The Chief Executive of the Association of the British Pharmaceutical Industry (ABPI) has expressed concerns that a lack of detail and funding for the Early Access to Medicines Scheme (EAMS) need to be addressed before the scheme can begin to benefit patients.
The ABPI and the BioIndustry Association (BIA) recently held a stakeholder event in London to publicise the Medicines and Healthcare products Regulatory Agency (MHRA) EAMS.
Held on 28 April 2014, the event provided interested parties with the opportunity to understand and discuss the practicalities of implementing the scheme. Pharmaceutical and biotech companies, as well as patient groups, medical research charities and clinical researchers were invited. The event informed stakeholders on how the guiding principles of EAMS were formulated and how the scheme could benefit them.
The ABPI’s Chief Executive, Stephen Whitehead, said: “We hosted the event to increase understanding about the scheme to help companies to make an informed decision about their participation.
“The regulation and development time for any new medicine is long and complex and the scheme should ultimately help patients with life-threatening or seriously debilitating conditions, without adequate treatment options, get faster access to innovative medicines.”
The ABPI held the event to help to address the lack of detail available from the government on how the scheme will work in reality. “It soon became apparent that we were far from having the full picture about the scheme, and our member companies fed back to us that much more detail would be needed to allow them to fully evaluate the utility of EAMS,” said Mr Whitehead. “We gathered all the key stakeholders; MHRA, NHS England, Government, patient groups and NICE and also members of the industry who could talk about their own experiences and impressions of the scheme so far. The day was hugely productive.”
The interest in the scheme was evident and stakeholders were keen to work collaboratively, flexibly and, in partnership with, industry.
According to the ABPI, the event went some way to addressing some of the key questions surrounding the scheme, such as making clear that the EAMS will sit alongside the EMA’s adaptive licensing. However, discussions at the event made it clear that there are still areas that require “greater clarification”, such as:
• The timeline and framework for commissioning within the NHS
• How many centres will take part in EAMS
• How the pathway for gaining commissioning approval will work
• The process for NICE evaluation and at what stage they will be involved in the commissioning.
Mr Whitehead said that the question of how EAMS will be paid for was a significant one for delegates: “The lack of funding for the scheme…was a much discussed topic and is a key feature which the ABPI and the BIA will continue to push for, particularly at a one-year review.
“We hope these points will now be taken back to organisations and addressed as a matter of urgency so that the scheme can quickly begin to benefit patients.”