Historically, insurance protection for a Qualified Person has been provided by the employer. Increasingly it is becoming evident that, should there be an error which leads to an investigation, the case for personal protection becomes apparent.
Since the well-being of patients and other end users is at stake, the pharmaceutical industry has found itself falling increasingly under the scope of both UK and European legislation. Much of this legislation focuses on the responsibilities and accountabilities of the Qualified Person to the extent that he/she is now recognised by all statutes relating to pharmaceutical manufacture.
In the UK, the Medicines Control Agency and the Veterinary Medicines Directorate not only require a Qualified Person to be named on any Manufacturers’ Licence but these bodies are also the final arbiter as to who can be named as a Qualified Person in the first place.
With all of the responsibilities that are incumbent to a position of such stature, the inevitable personal accountability and duty of care becomes particularly pronounced. Moreover, in exercising their responsibility, Qualified Persons will encounter a range of potential conflicts which they will need to identify, assess and appropriately manage.
At senior level, potential conflicts are an everyday occurrence; the job of a professional being to weigh up the competing pressures and choose a course of action that can be justified to peers. For Qualified Persons, the primary sources of conflict stem from their simultaneous duty to their employer and to the Supervisory Authority and its inspection service.
An additional dimension is the need to comply with the Code of Practice specified in European Directive 2001/83/EC drawn up jointly by the three professional bodies (The Royal Pharmaceutical Society of Great Britain, The Royal Society of Chemistry and the Institute of Biology). There also needs to be an observance of the Code of Ethics of the parent professional body.
Whilst the role of the Qualified Person is of considerable importance to the Pharmaceutical Industry, risks are inevitably compounded because Qualified Persons may not have line management responsibilities for many of the activities for which they are accountable. Sometimes it may not be possible to directly supervise any tests and checks as required.
Notwithstanding the increasing regulation of the Industry generally, the society in which we live is becoming ever more litigation conscious. Should the unthinkable happen and an error occur, the result can be very alarming, and not without consequences. Human considerations apart, the resultant investigation may involve attempts to apportion blame and with reputations at stake the subsequent legal and even possible compensation costs may prove extremely costly.
Historically, insurance protection for a Qualified Person has been provided by the employer. Increasingly it is becoming evident that, should there be an error which leads to an investigation, the case for personal protection becomes apparent. An alarming trend is now emerging where criminal proceedings are being instigated against individuals not their employers, by the Crown Prosecution Service, in the event that a serious error occurs. In several landmark cases recently, manslaughter charges have been laid against a doctor, a pharmacist and even a trainee.
With an employer’s insurance may well serve the employer’s interests, it may leave the individual Qualified Person exposed. There are many other and more common sources of concern, e.g. and issue related to terms of service, one caused by competing commercial and safety considerations, an Industrial Tribunal relating to an employment dispute or even a disciplinary hearing of the parent professional body.
Should there be a need for independent legal representation at any inquiry or tribunal or, in the worst case scenario, should compensation be required, the resultant costs could be well beyond the means of the individual. Increasingly professionals are realising that the protection that is of the greatest value in all of these situations is one that they carry in their own right – where no conflicts of interest can emerge.