§ Mr. Robin CookTo ask the Secretary of State for Health if any assessment was made of the effects of the increase in Medicines Control Agency fees on research and development by smaller companies.
§ Mrs. Virginia Bottomley[holding answer 26 February 1990]: We would not expect the increased fees for product licences to act as a disincentive to research and development by smaller companies. It is believed that the charges for product licences represent only a small fraction of the total cost of bringing a novel medicine to the market place.
§ Mr. Robin CookTo ask the Secretary of State for Health what has been the recent increase in the licence fee charged by the Medicines Control Agency and what are the reasons for it.
§ Mrs. Virginia Bottomley[holding answer 26 February 1990]: The latest amending regulations—the Medicines (Fees Relating to Medicinal Products for Human Use) Amendment Regulations 1990 SI 1990 No. 210— incorporate a 70 per cent. increase in all the licence fees charged by the Medicines Control Agency.
When the Medicines Control Agency was established it was made clear that it was to be fully funded by licence fees. Fee levels were originally set too low to achieve this objective and have had to be increased. A full review of charges will take place over the next few months.
§ Mr. Robin CookTo ask the Secretary of State for Health what progress has been made on reducing the Medicines Control Agency's fees for smaller companies on products with a limited market.
§ Mrs. Virginia Bottomley[holding answer 26 February 1990]: When the new fee structure for the MCA was established on 1 April 1989 we promised that there would be a full review of the fees charged during 1989–90. The 131W review has had to be deferred but will take place in the next few months and any adjustment which we consider necessary will be incorporated in a further set of amending regulations to come into effect in June/July 1990.
However, in the meantime we have introduced concessions which give small companies additional time to pay fees.