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Drug licensing

UK bill aims to allow off-patent drugs to be licensed for new purposes

Under the proposed law, the health secretary would have the authority to issue a licence for a new use.

Bill will go through Parliament to allow the National Institute of Health and Care Excellence (NICE) to use off-patient drugs to be licensed for new purposes


The private members bill had its second reading in the House of Commons on 7 November 2014

A bill is going through the UK parliament which would allow off-patent drugs to be used for new indications.

The Off-Patent Drugs Bill proposes giving power to the National Institute for Health and Care Excellence (NICE) to conduct technology appraisals for off-patent drugs if there is evidence they could be effective in treating new conditions.

Currently, no organisation or individual has an incentive to seek a licence for drugs with an expired patent. Under the proposed law, the health secretary would have the authority to issue a licence for a new use and would also be expected to produce an annual report detailing progress.

The private members bill, sponsored by Jonathan Evans, Conservative MP for Cardiff North, had its second reading in the House of Commons on 7 November 2014. Because there were fewer than 40 MPs present, the bill will need to be debated again on a date to be announced.

“No mechanism is in place to ensure the routine availability of existing drugs where patent protection has expired and where the drugs may be clearly shown later to be clinically effective but in a new way and for a new purpose,” Evans told MPs.

“Without a change in the system, no one is ever likely to make licence applications for off-patent drugs, even when they may be effective for new purposes. What this all boils down to is that off-patent, repurposed drugs are not routinely available on the NHS, despite minimal costs to the taxpayer and the clear, clinically proven health benefits.”

The Minister for Health and Innovation George Freeman said he agreed with the bill’s objective to promote off-label use of medicines. But added: “The only disagreement is on the mechanism to achieve that and whether the mechanisms proposed by the bill are the right ones.”

Freeman said he was continuing to work with Evans and others who support the changes to “find a way to achieve our agreed aims”.

The Association of the British Pharmaceutical Industry, which represents drug manufacturers, says it wants to see improved patient access to drugs but that the integrity of the medicines licensing system must be maintained. It promised to “engage with all stakeholders to explore further how best to advance the development of a medicine in this situation”.

The bill already has the support of a number of charities, including the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia and Lymphoma Research and the Alzheimer’s Society, which are calling on the government to support the proposals.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20067119

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