As of 1 July 2018 an amended version of the self-regulatory Code of Conduct for Pharmaceutical Advertising ("CGR Code") will become effective. The CGR Code contains provisions on pharmaceutical advertising and interactions between pharmaceutical companies and HCPs, including the disclosure of financial relations (Sunshine rules). The main changes in the CGR Code relate to:
- the relationships between pharmaceutical companies and persons other than HCPs;
- the specific conditions for sponsoring projects (grants/donations); and
- hospitality at (scientific) meetings.
The reason for updating the CGR Code is the publication of the updated version of the policy rules inducement Medicines Act 2018 ("policy rules") that became effective as of 1 April 2018. Consequently, the self-regulatory body CGR felt that further amendments to the CGR Code were necessary to align the CGR Code and the policy rules.
Relationships with persons other than healthcare professionals
On the basis of the Medicines Act it is not allowed to stimulate the prescription or supply of medicinal products by awarding, offering or promising benefits in cash or kind ("ban on inducement"). Several exceptions to the ban on inducements are laid down in relation to HCPs. On the basis of these exceptions, it is for example possible that HCPs provide services to pharmaceutical companies if the services are relevant to the practice of medicine, pharmacy, dentistry or nursing.
It remained relatively unclear how the relationship between pharmaceutical companies and persons other than HCPs should be assessed in view of the ban on inducement. Especially, if such persons are involved or have influence on the prescription, dispensing or use of a medicinal product. The amended version of the CGR Code addresses this lack of clarity and introduces a new (centralized) article 6.5.2. This article sets out the conditions that should be met in order to allow a financial relationship with persons other than HCPs. If the conditions are met, it is presumed that the relationship will fall out of the scope of the ban on inducement.
The main conditions that should be met are as follows:
- the relationship between the pharmaceutical company and the recipient may not influence the recipient to prescribe or supply medicinal products;
- the relationship should be transparent;
- the relationship should be laid down in a prior written agreement;
- the relationship will not affect the independency, integrity and credibility of the recipient; and
- the level of compensation should be limited to what is strictly necessary and may not exceed the level of compensation for similar financial relationships with HCPs in relation to hospitality, gifts and provided services.
Sponsorship of projects was already regulated in the CGR Code and was considered to be allowed (in short) if the support was related to innovative and/or quality-enhancing activities and if the support was intended to achieve a direct or indirect improvement of patient care or to advance medical science. However, due to the introduction of this form of sponsorship in the policy rules, the CGR Code is further amended to correspond with the conditions as set out in the policy rules.
Consequently article 6.5.3 (new) will be introduced, including conditions for sponsoring projects. If the conditions of this article are met, it is presumed that the sponsorship falls out of the scope of the ban on inducement.
One of the newly introduced conditions in the CGR Code extends to the prohibition to include a duty of performance of the sponsored party (other than mentioning the name of the sponsor). This condition is derived from the policy rules. The scope of this condition was not fully clear on the basis of the policy rules: the CGR Code now clarifies that performance of the sponsored project itself is not enforceable (no duty to perform). However, it is still possible to agree upon e.g. (periodic) reporting of the project. It should however be guaranteed that the nature and content of the sponsorship relation are limited to the purpose of the sponsored project.
Hospitality at scientific meetings and other events
The wording of the CGR Code in relation to allowed hospitality at scientific meetings and manifestations will be slightly amended and tightened up but the majority of the changes seem to be of a textual nature instead of substantial changes. However, it is notable to mention that the amended version of the CGR Code describes in more detail how the assessment in relation to allowed hospitality should be performed, for example in relation to the required balance between the (scientific) program and other parts of the meeting (such as coffee breaks, lunches and/or drinks) and in relation to when venues can qualify as suitable.