Efforts to address antimicrobial resistance (AMR) are reinforced, and stricter environmental requirements are introduced.
- We welcome the political agreement on the new legislation. It includes both small and major changes that will have significant impact in the years ahead. New policy tools can improve access to important medicines and strengthen Europe’s competitiveness. We welcome the revision and will invite Norwegian stakeholders to further dialogue during the implementation phase, says Director General Trygve Ottersen at the Norwegian Medical Products Agency (NOMA).
Better and more equitable access
A persistent challenge in Europe is that small markets are often considered less commercially attractive and may be deprioritised when new medicines are launched. The new legislation seeks to address this, including through the possibility of requiring launch across the entire EU/EEA as a condition for market authorisation.
For Norway, as a small market with a limited patient population, this can contribute to more stable supply and greater likelihood that new medicines are placed on the market.
Security of supply
Medicine shortages have received increasing attention in Europe in recent years. The new legislation strengthens security of supply through several measures:
- All countries will apply common criteria and processes to assess risks across the entire supply chain – from manufacturing to distribution.
- Improved information sharing between countries to identify supply risks at an earlier stage.
- Clearer obligations for industry regarding notification, reporting and contingency planning.
- More coordinated management of shortages across the EU/EEA.
This work is linked to other European initiatives, including the forthcoming Critical Medicines Act (CMA), which aims to ensure stable supplies of medicines of critical importance.
Strengthening innovation and Europe’s competitiveness
Strengthening Europe’s overall competitiveness is a key EU objective. The new legislation aims to make Europe more attractive for research, investment and manufacturing:
- The baseline of eight years of regulatory data protection is maintained, while market protection is reduced to one year. Companies may earn additional market protection by meeting specific conditions, such as developing medicines addressing unmet medical needs.
- Manufacturers of generic and biosimilar medicines may prepare for market entry while the originator product is still protected, enabling launch immediately after the protection period expires.
Antibiotics
Antimicrobial resistance (AMR) is one of the most serious global health threats. The new legislation introduces measures to combat resistance and improve access to antibiotics.
Antibiotics must be prescription-only medicines, and pack sizes must align with treatment guidelines, ensuring patients receive only the necessary dose.
Because antibiotic development is often commercially unattractive—due to high development costs and the need to limit use—a new economic incentive is introduced: transferable exclusivity vouchers. These vouchers provide stronger incentives for industry to develop and manufacture new antibiotics.
Simplification and efficiency
Under the current system, companies often have to apply for renewal of marketing authorisations after a certain period, and requirements may differ between countries. The new legislation significantly simplifies this:
- Renewal requirements are removed for many medicines.
- More processes are digitalised and standardised, reducing administrative burden and time.
- Assessment timelines for new marketing authorisations are reduced to 180 days.
- Paper package leaflets may be replaced by digital package leaflets.
For industry, this means that launching medicines in Europe becomes less resource-intensive. This aligns well with Norway’s objective of faster approvals where efficacy and benefit can be demonstrated.
Environmental requirements
Pharmaceutical manufacturing can pose significant environmental challenges. The new legislation introduces stricter requirements for emissions, waste management and environmental risk assessments in both production and authorisation processes. Antibiotics are subject to particularly stringent environmental requirements, due to their specific environmental risks.
The aim is to promote greener and more sustainable manufacturing methods and reduce the environmental impact of medicines.
Next steps
In the period ahead, the European Commission, EMA and Member States will cooperate on developing guidance and necessary adaptations. DMP will participate in this work.
As Norway is not an EU Member State, the legislation must also be incorporated into the EEA Agreement and implemented in Norwegian law.
See also:
EC press release: Commission welcomes political agreement on major reform of EU pharmaceutical rules
Council press release: ‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector
EP press release: Deal on comprehensive reform of EU pharmaceutical legislation
EMA press release: EMA welcomes political agreement on new EU pharmaceutical legislation