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Off-Patent Drugs Bill

written by

Leukaemia Care, Charity

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On the 6th November 2015 Parliament will be asked to vote on a Bill that, potentially, could improve the future treatment of patients throughout the UK.

The Off-Patent Drugs Bill was proposed by the newly elected Labour MP for Torfaen Nick Thomas-Symonds to address a key issue preventing clinically effective drugs being used in areas that differ from their original licence.

When a drug begins the development process, the pharmaceutical company will obtain a patent before research is carried out. This means that only that company is allowed to manufacture and market the drug. Once a patent is obtained and research has been carried out, they are then able to apply for a licence to market the drug but only within the market authorisation restrictions, based on the evidence put forward from the research.

Occasionally, drugs may later be found to be an effective treatment for a different condition from which they were originally developed. Although by this time the patent for the drug may have expired. The originator company often do not have a commercial incentive to invest in research to relicense drugs for different purposes. This is frustrating for both patients and clinicians if research has shown it could be a cheaper, more effective treatment option for a different condition.

The Bill would put into UK law a duty on the Government to take steps to secure marketing authorisation for repurposed drugs when pharmaceutical companies will not, and approve them for use in the NHS, acting in the public interest.  This would improve clinician access to low-cost, effective drugs and therefore present an opportunity to make these drugs readily available to patients. By reducing the barriers that determine availability of repurposed drugs, this Bill could benefit thousands of people, including those with limited treatment options and ultimately, potentially, save lives.

Leukaemia CARE are working with a range of not for profit organisations led by Breast Cancer Now and MP Nick Thomas-Symonds in order to raise the profile of the Bill and encourage support from MPs and the public alike. Leukaemia Care are supporting the idea that the government should play a bigger role in helping make off-patent drugs available to treat conditions that differ from their original licence. If 100 MPs vote in favour of the Bill, it could become law and if passed, blood cancer patients could have improved access to more effective treatment not previously available to them.