Emmanuel Macron announced plans to
replicate Germany’s DiGA Fast Track process.
French president Emmanuel Macron has
announced plans to follow in Germany’s footsteps by making digital therapeutics
available on prescription through the statutory health system.
In 2019 Germany introduced its DiGA Fast
Track process for rapid approval, testing, piloting and evaluation of health
apps, which is open to all companies in the European Union (EU).
Speaking at the HealthTech Innovation Days
(HTID) event in Paris earlier this month, French President Emmanuel Macron
announced: “We are also creating an immediate access procedure for market
access for innovative products, the same way as in Germany. I’m very direct
with you – we will just replicate what works in Germany.”
The DiGA initiative, created under the 2019
Digital Healthcare Act (DVG), means doctors can prescribe apps to the 73
million German citizens covered by public health, with costs reimbursed through
health insurance.
From 2020, medical apps for patients which
are CE-marked as Class 1 and 2a low risk medical devices have been able to
apply for fast-track market entry in Germany. There are currently 22 apps
approved for reimbursement, of which almost 50% are focused on mental health.
WHY IT MATTERS
The ‘fast track’ process is aimed at easing
the path for innovation into regular care. Under the initiative, developers no
longer have to carry out randomised clinical trials to deliver evidence and can
use other methods to demonstrate care benefits to the German Federal Institute
for Drugs and Medical Devices (BfArM).
As well as providing reimbursement, the
DiGA scheme can increase patient and provider awareness and trust in digital
therapeutics.
THE LARGER CONTEXT
The European Commission is creating a
common regulatory framework for digital transformation in all EU member states,
including regulations for data privacy - GDPR, medical devices, artificial
intelligence, and health technology assessment.
Meanwhile in South-West England, millions
of people will be given access to digital health libraries, through a
partnership between the Organisation for the Review of Care and Health Apps
(ORCHA) and seven Integrated Care Systems (ICSs). Each library will provide
hundreds of health apps relevant to different medical and lifestyle issues,
with a focus on mental health support and weight management.
NHS Scotland has also launched a digital
initiative to help adults suffering from anxiety and insomnia by providing free
access to Big Health’s digital therapeutics apps Daylight and Sleepio.
ON THE RECORD
Armin Scheuer, VP of business development
international at HIMSS, said: “There is no such thing as a European healthcare
system. All healthcare is really within the responsibility of the members
states. Nevertheless, the two biggest economies of the EU economy, Germany and
France have started to align some of their approaches and at the same time
these countries are really the engines of EU integration.
“We can expect that
this process and many other steps currently happening could drive the
development of a more aligned European health sector – certainly when it comes
to digitalisation.”
