The Department of Health (DH) has begun a consultation on plans to allow generic substitution in England, with the aim of bringing the substitution rate from 83% to 88%.

Announcing the consultation, which will run until March 30, the Department points out that the National Health Service (NHS) spends about £9 billion a year on branded prescription drugs in the UK. In England in 2008, 83% of prescription items were prescribed generically, the remaining 17% being prescribed and dispensed by the brand name. The great majority of these drugs are available only as branded products, but 5% were prescribed by brand where the drug concerned is available as a generic.

Therefore, says the Department, the generic prescribing rate for 2008 could potentially have been 88% - assuming that there were no clinical reasons why the patient needed a specific manufacturer’s product – and that closing this 5% gap is the key driver behind the proposal.

Realisation of savings will be most significant in relation to products that have very recently come off patent, when prices fall, it adds.

The consultation is seeking views on the following three options for the implementation of generic substitution in England:
1) do nothing – keep the current situation as it is;
2) introduce dispensing flexibility but with specific exclusions, so that the arrangements do not apply to a selected group of products on an exempt list; and
3) 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.

The Department’s preferred approach is Option 3, with an opt-out endorsement, it says, for reasons which include considerations relating to patient safety and clinical need, savings to the NHS and manageability of implementation for clinicians and prescription infrastructure providers.

“Where clinically appropriate, it is only sensible to allow more expensive branded products to be substituted with the same generic medicines which are just as effective as the branded version,” said Health Minister Mike O’Brien, commenting on the initiative.

Generic substitution will “deliver value for money and savings to the NHS which will go directly back into health services, ultimately benefitting patients and improving the care they receive,” he added.

The Association of the British Pharmaceutical Industry (ABPI) said it welcomed the consultation, and particularly the “essential emphasis” given to patient safety in the Department’s proposals.

“It is important to ensure that patients’ health and safety is not compromised in the implementation of this new policy,” said ABPI director general Richard Barker.

The ABPI points out that during the most recent Pharmaceutical Price Regulation Scheme (PPRS) discussions, it had specified the need - based on patient welfare and international best practice - to ensure that certain groups of products would be excluded from substitution. These include: modified or sustained-release preparations; different formulations; medicines with a narrow therapeutic index/window where there is evidence regarding the risk of adverse reactions or inadequate efficacy; vaccines; biosimilars; devices and routes of administration, include site of action; and controlled drugs.

Such exclusions could be achieved through either proposed Options 2 or 3, says the ABPI, which adds that it will review these in more detail before responding to the consultation.

The British Generic Manufacturers Association (BGMA) said it strongly supports the Department’s favoured alternative (Option 3) which, according to the group’s director Warwick Smith; “offers a perfect balance.”

The UK generics industry saves the NHS £7 billion every year, says the BGMA, and Mr Smith pointed out that the Department’s proposals focus on the “vast majority” of generics which are interchangeable and for which there is “no clinical reason for patients to receive much more expensive branded drugs rather than much more cost-effective generics.”

“For patients to receive the branded versions of these products achieves nothing but to waste scarce resources,” he said.

However, Mary Baker, president of the European Federation of Neurological Associations (EFNA), has said that the potential risk to the outcomes of “thousands of patients” from the introduction of automatic generic substitution is of “great concern.”

“It is already difficult for patients with long-term illnesses or with several conditions to keep up with all the different medicines they have to take each day. Complicating this further by introducing automatic generic substitution could make patients even less likely to take their medicines correctly,” she warned.