European Medicines Agencies Network Strategy to 2025
The European Medicines Agency (EMA) and the national competent authorities (NCAs) of the 27 EU Member States in addition to those of Iceland, Liechtenstein and Norway presented on 6 July 2020 a proposed network strategy for tackling healthcare challenges in a rapidly evolving environment (see, attachment). The strategy is supposed to apply until 2025 and stakeholders are invited to submit their comments in response to an online questionnaire by 4 September 2020.
The proposed network strategy focuses on what are identified as 6 key areas as follows:
- Availability and accessibility of medicines - This part of the strategy concentrates on both availability issues (supply disruption/shortages) and accessibility (commercialisation/downstream decision making in addition to therapeutic challenges in small markets). The document notes that the broader policy issues will form part of the European Commission’s Pharmaceutical Strategy for Europe which is not due until the fourth quarter of 2020 (see, Van Bael & Bellis Life Sciences News Alerts of 3 June 2020 and 17 June 2020). As an example, it claims that “commercial strategies, and pricing and reimbursement (P&R) considerations are major reasons for non-marketing of new medicines”.
- Data analytics, digital tools and transformation – The goal here is to utilise all available data and tools to generate evidence for better and more efficient regulatory and clinical decision making.
- Innovation – The network will have to develop sufficient competences to support innovators in various phases of medicines development. This requirement comes up in various settings, including the handling of novel borderline products; tackling precision and personalised medicine; making judgments about authorising medicines based on limited evidence; sanctioning innovative clinical trial designs; creating global alliances with regulatory partners; and establishing new criteria for storing data and maintaining the data lifecycle of medicines.
- Antimicrobial resistance and other emerging health threats – Under this heading the network combines the tackling of both a well-known established health threat (antimicrobial resistance) and new such threats, epitomised by the current Covid-19 pandemic. The common thread is the need for collaboration of stakeholders and regulators at every geographical level.
- Supply chain challenges – Under this heading come issues of oversight and quality control but also of supply chain resilience and reduced dependency on limited sources of supply (for example by offering support to a EU-based manufacturing base).
- Sustainability of the network and operational excellence – This chapter stems from the network’s self-assessment and considers issues of scientific and regulatory capacity, operational excellence, funding, governance and digitisation.