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  1. OK – so here we are a year-and-a-bit later, were your predictions borne out? Did the initial findings surprise you at all? I knew outsourcing levels were high but was a little surprised to find them that high – and rising. But more vitally in my experience working with both pharmacovigilance outsourcing providers AND their clients, I think a major aspect of drug safety is somewhat lost in your original survey. If the regulatory playing field was a level one then all things being equal, one would expect outsourcing across the developed world to eventually tail off as “big” pharma were able to achieve cost savings through economies of scale in sourcing PV in-house, while mid-sized companies used CROs and smaller ones were left to… well hope they didn’t show up on the regulatory radar.

    Instead, because the regulations change so frequently, there is an ongoing demand for pharmacovigilance expertise that cannot possibly be met with good, qualified staff. For example, the European rules were based on the European Commission’s document “volume 9a of The rules governing medicinal products in the European Union”. It was announced last year that this was being phased out – indeed that withdrawal happens in the summer of 2012 meaning that certain aspects of all European Pharmacovigilance systems will be rendered entirely obsolete. One of the biggest components to be axed is the Detailed Description of the Pharmacovigilance System. This document forms the basis of all current pharmacovigilance inspections across the EU and yet from July it will no longer be required. The obvious question is – what will they use to base the insepction on then?

    But moreover, how can internally trained, non-specialist (or semi-specialised) staff hope to cope with this changing morass of requirements from regulators? The obvious answer is outsourcing but that in itself is a risky business. With so much at stake in the granting and maintenance of marketing authorisations the cost savings in outsourcing could be a false economy. The question of whom to turn to for compliant European pharmacovigilance expertise has never been harder to answer than it is now.

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