However pharmacovigilance IS expensive. And pharmaceutical companies ARE companies and do have to make a profit, even the most responsible pharma company knows that it is answerable to its shareholders and stakeholders as well as the regulatory authorities.

So what to do?

Well one solution is to outsource some or all of the drug safety surveillance activities or to bring in consultants. Is this wise? Well it might be but it depends where the work goes and why the work is being outsourced in the first place.

In the end it must be remembered that the responsibility for product safety lies with the pharmaceutical company. It doesn’t matter whether you use a pharmacovigilance service provider or bring in contractors or consultants. The company that holdes the marketing authorisation (EU) – or manufacturer (US) is free to delegate some or even most of its pharmacovigilance responsibilities but overall control and responsibility lies with the pharmaceutical company itself. Therefore, all outsourcing of pharmacovigilance must have clear and proper accountability with transparent organisational strucutre and a decision making process for the client company that is robust. There also needs to be contract documentation that is both comprehensive and detailed in terms of dictating which party is to carry out which of the many pharmacovigilance activities. This is the only way that patients’ interests can be protected and that all of the company’s legal obligations may be met. satisfied and the patients’ interests protected.