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HoC Answers - 2.12.11
Medicines Supply Chain
Rosie Cooper (Labour, West Lancashire): To ask the Secretary of State for Health what steps his Department has taken to (a) review and (b) reduce the number of wholesaler dealer licences for medicinal products.
Mr Simon Burns (Minister of State for Health): The Medicines and Healthcare products Regulatory Agency (MHRA) an executive agency of the Department, regulates manufacturers and wholesale dealers of medicinal products for human use in the United Kingdom on behalf of the UK Licensing Authority (LA).
The MHRA has not reviewed the number of authorised wholesale dealers in the UK or taken steps to reduce the number of such traders.
The MHRA has a legal responsibility to assess all applications made for a wholesale dealers licence and will grant a wholesale dealer's licence where the applicant meets UK provisions and community obligations for the safe storage and distribution of medicinal products in the UK or to revoke a granted licence for non compliance.
Rosie Cooper: To ask the Secretary of State for Health what discussions (a) he and (b) his officials have had with the Medicines and Healthcare products Regulatory Agency on the (a) separation of pharmaceutical wholesaling from dispensing activities within pharmacies and (b) implementation of recommendation 6 of the EU High-Level Pharmaceutical Forum G10.
Paul Burstow (Minister of State for Care Services): Ministers and departmental officials meet regularly with the Medicines and Healthcare products Regulatory Agency (MHRA) to discuss a range of policy issues.
Pharmacies are currently exempt from having to hold a wholesale dealer's licence by virtue of Section 10(7) of the Medicines Act 1968. In October 2011 the MHRA brought forward proposals for the repeal of section 10(7), on the basis that it conflicts with European Union legislation. The proposed change would take place as part of a consolidation of existing medicines legislation, currently being consulted upon by the MHRA. The repeal of 10(7) will require that, in future, any pharmacy that wishes to engage in commercial wholesale dealing activity must hold a wholesale dealer's licence.
In implementing Recommendation 6 from the EU High-Level Pharmaceutical Forum G10, the MHRA has concentrated on working with the UK's Health Technology Assessment body-the National Institute for Health and Clinical Excellence-to provide joint scientific advice to companies during the drug development process.
Posted 2 December 2011