Government presses on with MCA merger
pharmafile | October 22, 2003 | News story | |
The UK Government is to press ahead with the merger of the Medicines Control Agency and its medical devices counterpart despite uncertainty surrounding the future of drug regulation in Europe.
The Medicines and Healthcare products Regulatory Agency (MHRA) is now scheduled to be created in April 2003 even though new European laws could sideline the agency in favour of an expanded EMEA by the following year.
MEPs voted last month to accept plans to relegate national agencies to approving non-innovative me-too drugs and generics and make centralised European approval through the EMEA mandatory for all other products.
UK stakeholders are nevertheless now being consulted on how the new UK agency should be funded, with the Government suggesting that industry fees should finance much of the MHRA work.
This is already the case with the MCA but not the MDA and the Government has been keen to stress that pharmaceutical industry fees will not subsidise work on medical devices.
The Department of Health said: "Ministers in the Department of Health have made a commitment that the accounts of the MHRA will be transparent, and that income will relate directly to expenditure on particular activities".
The DoH insisted that the new trading fund for new activities would not inevitably mean new fees would be introduced for the industry, promising a separate consultation on any such proposals.
The merger gained the blessing of the ABPI when it was announced in June, and says it is also in support of a trading fund for the new agency. Director-General Dr Trevor Jones warned, however: "It is of course very important that the new, merged authority is able to retain Britain's established reputation as a fast and efficient assessor of new products. The standards set by the MCA have been very high, and the industry would not want these prejudiced in any way".
An ABPI spokesman added that it would not be using the merger as an opportunity to press for new reforms of the UK drug approval process, but re-emphasised its concerns about the need for transparency in the MHRA's finances.
