Out-Law News 3 min. read
24 Nov 2014, 11:54 am
The 'Innovative Medicines and Med Tech Review' will begin early in 2015 with a report detailing the findings expected to be published in the summer next year.
Life sciences minister George Freeman said the review would cover a range of issues.
"It will focus on innovative types of product: in particular, drugs based on stratified medicine, new diagnostics, and digital health technologies," Freeman said. "It will examine the pathway from ‘first in human’ trials, through licensing and health technology appraisal, to commissioning, reimbursement and clinical practice. It will set out both short and long-term options for action by government and relevant bodies (including the National Institute for Health and Care Excellence, Medicines and Healthcare Products Regulatory Agency and NHS England)."
Freeman said the government expects the review to "recognise the public spending environment in which the NHS operates, and the overriding need to ensure value for money".
"[The review] will respect the parameters of the 2014 Pharmaceutical Price Regulation Scheme for branded medicines, and take account of the existing statutory responsibilities of NHS bodies and the European legislative frameworks for the regulation and procurement of medicines and medical technologies," he said.
In a white paper (20-page / 1.58MB PDF) published earlier this year, life sciences experts Paul Ranson and Helen Cline of Pinsent Masons, the law firm behind Out-Law, identified the potential for new technology in the health sphere to improve patient treatments and research and development into new drugs, including the effectiveness of clinical trials.
However, Ranson and Cline also said that there were legal and regulatory barriers that need to be overcome by drugs manufacturers to cut the time and associated cost of developing new treatments.
"Advances in a wide range of fields from genomics to medical imaging to regenerative medicine, along with increased computational power and the advent of mobile and wireless capability are allowing patients to be treated and monitored more precisely and effectively and in ways that better meet their individual needs," the Pinsent Masons paper said. "The current approach to regulation of medicines poses particular challenges in the era of ‘stratified medicines’ which involves looking at smaller groups of patients to try and find ways of predicting which treatments particular illnesses (e.g. cancers) are likely to respond to."
"There are practical challenges in building the clinical evidence base necessary for approval under current regulatory mechanisms where patient populations are very small," it said. "The current regulatory and HTA (Health Technology Assessment) processes and policies need to evolve in response to, and in anticipation of, scientific developments that will be critical for the development of a stratified and more personalised approach to precision medicines."
A major research initiative called the 100,000 Genome Project is in progress in the UK. Under the scheme, as many as 100,000 people's DNA is to be sequenced as part of research into the treatment of a number of chronic illnesses.
Earlier this month, Genomics England announced that it was seeking researchers, NHS clinicians and medical students to join a new 'Clinical Interpretation Partnership' (CIP) to work on the project, which would involve analysing the data generated in the research. At the time, Cline said that the project has the potential to deliver more personalised treatments in future.
"Digitalisation is recasting the entire healthcare system allowing patient self reporting in real-time which could potentially have a quantum effect on drug development pathways, allowing patients to have a bigger voice and enabling them to communicate what is of beneﬁt to them," Cline said.
However, there are already a number of initiatives, both UK and EU, aimed at helping medical researchers and drugs manufacturers to develop new drugs and get them out into the market faster.
Example's include the UK's Early Access to Medicines Scheme (EAMS) which allows drug companies to follow a fast-track process for bringing their products to market if they can show first show that their medicines, despite still being developed, should be classed as a 'promising innovative medicine' (PIM) and the European Medicines Agency's adaptive licensing pilot which is a flexible pathway for the approval of innovative medicines to treat unmet medical needs as understood in the current EU legislation.
The Medical Innovation Bill, currently before the UK's parliament, is also aimed at fostering innovation in health care. The purpose of the Bill is to encourage doctors to innovate responsibly when prescribing medical treatments by removing the threat that they could be held negligent for their actions in deviating from traditional treatment plans.