The new pharmaceutical strategy for Europe, which was first presented by the European Commission in 2020, aims to make the European pharmaceutical industry fit for the future and competitive. The aim is to strengthen security of supply, promote research and innovation and improve access to affordable medicinal products. The European Commission published its reform proposals on 26 April 2023 by means of the so-called "EU pharmaceutical package". The reform proposals also respond to weaknesses that have become apparent as a result of the COVID-19 pandemic.
The reform at a glance: goals and challenges
The significant changes introduced with the reform proposals include new regulations on data exclusivity, market exclusivity for orphan drugs and measures to combat antimicrobial resistance. The intended environmental requirements are also noteworthy. In future, an "environmental risk assessment" should minimise environmental impact over the entire life cycle of a medicinal product.
On 10 April 2024, the European Parliament adopted the EU Pharma Package at first reading and introduced its amendments to the Commission's proposals. Three central topics characterise the discussion:
- The data exclusivity that regulates the market access of generics.
- Compulsory licences in times of crisis to avoid supply bottlenecks.
- Unitary supplementary protection certificates (SPCs), which are intended to harmonise patent protection throughout Europe.
The aim is to speed up access to medicines and at the same time ensure Europe's competitiveness as a centre for pharmaceuticals. However, the political process is stalling as numerous details remain controversial.
Three central points of contention
1. Document protection: flexibilisation or weakening?
Data exclusivity protects the data of originators from being used by generic manufacturers. The 8+2+1 rule currently applies: eight years of data exclusivity, two years of market exclusivity and a further year for new indications.
The EU Commission proposed a shorter, more flexible regulation (6+2+0.5+0.5+1+2), which can be extended under certain conditions. The European Parliament introduced a 7.5+1+0.5+2 regulation, which provides for up to 11.5 years of data exclusivity, but only if there is demonstrable added value for patients or cooperation with European research institutions.
While generics manufacturers would benefit from shorter deadlines, the pharmaceutical industry warns that a shortening could weaken research incentives.
2. Compulsory licences: a tool for crises?
In order to prevent future supply bottlenecks, the European Commission is proposing an EU-wide regulation for compulsory licences. This would make it possible to produce generics or biosimilars more quickly in emergency situations without having to obtain the consent of patent holders.
However, opinions differ widely here: while some stakeholders welcome the measure as necessary to ensure security of supply, critics warn of abuse and a weakening of patent protection.
3. Unitary supplementary protection certificates: harmonisation of SPCs
Supplementary protection certificates extend patent protection for medicinal products by up to five years. The Commission is proposing the introduction of a centralised, unitary SPC system that would apply throughout Europe. This is intended to reduce bureaucracy and simplify the granting process. While large companies welcome the proposal, smaller market participants criticise potential hurdles for implementation.
Conclusion: a reform package between opportunities and uncertainty
Due to these points of disagreement, the reform could not be finalised before the European elections. The EU Council has not yet found a common position, as key issues such as the incentive systems for research and market access for generics remain controversial. The Polish Presidency, which began on 1 January 2025, has already announced that it will continue to work on the revision of pharmaceutical legislation. Depending on the progress of the negotiations, an agreement between the member states could be reached in the first half of 2025.
The biggest challenge remains to strike a balance between incentivising research into innovative medicines and competition from generics and biosimilars. At the same time, solutions to combat antimicrobial resistance and reduce environmental pollution must be given greater consideration.
In conclusion, it can be said that the EU pharmaceutical package has the potential to reform the pharmaceutical market in the long term. It remains to be seen whether agreement will be reached in the course of 2025. However, it is clear that the decisions made in the coming months will have a significant impact on the future of European pharmaceutical supply and innovation.
