Life Sciences Horizons Brochure 2025 - Flipbook - Page 100
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2025 Horizons Life Sciences and Health Care
Parliament’s opinion on European Commission’s data exclusivity proposal
In April 2023, the European Commission published
a proposal to reform the EU’s pharmaceutical
legislation, in an effort to make medicinal products
in the EU more accessible, affordable, and innovative.
In April 2024, the European Parliament adopted
its position on the legislative text, with several
amendments to the Commission’s proposal. The
Parliament’s position is especially important with
regard to regulatory data protection (RDP) and
orphan market exclusivity (OME).
RDP: The current standard period of RDP of which is 8 years,
would be reduced to 7.5 years, instead of 6 years as proposed
by the Commission. Extensions would be possible if:
In terms of reducing regulatory data exclusivity terms, the
Parliament’s text represents less of a change in status quo
compared to the original Commission proposal; yet, it still
shortens the overall data exclusivity periods.
The next step is for the EU Member States in the Council to take
a position on the Parliament’s text, after which the Commission,
Parliament, and Council will start negotiations on the final form.
The new protection periods proposed for regulatory exclusivity
terms could potentially affect the protection of products that are
already in the pipeline. Therefore, when developing and
investing in novel products, medical product sponsors should
take into account the potential modifications in EU regulatory
exclusivity rights.
the product addresses an unmet medical need (one
year extension);
comparative clinical trials are conducted (six months
extension); and/or
a significant share of the product’s R&D takes place in the EU
and at least partly in collaboration with EU research entities
(six months extension).
The Parliament aims to cap the combined data protection period
at 8.5 years. After the RDP, a one-time extension (one year) of the
two-year market protection period could be granted if the sponsor
obtains marketing authorization for an additional therapeutic
indication that provides significant clinical benefits compared
to existing therapies.
OME: The current baseline of 10 years would be reduced to 9 years
for most orphan medicinal products. This exclusivity period can
be extended by two years (11 years in total) if the product
addresses a “high unmet medical need.” The Parliament agrees
with the Commission to abolish separate 10-year orphan market
exclusivity periods for new orphan indications and to allow
marketing authorization applications two years before expiry
of OME.
Hein van den Bos
Partner
Amsterdam
Julia Mischie
Associate
Amsterdam
Milan Tuijp
Junior Associate
Amsterdam
Band 1
for Life Sciences in
Chambers Europewide, 2025
