Italy: New regulation of the Italian Medicines Agency on conflict of interest

In brief

The Italian Medicines Agency approved the new Regulations on conflict of interest, after incorporating suggestions from the Italian National Anti-Corruption Authority.


Key takeaways 

The new Regulation aims to prevent the interests of those who work or collaborate from even appearing to override the main interest, which is the protection of public health, and this is in line with the recent decision of the European Court of Justice, which overturning a decision of the EMA not to approve a particular drug, in the presence of a possible conflict of interest, ruled that the European Agency itself "is obliged to be vigilant to prevent the experts it consults from having a conflict of interest."

The Regulations considers a range of relationships and/or activities that constitute "direct secondary interests," including potential secondary interests of relatives or friends of Italian Medicines Agency's employees, managers and collaborators; dependent, consulting or collaborative relationships with a "sensitive" entity; money transfers from private individuals in the pharmaceutical industry; extra-institutional teaching activities; participation in strategic, scientific and steering committees organized or financed by sensitive entities; corporate offices, and so on.

Among the various penalties, violation of the obligations under the new Regulations entails disciplinary proceedings against Italian Medicines Agency's employees, and suspension of activity from three months to one year for experts, consultants, collaborators and working group members not directly employed by the Italian Medicines Agency.


Copyright © 2025 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.