A Glance at Some of the Challenges of the GC Role in Pharma

Abstract

In the heavily regulated environment in which pharmaceutical companies operate, success is defined by ensuring corporate compliance with disparate laws and regulations without fettering the creativity and innovation on which pharmaceutical companies depend. Business success can deliver life changing outcomes to patients worldwide. It is fundamental that the GC in a pharmaceutical company understands and facilitates this goal. Diminished drug pipelines have required companies to rethink the drug discovery process and move away from the search for new, small molecule drugs to focus instead on the re-purposing of known drugs and development of biologics and "personalised" medicines. New business models, often involving collaboration with third parties including competitors, universities and charities have been introduced. There is increased use of computer aided drug design, big data and artificial intelligence (“e-health”). All give rise to numerous legal issues: how will outputs from collaborative research be owned, protected and commercialised; what patient data can be used and how, in the drug discovery process for the benefit of society; how will regulators approve bespoke drugs for small patient populations for which a standard clinical trial is not feasible; how will pricing and reimbursement by governments and healthcare providers be determined given the pressures on healthcare budgets?