Pharma has public responsibilities way beyond ordinary business ethics

The pharmaceutical industry continues to be rocked by a succession of blows which are forcing it to redesign its business models.  Following on from the healthcare cost containment challenges in the '90s, the latest issues include a series of extremely high profile drug safety cases which are hitting public confidence and leading to regulatory transformation.

Previously, regulators had tried to keep control by inspecting the degree to which companies maintained compliance.  A little bit like a school exam, if you managed to cover the right question on the day, you passed.  As we all know, this doesn't always represent the full story, and this was also the case with the pharmaceutical industry.  The regulators are now encouraging companies to design quality in at source, in a way which proves they are in control of their processes.  The approach being taken is risk-based, which means the FDA and other like them will assess the degree of risk a company presents and hence the degree of rigour to which they will receive regulatory oversight.  There is a new awareness that pharma has public responsibilities way beyond ordinary business ethics.  Public safety is paramount.

To read the case study in full, please click on the pdf link below:

Managing Risk in Pharma and Compliance.pdf