharma companies and research institutions, often in the development phase. These relationships can take the form of: • Technology transfers • In-licensing and out-licensing • Co-development (platform development through to product pipeline) • Co-marketing Investment In order to gain access to venture capital funding or research collaborations it may be necessary to invest in Europe. This could take the form of setting up a branch of your company overseas, or acquiring a suitable European company. Clinical trials
  5. 5. It can be advantageous to run clinical trials in Europe, rather than in the USA. Some of the benefits are: • The Mutual Recognition Procedure means that trials conducted in one European Union (EU) country are approved in the other EU member states. • In many European countries trials are cheaper to run than in the USA. • Working with European scientists on a trial builds your credibility. • As the trial process can be quicker in Europe, you can start generating revenue faster. • Media coverage is easier to generate if you are in the market. • A collaboration partner can help the approvals process with the European authorities. The European Agency for the Evaluation of Medicinal Products can provide more information on clinical trials in Europe. Because of the need to protect intellectual capital, there is little e-commerce activity in the biotechnology sector. However, there are some networking and partner search sites, such as: • East of England Biotechnology Network (ERBI) • London Biotechnology Network • BioNow • Oxfordshire Bioscience Network • Scottish Enterprise- Life Science • BioScience Yorkshire Links and industry contacts Biotechnology–related resources
  6. 6. Agriculture and Environment Biotechnology Commission – Bioguide, UK biotech regulations – BioIndustry Association – Biotech Scotland – Biotechnology & Biological Sciences Research Council – Biotechnology Exploitation Platform e-community – Biotechnology Mentoring & Incubator Initiative – Bio UK – BioWise – East of England Biotechnology Network – European Agency for the evaluation of Medicinal Products - European Federation of Biotechnology - Food for our Future (UK GMO debate) – Link collaborative research program - London Biotechnology Network – UK Centre for Biotechnology Education – UK Government biotechnology support – Europe (general) The European Agency for the evaluation of Medicinal Products - European Federation of Biotechnology - (Last updated : February 2006)