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TOPRA Symposium 2023: Perspectives on new EU regulatory legislation

Posted on the 5th December 2023

TOPRA Blog Part One 1

Rachael O’Kane, Manager, Regulatory Affairs at G&L, gives an insight into the key topics and talking points at this year’s TOPRA Symposium.

Part one: Perspectives on new EU regulatory legislation

The Symposium’s initial session focused on EU pharmaceutical legislation, with stakeholders from the European Commission (EC) and regulatory authorities sharing their perspectives.

Olga Solomon, the European Commission’s Head of Unit Medicines: Policy, Authorisation and Monitoring, began with an overview of the EC’s proposals for reform of EU pharmaceutical legislation. The Commission published its Pharmaceutical Strategy for Europe in 2020.

The strategy aims to modernise the pharmaceutical sector via a patient-centred approach that ensures medicines’ quality and safety whilst fully supporting the innovative and competitive industry.

In April 2023, the EC adopted a proposal for a new Directive and a new Regulation, which revised and replace existing EU pharmaceutical legislation with the following key objectives:

  • Access Creation of a single market for medicines, ensuring that patients across the EU have timely and equitable access to safe, effective and affordable medicines

Health inequality currently represents a huge challenge across Europe, with patients in certain markets having to wait more than two years for access to medicines1.

To remedy this, the reform proposes the introduction of a modulated system of incentives that reward companies for launching their medicines in all member states, developing innovative medicines that address unmet medical needs, conducting comparative clinical trials, or developing medicines that can treat other diseases.

  • Availability Addressing medicine shortages and ensuring security of supply

Medicine shortages have been a critical concern for all EU countries for several years, with the COVID-19 pandemic highlighting the negative consequences of the current legal framework. More recently, in winter 2022, critical shortages of antibiotics devastated healthcare providers and patients.

The reform proposes improved coordination, monitoring and management of shortages between national authorities and the European Medicines Agency (EMA), with particular focus on critical shortages to ensure that patients always have access to medicines.

  • Affordability Improving access to affordable medicines, and continuing to offer an innovation-friendly framework for the research, development, and production of medicines in Europe

The reform would require pharmaceutical companies to publish information on all direct financial support for medical research and development received from public authorities or publicly funded bodies.

Increased transparency would improve negotiations between the authorities responsible for the pricing and reimbursement of medicines when agreeing prices with pharmaceutical companies, with the aim of reducing prices and improving access to drugs.

  • Regulatory simplification and future-proofing - Reducing the administrative burden and significantly reducing authorisation times for medicines, facilitating patient access

Reducing the standard marketing authorisation procedure from 210 days to 180 days has been proposed to align with an improved and streamlined EMA structure, characterised by simplified procedures and better use of data, digitisation, and regulatory sandboxes.

The reforms also outline increased pre-authorisation support for promising medicines, to accelerate development and attract investments.

Furthermore, additional regulatory support would be offered to SMEs and non-commercial organisations, to reduce the associated administrative burden and costs.

  • Environmental sustainability - Making medicines more environmentally sustainable

Scientific evidence shows that the production, use and improper disposal of pharmaceuticals may have negative impacts on the environment and on human health.

The revised legislation reinforces the requirement for marketing authorisation applications for medicinal products to include an Environmental Risk Assessment (ERA) and risk mitigation measures.

Failure to meet ERA requirements will lead to marketing authorisation refusal. This requirement is further extended to medicines already on the market before 2005.

  • Combating AMR - Addressing antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a ‘One Health’ approach

AMR causes 35,000 deaths per year in the EU1 which, without action, could equate to 10 million deaths globally each year by 2050. An EC Council Recommendation adopted in June 2023 advocates for more prudent use of antimicrobials, with the goal of reducing EU antibiotic consumption by 20% by 2030. It also recommends that member states set their own national targets to help achieve this goal.

Although responsible use of antibiotics is key to tackling AMR, medicine developers could see their sales volumes and return on investment affected. Therefore, the EC is proposing regulatory incentives such as transferable data exclusivity vouchers for the developers of ‘game-changing’ novel antimicrobials, to incentivise the development of innovative antimicrobials without direct financial contributions from member states.

The vouchers, which developers could use or sell, would offer an additional year of data protection from competition for the medicine to which the voucher applies.

Dr Paula Loekemeijer, Executive Directive of the Medicine Evaluation Board (MEB), discussed the reform proposal from a national competent authority (NCA) perspective.

NCAs intend to align with the EC’s objectives by:

  • Ensuring that regulatory frameworks and practices evolve with future innovations and pipelines
  • Understanding digitalization and in-house capacity
  • Simplifying processes and decreasing the administrative burden
  • Collaborating with broader networks
  • Increasing resources and capacity

NCAs are working to gain a full understanding of the proposed framework and its potential impact on their national operations. Collaboration with the EU network is critical to successful adaptation of the revised legislation.

Valentin Plouchard, Healthcare Regulatory Affairs Manager at EuropaBio, followed with the industry perspective. The streamlining of the EMA structure to reduce the marketing authorisation assessment and approval timelines was positively received and very much welcomed.

This is not without its challenges: the reduction of the standard process from 210 to 180 days renders the 150-day accelerated pathway less attractive. Additionally, although the proposal aims to reduce the administrative burden, the enforcement of the ERA requires additional forms and data to be provided.

However, it was also emphasised that reducing administrative burden should never take precedence over ensuring access to medical products.



Rachael O’Kane is a Manager, Regulatory Affairs at G&L.

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