UK regulator the Medicines and Health products Regulatory Agency is seeking public opinion on plans to allow patients on the National Health Service access to certain medicines before they are approved.
The Agency said it has now kicked off a 12-week consultation on the planned Early Access to Medicines Scheme, under which it would offer the NHS scientific opinion on the benefits and risks of medicines still awaiting regulatory approval.
It is envisaged that the scheme will largely apply to products in late Phase III testing, although in exceptional circumstances drugs still in Phase II could be considered, according to the regulator.
In December 2011 the government published a Strategy for Life Sciences, which seeks to make the UK an attractive place for investment by the life sciences industry, by focusing on creating a more progressive regulatory environment to fuel innovation and give patients quicker access to new medicines.
The government's criteria for the Scheme is as follows: “eligible products will be determined by a scientific opinion that the likely clinical benefits outweigh the risks identified to date where there is high unmet need; NHS funding for product must be cost effective; and the UK economy should benefit from the scheme.”
Under the plans, it will be up to the company developing the new medicine to request an opinion under the Early Access Scheme, for a basic fee of £29,000 (to recover MHRA costs). The Agency will then post its opinions on its website.
Any medicines given the green light for the Scheme will not be covered by the Pharmaceutical Price Regulation Scheme as they will be unlicensed, and as there is no other central ring-fenced funding on offer, local funders will have to make the decision on whether to pay for these drugs from their existing budgets.
The MHRA notes that the pharmaceutical industry has agreed that there will be a single price charged across the UK for these medicines.
Commenting on the consultation, Professor Sir Kent Woods, the MHRA's chief executive, said the Agency is “committed to ensuring that where pharmaceutical companies want to make their new medicines available under this scheme, clinicians treating patients have access to robust scientific information to help them to make appropriate treatment decisions".
While Steve Bates, chief executive of the BIA, welcomed the move, he also noted that "the proposal to limit the scheme to only one or two medicines a year, targeted at the end of Phase III trials, does not, in the BIA's view, meet the ambition the UK government set out in its Strategy for UK Life Sciences".
Stephen Whitehead, head of the Association of the British Pharmaceutical Industry, said it will "work closely with all relevant stakeholders to ensure that the Scheme achieves its primary aim of improving patient access to the most promising treatments whilst closely monitoring patient safety.”
It is hoped that the Early Medicines Access Scheme will be in place by the end of the year.
Elsewhere, the MHRA is taking forward another commitment from the Life Sciences Strategy, by setting up a group of experts from the government, the NHS, industry, regulators and the academic and third sector communities, that will meet quarterly to discuss healthcare regulation issues.
This group will have a role in assessing the outcome of the Early Access Scheme consultation, it said.