New initiative for medicine access

From April, the Medicines and Healthcare Products Regulatory Agency (MHRA) has been seeking applications for the Early Access to Medicines Scheme from the pharmaceutical industry and research organisations.

The scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation and where there are no suitable alternative licensed treatments.

The move comes just 18 months after Empower: Access to Medicine was launched by graduate Les Halpin (Mathematical Statistics and Operational Research 1979, Hon LLD 2011).

Les was diagnosed with motor neurone disease in 2011 and was shocked to discover there was only one drug available, which had been licensed over 20 years earlier. He spent the remainder of his life lobbying politicians, the medical profession and media to try to ensure that terminally ill patients could choose to take new medicines earlier in the licensing process, where there were no alternatives. Under the Halpin Protocol it was proposed that the medicines would only be available after the safety phase of testing had been completed and patients would have to be fully aware of any risks and give their full consent. It would also offer legal protection to the drug developer and prescriber.

Les died in September 2013, a year after his campaign was launched.

The Government announced its plans for the Early Access to Medicines Scheme in March this year and Empower held a Parliamentary Reception, attended by the Health Minister Earl Howe, later that month.

Empower: Access to Medicine has welcomed this positive step, but will be pursuing the Government to ensure the scheme works for patients and is funded appropriately.
“The campaign was launched only 18 months ago, and has achieved an awful lot in the time it has been going,” said Les’s wife, Claire (Biology 1979).

“I know that there are a lot of groups and organisations working collaboratively to achieve the same and similar aims as Empower and it is largely thanks to all of these putting pressure on the Government that we have achieved the recent breakthrough.”