To ask the Secretary of State for Health
(1) what research his Department undertook for the purposes of its consultation and impact assessment on automatic generic substitution in respect of assessment of the (a) effect on incentives for investments in research and development, (b) the potential health impacts on patients and (c) the one-off costs, ongoing costs and potential savings; and if he will make a statement;
(2) what steps his Department plans to take to ensure that patients continue to receive the most appropriate treatment under its preferred approach in the proposal for automatic generic substitution of medicines; what role the quarterly reviewed select list will play in this process; and if he will make a statement;
(3) whether his Department consulted the National Patient Safety Agency during its discussions on proposals to introduce automatic generic substitution of medicines.
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
The Department recognises that further evidence may be available, which is why we are holding a full public consultation, to which all those with an interest can input, including patients. We are also holding a number of consultation events (through NHS Primary Care Commissioning). The National Patient Safety Agency's views were not specifically sought before publishing the consultation document.
Under the Department's preferred approach (option 3), there are two mechanisms for ensuring that patients continue to receive the most appropriate treatment. Firstly, the creation of a select list will clearly define those drugs falling within the scope of the generic substitution arrangements. This list has been drawn up to include those medicines that deliver the most savings and excludes drugs where there are any general, clinical or patient safety concerns with regard to interchange between different manufacturers' products. Secondly, preservers' clinical autonomy to tailor prescribing to their individual patients' clinical needs will be maintained. Where a prescriber judges that there is a clinical need, a mechanism will be in place to ensure that patients can continue to receive a specific manufacturer's product.
The consultation document and partial impact assessment can be found on the Department's website at:
Copies have been placed in the Library. Details of the consultation events will be published on the NHS Primary Care Commissioning website at: