Desperate times call for Desperate Measures? Contrasting Thailand and India with respect to Circumvention of TRIPS (In)Flexibilities in the Access to Medicines Campaign
By Vinitha Johnson*
The submission focuses on the varied approaches taken by India and Thailand to ensure access to medicines for their populations. The Thailand experience demonstrates the widening of the TRIPS provisions in the application to diseases which are neither communicable, nor life-threatening. India, on the other hand, has utilized means other than compulsory licensing to ensure access to drugs such as Section 3(d) of the Indian Patent Act, and ensuring that an injunction to patent-infringement is not thwarted unless the ‘Balance of Convenience’ provision, at-least in the case of life-saving drugs has accounted for public interest provisions. The responses to such actions as received by interest groups worldwide is seminal in determining the possible applicability of these modes of ensuring local production and requiring manufacturing capacity territorially. These implications are considered in light of Roche’s sublicensing arrangements in India and China in order to address the extensive demand for Tamiflu. This article notes that sublicensing is an unsatisfactory trade-off which does not serve the best interests of the populace, especially in wake of a situation like a pandemic, where immediate access to the medicine can counter the spread of the virus.
Despite the TRIPS Agreement, and Paragraph 5 of the Doha Declaration, 2003 providing full liberty to a country for both, declaring the grounds for a compulsory license and further for deciding when a particular situation has reached a state of ‘national emergency’ or a ‘situation of extreme urgency’, it is found that especially in the wake of the Thailand experience on Government Use of certain drugs, the other repercussions following out of such action are possibly a need to justify such action to interested players such as the pharmaceutical companies, consumer action groups and other developed countries. The most tangible expression of such threats, is that of retaliation, which can be either unilateral, or enforced through the World Trade Organisation.
The general modus operandi for thwarting the access to essential drugs, at low prices, possibly through a mechanism of compulsory licensing is generally that the disease, if widespread, in a low-resource country, can nevertheless not be countered through pharmaceutical intervention. Further, it is difficult to prove the linkage in terms of diseases which are not imminently life-threatening, but erode the efficiency of a person over time, and to demonstrate an effective enough linkage which can be described as a ‘national emergency’. An unexplored mechanism was that of ‘suspending the patent ’ which was suggested by Senator Charles Schumer if Roche did not agree to license the drug’s production to other companies . Developing countries are generally hesitant to utilize the flexibilities enshrined in the TRIPS Agreement. However, following the case of eBay v. Mercexchange, an ongoing patent infringement is condoned by the court after requiring the payment of damages if necessary. Specifically in India, a few cases dealing with pharmaceuticals have further explored the conditions influencing the grant of an injunction, permanent or temporary, with respect to patent rights, specifically, in health care, where public interest influences the final “balance of convenience” reason.
With respect to the ‘Access to Medicines’ campaign, it is always interesting to note whether it is the WHO which ought to have credence over the WTO. Especially, in wake of the Pandemic crisis in 2009, a few essential lessons are to be gleaned considering a pandemic situation is never ‘over’ – being a cycle, there is always the looming threat of the pandemic strain reinventing itself and entering the ecosystem through another strain which the pharmaceutical companies are unprepared for. The World Health organisation is divided into 10 clusters: communicable diseases, health systems and services; information, evidence and research, family and community health, health action in crises, sustainable development and healthy environment, HIV/AIDs, TB and malaria; non communicable diseases and mental health; health systems and services, health technology and pharmaceuticals. The Communicable Diseases cluster contains in it the Control of Neglected Tropical Diseases, the Epidemic and Pandemic Alert and Response, and the Special Programme for Research and Training in Tropical Diseases . The preamble to the TRIPS Agreement enjoins that there be attempts at achieving inter-institutional equity between the WTO and the WIPO considering both organizations deal with the same subject matter. Furthermore, Articles 7 and 8 of the TRIPS Agreement, require that measures be taken for public health measures, though a mandate to do so, may not be derived from a reading of the agreement. Nevertheless, as illustrated in the Doha Declaration on Public Health, and further the August 2003 decision, it might be in the best interest of both organizations to interact and reach a mutually enforceable decision with respect to certain important decisions like keeping essential drugs off-patent, and the GAVI, and improving access of medicines to lower-income countries.
TRIPS, the Doha Declaration and Access to Medicines
The Doha Declaration on the TRIPS Agreement and Public Health adopted by November 2001 has permitted least developed countries to forgo the enforcement of patents on pharmaceutical products at least till January 1,2016 . Para 5 ( c ) of the Doha Declaration allows that each Member shall have the right to determine what constitutes a ‘national emergency’ or any other circumstance of ‘extreme urgency’. The Doha Declaration specifically dealt with access to life-saving medicines. The author(Brent Savoie) while espousing that perhaps the Doha Declaration was more pro-HIV/AIDs application than the other provisions had identified however, that the Doha Declaration was entrenched in concerns over contagious diseases, thereby complicating the application of these flexibilities in other situations. The author further identifies that a failure to negotiate terms with the patent-holder which can be circumvented through declaring a certain health crisis as a ‘national emergency’ cannot be applied effectively in the wake of a chronic disease as it would be difficult to characterize even a large number of people suffering from a certain disease in a particular state as being a ‘national emergency’ where the threat to life is not imminent, or apparent .
A reminder in Paragraph 7 of the Doha Declaration dictates that there is a commitment of developed-country Members to provide incentives to encourage technology-transfer under Article 66.2 . Paragraph 5(b) mentions that the right to grant compulsory licenses and the freedom to determine the grounds on which the licenses are granted are available to the individual member countries. Further in Paragraph 5(c) the Doha Declaration further states that member countries have the right to determine what constitutes a national emergency or other circumstances of extreme urgency. Paragraph 5(c) further identifies that situations relating to HIV/AIDS, tuberculosis, malaria and other epidemics could constitute a ‘public health crisis’.
Under the general principles of the TRIPS Agreements, particularly Articles 7 and 8, developing countries might find a route through which they might succeed in putting forth their claims relating to public health and access to life-saving medicines. Article 7 suggests that intellectual property rights in general should promote to technology transfer to the mutual advantage of producers and the end-users, and further that there should be an attempt to balance rights and obligations. Article 8 additionally enables, that members implementing TRIPS should be allowed to adopt those measures which are necessary to protect public health and nutrition. Article 30 of the TRIPS convention provides that the legitimate interests of third parties be taken into considering while considering exemptions to the exercise of exclusive rights by the patent-holder.