1.1 The key institutions involved in developing guidelines and regulations relevant to the UK
A brief description of some international organizations and their interrelationships is required for an understanding of the regulatory environment in the UK in 2005.
World Health Organization
Established in 1948 as the United Nations' specialized agency for health, the World Health Organization (WHO) is governed by 192 member states through the World Health Assembly. Its aim is the attainment of the highest possible levels of health by all people and clearly the availability of safe blood contributes to this aim.
The WHO produces recommendations, programmes and educational materials. The Global Collaboration in Blood Safety programme started in 1995. It was recognized
that with the increased movement of populations and plasma and plasma-derived medicinal products blood safety could only be improved through global collaboration. Consensus proposals and recommendations are addressed to the participant
WHO guidelines and recommendations are not legally binding in any of the 192 countries; however EU legislation in this field states that the advice emanating from the WHO has to be taken into account by the member states when formulating their own legislation.
Council of Europe and the European Union
The Council of Europe (CoE) and the EU are two totally distinct organizations. They are easily and often confused as much of the same terminology is used. In 2004 the CoE has 45 member states with approximately 770 million inhabitants and the EU 25, with a population of 470 million. All member states of the EU are member states of the CoE.
The Council of Europe Recommendations are not legally binding in the EU although they have to be taken into account by the EU member states. European Union Directives, however, are legally binding in the member states and have to be transposed into the laws of the member states, either existing laws or new ones, within clearly defined time frames.
Council of Europe
Founded in 1949, one of its founding principles was the promotion of increased cooperation between member states to improve the quality of life for the population of Europe. In the field of health the CoE has consistently addressed ethical issues; the most important of these is the non-commercialization of human substances: blood, tissues and organs. In the 1950s member states started to cooperate in blood transfusion activities. Through its committees and working parties composed of national experts the CoE has produced recommendations to ensure the quality of blood components and tissues and publishes guidelines as annexes to the Recommendations. These annexes are updated regularly to take account of advances in worldwide knowledge and technology.(5, 6)
Neither the recommendations nor the guidelines are legally binding but they are generally regarded as constituting basic best practice and many form the basis of EU Directives.
The EU was first proposed by the French Foreign Minister Robert Schuman in 1950, following the devastation of the Second World War. It was conceived to prevent further such wars. Initially it consisted of six countries and the European Coal and Steel Community (ECSC) was created in 1951: coal and steel had played a major role in the Second World War and cooperation over these assets was seen as a means of preventing further such cataclysms. The European Atomic Energy Community (EAEC or Euratom) came into force in 1958, as did The European Economic Community (EEC) created by the Treaty of Rome in 1957. The Treaty of Maastricht 1992 (the Treaty on the European Union) amended the three existing treaties giving the three Communities (ECSC, EAEC and EEC) increased powers. The EEC was renamed European Community (EC). A 'competence' in EU terminology is a subject over which it has legislative powers. These competences are agreed by the treaties and outlined in the acquis communautaire. Competence in the field of blood and blood components was conferred on the EU by the Treaty of Amsterdam 1999 Article 152. It is important to note that this Article stipulates that 'member states cannot be prevented from maintaining or introducing more stringent protective measures as regards standards of quality and safety of blood and blood components'.
In 2005 the EU does not have competence over member states' healthcare services nor clinical practice. This means that the laws governing blood, blood components and tissues extend only to cover the safety of the products and not their clinical use.
The five key EU institutions are:
Parliament: elected by the peoples of the member states
Council of the European Union: representing the governments of the member states
European Commission: the driving force and executive body
European Court of Justice: ensuring compliance with EU law
European Court of Auditors: controlling sound and lawful management of the European budget.
Amendments to the institutions and their roles to take account of increasing membership of the EU are suggested in the proposed EU constitution in 2004.
The European Commission is the only body that can initiate legislation; the processes whereby legislation is proposed and finally adopted are complex.
Issues regarding health come under a Co-decision Procedure, which means that both the European Parliament and Council (European Council not Council of Europe) have to agree the Commission proposals.
There is open consultation on any proposed legislation. The texts of the Directives and stages in the consultation process can be found on www.europarl.eu.int
Directives come into force on the day they are published in the Official Journal of the European Union (OJ) but defined time for transposition and implementation is allowed.
This CoE initiative was ratified by the EU and 30 participating member states. The Pharmacopoeias are collections of standardised specifications that define the quality of pharmaceutical preparations, their constituents and even their containers. The European Pharmacopoeia (Ph Eur) monographs are binding on the EU and the participating member states.
The success of the biological standardization programme for medicines for human use of the European Pharmacopoeia Secretariat led to further collaboration between the Commission of the EU and the CoE. The European Pharmacopoeia Secretariat changed its name to the European Directorate for the Quality of Medicines (EDQM): it is part of the administrative structure of the CoE.
The EDQM is organised in four divisions including the network of laboratories involved in the quality control of medicines for human and veterinary use (Official Medicines Control Laboratories (OMCL) network).
The European Medicines Agency (EMEA) www.emea.eu.int is a decentralized body of the EU based in London. Its main responsibility is the protection and promotion of public health through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the EU.
The Committee for Medicinal Products for Human Use is involved in evaluating industrially prepared plasma derivatives.
The CoE and EU work together in this field. Industrially prepared, fractionated plasma products are medicinal products and the Ph Eur monographs are mandatory.
Blood components are not 'medicinal products' and are now regulated by the EU 'Blood Directives'.
The United Kingdom is one member state in the EU, although since 1997 there has been devolved government in Wales and Scotland and sporadically in Northern Ireland. EU legislation must be transposed into member states' own legislation within a defined time frame.
An account of European decision-making and transposition is given in the Transposition Guide: How to Implement European Directives Effectively. This is available on www.cabinetoffice.gov.uk/regulation/publications.
The EU Directives regarding blood and blood components are transposed into The Blood Safety and Quality Regulations 2005(3) under Section 2(2) of the European Community Act (Maastricht 1992) and are binding across the UK.