The MHRA raises the issue of 'conditional medicines in its consultation: Challenges and priorities for the next five years.

If 'conditionally licensed' medicines are to be available for prescribing by general practitioners, or in any arrangement leading to their being supplied from pharmacies, the NPA considers that it would be essential to incorporate community pharmacies in the increased level of monitoring of safety and, indeed, efficacy in use. This would provide a vital safety net for patients and ensure that both the MHRA and the marketing authorisation holder received vital feedback about the product so that the 'conditional licence' could confidently be changed to a full marketing authorisation.

In fulfilling such a role community pharmacies would clearly expect to be remunerated but presumably there would be cost benefits for manufacturers, patient benefits in getting innovative products to market earlier albeit within a more controlled environment and also to the wider NHS in the improved health outcomes.

NPA Director of Practice, Colette McCreedy, added: The NPA would welcome the opportunity, in co-operation with the MHRA, to explore the process and develop a business case for community pharmacy based monitoring of 'conditionally licensed' medicines and we have requested a meeting with them."


1. What is a 'conditionally' licensed medicine? In the 'Cooksey' Review of UK Health Research Funding it was proposed that earlier 'conditional' licensing of medicines should be considered which would bring new medicines to the market at an earlier stage of development.

National Pharmacy Association