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ARTICLE · 22 JUNE 2026

Big News For The EU Pharma Sector!

Aera A/S
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The EU Council and European Parliament have agreed on a new “Pharma Package” – a major update to medicines rules in Europe. This is one of the biggest reforms in over 20 years. Once finally endorsed by the Council and the Parliament, the agreement will enter into force.

European UnionIntellectual Property
Mattias Salling Dahllöf
Mattias Salling Dahllöf
Alexander Bjørnå
Alexander Bjørnå
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The EU Council and European Parliament have agreed on a new “Pharma Package” – a major update to medicines rules in Europe. This is one of the biggest reforms in over 20 years. Once finally endorsed by the Council and the Parliament, the agreement will enter into force.

The agreement will:

  • Make medicines fairer and more affordable for patients
  • Strengthen the competitiveness of EU pharma and biotech
  • Improve the supply security of critical medicines
  • Support innovation while reducing unnecessary red tape

Major consequences for a biotech or pharma company’s IP strategy:

1. Exclusivity becomes more strategic, not automatic

Innovators enjoy 8 years of data protection and 1–2 years of market protection, but additional protection may depend on meeting public health goals (such as access across EU countries). IP teams may need to align patents, data exclusivity, and launch plans more closely with pricing and access strategies.

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