The European Medicines Agency (EMA) has unveiled a detailed procedural guide aimed at ensuring transparency and integrity among its scientific committees and experts. This guidance mandates the comprehensive declaration of interests to mitigate conflicts and uphold the credibility of the agency’s activities.
Who Must Declare Interests?
All members, alternates, and experts involved with the EMA’s scientific committees, including CHMP, CVMP, COMP, HMPC, PDCO, CAT, and PRAC, are required to complete a Declaration of Interests (DoI). This extends to participants in working parties, Scientific Advisory Groups (SAG), and other specialized groups such as the Emergency Task Force and Medicines Shortages Steering Groups. Activities necessitating declaration encompass a wide range, from the development and evaluation of medicinal products to managing public health emergencies and monitoring product shortages.
Types and Process of Declaration
The DoI process requires experts to disclose various types of interests, including current and past engagements with pharmaceutical and medical device companies, financial interests, and affiliations with research organizations. The guidance provides clear definitions and examples for each category, ensuring that declarations are thorough and precise. Experts must submit their DoI through the Experts Management Tool (EMT), where their interests are evaluated for potential conflicts based on their nature, timeframe, and relevance to EMA activities.
• Enhanced transparency helps build trust in EMA’s decision-making processes.
• Clear guidelines prevent omissions and ensure consistent declarations.
• The evaluation framework categorizes interests, facilitating appropriate management.
Experts are advised to regularly update their declarations to reflect any changes in their professional or financial circumstances. Non-compliance or incomplete declarations may result in exclusion from EMA activities, highlighting the agency’s commitment to maintaining high ethical standards.
The EMA’s stringent declaration process not only fosters an environment of accountability but also safeguards the integrity of its scientific assessments and regulatory decisions. By clearly outlining the expectations and providing detailed instructions, the EMA ensures that all stakeholders are aware of their responsibilities, thereby enhancing the overall efficacy and trustworthiness of the agency’s operations.
For experts and stakeholders, understanding and adhering to these guidelines is crucial. The comprehensive nature of the guidance serves as a robust framework for managing potential conflicts of interest, ultimately contributing to the reliable and unbiased regulation of medicinal products and medical devices within the European Union.
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