Following the outcome of a public consultation, the government has decided to abandon controversial plans for automatic generic substitution in primary care, Ministers announced late last week.

“We know there are valuable savings to be made from the use of generic medicines when it is clinically appropriate. However, we believe that national plans to enforce generic substitution in primary care are too prescriptive,” said Health Minister Lord Howe.

The public consultation, which ran from January to March this year, asked stakeholders to consider three options, of which the Department of Health’s preference was: “to 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.”

64% of responses to the consultation disagreed with this option, and it was particularly disliked by local pharmaceutical committees, pharmacy organisations, patients and carers. But neither of the other two options: – to 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 to do nothing – garnered sufficient support to emerge as the clear way forward.

Three key points became apparent through analysis of the consultation responses, Health Minister Simon Burns told the House of Commons late last week. First, he said, “there was a strongly-held perception by respondents that generic substitution posed a threat to public safety. If the proposals were to be implemented, these concerns would arise in the front-line delivery of NHS services, impacting on the workload of health care professionals.”

Second, “the position on the cost-effectiveness of generic substitution implementation is inconclusive. There is a strong sense that the effort involved in implementing a formal generic substitution scheme was simply too great for the potential gain,” Mr Burns told the House.

Finally, “other, less nationally-prescriptive mechanisms for further supporting the use of generic medicines can be explored,” he concluded.

The government’s decision was welcomed by the Association of the British Pharmaceutical Industry (ABPI), which pointed out that the right mix of branded drugs and generics is vital for cost-effective care.

“Most prescriptions in the UK are filled with off-patent medicines, but many patients need modern branded medicines to be adequately treated. However, we see parts of the NHS inappropriately switching such patients to low-cost generics and so putting their welfare at risk,” said ABPI director-general Richard Barker.

“The NHS is getting a great deal on both branded and generic medicines and so can use the right mix of the two to reduce the long term burden of disease, and so deliver cost-effective care,” added Dr Barker.

The Ethical Medicines Industry Group (EMIG), which represents small to medium-sized pharmaceutical companies operating in the UK, said it was “delighted” at the scrapping of the proposed  “costly and unwanted system” which could, it said, have hindered patient safety.

Nor would generic substitution result in significant savings to the NHS, given that approximately 83% of drugs are already written generically, the group added. “Indeed, it may actually have increased the NHS medicines bill by eliminating any incentive for the continued development of medicines that offer greater patient choice as well as value for money to the NHS,” said EMIG’s chairman, Leslie Galloway.

Particular debate and confusion was generated during the consultation by the issue of whether a brand or branded generic should be supplied when it is cheaper than the related brand. “Tension was apparent between the local level, where prescribing cheaper brands can make significant savings for individual Primary Care Trust (PCT) budgets, and the national level, where prescribing ‘more expensive’ generics can actually result in savings for the NHS as a whole,” the analysis of responses comments.

Adding her welcome to the government’s decision, Sue Sharpe, chief executive of the Pharmaceutical Services Negotiating Committee (PSNC), said that prescribing of branded generics is currently causing significant problems for contractors in many parts of the country, and much more needs to be done on a local level to prevent it.

“Whilst PCTs may save small sums in the short term by encouraging this thoroughly counterproductive practice, its ultimate effect is to frustrate pharmacies’ effective commercial activity and work against the delivery of long-term cost-savings for the NHS. PSNC is completely against this practice, and is working with the Department of Health to develop effective deterrents,” said Ms Sharpe.