Laurent Clerc: 'If I could change one thing…'

I would give local affiliates greater freedom to adapt corporate processes to overcome the challenges of local regulatory compliance constraints.

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 standardise processes and how subsidiaries operate. This standardisation comes at the expense of the taking into account specific local requirements some of which cannot be covered by standardised processes. Ultimately, it weakens the aim of full compliance.

Standardisation 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 needs and facilitate cross-disciplinary compliance management.

• Flexibility – with a degree of freedom a subsidiary will be able to react quickly to a rapidly changing environment, especially when it comes to regulatory issues. For example, in the UK, the local affiliate 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 standardise operations between subsidiaries and their corporate offices: it makes perfect sense due to the existence of supranational codes (eg, EFPIA) and legislation. However, this should be supported by crossdisciplinary working at local affiliate level to ensure that global process 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.

The Author
Laurent Clerc is Managing Director of BMI SYSTEM Ltd, software editing company for regulatory compliance.
For further details, contact Laurent Clerc on +44 (0)207 092 6619 or l.clerc@bmi-system.com.