The module brings together regulatory knowledge and social science perspectives on pharmaceuticals and medicines. It considers what medicine are, the various forms they take, how they are developed, regulated and marketed, drawing from the recent experiences with developing COVID-19 vaccines. It will discuss the development of the concept of essential medicines and the World Health Organisation's essential medicine's list. It will give an overview of the development of the pharmaceutical industry including a discussion of patented and generic medicines. It will also consider the different ways in which pharmaceutical companies exercise power within the market, for instance through marketing strategies they are able to shape health care needs. It will provide an overview of the medicine approval system and prerequisites for ensuring the safety, efficacy and effectiveness of medicines.
The module will also consider drug discovery and the forms and stages of clinical trials, drawing from the ongoing experieces with developing vaccines and treatments for the COVID-19 epidemic. A further focus will be on the regulation of medicines and how patterns of national and regional pharmaceutical production and supply are affected by international regulation such as TRIPS, TTIP and international institutions such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The module will also give a comparative overview of national regulatory standards for the production, quality control, distribution, prescribing of medicines, and systems of pharmacovigilance. It will also cover issues related to access to medicine and identify areas in which the market has failed to meet global health needs. For example no new drugs have been developed since the 1950s for ‘neglected diseases’ such as chagas in Latin America and leishmaniasis in Africa, and current drugs for these diseases are prohibitively expensive; at the same time infectious disease in poorer societies remains untreated, and the global market for anti-depressants has grown.
