Paper short abstract:

In Latin America, we continue to witness cross-national variation in generic drug regulation. We propose a typology that facilitates comparative analysis. Variation are reflective not of technical choices, but political interaction between state actors, pharma industries, and medical communities.

Paper long abstract:

The United Nations Sustainable Development Goals agenda reinforces the urgent need to provide access to affordable essential medicines. By promoting generic drug competition, countries can reduce the prices of essential medicines, yielding benefits for public health in terms of increased access and public finances in terms of reducing pharmaceutical expenditures. Consistent with these concerns, international organizations such as the World Health Organization and the Pan American Health Organization have made remarkable efforts to help countries establish frameworks for promoting and regulating generic drugs. In Latin America, however, notwithstanding common concerns and external support, we continue to witness important cross-national variation in this area. In this paper we propose a typology of different approaches to generic promotion and regulation that facilitates comparative analysis of national approaches, and tentative explanations for cross-national differences. Our typology considers countries' rules and regulations across four dimensions: (1) the demonstration of therapeutic equivalence, (2) pharmaceutical packaging and labelling, (3) drug prescription, and (4) drug substitution. Variation on these dimensions is reflective not of technical choices alone, but political interaction between state health officials and regulators, pharmaceutical industries, and medical communities. To understand and compare national approaches toward generic drug promotion, it is crucial to carefully distinguish among these four dimensions and the political economy dynamics that drive variation. Empirical content is from the cases of Argentina, Brazil, Chile, Colombia, and Mexico.

Paper short abstract:

Does India's experience in the last two decades suggest a re-thinking about the relationship between patents, R&D and innovation in developing countries? Does import trade regime matter for a more developed industry? What does India's experience in biotechnology products and APIs suggest?

Paper long abstract:

The business environment of the pharmaceutical industry has changed dramatically in India since the 1990s especially with respect to patent regime and import trade regime.

The abolition of product patents in pharmaceuticals in 1972 was a major factor behind the rise and growth of the industry led by Indian private sector. What has been the impact of the re-introduction of product patents in pharmaceuticals in 1995? Like the MNCs, Indian companies are operating in different parts of the world not only as exporters but also as investors in manufacturing and marketing operations. Again like the their western counterparts, Indian companies have also started investing in R&D for the development of new drugs. But overall did the change in the patent regime benefit Indian companies? Are Indian generic companies mature enough to take advantage of stronger patent protection? Does India's experience in the last two decades suggest a re-thinking about the relationship between patents, R&D and innovation in developing countries?

Second issue relates to import liberalization. India's success as an exporter of cost effective chemical based pharmaceutical formulation products has obscured the negative impact that import liberalization had on biotechnology products and many active pharmaceutical ingredients and intermediates. The second part of the paper will analyse the implications of such an import dependence on sustainable growth of the industry. It will argue that even a more developed industry such as pharmaceuticals in a developing country such as India require active government intervention to promote the growth of industry.

Paper short abstract:

The paper presents data on patent provisions in bilateral trade agreements that exceed what is required from the World Trade Organization. I review debates over the effects on drug prices of such provisions and focus on the conceptual and methodological challenges that analysts must overcome.

Paper long abstract:

The global politics of intellectual property underwent a fundamental shift in the closing decades of the 20th Century, as the World Trade Organization's (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) made pharmaceutical patent protection obligatory for all WTO members. By 2005 pharmaceutical patents were universally available, in all but the poorest countries. Increasing the geographic scope of patent protection generated fears that public health budgets would come under stress and many would be left without access to essential medicines. These fears were augmented dramatically by the inclusion of further provisions in the flurry of regional and bilateral trade agreements that have been negotiated since the early 2000s between the USA (and also European Union) and developing countries in Asia, Africa, and Latin America. This paper analyzes the spread of "TRIPS Plus" rules in bilateral trade agreements, explaining the challenges that they create and the shortfalls of recent studies that attempt to measure their impact. The paper places particular emphasis on the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, including the choice of what variables to focus on, how to operationalize these variables, and the importance of timing in analyzing the effects of TRIPS Plus provisions.

Paper short abstract:

The comparative dynamics of local pharmaceutical production in sub-Saharan Africa are explored, with a particular focus on agreements and divergences between health and industry policymakers, and how those differences vary across a number of selected countries.

Paper long abstract:

In recent years, in light of a dependence on imported medicines, an agenda has emerged in support of local pharmaceutical production in sub-Saharan Africa. Yet at times local production has also been questioned by health interests who argue that promoting locally produced over imported medicines may reduce access to medicines. This paper draws on comparative field research on the dynamics of industrial policy in support of local pharmaceutical production in sub-Saharan Africa. It demonstrates how in South Africa and within East Africa, diverging perspectives have emerged between industry and health policymakers over support for locally produced medicines. In comparison, in Ghana and Ethiopia greater support is shared between health and industry policymakers. The case is situated in relation to the comparative dynamics of African industrial policy today.