§ Mr. Atkinson
To ask the Secretary of State for Health if he will make a statement about the proposed increase m fees relating to the Medicinal Products for Human Use Regulations 1989 (S.I., 1989, No. 418) by the Medicines Control Agency.
§ Mrs. Virginia Bottomley
On 24 November 1989 the Medicines Control Agency, in accordance with Section 129(6) of the Medicines Act 1968, wrote to all licence holders and interested organisations to consult them about proposed amendments to the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 (SI 1989 No 418).
The letter contains a statement by the joint consultative group comprising senior representatives of the Department of Health (including the Medicines Control Agency) and of the Association of the British Pharmaceutical Industry (ABPI) and the Pharmaceutical Association of Great Britain (PAGB). In that statement the group recognise that the deficit in the agency's fee income for 1989–90 will need to be carried forward into the calculation of fees for 1990–91. Also in 1990–91 the agency may require additional resources to improve its performance further and to eliminate the substantial backlog of applications. The group has concluded that, subject to statutory consultation, fee levels will have to be increased by 70 per cent. from 1 February. They go on to say that this may not be enough to put the agency into a sound financial position in 1990–91 to enable it to carry out its function effectively. They will, therefore, consider the matter further in the new year in the light of additional information which will become available. This will include better information on the likely volume of different types of licence applications and more precise costing information. It is hoped that this information will enable 333W the group to consider a fee structure that will provide stable funding and will place the agency on a sound financial basis.
Subject to the results of the consultation exercise amending regulations will be laid before the House in January.
A copy of the consultation letter (MLX 178) has been placed in the Library. The letter contains examples of the fee increases and explains the reasons behind these. Comments on the fee proposals have been requested by 22 December 1989.
§ Sir Hector Monro
To ask the Secretary of State for Health (1) if the new formularies set up under the new proposals will be established on a local and voluntary basis; and whether new medicines will be included;
(2) if there will be any disincentive on the use of new medicines by general practitioners and hospitals under the reorganisation proposals.
§ Mrs. Virginia Bottomley
The aim of indicative prescribing budgets which will apply to general medical practitioners and not to hospitals, is to encourage more cost-effective prescribing to the advantage of patients individually and the NHS overall. General practioners will remain free to prescribe the medicines which are clinically necessary for their patients including of course new medicines.
The development of formularies at local level represents a further initiative to improve the quality of prescribing. It will be for each formulary's authors to decide which drugs to include. There should be no disincentive to the adoption of new medicines which have therapeutic advantages over existing drugs. It will be for individuals GPs to decide whether they wish to adopt a formulary. The fact that a new drug does not appear on a particular practice's formulary would not prevent a GP from prescribing it, since the use of formularies is voluntary.