How International IP Policy Reconfigured National Politics: An Interview With Prof. Ken Shadlen

The recently published book Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America by Professor Ken Shadlen of the London School of Economics 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 costs of providing private property rights over knowledge, developing countries did not allow drugs to be patented. Now they must do so, an obligation with significant implications for industrial development and public health. This book analyses different forms of compliance with this new imperative in Latin America, comparing the politics of pharmaceutical patenting in Argentina, Brazil, and Mexico. The book focuses on two periods of patent politics: initial conflicts over how to introduce drug patents, and then subsequent conflicts over how these new patent systems function.

Neither Argentina, Brazil, nor Mexico offered pharmaceutical patents as of the late 1980s, when they came under considerable pressure to do so. When they acquiesced to international pressures and agreed to introduce pharmaceutical patents, they did so differently, and when they subsequently revised their new pharmaceutical patent systems they did so differently again. Shadlen’s book [view table of contents and first chapter here] presents comparative analyses of these experiences, showing how the interaction of external pressures and the mobilization of domestic actors generate distinct trajectories in the three countries (for more background on this see below the interview).

Intellectual Property Watch recently conducted a Q&A with Prof. Shadlen, who is a political scientist and Professor of Development Studies at the London School of Economics, currently Head of Department in the Department of International Development (bio here).

INTELLECTUAL PROPERTY WATCH (IPW): What motivated you to write this book?

PROF. KEN SHADLEN: The reason why I felt that the book was important to write, is that so much of analysis of the politics of IP has been about what happens at the global level, and much less about how countries react to international changes and what the politics of IP looks like within countries. The literature on the global questions is huge — why we have TRIPS and why we have IP rules that go beyond TRIPS in bilateral trade agreements, for example, or how governments fight over the international rules, be it in the WTO or WIPO, and so on. In contrast, there aren’t many studies of what happens nationally. Of course there are some, and I cite many of these in the book, but I wanted to try to write something comparative across countries and also across time periods, as TRIPS implementation has been going on for more than two decades now. Also, as a political scientist in the field of comparative and international political economy, where the challenge of understanding the drivers of national responses to global change is pretty much what the field is all about, national reactions to TRIPS — particularly the imperative to grant pharmaceutical patents — offered a great opportunity to study this sort of question. It’s not often that researchers are presented with an identical external shock hitting so many countries at just about the same time.

It’s not often that researchers are presented with an identical external shock hitting so many countries at just about the same time. – Prof. Shadlen

IPW: What are some surprising things you found in the research?

Dr. Ken Shadlen

SHADLEN: One of the most surprising findings is how little the normal indicators of Presidents’ power and ideologies seem to matter. I mean this both in terms of outcomes, in that even “powerful” Presidents don’t always get their way, and also preferences, in that sometimes “conservative” governments (and politicians within conservative governments) seek policies that don’t really conform to expectations. The cases in the book illustrate this. For example, in Argentina in the 1990s, President Menem got his way on virtually everything; he had to negotiate, he didn’t simply rule by decree, but he generally got the policy outcomes that he wanted. Here he lost, however: Menem sought to give the US and the international pharmaceutical sector everything they wanted, and tried desperately to secure that outcome, but ended up accepting a “minimalist” approach for adopting pharmaceutical patents. And after that state policy changed, even under Menem; Argentina’s approach since the late 1990s, regardless of who is in power, has been to defend minimalism and help local firms. In Brazil and Mexico, which both did please the US and transnational firms much more in the 1990s (in the book I refer to this as “over-compliance”), subsequent urges to reform the patent systems came from conservative governments. In Brazil, this started with Cardoso, when reforms were initiated, and then continued under the PT governments post-2003; in Mexico, where reformers were much less successful, we see this under the Fox and then Calderón governments. National impulses to reform the patent system come from conditions, not ideology, but so too do abilities to successfully execute reforms.

IPW: In the book, you analyse each country in two time periods. What are some interesting differences in the politics of pharmaceutical patents in the two periods?

SHADLEN: The sorts of things that were hot issues at one point are no longer very salient. Some of that is unavoidable: once a country starts granting drug patents, for example, issues such as when and how it should do so, issues that were all-consuming at their moment, cease being points of debate. Of course, countries could be debating about whether to have patents at all, but, for better or worse, they’re not — the debates now are about how the patent system functions. National debates are no longer about whether drug firms should get patents, but how strong the associated rights should be, and how long these rights of exclusion should last for. How easy or difficult should it be to obtain additional “secondary” patents on alternative forms of existing drugs? How easy or difficult should it be to issue compulsory licences? Should we have a linkage system? Should we offer data exclusivity? And so on. These are what consume attention.

National debates are no longer about whether drug firms should get patents, but how strong the associated rights should be, and how long these rights of exclusion should last for.

As a researcher, I’m fascinated by how these debates have moved on. It’s quite an amazingly fast rate of change. Not long ago, the question of whether a country should have a pharmaceutical patent system was a super-contested issue, but now within just two decades in most countries pharma patents are accepted as a given, as the way the world works. A lot of analysts continue to question the relevance of patent protection for pharmaceutical innovation and suggest alternatives. I follow those debates closely and find them fascinating. But I was amazed at how distant these debates were from what was being considered and debated in countries.

Another thing that struck me in doing the research is how, in the first time period (the 1990s, when countries were introducing pharma patent systems) the same issues were salient and dominated debate in all countries, but how in the second period (2000s, when countries were revising their patent systems) different issues had different degrees of salience and importance in each country, largely because of the earlier decisions. So, for example, in Brazil a huge issue was compulsory licensing, because of the large number of patents in force on key drugs. That was the case in Mexico too, though the steps these two countries took in this regard were almost diametrically opposite, for reasons I explain in the book. By contrast, in Argentina, where the way patents were introduced meant that for much of the 2000s there were still many fewer drugs protected by patents, debate was consumed by other issues, including for example some that came from outside pressures (e.g. data protection and preliminary injunctions) and some that emerged endogenously as a consequence of the decisions of the 1990s. More generally, what I try to show in the book is which issues become salient in the second period, and how conflicts over these issues resolved, is shaped to large degree by initial choices made in the first period.

IPW: If countries are now granting pharmaceutical patents, does that mean the debates are over?

SHADLEN: One reading of that is that conflicts are now waged over smaller issues, in that the sorts of things that affect how a pharmaceutical patent system functions are more narrow issues than things such as when to start granting patents and whether to do so retroactively (not to mention the first order question of whether to have a patent system at all). But while that’s all correct, the conflicts remain intense in this more narrow space.

IPW: For years at the international policy level we have heard the cry from developed country industry for greater harmonization of patent laws. To what degree did you find this goal of harmonization has been reached, and why would industry or others seeking that goal still feel the need to go further?

SHADLEN: Without any doubt we have witnessed substantial harmonization, in that all but the poorest countries now grant pharmaceutical patents, when that wasn’t the case before. That’s harmonization! But harmonization is not the same as equivalence, and patents that are granted in one country are not necessarily granted in another country, and even where patents are granted in multiple countries the rights of exclusion are not equally strong. Hence the demands from the originator industry (and many OECD governments) for yet more harmonization.

[H]armonization is not the same as equivalence, and patents that are granted in one country are not necessarily granted in another country, and even where patents are granted in multiple countries the rights of exclusion are not equally strong

IPW: Looking forward, how to you expect the politics of pharma patents to look?

SHADLEN: I expect more attention to be paid to ancillary measures that are needed for countries to live with patent systems. I think of this in terms of potential benefits and the potential costs of having a patent system, and the challenges countries have in harnessing the benefits and mitigating the costs. A lot of the discussion is about building capabilities to harness the benefits, for example increasing R&D expenditures so that local actors can take advantage of the patent system too. But increasingly attention is also being to mitigating costs, for example building regulatory capabilities to monitor and sanction abuses of the patent system.

I ended the book calling for a global push for building these capabilities, an obvious (and I think obligatory, from a global justice perspective) complement to the global push to make pharmaceuticals patentable that started all of this.

I ended the book calling for a global push for building these capabilities, an obvious (and I think obligatory, from a global justice perspective) complement to the global push to make pharmaceuticals patentable that started all of this. I’m not optimistic that we’ll see much global movement on this, a new crusade to build competition authorities, as much as I’d like to, but do I suspect such efforts will grow from within countries.

IPW: Thank you.

The book Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America is available from Oxford University Press.

Background note: Over the course of these two periods of change, Argentina produced a ‘market-preserving’ patent regime, featuring minimalist, by-the-books adherence to the country’s new international obligations, complemented by regulatory changes designed to help local firms adjust to the new status quo and retain a dominant position viz-a-vis with respect to international competition. Brazil yielded a “neo-developmentalist” system, with the country adopting global norms in a way that puts IP and innovation at the heart of development policy, but at the same time introducing a range of measures designed to ameliorate the effects of stronger protection. And Mexico produced an “internationalist” patent regime, marked by an expanding embrace of global norms and adoption of “best practices,” all with an eye toward attracting foreign investment into the pharmaceutical sector.

Image Credits: Oxford University Press