Expanding into new markets is a critical step for Pharma companies, but compliance missteps can lead to costly delays, regulatory scrutiny, and wasted resources. When launching above-country projects in Europe’s Big Five markets (France, Germany, Italy, Spain, and the UK), companies often assume that a broad regional approach will be sufficient. However, the reality is that each country has its own specific requirements that can significantly impact commercial and medical activities.
So how do you balance efficiency with local compliance? The key lies in understanding the difference between baseline knowledge and in-depth, country-specific expertise, and using that knowledge to make informed, strategic decisions.
Baseline Compliance Knowledge vs. In-Country Expertise
A baseline understanding of compliance gives teams a solid foundation to plan and execute above-country projects efficiently. This knowledge covers the overarching principles of major regulatory codes, like EFPIA requirements, and helps commercial, medical, and compliance teams anticipate potential risks.
However, baseline knowledge does not replace in-depth local expertise. While above-country teams can use this understanding to inform their commercial and medical strategies, they cannot rely on it alone when executing in specific markets. For example, knowing that an HCP engagement approach works in Germany does not mean it will be compliant in Italy, where meeting restrictions may apply. Without local insight, teams risk developing strategies that cannot be executed, leading to wasted time and resources.
Common Compliance Pitfalls in Above-Country Planning
Without a structured approach to understanding both baseline and country-specific requirements, Pharma teams frequently encounter:
- Misalignment between regional and local execution – Commercial teams plan initiatives based on European-level guidance, only to discover that national laws prevent them from moving forward.
- Last-minute compliance roadblocks – Content is developed for multi-market use, only to be rejected by in-country teams due to regulatory nuances.
- Wasted resources – Marketing and medical materials are created at a regional level, but cannot be adapted for local use without significant rework.
- Inspection risks – Regulators expect evidence of compliance governance across markets, and a lack of awareness can lead to significant findings.
How Pharma Integrity Academy Solves This Challenge
At the Pharma Integrity Academy, we bridge the gap between regional planning and local execution by equipping above-country teams with the right level of knowledge to make informed decisions—without overcomplicating the process.
- Practical Training on the Big Five Markets
We provide country comparison modules that give commercial, medical, and compliance teams an operational understanding of major differences between the UK, France, Germany, Italy, and Spain. This ensures that companies can plan more effectively, reducing rework and unnecessary delays.
- Guidance to Avoid Compliance Pitfalls
We highlight common missteps in above-country projects and provide insights on how to structure strategies that work across multiple markets, without risking compliance breaches.
- Inspection Readiness Support
Regulators expect evidence of good governance over training and compliance awareness. Our modules ensure that above-country teams can demonstrate structured learning and oversight, helping companies stay audit-ready at all times.
Future-Proofing Above-Country Projects with the Right Compliance Knowledge
To operate successfully in Europe’s Big Five, companies must move beyond one-size-fits-all compliance approaches. With the right baseline knowledge, teams can plan efficiently, avoid costly mistakes, and engage HCPs in a compliant and impactful way.
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