The Evolving Dynamics in Life Sciences Meetings & Regulatory Compliance

We’re back to in-person meetings as if the 2-year pause never happened. Pharma and Med Tech companies are enthusiastically arranging engaging meetings for medical congresses, maximizing their sponsorships. Global regulators are now swiftly updating codes to match recent changes in the life science landscape, replacing the slow COVID-era pace with determination and rapid decisions.

In the life sciences meetings sector, things are moving at a dizzying 200 km/h pace, making it challenging to stay current. So, here’s a recap of last year’s healthcare compliance updates that impact medical associations’ operations. This will provide you with valuable insights as we enter the final quarter of the year. Be on the lookout for more updates before year-end.

Without further ado:

Updates to the Portuguese Pharma Code of Conduct (entered into force in January 2023)

• By expanding the definition of health organizations to include also medical associations and scientific societies, it effectively regulates the way industry interacts with those organizations;
• It expands the definition of health professionals to include pharmacy technicians, medical devices and diagnostic technicians, and laboratory technicians. If you are organizing a congress in Portugal keep this in mind in terms of access rights to the exhibition floor;
• It states that the compensation for sponsorships for the organization of events by health organizations should be a tangible benefit. It clearly stipulates that company logo placement and/or verbal acknowledgment from the sponsored organization does not constitute a tangible benefit;
• It makes the e4ethics platform event assessments mandatory for its members. Refer to my previous article in relation to streamlined CVS assessments for more information.
• It mandates that pharma companies are not allowed to demand that they are the sole sponsor of health organizations, or the events organized by them. 

Updated MedTech Code of Ethical Business Practice (entered into force as of January 2023)

• It includes a new annex in relation to defining and calculation of in-kind educational grants;
• It also includes a new chapter on third-party intermediaries. This in effect imposes bigger scrutiny responsibilities upon MedTech companies, as they are liable for the activities of those intermediaries when they interact with HCPs or Healthcare Organizations in connection with the sale, promotion or other activity involving MedTech Europe’s Member Companies’ products and/or services.

The Prescription Medicines Code of Practice Authority (PMCPA, the self-regulatory body which administers the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry,) Social Media Guidance 2023 (issued in January 2023)

• It aligns with the EFPIA and IFPMA Joint Guidance on social media and digital channels of communication (see my previous article on the topic)
• It writes down the rules and principles developed throughout the PMCPA’s caselaw that has been developed in relation to social media;
• It underlines the importance of transparency – for example, if a Pharma company is involved in a social media post (i.e. by publishing, producing or directing the content or funding/sponsoring the platform or post), it needs to be clear from the outset;
• It clarifies (aligning with the EPFIA and IFPMA guidance) in which cases Pharma companies are responsible for the social media activities performed by third parties on the company’s behalf; 
• It strongly suggests that Pharma companies also have the responsibility to preview (and where necessary certify) content created on their behalf by third parties, and will require withdrawal rights in case of non-compliance;
• It underlines (aligning with the EPFIA and IFPMA guidance) that when mentioning a prescription only medication (including the name and/or indication of a medicine) in a social media post is likely to be considered promotion to the general public and it is therefore prohibited

EFPIA’s updated meals and drinks score card (updated multiple times this year / most recent update dates from July 2023)

• Even though the limits in the score card are not always reflective of the limits mentioned in the codes of each country, the score card is worth paying attention to as it reflects the “reasonable” meal standard in each country.

Update of the guidance to the Danish Code of Conduct for Pharma promotion (issued in May 2023)

• When advertising medicinal products to HCPs, certain information about the product is to be provided in the advertisement. The new comments to the Promotion Code’s article 5 (2) states how much information is to be included when advertising through a dynamic banner (advertisement which extends over multiple pages, where not all pages can be viewed at the same time).

The newly published IFPMA note to Guidance on sponsorships of events and meetings (issued in May 2023)

• It remind its members that the main purpose of Company Programs (events organized directly by Pharma companies) and third-party events for HCPs “should be to provide scientific or educational information and/or to Inform HCPs about therapeutic areas, interventions and products for the enhancement of patient care”. It also provides a few key questions to keep in mind when evaluating the quality and suitability of such events;
• It is underlined that supporting HCP attendance at Company Programs or third-party events is to be solely based on the relevance of the said event to that HCP’s “expertise, qualifications, experience, and educational needs”. Such support cannot be conditioned on or offered as an inducement to prescribe, recommend, purchase, supply, etc. a product or therapy. Here as well, the document offers a set of questions to be considered when selecting HCPs. IFPMA also strongly suggests added scrutiny when considering support of HCPs to third-party events (for example, congresses); and underlines that when HCPs do not have an active role in the event (ie as speaker, poster presenter, etc.) support for virtual attendance should instead be chosen for. Lastly, in line with the current trend in the Life Sciences industry, it is suggested that, where possible, the costs for HCP support should be provided to the service provider (e.g. third-party meeting organizer, travel company, etc.).
• It is stressed that events are to be organized in or near the HCPs’ country of practice. International congresses are the obvious exception, as they draw international attendance. It has also been reminded again that the location should not be the main attraction of the event, and that the venue must be conducive to the scientific or educational objectives and the purpose of the event at hand.
• It has again been reminded that hospitality should always be “modest, incidental and reasonable”, where meals are to be judged as reasonable by “local standards and should be set by local industry associations and/or companies”. It is also stressed that member companies are not to organize or pay for entertainment or other leisure or social activities. Such opportunities may be provided during third-party organized events, but these should be outside of the scientific schedule, not interfere with the overall program, and be subject to a separate fee, which is to be covered by the HCPs themselves. The implementation of contractual clauses to that effect has been strongly suggested to the member companies.

Updates to the Greek Pharma Code of Conduct (entered into force as of March 2023, with updates on sponsorships in September 2023)

• It updates its scope by codifying its connection with EFPIA and IFPMA. Thus, the Greek SFEE (the Hellenic Association for Pharmaceutical companies) has created an obligation for Pharma companies to comply with the Greek code when operating in Greece, even if that company is not a member of the SFEE but only of EFPIA and/or IFPMA. This is due to the SFEE membership in EFPIA and IFPMA;
• It has added a new category of events to the code. It has specific conditions that need to be met in terms of approval; a minimum duration of educational content per day (4 hours/day); maximum registration fee limit per HCP (F2F: €200; virtual: no registration fee) and limitation on the amount of sponsorship that can be provided for the entire cycle per Pharma company (F2F: €5000; virtual: €2500).
• It shows the importance of adherence to the GDPR within the terms of the code.
• It prohibits the company brand name and direct or indirect advertising messages to be put on promotional materials. Company logo is, however, allowed.
• It introduces a reduction on sponsorships to scientific events by 30%. This seems to be counterbalanced by the reduction of 30% on the limit for registration fees HCPs are to be charged per registration. The SFEE does underline that international congresses evaluated by the CVS system (EFPIA and MedTech Europe approval) are excluded from this limit.