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Health: Generic Substitution of Medicines

Volume 716: debated on Tuesday 5 January 2010


My right honourable friend the Minister of State, Department of Health (Mike O’Brien) has made the following Written Ministerial Statement.

The department committed to the introduction of generic substitution in primary care in the National Health Service, subject to discussion with affected parties, in the Pharmaceutical Price Regulation Scheme 2009. The department is today commencing a consultation on the proposals to implement generic substitution, where a generic medicine is dispensed instead of a branded medicine.

Discussions with, and views expressed by, stakeholders during the course of the last year have proved invaluable, endorsing in particular the need to appropriately account for patient safety in the implementation of generic substitution, and enable prescribers to continue to meet individual patient clinical need. Further to this engagement, the department is consulting on three options for the implementation of generic substitution in primary care in England. These options are to:

do nothing

introduce dispensing flexibility, but with specific exclusions, so that the arrangements do not apply to a selected group of products on an exempt list; and

introduce dispensing flexibility, but limiting the scheme in such a way that the arrangements only apply to a selected group of products on a select list.

The department’s preferred approach is the third option, supplemented by an “opt out endorsement”. The reasons for this include considerations relating to patient safety and clinical need, savings to the NHS and manageability of implementation for clinicians and prescription infrastructure providers.

This consultation runs from 5 January 2010 to 30 March 2010. Further details, including the consultation document and how to respond, can be found at There will be consultation events, and details of these will be published on the NHS Primary Care Commissioning website at

A copy of the consultation document has been placed in the Library and copies are available for honourable Members from the Vote Office.