Government drops plans for generic substitution amid safety concerns

BMJ 2010; 341 doi: (Published 15 October 2010) Cite this as: BMJ 2010;341:c5780
  1. Zosia Kmietowicz
  1. 1London

The government has said it will not introduce automatic substitution of generic drugs in primary care in England after a consultation showed that many people thought it posed a risk to the safety of patients and could create more work for NHS staff.

Announcing findings from a public consultation launched by the Department of Health under Labour in January (BMJ 2010;340:c135; doi:10.1136/bmj.c135), the health minister Lord Howe said, “We know that there are valuable savings to be made from the use of generic medicines where it is clinically appropriate. However, we believe that national plans to enforce generic substitution in primary care are too prescriptive.”

He said that it wasn’t clear whether the proposals, which under the option preferred by the health department allowed for generic substitution of a specified group of products, would provide “substantial benefit to the NHS.”

Instead, the department said it would be looking at other ways to support the further use of generic drugs.

At 83% the UK has one of the highest rates of generic prescribing in Europe. However, a partial impact assessment by the department indicated that adopting the preferred option would lead to savings of around £19m (€22m; $30m) a year, with implementation costs of around £3.8m.

Of the 423 organisations and individuals who submitted written responses to the consultation, 63% were against the department’s preferred option for generic substitution. However, a breakdown of the responses by type of respondent showed that while 80% (12 of 15) of doctors and 64% (21 of 33) of NHS organisations supported this option, only 10% (one of 10) trade bodies, and 33% (three of nine) of pharmacists did.

More than a third of the written responses were from people who sent in templates developed by the charities Epilepsy Action (51 responses) and Liver North (103 responses), a support group for patients with liver disease. Among epilepsy patients or carers only 12% (five of 41) supported the favoured option.

Many respondents were unconvinced by the figures, said an analysis of the consultation carried out by the market research company Greenstreet Berman. In particular, they were sceptical about two assumptions made in the calculation. One was that it was possible to extend generic prescribing by a further 5%. The other assumption was that it would be possible to switch 50% of drugs currently prescribed as branded products to generics. Some respondents also questioned whether the effort to introduce the scheme was too great for the potential savings to be made.

The National Society for Epilepsy welcomed the government’s decision. It ran a campaign warning that switching to generics could provoke seizures in people with epilepsy.


Cite this as: BMJ 2010;341:c5780


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