Medicines Control Agency (Hansard, 8 March 1991)

§ Mr. Kennedy
To ask the Secretary of State for Health if he will reintroduce a turnover-related element into the Medicines Control Agency fee system.

§ Mrs. Virginia Bottomley
In the course of its full review of the fee structure, the Medicines Control Agency (MCA) has been considering a number of options. The MCA will be publishing its proposals shortly.

§ Mr. Kennedy
To ask the Secretary of State for Health whether he has any plans to meet the chairman of the Association of Pharmaceutical Importers to discuss the accountability of the Medicines Control Agency.

§ Mrs. Virginia Bottomley
No, but I understand that the chairman of the Association of Pharmaceutical Importers has had informal discussions with Medicines Control Agency officials and a further meeting is planned.

§ Mr. Kennedy
To ask the Secretary of State for Health what representations he has received about the upper limit on turnover for companies to be eligible for the payment concessions from the Medicines Control Agency.

§ Mrs. Virginia Bottomley
We have received a number of representations that the limit on turnover, which allow companies to qualify for concessions in time for payment, should be raised. We are considering these in the full review of the Medicines Control Agency's fee structure.

§ Mr. Kennedy
To ask the Secretary of State for Health what representations he has received calling for the Medicines Control Agency fee structure to be amended; if he has any proposals to amend the fee structure; and if he will make a statement.

§ Mrs. Virginia Bottomley
A number of representations have been received suggesting that the Medicines Control Agency's fee structure should be amended. The Medicines Control Agency has been carrying out a full review of its fee structure. New proposals should be published shortly.

§ Mr. Kennedy
To ask the Secretary of State for Health what mechanisms there are for hon. Members to raise the question of particular outstanding applications to the Medicines Control Agency.

§ Mrs. Virginia Bottomley
It is open to hon. Members to write to Ministers at any time to inquire on behalf of an applicant about progress of a particular application. Information about a licence application is, however, commercial in confidence and cannot be divulged without the permission of the applicant.

§ Mr. Kennedy
To ask the Secretary of State for Health what steps are being taken to ensure that the Medicines Control Agency processes product licence (parallel imports) licence applications quickly and effectively.
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§ Mrs. Virginia Bottomley
From April 1990 the number of staff employed on product licence (parallel import) applications has been increased and procedures have been streamlined follwing the re-organisation of the Medicines Control Agency into separate businesses. The director of the Medicines Control Agency has recently announced in a speech to the British Institute of Regulatory Affairs the objective of eliminating all licence backlogs by April 1992.

§ Mr. Kennedy
To ask the Secretary of State for Health if he will make it his policy for the Medicines Control Agency to give an explanation if a product licence application is outstanding for more than six months.

§ Mrs. Virginia Bottomley
No. It is open to applicants to inquire to the Medicines Control Agency about the progress of their applications at any time. In addition, information on the time taken to grant licences is published by the MCA at regular intervals in the Medicines Act information leaflet.