LS&HC Horizons 2023 - Flipbook - Page 64
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
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The new EU pharmaceutical law package 2023
The European Commission is set to publish its
proposal for a new general pharmaceutical law
and revision of the regulations for rare diseases
(orphan medicinal products) and pediatrics in
2023. The new package aims to be future-proof
and crisis-resistant, drawing lessons from the
COVID-19 pandemic.
Among the main topics are regulatory
exclusivity rights (regulatory data protection,
orphan market exclusivity, pediatric rewards).
This topic relates to one of the main goals of the
revision of the legislation: to foster innovation,
including in areas of unmet medical need.
The rationale of regulatory data protection is
that incentives and rewards are the foundation
on which innovation is built. By providing
exclusivity for a limited period of time after the
medicinal product is authorized, companies
are encouraged to invest in innovation, in
particular for medicines in areas of unmet
medical need.
Hein van den Bos
Partner, Amsterdam
Multiple potential controversial amendments
to regulatory data protection in the EU have
been suggested:
• Differentiating incentives and protection
periods, to specifically incentivize unmet
medical need areas? However, what is
‘unmet need’?
• Perhaps the time or extent of regulatory data
protection will be limited. Would limiting
certain incentives have a negative impact on
innovation in areas of unmet medical need?
• Could transferable innovation vouchers work
in the EU?
• Will compulsory licensing be part of
the proposal?
Coordinated EU public health research and
innovation was also suggested, in part as a
potential solution for supply shortages. Other
topics on the table include transparency
on pricing and antimicrobial resistance.
Julia Mischie
Associate, Amsterdam
