Arete-Zoe participated at IARMM 4th World Congress of Clinical Safety in Vienna, Austria

Date: 28-30th September, 2015
International Association of Risk Management in Medicine (IARMM)

For details see Congress Bulletin

Title: Are regulations becoming a negative factor in pharmaceutical safety? Lessons from Three Mile Island
Topic: Philosophy and strategy of clinical risk management and governance.

Abstract: Pharmaceutical and clinical research industries are global in nature. Most clinical trials are conducted in multiple jurisdictions and often on several continents. Pharmaceuticals are manufactured in large centers in Asia and transported over vast distances to target markets. At the same time, regulations are enforced predominantly at national level with little emphasis on soft law in the form of international guidelines unless implemented directly in national legislation. Once regulations become as voluminous and complex as those now in place in the pharmaceutical sector, they can serve as a negative factor in patient safety. Conclusions from the Three Mile Island accident report are used to demonstrate the same type of risk factor in a different industry. Because of the sheer volume and complexity of pharmaceutical regulations, the industry invests tremendous efforts into compliance with these regulations, equating due diligence and compliance with 'safety' as a result. It is, of course, the responsibility of the respective lawmaking bodies and regulatory agencies to write laws and issue regulations to ensure only drugs and biologics with favorable risk:benefit profile are made available to the public. Governments and regulatory bodies rarely take synchronized action to design an inherently safe system with adequate coordinated controls. Regulatory agencies use different algorithms for assessment of risk, depending on local circumstances, culture, and information and resources available, as well as political risks stemming from widely publicized failures. This paper argues that due diligence and compliance with national regulations alone is not enough to manage risks and ensure patient safety.