In our newsletter of February 2018, we brought the news that Danish Regions in February 2018 issued a new set of guidelines stipulating that companies wishing to financially contribute to supplementary training of healthcare professionals (HCPs) within the Danish public health service must approach the hospital management and not the individual HCP.

Following the publication of these guidelines, the Capital Region of Denmark has now formally entered into an agreement with the Danish Association of the Pharmaceutical Industry (LIF) on the parties’ collaboration in regard to sharing of knowledge, professional advisory and funding of supplementary training to HCPs. The agreement applies to HCPs employed at hospitals in the Capital Region of Denmark and is subject to control and sanctioning by the Ethical Committee for the Pharmaceutical Industry (ENLI) meaning that pharmaceutical companies violating the terms of the agreement may for example be ordered to pay a fine.

Professional meetings and advisory boards

The agreement provides that professional meetings between representatives of a pharmaceutical company and HCPs must be agreed in advance and in writing together with the purpose of the meeting. To this end, e-mail correspondence will suffice.

As for meetings with more than three participants, the meeting’s subject and form must be authorised   in advance by the department management at the hospital. Further, when visiting the hospital, the representatives shall register their visit in accordance with the hospital’s applicable requirements and procedures.

Further, the agreement stipulates that HCPs’ participation on advisory boards initiated by pharmaceutical companies is subject to prior written approval from the department management at the hospital (and if a member of the department management wants to participate, his or her superior must approve it).

Such advisory boards must have a scientific, research- related or similar professional purpose, as HCPs are not entitled to participate in a pharmaceutical company’s marketing activities.

Training of healthcare professionals requires approval

The agreement further stipulates that pharmaceutical companies hosting or co-hosting training (courses, conferences, etc) that wish to invite HCPs to participate in such an event must always send a written invitation directly to the management of the relevant department at the hospital (or their superior if such members of the management wish to attend themselves).

The department management then decides which (if any) of its HCPs that will be allowed to participate in the event.

In the written invitation, the pharmaceutical company may state the maximum number of invitations, including if the pharmaceutical company offers payment of the participants’ expenses in connection with the event (e.g. transport or accommodation). The department management decides whether participants will be allowed to have such expenses covered.

The pharmaceutical company may also state whether the event is aimed at HCPs with specific competencies, but the event must not in any way be directly or indirectly aimed at specific individuals. However, in special cases, the pharmaceutical company will be allowed to reject specific participants chosen by the department management, if such rejection is based on current legislation, company-specific or industry- specific compliance, rules on impartiality or on the individual HCP’s lack of relevance in terms of the professional field of the event.

Additionally, the agreement stipulates that if a pharmaceutical company wishes to sponsor HCPs’ participation in international congresses (in Denmark or abroad), which are hosted by a third party, the pharmaceutical company must also send a written invitation directly to the department management. In that case, similar rules apply in regard to the contents of such written invitation, the department management’s approval of the sponsorship and the pharmaceutical company’s option(s) for rejecting specific participants chosen by the department management. Moreover, the pharmaceutical company must inform the department management to what extent it will cover participation fees, transport, accommodation and/or hospitality of the

Additionally, the agreement stipulates that if a pharmaceutical company wishes to sponsor HCPs’ participation in international congresses (in Denmark or abroad), which are hosted by a third party, the pharmaceutical company must also send a written invitation directly to the department management. In that case, similar rules apply in regard to the contents of such written invitation, the department management’s approval of the sponsorship and the pharmaceutical company’s option(s) for rejecting specific participants chosen by the department management. Moreover, the pharmaceutical company must inform the department management to what extent it will cover participation fees, transport, accommodation and/or hospitality of the participants and whether it will host any additional, supplementary symposiums outside the official program of the congress which the participants are invited to participate in.

The pharmaceutical company must never condition a sponsorship on the HCPs participation in specific parts of the congress’ official program or participation in supplementary symposiums.