I am today announcing an external review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology.
Technological advances including digital diagnostics, cell therapy, genomics and stratified medicines are fundamentally changing the health care landscape and the way in which these advances are developed and utilised. These advances have real potential to transform prevention and treatment, improving patient outcomes. Yet they are increasingly challenging traditional systems of regulation, assessment and adoption, the subject of growing public and professional debate.
The innovative medicines and medical technology review will consider how our health care and regulatory systems can best respond and adapt to this new landscape of innovation. We are strongly placed to do this: our £1 billion National Institute for Health Research programme provides a platform for testing and evaluating medical innovations, and we have internationally—renowned expertise in evidence—based assessments of the health economics of drugs and devices.
The review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices. It will focus on innovative types of product: in particular, drugs based on stratified medicine, new diagnostics, and digital health technologies. 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.
We expect the review to recognise the public spending environment in which the NHS operates, and the overriding need to ensure value for money. It 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. It will start early in 2015 following the appointment of an independent organisation to lead the work, and report back in the summer.