European regulations

The overall philosophy behind granting a marketing authorization for a new drug is broadly similar in the USA and Europe. There are, however, major differences in the systems by which these philosophies are implemented in the two regions.

The European Union (EU) is currently composed of 15 member states and a total population of 371 million (compared with 249 million in the USA and 124 million in Japan — the other two world pharmaceutical markets). The total European pharmaceutical market value stands at €70 billion, representing almost 33% of world sales (the US and Japanese figures are 31% and 21%, respectively). Annual expenditure on European pharmaceutical R&D stands at about €17 billion.

Prominent within the EU organizational structure is the European Commission. The Commission is composed of 20 commissioners (with at least one being from each member state) and several thousand civil servants. The major function of the European Commission is to propose new EU legislation and to ensure enforcement of existing legislation (European drug law, therefore, comes under the auspices of the Commission).

Two forms of legal instrument can be issued from the centralized European authorities: a ‘regulation’ and a ‘directive’. A regulation is a strong legal instruction which, once passed, must be implemented immediately, and without modification, by national governments. A directive is a looser legal term, and provides an individual member state with 18 months to translate the flavour of that law into national law. Pharmaceutical law within the EU has been shaped by both directives and regulations, as discussed later.

In all European countries, there exist national regulatory authorities. These authorities are appointed by the government of the country in question and are usually located in the national Ministry of Health. They serve to apply national and European law with regard to the drug development process. In many countries, different arms of the regulatory authorities are responsible for authorizing and assessing clinical trials, assessing the resultant drug dossier and deciding on that basis whether or not to grant a (national) marketing authorization/product licence. They are also often responsible for issuing manufacturing licences to companies.

In 1993, a significant advance was made in simplifying the procedures relating to drug marketing authorization applications in the EU. At that time, the legal basis of a new drug approval system was formed by an EU regulation and three directives. Central to this was the establishment of the European Medicines Evaluation Agency (EMEA), which is based in London and began work in January 1995.

Answer the questions.

1. Which of the world pharmaceutical markets do you know?

2. What function does the European Commission have?

3. How many forms of legal instrument can European authority use? And what?

4. What is national regulatory authorities necessary for?

5. Where is EMEA situated?