For donations or grants for hospitals, this clause has now been supplemented by Lif’s ethical rules for donations and grants for hospitals by the pharmaceutical industry which took effect on 1 September 2011. The new code supplements and further restricts Article 15 in some areas with respect to donations and grants to hospitals, including the fact that companies should ensure that grants or donations are used for the intended medical scientific purposes (or make these conditional) and that it is the hospital /hospital department that controls the donation or grant and that the actual transfer must be approved by a duly authorized person from the hospital and there must in any event be written and signed documentation for the terms and conditions.
This clause does not cover issues regulated by Article 13 on sponsorship for individual participants' attendance at professional meetings, including hospitality.
The clause corresponds to EFPIA HCP Code Art. 11 and is also in line with Article 21 Advertising Order, and Article 25, although the clause does go a little further than the Advertising Order with respect to the
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requirement for documentation, registration and publication. The clause also clarifies the fact that sponsorship must not be equated with promotion for a medicinal product, cf. also the definition of promotion.
It is a requirement that any support must be aimed at medical or scientific purposes covered by (1), i.e. support for healthcare services or research. The investigations panel understands the term 'healthcare services' in accordance with the Promotion Code as meaning professional healthcare services that a healthcare professional is authorized to undertake. The Panel of Investigators therefore finds that donations and grants must be made in connection with an activity that is an integral part of prevention, examination, diagnosis, treatment or subsequent checks on the patient. The Panel finds that a similar conclusion is supported by Arts. 4 - 5 Donations Code which provides that such donations and grants must be made respectively for "healthcare services or research or other medical activities for the benefit of
treatment for patients or the hospitals.” The supported service must therefore specifically relate to
professional healthcare in accordance with the concept of healthcare services above.
The former Danish Medicines Agency did however state that in assessing lawfulness, it emphasised the importance of funds going to the operation of medical services, that the hospital, association or individual hospital department could make dispositions over the funds they had received; and that sponsors generally would have no influence on operations, tasking or what the funds should specifically be used for, cf. for example the Agency's ruling on the Network for Heart Failure Clinics dated 22 May 2007 (end).
It should be noted that the Agency took a different, more lenient view of the concept of "professionalism og a medical/pharmacy nature" then that historically taken by the Committee. The Agency accordingly accepted that support for management courses, etc., was lawful whereas the Committee does not regard such courses as "professional," cf. also re. (13) above.
In a specific prior assessment, the investigations panel found that on certain conditions, loans of iPads to hospital departments could be made in accordance with this clause as well as Arts 4 - 5 Donations Code. In this specific case, iPads were loaned for an agreed period and contained a specially designed web
application with information about an area of disease for patients, and also a web application aimed at healthcare professionals with two modules with e-learning and product information respectively. Access to the information aimed at healthcare professionals was effectively restricted and the iPads concerned were fitted with a technical system to prevent them from being used for other than the intended purpose. It was accordingly not possible for users to install their own programs or games, download music and films or check e-mail, etc, since any access by users to the internet was barred. The purpose of loaning the iPads concerned was to optimize healthcare professionals’ communication with especially young patients with the specific condition. The group of patients was characterized by having poor understanding of their condition and poor awareness of their life situation. So for this group of patients, it was especially important to use a form of communication with which patients were comfortable and which did not appear intimidating.
Re: Section 15 (2).
The prohibition against sponsoring individuals follows from the EFPIA HCP Code, but also from the practice laid down by the Danish Health and Medicines Authority (formerly the Danish Medicines Agency) and the
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former NSL. The then Danish Medicines Agency's rulings are discussed in detail in NMI’s annual report for 2007 (Annex B). This provides that:
Support for hospitals, groups of hospitals and specific hospital departments (in contrast to individual healthcare professionals in hospitals) does not conflict with the rules. In a meeting on 27 June 2008, the Agency stated that this would also apply to private hospitals operated on a corporate basis with more than one shareholder.
Support for individuals and groups of individuals (healthcare professionals) is not lawful. This also applies, according to the practice of the former Danish Medicines Agency, to support for medical societies (which are associations of individuals), regardless of whether the support is for a medical or scientific purpose (e.g. for setting up websites, distribution of material or drawing up treatment databases, etc.).
Lawful support naturally predicates that the support is for the professional purposes set forth in (1). Re: Section 15 (3):
For donations or grants to hospitals, this rule has now been supplemented by the requirement for pharmaceutical companies to publish a schedule on their website, cf. Lif’s ethical rules for the
pharmaceutical industry's donations and grants to hospitals that took effect on 1 September 2011. The new code supplements and further restricts Article 15 in some areas with respect to donations and grants to hospitals, including the fact that companies should ensure that grants or donations are used for the intended medical/scientific purposes (or make these conditional), that the hospital /hospital department controls the donation or grant and that the actual transfer must be approved by a duly authorized person from the hospital, and there must in any event be written and signed documentation for the terms and conditions.
Re: Section 15 (4):
The clause corresponds to EFPIA HCP Code section 12.01