EU revises pharma package law for the first time in 20 years

to improve access to generic medicines

European Council approves the revision; final approval by European Parliament pending

Innovative drug manufacturers to enjoy 8 years of data exclusivity and up to 2 years of regulatory protection

Intellectual property rights waived for generic and biosimilar drugs to support early market entry

The European Union (EU) is pushing for revisions to its “Pharmaceutical Package” law on major drugs for the first time in 20 years.

 

The core of the revision, which is now awaiting final approval by the European Parliament, can be summarized as expanding the exclusivity of innovative drugs and strengthening supply obligations within Europe.

 

In addition, measures such as exempting relevant intellectual property rights are being promoted to improve access to biosimilars and generics.

 

According to the Korea Biotechnology Industry Organization on the 10th, the European Council (EC) recently agreed to the European Commission's revision of the “Pharmaceutical Package.” The only remaining procedure is the final approval by the European Parliament.

 

The Pharmaceutical Package, established in 1965, forms the foundation of pharmaceutical laws in Europe.

 

The last revision was in 2004.

 

However, over the past 20 years, issues regarding pharmaceutical access have been consistently raised, particularly in certain countries.

 

In response, in April 2023, the European Commission drafted a revision to the pharmaceutical package law.

 

The revision focuses on three main points: extending protection for innovative drugs, imposing a supply obligation for pharmaceuticals, and supporting the early entry of generics and biosimilars.

 

First, to protect innovative medicines, additional incentives will be provided to companies that develop and produce them.

 

Specifically, companies producing innovative medicines will be granted an 8-year data exclusivity period.

 

During this period, competing companies will not be able to access the development data for the medicine.

 

Additionally, companies producing innovative medicines will be eligible for a 1-year regulatory market protection benefit.

 

This benefit may be extended to 2 years if certain conditions are met.

 

Furthermore, a new provision (56A) will be added to strengthen supply obligations.

 

EU member states will be able to impose obligations on drug marketing authorization holders to ensure that their patients have sufficient access to necessary drugs.

 

Early market entry for generics and biosimilars will also be supported.

 

To this end, the provisions known as the “Bolar exemption” are clarified.

 

The Bolar exemption recognizes exemptions from certain requirements, allowing generic and biosimilar manufacturers to conduct clinical trials and prepare regulatory documents for patented drugs.

 

This revision ensures the availability of generic and biosimilar drugs on the first day after patent expiration.

 

Once a patent or exclusive period expires, competitive products (generic drugs) can be launched immediately without bureaucratic delays.

 

If a drug is sold after patent expiry, its generic and biosimilar manufacturers can complete the submission of a Health Technology Assessment (HTA) beforehand.

 

Furthermore, they can participate in national tenders through hospital contracts even before the exclusive rights of the original manufacturer expire.