Journal of the International Relations and Affairs Group, vol. 2, issue 1, June 2012

 

Abstract: Pharmaceutical industry has long been recognized as one of strategic industries, both in terms of countermeasures in case of public emergency and in terms of dependency on a strategic commodity. Policy relating to the need to improve efficiency and cost, speed up development of new drugs, and the risks of strategic dependency remains highly inconsistent in the U.S., whilst in the UK both industry and government administration unanimously prefer outsourcing of vital industries to a strategic competitor for business and cost-saving reasons. Pharmaceutical industry is highly regulated, and ethical codes are in theory legally binding worldwide. Cost-cutting efforts resulted in mass outsourcing of operations to emerging markets, especially to India. Number of clinical trials conducted in developing countries, especially sub-Saharan Africa and India skyrocketed. This brings new challenges such as compliance with ethical standards, as demonstrated on the Trovan case, and quality and transferability of produced data. Recent disaster in Mexican Gulf and costly industrial disasters which resulted from a failure to detect a safety signal are used as examples of lessons which can be learnt from different industries in terms of risk management and mitigation. With regards to management of sensitive medical data and management of workforce with sensitive skill sets, the industry should learn from the field of intelligence where the importance of data and personnel security is well recognized. Historical examples of WW2 Nazi experiments are used to describe malignant client relationship between medical professionals and a state. Non-compliance with international ethical standards in medicine and abuse of human rights in countries with less rigorous law enforcement comes at a cost, and that is fuelling of resentment and conflict. The ways of improving adherence of non-state actors such as multinational corporations which are not otherwise subject to international law to international ethical standards in drug testing mainly include litigation and market exclusion through import bans. Claims under the Alien Tort Statute are on the increase as well.