The UK government has said it will not progress with plans for automatic generic substitution of medicines in primary care because “it is not clear whether the proposals would have provided substantial benefit to the NHS”, according to the UK Health Minister Lord Howe.

“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,” said Lord Howe in a press statement.

The final decision seems to have elicited a sigh of relief from many industry stakeholders. “The introduction of generic substitution has faced opposition from patients, professionals and industry,” Leslie Galloway, Chairman of the Ethical Medicines Industry Group, said in a statement. “We are delighted that the Department has listened to our concerns and abandoned its proposals to implement this costly and unwanted system.”

Epilepsy Action, a UK charity, has also expressed its support for the decision, explaining in a press statement that “there is strong evidence that brand switching for many people with epilepsy has caused breakthrough seizures, worsening of their seizure control or worsening of side-effects”.

Genetic efficacy questioned

The proposal for automatic generic substitution of medicines in UK primary care was first announced in 2009. The UK’s Department of Health (DOH) had estimated the potential annual savings of automatic generic switching to be in the region of approximately £41 million, and also added that the scheme could increase flexibility for dispensers and, by using drug names rather than proprietary brand names, help health professionals to better understand their patients’ treatment needs.

During the public consultation process, however, a number of concerns were raised including:

• the impact of generic substitution on patient safety and wellbeing
• the cost-effectiveness of generic substitution
• the effects of generic substitution on GP and pharmacist workloads and relationships
• impact on the pharmaceutical industry.

The majority of comments received during the consultation related to patient safety and wellbeing, with particular concerns being raised about whether some generics are true equivalents of the branded medicine. Specific concerns were raised about the potential effects of substitution of anti-epileptic drugs (AEDs). Although AEDs were described in the consultation document as unsuitable for substitution, respondents were concerned that they may be added to a generic substitution scheme in future.

Comments were also made about the supposed economical benefits of generic substitution, with respondents pointing out that the majority of prescriptions in the UK (83%) are already for generic medicines. In its response, Bayer HealthCare also added: “There is no recognition that prescribers already make a brand / generic choice in their prescribing and that there is little further scope. Seventeen of the treatments on the proposed limited list already have generic prescription rates of 97% or greater. It is highly questionable as to whether a further increase in generic prescribing rates is possible for this group.  It is fair to assume that branded prescribing in this group is taking place for a particular reason.”

The effort outweighs gains

A number of respondents also felt the effort of implementing a formal generic substitution scheme far outweighed the potential gain. “We have no robust evidence either way; however, the predicted financial gain of £50 million against a national spend in excess of £8 billion would indicate that this is a sledgehammer to crack a walnut,” said a comment from the UK’s Hampshire & Isle of Wight local pharmacy committee.

“We have listened to the concerns from the public, patients and other interested parties about legislative proposals to enable pharmacists to replace a branded medicine with a generic medicine.  It is also not clear whether the proposals would have provided substantial benefit to the NHS, compared to the efforts of frontline staff to implement them. This is why we have decided not to progress with national implementation,” said Lord Howe.

The Association of the British Pharmaceutical Industry (ABPI) has also issued a statement in response to the decision, suggesting that perhaps the uptake of generic medicines has led to a move away from more innovative medicines. “Most prescriptions in the UK are filled with off-patent medicines, but many patients need modern branded medicines to be adequately treated,” Dr Richard Barker, Director-General of the ABPI, said in the statement. “It’s vital that patients, not short-term financial targets, come first in the choice of prescription medicines.”

All of this doesn’t mean that the UK generics industry will suffer because of this decision. Generic drugs already form the bulk of UK prescriptions and Lord Howe emphasized that the government will be looking at “more appropriate ways of supporting the use of generic medicines”.

The ABPI has also recommended that a mix of both branded and generic medicines is required to reduce the burden of disease and deliver cost-effective care.