The Off-patent Drugs Bill 2015

This Briefing Paper has been prepared for the Second Reading of the Off-patent Drugs Bill 2015 on 6 November 2015.

The Off-patent Drugs Bill 2015 is a Private Members’ Bill tabled by Nick Thomas-Symonds after he came eighth in the Private Members’ Bill ballot this year. It had its first reading on the 24 June and is tabled for Second Reading on 6 November 2015. It is the second Bill on the list for consideration on this day.

The Bill intends to address the situation where a drug that has an expired patent is discovered to be effective for a new indication that is not within the scope of its licence. It would require the Secretary of State:

• to seek licences for off-patent drugs in new indications; and
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• to request the National Institute for Health and Care Excellence to conduct technology appraisals for off-patent drugs in new indications.

Nick Thomas-Symonds described the Bill and its intentions in an article for the Independent in July 2015. He said that it would improve access to low-cost treatments for a range of conditions, including Parkinson’s disease, Breast Cancer and Multiple Sclerosis.

A very similar Private Member’s Bill was tabled by Jonathan Evans MP in the 2014 Parliament. This did not pass Second Reading. In responding to the Bill, the Under-Secretary of State for Life Sciences said that the Government agreed with the intention of the Bill but did not believe it was necessary, as doctors can already prescribe ‘off-label’ where this in the patient’s best interests and there is no licensed alternative.

The Bill has support from a number of medical charities, including Breast Cancer Now, Multiple Sclerosis Society UK and the Cure Parkinson’s Trust.