European legislation governs most areas of medicines regulation. This page sets out in brief the process by which EU legislation is proposed, negotiated, agreed and implemented in the UK.
Institutions involved in agreeing EU legislation
There are three institutions involved in the process of agreeing EU legislation:
- the European Commission which has the sole right to propose new legislation in the areas in which it has been given powers (or ‘competence’)
- the Council comprises ministers from each of the 27 Member States - depending on the subject area for discussion, ministers (or officials) responsible for that subject (eg health, finance, social affairs, transport, agriculture) will attend meetings of the Council
- the European Parliament which comprises 736 elected members from the 27 Member States; members of the European Parliament (MEPs) are elected for five years.
Directives and Regulations
Most EU legislation takes the form of either a Directive or a Regulation.
A Directive is a legislative act of the European Union which requires Member States to achieve a particular result without dictating the means of achieving that result. Directives need to be transposed into national law, and Member States are usually given some time (often 18 months) to implement them.
A Regulation is directly applicable in each Member State and does not need to be transposed into national law. The ‘coming into force’ date of Regulations can, however, be postponed if deemed necessary by the Commission.
Decision making
Most EU legislation is agreed under the ‘co-decision’ procedure, which involves both the Council and European Parliament finding an agreement with the Commission on the provisions in the legal instrument to be adopted.
The work to find agreement among Member States to the Commission’s legislative proposals is undertaken in Council Working Groups, where officials representing each Member State and the Commission meet to negotiate the proposed legal texts.
The process of negotiation and achieving agreement between the three institutions can take a considerable time (usually longer than 12 months). The MHRA negotiates all relevant EU medicines legislation on behalf of the Department of Health.
Council decisions are taken mostly by qualified majority vote. This weights votes per Member State according to size. The UK is one of four Member States with the greatest number of votes.
Presidency of the Council
The Council (and working groups negotiating texts) is chaired by the Member State that is at that time holding the Presidency of the Council, which changes every six months. Presidencies work together in threes to encourage a more consistent approach to business.
| Year | Term | Member State |
|---|---|---|
| 2010 | January to June |  Spain |
| July to December |  Belgium |
|
| 2011 | January to June |  Hungary |
| July to December |  Poland |
|
| 2012 | January to June |  Denmark |
| July to December |  Cyprus |
|
| 2013 | January to June |  Ireland |
| July to December |  Lithuania |
|
| 2014 | January to June |  Greece |
The MHRA, on behalf of the UK, takes a proactive approach to working in Europe, and, where we can, we seek to promote our views with informal and early discussions with the Commission on forthcoming legislative issues and in making appropriate links with members of European parliament (MEPs).
Further information
For further information on the activities of the Council (including the distribution of votes and rotation of Presidency please see the Council of the European Union website (external link).
Information on the European Parliament can be found on the European Parliament website (external link).
Further information on the European Commission can be found on the European Commission website (external link).
