Feature

Key Compliance Updates for Medical Associations

As COVID-19 has had a big impact on the way medical congresses are organized, medical associations still need to give the utmost attention to Pharma and Medical devices codes, laws and regulations – and compliance in general. In this special contribution to Boardroom, Yana Budel from GCO Global, provides you with the latest updates on this delicate matter.

Now that the world of healthcare meetings has begun returning to live meetings, medical associations/societies may be curious to find out about any recent updates to the Pharma and MedTech compliance codes, regulations, and laws that might affect industry’s behavior and decision making in the run up to- and during medical congresses.  

In general, before and during the first year of the COVID pandemic, a lot of the regulatory framework did not consider virtual channels of communication with HCPs. Now most European country codes or regulations have been updated (with varying details) to reflect the interactions with HCPs through digital channels or to at least acknowledge those. And this is as it should be, as virtual meetings are here to stay and are now intertwined with the live ones in what has become known as hybrid.

Let us start with the Joint Guidance on Virtual and Hybrid International Medical Congresses by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). 

The three associations led the way when it came to guiding healthcare meeting organizers and industry in relation to virtual and hybrid meetings. They indeed published the guidance only a couple of months after the first lockdowns were announced – it has since been updated to include information on hybrid meetings. Below, you will find a summary of the most relevant points for medical association/societies and medical congresses:

  • When selecting the promotional label for an international virtual congress, pharmaceutical companies have been advised to consider the code of the region from which the majority of delegates will be expected to come from, based on past experience. For example, if most of the participants will be coming from the US or Europe, the industry will choose the USA or European label to be displayed respectively. For international hybrid congresses, the guidance suggests that the rules of the live location are to be considered. 
  • Companies are advised to base the selection of industry code (for international virtual/hybrid congresses) on industry practice, rather than relying on the code as selected by the medical association/society. 
  • Industry has been advised to work with the medical association/society in order to ensure that access to promotional materials is limited to HCPs only. Restrictions on non-HCPs attendees are not considered relevant in relation to industry representatives or third parties engaged by the industry.
  • The importance of respecting privacy laws has been underlined as well, in two ways. First, the guidance document advises pharma companies to familiarize themselves with the terms and conditions and privacy statements which the registering attendees will need to sign/acknowledge. Secondly, it requires medical associations/societies to ensure that data privacy requirements of the European Union as well as other regions (where necessary) are embedded in the overall congress platform (e.g. registration, access controls to different sections like commercial exhibition or scientific sessions).
  • Industry and medical associations/societies have been advised to ensure (as much as possible) that microsites and other related websites where materials for restricted access are placed should be accessible though the congress platform only and not through search engines or links.

The MedTech Europe Code of Ethical Business Practice had given some recommendations for virtual interactions before the pandemic started. That code was updated in March this year, and will enter into force in 2023: it provides clarity, additional guidance on Collaborative Research, new definitions in the Glossary and an explanation of the existing Code provisions, as well as the consolidation and clarification of the existing rules around Distributor Relations and Virtual Events.

Yana Budel is Compliance Advisor at GCO Global and is based in the Netherlands. GCO Global is a full-service organization delivering strategic meeting management solutions for the Life-Sciences industry.

Now let’s move to the most important updates in the US, relevant to virtual meetings and medical congresses in general:

  1. The AdvaMed code (the USA medical technology company code) that entered into force on June 1, 2022, has been updated to address virtual interactions, meetings, and programs. For example, it states that the delivery of food packages provided on the occasion of virtual meetings are allowed, which is in contrast with the standard in Europe – no meals to be provided during virtual interactions with HCPs. 
  2. The OIG Special Notice about speaker programs made quite a bit of noise and caused Pharma companies to noticeably alter the way they conduct meetings with HCPs. In fact, as a result of the alert, the Pharmaceutical Research and Manufacturers of America (PhRMA) revised its code in January of 2022. Below is a summary of the updates to the code:
  3. It refers to speaker programs but, given their definition, in the context of a medical congress in Europe, this will cover industry symposiums with an American HCP speaker. Based on this, medical associations/societies in Europe may already hire fewer USA HCP speakers during industry symposiums and if an American HCP is hired, then special measures may be taken by the industry to secure themselves against accusations of wrongdoing. For example, the speaker may be based in a different location than the attendees and he/she will present virtually.  
  4. It is made clear that invitations to attend a speaker programs (also symposiums) should only be limited to those who have a bone fide educational need for the information presented in the program. 
  5. It is stated that meals should be incidental business courtesy and no alcohol should be provided.
  6. It is also reiterated that repeat invitation to attend a program (which has already been attended before) on the same or substantially the same topic (where a meal is being served) is not appropriate. Speaking at a program and attending a program on the same or substantially the same topic is now also not appropriate. 

Keeping up to date with the regulatory framework can be time consuming, and therefore, having a trusted partner who can help you stay well informed is essential.  With its extensive experience working with Pharma and MedTech companies, GCO’s compliance department has come to understand their motives, working methods and have insights in the latest industry trends.

Hit enter to search or ESC to close