The Medicines and Healthcare products Regulatory Agency (MHRA)
and the National Institute for Health and Care Excellence (NICE)
today (Wednesday, 6 August) described how the 10-Year Health Plan
will lead to faster medicines access for patients in the NHS in
England.
Under a joint information sharing agreement, pharmaceutical
companies will be invited to register early with both agencies to
allow parallel decision making over licencing and value. It will
mean more medicines receive approval for use on the NHS in
England at the same time as they are licensed for use in the UK.
It's anticipated that patients in England will receive the newest
medicines 3-6 months earlier as a result.
Part of the 10-Year
Health Plan and industrial strategy, the new joint service
reflects the government's commitment to smarter regulation, with
a target to cut administrative costs for businesses by 25%.
The enhanced coordinated approach offers medicine developers an
integrated advice service and an aligned pathway to help them
streamline both regulatory and Health Technology Assessment (HTA)
requirements and provides a clearer route to help get their
treatments to patients.
To benefit from this service, companies should register their
products on UK
PharmaScan, the national horizon scanning database, at least
three years before their expected marketing authorisation.
Health and Social Care Secretary, , said:
“This government is slashing red tape and turbocharging economic
growth of the life sciences sector so patients can get the
innovative treatments they need, faster.
“To save our NHS and make it fit for the future we have to do
things differently. By having two of our most important
regulators join forces we'll rapidly remove barriers, get
patients access to vital medicines, and grow the economy.
“With a technological and life sciences revolution taking place,
Britain should be at the forefront of it. Our 10 Year Health Plan
and Life Sciences Sector Plan will help us drive the
breakthroughs we need to be best in class and boost growth across
the country.”
Lawrence Tallon, Chief Executive of the MHRA,
said:
“We are completely focused on making sure patients can benefit
from safe, effective and affordable medicines and treatments as
soon as possible.
“We are working in closer partnership with NICE to build a faster
and more efficient regulatory system, designed to accelerate UK
market entry and deliver innovative, life-changing treatments to
NHS patients faster.
“This marks an important step in delivering smarter regulation –
strengthening UK's global life sciences offer and reinforcing our
position as an attractive destination for innovation and
international investment.”
Dr Sam Roberts, Chief Executive of NICE, said:
“Patients in England are already receiving medicines much earlier
as NICE is evaluating treatments faster than ever before. In the
year to March the time between licence and guidance was cut by
26% and when companies work with us to reduce timelines NICE
guidance is published on average just 48 days after licence.
“This joint working with our partners at the MHRA will allow us
to accelerate medicines into the NHS even further to help
transform the health of the nation, alleviate pressure on the
service where possible and support a thriving life sciences
sector in this country.”
Mark Samuels, Chief Executive of Medicines UK,
said:
“This new joint approach between NICE and the MHRA is very
welcome, particularly in supporting the earlier launch of new
biosimilar medicines, which means more patients can be treated
sooner.
“Streamlining market entry will further enhance the UK's
attractiveness as a first-choice country for introducing new
medicines.”
Richard Torbett, Chief Executive of the Association of
the British Pharmaceutical Industry, said:
“We welcome this initiative, which represents one of many
necessary improvements in the UK health and life sciences
ecosystem. Streamlining approval processes will allow both
agencies to give patients earlier and equitable access to the
innovative medicines needed to improve UK health outcomes.
“We look forward to continued progress in other areas to enable
the life sciences sector to fulfil its growth potential for the
benefit of patients, the NHS and the economy.”
