European Commission kicks off review of pharmaceutical legislation

Regulatory NewsRegulatory News | 01 April 2021 |  By 

As part of its broader pharmaceutical strategy, the European Commission on Tuesday released a roadmap for its planned revision of the EU’s aging pharmaceutical legislation next year.
The Commission adopted its pharmaceutical strategy last November following a public consultation earlier in the year. “[The strategy] is intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant,” the Commission writes. (RELATED: European Commission consults on roadmap to pharmaceutical reforms, Regulatory Focus 2 June 2020; EC’s new pharmaceutical strategy highlights support for innovation, R&D, Regulatory Focus 25 November 2020).
Upon adopting the strategy, the Commission also committed to revising the pharmaceutical legislation, namely Directive 2001/83/EC and Regulation (EC) No 726/2004, by the end of 2022. The Commission says the revision will address “potential weaknesses” in the legislation that have hampered innovation and competition.
“The EU pharmaceuticals system should ensure the quality and safety of medicines, while boosting the sector’s global competitiveness and creating a regulatory environment, which is attractive for innovation and investment and supported by international harmonised standards and, where possible, regulatory convergence,” the Commission writes.
In the newly released roadmap, the Commission says its objective in revising the pharmaceutical legislation is to improve access to medicines and address unmet medical needs, enable innovation, enhance supply chain security and reduce regulatory burdens. The roadmap lays out 14 elements that the Commission aims to develop policy options to address following its evaluation of the current legislation. Following the evaluation, the Commission will conduct an impact assessment expected to run until Q1 2022 before moving forward with any initiative to revise the legislation.
Under the baseline scenario, in which the current framework is unchanged, the Commission says it will “prove challenging” to achieve its objectives. Among the targets for reform are regulatory burdens, market incentives and generic and biosimilar competition.
The Commission says it will look at policy options to speed drug approvals, reduce regulatory costs and give regulators the ability to adapt the terms of marketing authorizations on their own initiative.
In terms of incentives, the Commission says it wants to develop a more tailored system of incentives to promote innovation in areas of high need that link rewards to obligations. “Options shall explore novel incentives that complement or replace or adjust the market protection (or a combination thereof) taking into account the relationship with intellectual property rights,” the Commission writes. New incentives will be considered for antimicrobials, along with rules to ensure their responsible use.
The Commission will also look at ways to increase support for the development and authorization of medicines that fulfill unmet medical needs and will attempt to future-proof the legislation to be more adaptable to innovative technologies.
Other elements include developing a single assessment process for active substances master files; improving supply chain security, transparency and oversight; and enhancing environmental sustainability.
In its preliminary assessment, the Commission takes a favorable view of the economic, social and environmental impacts of the potential legislative overhaul.
“The impact on the European economy as a whole is expected to be a positive one. Elements such as regulatory flexibility to accommodate swiftly emerging scientific and technological developments, and the ability to use new evidence generation tools and simplification will make the EU more attractive for investment and marketing of innovative medicinal product,” the Commission writes.
The Commission also says the tweaks to EU incentives for pharmaceuticals will encourage development in areas of the market that currently attract little investment. On the flip side, the Commission says that changes to allow for faster generic and biosimilar competition will cut costs for member state health systems and EU citizens.
European Commission


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