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HouseofLordsNovember 11 2015

Attempts to introduce legislation requiring the Government to license off-patent medicines with new indications have been delayed.

A second reading of the Off-Patent Drugs Bill in the House of Commons had seen MPs raising concerns that doctors are reluctant to prescribe medicines for non-licensed indications (‘off label’), if a medicine was seen to have more uses than the initial indication it was licensed for. While manufacturers of medicines still in patent may want to apply for secondary indications, extending the patent, there would be little interest for medicines that were off patent.

Where a new use for an off patent medicine was recognised as useful and clinically appropriate, the MPs were proposing that the Government should be required to license medicines for these new indications if no manufacturer was prepared to.

However, Minister for Community and Social Care Alistair Burt MP prevented the Bill progressing, saying that GPs could prescribe off label already. Instead of introducing more legislation, the minister said that providing doctors with more information could encourage better use of off label prescribing.

Torfaen MP Nick Thomas-Symonds said that doctors were reluctant to prescribe drugs such as raloxifene prophylactically for women at a high risk of breast cancer because the medicine is not licensed for such use. He had opened the debate saying that the Bill would create “a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so.

“There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to licence it, and to ensure its adoption on the NHS,” he said.

“Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.”

Mr Thomas-Symonds said that the Bill had the backing of 12 medical research charities, NHS clinical commissioners in England, and the British Medical Association. He added that “repurposing is becoming increasingly common. Approximately 10% of the Brain Tumour Research portfolio is in repurposed drugs. For the Cure Parkinson’s Trust, the figure is 50%, and for the Alzheimer’s Society it is 13.6%.”

A written question in October had pointed out that as the Secretary of State for Health is the UK licensing authority for medicines, it would be inappropriate for him to apply to himself for a new license for an off-patent medicine. He would also have an obligation as a licence holder to become a routine participant in pharmaceutical markets.

In the Commons debate, Mr Burt had clarified that off-label prescribing was possible, but was not occurring routinely due to concerns by doctors about liability. “We believe that if it is possible to prescribe off-label, the Bill is not necessary,” he said, but acknowledged the strong feeling from MPs and others.

“No sensible Government would seek to resist people having access to drugs in any way. The reason for resisting what is proposed is that the Government believe that there is another pathway. However, I am also persuaded by what I have heard today and feel sufficiently uncomfortable about the current situation to know that this is not an end of the matter.

“I will resist the Bill today, but my advice to colleagues in the Department of Health will certainly reflect the mood of the House and what has been said.”

As the minister had not given way allowing MPs vote on whether the Bill should go to Committee stage, the debate was adjourned to be resumed on December 4.

Links:

Hansard - Off-Patent Drugs Bill Debate November 6 2015

House of Commons Written Question

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