Pharmaceutical Industry in the Global South: Introduction to Special Issue

Pharmaceutical industry in the Global South is in a state of flux. The emerging international gold standards institutions (GSIs) of intellectual property, quality standards and counterfeit drugs have substantially restricted its ability to produce and distribute cheaper generic drugs. These institutions have necessitated development of capabilities in newer directions of bioequivalence, clinical trials and drug discovery. The developing country firms have to devote substantially more resources to knowledge building exercises. Their current activities with regard to research and development, however, remain below par. Additionally, development of these capabilities requires building up of systemic linkages among policymakers, universities and research institutes, healthcare systems, patients groups and industries. Many countries in the Global South do not have adequate policy capacity in place to design such a comprehensive systemic linkage. Public opinion in countries like India remain divided on issues of permitting clinical trials on Indian population, calling for intense negotiations among diverse groups to create an appropriate policy space.

However, the demand for cheaper, effective as well as new drugs is on the rise across the globe. The various relaxations in recent years to least developed countries with regard to intellectual property rights compliances, and access to affordable drugs by the World Trade Organization (WTO) recognise the importance of this demand, much in line with the Doha Declaration. However, the tendency of the advanced countries to seek bilateral or regional treaties with the countries of the Global South remain a source of concern for these treaties often bypass the multilateral commitments under WTO, and the concerns of the Doha Declaration, and continue to push for greater protection for data and intellectual property.

The current issue is an attempt to bring diverse perspectives on some of these issues together. The first article by Orsi, Singh and Sagaon-Teyssier discusses the way an absence of strong intellectual property rights coupled with active participation of public sector and UN organisations in pharmaceutical distribution helped reduce the prices of artemisinin-based combination therapies and ensured its wide access in Africa. The article by Banerjee and Sargent brings out the other facet, by analysing how strong intellectual property rights and international treaties indeed makes access to cancer therapies difficult. The article by Hu, Hsu and Wu builds on the case of Taiwanese biopharmaceutical industry to points out the difficulties faced by the latecomer firms in this industry to catch up and grow, due to weak entrepreneurial capacity to adapt to external institutional contingencies. In their article, de Padua, Fontes and Sausa provide a detailed exposition of how the developing country firms are attempting to contribute to the research on drug discovery through diverse patterns of systemic linkages.

The article by Bhaduri and Kipgen analyses the process of new drugs approval in India. The article points out an over dependence on regulatory knowledge produced elsewhere, lack of proper deliberations and documentation of the decision-making process and uneven growth of regulatory capacity between the central unit and its state counterparts as some of the key features of India’s regulation making processes in this field. These weaknesses may not only adversely affect the quality of regulatory responses to emerging challenges, but also deter long-term regulatory capacity building in this area. The article by Regal is a practitioner’s perspective on the recent controversies on clinical trials in India. On the basis of a detailed account of the recent history of the regulatory flip-flop, public outcry and the activism by the judiciary and the media he argues for a better mechanism to identify and tap expert’s knowledge and better integration of territorial laws with the international laws. The article by Quet, Pordie, Bochaton, Chantavanich, Kiyeting-Angsulee, Lamy and Vungsiriphisal focuses on non-state regulation making process in the ASEAN countries using a ‘regulation multiple’ framework. They show that domestic and international interests, geopolitics and spatial configurations, commercial and health considerations, governmental policies and individual behaviours and legal and illegal transactions all contribute to regulate the pharmaceutical milieu.

The search for cheaper medicine has encouraged the modern pharmaceutical industry to turn to the rich reservoir of traditional medicinal knowledge, located in the countries of the Global South. However, we are yet to have an effective design to reconcile the differences between the two systems of knowledge. In this direction, the article by Priya and Kurian reminds the need to frame the ongoing policy deliberations at the international and national level, for access and benefit sharing of traditional health knowledge, using a holistic health system perspective.