Geneva, 30 Jul (D. Ravi Kanth) – South Africa has called for a “more holistic approach to TRIPS flexibilities” in combating the ravaging Covid-19 pandemic that appears to have become a new gigantic “milking cow” for the world’s leading pharmaceutical companies to secure billions of dollars of public funds and adopt predatory pricing policies for new therapeutics and vaccines.
At a special TRIPS Council meeting on 30 July, South Africa’s proposal on “Intellectual Property and Public Interest: Beyond Access to Medicines and Medical Technologies Towards a More Holistic Approach to TRIPS Flexibilities” is expected to generate a major debate on the issues concerning TRIPS flexibilities, said people familiar with the meeting.
In its four-page proposal (IP/C/W/666), South Africa said that “a main focus at the WTO has been how to facilitate access to medicines (for addressing the Covid-19 pandemic) in the context of the Doha Declaration on TRIPS and Public Health.”
The amendment to the TRIPS agreement came into force in 2017 for implementing the TRIPS mechanism, which has been referred to in the context of the access to medicines and medical technology through compulsory licences or government use.
South Africa cited the United Nations high-level panel report on access to medicines in 2016 to demonstrate that “… WTO Members retained important public health flexibilities that can be used to adapt their intellectual property law, policies and practices to meet human rights and public health objectives. These include the ability to determine patentability criteria, issue compulsory licences, authorise parallel importation, apply general exceptions and employ competition laws to limit and remedy the abuse of intellectual property rights in domestic legislation.”
South Africa noted that “there are still a significant number of countries that do not make full use of available flexibilities under the TRIPS Agreement.”
Calling for “an integrated approach to TRIPS flexibilities,” South Africa said that “the use of TRIPS flexibilities to address a public health concern is usually seen as a matter concerning patents.”
Significantly, “the COVID-19 pandemic requires a more integrated approach to TRIPS flexibilities that include various other types of intellectual property (IP) rights including copyrights, industrial designs and trade secrets,” South Africa emphasized.
At present, there is lack of understanding at the national level on the use of TRIPS flexibilities in other areas of intellectual property, beyond patents, South Africa argued, adding that “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,” said South Africa, emphasizing that “the COVID-19 crisis created the need to produce essential equipment and medical supplies, (and) there is a growing need to be able to manufacture essential medical devices such as masks, ventilators and other personal protective equipment.”
Given the raging debate over Covid-19 beyond medical issues, “the nature of the pandemic requires non-medical approaches to detect, diagnose and trace the coronavirus,” South Africa said.
It argued that “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,” suggesting that other than the disease of smallpox, no other infectious disease is comparable to COVID-19 in its broad geographic distribution.
Referring to the recent GAVI (the global alliance for vaccines and immunization) study, South Africa said that GAVI cautioned about the uncertainty around the technical feasibility of eradicating COVID-19.
Therefore, the global community needs to plan for the possibility that COVID-19 will be in global circulation indefinitely.
“In the absence of prophylaxis through a vaccine and more effective treatments, non-medical measures have been an important priority in dealing with the devastating impacts of COVID-19,” it pointed out.
Given the proliferating shortages of masks, face shields, and hand sanitizers to guard against the Covid-19 disease around the world, many developing and least-developed countries at the WTO need domestic manufacturing capacity to avoid dependence on imports to meet their medical needs, South Africa suggested.
Explaining the salient features of the amendment to the TRIPS Agreement following the establishment of the TRIPS mechanism in 2003 for tuberculosis, HIV/AIDS and other contagious diseases, South Africa said that Article 31bis of the TRIPS Agreement enables an exporting country to produce vital medicines under compulsory licence.
However, the stringent conditions attached to the TRIPS amendment made it almost impossible to avail of the TRIPS mechanism until now.
“In any event, many developing country Members may also face legal, technical and institutional challenges in using TRIPS flexibilities”, particularly for countries that have never utilized flexibilities such as compulsory licenses, South Africa argued.
More disturbingly, the World Health Organization’s Covid-19 Technology Access Pool (C-TAP) has not been useful until now as the pharmaceutical behemoths have refused to share their IPRs.
The C-TAP requires 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 voluntary non-enforcement of intellectual property rights, as appropriate, during the COVID-19 pandemic, to facilitate the wide-scale production, distribution, sale and use of such health technologies throughout the world.”
“However, to date no company has committed to doing so [and] instead limited, exclusive and often non- transparent voluntary licensing is the preferred approach of pharmaceutical companies, which will be insufficient to address the needs of the current COVID-19 pandemic,” South Africa observed.
In a news report in the Financial Times on 28 July, titled “Moderna pitches virus vaccines at about $50-60 per course”, it was pointed out that the high prices to be charged for the vaccine is a cause for concern.
“A proposal by the World Health Organization to pool intellectual property for effective Covid-19 interventions, including vaccines, has thus far garnered limited government support and no backing from pharmaceutical companies,” according to the FT news report.
In its proposal, South Africa has provided several examples for considering the TRIPS flexibilities beyond patents.
1. The “big data outside of the health system” in which “Smartphones, mobile data, artificial intelligence, databases and algorithms have been used in the COVID-19 pandemic to leverage the detection and control of the virus. Different types of IP rights remain 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,” and “national security concerns may also arise in the context of Article 73 of the TRIPS Agreement.”
2. Even in the use of 3D printing technology, there were several obstacles for manufacturing vital medical equipment during the current Covid-19 pandemic. Furthermore, a law firm advises that any person or company intending to manufacture parts using 3D printing should carry out some due diligence to identify:
* who ultimately holds the intellectual property rights in the component;
* whether the part is protected by patent or registered design;
* whether the rights holder is willing to permit the parts to be manufactured in return for a small or nominal royalty for the wider public benefit; and
* whether any regulatory approval is needed for supply of the parts.
“This case clearly demonstrates the interface between IP and new technologies such as 3D printing and may require a better understanding of how a balance may be achieved between rights holders and third parties,” South Africa suggested.
3. Trade secrets encompass vast quantities of information needed to discover, test, create, and manufacture diagnostics, treatments, and vaccines. 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. Given the protection accorded to industrial secrets under Article 39.2 of TRIPS Agreement, both voluntary and compulsory licenses, though common in other forms of IP, are unusual in trade secrets.
According to Professor David. S Levine, in his article on “Covid-19 should spark a re-examination of trade secrets’ stranglehold on information,” it is argued that “clearly, there should be times when trade secrecy’s ability to lock down information gives way to broader national and international information sharing concerns. If there were ever a case for re-examining trade secrecy’s unquestioned dominance, a public health crisis on the scale of Covid-19 would be the time.”
“What seems initially like a narrow issue involving intellectual property law and innovation may actually be a critical barrier to our ability to rapidly, effectively, affordably, and safely solve the Covid-19 pandemic,” Professor Levine argued, emphasising that “the time is now to examine, and re-examine, trade secrecy’s hold on information and our collective health.”
South Africa raised four questions for WTO members to consider at the TRIPS Council meeting.
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?
In short, South Africa has brought to the centre stage at the WTO the TRIPS flexibilities beyond patents for addressing issues concerning copyrights and trade secrets that could prove a major IPR barrier for combating the Covid-19 pandemic.