Thoughts on Global Medical Affairs
A reader (and now friend) recently contacted me with an interesting challenge and agreed to allow me to recap our discussions here (de-identified, of course).
He/she was recently promoted into global responsibilities for managing the MA field force. For their mid-sized biopharma company, global meant US and EU and this person already had managed the US field force. He/she wanted to discuss keys to taking on the EU MSLs (although they use a different term).
1. Time to make your “Grand Rounds” of the EU
Although no one has the time or budget, it is critical to find a way to meet with the EU MSL team members in their individual countries, rather than as a set. Given the way many EU country organizations are run, the MSL may be significantly more focused on their country-level needs than overall EU level needs. So you need to go out to the countries and meet them and their key internal stakeholders in the country leadership. MA’s work with commercial can be more flexible in the EU than in the US, so it is important to explore how the MSLs are supporting their country needs.
This is a critical time to listen and not judge. The goals and programs of the MSLs tasks can differ quite a bit from the mean country to country. It is not unusual to find some activities that strike you as being in the grey area (by EU standards) have crept into the MSL remit, especially if the country lead is unclear on the standards and the MSLs don’t hold to the standards clearly. These activities are usually driven by some high-value, country-specific scientific need so you need to be careful about simply pulling the plug. Instead you should first explore the compliance aspects (see next point below) and if you decide to terminate them, work with the local stakeholders to find a more compliant alternative.
Regardless, you should come away from the Grand Rounds understanding not just your new MSL team but the environment in which they operate.
2. Make friends with EU Compliance internal resource or get name for who the organization uses externally to support compliance in the EU
My friend understood that the difference between the EU regulatory environment and the US environment in general, but one of the key points when first managing MSLs in the EU as an American is to break the US-conditioned mind-set that EU countries are the equivalent of US states. While everyone understands this, it is very common to fall into assumptions about a broad set of rules that apply equally to all of the EU. There are some of these (privacy laws being one of the biggest differences from the US) but there are also a range of country-specific rules which must be taken into account when considering MSL goals and activity in the EU.
If you are lucky enough to have in-house compliance counsel with EU expertise, my recommendation is that you approach them after each of your country visits, which will allow them to tackle the issues without overloading them. If you use outside counsel, hold all your questions until the end since them always seem more efficient when you give them a raft of questions vs. one or two at a time.
3. Determine how much global alignment you want to force
Determining how similarly you want to run the US and EU groups should be carefully considered. It is possible to force full alignment between the US and the EU, one set of rules, standards and measures for all. The downside is that you have to go with the strictest regimen between the US and the EU and countries, and this can really stand in the way of effectiveness on both sides of the Atlantic.
Instead, I suggest maintaining two sets of standards. For example, given the different compliance regimes, to maximize the value in each country a different set of SOPs may be reasonable, despite the cost and inefficiency of having two sets. Systems may need to vary given EU privacy rules or at least communication about the content of the system. Even basic metrics and measures of performance will likely need to vary.
What advice do you have for the “American in Paris”? Leave a comment.
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