New protocol could lead to better medicine access

Dr Les Halpin (Mathematical Statistics and Operational Research 1979, Hon LLD 2011) was diagnosed with motor neurone disease (MND) in 2011 and was shocked to discover there was only one drug available, which had been licensed over 20 years earlier.

He launched the campaign Empower: Access to Medicine which aims to find ways for drugs to be taken earlier in the licensing process, by people with life-threatening conditions who have no alternatives.

This summer the organisation hosted a round-table discussion of experts, from the pharmaceutical, medical, ethical, regulatory, legal, academic and insurance communities and chaired by the eminent immunologist, Professor Sir Peter Lachmann. The group was considering the barriers which currently exist to accessing new medicines.

As a result of these discussions and its work over the past year, Empower has launched the Halpin Protocol. Its aim is to give patients the choice of trying new medicines earlier in the licensing process, where they have no other alternatives. At the same time it would offer legal protection to the drug developer and prescriber.

The medicines would only be available after the safety phase of testing had been completed and the patients would have to be fully aware of any risks and give their full consent.

Using the data from these patients might reduce the need for the expensive Phase lll randomised trial process, which currently accounts for about 50 per cent of the drug development costs. Les believes that cost saving could encourage more companies to develop medicines for less common diseases and conditions.

“What is clear to me is that there are no simple solutions, rather a variety of paths that one could take,” he said. “It certainly seems there is a significant degree of flexibility in our existing systems of drug approval that could be better utilised to the benefit of patients who cannot currently access satisfactory treatment.

“I look to America for some of the positive headway they have made in fast tracking certain drugs and wonder what lessons can be applied in Europe.”

The Halpin Protocol is now going out to consultation led by Sir Peter Lachmann and Les’s MP, Geoffrey Clifton-Brown. Its launch coincides with the introduction to the House of Commons this week of the Medical Innovation Bill, which calls for doctors to be given more space to innovate responsibly.

Read more about the Halpin ProtocolHalpin Protocol‌.