LSHC Horizons Brochure 2024 - Flipbook - Page 79
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Europe
Early access in Europe: New schemes and trends for
compassionate provision of unapproved product
There is an increased number of medicinal
products for unmet medical needs in late
stage clinical development or under pending
marketing approval in the European Union.
Some of these products may already be author
in the U.S., but not yet in Europe. These are the
situations where increasingly informed patients
seek for access to these products – and treating
physicians requesting compassionate supply by
the respective pharma and biotech companies.
We see an increased trend at our companies to
affirmatively address these requests for ethical
reasons but also, where possible, to generate
early revenue.
In each of the European jurisdictions there are
schemes to make product available prior to
marketing approval. Often, patients can even
receive reimbursement for the costs of such
products. While the approach of companies
may be to make the product available across
Europe or even beyond, each jurisdiction has
its own schemes which vary significantly.
Taking two examples, Germany and France:
In Germany, early access via importing
commercial product from countries where the
product is already authorised, often the U.S.,
allows companies to generate revenue and
patients a chance to receive reimbursement.
The other scheme for wider compassionate
use programs for patient cohorts, however,
stipulates that the product has to be provided
by the company free of charge. However, it
may still be ethical and commercially viable,
also considering a later commercial launch in
Germany, to supply product under this scheme.
Charlotte Damiano
Partner
Paris
In France, the situation is different and
two categories of early access programs
are available: (1) “compassionate access”,
designed for a specific patient at the request
of a prescriber; originally, the “compassionate
access” was intended for products at an
early stage of development in Europe (often
authorized in the U.S.) but is now authorized
much more widely by the French authorities.
The second is “early access”, which allows a
cohort of patients to be treated even before
marketing authorization. The distinctive
feature of these two systems compared to other
European schemes is that they allow companies
to set a temporary sales price, subject to
substantial clawbacks once the reimbursement
price has been negotiated. In the case of “early
access", the company also undertakes to
finance the collection of data to be used in
the scientific evaluation of the product.
In other jurisdictions, again, the situation
is different.
We have done research on the different schemes
applicable in many jurisdictions. Further, we
conducted audits with clients on the compliant
implementation of early access throughout
the world. In this regard, please refer to the
article on “Compliance and overarching
recommendations for early access” in our
brochure “Early access to pharmaceutical
products in major European markets”.
Dr. Jörg Schickert
Partner
Munich
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