[Ip-health] WTO TRIPS Council (July 2020): South Africa’s submission on IP and the Public Interest – Beyond Access to Medicines and Medical Technologies towards a more Holistic Approach to TRIPS Flexibilities

Thiru Balasubramaniam thiru at keionline.org
Tue Jul 21 01:14:31 PDT 2020


https://www.keionline.org/33551

WTO TRIPS Council (July 2020): South Africa’s submission on IP and the
Public Interest – Beyond Access to Medicines and Medical Technologies
towards a more Holistic Approach to TRIPS Flexibilities
Posted on July 21, 2020 <https://www.keionline.org/33551> by Thiru
<https://www.keionline.org/author/thiru>

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 <https://www.keionline.org/wp-content/uploads/W666.pdf>) 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
<https://www.techtimes.com/articles/248121/20200317/maker-ventilator-valves-threatens-sue-volunteers-using-3d-printed-coronavirus.htm>
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?


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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