LS&HC Horizons 2022 - Flipbook - Page 59
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
59
Europe
The European Commission’s revision of EU pharmaceutical law, in particular relating to
regulatory data protection and market exclusivity
The European Commission is revising the EU pharmaceutical
legislation. In addition to assessing supplementary protection
certificates (which extend patent protection) and the orphan drug
regulation including orphan market exclusivity, regulatory data
protection is one of the main topics for the review.
Regulatory data protection aims to reward innovation and
development of new medicinal products. It is an incentive in return for
the mandatory pre-clinical and clinical data that must be submitted
in order to obtain a marketing authorization. Currently, innovator
medicinal products enjoy eight years of data exclusivity during which
no generic or biosimilar marketing authorization application may be
filed. During another two years of market exclusivity, no generic or
biosimilar medicinal product maybe placed on the market.
In its review of the current legislation, the European Commission
notes the importance of supporting innovation, especially to address
unmet medical need. At the same time, it strives to ensure access to
affordable medicines, by supporting competitiveness and availability
of generics and biosimilars.
Several alternatives to the current system are being considered. These
include (i) differentiating protection periods depending on the type
of product; (ii) reducing the current protection periods allowing for
earlier generic and biosimilar market entry; and (iii) introducing
new types of incentives such as a transferable exclusivity voucher or
a priority review voucher; and (iv) allowing early generic entry in the
event of delayed innovator market launch across the EU.
The European Commission is expected to present proposals for
revised EU pharmaceutical legislation by the end of 2022.
Hein van den Bos
Partner, Amsterdam
