Our negotiations in Europe

Much of the legislation that the MHRA and the UK pharmaceutical and devices industry operate to is negotiated at EU level. This page outlines the decision making process by which EU legislation is negotiated and agreed.

The European Commission is the institution that makes proposals to the Council and European Parliament to introduce new or amend current EU legislation.  The Council is the main decision-making body of the EU.  Ministers from each Member State meet within the Council to make key decisions although it is the Member State officials that participate in most of the discussions (with mandates from their Ministers) within Council Working Groups.  Depending on the subject area, each Member State will be represented by the Minister or official responsible for that subject (health, finance, social affairs, transport, agriculture, etc.). 

The Presidency of the Council is held for six months by each Member State on a rotational basis. France holds the Presidency from 1 July 2008 – 31 December 2008, followed by the Czech Republic until the end of June 2009. Within the Council, Member States have different numbers of votes, set by the EU Treaties. The Treaties also define cases in which a simple majority, qualified majority or unanimity are required. The numbers of votes are roughly equivalent to the population of each Member State. The UK is one of four Member States with the greatest number of votes (29 from 321). The Council agrees EU laws, usually legislating jointly with the European Parliament through the Co-decision procedure.

In the UK, we work closely with the European Commission in the development of proposals to introduce or amend legislation.  We also take the opportunity to work closely with the European Parliament and other Member States during the co-decision procedure to influence the outcome of negotiations.

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)

 

 


Page last modified: 06 October 2008