Conference Matters international
The regulatory landscape surrounding pharmaceutical advertising is complex, requiring meticulous attention to detail and strict adherence to guidelines to maintain ethical standards and safeguard against undue influence. By navigating these regulations conscientiously, stakeholders can uphold the integrity of healthcare practices and ensure transparency in industry interactions.
Organizers of medical events facilitate interactions between healthcare professionals and pharmaceutical companies during scientific conferences or refresher trainings. These interactions are valuable for the dissemination of knowledge from healthcare professionals to pharmaceutical companies and vice versa.
In both the Netherlands and beyond its borders, stringent regulations govern pharmaceutical advertising and financial relations between healthcare professionals and these companies. The aim is to maintain ethical standards and prevent undue influence on healthcare professionals. These rules extend to various aspects, including events sponsored or organized by pharmaceutical companies. Let's delve into the intricacies of these regulations, exploring the Dutch Code of Conduct for Pharmaceutical Advertising (CGR) and its implications for medical events.
Pharmaceutical advertising is tightly regulated in the European Union. Pharmaceutical companies are allowed to advertise their prescription-only medicinal products (PO-medicines) to healthcare professionals that are licensed to prescribe or supply such PO-medicines. Conversely, it is strictly prohibited to target the general public or healthcare professionals who are not licensed to prescribe or supply PO-medicines with such advertisements. The rationale here is that this group of non-healthcare professionals is not well-positioned to judge pharmaceutical advertising on its merits, due to a lack of education on this topic.
These rules apply to everyone, which means that organizers of medical events need to take the measures within their power to ensure that no undue pharmaceutical advertising takes place.
Pharmaceutical advertising covers everything that can be considered promoting a specific PO-medicine and has persuasive character. Information on prescription-only medicines which is directed at non-healthcare professionals is permitted. Advertising for the company itself (‘corporate advertising’) is also allowed, as this is not considered advertising a specific PO-medicine.
The ban on advertising PO-medicines to the public encompasses various mediums, such as showing the product name at stands (product stands), programme booklets, folders, scientific presentations, video messages and apps. Non-healthcare professionals may not be exposed to such advertising claims.
Indirect advertising to the general public for prescription-only medicinal products is not permitted either. This is the case if a company advertises for an administration device (such as an injection pen or inhaler) which is used only in combination with certain prescription-only products. Advertising for the company itself (‘corporate advertising’) may be directed at the general public.
Events attended by both healthcare professionals and non-healthcare professionals necessitate meticulous planning to prevent inadvertent exposure to PO-medicine advertising. Clear demarcation between areas where such advertising is permitted and restricted is essential. Badges should indicate whether a participant is a healthcare professional or a non-healthcare professional. Detailed agreements between pharmaceutical companies and event organizers are crucial to ensure compliance and avoid unintentional breaches.
Please note that the ban on public advertising does not apply to the attending employees of pharmaceutical companies, the conference organisers, the conference venue and the catering.
Exceptional circumstances, such as large-scale international medical conferences primarily targeting healthcare professionals, may present challenges in completely isolating non-healthcare professionals from prescription-only product advertising. To avoid unproportionally hindering the organization of scientific events, large-scale international conferences, the organization does not have to take additional measures to prevent non-healthcare professionals from being exposed to advertising for PO-medicines in case of large scale international conferences (see inset).
In the case of a conference that (also) specifically targets non-healthcare professionals, the promotional claims made during this conference will be deemed to be directed at non-healthcare professionals, resulting in a violation of the ban on pharmaceutical advertising to the public. In these circumstances conference organisers must take additional measures to prevent exposing non-healthcare professionals to advertising for PO-medicines.
Pharmaceutical industry sponsorship of events must adhere to strict guidelines regarding program content, venue selection, and financial contributions in order to avoid unduly influencing healthcare professionals. The focus should remain on scientific content, with a suitable venue (not too luxurious) and hospitality costs kept within reasonable bounds (participant’s travel expenses, meals, accommodation costs and registration fees). The speakers’ fees must be reasonable in relation to the services they provide: the CGR sets maximum hourly rates for healthcare professionals based on their educational background.
Healthcare professionals need to pay for recreational and social activities themselves. Detailed budgeting and transparent reporting are imperative to monitor compliance and ensure ethical conduct.
The Dutch Healthcare Transparency Register serves as a vital tool for disclosing financial relationships between pharmaceutical companies, healthcare professionals, and patient organizations. Financial transactions exceeding a specified threshold trigger mandatory reporting, fostering transparency and accountability within the healthcare sector.
Additionally, healthcare professionals that contribute to an event as a speaker need to disclose their ties with pharmaceutical companies to their public.
Event organizers bear the primary responsibility for ensuring compliance with advertising regulations. This means that the pharmaceutical companies must be informed about the participating target groups and that organisational measures must be taken for non-healthcare professionals, with regard to both advertising for PO-medicines and hospitality. If the initiator engages an external conference organisation to organise the event, it is important that clear agreements are made about the responsibilities between these parties
Pharmaceutical companies that are represented at an event with a stand have the primary responsibility to ensure that non-healthcare professionals are not exposed to advertising for PO-medicines. The hospitality offered by the company from the stand directly, such as meals and drinks, will, moreover, have to remain limited to what is ‘strictly necessary’ for participating in the event.
A pharmaceutical company will likely require information in advance about the programme of the event, the speakers, the budget, etc. in order to check in advance whether its sponsoring satisfies the legal requirements. It will also request a final settlement after the event has been held.
Under the following circumstances, we speak of large-scale international conferences:
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