The following article reflects my top takeaway thoughts following my attendance at the ABPCO workshop on compliance that took place in London in March 2018. Links to further resources can be found at the bottom of the page.
“I find compliance for meetings and events interesting”
Very few of my industry peers will agree with that statement but I find the level of self-moderation across pharma and medical devices fascinating. Whilst it’s true to say that some of it comes from regulatory bodies, very few industries have imposed such self-regulation upon themselves.
A few weeks ago I attended an event organised by ABPCO which gave a good insight into the complexities and rationale of compliance. The content was expertly delivered by Caroline Mackenzie of Global Association Partners, a fellow Full Member.
There is no doubt that compliance in relation to medical meetings can be complex, there is no one set of overriding rules for all meetings. Variances can be found between local, national and continental laws and guidance. So rather than providing an in-depth analysis this article contains my top 5 takeaways from the session.
Compliance is common sense
The foundation of compliance is really around the appropriate marketing of products to both health care professionals (HCPs) and consumers. This subtitle says it all. The rules and regulations stem from what is deemed “appropriate” behaviour, i.e if it’s not appropriate you shouldn’t be doing it!!!
Golf days, financial incentives, gifts and luxury are out, but are education, support and subsistence in.
Medical associations need to do more
Many medical associations still believe that accountability for compliance sits outside their remit. To some extent this is true, however, if organisations wish to work with industry they need to adapt some of the ways they work. Some examples of this are ensuring that sponsored and scientific content is kept separate in the programme, ensuring that venues are appropriate, getting your event approved by Ethical Medtech,
Not adapting to regulation may lead to medical associations losing out on valuable commercial income.
Decisions not limited to guidance from one body
The various legal and voluntary government bodies can often give conflicting messages, particularly between national and European codes of conduct. Often there are different rules for pharmaceutical meetings than those around medical devices. Often a compromise may need to be made between the different rules. For example, national HCP hospitality allowances for meetings can often be lower than than similar European-wide guidelines. Another example might be where one body will allow giveaway coffee-mugs, another will not. You may argue that a mug could hardly be seen as an incentive or item of value, however, some regulations require the value (known as Transfer of Value) to be reported. Imagine having to keep a list of everyone you have a mug too……priceless!!!! So it’s easier to just not allow it in the first place.
Perception plays a big part
It’s not just about doing the right thing but also ensuring you don’t appear to be doing the wrong thing. Pharmaceutical and medical device manufacturers should be seen to be behaving in an ethically acceptable way. For this reason venues for association meetings need to be appropriate, and this is usually interpreted has having a maximum four-star rating (or equivalent for venues that are not part of a hotel). However, this is not necessarily the case as 5* venues can be used when an “appropriate” 4* venue isn’t available. No-one ever said compliance wasn’t confusing!!!
So those are my main takeaways. However, I would encourage you to to read around the subject yourself, and I’ve listed some of the resources available below:
By Rob Eveleigh
First published 25/04/18