By Sanya Zehra Rizvi
On 29 May 2020, the World Health Organisation (‘WHO’), along with the Costa Rican Government launched the COVID-19 Technology Access Pool (‘C-TAP’) to promote universal accessibility to potential vaccines, technologies, diagnostic kits, etc. It is “voluntary and based on social solidarity and aims to accelerate the discovery of vaccines, medicines and other technologies through open-science research, and to fast-track product development by mobilizing additional manufacturing capacity”. Intellectual property (‘IP’) owners that become a part of the pool allow WHO to provide licenses, on certain conditions, to those interested in manufacturing the products or technologies necessary for the treatment of COVID-19, without having to negotiate separately with the owners.
Subsequently, a “solidarity call to action to realize equitable global access to COVID-19 health technologies through pooling of knowledge, intellectual property and data” was issued by WHO, asking all stakeholders to join the initiative. However, as on 25 July, only 39 countries had joined the initiative, with major players involved in the development of health technologies—like the USA and UK—missing. India too, had not joined as of 25 July, 2020.
This article makes a case for a global technology access pool. In doing so, it focuses on the need for such an initiative, the legal obligations (if any) of doing so, and the feasibility of the Indian Government to partake in the initiative. Learning from prior experiences, the article also suggests the way forward.
The Need for this Initiative
The search for a vaccine against COVID-19 is underway with experts claiming that a vaccine could be made available by mid-2021. Countries like USA and the UK have already invested millions of dollars with various potential contenders expecting supplies on a priority basis. To illustrate, in May 2020, Sanofi, a French pharmaceutical firm confirmed that USA will get the first shipment of any vaccine developed by them because of the early, and hence high-risk investments that USA made in the development of the vaccine. Earlier this year, the UK and the Netherlands accused Roche, a leading diagnostic kit manufacturer, of withholding the chemical formula of a reagent required in the testing process of Coronavirus. This withholding resulted in limited supply of the reagent which in turn resulted in a delay in conducting tests. However, legally, Roche had sufficient IP protection to deny sharing the formula of the said reagent. Thus, we see that many of these essential products and health technologies are IP protected and developed influential countries are already restricting the global access by claiming priority rights. These countries are overlooking the fact that the speed with which the virus spreads means that any failure to control such spread in developing countries risks the reoccurrence of more such epidemics in the future.
To overcome the abovementioned and any future difficulties that may hinder access to sufficient quantities of an affordable vaccine, and other necessary products and technologies, many countries like Israel, Chile, Germany, have already made legal changes that allow them to grant Compulsory Licences (‘CLs’). A CL is a system wherein the governments can authorise third parties to manufacture, use, or sell patent protected products without the owner’s permission, and thus bypass the IP protections. However, any such grant of CLs is made on individual basis and any initiative with one or a handful of manufacturers will in most likelihood not be able to meet the huge demands of the vaccine.
The C-TAP, on the other hand, as a one stop platform for open and collaborative pooling of COVID-19 related knowledge, date and IP on all existing and latest health tools has the potential to avoid duplication of efforts by ensuring better coordination and to mobilise maximum production capacity by providing access to priority health technologies to all interested manufacturers. This helps in providing more equitable and affordable access to health products.
Addressing opposing views
The initiative has garnered criticism from various pharma giants like Pfizer. Some claim that it downplays the role that IP plays in promoting innovation by taking away the incentive to innovate. They maintain that instead of pooling, the need of the hour is for them to provide their products at no profit whenever needed. Some companies like Gilead Sciences have also considered providing voluntary licenses to generic companies to manufacture and sell certain potential medicines.
The above mentioned criticisms overlooks that such methods are disintegrated and work on a one to one basis which will delay the production and fail to maintain the quantity demanded in present times. Further, instead of taking away the incentive to innovate by seizing IP rights, C-TAP aims to seek contributions and provide royalties to the IP owners for their contributions. A large number of licensees in the C-TAP have the potential to increase the manufactured quantity which in turn will increase the royalties paid per unit making it more profitable than royalties that may be collected through the grant of compulsory or voluntary licenses to individual companies.
Thus, the C-TAP by serving as a one stop platform for all stakeholders not only supports collaborative research which hastens product development, ensures affordable and equitable access to health related technologies but also respects the IP regime by providing adequate royalties.
International Legal obligations
Joining the C-TAP aligns with international legal obligations of member nations of the respective instruments. General Comment (‘GC’) 14 to Article 12 of the International Covenant on Economic, Social and Cultural Rights (‘ICESCR’) recognizes the access to affordable, essential medicines as one of the core obligations of the right to health. This includes the obligation to respect, protect and fulfil that right. The obligation to protect is breached on the failure to regulate the activities of corporations that violate the right to health of others. Further, the obligation to fulfil requires countries to fulfil the right to health when people are unable to realise these rights on their own. Lack of availability of sufficient quantity of affordable health products either by failure to regulate the conduct of pharmaceutical companies or by failure to make these products available to those who can’t afford them can therefore be argued to be a breach of international obligations of 171 countries that are parties to the ICESCR.
Para 39 of GC 14 also clarifies that states should facilitate access to essential health facilities in other countries based on resource availability. Further, the agreement on Trade-Related aspects of the Intellectual Property Rights (‘TRIPS agreement’) also allows countries to take measures necessary to protect public health. The Doha Declaration adopted within the TRIPS framework also states that the TRIPS agreement should be implemented in a manner to “protect public health and… promote access to medicines for all”. Thus international law can be relied on to argue that nations that are a part of ICESCR and TRIPS are not only required to act to ensure access to essential medicines and health technologies to its citizens but also cooperate with other nations in doing the same.
Although, India is a signatory to both the ICESCR and the TRIPS agreement, it has not joined the C-TAP. Indian patent law has several provisions that may be employed in the current situation, however, joining the C-TAP is the most viable option in the author’s opinion. Some of the relevant provisions are discussed here. Section 92 of the Patent Act authorises the Government of India to make a declaration for the grant of CLs against any patent in force in India in cases of public non-commercial use, extreme urgency or emergencies. This explicitly includes situations of public health crises like epidemics. The Controller of patents can then grant CLs upon receiving applications of interested parties, after endeavouring to secure that the product is available at the lowest possible price, while also ensuring that the patent owners derive sufficient benefit. The Controller can even waive the hearing of the patent owner’s claim by notifying the same to him/her. Another provision that can be employed is the revoking of patents under Section 66 on grounds of the patent being “generally prejudicial to the public.” Grant of patent to a COVID-19 related product can restrict access and thus can be argued to be prejudicial to the public. This, however, requires giving the patentee an opportunity to be heard. Further, Section 100 of the Act provides that upon the authorisation of the central government, companies would be allowed to use patents, even if the patent grant is still pending.
These provisions gain particular importance in the present times. However, any such grant or revocation of CLs will be on a one to one basis and each product may have numerous patent protections and the patent owners may contest such grant or revocation, resulting in legal disputes that can delay the availability of the product or technology. The production of a vaccine would be further delayed as potential licensees fearing involvement in expensive litigation tend to delay their investments in the production until there is some clarity on licensing costs and the willingness of necessary right holders to license their rights. Involvement of the right holders in the C-TAP pool will signal their intention to make their rights available at a standard price and thus, stimulate early and greater investments in the manufacturing process.
Any grant of CLs or revocation of patents will also come with its challenges from big pharmaceuticals and trade partners. Illustratively, when India’s first CL for a public interest purpose was granted for a kidney drug, Bayer’s (the company developing the said drug) executive claimed that they did not develop the drug for Indians but for those who could afford it. This position was heavily favoured by the US Government. Additionally, the Indian Pharmaceutical Alliance in its representation to the United States Trade Representative for removing India from the Special 301 Priority Watch List, a list that determines trade relations on the basis of countries’ compliance with IP obligations under the TRIPS regime, stated that India has not granted any CLs in the last seven years. Thus, granting CLs has the potential to significantly jeopardize India’s trade relations.
Further, even after the grant or the revocation, there will be considerable time spent for developing the generic versions in the required quantity. The Indian Government may also consider bulk procurement of products but it is unlikely that this will be sufficient to cater to the demands expected from India in a short time.
Learning from Prior Experience and the Way Forward
The pharmaceutical industry is extremely wealthy and its net worth is pegged at 1.4 trillion dollars by the end of 2020. But this industry is extremely profit-driven and prior experience shows that it has successfully managed to evade its responsibility to the society. The initial research for development of antiretroviral drugs were heavily funded by the public sector, yet owing to its market exclusivity, the final product was provided at a price that was unaffordable to many. Research shows that most of the early research in the current pandemic are also being funded by the public sector. Thus, the Costa Rican government’s proposal to WHO for signing an MoU with those involved in the C-TAP pool, specifying the intent to share rights in developments that were publicly funded, deserves serious consideration.
The response from the pharmaceutical companies shows their obvious reluctance to join C-TAP. The incentive to collect royalties and improve their public goodwill has not been enough to convince them to join the C-TAP. While some IP protection holders, including AbbVie, have pledged not to exercise their exclusive rights, matters as crucial as saving lives depend on the magnanimity and goodwill of IP right holders on a large scale. At this point, the governments and public institutions funding the research and development of the health products or technologies should push for them to join the C-TAP. Those nations that are not involved in the funding should push by threatening to use CLs and other flexibilities, provided within the TRIPS agreement like Article 73(b) which prohibits anything in the TRIPS agreement to be construed to prevent a member state from taking an action it considers necessary to protect its essential security interests.
The need of the hour is not to proceed on a case by case basis but to commit fully by joining the C-TAP. It is high time that the IP regime starts accelerating the access to health technologies lest it lead to an anti-IP sentiment where the world starts despising the IP regime and its excessive interest in favouring commercial gains.
The author, Sanya Zehra Rizvi, is currently a law student at National University of Juridical Sciences (NUJS), Kolkata. She is also an Associate Editor at JILS.
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