The rules on continuing medical education (“CME”) have changed since a new agreement between the Italian government, the Italian Regions and the autonomous provinces of Trento and Bolzano has come into force on February 2, 2018. You may find the new agreement here or here (only in Italian, sorry).
The agreement is an “upgraded version” of the previous principles, which remain largely unchanged, but are now better defined, stricter and hopefully more effective.
- THE RIGHT TO CME. Health care professionals (“HCPs”) have the right to obtaining CME and regulators will need to remove impediments in order to allow the exercise of such right.
- ACCREDITATION OF PROVIDERS. As before, providers of CME need to be accredited, but accreditation will be subject to stricter rules, which particularly focus on avoiding any conflicts of interest. Providers will also need to adopt an internal regulation setting forth how to prevent and exclude (even potential) conflicts of interest.
- SPONSORSHIP OF EVENTS. Sponsorship of CME events will be possible by private companies, provided that the principles of transparency, objectivity, impartiality and independence are complied with. No advertisement of medicinal products or medical devices can be carried out during the CME event, but only before, after and outside the event. No direct payments or reimbursements are allowed to speakers or moderators of the CME events.
- NO ACCESS TO PERSONAL DATA OF HCPs. On the data protection front, note that sponsors of CME cannot have access to lists and addresses of participants, speakers or moderators.
- SPONSORSHIP OF HCPs. Lastly, HCPs may be sponsored by commercial firms operating in the health industry, but cannot fulfil more than one third of their CME requirement through such sponsorship. This is bound to change how CME has been handled before, forcing HCPs to bear the cost of at least two thirds of their CME requirements.
Have a great weekend!
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.