The UK’s proposed scheme for early access to unlicensed medicines should be launched as soon as possible, a panel of experts has told the government.
The Expert Group on Innovation in the Regulation of Healthcare also urges ministers to conclude funding arrangements for the scheme, and calls on the Medicines and Healthcare products Regulatory Agency (MHRA) to press for “available legal flexibilities” to be used to get innovative new treatments speedily to patients.
Also, the European Medicines Agency (EMA) “should be pressed to launch a call for adaptive licensing at the earliest opportunity, so that companies could put forward pilot products,” says the Group, which was established in June 2012 following Prime Minister David Cameron’s 2011 Strategy for UK Life Sciences.
In relation to quality, safety and efficacy, the concept of adaptive licensing would need to relate to a more proactive use of existing flexibilities in European Union (EU) law; the development of new or revised legislation requires a lengthy process, says the Group.
It also points out that, this year, EMA is due to publish a number of retrospective case studies for adaptive licensing, together with guidance and a call for products to go through the process, but UK-based companies have been reluctant to come forward with specific pilot products for adaptive licensing until the details of EMA’s proposals are made clearer.
“When they are able to do so, areas that are government priority areas for action, such as antimicrobials or rare or debilitating diseases where there is unmet medical need, might be suitable candidates,” the Group suggests.
It also calls on the government to consider adopting a designation that “would send signals to investors” – as the US breakthrough designation does – perhaps in the context of the proposed UK Early Access Scheme, and for MHRA to press for Europe to consider a similar approach at EU level, “bearing in mind the need to progress quickly on this agenda, given the apparent early success of the US designation.”
Steve Bates, chief executive at the BioIndustry Association (BIA), welcomes the Group’s recommendations, pointing out that, in just a year since the new US new breakthrough designation rules were put in place, the Food and Drug Administration (FDA) has granted 32 drugs such designations and has already approved two of them.
“As well as holding the potential to significantly accelerate such treatments to those patients who need them, breakthrough designation has had a positive effect on the companies developing the products and on the investment community’s perceptive of those companies,” he added.