Early Access Scheme
We are proud to update you on a significant development for the campaign. After 18 months of activity and following our constructive roundtable with the Health Minister Earl Howe, the Government have committed to an Early Access Scheme.
At this stage we only have the preliminary details, however, initial analysis indicates that the Government have adopted many of the recommendations that we have made over the course of the campaign.
Empower: Access to Medicine was invited to provide a quote, alongside the Health Secretary, Jeremy Hunt, and Cancer Research UK, in support of the new scheme.
Claire Halpin, Les’ wife, had this to say:
“There is no question that Les Halpin, my husband and founder of the Empower: Access to Medicine campaign, would have recognised this significant step forward on the road to ensuring those patients in desperate need have the opportunity to access treatments they could not in the past.”
“Empower: Access to Medicine welcomes this announcement and looks forward to working with the Department of Health and the MHRA to make sure that this scheme truly works for those with life-threatening illnesses and unmet clinical need. For many of these patients do not have the luxury of time.”
Announcing the scheme Jeremy Hunt said:
“Making Britain the best place in the world for science, research and development is a central part of our long term economic plan.
"This ground-breaking scheme will provide cutting edge medicines earlier, give hope to patients and their families and save lives. And as part of our strategy for Life Sciences it will create more jobs and opportunities for people, helping secure a better future for our country.”
Geoffrey Clifton-Brown, Les Halpin’s local MP who has played a pivotal role in promoting the campaign at Westminster said:
“My late constituent, Les Halpin, who died of Motor Neurone disease towards the end of last year, asked me to spearhead a campaign to persuade the Government to allow terminally ill patients the chance to participate in early trials for new medicines.
“This has been an active campaign with questions and debates in the House of Commons and all sorts of events in Westminster, most recently a roundtable with a range of experts from the field, affected patients and the Rt Hon Earl Howe, Parliamentary Under-Secretary of State for Quality in the Department of Health.
“I am therefore delighted that the campaign appears to have succeeded with the Secretary of State, the Rt Hon Jeremy Hunt MP saying that severely ill patients with life-threatening and seriously debilitating conditions will be offered the lifeline of trying ground-breaking new medicines years before they would normally reach the market via the Early Access to Medicines scheme.
“This is clearly a win win situation. It is a win for patients with terminal illnesses and gives them the hope that access to drugs will speed up for their often quite rare conditions. It is a win for clinicians in that they should have a wider range of drugs to treat those patients and it is a win for the drug companies because the period between development and use by patients should now be considerably shorter in the UK.”
How will it work?
This is a hugely important moment for the campaign, and though the detail of the scheme will no-doubt reveal challenges ahead, it is a significant positive step for patients with unmet clinical need.
The scheme will come into effect in April and will see an accelerated approval process for certain treatments. The MHRA is responsible for the scientific aspects of the scheme. The scientific opinion is provided after a two-step evaluation process. Step I, the Promising Innovative Medicines (PIM) Designation and Step II, the Early Access to Medicines Scientific Opinion.
A PIM designation (not dissimilar to the USA ‘breakthrough’ designation, advocated by Empower) will provide an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme (based on early clinical data for example from phase II studies).
The PIM designation will be issued after a MHRA scientific meeting and could occur several years before licensing. Companies who wish to gain entry into the scientific opinion step can do so if they hold a PIM designation and relevant data on quality, safety and efficacy. The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to the MHRA by an Applicant. The opinion will support the prescriber to make a decision with the patient on using the medicine, before its licence is approved.
Medicines in the Early Access Scheme will typically be commissioned by NHS England through its specialised commissioning arrangements, delivering a single national approach to commissioning.
There will be ongoing discussions on the funding mechanisms for this scheme; and Empower looks forward to working with the Department of Health and MHRA on ensuring the scheme is best fit for patients.
In the meantime I hope you can join us on 25th March in the House of Commons to mark this significant development.
Please register your interest with James Hargrave at email@example.com or by calling 0203 267 0074.