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global justice in healthcare developing drugs for the developing world william w fisher talha syed table of contents introduction 583 i reasons 585 a national self interest 588 b historical ...

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                                             Global Justice in Healthcare: 
                                    Developing Drugs for the Developing 
                                                                                *
                                                                   World  
                                                                          **               *** 
                                                       William W. Fisher  & Talha Syed
                                                               TABLE OF CONTENTS 
                                   INTRODUCTION................................................................................... 583 
                                    I. REASONS................................................................................... 585 
                                          A. National Self-Interest......................................................... 588 
                                    B. Historical Equity............................................................... 591 
                                    C. Social Utility..................................................................... 602 
                                    1. The Basic Reasoning................................................... 604 
                                               2.  Distribution of the Cost-Burden for Global R & D ... 606 
                                               3.  Allocation of Global R & D Resources....................... 611 
                                    4. The Value of DALYs................................................... 613 
                                    5. The Vulnerabilities of Utilitarianism......................... 618 
                                          D.  Distributive Justice in Healthcare....................................... 624 
                                    1. Deontological Theories.............................................. 624 
                                    2. Teleological Theories................................................. 637 
                                    3. A “Right to Health”.................................................... 641 
                                    II. OBJECTIONS.............................................................................. 647 
                                          A.  The Limits of Ethical Commitments................................... 648 
                                    1. Obligations to the Needy............................................ 649 
                                    2. International Distributive Justice............................... 653 
                                    3. Robust Cosmopolitanism........................................... 663 
                                          B.   Compromising the Patent System....................................... 667 
                                          C.  Interfering with the Market in Pharmaceutical Products.... 674 
                                    
                                       * This paper was first presented at a conference on Intellectual Property and 
                                   Social Justice, held at the UC Davis School of Law School on March 10, 2006.  We are 
                                   grateful to the commentator, Robert Merges, and to the other participants in the 
                                   conference for their suggestions. 
                                      **
                                         Hale and Dorr Professor of Intellectual Property Law, Harvard Law School. 
                                     ***
                                         S.J.D. (Doctoral) Candidate, Harvard Law School. 
                                                                        581 
                             
                           582             University of California, Davis [Vol. 40:581 
                                                      ***
                                     
                                   2007]                   Global Justice in Healthcare 583 
                                                                  INTRODUCTION 
                                      Each year, roughly nine million people in the developing world die 
                                   from infectious diseases.1  The large proportion of those deaths could 
                                   be prevented, either by making existing drugs available at low prices 
                                   in developing countries, or by augmenting the resources devoted to 
                                   the creation of new vaccines and treatments for the diseases in 
                                   question.  Several legal and social circumstances contribute to this 
                                   outrage.  In this Article, we focus on two.  First, the majority of the 
                                   most effective drugs are covered by patents, and the patentees typically 
                                   pursue pricing strategies designed to maximize their profits.  Second, 
                                   pharmaceutical firms concentrate their research and development (“R 
                                   & D”) resources on diseases prevalent in Europe, the United States, 
                                   and Japan — areas from which they receive 90-95% of their revenues 
                                   — and most of the diseases that afflict developing countries are 
                                   uncommon in those regions. 
                                      In a forthcoming book,2 we substantiate the foregoing assertions — 
                                   some of which are controversial — and then consider several ways in 
                                   which the legal system might be modified to overcome the two 
                                   obstacles and thus help alleviate the crisis.  Some of the possible 
                                   reforms we examine involve providing pharmaceutical firms financial 
                                   incentives to modify their pricing practices or R & D policies; others 
                                   would use various legal levers to force the firms to modify their 
                                   behavior; still others would increase the roles of governments in the 
                                   development and distribution of pharmaceutical products.  We then 
                                   attempt to identify a politically palatable package of reforms that 
                                   would both result in lower prices in developing countries for existing 
                                   drugs and accelerate the production of new drugs that address the 
                                   health crises in those areas. 
                                      Our analysis gives rise to an ethical problem:  most of the legal 
                                   reforms we consider would increase the already significant extent to 
                                   which the cost of developing new drugs — including some whose 
                                    
                                       1  By comparison, the same diseases claim 200,000 lives in the developed world, a 
                                   region containing one quarter as many people.  In other words, the mortality rate from 
                                   infectious diseases is over ten times higher in the developing world than in the 
                                   developed world.  These figures are derived from WORLD  HEALTH  ORGANIZATION, 
                                   WORLD  HEALTH  REPORT:  CHANGING  HISTORY 2004 (2004), available at 
                                   http://www.who.int/whr/2004/en/.  Throughout this Article we will adopt the World 
                                   Health Organization’s (“WHO”) usage and use the terms “developed” and 
                                   “developing” countries or worlds, which are roughly synonymous with “North” and 
                                   “South,” “First World” and “Third World,” and “the West” and “the Rest.”  Each pair 
                                   of terms has its drawbacks. 
                                       2 WILLIAM W. FISHER & TALHA SYED, DRUGS, LAW, AND THE HEALTH CRISIS IN THE 
                                   DEVELOPING WORLD (forthcoming) (manuscript on file with authors). 
                                     
                                   584                   University of California, Davis [Vol. 40:581 
                                   principal function is to alleviate suffering in the developing world — 
                                   is borne by the residents of the developed world, either as consumers 
                                   purchasing patent-protected drugs or as taxpayers.  Why should the 
                                   law be organized in this fashion?  The goal of this Article is to answer 
                                   that question. 
                                     The analysis proceeds in two stages.  In Part I, we consider several 
                                   possible reasons why developed country residents should help 
                                   alleviate the health crisis in the developing world.  We begin by 
                                   canvassing, briefly, considerations from national self-interest.  Finding 
                                   these implausible and unattractive, we then consider several 
                                   arguments grounded in considerations of justice, or in sentiments of 
                                   mutual concern and well-wishing, that extend beyond national 
                                   borders.  These include arguments from historical equity, social 
                                   utility, and deontological and teleological theories of distributive 
                                   justice.  We show that each of these frameworks or perspectives 
                                   provides support for our proposals.  Further, we contend that, not 
                                   only do the arguments individually support our goals, but, suitably 
                                   qualified, each tends to reinforce, or at least converge or “overlap” 
                                                     3
                                   with, the others.  
                                     In the course of our analysis in Part I, we address several criticisms 
                                   that have been or might be made of particular arguments we offer in 
                                   support of our proposals.  In Part II, we confront the following more 
                                   sweeping objections to our approach:  that full acceptance of the 
                                   commitments we identify would impose intolerable moral burdens on 
                                   the citizens of developed countries; that questions of distributive 
                                   justice are properly limited to the level of individual polities; that 
                                    
                                      3  We mean to invoke, loosely, the concept of “overlapping consensus” developed 
                                   by John Rawls in  Political Liberalism.  JOHN  RAWLS,  POLITICAL  LIBERALISM  385-95 
                                   (expanded ed., Columbia Univ. Press 2005) (1993).  Rawls offered the concept as a 
                                   solution to the problem of disagreements between “comprehensive doctrines” or 
                                   worldviews.  Id. at 385-86.  It seemed unlikely to him that reason could solve such 
                                   disagreements.  Id. at 387.  Consequently, as a “political” solution to this “fact of 
                                   reasonable pluralism” in the realm of moral metaphysics, he urged that, when 
                                   debating core issues of public life, efforts be made to find an “overlapping consensus” 
                                   about the fair terms of social cooperation.  Id. at 390-91.  This entails framing 
                                   arguments in a shared vocabulary of “public reason,” so that adherents to different 
                                   “reasonable” comprehensive doctrines can recognize the arguments of others as 
                                   congruent with, or even representing in altered form, their own deeper commitments.  
                                   Id. at 392.  Without committing ourselves to the assumptions underpinning Rawls’s 
                                   overall enterprise, we point out that a rough parallel exists between his concept and 
                                   our attempt here to accommodate current disagreements (although in our case the 
                                   disagreements are not between worldviews but between rival political philosophies, 
                                   and they do not concern Rawls’s “constitutional essentials” so much as “legislative” 
                                   questions of social policy). 
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...Global justice in healthcare developing drugs for the world william w fisher talha syed table of contents introduction i reasons a national self interest b historical equity c social utility basic reasoning distribution cost burden r d allocation resources value dalys vulnerabilities utilitarianism distributive deontological theories teleological right to health ii objections limits ethical commitments obligations needy international robust cosmopolitanism compromising patent system interfering with market pharmaceutical products this paper was first presented at conference on intellectual property and held uc davis school law march we are grateful commentator robert merges other participants their suggestions hale dorr professor harvard s j doctoral candidate university california each year roughly nine million people die from infectious diseases large proportion those deaths could be prevented either by making existing available low prices countries or augmenting devoted creation new...

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