Prescient Perspectives – The Agreeable: The EC’s drive to push the EMA into the 21st century by drastically reducing administrative burden and increasing flexibility is likely to be met with widespread support from the industry. Streamlining and simplifying operations will make it easier for drug developers of all sizes to ensure business predictability. Clearer evidence requirements, coupled with a revamped pediatric investigation plan (PIP) framework that promises to be more flexible and less burdensome, will reduce uncertainty and investment risk. New product planning and R&D teams in particular will benefit from an increase in earlier, more frequent scientific and regulatory support and a pharmaceutical framework that can evolve alongside their own clinical development plans. A bonus from the streamlining efforts is the EMA’s commitment to reduce the CHMP’s standard (non-accelerated) MAA review time from 210 days to 180 days (excluding clock stops), and the EC’s time-to-decision from 67 days to 46 days, aligning the EMA more closely with the FDA’s recent efforts in improving review times.

Among the numerous measures aimed at reducing AMR, the EC’s proposal of offering a TEV to developers of priority antimicrobials (AMs) is likely to be the most lobbied for by originator developers, but spurned by generics players. If a developer is awarded a TEV after meeting the EC’s criteria, it can use it on either another (non-AM) product in its portfolio, or sell it to another developer. SMEs already developing priority AMs can quickly benefit from such a scheme, both from a market exclusivity and venture capital perspective. Further, linking the reward to a product other than the AM can be particularly lucrative to developers that have blockbuster drugs that are nearing patent expiry. Despite the concept being much debated and untested in the real world, the significant costs to healthcare systems due to the ‘silent pandemic’ of AMR are compelling the EC to propose this approach to drive innovation.

Prescient Perspectives – The Contentious: The measures aimed at modulating data exclusivity periods have already been dismissed by industry groups, which have labeled them a threat to the innovation and competitiveness of the EU, but is this really the case? In the simplest terms, at approval, non-orphan drugs would have their total regulatory protection (RP) reduced from the current 10 years to a new eight-year baseline, while orphan drugs’ RP would be reduced from 10 to nine years. Through its ‘quid pro quo’ approach, the EC offers developers incentives to win back those precious years of RP in exchange for certain criteria being met. Orphan drugs could claim a maximum of 12 years’ RP, while non-orphan drugs could claim 13; these maximums are, however, theoretical unless all incentive criteria are met.

Of the various exclusivity incentives, the access conditionality incentive is the most contentious. A first-of-its-kind policy measure, it is central to helping the EC achieve its vision of equal access to medicines for all EU citizens. The EC makes its table stakes clear – failure to comply within the two-year period will result in earlier market entry for generics and biosimilars. Industry stakeholders working in market access roles know that no two Member State health technology assessment (HTA) bodies are equal. Varying capabilities, duplicative evidence requirements and sub-optimal harmonization at national and EU levels are key factors contributing to the EU’s access issue. These factors often influence industry decisions that hinder the launch of new medicines in specific markets, particularly for SMEs that lack the capacity and resources to coordinate reimbursement and commercial launch activities across multiple markets.

One of the ways the EC intends to reassure industry is through a separate but parallel HTA Regulation (2021/2282), going into effect in 2025 via a rolling phase through 2028. This regulation aims to significantly improve harmonization between Member States’ HTA operations and reduce duplicative requirements for the industry. If the EC can demonstrate to the industry that tangible improvements to national-level HTA processes are being made, then perhaps this measure can stand. At present, it is hard to imagine industry conceding its upper hand to public authorities, and two years of RP, without a fight.