The ABPI welcomes publication today of a consultation regarding the introduction of generic substitution in England, giving all stakeholders an opportunity to express their views. ABPI particularly welcomes the essential emphasis given to patient safety in the Department of Health’s proposals.


Richard Barker said ‘We welcome the opportunity given to all stakeholders, including industry, the NHS and patient groups, to provide input and comments to the Department of Health in response to its consultation on generic substitution.’

‘It is important to ensure that patients’ health and safety is not compromised in the implementation of this new policy’.

Indeed, patient safety should prevail and prescribers should retain the right to prescribe a particular branded generic.

During PPRS discussions, ABPI had specified the need to ensure exclusion from substitution of certain groups of products based on patient welfare and international best practice, including:

  • Modified or sustained release preparations,
  • Different formulations,
  • Medicines with a narrow therapeutic index/window where there is evidence regarding the risk of adverse patient reactions or inadequate efficacy,
  • Vaccines,
  • Biosimilars,
  • Devices and routes of administration, including site of action, and
  • Controlled Drugs.

Such exclusions for patient welfare could be achieved through either option 2 or 3 in the consultation, and the ABPI will review these options in more detail before responding to the consultation.

ABPI also maintains the view that generic substitution should only take place if the dispensed product makes savings for the NHS compared to the prescribed product.

The Generic Substitution consultation will run from the 5th January to the 30th March 2010.

Notes to Editors:

The Generic Substitution consultation can be found at:

It will run until the 30 March 2010

For more information please contact the Department of Health press office on: 0207 210 5221 

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