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EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

 
• By Eliza Slawther

High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.

Confusing Conversation
Industry needs clarity on terminology used in the new EU pharma regulation • Source: Shutterstock

The European Commission, European Parliament and Council of the EU must ensure that the ongoing reform of the pharmaceutical legislative framework supports the pharmaceutical industry and the competitiveness of the EU, according to EUCOPE, the organization which represents small and medium-sized pharmaceutical and biotech companies.

In particular, the current draft of the new general pharmaceutical legislation contains some “subjective” terminology that should be made clearer, particularly to attract investment in the development of medicines,

Key Takeaways

  • EUCOPE has called for more clear definitions of terminology such as high unmet need in the new EU pharmaceutical legislation to improve predictability for industry.

  • The organization is supportive of the overall aims of the legislative reform and of other initiatives, such as the HTA Regulation and EHDS

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