PHARMACOVIGILANCE THROUGH MERGERS AND ACQUISITIONS By Tom Nichols
Mergers and acquisitions (M&A) are an everyday part of the pharmaceutical industry. Whether it involves acquisitions of companies (complete or partial) with the integration of departments, or ‘just’ the sale of assets, M&As are something that we will all have to deal with at some point in our careers. There is no one-size-fits-all approach to pharmacovigilance (PV) during M&A activities, and they are mainly driven by the wider commercial approach being taken by the companies involved. This article looks at some of the key considerations involved. Such is the ubiquity of M&A, Good Vigilance Practice (GvP) Module I ‘Pharmacovigilance systems and their quality systems’ specifically mentions it:
PV departments and expect them to pick up the pieces. However, the best way to avoid this happening is to proactively foster relationships with the wider business and senior decision makers, so everyone is aware of this in advance. Much more difficult to try and amend things after the event, even if you are given authority by your company.
“When a marketing authorisation holder intends to expand its product portfolio, for example, by acquisition of another company or by purchasing individual products from another marketing authorisation holder, the QPPV should be notified as early as possible in the due diligence process in order that the potential impact on the pharmacovigilance system can be assessed and the system be adapted accordingly. The QPPV may also have a role in determining what pharmacovigilance data should be requested from the other company, either pre- or postacquisition. In this situation, the QPPV should be made aware of the sections of the contractual arrangements that relate to responsibilities for pharmacovigilance activities and safety data exchange and have the authority to request amendments.”1
While this article will focus on some of the practical considerations involved in M&A, changing a PV system is not just a series of faceless processes and systems being updated. The human aspect is, if anything, more important. Even though processes and systems are drummed into us, I have never seen a PV system that doesn’t also lean on human knowledge. Even down to the mundane “where can I find this document?”. The PV changes can be sold to people as development opportunities, but it’s very difficult to come up with the advantages of potential redundancies or having to relocate. Even the importance of development opportunities can take a bit of time and distance to understand and appreciate, as I can personally attest. It is vital to manage engagement and communication throughout, as both key messages and staff moral can be undermined without it. Differences in view between ‘the company’ and staff on the ground can often not be more different. It is also important to be aware of differences in work culture and employment rights around the world (for example, between the EU and US), so attitudes may be quite divergent.
The FDA also recognise it as an area that should not detract from the successful completion of PV activities: “When inspecting firms undergoing corporate transitions, determine that written procedures have been appropriately updated to ensure that the surveillance, receipt, evaluation, and reporting of PADEs remains in a state of compliance.”2 Although there is this regulatory requirement to be involved as soon as possible in the due diligence process, in reality this often doesn’t happen, and PV departments are having to fight reactively. The key words here I think are the QPPV having the “authority to request amendments” to the contracts and safety data exchange agreements (SDEAs). This shouldn’t just be dropped on
The following table provides just a few, high level, key considerations for when you approach any merger or acquisition. For all these, you must remember that PV does not work in isolation. Liaison with regulatory is essential for Eudravigilance updates and with Legal 34
