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  • Print publication year: 2008
  • Online publication date: January 2010

27 - The regulatory environment in Europe

from Section 3 - Surveillance, risk and regulation



When we look at the chequered history of the blood industry, a thrilling account of which is given by Douglas Starr (Starr, 1999) it is not surprising that legislation covering blood, blood components and industrially prepared plasma derivatives is increasing throughout the world.

The regulatory environments are complex and vary in different countries, as they depend on political structures, institutions and legal systems; all such environments change with time. The legislation in force is thus both time and place dependent.

This chapter will give a general overview of the regulatory environment in Europe in 2004, dealing with the legislation in the 25 member states of the European Union (European Union Member States in 2004: Germany, United Kingdom, France, Italy, Spain, Netherlands, Greece, Belgium, Portugal, Sweden, Austria, Denmark, Finland, Ireland, Luxembourg, Poland, Czech Republic, Hungary, Slovakia, Lithuania, Latvia, Slovenia, Estonia, Cyprus, Malta (total population: approx 470 million)). Whilst this legislation applies only in EU member states, the key issues are those generally addressed by legislation in one form or another throughout the world.

European Union legislation forms part of the ‘acquis communautaire’ of the EU and as countries join the EU (current candidate countries are Bulgaria, Romania, Croatia and Turkey) they will need to adopt the acquis and all it involves.

A clear distinction has to be made between two very distinct approaches to achieving blood safety: guidelines and law. Guidelines, recommendations and best practice are generally written in a language which allows interpretation; they are not legally binding.

Council of Europe (1999) The Conscience of Europe ISBN 92-871-4030-8. Council of Europe Publishing Strasbourg.
Council of Europe (2003) Guide to the Preparation, Use and Quality Assurance of Blood Components. 10th edn. ISBN 92-871-5393-0. Council of Europe publishing, F-67075 Strasbourg, Council of Europe Publishing.
Council of Europe (2004) Guide to the Safety and Quality Assurance for Organs, Tissues and Cells. 2nd edn. ISBN 92-871-4891-0. Council of Europe publishing, F-67075 Strasbourg, Council of Europe Publishing.
Commission Directive 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components becomes legally binding at the same time as Directive 2002/98/EC, European Parliament.
Commission Directive 2005/62/EC OJ L256/41, European Parliament.
Commission Directive 2006/17/EC OJ L38/40, European Parliament.
Directive 85/374/ EEC On the approximation of laws, regulations and administrative provision of the member states concerning liability for defective products. OJ L210 7 August 85, European Parliament.
Directive 95/46/EC Protection and processing of personal data and the free movement of such data. OJ L 281 23 November 1995, European Parliament.
Directive 98/79/EC In vitro diagnostic Medical Devices. OJ L331/1 7 December 98, European Parliament.
Directive 2000/70/EC Amending Directive 93/42/EEC on Medical Devices. OJ L313/12 13 December 2000, European Parliament.
Directive 2001/83/EC On the Community code relating to medicinal products for human use. OJ L 311/67 28 November 2001, European Parliament.
Directive 2002/98/EC Setting standards of quality and safety for the collection, testing, processing and storage and distribution of human blood and blood components. OJ L33/30 14 October 2003, European Parliament.
Directive 2003/94/EC Laying down the principle and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. OJ L 262/22 14 October 2003, European Parliament.
Directive 2004/23/EC On setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. OJ L102/48 7 April 2004, European Parliament.
European Pharmacopoeia (2002) 4th edn ISBN 92-871-4587-3.
United Kingdom Regulations
Blood Safety and Quality Regulations 2005 Statutory Instrument 2005 no. 50.
Medical Devices Regulations 2002 Statutory Instrument 2002 no. 618
Medicines Control Agency – Rules and Guidance for Pharmaceutical Manufactures and Distributors (Orange Guide).
Good Manufacturing Practice for Medicinal Products (1998) ISBN 92-828-2092-X Office of official publications of the EEC
Mascaretti, L. J. V., Barbara, J.Cardenas, J. M., et al. (2004) Comparative analysis of national regulations concerning blood safety across Europe. Transfusion Medicine, 14, 105–111.
Rossi, U. and Aprili, G. (2002) Present and Future Problems of Transfusion Medicine in South-east Europe. Editors SIMTI edn ISBN 88-87075-21-2.
Starr, D. (1999) Blood: an Epic History of Blood and Commerce. Little Brown and Company, Harper Perennial.