UK dementia treatment review to focus on patents, funding and getting new drugs to patients earlier

Speaking at an industry conference in London, David Cameron said that the work would focus on patents, funding and getting new drugs onto the market more quickly. The UK government would bring forward specific proposals on patent extensions, earlier access to new drugs for patients, greater research collaboration and encouraging investment by October, he said.

Life sciences experts at Pinsent Masons, the law firm behind Out-Law.com, welcomed the announcement, which they described as the latest in a string of initiatives designed to remove regulatory barriers and encourage and support innovation.

"Public private partnerships (PPPs) such as the UK Dementia Research Platform (UKDP), launched today; the increased willingness of patients to share their data, and the digitalisation of healthcare - allowing patient self-reporting in real-time - are facilitating a move to a more adaptive regulatory and reimbursement environment and with it the potential for an accelerated route to market for innovative medicines," said Helen Cline of Pinsent Masons.

"Challenges to accelerated access to medicines have included the historic lack of a co-ordinated approach to evidence-gathering by the regulatory and health technology assessment bodies; prescribing practices, often dictated by concerns around safety, liability and insurance; and eroding regulatory and intellectual property protection," she said.

Speaking at the Global Dementia Legacy Event, UK prime minister David Cameron said that government action was needed to tackle a "market failure" in dementia treatment research, with global spending at a level five times below that spent on cancer research. There are around 800,000 people living with dementia in the UK and 40 million people worldwide – a number which is set to double every 20 years, he said.

"We need investment in research, greater collaboration, better incentives for taking new treatments to market and earlier access to innovative new treatments for patients," he said.

"We need to join up the dots and create a big, bold global push to beat this. It will take years of work but we have shown with other diseases that we can make progress and we will do so again," he said.

The UK government intends to double the amount of funding it provides for dementia research by 2015 while Dr Dennis Gillings, the newly-appointed 'world dementia envoy', intends to develop a global research fund with the potential to attract billions in private and public sector investment. Meanwhile the publicly-funded Medical Research Council (MRC) has announced the creation of UKDP, a new PPP involving six biopharma companies, as the world's largest research partnership for dementia. All data collected by UKDP will ultimately be made available to the global research community after a limited exclusion period for consortium partners only.

According to the government, only three new dementia drugs have made it to market in the past 15 years. It now intends to focus on ways to encourage innovative research and development into dementia drugs, with an initial report due in October, it said. As well as looking at ways to incentivise this research through the patent system, its programme of work would look at ways of giving patients earlier access to new drugs that would take years to become available in the current system, and developing a 'sliding scale' with pharmaceutical companies to ensure that new treatments were affordable to countries across the globe, it said.

"Balancing access to new drugs with the need to ensure a positive benefit/risk data so as not to compromise patient safety is an ever-present dilemma," said life sciences expert Paul Ranson of Pinsent Masons. "Although there are existing legal mechanisms in Europe and internationally that speed up access to both unlicensed and licensed medicines, current regulatory systems are seen by some as a barrier to early patient access to new medicines."

"Efforts to remove regulatory barriers and encourage and support innovation are already underway with the announcements recently of a number of initiatives to facilitate accelerated patient access within the current legislative framework without compromising patient safety. The European Medicines Agency (EMA) recently announced a pilot scheme for its adaptive licensing pathway. Additionally, in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced a new Early Access to Medicines Scheme (EAMS). There is also a legislative proposal, the Medical Innovation Bill, in the UK to more clearly define clinicians' liability for prescribing unlicensed medicines in order to encourage and support innovation," he said.

Adaptive licensing is a term used to describe a new flexible pathway for the approval of innovative medicines to treat life-threatening conditions, the aim of which is to balance timely access for patients to possible life-saving treatments with the need for evidence of benefit and safety. While testing and development is still being carried out an initially restricted number of patients receive new treatments before they are licensed for use by more people as more information on the drug is known.

In a new paper, Pinsent Masons examined how adaptive licensing could potentially impact on drug discovery, drug development and existing business strategies within the existing flexibilities of the current regulatory and legislative framework (summary; 8-page / 1.2MB PDF). The growth of adaptive licensing could also lead to a re-appreciation of development risk by potential investors and licensees in life sciences technology where they could see earlier marketing potential, the paper said.