On 5 May 2025, IFPMA delivered a statement at the open session of the meeting of the 25th WHO Expert Committee on Selection and Use of Essential Medicines.
Innovation driven by the pharmaceutical industry is essential to advancing healthcare through medicines and vaccines that enable new ways to prevent, treat, and cure disease. Representing the innovative pharmaceutical sector, the (IFPMA) is committed to ensuring that scientific progress translates into the next generation of medical solutions – delivering a healthier future for people, globally.
IFPMA recognizes the importance of the WHO Essential Medicines List (EML) in the global health context. Products placed on the EML demonstrate the critical role played by the biopharmaceutical industry in creating therapies that are safe, efficacious, and essential in reaching the UN Sustainable Development Goals and achieving universal health coverage.
IFPMA welcomes the inclusion on the EML of innovative medicines that bring significant clinical benefit. However, it is important to acknowledge the complex infrastructure requirements that may come with some of these products, particularly in healthcare settings with varying levels of health systems and legal frameworks, especially in low- and middle-income countries (LMICs). To ensure that these medicines can be effectively and sustainably used, greater collaboration between WHO and governments is needed to strengthen health systems, including investments in diagnostic tools, trained professionals, and laboratory capacity. A careful assessment of effectiveness and resource tradeoffs with other needed health interventions should guide EML decisions, ensuring that new listings contribute meaningfully to health system improvements. By working more closely with countries on health system strengthening, WHO can help ensure that listing medicines on the EML translates into real-world access and improved patient outcomes.
IFPMA member companies have contributed to the EML update process by submitting applications for the inclusion of new products and through comments on specific product applications, including data that may support the Expert Committee’s decision-making. This engagement reflects industry’s interest in ensuring that decisions are informed by a broad range of perspectives and based on robust evidence.
Key considerations from the innovative pharmaceutical industry
Below are key considerations from the innovative pharmaceutical industry to support a more effective and impactful WHO EML:
- Support countries in strengthening health systems: The WHO EML is above all a guiding tool for healthcare systems. Greater focus on system-wide investments is needed to ensure that EML-listed medicines can be used by healthcare providers to ensure effective patient access and improved patient outcomes within local context. Medicines on the EML, particularly those on the complementary list, often require specialized infrastructure and trained healthcare professionals in order to be safely and effectively delivered to patients. The WHO EML should not be as a lever to stretch limited health system capacities, to drive licensing policies or circumvent national procurement practices. The WHO EML should focus on its core function of guiding countries in medicine selection for national EMLs based on clinical evidence. To enable patient access, other efforts should be made in tandem by WHO and other stakeholders to tackle systemic health access barriers and advance universal health coverage.
- Ensure an inclusive and evidence-based decision-making process: The WHO EML update process should involve a broad range of experts, including from industry, academia, healthcare providers, patients, payers, and national regulatory agencies. Transparent, data-driven decision-making will strengthen the credibility and utility of the EML. IFPMA stands ready to bring its expertise and work with WHO and other stakeholders in collecting relevant data in between update cycles, helping to ensure that each Expert Committee meeting is informed by the most up-to-date evidence. In this context, IFPMA notes the recent publication of the report from the expert consultation meeting on cancer medicine candidates for the 2025 EML. While we recognize the effort to provide input to the EML process, we are concerned that there was no opportunity for industry or other stakeholders to contribute to the series of meetings that led to the development of this report. Moreover, the report was published only days before the final submission deadline, significantly limiting the ability to engage with its content. Industry should be seen as a constructive partner, able to contribute relevant data on its products to strengthen the evidence base used in such assessments. We would welcome a more transparent and structured approach for future expert consultations, with defined timelines and opportunities for broader stakeholder input.
- Improve data collection and key performance matrix: The WHO EML process should also include metrics on implementation and success. to better understand the real-world impact. Collection of data on country-level access to EML-listed medicines and EML implementation with relevant Key Performance Indicators (KPIs) can help WHO, member states, and stakeholders develop access strategies based on feasibility and assess whether the EML is effectively improving medicine availability.
IFPMA and its members remain committed to collaborating with the WHO, governments, and other stakeholders to ensure the EML fulfills its role in guiding health systems by providing a list of the essential medicines that should be ‘available to satisfy the priority health care needs of the population’. By working together and further developing the assessment process with additional criteria such as feasibility and developing a KPI performance matrix, a sustainable framework that guarantees safe, efficient, and sustainable patient access to both current and future medical innovations across different health systems, can be created.
