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Healthcare compliance: an evolving landscape with some new grey areas

Following on from the second Compliance Workshop in Hammersmith hosted by Healthcare Venues, Dominic Bemrose explores the shifting regulatory landscape and what the trends mean for pharma and medtech companies and their agency and venue partners.

At TTA, we put a lot of emphasis on continuous learning when it comes to the practical implementation of healthcare compliance. I recently attended the second Compliance Workshop in Hammersmith hosted by Healthcare-Venues.com, which united corporates, agencies and venues in a discussion of the trends and challenges in healthcare compliance brought about by an increasingly restrictive regulatory environment. In this two-part blog, I’ll share my key take-aways from the day.

Face to face still matters

First, the good news. The HCP meeting landscape is undoubtedly evolving and adapting to the demands of the digital age, but face-to-face meetings still play a prominent role in the educational mix. Over half of HCPs (51%) say their attendance at congresses has increased in the last twelve months while 41% stated it has stayed the same, despite the rise in hybrid meetings.

Perhaps rather than dwell on virtual versus physical attendance, it pays to think of HCPs as consumers of continuous medical education, and in-person events provide opportunities for personalised learning experiences, networking with peers and cross-fertilisation of ideas that digital channels can’t yet hope to match.

Codes of Practice are evolving

The pace of regulatory change is accelerating: whereas a key change of practice typically used to be introduced every five years or so, in Europe, we are now seeing changes every 1.7 years on average.

There has been some consolidation of Codes of Practice – for example, in 2019, the European Federation of Pharmaceutical Industries & Associations (EFPIA) amalgamated its three existing codes into one to simplify the concepts and clarify the content. However, the feasibility of implementing a single, global Code of Practice is virtually nil, as there are huge variations from country to country: what might be deemed proportionate by an affluent nation could be perceived as extravagant in developing economies.

The International Federation of Pharmaceutical Manufacturers & Associations’ (IFPMA) Code of Practice has been revised five times since its inception in 1981. The 2012 revision saw the code’s scope expanded beyond marketing practices to cover all interactions with HCPs, medical institutions and patient organisations. What jumped out at me is that the 2019 iteration contains a significant change: the development of an “IFPMA Ethos”, which “aims to shift from a rules-based to a values-based code”.  By instituting a culture grounded on values and principles, this puts a greater emphasis on the perception of compliance and introduces infinite possibilities for grey areas. That’s quite disconcerting for those who prefer their rules to be black and white!

Take clause 7.1.7 for example: “Member associations are encouraged to provide written guidance on the meaning of the terms “renowned” and “extravagant” as used in Article 7.1.4 of this Code, and the meaning of the terms “moderate” and “reasonable”, as used in Article 7.1.5 of this Code. As a general rule, the hospitality provided must not exceed what participants would normally be prepared to pay for themselves.”  That’s all well and good, but what might constitute an everyday meal to a consultant surgeon could be seen as a relative luxury for a junior doctor. Our challenge is therefore to determine what is appropriate according to the delegate base – and sometimes it’s not just about doing the right thing but also ensuring that our client doesn’t appear to be doing the wrong thing. 

It is becoming standard procedure in many European countries to subject HCPs to an advance visa procedure when inviting them to participate in events that involve at least one overnight stay, and we can expect more countries to follow suit. From an agency and client perspective, this introduces additional complexity and a degree of frustration. But what is perhaps overlooked is the impact of beefed-up compliance measures on the HCP experience. We’re increasingly challenged to bridge the gap between what we are allowed to do on behalf of our clients in a regulated environment and delivering the best possible attendee experience. 

Medtech is playing catch-up on compliance

Pharmaceutical companies are substantially advanced along the compliance maturity curve, but medical device manufacturers are lagging behind by about a decade. We’ve witnessed this first-hand at a recent exhibition where comformance in respect of booth activity varied considerably among medtech exhibitors.

We always act in our clients’ best interests. This often involves advising stakeholders on which activities they can undertake, helping them to protect their reputation and avoid the prospect of hefty fines. For the time being, medtechs aren’t competing on a level playing field, but this will change as more non-conformances are reported and the penalties become more visible.

In part two of this blog, I’ll cover the key insights and observations from the panel discussion on how healthcare companies, agencies and venues can work together more effectively - and empathetically – in the pursuit of compliance. 

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