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Putting off-patent drugs back to work


We’re supporting a campaign to ensure off-patent drugs get licensed for new indications –providing patients with access to a wider range of treatments

Posted on 30 October, 2015 by Professor Paul Workman

Today, six clinicians here at The Institute of Cancer Research, London, have joined colleagues from across the UK in writing to The Telegraph to show their support for the Off-Patent Drugs Bill.

The ICR has been backing the campaign to get this Bill passed, and I wanted to take the time to tell you my personal reasons for supporting it – and why I believe it can help ensure that the results of our research reach patients.

Anyone who follows this blog will know that I am passionate about finding ways to accelerate patients’ access to innovative new cancer treatments.

I’ve blogged before about how financial incentives – balanced with other measures – are important for encouraging companies to conduct the high-risk research into novel and challenging targets needed for genuine step changes in cancer outcomes.

One important type of financial incentive is the drug patent. There has been a lot of discussion lately on whether patents are effective at encouraging innovative research – and what happens when those incentives disappear (through, for example, the expiry of the patent).

My view is that being able to patent drugs is essential for rewarding and encouraging innovation. Technologies such as new drugs – where large investment is needed from companies to take the product to patients – would simply not be developed without a market incentive in the form of a patent.

And in fact patents encourage further innovation in an area as they must include detailed information on the invention – which can then form the basis for others to make additional new inventive leaps.

So the patenting system encourages researchers and companies to carry out innovative research and rewards them for doing so, meaning they stimulate innovation generally. The problem comes when the patent ends. Once a patent has expired, drugs can be cheaply manufactured and sold by other companies. There is therefore no financial incentive for the pharmaceutical company to develop the drug for a new group of patients – even if research emerges demonstrating that it is effective for them. So patients are deprived of important treatments.

A good recent example is provided by a class of drugs called bisphosphonates. These drugs have been around for decades, and were finally licensed in the 1990s for treatment of osteoporosis, but have now been off patent for some years. Yet earlier this year, research strongly suggested that these old pharmaceutical dogs may have a new therapeutic trick – with evidence that the drugs could be of significant benefit for women with breast cancer. This is known as drug repurposing.

The problem is that evidence alone isn’t enough to ensure that off-patent drugs like bisphosphonates that are shown to be effective in a new indication are actually used to treat patients. Off-patent drugs can be prescribed ‘off label’ outside of their original licenced indication, but prescribing repurposed drugs in this way requires clinicians to accept a greater degree of risk than when prescribing a licensed drug, and that can be a barrier to a treatment becoming widely used.

For widespread use, a drug first needs a licence from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the new indication, vouching for its efficacy and safety. And applying for such a licence is an expensive and bureaucratic process – so expensive and bureaucratic that it is often not worth the bother for companies once drugs have gone off patent.

That’s what the Off-Patent Drugs Bill is all about – ensuring that where an off-patent drug is shown to be effective in a new way, a mechanism will exist for making sure it gets to patients.

Under the terms of the Bill, the Government would step in and coordinate licence applications in new indications – in situations where pharmaceutical companies were unwilling to do so.

It won’t require the MHRA to license off-patent treatments if there isn’t the evidence that they are safe or effective – the MHRA would still carry out its appraisal in the usual way.

What this new Bill would do is put the responsibility on the Secretary of State for Health to make sure licence applications to repurpose off-patent drugs are processed.

I’m hoping that will result in patients getting access to a greater number of cancer treatments. So too are many of our top clinicians, which is why they were happy to sign up to the letter in support of the Bill.

If you want to join us in lending your support to the proposed legislation, there’s plenty that you can do too. The Bill needs 100 MPs to vote in support if it’s to progress to the next stage, so it’s important that MPs are aware of its benefits.

There is a great resource on the Breast Cancer Now website where you can message your MP and ask them to go to the reading of the Bill on 6 November and vote in support.

Let’s hope enough of them do so to turn this important Bill into law. That way, patients can benefit through the unlocking of new indications for old drugs – putting off-patent drugs back to work.


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