To ask the Secretary of State for Health pursuant to the answer of 25 January 2010, Official Report, column 553W, for what reason the views of the National Patient Safety Agency were not sought before publication of his Department’s consultation on proposals to implement generic substitution in primary care. (322158)

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 Pharmaceutical Price Regulation Scheme (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 recognise that we could not have meetings with all stakeholders that might have views on the PPRS commitment and this informed our decision to hold a full public consultation, which gives all stakeholders the opportunity to input.

Patient safety is at the core of the proposals. Substitution will not be permissible where it may pose a potential risk to patient safety. Option 1 involves no change to the current arrangements. Both options 2 and 3, which involve changes, would give the flexibility to create a list of drugs that is either exempt from any arrangements (option 2), or included in any arrangements (option 3), which allows implementation to take account of whether there are any general clinical or patient safety concerns with regard to interchange between different manufacturers’ products. Furthermore, both options 2 and 3 also maintain prescribers’ clinical autonomy to tailor prescribing to their individual patients’ clinical needs, through the ability of prescribers to opt in or out of the generic substitution arrangements for any prescription item. Therefore, patients would continue to receive a specific manufacturer’s product where their treating clinician judges that there is clinical need.

To ask the Secretary of State for Health for what reason his Department opted to undertake a partial impact assessment on its proposals relating to automatic generic substitution; and what his Department’s practice is on the preparation of (a) full and (b) partial impact assessments on matters which concern patient safety. (322159)

Generic substitution is not automatic under any of the options which are currently being consulted on and patient safety is at the core of these proposals.

It is good practice to issue a consultation impact assessment (previously known as a partial impact assessment) alongside a consultation paper and to seek views from stakeholders on its content, so these can be considered in the final impact assessment later in the policy development process.