This week we submitted our response to the Ministry of Social Affairs’ consultation on EU pharmaceutical legislation: Commission proposal for a regulation and directive on medicinal products for human use (S2023/01768 ).
The bill seeks to strengthen innovation through regulatory changes and ensure access to medicines for all members of the Union.
SwedenBIO supports both these ambitions but is strongly critical of parts of the proposed reform that risk leading to the exact opposite. SwedenBIO opposes the proposal to change regulatory data protection, which is a wrong mechanism to use and which risks killing the investment climate in European life science.
In our consultation response, we address how the legislation in general may negatively affect the European innovation climate and Swedish companies, and specifically how we see it affecting the conditions for the investment climate, for orphan drugs, and for the development of new antibiotics.