Advocacy in times of TRIPS waiver

Advocacy in times of TRIPS waiver

Introduction

COVID-19, the novel coronavirus first discovered in December 2019 in Wuhan, China, is an extremely contagious virus which spread at an unimaginable rate. On 11 March 2020[2] the World Health Organization (WHO) declared it a pandemic. Suddenly, we had to adapt to new ways of living, working and socialising. Governments, scientists and pharma companies raced towards developing vaccines. Pharma companies like Pfizer, AstraZeneca, Moderna and Johnson & Johnson[3] were able to develop vaccines at a speed never witnessed before.[4] There was a sense of relief that soon everyone would be vaccinated and the world would go back to being normal. However, that expectation was far away from the reality of what ensued.

Vaccine and medical product shortages

The enormity of what followed can only be captured in terms such as “vaccine apartheid”, “vaccine nationalism” and “vaccine inequality”. We saw a gap in access to vaccines between the countries in the global North and global South,[5] and the stockpiling of vaccines by Canada, the EU and the US[6] while the marginalised population of the world either had no access or could only get them at prices much higher than those in the developed world.[7] We saw people living in the global North getting booster shots and those living in middle- and low-income countries not even receiving their first one.[8] At the date of writing this, only 19% of Africa[9] is vaccinated while 68% of the US population is fully vaccinated.[10]

This is a narrative of broken promises. At the start of the pandemic the global North promised “universal, common good”[11] vaccines to the world. They pledged donations to COVAX, a facility set up to promote the equitable distribution of vaccines.[12] However, COVAX failed because developed countries did not keep their promise.

The problem was not limited to vaccines alone. Since the beginning of the pandemic, we witnessed supply chain problems: there were acute shortages of medicines, testing kits,[13] N95 masks, PPE kits, ventilators and other medical products. As more deadly COVID waves ravaged the world, citizens in developing countries also faced the problem of corrupt black-market practices[14] because of acute shortages of medicines and medical products. Advocates wrote letters[15] to companies to raise issues of shortages faced by middle- and low income-countries. There was an urgent need to scale up manufacturing of medical products and vaccines. As the pandemic progressed, countries in the EU and the US and India put export restrictions in place to meet their own domestic needs.[16] This directly impacted nations dependent on them for medical supplies.

How did IP become a problem?

The only solution to this public health crisis was to rapidly scale up manufacturing, which could only be achieved by technology transfers and sharing know-how. During World War II, the need for penicillin for injured soldiers was met only because the proprietor, Oxford University, decided to waive its intellectual property (IP) rights and share the know-how.[17] COVID-19 called for a similar human rights-based response. However, the IP owners refused to share their knowledge.

Civil society organisations (CSOs) demanded action to create patent pools for tech transfer and sharing know-how to scale up production to meet any shortages.[18] In May 2020, the WHO set up the COVID-19 Technology Access Pool (C-TAP)[19] as a “single global platform” to share IP and data using voluntary licensing for those scaling up production of COVID-19 vaccines and medical products. The forum was set up with much anticipation that it would act as an enabler to overcome global shortages. However, the pool remained relatively empty[20] for a long time. It took almost two years for the first tech transfer to take place.[21] C-TAP was welcomed with a cold shoulder by global pharmaceutical companies[22] as they did not want to give up their monopoly. Instead, they opted for bilateral agreements with restrictive clauses that limited scaling up production. Almost 250 advocacy groups raised concerns in a letter to the director-general of the World Trade Organization (WTO)[23] on how these exclusive agreements with only certain manufacturers in developing countries created artificial shortages. For example, Gilead entered into an exclusive agreement to produce Remdesivir with five manufacturers that were allowed to cater to a limited number of countries, leaving almost 70 countries to purchase the same medicine from Gilead at much higher prices.[24]

It is a lie when the pharma companies insist that IP is not a barrier. The truth is that they did not want to part with their knowledge. There are numerous examples which prove that IP rights have created barriers in producing and accessing vaccines and medical products.[25] While Pfizer excluded Latin American countries from its deal with C-TAP,[26] a recent study revealed that BioNTech is trying to stop an mRNA[27] vaccine hub in South Africa from using the mRNA technology, claiming it will “infringe on patents.” This hub aims to scale up its capacity to 60% by 2040.[28] The same study has identified 120 manufacturers across the world that have the capacity to produce the mRNA vaccine.[29] It is proof against the long-standing argument by pharmaceutical companies that the global South lacks the capacity to manufacture mRNA vaccines. Advocacy groups[30] have written letters to the US and German governments to take action to ensure that tech transfer takes place with these manufacturers.

The current pandemic has revealed at every step that IP rights are barriers. If manufacturers in countries like India, South Africa, Bangladesh and Egypt were allowed access to technologies and know-how, their manufacturing capacity could have been easily, efficiently and effectively scaled up to meet the global needs at affordable and equitable prices. We could have probably averted the heartbreaking Delta wave in India and Latin America.

What is the TRIPS waiver and why was it needed?

On 2 October 2020, India and South Africa together presented a proposal to the WTO called the Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver. The waiver asked that all IP rights for technologies that are important to develop vaccines, medicine, equipment and kits be waived until “the majority of the world's population has developed immunity.”[31] The proposed waiver aimed to overcome the restrictive global IP rules to help countries enter tech transfer partnerships and export medical products without fear of sanctions or trade disputes[32] to scale up and help produce “second-generation” vaccines against emerging variants.[33]

Australia, Canada, the EU, Japan and the US opposed the waiver, standing their ground that existing TRIPS flexibilities were sufficient to overcome the IP issues.[34] The proposal quickly gathered support from many developing countries, advocacy groups and CSOs, as well as organisations like the WHO and UNAIDS.[35] Those advocating for the waiver knew that for it to be approved, the global North had to be on board. From here on began months of hard work and advocacy campaigning. CSOs started raising their voices and making fierce efforts to be heard by developed countries. CSOs from developing countries, and international, regional and domestic advocacy groups from the global South, sent letters to call on the US president and leaders of the developed world to support the waiver. A global advocacy movement grew. There were open letters and petitions, including from the South African Anglican Archbishop of Cape Town, Thabo Makgoba,[36] in support of the TRIPS waiver, and petitions to the US president and administrators by Health Gap, The Delhi Network of Positive People,[37] Amnesty International USA[38] and Partners in Health,[39] to name a few. The pharma lobby was not far behind as they also sent a letter to US administrators not to back the waiver. The pharma lobby criticised the waiver as vague, broad and a tool to weaken IP rights.

On 5 May 2021, in an extraordinary move, the US announced[40] its support for the TRIPS waiver for vaccines “in service of ending this pandemic” after months of opposing it. It was a big moment in the world of access to medicine advocacy and it played a critical role. Had the advocates not worked hard, rallied politicians, and built global campaigns, this would not have happened. However, the US did not deliver on the leadership, giving the EU an opportunity to block any progress on the waiver.[41] In June 2021 they put forward their own “counter proposal”[42] covering only patents but excluding other IP rights (copyright, trade secrets, regulatory data and biologics) and promoting the use of compulsory licensing and voluntary licensing.[43] It was old wine in a new bottle. Compulsory licensing is a complicated process which comes with its share of pre- and post-approval requirements which are time consuming, cumbersome and often export restricting. Compulsory licensing can be an effective tool if the existing rules and regulations are simplified. Advocacy groups across the globe staged protests[44] and delivered petitions to the Biden administration for them to get back in the game and not back down on the waiver. However, developed countries refused to give in and this resulted in a revised TRIPS waiver far away from what was proposed.[45]

During the 12th WTO Ministerial Conference (WTO MC-12) negotiations, advocacy groups led a vocal campaign to call out countries blocking the waiver. On 15 June 2022, around 223 CSOs sent a letter to the trade ministers at the WTO to reject the revised proposal.[46] CSOs, advocacy groups and academics across the globe pleaded to heads of states to not to agree to the revised waiver.[47] However, after two years of intense battle, on 20 June 2022 the WTO reached a ministerial decision on the waiver.[48] The final text is very different from the original proposed waiver. It only covers vaccines and is limited to patent. We would not have reached this stage if the IP was open for use.

Open knowledge

Open knowledge is “any content, information or data that people are free to use, re-use and redistribute without any legal, technological or social restriction.”[49] It leads to swift, efficient and collaborative policy decisions. As an umbrella term, open knowledge encompasses open science, open data and open source software, and open education such as MOOCs, among other forms of “free-to-use” knowledge that are available to people. Open licences are a tool to achieve open knowledge.

Open licences used by inventors, researchers and institutions lead to the dissemination of their work to the public by overcoming restrictive IP barriers[50] and help to optimise public funding.[51] One example of open licensing is Creative Commons, created as a response to a US copyright case that extended the monopoly power of the creator.[52] These licences are now extensively used by research institutions, CSOs and government-run agencies.[53] Creative Commons has been driving awareness around the lack of effectiveness of voluntary licensing in disseminating knowledge and is actively promoting a mindset of “progressive copyright law” through national and global awareness.[54]

Over the years we have witnessed growing advocacy for open knowledge. The Open Knowledge Network, Public Domain and the Comprehensive Knowledge Archive Network (CKAN) are a few examples[55] of open sources which share knowledge.

There exist many new advocacy opportunities to embrace when it comes to open knowledge and open licensing. However, in the context of the current geopolitical struggle around vaccine advocacy, TRIPS waiver-like advocacy may not work in the context of open knowledge. The vaccine advocacy occurred against the background of a grave global health crisis which had both social and economic impacts. In the case of open knowledge, the gravity of the situation does exist, but it is not backed by COVID-19-like time-sensitive circumstances. This works against advocates for open knowledge. Does this mean we should give up? No. A realistic assessment of potential impediments is required.

Roadblocks to an open system

The advocacy will not easy because:

First, many advocates suggest that a global agreement on open knowledge is the need of the hour.[56] Even UNESCO, during the 41st session of its General Conference in November 2021, recommended having an internationally regulated national legal instrument in place to promote open science.[57] Any negotiations and debates to make a binding instrument a reality necessitate a collective will from the global North and global South to agree on IP and transfer issues.[58] However, the negation of the TRIPS waiver does not leave much to hope for, as we can expect protests and blockades from developed countries and industries.

Second, when it comes to open data advocacy, there will be resistance from big tech giants backed by developed countries who would not want to lose their monopoly over revenue-generating big data or aggregated data. A prime example of such solidarity is the 24-year-old moratorium on custom duties in electronic transmission[59] because of US lobbying, despite South Africa and India’s protest at the WTO.

Third, there are legitimate issues of cross-border data flow, consumer privacy and national security. Most countries, both in the global North and global South, lack a robust regulatory framework to protect consumer data. There is no legally binding international treaty to manage international data flow.

Fourth, we must realise that in this globalised world, knowledge becomes truly open when it is free, diverse and inclusive. Advocacy needs to be built beyond the issue of IP barriers. It must focus on making research accessible in every “voice and language” to make it truly open.[60]

Fifth, negotiation processes at the multilateral level are often slow. For example, the definition of “Traditional Cultural Expressions” has been under debate at the World Intellectual Property Organization (WIPO) for many years now, yet there is no common ground to agree on because the developed and developing countries fail to reach a commonly agreed definition every year.[61]

Yes, there are opportunities. There is an urgent need to build advocacy on inclusion. In a world which is getting smaller and smaller because of the internet, open knowledge must be based on the principles of inclusion, diversity and non-discrimination. There is a need to build advocacy around promoting these principles.

Another area which has gained immense relevance is open data. First, there is a need to generate awareness around how open data should be collected for it to be inclusive. Second, data is reusable. The same data sets can be used for different purposes resulting in meaningful outputs. The application of AI and big data analysis poses a threat to individual privacy, because it de-anonymises anonymous data. The need to build awareness around these issues cannot be overlooked. In the case of open software there is a need to focus on how to make open software better and improve its quality.

However, for open knowledge, any advocacy has to address issues which are multi-sectoral and require a focus on both national and international level advocacy. Advocacy needs to be realistic and consistent. There will be periods of quiet and periods where it has to be vociferous. This makes the advocacy terrain incredibly complex for civil society organisations, which require advocacy specialists, global partnerships and alliances with governments and sympathetic voices in the private sector to create an effective movement. This renewed debate on IP is a golden opportunity to reinvigorate advocacy around open knowledge. There are many lessons from the TRIPS waiver and the most important one is to not be threatened by the limitations of licensing and super profits.