On Friday, 17 July 2020, South Africa submitted a paper to the World Trade Organization (WTO) TRIPS Council entitled, Intellectual Property and the Public Interest: Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach To TRIPS Flexibilities. This submission (document IP/C/W/666) will be discussed at the next session of the TRIPS Council on 30 July 2020.
In setting out the premise of its submission, South Africa noted that the COVID-19 response required looking beyond patents towards a more “integrated approach to TRIPS flexibilities that include other various types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets” (Source: IP/C/W/666).
The use of TRIPS flexibilities to address a public health concern is usually seen as a matter concerning patents. However, the COVID-19 pandemic requires a more integrated approach to TRIPS flexibilities that include other various types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets. The use of TRIPS flexibilities in other areas of intellectual property, beyond patents, is less understood at the national level. In fact, in other fields of IP, national IP laws may not even provide for sufficient flexibilities to address issues of access. A variety of IP rights are relevant in the fight against COVID-19 (Source: Ibid).
On essential medical devices, the South African submission states,
The COVID-19 crisis created the need to produce essential equipment and medical supplies, there is a growing need to be able to manufacture essential medical devices such as masks, ventilators and other personal protective equipment. As the debate over COVID-19 moves beyond medical issues, the nature of the pandemic requires non-medical approaches to detect, diagnose and trace the coronavirus. Studies have found that levels of neutralizing antibodies against SARS-CoV-2 remain high for a few weeks after infection, but then typically begin to wane. So far, only one infectious disease comparable to COVID-19 in its broad geographic distribution has been eradicated, this disease is smallpox.
Other goods and services that are needed to tackle the epidemic include protective equipment such as masks, face shields, and hand sanitizers. Such equipment and material remain in critical shortage in many countries around the world. Many WTO Members lack domestic manufacturing capacity and would be dependent on imports to meet their medical needs. (Source: Ibid).
In relation to compulsory licensing and Article 31bis of the TRIPS Agreement, the paper stressed that many developing countries face “legal, technical, and institutional challenges in using TRIPS flexibilities”.
When an exporting country is producing under a compulsory license mainly for export, the mechanism established by the 30 August 2003 decision, and later translated into an amendment of the TRIPS Agreement as Article 31bis, would be applicable. This mechanism waives the condition in Article 31(f) that a compulsory license should be predominantly for the supply of the domestic market. It should be noted that the implementation of the Article 31bis mechanism at a national level is very limited and may not achieve its intended objectives. In any event, many developing country Members may also face legal, technical and institutional challenges in using TRIPS flexibilities. This is especially true for countries that have never utilized flexibilities such as compulsory licenses (Source: Ibid).
The South African submission describes WHO’s COVID-19 Technology Access Pool (C-TAP),
The World Health Organization has launched the COVID-19 Technology Access Pool (C-TAP) inter alia calling on intellectual property holders to voluntarily license such rights on a “non-exclusive and global basis to the UNITAID-established and supported Medicines Patent Pool and/or through other public health research and development mechanisms, consortia or initiatives that facilitate global and transparent access; and/or voluntary non-enforcement of intellectual property rights, as appropriate, during the COVID-19 pandemic, to facilitate the widescale production, distribution, sale and use of such health technologies throughout the world”. However, to date no company has committed to doing so. Instead limited, exclusive and often non-transparent voluntary licensing is the preferred approached of pharmaceutical companies, which will be insufficient to address the needs of the current COVID-19 pandemic (Source: Ibid).
The South African COVID-19 submission details examples from three areas where policy tensions involving intellectual property have arisen in the COVID-19 response: 1) Big data outside of the health system, 2) 3D printing technology and 3) Trade Secrets.
On big data, the South African paper noted,
Smartphones, mobile data, artificial intelligence, databases and algorithms have been used in the COVID-19 pandemic to leverage the detection and control and control of the virus. Different types of IP rights are relevant to protect AI algorithms, some may be protected by copyright and trade secrets while other technology is protected by patents while database rights and trade secrets may also be relevant.
While these approaches help with efforts to contain the spread of the virus, they can raise issues about the right to privacy and personal freedoms. National security concerns may also arise in the context of Article 73 of the TRIPS Agreement (Source: Ibid).
In relation to 3D printing, South Africa provided an example of an IP dispute from Italy involving ventilator valves.
South Africa concluded that
This case clearly demonstrates the interface between IP and new technologies such as 3D printing and may require a better understand of how a balance may be achieved between rights holders and third parties. More collaborative approaches have been achieved through various pooling mechanisms for access to medicines, this is also true for more generic IP pledges that covers a broad range of equipment,software, network and device applications useful in healthcare, containment, tracking, diagnostics, emergency response and social distancing. Such approaches nonetheless are limited and may require action on the side of national authorities to ensure access to such technologies where pledges or voluntary licenses cannot be secured on commercially reasonable terms (Source: Ibid).
In relation to trade secrets, South Africa stressed that,
Potential trade secrets include manufacturing processes, test data, medical formulas, and more. For vaccines and other biologic medicines, cell lines, genomic information, and other biological material can also be held as trade secrets. Data about the effectiveness of medicines and vaccines are trade secrets. Even so-called negative information —information about what does not work —can be a trade secret (Source: Ibid).
In advance of the July TRIPS Council meeting, South Africa posed the following four questions for WTO members to address. The fourth question on trade secrets may provoke robust discussion and reflection as WTO members address whether trade rules are fit-for-purpose in the COVID-19 response.
1. To what extent are TRIPS flexibilities embedded in areas outside patent protection well understood? If so, how are Members implementing such understandings in their national and regional laws?
2. What are the likely difficulties that Members may face in dealing with a changing technology landscape where embedded IP rights may affect the dichotomy between IP rights as private rights and the public interest dimensions recognised in the TRIPS Agreement?
3. What are the benefits and limitations of initiatives such as voluntary licenses and pledges to access much needed technology to deal with the COVID-19 pandemic?
4. Are there circumstances where trade secrets can be shared more broadly? If so, what are those circumstances? Would national or international health pandemics fall within this category?