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Minister for Health and Senior Citizens
European Commission
DG Health and Food Safety
Date: 05-01-2021
Section: MEDINT
Case Officer: DEPKLN
Case: 2017635
Doc. No.: 1526660
Consultation response on Inception Impact Assessment on
the revision of the EU legislation on medicines for children
and rare diseases
The Danish Government welcomes this opportunity to put forward our response to
the consultation over the inception impact assessment on revision of the EU
legislation on medicines for children and rare diseases published by the Commission
on 25 November 2020.
The Regulation for medicines for rare diseases and the Regulation for medicines for
children were initially adopted to improve treatment options for children and
patients affected by rare diseases. Both Regulations introduced a mixture of
obligations, incentives and rewards to address the apparent market failure in these
areas. The joint evaluation of the two Regulations has shown that although both
legislative instruments have stimulated research and development of medicines for
children and rare diseases the legal framework also has significant shortcomings.
The inception impact assessment lists a number of different policy options for
revision of the two regulations, respectively, and describes how interested parties
will be consulted in the process.
The Danish Government welcomes the initiative to address the shortcomings of the
existing legal framework.
However, the design of incentives and rewards under the two regulations have a
heavy impact on business decisions involving investments, research and development
for new medicines, where a solid IPR protection ensures and maintains an innovative
life science sector in the EU. Business decisions are also influenced by a number of
other factors such as national systems and regulations for pricing and
reimbursements of medicine and global competition, why it is important that a
comprehensive impact assessment is performed before policy decisions are made
and the legislation is drafted.
The inception impact assessment reveals that there are many interconnected and
complex issues once you start looking at the current regulation. The Danish
Government notes with satisfaction that an impact assessment will be performed and
that a study to support the assessment will be commissioned to provide a solid base
for the contents of the future legal proposals.