Publication of an article in Pharmaceutical Market Europe about the adaptability of local branches to their own regulatory compliances constraints. Laurent Clerc (Managing Director of BMI SYSTEM Ltd) was the author of a text “If I could change one thing…” in the June edition of PME. In this text is discussed the impact of a global policy for transparency compliance and the necessary degree of freedom given to subsidiaries.
Direct link to PMLiVE: PMLiVE

Full text :

Too often pharmaceutical companies take a top down approach to compliance, from corporate offices to subsidiaries. Therefore compliance becomes a tool for corporate offices to standardize processes and how subsidiaries operate. This standardization comes at the expense of the taking into account specific local requirements some of which cannot be covered by standardized processes. Ultimately, it weakens the aim of full compliance.

Standardization  often leads to a “silo management” approach (complaints handling, pharmacovigilance, medical information, training …), each activity being managed more or less independently.
So what can be done? Subsidiaries could have the freedom to adapt processes to local need and facilitate cross-disciplinary compliance management:

–   Flexibility – with a degree of freedom provided to the subsidiary will enable greater reactivity to a rapidly changing environment, especially on a regulatory aspect. For example, in the UK, the local branch must consider pharmaceutical regulation, codes of practices but also the provisions of the Bribery Act

–   Cross discipline – while compliance requires a global and systemic vision of all critical processes, no process functions independently. To avoid the risk of non-compliance (at the point at which these siloed processes meet), it is important to encourage cross-functional working.

Of course, there will always be a need to standardize  operatins mode between subsidiaries and their corporate offices: it makes perfect sense due to the existence of supranational codes (e.g.EFPIA code) and legislation. However, this should be suported by cross-disciplinary working at local affiliate level to ensure that global processes can be shaped to meet local needs.

Advances in computer technologies for process management can support cross-functional working by ensuring that:

–   Each subsidiary can adapt corporate processes to meet their own needs and challenges

–   Affiliates communicate with each other across a single platform to allow control of all critical processes (HCPs relationships transparency, product risk, product information…), without exception.