ABPI news: November 2005

This column has in the past looked at the development of the European Union's REACH system for the future registration, evaluation and authorisation of existing chemicals.

The drafting of this legislation, which will appear in the form of an EU Regulation, has reached a crucial phase during the autumn of this year as attempts are made to come to an agreement on the system by the end of the UK Presidency; there is an apparent growing momentum to reach a political agreement in the Council of Ministers during November.

The proposed legislation has also now been through the various Committees of the European Parliament and it has become obvious that there is some diversity of opinion between the Environment Committee and the industry and internal market Committees - particularly around application of the provisions to low-tonnage products.

However, there appears to be some consensus growing between these groups and the proposal was due to be put to the vote in a plenary session of Parliament in mid-November.

At the time of writing, the extent to which substances controlled by other regulatory provisions (including pharmaceuticals) would be included within the scope of the Regulation was unclear and had been the subject of several amendments proposed by members of the European Parliament.

Whatever the outcome in relation to this latter point, there will be continued interest in how the provisions of the Regulation might affect the pharmaceutical supply chain.

I will return to this issue when the final form of the legislation becomes known.