§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)Following a public consultation earlier this year on proposals to restructure the advisory committees laid down in the Medicines Act 1968, I am pleased to inform the House of the new structure that the Government have decided to put in place. I am also informing the House of proposals to revise the code of practice on interests that will be applied to them.
In summary, the new advisory committee structure will comprise:
- a new commission that amalgamates the responsibilities of the present Medicines Commission and the Committee on Safety of Medicines and will advise Ministers direct on regulatory matters associated with medicines for human use;
- a number of Section 4 committees which will be able to advise Ministers direct on issues for which they are responsible;
- sub-committees and expert advisory groups (EAGs);
- a list of experts on whom the commission and the other committees and groups can call for advice;
- lay/patient representatives on each of the committees, sub-committees and groups.
The new structure will closely align the advisory bodies established under the Medicines Act with the structures being established in the European medicines regulatory system. This will allow the department's Medicines and Healthcare products Regulatory Agency (MHRA) to continue to play a highly effective role in that system. There will be greater public and patient involvement in the regulatory process which will strengthen the agency's ability to take account of the public interest. As patients become increasingly knowledgeable about healthcare we want to ensure that there is a means to enable them to advise on the safety and efficacy of their medicines.
Today a public consultation is being launched on proposals to revise the code of practice on interests that applies to chairmen and members of the advisory bodies established under the 1968 Medicines Act. This is part of a wider programme of restructuring the advisory bodies that advise Ministers on matters relating to the Act, the exercise of powers under it and otherwise relating to human and veterinary medicines.
These proposals will also provide the means to comply with new EU legislation dealing with the financial and other interests of experts concerned with the authorisation and surveillance of medicinal products. Indeed our proposals go further than the requirements set out in the EU legislation.
The proposals cover the financial and non-financial interests of the chairmen and members of the new commission, the Section 4 committees established under the Medicines Act (except the British Pharmacopoeia 25WS Commission), the sub-committees and expert advisory committee and any experts co-opted on to the committees. We are also proposing that chairmen and members must declare interests of immediate family of which they are aware, and any other matter that may affect, or may reasonably be perceived as affecting, their impartiality.
A wide range of bodies, representing patients, industry and healthcare professionals is being consulted. I am placing a copy of the consultation document—MLX316—in the Library, together with today's press release announcing these new measures. The consultation document can also be obtained from the MHRA website.
The Government are committed to ensuring that the MHRA operates in a transparent and open way. Because medicines form such an essential component of effective healthcare delivery, we are also committed to ensuring that patients and the public have an effective role to play in the regulatory process.