Tag Archives: ECM

Continuing Medical Education: New Rules under Italian Law (and How to Comply with Them)

A new regulation has been enacted in Italy, overhauling continuing medical education regulations. The new provisions will not only have an impact on healthcare professionals, who are subject to educational requirements, but also on pharmaceutical companies and medical devices manufacturers supporting educational events and congresses, as well as on third party providers and organizers. The new regulation has been adopted following consensus among regional authorities and the Ministry of Health on February 2, 2017.

The national commission for continuing medical education is entrusted with the task of determining the requirements and quality levels of educational events, as well as the minimum educational goals applicable nation-wide. The commission shall also adopt a manual for the certification of event organizers (so called CME providers). Regional authorities, on the other hand, must ensure a proper and adequate planning for medical education within their territories.

Furthermore, each professional shall develop and comply with an individualized educational plan (so called “dossier”), in order to ensure a coherent and complete education. Educational events attended abroad may also be recognized for purposes of medical education, in accordance with the criteria that will be established by the national commission.

As far as industry operators are concerned, the new regulation reiterates and strengthens the requirements of transparency and independence of educational providers from pharmaceutical/medical device companies. In particular:

  • CME providers must disclose any relationship between speakers/moderators and any private entity active in the healthcare industry;
  • CME providers must not have any direct or indirect interest in any pharmaceutical/medical device businesses or engage in any relationship with such businesses, other than the sponsorship pursuant to CME regulations;
  • CME providers must not organize any promotional events on specific products; a full segregation of activities between educational CME providers and other event organizers is therefore established;
  • The regulation further expands on the definition of conflict of interests and aims at better regulating all relationships and interests between the industry and educational providers;
  • More stringent provisions concerning advertisement and promotion during educational CME events are introduced, including restrictions for employees of the sponsor to attend educational classes and seminars.

While several provisions of the new regulation directly target CME providers, the industry should also be prepared to the new regulatory framework. Here is a list of what private operators should immediately think of:

  • Train your staff on the new regulations (both at your headquarters and on the field);
  • Check if internal company procedures needs to be updated;
  • Check if internal sponsorship documentation (including contracts) needs to be updated;
  • Review ECM providers with whom you usually work to ensure they comply with the new requirements and avoid conflicts of interests.
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