Distribution of educational materials targeting healthcare professionals

Distribution must always include all doctors who could in practice prescribe the medicinal product in question, as set forth by the conditions and obligations associated with the marketing authorisation of the medicinal product. In justified cases, this concerns also doctors who could prescribe or use the medicinal product beyond the scope of approved indications (so called off-label use). Distribution must not be limited by the MA holder solely to doctors or other healthcare professionals among whom the product is actively promoted or who are visited by specialised company representatives. In case of distribution of some EM, it is necessary to include also the concerned pharmacies, such as hospital pharmacies or pharmacies with specialised workplaces, among the distribution groups.

Any educational program must be completely separated from promotional activities.

Primary distribution method in terms of fulfilment of obligations set forth by the marketing authorisation of the medicinal product in question

The primary (i.e. main) distribution method must be proposed in the Distribution Plan and approved by SÚKL. The primary distribution of EM for healthcare professionals must ensure targeted outreach to the concerned healthcare professionals and must be carried out directly, i.e. via post, electronic communication, or specialised representatives. A specialised representative shall mean a person who acts as an agent of the pharmaceutical company of the MA holder, is adequately qualified, and will provide the target expert with any information as necessary.

SÚKL considers EM to be materials of non-advertising nature, hence obviously not serving for the purposes of promoting the prescribing, deliveries, sale, dispensing or consumption of human medicinal products. Their purpose is, in particular, to notify of, alert of, and provide information regarding warnings associated with human medicinal product safety concerns.

Distribution of EM by the MA holder´s specialised representatives shall not be considered advertising. Its separation from promotional activities must be preconditioned by the fact that upon EM hand-over by the company´s specialised representative, a clear and straightforward statement is made to the effect that these are materials intended solely to safeguard risk minimisation measures.

EM cannot be handed over together with advertising materials. EM hand-over must be clearly separated in time as well as verbally so as to convey the clearly different purpose of the EM from that of advertising materials. It must be clearly stated that the meeting does not concern promotional purposes as referred to under the Act on Advertising Regulation.

Distribution of EM may be outsourced with specialised agencies preparing or organising the distribution proper via post or e-mail which is contracted to ensure the provision of EM directly to the hands of the concerned healthcare professional. The MA holder must, thereafter, receive an assessment (process indicators) of distribution effectiveness from the company, which shall be archived by the former for the purposes of e.g. audits or pharmacovigilance inspections. Distribution, however, cannot be carried out via another agent (e.g. a distributor of pharmaceuticals).

Secondary distribution method (web platforms, mobile applications, videos)

In addition to the primary distribution method, other distribution channels may be also made use of as so called secondary distribution method in order to provide complex information about the medicinal product to healthcare professionals. Not always do the secondary distribution methods have to be approved by SÚKL. Nevertheless, the websites/web platforms or mobile applications may not be labelled as approved by SÚKL. The indication of approval may be shown solely on the EM or those secondary distribution methods which were specifically approved by SÚKL.

For the purposes of approval of secondary distribution methods, SÚKL requires, in particular, the following:

• specially created websites which are not linked to the websites of the MA holder and which do not contain any link or click-through to the MA holder´s website;
• for access to the content of the EM it is not possible to request that, in addition to the declaration of whether the user is or is not a healthcare professional, the user should log in and/or enter any other identification data;
• possibility to download the EM in a common no-editable format (such as PDF);
• it is not possible to prohibit making of copies and sharing of the EM from this website;
• a short and easy-to-remember website address;
• absence of any advertising elements.

SÚKL is not responsible for the business terms and conditions of such websites and its approval of the content of the website does not imply that it agrees with the text and content of the business terms and conditions provided by the MA holder on such websites.

If the MA holder is the owner of websites which are not only educational in nature, SÚKL shall not prevent the publication of approved EM on these websites (with the possibility to download the EM in a non-editable format, such as PDF). This concerns a secondary distribution method which, however, is not approved by SÚKL, and hence should not form part of the Distribution Plan.

SÚKL encourages any activities of the MA holder aimed at obtaining information about the effectiveness of the educational program on the basis of data obtained from these very websites. This purpose and intension, however, has to be clearly stated on the websites.

The hand-over of EM to healthcare professionals at professional events (e.g. medical congresses) is also permissible as a secondary distribution method, if carried out in order to provide complex information about the medicinal product outside the scope of promotional activities. Such events, however, must not be events associated with the placement of a new medicinal product on the market (so called launch symposia).

Making use of various digital channels, such as websites, social media, specialised web interfaces or mobile applications for the distribution of EM is permissible provided the aforementioned conditions are met. The recipient of the EM must be clearly specified (patient/healthcare professional) and the non-promotional nature of EM provision ensured. Furthermore, the provided information must be up-to-date so as to avoid any confusion on the part of healthcare professionals as well as the general public. If the MA holder publishes EM, they shall be obliged to arrange for the publication of updated versions, no later than within one month of the approval of the change by SÚKL.

SÚKL recommends to avail also of other EM distribution routes, such as publication on the websites of professional associations.