Ministers reject bid to revive Off Patent Drugs Bill
pharmafile | February 1, 2016 | News story | Research and Development, Sales and Marketing | Access to Medical Treatments (Innovation) Bill, Off Patent Drugs Bill, Off-Patent Drugs Bill, george freeman, parliament, repurposing drugs
Ministers have rejected amendments to a proposed Parliamentary Bill that sought to reintroduce elements of the Off Patent Drugs Bill, to encourage doctors to use ‘repurposed’ older drugs for conditions in which they have not been treated.
On Friday MPs debated the Access to Medical Treatments (Innovation) Bill (AMTI), which was put forward by MP Chris Heaton-Harris, and supported by Life Sciences Minister George Freeman.
“I’m delighted that after extensive cross-party working, I will be announcing government support for a package of amendments to this bill in order to help accelerate access to new drugs for NHS patients,” Freeman said.
During the debate, aspects of the Off-patent Drugs Bill – which fell at its second reading – were proposed for inclusion in the AMTI Bill by a group of cross-party MPs who had strongly supported the Off-patent Drugs Bill.
But although these amendments were rejected, ministers committed to exploring a number of these areas of policy, without legislation, in order to improve access to repurposed off-patent drugs.
The bill, which has some cross-party support, would allow doctors to search a database for drugs that are in trials or are licensed for a different use. The database of innovative medical treatments will also use clinicians’ patient notes to record ‘innovations’ – a record of drugs that have been used off-patent – and provide other clinicians with information to consider pursuing these innovations. The Bill would also clarify issues around clinical negligence, which had been an issue in the Off Patent Drugs Bill.
Its supporters say this would encourage innovation by giving doctors a framework to try unlicensed drugs – which Mr Freeman says could be evaluated by NICE. But opponents warn the new legislation may compromise patient safety.
The database will also have details of drugs earmarked for accelerated access to the NHS, and flagged up in the ongoing Accelerated Access Review, chaired by Sir Hugh Taylor, which is due to report in April.
Baroness Delyth Morgan, chief executive at Breast Cancer Now and a strong supporter of the original Off Patent Drugs Bill, says: “We’re encouraged by the Minister’s willingness to make progress on access to repurposed off-patent drugs and the continued cross-party support that this issue has received.
“These commitments embrace, to some extent, the spirit of the Off-patent Drugs Bill that fell last November and we now look forward to working closely with the Department of Health on this issue going forward; there is still a long way to go to ensuring routine access for patients that could benefit from such drugs.
The repurposing of drugs has a vital role to play in the future of cancer treatment, and, if the Government can now build on these commitments, the UK could become a world-leader in re-using off-patent drugs for new purposes.”
The ABPI has set out several of its concerns with the AMTI Bill, which it says “will promote the prescription of unlicensed medicines, before they have received regulatory approval and are deemed safe for use.”
In a statement the UK trade body says: “The ABPI welcomes the intention of the Bill to increase patient access to innovative medicines and treatments. However, the ABPI has a number of concerns with the Bill, including unintended consequences of the Bill and the Bill’s proposals potentially undermining the UK’s regulatory system for healthcare products. Due to these concerns, and the fact that primary legislation is not required to set up a database of innovative medical treatments, the ABPI does not support the Bill.”
Lilian Anekwe
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