American Journal of Law & Medicine

Should access to medicines and TRIPs flexibilities be limited to specific diseases?


The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low- and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies. After an extensive consultation process, in 2006, the World Health Organization's Commission on Innovation, Intellectual Property and Public Health issued its Report (the WHO CIPIH REPORT), finding this concern to be significant:

   In the context of our work one of the important points is that, 
   where the market has very limited purchasing power, as is the 
   case for diseases affecting millions of poor people in developing 
   countries, patents are not a relevant factor or effective in 
   stimulating R&D and bringing new products to market. (1) 

On this issue, the WHO CIPIH REPORT was preceded by the Access to Medicines movement, an informal coalition of civil society organizations such as Medecins Sans Frontieres, Treatment Action Campaign, Health GAP, Oxfam, and Knowledge Ecology International (formerly the Consumer Project on Technology). These groups and many others identified patents on pharmaceuticals as an inappropriate barrier to access in developing countries. (2) They devoted particular attention to the World Trade Organization TRIPS Agreement, which is the minimum global legal standard for pharmaceutical patents. (3) In response to challenges about the need for innovation, some have reframed the movement as "Access + Innovation." This article follows in the Access + Innovation genre, attempting to simultaneously address both equitable access and optimal innovation. (4)

Global patent-based pharmaceutical companies and the United States Trade Representative (USTR) have not been particularly supportive of the Access + Innovation agenda. (5) Many attempts have been resisted, even to the point of suing South Africa for its use of unlicensed AIDS drugs in the face of an epidemic. (6) In response to sustained global pressure, the companies eventually conceded the case in South Africa, and the WTO members unanimously adopted the Doha Declaration in November 2001. However, several attempts have been made to limit access initiatives and TRIPS flexibilities to particular diseases, namely AIDS, tuberculosis and malaria, or more generally to infectious public health emergencies. (7)

The primary concern appears to be profit-driven: companies are concerned that any flexibilities for LMICs could lead to price erosion in high-income markets, through physical or virtual arbitrage, (8) demands for expanded access, compulsory licensing, or other TRIPS flexibilities. (9) These concerns are especially acute for blockbuster drugs treating major chronic diseases.

Nothing in the TRIPS Agreement limits compulsory licenses or other flexibilities to a narrow category of diseases. In the Doha Declaration itself, the U.S. requested an explicit limitation to particular diseases, and was the last country to assent to the unanimous resolution. (10) The ultimate compromise language states:

   We recognize the gravity of the public health problems afflicting 
   many developing and least-developed countries, especially those 
   resulting from HIV/AIDS, tuberculosis, malaria and other 
   epidemics. (11) 

At first blush, this appears to be a disease-specific limitation, but the Doha Declaration merely uses the Big 3 to illustrate examples of "national emergency or other circumstances of extreme urgency." (12) The Doha Declaration clearly supports WTO Members' rights to utilize TRIPS flexibilities--including compulsory licensure and parallel trade--to "protect public health" without regard to the type of disease: (13)

   Accordingly, while reiterating our commitment to the TRIPS 
   Agreement, we affirm that the Agreement can and should be 
   interpreted and implemented in a manner supportive of WTO 
   Members' right to protect public health and, in particular, to 
   promote access to medicines for all. (14) 

This point has been honored primarily in the breach. Under the Doha Declaration "Paragraph 6" process, compulsory licenses could be issued for export to low-income countries, bypassing Article 31(f) of the TRIPS Agreement, which restricts compulsory licenses predominantly for domestic use. When Canada enacted its Access to Medicines Regime to permit Paragraph 6 exports, the law limited compulsory licenses to specific listed medicines. (15) This list has been criticized for its excessive narrowness--only 57 drugs or vaccines. (16) The list is effectively limited to AIDS and off-patent medications. Many of the listed drugs treat AIDS; and most of those AIDS drugs are available generically already. Almost all of the other drugs on the list are off-patent or face legal generic competition in a similar form. (17) The only patented non-AIDS drugs on the list are eflornithine (for the treatment of African sleeping sickness) and levofloxacin (an important antibiotic). Others are just curious choices considering the global burden of disease (testosterone injection). Ivermectin is also listed, despite Merck's promise to donate it in the river blindness campaign. The very narrow positive list in the Canadian Access to Medicines Regime operates as a disease-specific limitation on compulsory licensure under Paragraph 6.

More recently, major drug companies and USTR have resisted Thailand's efforts to issue compulsory licenses on patented drugs for heart disease and cancer. (18) When Thailand attempted to use the very TRIPS flexibilities guaranteed and encouraged by the Doha Declaration, a backlash ensued from conservative media, pharmaceutical manufacturers, and the U.S. government. The WALL STREET JOURNAL editorial page attacked the Thai compulsory licenses as "seizures" that cynically distorted WTO rules, while a property-rights activist group charged the Thai government with violating global trade rules. (19) Abbott, the manufacturer of lopinavir/ritonavir, withdrew pending applications for drugs in Thailand, including a heat-stable version of an important fixed-dose combination drug for AIDS with particular usefulness in a tropical climate. (20) The USTR then placed Thailand on the special 301 "priority watch list" for alleged violations of intellectual property law, mentioning in particular the compulsory license. (21)

The TRIPS Agreement is subject to dispute resolution under the WTO Dispute Settlement Understanding, but the U.S. Government is unlikely to initiate a WTO panel against Thailand. The TRIPS Agreement authorizes members like Thailand to issue compulsory licenses for these drugs. (22) For all the bluster in the WALL STREET JOURNAL, it is clear that the controlling legal texts do not limit the use of TRIPS flexibilities to any particular set of diseases.

Nor should they. From the perspective of public health, limiting access programs and TRIPS flexibilities to particular diseases would be quite dangerous and unnecessary. Dangerous because the diseases of the world's rich and poor countries are converging, including non-communicative diseases such as heart disease, stroke, diabetes, cancer and depression. Radically cheaper medicines for these conditions could significantly improve health in LMICs. Limitation is also unnecessary because proven tools can be deployed to preserve high-income markets while LMICs pursue equitable flexibilities. (23)

Perhaps another factor is at work here as well. An implicit assumption is that the diseases of developing countries are essentially different from diseases in the United States or Europe. Paradigmatic cases include exotic tropical diseases such as ebola hemorrhagic fever (24) and onchocerciasis (river blindness). These neglected diseases and their victims are so remote from the U.S. experience that special charitable programs seem unobjectionable. Only a very small portion of the disease burden in developing countries comes from these exotic tropical neglected diseases. (25) Drugs produced for high-income markets can treat most of the global disease burden, such as the pressing need for cancer therapies in LMICs, where cancer deaths outnumber AIDS deaths. (26) The number one cause of death in LMICs is not a neglected tropical disease, but a familiar "rich country" killer: heart disease. (27)

To date, the important global legal texts retain broad application to all relevant diseases, but some parties continue to propose disease-specific limitations, most recently in the World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (the "WHO IGWG"). (28) The WHO IGWG's task is to distill the WHO CIPIH REPORT into a global strategy and plan of action. This article hopes to influence the final text of the IGWG GLOBAL STRATEGY, finding that disease-specific limitations on access programs and TRIPS flexibilities are inappropriate in markets for medicines, but may have a place in markets for neglected disease innovation.


In order to understand the relevance of disease-specific limitations, we must distinguish between markets for medicines and markets for innovation. The patent system joins them together, using patent-protected high prices for medicines to create markets for innovation. James Love and Tim Hubbard have suggested separating these markets through a prize system and generic licensing, (29) but for the purposes of this article we need only to conceptually distinguish between the two. My aim is to evaluate whether significant differences exist between high-income countries and LMICs that are relevant to global pharmaceutical markets.


IP rights stimulate pharmaceutical innovation by creating an artificial market enforced by patents, trademarks, and exclusivity periods. IP rights enable companies to charge higher prices, which make these medicines more expensive in the absence of generic competition. Patent rents can price most of humanity out of the market, reducing access to life-saving medicines. (30) Paul Hunt, the UN Special Rapporteur on the right to the highest attainable standard of health, estimates that more than 2 billion people are effectively priced out of the market for patented drugs. (31) This message has been articulated for many years by leading advocates for equitable access to medicines. (32) The WHO CIPIH REPORT found that the effectiveness of IP rights depends greatly on the context, especially the poverty of the patients needing medicines:

   But where most consumers of health products are poor, as are the 
   great majority in developing countries, the monopoly costs 
   associated with patents can limit the affordability of patented 
   health-care products required by poor people in the absence of 
   other measures to reduce prices or increase funding. Thus the 
   overall effect of intellectual property regimes is 
   context-specific--the impact in a country such as India may differ 
   from that in Thailand or in Ghana. … 

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