Ken Shadlen

• PhD
• Professor at London School of Economics and Political Science

This volume assesses the role of intellectual property in pandemic times through lessons learned from COVID-19. Authored by an international roster of experts, chapters diagnose causes for the inequitable distribution of lifesaving COVID-19 vaccines and offer concrete suggestions for reform. From delinking vaccine development from monopoly rights i...

This article contrasts the different approaches to COVID-19 vaccine development adopted by Oxford University, on one hand, and Texas Children's Hospital and Baylor College of Medicine (collectively, Texas), on the other hand. Texas was praised widely in the press and academic literature for adopting an “open source” approach to vaccine development....

The COVID-19 pandemic, which featured international pharmaceutical firms seeking to build global manufacturing networks to scale-up the supply of vaccines, has generated heightened interest in understanding the role of firm-to-firm technology transfer. While considerable attention has been given to tracking the extent of international vaccine techn...

As the world struggles to meet the challenges of vaccination against COVID-19, more attention needs to be paid to issues faced by countries at different income levels. Middle-income countries (MICs) typically lack the resources and regulatory capacities to pursue strategies that wealthier countries do, but they also face different sets of challenge...

The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve glo...

The coronavirus disease 2019 (COVID-19) pandemic response brought forth major changes in innovation policy. This paper takes stock of the key features of the COVID-19 innovation system. Before the pandemic, innovation in biomedical research and development consisted largely of "push" funding from the public sector in support of basic research and "...

The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve glo...

In this introduction to the special issue, we take stock of the impact of the TRIPS agreement on international business in the hyper-globalised world of the late twentieth and early twenty-first century. We begin by providing a brief background on TRIPS, putting it in the historical context of international agreements on intellectual property (IP)...

Background: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the lar...

This article analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreeme...

Brazil’s strategy for addressing hepatitis C, which combines evidence-based treatment protocols and innovative initiatives for local production of generic direct-acting antiviral drugs, needs to be considered in light of ongoing conflicts over pharmaceutical patents.

India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of “secondary” pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against second...

“Data Appendix.pdf” This file provides information on data construction and code to reproduce the all results in the text. (PDF)

Brazil has encouraged an ambitious set of policies toward the pharmaceutical industry, aiming to foster technological development while meeting health requirements. We characterize these efforts, labeled the “Health-Industry Complex” (Complexo Industrial da Saúde, CIS), as an outcome of incremental policy change backed by the sustained efforts of p...

Coalitions and Compliance examines how international changes can reconfigure domestic politics. Since the late 1980s, developing countries have been subject to intense pressures regarding intellectual property rights. These pressures have been exceptionally controversial in the area of pharmaceuticals. Historically, fearing the economic and social...

Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap fo...

Pharmaceutical firms’ use of secondary patents to extend periods of exclusivity generates concerns among policymakers worldwide. In response, some developing countries have introduced measures to curb the grant of these patents. While these measures have received considerable attention, there is limited evidence on their effectiveness. We follow a...

This article compares national approaches toward secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures countries have enacted policies to address applications for secondary pharmaceutical p...

In this introduction we briefly review the literature on intellectual property rights and access to medicines, identifying two distinct generations of research. The first generation analyzes the origins of new intellectual property rules, in particular the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights...

Why do developing countries negotiate North-South trade agreements, when they already enjoy preferential market access to developed country markets? Most developing countries benefit from the Generalized System of Preferences (GSP) and related schemes when they export to the US, the EU and other developed economies. And yet, many pursue fully recip...

In contrast to analyses that regard health policy and industrial policy as anathema to each other, either because an emphasis on health implies neglect of industry or because gains in industrialization come at the expense of health, we show positive synergies between the two realms. Government intervention into the health sector can catalyze interv...

In contrast to analyses that regard health policy and industrial policy as anathema to each other, either because an emphasis on health implies neglect of industry or because gains in industrialization come at the expense of health, we show positive synergies between the two realms. Government intervention into the health sector can catalyze interv...

This well-documented study brings together leading scholars from multiple disciplines, including intellectual property, human rights, public health, and development studies, as well as activists to critically reflect on the global health governance regime. It explores the implications of high international intellectual property standards for access...

Patents affect the terms on which knowledge is owned and used, and how knowledge is owned and used is crucially important for development. In this article I analyse the trade offs that countries face in pursuing three objectives in governing the ownership and use of knowledge: the desires to (1) examine patent applications quickly, (2) assure high...

An Indian Supreme Court decision about variants of existing compounds could affect access to affordable drugs.

An Indian Supreme Court decision about variants of existing compounds could affect access to affordable drugs.

Cet article analyse les politiques de brevets et d′innovation au Mexique. Contrairement à de nombreux pays en développement, le Mexique a accueilli avec enthousiasme les pressions extérieures visant à renforcer la protection par brevets. Pourtant, au Mexique, contrairement à d′autres pays, la transformation du système de brevets n′a pas été accompa...

Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applica...

The Politics of Pharmaceutical Patent Examination in Brazil Since the 1980s, the world of intellectual property (IP) has undergone a sea change in the direction of harmonization. Reflecting a goal to universalize the high levels of IP protection common throughout the OECD, the United States and the European Union worked to replace the flexible and...

'This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume's editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars...

http://www.e-elgar.co.uk/Bookentry_DESCRIPTION.lasso?id=13402

After introducing pharmaceutical patents in the 1990s, Brazil subsequently adjusted the patent system to ameliorate its effects on drug prices while Mexico introduced measures that reinforce and intensify these effects. The different trajectories are due to the nature of the actors pushing for reform and subsequent patterns of coalitional formation...

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Intellectual property (IP) regimes serve dual purposes: to provide incentives for the generation and commercialization of innovations and to foster dissemination and use of knowledge. An IP regime alone cannot maximize these two objectives simultaneously. After all, IP establishes incentives to innovate precisely by restricting use, so absent other...

National policies toward intellectual property (IP) were revolutionized in the 1990s, as countries adopted new systems to conform to the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). TRIPS-style IP regimes make patents available for more types of knowledge, grant long periods of patent...

This paper examines the contemporary politics of intellectual property (IP) and investment in the World Trade Organization (WTO). I examine the underlying and perennial conflicts that pit developing and developed countries against each other in these two areas and the nature of the two agreements reached during the Uruguay Round, the Agreement on T...

Global governance in intellectual property (IP) has changed dramatically in the last two decades. What was once principally an instrument of national policy is now increasingly subject to international disciplines. I contrast the new restrictions placed on IP management that developing countries accept as parties to the World Trade Organization’s A...

The 1990s and the early years of the twenty-first century witnessed important changes in patterns of regional integration, namely the emergence of formal “trade” agreements between developed and developing countries. These agreements typically liberalize trade in most goods and services, and they also coordinate measures on a broad range of economi...

Benefiting from a truly Pan-American perspective, these essays evaluate the economics and politics of the new patterns of North-South integration in the particular context of the Americas, questioning if regional and bilateral trade agreements like NAFTA, CAFTA or the FTAA are appropriate mechanisms to promote economic development.

This article explores the dynamics of regional economic integration in the Americas. Economic globalisation, or an increased volume of trade and investment and increased mobility of capital, presents developing countries with new opportunities and challenges. In particular, the emergence of south-east Asia as a major site for the production and exp...

This paper analyzes the politics of intellectual property (IP) and public health in Brazil and Mexico. Both countries introduced pharmaceutical patents in the 1990s, to comply with their international obligations. Indeed, both countries’ IP systems were markedly similar in being favorable to the interests of the transnational, innovation-based phar...

This article examines the relationship between intellectual property (IP) and public health, with a focus on the extension of AIDS treatment in the developing world. While most of the literature on IP and health examines the conditions affecting poor countries' capacities to acquire essential medicines, I show the distinct - and more complicated -...

Little is the same in the international economy since the 1980s. New patterns of investment, production, and trade (i.e., "globalization") present fundamental challenges to governments, firms, and social actors across the board. New forms of governance in the international political economy create new opportunities but also place constraints on wha...

Are CAFTA's labor standards likely to impede or facilitate industrial upgrading? The Dominican Republic (DR) offers a quasi-experimental answer. While the island nation's policymakers responded to foreign pressure by adopting a new labor code in the 1990s, and thereby brought their laws and edicts into compliance with internationally recognized nor...

Do international labor standards impede or facilitate industrial upgrading? The Dominican Republic (DR) offers a quasi-experimental answer. While the island nation's policymakers responded to foreign pressure by adopting a new labor code in the 1990s, and thereby brought their laws and edicts into compliance with internationally recognized norms an...

This paper analyzes the developmental trade-offs involved in multilateral versus regional-bilateral strategies of integration into the international economy. I contrast the regulations that guide policy in the areas of trade, investment, and intellectual property in the World Trade Organization (WTO) and in regional-bilateral agreements between the...

The end of the twentieth century was marked by a sea change in global governance in the realm of intellectual property rights (IPRs). Whereas countries historically retained substantial autonomy with regard to what they defined as intellectual "property" and the rights granted to the owners of intellectual property, the 1990s witnessed the establis...

Global governance in intellectual property (IP) has changed dramatically in the last two decades, and these changes have profound - and worrying - implications for late development. What was once principally an instrument of national policy is now increasingly subject to international disciplines, as the world moves ever-closer to harmonization in...

The paper draws attention to broad issues in international political economy that affect responses to the HIV|AIDS epidemic in the developing world. I argue that stable access to affordable medicines is essential for developing countries to tackle HIV|AIDS epidemics. Developing countries must overcome the 'price-infrastructure trap', where high pri...

In this paper I draw attention to how broad changes in the global political economy affect responses to the HIV/AIDS epidemic in the developing world. I argue that stable access to affordable medicines is essential for developing countries to tackle HIV/AIDS epidemics. Developing countries must overcome the "price-infrastructure trap," where high p...

Developing countries have limited control over the distributional and substantive dimensions of international institutions, but they retain an important stake in a rule-based international order that can reduce uncertainty and stabilize expectations. Because international institutions can provide small states with a potential mechanism to bind more...

Small industry in Mexico illustrates how representation can decrease during democratization. Core sociopolitical attributes that affect capacities for collective action and electoral resources distinguish small firms from big business and labor. These attributes make it particularly difficult for small firms to take advantage of increased social pl...

Confronts conventional wisdom about tradeoffs between unemployment and inflation, economic growth and displaced workers, and capitalism and socialism

In the decades after the Second World War, the inflow of foreign investment into manufacturing changed the role of Latin America in the global economy. Moreover, the distinct challenges presented to various social groups by industrialization via internationalization fundamentally changed the role of the international economy in Latin America. This...

In the 1980s and 1990s, neoliberalism and changing policy-making regimes presented social actors throughout Latin America with new challenges and opportunities. This article analyzes the political strategies developed by two organizations representing small manufacturers in Mexico for responding to these sweeping economic and political changes, emp...

MEXICO'S NATIONAL, MID-TERM ELECTlONS OF JULY 1997 PRODUCED important changes in the country's political landscape. The ruling Institutional Revolutionary Party (PRI), which has dominated virtually all realms of Mexican politics since the late 1920s, suffered an unprecedented setback, losing its majority in the lower house of the Mexican Congress....

In the 1990s developing countries implemented new patent regimes to comply with their international obligations under the TRIPS Agreement. In general, the new TRIPS-style regimes adopted in most countries, which offer private rights of exclusion over more types of knowledge and grant owners with stronger and longer-lasting rights of exclusion, were...

This paper explores the relationship between China's emergence as a global economic power and the dynamics of regional economic integration in the Americas. I argue that concern over diminishing shares of the US market triggers a race to lock in stable and preferential access to the US for manufactured exports, and that collective action dilemmas a...

This article uses the contemporary international politics of intellectual property rights (IPRs) as a lens to examine North-South conflicts over international economic governance and the possibilities of institutional reform. Although developing countries have limited control over the distributional and substantive dimensions of international insti...

Intellectual property (IP) policies influence trajectories of industrial development and capacities to address humanitarian concerns. As pillars of national systems of innova- tion, IP regimes drive technological change through their effect on knowledge-creation and knowledge-diffusion. By affecting access to technologically intensive goods, such a...

Abstract This paper explores the dynamics of regional economic,integration in the Americas. Economic globalization, i.e. increased volume of trade and investment and increased mobility of capital, presents developing countries with new opportunities and challenges. In particular, the emergence,of Southeast Asia as a major site for the production an...

Abstract will be provided by author.

Abstract will be provided by author.

Books reviewed: Sonja Boehmer-Christiansen and Aynsley Kellow - International Environmental Policy: Interests and the Failure of the Kyoto Process Rolf Jungnickel (ed.) - Foreign-Owned Firms: Are They Different? Thomas Cottier and Petros C. Mavroidis (eds.) - Intellectual Property: Trade, Competition, and Sustainable Development J. Bruinsma (ed.) -...

Although it has become accepted as a matter of course that small firms are important for economic development and there exists an abundant literature on small enterprise promotion, very little attention is given to understanding the factors that affect small firms' capacity to participate in politics. Filling this gap is important, for supporting s...

Global governance in intellectual property (IP) has changed dramatically in the last two decades, and these changes have profound – and worrying – implications for late development. What was once principally an instrument of national policy is now increasingly subject to international disciplines, as the world moves ever-closer to harmonization in...