5 December 2022
Esteemed Mme Secretary Raquel Buenrostro Sánchez
Mexican Secretariat of Economy
Civil society organizations in Mexico and across the world are watching with attention and concern the recent developments on the extension of the Ministerial Decision on the TRIPS Agreement, adopted on 17 June 2022, to therapeutics and diagnostics, at the World Trade Organization (WTO).
On 1 November 2022, Mexico and Switzerland submitted a joint communication to the WTO TRIPS Council presenting flawed and biased data, largely from Big Pharma, in order to dismiss the need for the extension. Mexico’s role in delaying and blocking the extension is worrying and problematic, especially considering that a Mexican government representative had publicly supported, on 28 March 2022, the original TRIPS waiver proposal highlighting the need to expand manufacturing capacity and to increase the supply of diagnostics and therapeutics across the global South.
The importance of diagnostics and therapeutics as critical tools to deal with the COVID-19 pandemic is undisputed. Inequity in the timely availability and affordability of these tools is widely acknowledged. In October, the International Health Regulations (IHR) Emergency Committee convened by the World Health Organization (WHO) specifically highlighted the “persistent inequities to WHO-recommended therapeutics”, that “have resulted in many COVID-19 deaths that may have otherwise been avoided.” The ACT-Accelerator report of September 2022 stressed that “the pandemic is not over and issues of access to COVID-19 therapeutics and diagnostics must be addressed.” It added that developing countries still experience limited access, unaffordable prices and extensive delays, linked to the unavailability of generic alternatives. The ACT-A report as well as the Emergency Committee have highlighted with concern the challenges posed by the high concentration of manufacturing, and the need for diversified production at the local level, in order to address the problem of inequitable access.
It surprises us that Mexico has sided with developed countries like Switzerland that are primarily interested in enabling Big Pharma’s profits. This is to the detriment of access and equity within its own region. Latin America has the highest excessive COVID-19 death rate in the world – 254.0 per 100,000 people, double the world average of 120.3 deaths per 100,000 people. This has been largely due and will continue to be affected by the lack of access to affordable therapeutics. Today, developed countries account for 76% of total known supply deals. This also impacts Mexico detrimentally at the national level by benefiting Big Pharma at the expense of transparency and the promotion of the human right to health. This is clear in Mexico’s agreement with Pfizer for the production of Paxlovid. To date, Mexico’s Ministry of Health has only been able to procure 300,000 treatment courses for the whole country, making the drug extremely inaccessible, while civil society, patients and the public, in general, have remained in the dark regarding the conditions of the agreement.
In its joint communication with Switzerland, Mexico argues that there is no demand for COVID-19 therapeutics. This flawed argument fails to reflect actual need, i.e. the number of people infected globally, especially those at the highest risk of disease progression, hospitalization, and death. Given the nature of the virus, it is just a matter of time before infection rates increase. A recent report concluded that the lack of demand does not represent the actual need for therapeutics since prices are unaffordable, and in many countries, there is a lack of knowledge of their existence. Furthermore, in the absence of widely available affordable treatments, governments are unable to put test and treatment strategies in place.
Mexico also argues that signed voluntary licenses (VL) will ensure supply, and therefore there is no need for the waiver extension. However, these licenses exclude supply to many developing countries and are subject to terms and conditions that may delay or hinder access. The VL between Merck and the Medicines Patent Pool (MPP) for the production of generic Molnupiravir excludes supply to almost 80% of the Latin American and Caribbean population, leaving out countries such as Argentina, Chile, Colombia and the Dominican Republic. Similarly, Pfizer’s VL with the MPP for the combination of nirmatrelvir+ritonavir (brandname: paxlovid), excludes supply to 47% of the world population, including most of Latin America. While some excluded countries have manufacturing capacities and sufficient market demand, others have neither. This means they are dependent on countries with manufacturing capacity for supply. An extension of the 17th June decision would support the production and export of supplies for dealing with COVID-19. Furthermore, paxlovid costs $500 per treatment course in some developed countries and more than $250 in some developing countries. With sufficient generic competition, facilitated by the extension, the cost of a 5-day treatment can be as low as $73.
In the case of baricitinib – a WHO-recommended treatment for patients with severe or critical COVID-19 – there is no similar VL from the drug’s patent owner Eli Lily. The company currently holds baricitinib patents in more than 50 developing countries, including most of Latin America. baracitinib’s patents would only begin to expire in 2029, but Eli Lilly’s monopoly could be extended if additional patents are granted. In the US, baricitinib is prohibitively priced at US$ 822.78 for a 14-day treatment course. Some developing countries are paying much higher prices for the original version: in Argentina, the treatment course is US$ 886.48 However, where patents are not a barrier, generic versions of baricitinib are available for about US$ 6-7 per treatment course, i.e. nearly 158 times less than Eli Lilly’s price in the US.
The pandemic is known to have disproportionately larger effects in relation to gender, especially in intersection with other factors such as race, ethnicity, caste, migration status, sexual orientation, gender identity, etc. These effects manifest themselves in the form of increased domestic violence, barriers to accessing sexual and reproductive health services, unemployment, lack of income, indebtedness, increased care workloads, school closures, and the murder of trans and gender non-conforming people. Without the needed resources and technologies to respond to the continuously mutating virus, women – who make up the majority of frontline healthcare workers – will continue to be detrimentally affected by the pandemic. Women are more likely to have jobs with precarious work contracts, have less access to personal protective equipment, and are more likely to become infected and ultimately die. For instance, 80% of Brazilian healthcare workers who died of COVID-19 were women. Of these, 47% were black and brown women, and 66% had no work contract. Nursing auxiliaries and technicians (70%) had higher death rates than nurses (25%), and doctors (5%). Therefore, it seems contradictory to us that Mexico would take a stand against its own commitment to gender equality and well-being as stated in its Feminist Foreign Policy.
Equitable access to diagnostics and therapeutics is an essential component of the right to the enjoyment of the highest attainable standard of physical and mental health, as well as the right to enjoy the benefits of scientific progress and its applications. All states, including Mexico, have a duty of international cooperation and assistance to ensure equitable access. This means refraining from taking measures that obstruct this goal. Mexico has an international obligation to respect the enjoyment of the right to health in other countries and to prevent the violation of this right by opposing the extension of the TRIPS decision to cover diagnostics and therapeutics. Failure to do so will impair the protection of global public health and will prohibit urgent economic recovery from the impact of the COVID-19 pandemic.
The undersigned organizations, therefore, urge the Mexican government to:
(I) Review its position and support the expeditious unconditional extension of the Ministerial Decision on the TRIPS Agreement adopted on 17th June 2022 to the production and supply of COVID-19 diagnostics and therapeutics;
(II) Support the full use of existing TRIPS flexibilities such as compulsory licensing of patents and adequate exceptions to the protection of undisclosed information, copyright and industrial designs.