New EU legislation needs new ENTRI strategies

The biggest reform to hit EU pharmaceutical legislation in 20 years will soon be upon us. The European Commission’s current proposals will trigger significant changes to the way manufacturers prepare for pharmaceutical launches in Europe. The question is whether pharma and biotech companies are ready to adapt to the most extensive changes we are yet to see in the 21st Century?


Why reform and why now?

The EU pharmaceutical legislation was born from the EU pharmaceutical strategy, originally proposed in 2020. Whilst COVID-19 was a major catalyst of driving change, there were other key factors: recognition of the EU pharmaceutical sectors contribution to the economy; an ageing population's increasing need for more healthcare spend; inequitable access to medicines across the member states and the increasing cost of medicines. As a result, a roadmap for the EU pharmaceutical strategy was developed around four pillars, including both legislative and non-legislative action (see below). The desire to ensure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines is arguably the central foundation of the proposed legislation.


EU Pharmaceutical Strategy Pillars
  • Affordable access to medicines and addressing unmet medical needs, specifically for rare diseases and antimicrobial resistance.
  • Supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry
  • Enhancing crisis preparedness and response mechanisms to address medicine shortages
  • Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards

Fast forward 3 years since the initial strategy was outlined and the Commission adopted a proposal for a new Regulation and a new Directive. It is the proposed legislative changes that will have a marked impact on EU access and commercialisation strategies for all companies looking to enter Europe.


What are the proposed changes?

There are several proposed changes of the EU pharmaceutical legislation. Below we have outlined the changes that are likely to have the most significant impact to manufacturers. Ultimately the changes impact the ability of the pharmaceutical community to extend regulatory data protection (RDP) to reflect the R&D investment and innovation commitment.

Most importantly, the Directive proposal has a revised standard RDP of six years, down from the current eight years. There are, however, several methods in order to extend the exclusivity, the question is how realistic these extensions are to achieve. The longest additional RDP comes from what the Commission describe as ‘Launch Conditionality’ (conditions in Article 82). An additional two years RDP is granted if manufacturers can demonstrate either the release or continuous supply of a sufficient quantity of medicine across all 27 member states. The feasibility of achieving that is another matter, more to come on this later. Proof of Launch Conditionality will require either confirmation from each Member State, or a positive pricing and reimbursement decision. Launch Conditionality benefits are extended to three years for small and medium-sized enterprises (SMEs), not-for-profit entities, or manufacturers with less than five centralized medicines authorised.

Other ways to extend the RDP:
Manufacturers can receive an additional six months of RDP for their product if it addresses an unmet medical need at the time of the the initial market authorisation. Unmet need is defined across 3 criteria, all to be met for the benefit to be recognised: 1) life threatening or seriously debilitating condition; 2) lack of available treatment or remaining high mortality or morbidity; and 3) decrease in mortality or morbidity brought by the new therapy.
An extra six months RDP will be granted to medicinal products that contain a New Active Substance.
Manufacturers can also receive an additional one year protection if an additional therapeutic indication is authorised which provides “significant clinical benefit” over existing therapies. Note this can only be granted once to a therapy.


Launch Conditionality

In 2022, the Technopolis group evaluated the impact of the EU general pharmaceuticals legislation. As part of their assessment they evaluated 78 products with RDP expiry 2016-2024 launched in member states. Of these, not one product was launched across all 27 member states. The widest access span was in 20 member states, achieved by only 12.8% of molecules.

Whilst we at ENTRI recognise the importance of making medicines accessible to those patients in need, we must balance that with the ability of manufacturers to achieve that in a sustainable way. Making medicines more environmentally sustainable, was at core of the EU pharmaceutical strategy. Making those medicines financially sustainable is as important. Without financial sustainability, investment and innovation will be sorely limited to those manufacturers that can afford to take occasional financial hits. The feasibility for SME’s to achieve that is questionable at the very least.


Planning for the Future: a new ENTRI strategy

The new Directive is unlikely to come into place before 2026. Whilst many changes to the legislation are currently being challenged, timely and equitable access is likely to stay. Launch conditionality means manufacturers need to plan for a different ENTRI strategy to optimise RDP and return on R&D investment. At ENTRI, we help our clients achieve successful reimbursement and seamless product launches across Europe. Our team of seasoned commercialization experts possesses a deep understanding of the unique challenges faced in each member state. We leverage this knowledge to craft tailored strategies and provide invaluable support throughout the entire product lifecycle.

Find out how we at ENTRI can help you successfully prepare for the biggest reform to hit EU pharmaceutical legislation. Contact us at info@entri.eu





References

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761

European Commission, Directorate-General for Health and Food Safety, Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation – Impact assessment report, Publications Office of the European Union, 2023, https://data.europa.eu/doi/10.2875/00611