UK: Department of Health opens consultation regarding the implementation of ‘Generic Substitution’


On 5 January 2010, the Department of Health published a public consultation document relating to the implementation of generic substitution in England. Generic substitution would enable dispensers of pharmaceuticals to fulfil a branded medicine prescription by providing an equivalent generic medicine. The Pharmaceutical Price Regulation Scheme (PPRS) is a voluntary scheme agreed between the Department of Health and the Association of the British Pharmaceutical Industry which indirectly regulates the prices of branded medicines sold to the NHS. The PPRS 2009 included provision for the introduction of generic substitution in primary care, subject to discussion with stakeholders. The aim of the introduction of generic substitution would be closing the gap in relation to the 5% of items prescribed by brand where the medicine concerned is available as a generic, which would maximise the savings delivered by the PPRS agreement.

The Department of Health has ruled out any option which would prohibit the prescribing of branded medicines where there is a generic equivalent available due to the resulting restriction on clinical flexibility. The three options which are the subject of the consultation are as follows:

1. do nothing;

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

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

The Department of Health’s favoured approach is option 3, with an endorsement which would enable the prescriber to opt the prescribed item out of the arrangements. The Department of Health believes that this represents the most proportionate implementation approach.

The consultation although seeking views on all aspects of the potential arrangements poses ten key questions with which the Department of Health are concerned. The consultation runs until 30 March 2010, the full text of the consultation document can be found at