Expert group calls for earlier patient access to medicines

The Expert Group on Innovation in the Regulation of Healthcare of the UK's Medicines and Healthcare products Regulatory Agency is calling for greater uptake of existing legal flexibilities to accelerate patient access to innovative medicines to address areas of unmet medical need and urges the government to launch the scheme as soon as possible.

In its report, Innovation in the regulation of healthcare, the Expert Group urges the MHRA to press the European Medicines Agency (EMA) to launch adaptive licensing at the earliest opportunity.

In addition, the Group recommends that the government considers accommodating within the scheme a designation that a product was a potential candidate for the early access scheme.

The MHRA Innovation Office – which was set up in March 2013 – will continue to be available to help organisations who are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes so that they are able to progress their products or technologies. In addition, the Agency offers a scientific advice service to advise applicants in the design of their development programmes.

'The MHRA is committed to play its part in creating an environment that will encourage innovation and help patients get faster access to new, innovative medicines and treatments,' said Ian Hudson, Chief Executive of the MHRA.

The MHRA is committed to play its part in creating an environment that will encourage innovation and help patients get faster access to new medicines

'We want to see improvement in the health of millions of people. There are a range of regulatory tools that can be appropriately used to allow innovative products to be developed in an optimal way for the benefit of public health. Organisations developing innovative products can come to us as a one stop shop for scientific legal and regulatory advice.'

Steve Bates, Chief Executive of the UK's BioIndustry Association (BIA), urges the government to implement a properly funded and reimbursed Earlier Access to medicines Scheme (EAS).

'I am also pleased that the expert group wants the European Medicines Agency to launch a call for adaptive licensing at the earliest opportunity so that companies could put forward pilot products; and that the group proposes the idea of adopting a new breakthrough designation for new therapies both at a UK and EU level,' he said.

'In just a year since new rules were put in place for the development of treatments in the US, 32 drugs have been granted breakthrough designation by the US regulator, the Food and Drug Administration (FDA). This designation has rapidly speeded up the process for drugs to become available for patients who need them. These have been for products where there is a desperate need for new drugs, for example in multiple myeloma, cystic fibrosis, hepatitis C, acute heart failure and Duchenne muscular dystrophy. Two drugs with breakthrough designation status have already been approved by the FDA.

'If UK patients are to benefit from the most promising new drugs and UK biotech companies are to develop those therapies here rather than overseas we need a similar 'breakthrough designation' scheme here. 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 perception of those companies.'