LSHC Horizons Brochure 2024 - Flipbook - Page 80
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Europe
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EU regulatory data exclusivity under the EU Pharmaceutical Law Package
In an effort to make medicinal products in the
European Union more accessible, affordable
and innovative, the European Commission
published a proposal to reform the EU’s
pharmaceutical legislation (Pharmaceutical
Law Package). The proposal, which was
published on 26 April 2023, is expected to
drastically change a number of topics within
pharmaceutical law. One of the main topics
being regulatory exclusivity rights – more
specifically – regulatory data protection (RDP)
and orphan market exclusivity (OME).
RDP: The current standard period of RDP
of eight years will be reduced to six years.
Extensions would be possible if:
• the product is launched and continuous
supplied in all 27 EU Member States (two
year extension);
• the product addresses an unmet medical
need (six months extension); and/or
• comparative clinical trials are conducted (six
months extension).
A further extension, on top of the baseline and
possible additional protection period, could be
available if:
• a new therapeutic indication with significant
clinical benefit compared to existing
therapies is approved (one year extension).
Hein van den Bos
Partner
Amsterdam
OME: The current baseline of ten years is
reduced under the proposal to nine years for
most orphan medicinal products. This market
exclusivity period can also be extended under
certain conditions. Under the proposal, there
will not be any separate 10 year orphan market
exclusivity periods for new orphan indications:
those would only result in a one year extension.
Concerns have been raised that the conditions
for obtaining any of these extensions are
uncertain and complex. For example, the
extension for the launch in all EU Member
States within two years after marketing
authorization is controversial, due to hurdles
in opportunity for effective launch, also due to
different and time-consuming procedures for
pricing and reimbursement in the various EU
Member States.
For 2024, it is expected that political debate
and policy advocacy around the Pharmaceutical
Law Package will continue, resulting perhaps
in amendments to the proposal. If and when
adopted, there will be a transition period.
Nevertheless, the new protection periods for
regulatory exclusivity rights could potentially
affect protection of current pipeline products.
When developing and investing in novel
products, it is recommended to already take
into account the potential modifications and
reductions in EU regulatory exclusivity rights.
Julia Mischie
Associate
Amsterdam
Milan Tuijp
Junior Associate
Amsterdam
Band One for Life
Sciences in Chambers
Europe-wide, 2024
