Just as cricketers bat for their teams and as their fans bat for their favourite players, I was tempted to bat for ‘Pharmacovigilance Independence’ when I sat to put together my thoughts for this October 2017 edition of Oviya MedSafe‘s newsletter!
Of course, independence is something that everyone ‘wants‘. But, why does Pharmacovigilance ‘need’ to be independent? The obvious answer would be that Pharmacovigilance deals with lives and therefore should be devoid of interference from any other domain. A quick sub-query might be on what independence will mean in this context. Let us try to resolve the puzzle together, having in mind the general scenario in the pharmaceutical industry!
To start with, having an exclusive Pharmacovigilance department in a pharmaceutical company may itself be considered by some as independence, as the head of the department may have dedicated staff and may get to directly report to the top management. However, this is far from reality because Pharmacovigilance is an interdisciplinary function and in fact, it is difficult for routine Pharmacovigilance activities to be performed without the involvement and rather the co-operation of other departments. Moreover, decision-making in Pharmacovigilance matters doesn’t always rest with the department alone due to the business-critical nature of some decisions in which other departments such as Manufacturing/Marketing/Regulatory Affairs may even have a stronger say. In fact, even this limited degree of independence can be said to exist only when the top management encourages the Pharmacovigilance department to make unbiased recommendations on the safety of their products without hesitation, before a corporate decision is made.
Moving to the next level, independence may be seen as the capability and the authority available with the Pharmacovigilance department to be emphatic in documenting and appropriately acting upon a potential harm identified to be associated with their company product, overriding all other interests. In the real world, this is not impossible but many a time difficult. The strength of the Pharmacovigilance department’s argument for ‘Patient Safety‘ and the dynamics of power in the concerned organization are important determinants of the level of independence that could be achieved. Whether the company product is in the clinical trial stage or in the post marketing stage is another factor that may come to play. Similarly, the ‘innovative‘ or ‘generic’ categorization of the company itself may influence the level of independence to a great extent.
While it is true that the autonomous and controlling role played by regulatory agencies insulates the Patient Safety risk due to the total or partial lack of ‘Pharmacovigilance Independence‘ in the industry, it is important for the industry to grant the due independence to Pharmacovigilance. I tend to think that the pharmaceutical industry can best achieve the highest level of ‘Pharmacovigilance Independence‘, in all good sense, by externalising Pharmacovigilance from their core business focus. Having a knowledgeable, reliable and durable ‘Pharmacovigilance Partner‘ may be of immense support to a pharmaceutical company especially when its internal Pharmacovigilance department is held back by its unknown fears.
I believe it may be appropriate at this juncture for me to recall Oviya MedSafe’s July 2017 newsletter edition, in which I had traced the life cycle of ‘Pharmacovigilance Outsourcing‘ and highlighted how Oviya MedSafe has been negotiating the paradigm shift in this field. I wish the act of batting for ‘Pharmacovigilance Independence‘ could be seen as extrapolation of the defining work Oviya MedSafe has done in Pharmacovigilance since 2012. Standing testimony to this assertion is our long list of clients who have implicit trust in our commitment to them, which in turn drives us to always go at least one step higher than just satisfying their business needs.
With more independence, we have always been more responsible, and that makes everyone at Oviya MedSafe proud of ourselves as a team!
Looking forward to share more thoughts with you in November 2017,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,