In a move to enhance transparency and accountability, the Italian Medicines Agency (AIFA) has introduced a new, rigorous framework to manage conflicts of interest, while simultaneously enabling the utilization of high-profile professionals for pro bono opinions and advice. This regulation aims to balance the need for specialized expertise with the imperative of safeguarding public health against biased influences.
Strengthening Conflict of Interest Regulations
Under the newly adopted guidelines, spearheaded by AIFA’s administrative director Giovanni Pavesi, professionals within the agency, including employees and external consultants, are now required to declare any potential conflicts of interest. This directive mandates abstention from participation in agency-related activities that could culminate in a conflict.
- Declaration of Interests: Both permanent staff and external advisors must submit a Disclosure of Interests (DOI) to their supervisors, adhering to a policy inspired by European standards.
- Scope of Secondary Interests: These include any financial or advisory connections to pharmaceutical entities, ownership of shares, or involvement in activities funded by industry-related organizations.
- Independent Oversight: The Committee of Guarantors, comprising experienced experts like Lorenzo D’Avack, oversees any complexity arising from reported conflicts.
- Risk Assessment Levels: The framework categorizes interests into absent, relevant, and elevated risks, each bearing specific operational restrictions.
Enhancing Professional Input
Acknowledging the instrumental value of top-tier professional insight, AIFA is facilitating pathways to obtain expert opinions and guidance without entailing financial compensation, ensuring that the agency’s decisions are underpinned by diverse and unbiased expertise:
- Avoidance of Professional Bias: The policy allows for non-monetary consultancy to bolster informed decision-making processes, excluding board members from providing such consultations.
- Selective Authorization: Only with explicit authorization, can agency personnel participate in external events linked to the pharmaceutical domain, safeguarding impartiality in narrative and representation.
Enforcing Compliance and Ethical Conduct
The regulations establish concrete consequences for breaches concerning involvement in decision-making processes where conflicts of interest exist:
- Suspensions and Discipline: Violations could lead to suspension from three months to a year for independent collaborators, whereas formal disciplinary action is reserved for direct employees.
- Code of Conduct Enhancements: AIFA is also set to introduce an augmented internal code emphasizing data ethics and responsible social media use, aligning with European jurisprudence which mandates neutral expert advisories.
This step affirms AIFA’s commitment to preserving public trust while embracing necessary reforms inspired by continental trends, reflecting a strategic positioning as a paragon of regulatory integrity and efficacy in the pharmaceutical sector. This initiative further reinforces AIFA’s dedication to delineating a transparent operational landscape advantageous for both public health safeguards and expert involvement.
Fonte: AIFA