In Italy a new practice involving continuing medical education (CME) courses has been recently introduced which further strengthens the obligations and duties of both providers and sponsors.
In particular, the recent Agreement between State and Regions (i.e. “accordo Stato-Regioni”) of 5 November 2009 on CME, which was followed by a number implementing regulations dated 13 January 2010, introduced important new rules, in particular, on: (i) credits to healthcare professionals (“HCPs”) issued directly by (private) authorised providers (and not, as previously, provided by the experts committee of the Ministry of Health); (ii) more stringent rules on conflicts of interests of said providers; and (iii) more stringent rules on sponsors’ permitted activities.
As to (i) above, CME providers must now go through an in-depth authorisation procedure which is intended to ensure they have the required expertise and independence to grant credits directly to HCPs. In particular, three different levels of authorisations are envisaged according to the territorial scope of the courses offered by providers (i.e. authorisations granted by the National committee for the continuing medical education, the Italian Regions and the autonomous provinces). A new body in charge of ensuring compliance of all participants with the new system has been also appointed, the Guaranty Committee (i.e. “Comitato di Garanzia”).
As to (ii) above, CME providers shall now provide information and evidence showing they (i.e. the company, its managers and directors) do not have any conflicts of interest, including detailed information on the activities performed by their affiliated companies.
As to (iii) above, the sponsors shall now refrain from inviting HCPs to specific CME courses that they have financed. A set of specific rules on permitted product advertising during CME courses has also been introduced.
The new practice confirms the basic principles set out by the previous law, aimed essentially at (a) avoiding any influence by the sponsors on the courses’ scientific content; and (b) keeping a clear distinction between promotional and education activities. In order to ensure these objectives are achieved, the new practice provides that CME providers shall now also be obliged to prepare and submit ad hoc questionnaires for HCPs about the courses’ scientific quality and possible conflicts of interest.
The new CME system will be entirely self-financed with part of the incomes of the CME providers being used for the financing of the whole authorisation and its supervision activities.
The new CME practice has been highly debated by companies (both providers and sponsors). In particular, if the “100% no conflict of interests criteria” (the principle on which the practice seems to be based) is unlikely to be achieved in this area, a system ensuring that where conflicts do exist, they are actually declared, would be preferable.