Events organisers need to be aware of new regulations governing medical association conferences

 

Since the “Sunshine Act” was adopted in the USA in 2010 and the subsequent review in Europe of the ethical practice codes by the pharmaceutical and medical device industries, medical associations have increasingly come to realise that this is a factor which needs to be an integral part of their congress and meeting planning.

This is particularly true if they want to continue to engage the support from the commercial sector and healthcare professional (HCP) community within their events. But once we think “we’ve got it”, the codes change and/or new cases, where a breach ruling is found, cause planners and industry alike to question what is permissible and what might be viewed as a misdemeanour.

Recently, we have seen in Europe(which has been cascaded to a national level) the requirement in the pharmaceutical industry for companies to record and publicly report payments, financial and in kind, made to healthcare profes sionals (‘transfer of value reporting’ – ToV). This stems from the regulatory body EFPIA (European Federation of Pharmaceutical Industries and Associations) which has overseen changes to legislation in 2014 and goes further in its scope than the US Sunshine Act.

This can only be a good thing to improve transparency, however the knock-on effect has been to prohibit sponsorship of branded items such as notebooks, pens, lanyards, delegate bags and more as they cannot be classed as educational and can’t be tracked by companies for reporting purposes. The result for the medical associations has been withdrawal of sponsorship revenues from what had once been premium delegate items.

A FURTHER impact has been how exhibition booth activity has been curtailed resulting in many cases of companies shrinking their booth size, which has an impact on both the association revenue and also that of the venue, as associations are in the main requiring smaller exhibition halls.

Since January this year, the European medical device industry – overseen by the regulator MedTech Europe – has introduced a ban on the direct funding of “non-active” healthcare professionals (HCPs) to attend third-party organised congresses, resulting in some associations already seeing a noticeable reduction in attendees. Whilst these changes have the intention of improving the image and protocol of engagement between “industry” and the HCPs, which is all the more visible at a time when health service funding and access to medical services is in the press on an almost daily basis, these changes are definitely having an impact on medical association meeting activities. For many medical associations, funding from the commercial medical sector is essential to fund the cost of running the meeting and in some cases fund the wider objectives of the associations.

The majority of medical associations do have an awareness that compliance has to be considered as part of their event planning but many are still getting to grips with recent changes. Consequently, they are still having discussions with their industry supporters to understand fully how they are managing their activities within the confines of the revised landscape. The first point of discussion needs to be “What do you want to achieve from supporting congress x,y,z?”, and not simply an email blast of the sponsorship brochure and shopping list! Through discussions, everyone will glean a much more in-depth understanding of how each supporting company is adopting the regulatory requirements within their own internal codes of practice, as differing organisations are implementing the codes in differing ways. We have, for example, seen some pharma companies deciding to stop direct funding of HCPs to association congresses; and in the medical device industry an increase in the stand-alone company organised meetings, where direct HCP funding is still permitted.

So what does this mean? In short, associations who still want to engage the commercial sector and healthcare professional community within their events need to:
– Keep abreast of the changes – whilst any infringement of the industry codes falls onto the shoulders of the companies found in breach, there is the potential for reputational damage for the association if they haven’t ensured through their actions that the environment created is compliant.
– Dialogue – speak to industry supporters, understand what their goals are and through that exchange find ways to source new areas of support and cooperation that can still gain industry support and add value to the conference.
– Be imaginative – think of ways you can evolve your event that will help it to develop and keep supporters on board. Areas such: as extending the dialogue and engagement beyond the 3 or 4 days of the face-to-face meeting; capturing and repackaging content; increasing online learning; and platforms in between the annual meeting. These are just some ideas that add value for all but are not necessarily as cost-intensive as often thought.

What’s next? It’s a good question for us in the UK with Brexit looming as we have many uncertainties ahead. It’s likely that the UK will continue to adopt the regulatory codes of the rest of Europe because alignment in the medicinal product licensing environment is key and the government is seeking special arrangements for the Healthcare and Life Science sector, but we must wait and see how this evolves.

The other area to watch is that of the patient becoming increasingly involved in meetings that have traditionally been the domain of the HCP. With promotion of prescription- only medicines in Europe being banned to non-HCPs this is increasingly creating complexities for meeting planners on how to maintain a compliant environment balanced against the commercial activities of industry.

One thing is for sure, healthcare compliance will be with us for a long time to come.

 

Caroline Mackenzie is a Director of Global Association Partners, a specialist PCO and event consulting company that advises associations and organisations working with the healthcare and life science sector.