HC Deb 11 July 2002 vol 388 cc1219-20W
Mr. Heald

To ask the Secretary of State for Health (1) if he will make a statement on the progress to the changes proposed to the definition of a medicinal product and the Government's position on these changes; [66854]

(2) if he will make a statement on progress that has been made to secure Her Majesty's Government's policy for no change to the scope of the centralised procedure with regards to the EU proposed amendments to the authorisation of human and veterinary medicines; [66850]

(3) if he will make a statement on the proposals to extend the use of the centralised system for the authorisation of human medicines; [66853]

(4) what assessment he has made of the impact the reduction in the amount of mutual recognition work concerning medicinal products will have on the relevant UK regulatory bodies. [66857]

Mr. Lammy

[holding answers 4 July 2002]: The European Commission published proposals for wide-ranging amendments to the regulatory regime for human and veterinary medicines in December 2001. Among the proposed changes were the mandatory use of the centralised system for the authorisation of human medicines containing a New Active Substance (NAS) and a new definition of a medicinal product.

The UK, together with a number of other member states, has strongly opposed the mandatory use of the Centralised Procedure in negotiations. We do not see any scientific justification for this proposal, as it is the regulatory bodies in the member states who possess the expertise to carry out the scientific work. Nor do we believe that the proposal will improve the competitiveness of the pharmaceutical industry, as it reduces business flexibility.

The UK has promoted this view in the Council of Ministers and in the European Parliament and we have the support of a number of other member states. Final decisions have not been taken in either institution and the UK will continue to argue its case strongly in the meantime.

The Government agrees that there is a need to ensure that definition of a medicine is drafted in such a way that will allow new therapies to be appropriately regulated. However, the UK view is that the extension of the scope of the medicines legislation, particularly when linked to the new definition, is unwarranted and unacceptable, as it would capture many products already covered by other sectoral legislation. The Government sees no justification for this proposal and will continue to resist it. This position is shared by most other member states.