The Department of Health published its consultation on generic substitution on 5 January. The document sets out three options and proposes an inclusion list of selected drugs to which generic substitution would apply.

The consultation considers the pros and cons of the three options and the opt-out system. Key points include:

Option 1. Doing nothing - this is dismissed because it would not deliver the savings to the NHS identified in the 2009 PPRS.  

Option 2. Creating an exemption list - this is identified as having several problems including that:

  • The exemption list would be very long and difficult to manage. It would need to be updated on an almost continual basis;
  • Drugs would remain on the list for varying amounts of time;
  • Since a product has to be actively placed on the list, this is likely to lead to a greater scope of products included in the short-term while there is administrative lag;
  • The system would require prescribers and dispensers to continually familiarize themselves with the list for all the reasons above; and
  • The approach would require a definition of “generic equivalent” that could be very difficult to settle.

Option 3. Creating a list of drugs that generic substitution would apply to - this is preferred because it will be “a lot narrower”, with a specific list of drugs, with provision for exclusion where serious patient safety or clinical concerns arise. The Department suggests the list would be reviewed quarterly.  

Tick-box. The consultation raises concerns over the tick-box system including:

  • The prospect of the box being completed by someone other than the prescriber – for this reason, the system would have to be operated electronically;
  • Where there is more than one item on a prescription, there would be insufficient room for multiple tick-boxes and, if the prescription was extended to facilitate them, this would lead to increased prescription charges for the patient.

Endorsement. This system requires the prescriber to use an acronym to indicate whether opt-out is required, which would operate under existing electronic and manual prescription formats. This would have the benefit of accommodating more than one item per prescription, and GPs already have the systems in place to deal with it.

  • The consultation expresses a preference for Option 3, and giving the prescriber an opt-out facility through an endorsement, as opposed to a tick-box system.

The consultation notes that the preferred position has been arrived at as a result of a number of concerns raised by manufacturers, patient groups, GPs and pharmacists, including, patient safety impacts, concerns over the workload of clinicians, and doubts over whether generic substitution will have a significant impact, given the level of existing generic prescribing. The consultation document, including a full list of the questions to address in response, is available at

Comment - The consultation closes on 30 March 2010, which is likely to be days before a general election is called and policy announcements are put on hold until after the election. Given that a period of months will be required to amend legislation to reflect the outcome of the consultation, the likelihood of any policy change before the election is remote.