BRUSSELS, Belgium – The new “master” Regulation merges Commission Regulation No 726/2004, Orphan Medicinal Products (OMP) Regulation No 141/2000 and Paediatric Regulation No 1901/2006, and a proposal for a Directive, repealing Directive 2001/83/EC.
The review revolves around a few key objectives:
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines
- Continue to offer an attractive and innovation-friendly framework for the research, development, and production of medicines in Europe
- Reduce the administrative burden “drastically” by speeding up procedures significantly, reducing authorization times for medicines, so they reach patients faster
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a “One Health” approach
- Make medicines more environmentally sustainable
To achieve these aims, the Commission proposes the following:
- New incentives to encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs
- Focus on AMR; The reform offers incentives through transferable vouchers to companies that invest in novel antimicrobials that can treat resistant pathogens
- The review also introduces greater transparency regarding public funding of medicines, as well as incentivizing the generation of comparative clinical data
- An “innovation-friendly” regulatory environment for the development of new medicines and the repurposing of existing ones
- The scientific evaluation and authorization of medicines will be sped up – for its assessment, EMA will have 180 instead of 210 days. For the authorization, the Commission will have 46 instead of 67 days
- The European Medicines Agency (EMA) will provide better early regulatory and scientific support for developers of promising medicines to facilitate the fast approval and help SMEs and non-profit developers
- Europe will grant regulatory protection of up to a maximum of 12 years for innovative medicines, combined with the existing intellectual property rights, to help “ensure Europe remains an attractive hub for investment and innovation”
- The reform will move the current system away from its “one-size-fits-all” regulatory protection towards a “more effective incentives framework”– it wants to do this via a minimum period of regulatory protection of eight years that can be extended in the some cases
- The reform introduces new requirements for monitoring of shortages of medicines by national authorities and EMA and a stronger coordination role for EMA – companies are requested to report shortages earlier, and an EU-wide list of critical medicines will be established
- Stronger environmental requirements
One of the main talking points of the review is cutting the current exclusivity period from 10 years to eight. Many industry voices have pushed back against this proposal since the EC document was first leaked, worrying that the shortened timeframe could stifle innovation in Europe.
The eight-year limit, according to the Commission’s document, can be extended in the following cases: If medicines are launched in all Member States, if they address unmet medical needs, if comparative clinical trials are conducted, or if a new therapeutic indication is developed.
Despite welcoming the overall objectives of the revision, EUCOPE worries that overhauling the incentive framework poses significant risks for small and mid-sized innovative biopharmaceutical companies that drive innovation.
Secretary-General of the group, Alexander Natz, said: “An attractive and predictable EU pharmaceutical ecosystem is crucial for small and mid-sized companies to continue bringing innovation to Europe. The Commission’s revision includes troubling proposals, such as the introduction of (High) Unmet Medical Need, which risk reducing the EU’s global competitiveness in life sciences, thereby limiting the development and availability of innovative therapies.”
To mitigate any concerns, EUCOPE has also made some recommendations. The group believes that the incentive and regulatory framework should “support a larger, mutually reinforcing pharmaceutical ecosystem that stimulates a virtuous cycle addressing key barriers to developing novel therapies, such as a fundamental lack of knowledge in the area of rare diseases.”
EUCOPE wants the Commission to consider the policy proposals developed by the Orphan Drug (OD) Expert Group, to improve the OMP incentive framework. It is also concerned about the Commission’s proposal to modulate and reduce the Regulatory Data Protection (RDP) period from eight to six years. The group urges a “careful approach” to avoid duplication of work and additional burdens on small and mid-sized companies.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), another influential organization in Europe, condemned the paper, suggesting it “risks sabotaging Europe’s life science industry putting European patients further away from the cutting-edge of healthcare.”
Nathalie Moll, Director General, EFPIA, worries that the proposal “manages to undermine research and development in Europe while failing to address access to medicines for patients.” She added, “The approach set out in the pharmaceutical legislation, penalizing innovation if a medicine is not available in all Member States within two years is fundamentally flawed and represents an impossible target for companies. The vast majority of delays in access to new medicines are known to occur after a company has filed for pricing and reimbursement and is awaiting a decision, so that the new treatment can be made available to patients.
“Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.”
The legislative proposals will now be submitted to the European Parliament and the Council. NAVLIN Daily is keeping an eye on industry and public feedback and will continue to report on the review as the situation unfolds.