LS&HC Horizons 2022 - Flipbook - Page 58
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
58
Europe
Early access in early launch markets France and Germany
Pharma and biotech companies wanting to bring a new product
to patients in the EU go first to France and Germany. The reason,
besides the size of these markets, is local reimbursement schemes.
Both countries allow companies to commercially launch a product and
generate revenue – and only then negotiate the price – thus making
France and Germany very attractive early launch markets.
In addition, many companies enter Europe by way of early access
programs in France and Germany. These programs allow for prelaunch access to drugs in advance of marketing authorization
(MA). The overarching European law only provides a rudimentary
framework for early access such as by offering a product for
compassionate reasons. Local laws differ widely and determine the
early access pathway.
In France, a major reform of early access came into force on 1
July 2021. The basic principles of early access remain, such as
delivery to health care providers (HCPs) under a free price subject
to repayment in exchange for immediate financing by the health
insurance. However, the decision-making system and criteria have
been clarified. In particular, two health authorities will be involved
to decide on the presumption of innovation and benefit / risk,
depending on whether the request for early access is made before
or after MA. The financial regulation system has also been made
more complex. Also, to compensate for its deficit in terms of time
to market for innovations compared to other European countries,
the French government introduced a system of direct access to the
market for innovative products that cannot benefit from early access,
following the example of the German model, such as where the
product is already authorized elsewhere.
Germany, likewise, is an early launch market. Germany allows
companies to fully commercially launch a pharma product and to
determine the price for the product. The commercially launched
product can be sold to the entire German population at that
price. Only one year after the first commercial sale a negotiated
reimbursement price kicks in. However, even before such commercial
launch, many companies bring their product to German HCPs and
patients by way of early access, either by way of allowing importing
product, which is authorized elsewhere, or under an official
compassionate use program, like in France.
Charlotte Damiano
Partner, Paris
Dr. Jörg Schickert
Partner, Munich
For more details we refer to our
client brochure Early Access to
pharmaceutical products in
major European countries.
