Abstract
In her impressive monograph Soft Law and Global Health Problems, Sharifah Sekalala offers an innovative and meticulously argued legal perspective on the struggle over intellectual property and access to essential medicines in the global south. Playing out from the mid-1990s, and a centrepiece of global health studies, this conflict has been written about from many perspectives. The levelling-up and globalization of patent rules through the World Trade Organization’s (WTO’s) TRIPS agreement after 1995 has drawn the attention of IP scholars and trade lawyers alike. They have been joined and interrogated by human rights analysts, particularly those concerned with the substance and bite of the right to health set out in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICSECR) and equivalent provisions of other UN treaties. Constructivist international relations scholars have studied the manner in which pharmaceutical industry representatives and pro-access activists each formed coalitions for law reform and cultivated wider publics by strategically framing the issues. Economists and ethicists have reflected on how to mobilize resources and incentivize drug development for neglected diseases and marginalized populations. This manifold scholarly and practical effort has of course gained urgency from the unfolding HIV/AIDS pandemic and the failure to contain and eliminate endemic diseases such as tuberculosis and malaria.
Less attention has been paid to the specifically legal quality of the different landmarks in this struggle: the TRIPS agreement itself; the Doha Declaration of WTO members in 2001 which clarified the agreement in the light of the HIV/AIDS emergency; and the subsequent implementation of pro-access strategies, including the formal amendment of TRIPS, but also drug delivery schemes set apart from world trade law. As even this list itself suggests, we are concerned here with a notable variety of legal measures and instruments. Not least among the contributions of Soft Law and Global Health Problems is that it takes this variety seriously as such. It insists that the struggle for accessible treatment and prevention measures has inherently been a struggle over legal form. The rise and fall and rise again of strong IP rights, imposed on the global south through multilateral and bilateral trade agreements, and the resistance offered in international and national fora, can only be fully grasped with the aid of analytical jurisprudence broadly understood.
As her title suggests, Sharifah Sekalala’s analytic is oriented by the well-established, though consistently argued-over distinction between hard and soft law. The former, on her account, is identifiable through the normative character of its obligations, its precision (or at least its capacity to be precise), and the presence of an effective adjudicatory body. In the context under discussion hard law is most clearly represented by the TRIPS agreement itself: a set of binding obligations, set out in the form of a treaty between sovereign states and subject to enforcement through the Dispute Settlement Process of the WTO. Sekalala’s similar characterization of the international right to health is less convincing, given the manifestly weak mechanisms for enforcing this and other state obligations under the ICESCR. If Article 12 has lacked influence in the debate over access to medicines, that is unlikely to be due its nature as ‘hard law’.
Like hard law, soft law also possesses normative character and is based on agreement between states. Unlike hard law, it is not subject to formal adjudication or enforcement mechanisms. The Doha Declaration provides the key example of soft law in this book. A ‘win’ for developing countries, its utility lay in its framing at the level of general principles which allowed states in the global south to issue compulsory licences on broad grounds and to permit the importation of cheap generic medicines. By contrast, subsequent moves to specify these principles in the form of a hard law amendment to TRIPS have met with less practical success, being cumbersome and difficult to implement. In later chapters, Sekalala extends the soft law category to include institutional innovations, such as the Global Fund for AIDS, Tuberculosis and Malaria and the UN’s 3 by 5 initiative to widen access to antiretroviral therapies. These allowed international policymakers and sympathetic governments to outflank the blockage caused by the turn to hard law.
Moving beyond the merely descriptive, Sekalala presents these soft law measures in approving terms. Her appraisal shares the strongly functionalist orientation of much global health scholarship. What matters is what works in terms of sustainable drug delivery and health promotion. The posited characteristics of soft law guarantee its greater effectiveness in enabling a timely and adequate response to multiple global health crises. It can be rapidly created and amended, to reflect scientific advances and political change, since it does not have to be ratified domestically. It allows agreement to be reached by some, if not all states. It facilitates the emergence of harder law as that consensus widens.
In the meantime, soft law also serves an educative purpose, not only about the desired content of the law but also as regards the seriousness of the problems which it addresses. This was obviously the case with HIV/AIDS, largely ignored by the ‘international community’ in its first decade and half, and it remains relevant to many neglected ‘tropical’ diseases today. Sekalala gives short shrift to the concerns of positivist theorists that acknowledging soft law will undermine the normativity, coherence and focus of international law. Such arguments, she claims, fail to account for the already-existing normative diversity produced by the rise of non-state actors in global health and cognate areas.
Sekalala’s case rests on a contrast between the meliorative nature of soft law and the rigidity of hard law, which, she claims, tends to favour European and North American states and their IP-holding corporations. Indeed, the career of TRIPS to date bears her out on this. Nonetheless, it is worth emphasizing a point made in passing, though not developed in her text, namely that this contrast is sometimes reversed. Soft law rhetoric can mask hard power politics, especially in the context of relations between global north and south. Critical international law scholars have recounted how the insistence of Third World countries on their formal rights as sovereign states in the 1960s and 1970s was thwarted in the 1970s and 1980s. The moment of challenge was deflected and reversed through the imposition of global governance, or soft law strategies, such as loan conditionalities, measurement techniques and peer review, realized through the enforcement activities of actors above and below the level of the nation state.
The insurgent south was disciplined, through structural adjustment regimes, first in the economic core of the state and later in social sectors such as health. Apart from their often-disastrous consequences for the welfare of citizens, these measures have been persistently criticized for their anti-democratic nature and their replication of colonial modes of domination. This tendency is also clear in areas beyond the scope of Sekalala’s book such as infectious disease control. For example, the World Health Organization’s (formal) International Health Regulations are supplemented and enforced by (informal) governance mechanisms such as real-time on-line outbreak notification by non-state sources, all underpinned by the scientific output of the US government’s Centres for Disease Control. As David Fidler has argued, the crystallization of this hybrid regime during the SARS outbreak in 2003 saw China, which had been reluctant to make notification, effectively sanctioned for ‘acting Westphalian in a Post-Westphalian world’. Both these cases show the potential for mixed motives whereby soft global health law also serves to advance the strategic economic and security interests of established powers.
These queries indicate the value of Sekalala’s work in offering fresh and engaging insight on a much-studied field. The discussion is authoritative and measured throughout. Legal, institutional and political detail is presented in accessible and coherent terms. For its theoretical contribution, Soft Law and Global Health Problems will be recognized as an important moment in the development of global health law scholarship. It deserves a wide readership.