Drugs used by National Health Service doctors (NHS) in the UK need to be licensed for each new indication, either by the European Medicines Agency (EMA) through its centralised procedure or by the Medicines and Healthcare products regulatory Agency (MHRA).
While a drug is under patent the manufacturer involved is – more often than not – likely to seek licenses for it in every indication in which it is effective.
But, when a drug goes off-patent there is no incentive for a manufacturer to seek more licenses as doing so would benefit competitors. This means that, under NHS rules, patients can only access such drugs if their doctor is willing to prescribe them “off label”.
This is a problem according to Conservative MP Jonathan Evans, who introduced a private member’s Bill to try and compel the Secretary of State to take responsibility for obtaining new licenses for off-patent drugs to ensure they can be adopted by the NHS.
As a fall back solution the Bill also proposes that NICE conducts a technology appraisal for off patent drugs known to be effective in new “priority” indications
Evans said: “This Bill is a unique opportunity to take advantage of existing treatments that could have a positive use in a new way. We are talking about low-cost treatments that have been around for a long time but that have the potential to transform lives.”
Industry response
Evans’ proposal – which is also backed by Annette Brooke, Alan Meale, Angela Watkinson, Liam Fox, Robert Neill, John Healey, Glyn Davies, Phillip Lee, Mr Elfyn Llwyd, David Nuttall and Sarah Wollaston – is still at a very early stage.
This was pointed out by Paul Catchpole, ABPI Director of Value and Access, who told in-Pharmatechnologist.com that: “Whilst the bill is in very early stages of development, we welcome the debate, which will encourage improvements in access to medicines for the benefit of NHS patients.
“It is important to note that the regulatory process for the licensing of medicines is in place to protect the safety of patients and is the responsibility of the MHRA.
Catchpole added that: “We are committed to engaging with Government and key stakeholders as the bill develops in order to contribute to the debate to ensure that NHS patients are able to get access to the best medicines that are both safe and effective.”
The next reading of the Bill is scheduled for November.
Vive la difference
The introduction of the UK Bill – which would both reduce off label prescribing and give generic drugmakers other marketable indications for their products - comes days after the French National Assembly backed a draft law to let doctors use drugs off-label, even if an alternative product is approved, in a bid to cut healthcare costs.
The plan – which still needs to be reviewed by the French Senate and Constitutional Court – was criticised by director general of European drug industry group EFPIA, Richard Bergstrom.
“A worrying trend is growing across Europe with governments bypassing important health safeguards and making public health decisions based purely on short-term economic considerations. This move is a material breach of the regulatory framework created to preserve the highest standard of patient safety in Europe.”
Bergström added: “This is a serious public health issue which the European Commission must address urgently before it becomes more widespread. EU Member States should not be creating secondary, national marketing authorizations for reasons that undermine the EU regulatory framework and could potentially put patients at risk, and deliver only short-term economic gains.”