[Ip-health] The Lancet on the TRIPS waiver proposal

Thiru Balasubramaniam thiru at keionline.org
Fri Dec 4 04:50:53 PST 2020


WORLD REPORT| VOLUME 396, ISSUE 10265, P1790-1791, DECEMBER 05, 2020

South Africa and India push for COVID-19 patents ban

Ann Danaiya Usher

They want the WTO to temporarily suspend intellectual property rights so
that COVID-19 vaccines and other new technologies are accessible for poor
countries. Ann Danaiya Usher reports.

South Africa and India have called for the World Trade Organization (WTO)
to suspend intellectual property (IP) rights related to COVID-19 to ensure
that not only the wealthiest countries will be able to access and afford
the vaccines, medicines, and other new technologies needed to control the
pandemic. The pharmaceutical industry and many high-income countries (HICs)
staunchly oppose the move, which they say will stifle innovation when it is
needed most.

Without special measures, proponents argue, rich countries will benefit
from new technologies as they come onto the market, while poor nations
continue to be devastated by the pandemic. The proposal states that IP
rights such as patents are obstructing affordable COVID-19 medical
products. A temporary ban would allow multiple actors to start production
sooner, instead of having manufacturing concentrated in the hands of a
small number of patent holders.

“What this waiver proposal does is it opens space for further
collaboration, for the transfer of technology and for more producers to
come in to ensure that we have scalability in a much shorter period of
time”, says Mustaqeem De Gama, counsellor at the South African Permanent
Mission to the WTO, who helped write the proposal.

WTO decisions are normally reached through consensus. Dozens of low-income
and middle-income countries (LMICs) support the proposal. However, HICs
including the UK, the USA, Canada, Norway, and the EU have rejected it
outright, saying that the IP system is required to incentivise new
inventions of vaccines, diagnostics, and treatments, which might dry up in
its absence. They dismiss the claim that IP is a barrier to access, and
argue that equitable access can be achieved through voluntary licensing,
technology transfer arrangements, and the donor-funded COVAX Advance Market
Commitment for vaccines.

An EU spokesperson said: “There is no evidence that IP rights in any way
hamper access to COVID-19-related medicines and technologies.” The UK
Government declared that the world urgently needs access to these new
products to fight the pandemic, “which is why a strong and robust
multilateral IP system that can meet this challenge is vital”. The UK, by
far the largest funder of the COVAX Facility, urges other countries to
contribute more.

The patent waiver proposal was presented to the WTO's Trade-Related Aspects
of Intellectual Property (TRIPS) Council on Oct 16, 2020, and discussed
again at a council meeting on Nov 20. There, the South African Government
responded to objections, pointing to examples of how IP has created
barriers to access. Manufacturers of monoclonal antibody therapeutics that
are under patent protection, such as Regeneron and Eli Lily, have locked up
most of their capacity in bilateral deals. “Disparity in access is certain
unless concrete steps are taken to address intellectual property barriers”,
South Africa's statement reads. For vaccines, South Africa cites the legal
battle in India between Médecins Sans Frontières (MSF) and Pfizer over its
pneumococcal vaccine, where a patent has blocked development of alternative
versions of the vaccine. In South Korea, Pfizer sued SK Bioscience, which
had developed a pneumococcal conjugate vaccine (PCV), forcing the Korean
developer to close production of PCV-13.
South Africa argues that a similar situation will arise with COVID-19
vaccines unless steps are taken to address the IP barriers.

John-Arne Røttingen, who chairs the WHO Solidarity Trial of COVID-19
treatments, agrees that technology transfer is crucial, but says that
voluntary mechanisms are a better way to achieve this. The patent waiver,
he says, is the “wrong approach” to the problem because COVID-19
therapeutics and vaccines are complex biological products in which the main
barriers are production facilities, infrastructure, and know-how. “IP is
the least of the barriers”, he says.

Røttingen, recently appointed as Norway's Global Health Ambassador, says
waiving IP might help in producing small molecular weight substances. “But
if you want to establish a biological production line, you need a lot of
additional information, expertise, processes, and biological samples, cell
lines, or bacteria” to be able to document to regulatory agencies that you
have an identical product. Instead, he says, individual companies should be
pressured to allow non-exclusive licences and technology transfer of their
products, along the lines of the agreements that AstraZeneca and Novavax
have established with the Serum Institute of India for vaccines. This
partnership model would be much faster, he says. “Instead of going for an
unreachable, ‘ideal’ solution that will not fly, they should identify where
the barriers are and work on those.”
MSF has been advocating for a waiver on COVID-19 patents for several
months, arguing that it is justified on emergency health grounds and
necessary for LMICs that cannot afford to pay HIC prices for vaccines and

Yuanqiong Hu, Senior Legal and Policy Adviser at the MSF Access Campaign,
says the India–South Africa proposal would also make it easier for
non-patent holders to produce necessary medical equipment like ventilators,
masks, and protective gear. Regarding the need for technology transfers,
she says, it is not an “either/or” question. Governments need the full
package of toolkits, including technology transfer deals and legal measures
such as the patent ban.

She says voluntary transfer via company-led initiatives has delivered
limited results. AstraZeneca's vaccine manufacturing agreements with Indian
and Brazilian companies lack transparency about costs, and Pfizer and
BioNTech, whose vaccine candidate has shown promising results, have shown
no sign of licensing or technology transfer of their patented products, she
says. Pfizer told The Lancet that it will consider all viable options to
ensure vaccines get to those who need them, but “a one-size-fits-all model
disregards the specific circumstances of each situation, each product and
each country“.

Regeneron, which has received emergency use authorisation for its
monoclonal antibody treatment, is collaborating with Roche to more than
triple the supply of its antibody cocktail. Hu says that if Regeneron
adapted a global non-exclusive strategy of licensing, transferring know-how
and technologies, “many more companies than Roche would be able to start
getting ready to produce and supply”.

A Regeneron spokesperson points out that when both companies are at full
capacity, they expect to produce at least 2 million treatment doses per
year and would look to increase that even further should the need exist.
“Manufacturing antibody medicines is incredibly complex and transferring
the technology takes many months, as well as significant resources and
skill. Unfortunately, it is not as simple as putting a recipe on the
internet and committing to not sue other companies during the pandemic”,
the spokesperson says. Hu says putting the recipe online and committing not
to sue “would be a welcome first step”.

The co-sponsors of the patent waiver proposal say COVAX, funded through
donations from HICs, is insufficient for ensuring timely and equitable
access to COVID-19 products. COVAX aims to procure 2 billion doses of
vaccine and to share them equally between HICs and LMICs. However,
according to data collected by Duke University, the COVAX Facility has
reserved only 700 000 vaccine doses so far. By comparison, HICs have
reserved 6 billion doses for themselves through bilateral deals with
pharmaceutical companies. Low-income countries, meanwhile, with a combined
population of 1·7 billion people, have not yet signed a single bilateral
vaccine deal.

COVAX is part of a larger effort, the Access to COVID-19 Tools Accelerator
(ACT-A), to supply not only vaccines, but also new medicines such as
monoclonal antibodies, diagnostic tests, personal protective equipment, and
oxygen to LMICs. An ambitious collaboration—led by WHO; The Global Fund to
Fight AIDS, Tuberculosis and Malaria; Gavi, The Vaccine Alliance; and the
Bill & Melinda Gates Foundation—ACT-A has set specific, time-bound
procurement targets. For example, of the 2 billion vaccine doses that the
COVAX Facility aims to deliver, fewer than 1 billion would go to LMICs. If
the vaccine requires two doses, as Gavi assumes, this amount will be enough
for fewer than 500 million people. Similarly, ACT-A's diagnostics pillar
aims to procure 500 million tests which, says Peter Sands, executive
director of The Global Fund, is “only a fraction” of what is required.

As such, ACT-A is, even if fully financed, at best a partial solution to
the access problem. Moreover, because of a massive funding gap, even these
targets are far from being reached. To date, donors have provided US$5
billion of ACT-A's $43 billion required budget for LMICs over the next year.

India's statement to the Nov 20 TRIPS Council meeting reads: “On one hand,
these countries are buying up as much of the limited supply as they can,
leaving no vaccines in the pie for developing and least-developed
countries. On the other hand, and very strangely, these are the same
countries who are arguing against the need for the waiver that can help
increase the global manufacturing and supply to achieve not just equitable,
but also timely and affordable access to such vaccines for all countries.”

de Gama says ACT-A fails to address the supply constraints and gives no
guarantee of the universal access that is required. He compares it to a
small plaster on a gaping, bleeding wound. “In a perfect world, we would
only need instruments like [ACT-A]. Unfortunately, it is insufficient to
address the consequences of COVID-19”, he says.

Given the entrenched positions on the proposal, reaching a consensus in the
TRIPS Council is unlikely. Putting the matter to a vote is theoretically
possible, but members have never let it happen in the past, and they are
unlikely to do so now, says Peter Ungphakorn, former senior information
officer at the WTO Secretariat.

“It would be difficult to go in the direction of a vote”, de Gama admits.
“But that is not the only mechanism we have”. South Africa hopes to elevate
the issue to the WTO General Council and to spur a broader debate on public
health issues in general. “We realise this waiver is not a silver bullet.
But COVID has proven that the IP system doesn't work. It is not designed to
deal with pandemics. Hopefully, this puts us on a path to talk about how to
reform the IP system to react to the needs that members have. Because this
is not the only pandemic we will face.”

Article Info

Publication History

Published: 05 December 2020


DOI: https://doi.org/10.1016/S0140-6736(20)32581-2

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

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