'Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016' by Ellen FM ‘t Hoen, Jacquelyn Veraldi, Brigit Toebes and Hans V Hogerzeil in (2018) 96(3)
Bulletin of the World Health Organization 185–193 comments
Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because
they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the
TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of
intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known
as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of
medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the
use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of
TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40
(22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3
research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products
for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired
immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed.
Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS
flexibilities for accessing lower-cost generic equivalents is increasingly important.
The authors state
The extent to which countries have deployed TRIPS flexibilities,
such as compulsory licences or public noncommercial
use licences, for procuring medicines remains underreported.
Previous studies have documented well-known and widely
publicized cases of compulsory licensing, but have not examined
the use of TRIPS flexibilities in procurement. Moreover,
several reports in the literature perpetuate the belief that,
since 2001, the use of TRIPS flexibilities has been sporadic
and limited.
The aim of our study was to document the use of TRIPS
flexibilities to gain access to lower-priced generic medicines.
Although we recognized that the TRIPS Agreement offers a
range of flexibilities relevant to national pharmaceutical and
patenting policies, including the right of countries to define
and apply patentability criteria and to refuse to grant patents
for certain subject matter (e.g. plants and animals), we focused
on measures that can be directly applied to the procurement
and supply of medicines. The most relevant measures for
increasing access to medicines were: (i) compulsory licensing
(including public noncommercial use licensing); (ii) the
least-developed countries pharmaceutical transition measure; (iii) parallel importation; and (iv) the research
exception. Parallel importation is
the importation and resale of a product
from another country (where the same
product is legitimately on sale at a lower
price) without the consent of the patent
holder. The research exception refers the
use of a patented product or process for
research or experimentation without the
consent of the patent holder.
'The WTO “Paragraph 6” system for affordable access to medicines: Relief or regulatory ritualism?' by
Muhammad Z. Abbas and Shamreeza Riaz in (2017)
The Journal of World Intellectual Property comments
Regulatory Ritualism means acceptance of regulatory goals while losing focus in achieving them. In other words, it means ignoring of goals or objectives of a process or mechanism and focusing too much on regulations, rules, and formalities. Advanced countries and developing countries have been in a continuous negotiation over access to drugs ever since coming into effect of TRIPS Agreement. The Doha Declaration was a rare negotiation win for third world countries. This paper endeavors to apply the notion of Regulatory Ritualism to Paragraph 6 of the Doha Declaration 2001 and to subsequent WTO General Council's Waiver Decision 2003 which aimed at giving effect to Paragraph 6 flexibility. The first part of the paper discusses the historical background of the Doha Declaration and 2003 Decision. The second part of this paper analyses Paragraph 6 of the Doha Declaration and subsequent Waiver Decision in the light of the notion of Regulatory Ritualism and Rule Complexity, with a special focus on Apotex‐Rwanda case study, the case of India and the case of Australia. The final part of this paper sums up the discussion on the issue and provides suggestions.
The authors argue
The Trade‐Related Aspects of Intellectual Property Rights (TRIPS) Agreement required patent protection for inventions in all fields of technology including pharmaceuticals (WTO, 1994). An obvious and direct consequence of monopoly on drugs is an increase in prices of needed medicines; patent protection on medicines, therefore, emerged as a common issue for third world countries where purchasing power is too low to afford patented medicines (Rozek, 2000). The access to drugs problem was foreseen and TRIPS included public health safeguards like non‐voluntary licensing of drug patents but this flexibility was of little significance for least developed countries and developing countries with no drug manufacturing capacity because of the “domestic use” condition attached to it (WTO, 1994). This very issue was highlighted by human rights activists, NGOs, and public health advocates in the wake of the outbreak of HIV/AIDS in Africa in the very beginning of the Twenty‐first century. The Doha Declaration 2001 (Amendment of the TRIPS Agreement (TRIPS Amendment), 2005), and subsequent WTO General Council's Waiver Decision 2003 (WTO, 2003a, 2003b 2003, 2003c) aimed at reforming the existing system in order to resolve the issue of access to drugs for poorer countries.
It has been observed that the issue of access to drugs has remained a hot issue even after breakthrough pro‐access developments like Doha Declaration (WTO, 2001) and 2003 Waiver Decision. The adoption of a resolution on “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” presented by 13 countries (Saez, 2016) in the 32nd session of the Human Rights Council (13 June 2016–1 July 2016) is a recent development in this regard (Kulkarni, 2016). The resolution notes that actual or potential conflicts exist between the implementation of the TRIPS Agreement and access to affordable medicines (Mitra‐Jha, 2016); the resolution urges member states to make full use of TRIPS flexibilities for affordable access to medicines (Human Rights Council, 2016) and specifically recalls the Doha Ministerial Declaration on the TRIPS Agreement and Public Health in this context (Kulkarni, 2016). The resolution fully recognizes the implications of pharmaceutical patent monopoly for policy coherence in developing countries.
The United Nations Secretary‐General's High‐Level Panel on Access to Medicines Report released on 14 September 2016, is another recent development. The Report found that the Paragraph 6 system has failed to provide a workable solution for countries lacking drug manufacturing capacity of their own. The Report recommended that “WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license” (UN, 2016). On one hand, World Health Organization aims that “by 2030, the deadline for the Sustainable Development Goals, all countries must be able to provide full coverage for quality health services to their entire populations” (Kieny, 2016) while on the other hand access to drugs remains an “illusive goal” for millions of people (Mitra‐Jha, 2016).
Bilateral and regional free‐trade agreements, which set TRIPS‐Plus intellectual property standards, have arguably constrained the use of legitimate TRIPS flexibilities reaffirmed in the Doha Declaration (Abbas & Riaz, 2013). The Trans‐Pacific Partnership (TPP) — an ambitious free trade agreement that the United States has negotiated with 11 other countries (New Zealand, Australia, Canada, Japan, Singapore, Brunei Darussalam, Chile, Malaysia, Mexico, Peru, and Vietnam) — is the most recent example of such trade deals requiring enhanced rights and remedies for multinational drug companies. Article 18.6.1(b) recognizes the right of member states to utilize the Waiver flexibility but it neither makes any commitment for effective implementation of this public health solution nor puts any obligation on member states to take necessary steps to use this flexibility for the sake of improving access to essential medicines in the poorer countries. This provision stipulates that:
In recognition of the commitment to access to medicines that are supplied in accordance with the Decision of the General Council of August 30, 2003 on the Implementation of Paragraph Six of the Doha Declaration on the TRIPS Agreement and Public Health (WT/L/540) and the WTO General Council Chairman's Statement Accompanying the Decision (JOB(03)/177, WT/GC/M/82), as well as the Decision of the WTO General Council of December 6, 2005 on the Amendment of the TRIPS Agreement, (WT/L/641) and the WTO General Council Chairperson's Statement Accompanying the Decision (JOB(05)319 and Corr. 1,WT/GC/M/100) (collectively, the “TRIPS/health solution”), this Chapter does not and should not prevent the effective utilisation of the TRIPS/health solution (The Trans‐Pacific Partnership Agreement, 2015).
Most recently, the intergovernmental South Center organized a discussion on implementation of WTO “Paragraph 6” System alongside the WTO Council for TRIPS meeting held on 8 November 2016 (The South Centre, 2016). The panelists, including Yuanqiong Hu, Dean Foster, Denis Broun, and Suerie Moon, generally considered the Paragraph 6 system an unworkable solution to provide affordable access to medicines to patients in poorer countries. Roger Kampf, Counsellor at the Intellectual Property Division of the WTO, presented several issues for consideration such as: how to use the Waiver scheme as a practical procurement tool; how to actively engage ministries of health and procurement agencies in the process; and how to make generic drug companies’ participation in the scheme economically viable (Nightingale, 2016). Keeping in view the significance of access to a cheap generic version of medicines in attaining global public health goals, this paper aims at critically evaluating the practical implications of implementing Paragraph 6 of the Doha Declaration and the Waiver flexibility in the light of the notion of Regulatory Ritualism.
According to John Braithwaite, Ritualism means, “acceptance of institutionalized means for securing regulatory goals while losing focus on achieving the goals or outcomes themselves” (Braithwaite, 2008). Similarly, according to Jolyon Ford, “The ‘ritualism’ concept relates to formalistic participation in a regulatory system, engaging in the institutional processes created to achieve substantive regulatory goals but taking these verification and reporting processes as the point of the exercise, while losing all focus on the goals themselves” (Ford, 2016). The central theme of this paper is that the flexibility provided under Paragraph 6 of the Doha Declaration has been over‐shadowed by the procedural formalities that are unnecessarily complex and burdensome and do not comply with the intended purpose of the flexibility.
'Compulsory licensing of pharmaceuticals reconsidered: Current situation and implications for access to medicines' by Kyung-Bok Son and Tae-Jin Lee in (2018) 13(10)
Global Public Health 1430-1440 comments
To examine patterns and trends in attempts, distinguished from issuance, to issue compulsory licensing of pharmaceuticals and to assess related implications in the era of high-cost medicines. Documents from various civil society organisations were primarily used to search attempts, as well as published literature. The identified attempts were analysed by pharmaceutical level, national level, claimers, and the outcomes of the attempts. There have been 108 attempts to issue compulsory licensing for 40 pharmaceuticals in 27 countries since 1995. Most of the attempts were in Asian, Latin American, and African countries and mainly for HIV/ AIDS medicines. Moreover, when the claimer was the government, the likelihood of approval and positive outcomes increased. Compulsory licensing, which was devised to cope with the HIV/AIDS pandemic in low-income countries, became a practical measure in several Asian and Latin American countries, even for non-HIV/AIDS medicines. Resurgent compulsory licensing in 2012 and 2014, influenced by the global justice movement, might represent a policy window in the near future as the Doha Declaration did in the 2000s. In this context, various experiences should be circulated and analysed at the global level to better understand the circumstances under which successful issuance has been achieved at the country level.
The authors argue
Compulsory licensing occurs when a government allows someone other than the patent holder to produce the patented product without the consent of the patent holder (WTO, 2017). In international agreements such as the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) and the Trans-Pacific Partnership Agreement (TPPA), compulsory licensing is recognised as a valid legal right of a member country (Son & Lee, 2017). Legally, low- and middle-income countries can utilise compulsory licensing to protect public health in case of national emergency or for public non-commercial use. However, most low- and middle-income countries have not issued compulsory licensing (Beall & Kuhn, 2012; Bucknell, 2007; Consumer Project on Technology, 2010; WHO, 2008).
When pharmaceuticals that are in demand are not on the market or are not fully available (for example, given the high cost of medicines), a government can issue compulsory licensing. This is not, however, a magic bullet that can solve the limited access to medicines caused by patents. Limited access to medicines for HIV/AIDS, influenza, and tuberculosis in low- and middle-income countries is not solely related to patents (Van Gelder & Stevens, 2010). However, we cannot underestimate the importance of patents and their detrimental effect on access to medicines from the perspective of affordability (Cohen and Illingworth, 2003; Hestermeyer, 2007; WHO, 2006). Many HIV/AIDS patients in low- and middle-income countries are experiencing resistance or intolerance to old drugs, and an increasing number of patients need new and expensive ones presently protected by patents (Luo, Oliveira, Ramos, Maia, and Osorio-de-Castro, 2014; Over et al., 2007). Furthermore, the affordability of pharmaceuticals is an important issue regardless of income level. The high prices of new medicines are common problems even in high-income countries (Iyengar et al., 2016; Kesselheim, Avorn, and Sarpatwari, 2016; Vitry and Roughead, 2014).
Since 1995, there have been continuous discussions regarding compulsory licensing of pharmaceuticals in the field of public health and law (Beall, Kuhn, andAttaran, 2015; Lybecker and Fowler, 2009; Reichman, 2009). However, relatively little information exists about the compilations of compulsory licensing, and studies of various past attempts to issue compulsory licensing remain an untouched area (Beall and Kuhn, 2012; Bucknell, 2007; Consumer Project on Technology, 2010; WHO, 2008). Among the available literature, Beall and Kuhn (2012) have constructed a significant database of compulsory licensing episodes with the active support of the government of a World Trade Organisation (WTO) member country. However, in their study, some episodes not characterised by an active governmental role, such as instances of compulsory licensing requested by non-governmental entities, were excluded. It is worth noting that even though a government alone can issue compulsory licensing, non-governmental entities can also request the government to do so. Given this, attempts by various actors, as distinguished from the government, are foregrounded in this study. This study was conducted to examine patterns and trends in attempts to issue the compulsory licensing of pharmaceuticals, and to assess the related implications for access to medicines in the era of high-cost medicines.
