To ask Her Majesty's Government which external bodies they consulted in preparing their impact assessment report in respect of the consultation on automatic generic substitution of branded medicines in the National Health Service. [HL2158]

To ask Her Majesty's Government whether they will publish the evidence on which they built their view in the impact assessment report regarding automatic generic substitution of branded medicines in the National Health Service that the effects of the policy on (a) safety, (b) liability in the event of adverse events, and (c) job losses, would be negligible. [HL2159]

In developing the proposals and analysis set out in the consultation document The Proposals to Implement “Generic Substitution” in Primary Care, Further to the Pharmaceutical Price Regulation Scheme (PPRS) 2009 and its associated partial impact assessment, published on 5 January 2010, the department was informed by information from stakeholders. During 2009, the department undertook a series of meetings with key national stakeholders, representing general practitioners, community pharmacists, and manufacturers, to discuss the commitment in the PPRS agreement in England. These national stakeholders were the General Practitioners Committee of the British Medical Association, the Pharmaceutical Services Negotiating Committee, the Association of British Pharmaceutical Industry, the British Generic Manufacturers Association and the Ethical Medicines Industry Group. We also received written representations from a number of other stakeholders, such as individual manufacturers and patient groups, for example those representing people with epilepsy.

The department will publish references to the key articles reviewed to support the partial impact assessment on its website. We recognise that further evidence may be available in relation to these issues, which is why we are holding a full public consultation, to which all those with an interest can input. The consultation document and partial impact assessment can be found on the department’s website at www.dh.gov.uk/en/consultations/index.htm.

Copies of the consultation document have already been placed in the Library. Details of the consultation events can be found on the NHS Primary Care Commissioning website at www.pcc.nhs.uk/events.