How to promote medical innovation

July 6, 2015 4:01 pm

When Tory MP Chris Heaton-Harris introduced a Private Member’s Bill last week, he kicked off a renewed backbench effort to ensure patients with rare diseases have access to new treatments. Mr Heaton-Harris’s efforts in the form of the Access to Medical Treatments (Innovation) Bill weren’t alone. The House of Lords also saw the reintroduction of Lord Saatchi’s much talked-about Medical Innovation Bill.

But for Westminster’s current interest in medical innovation and access to treatment, it’s wrong to suggest – as some have – that these Bills are a panacea. Actually, the suggestion is wide of the mark. Neither Bill addresses issues like funding for new treatments, or breaks down institutional and regulatory barriers to research and clinical trials.

The Bills seek to allow patients’ access to drugs and treatments yet to receive full clinical approval, while allowing the pharmaceutical industry to trial treatments without fear of excessive litigation. The goal is to create an environment that promotes innovation and the development of new treatments.

Both Bills have received the backing of some Conservative ministers, with Life Sciences Minister George Freeman stating his support – conditional on the inclusion of safeguards against dangerous treatments. But the legislation will likely be subject to the same criticisms received by Lord Saatchi’s bill in the last parliament, which received a considerable amount of support but was blocked by the Liberal Democrats.

Health Select Committee chair Dr Sarah Wollaston argued that the previous Lord Saatchi Bill endangered patients by removing protections against potentially damaging treatments. Sir Robert Francis QC, the author of Mid-Staffordshire reports, dismissed the claim that the Bill would foster innovation, saying “the law of negligence does not prevent responsible innovation and never has.” Even the pharmaceutical industry, which some quarters claimed would benefit from the Bill, expressed doubts over its need, with the Association of the British Pharmaceutical Industry (ABPI) meeting with the Department of Health in early 2014 to raise concerns about potential unintended consequences.

But neither new Bill looks at funding for new treatments. Speaking shortly before NHS England published its annual investment decisions for certain specialised services, which left out treatments for rare conditions like mesothelioma and phenylketonuria, James Palmer, NHS England’s national clinical director for specialised services warned the NHS won’t be able to afford many new drugs and treatments, due to a shift in focus towards primary and community care. He said that NHS England had forecast an annual cost increase for drugs in specialised services of 11%, rising from £2.4 billion in 2013-14 to £4.5 billion in 2019-20. But, this increase will not be enough to pay for all the new drugs. The knock-on effect for the pharmaceutical industry will be a shift in plans for the drugs that the industry can bring to the market.

So where does the solution lie? Partly, with the Government’s ambitious Accelerated Access Review, which will bring together government bodies, the pharmaceutical industry and patients to break down the barriers to treatment innovation and uptake. Due by the end of 2015, it will not only address existing processes to bring drugs to proof of concept, it will specifically look at how NHS England can commission drugs more effectively. However, pricing is likely to remain a difficult issue to resolve, with a fine balance to be achieved between a fair deal for developers of treatments and costs to the NHS.
lised services of 11%, rising from £2.4 billion in 2013-14 to £4.5 billion in 2019-20. But, this increase will not be enough to pay for all the new drugs. The knock-on effect for the pharmaceutical industry will be a shift in plans for the drugs that the industry can bring to the market.

So where does the solution lie? Partly, with the Government’s ambitious Accelerated Access Review, which will bring together government bodies, the pharmaceutical industry and patients to break down the barriers to treatment innovation and uptake. Due by the end of 2015, it will not only address existing processes to bring drugs to proof of concept, it will specifically look at how NHS England can commission drugs more effectively. However, pricing is likely to remain a difficult issue to resolve, with a fine balance to be achieved between a fair deal for developers of treatments and costs to the NHS.

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