[Ip-health] KEI submission to Canada Standing Committee on International Trade and Investment Policy: Concerning COVID-19 | Knowledge Ecology International

James Love james.love at keionline.org
Sat May 1 12:13:41 PDT 2021


https://www.keionline.org/36045
Brief to Standing Committee on International Trade and Investment Policy:
Selected Consideration Concerning COVID-19 Vaccines

Knowledge Ecology International
James Love and Arianna Schouten
30 April 2021

This brief will discuss (1) the scope and purpose of the proposed World
Trade Organization TRIPS waiver (“the waiver”), (2) comment on arguments
put forth by opponents, (3) discuss the government of Canada’s statements
to the WTO TRIPS Council about its Canadian Access to Medicines Regime
(CAMR) as a “system [that] has worked as intended,” despite the government
failing to include COVID-19 vaccines as eligible products, and (4) make
recommendations.

The TRIPS Waiver proposal

In October 2020, South Africa and India proposed a waiver of certain
provisions of the TRIPS Agreement for the prevention, containment and
treatment of COVID-19 (IP/C/W/669). Specifically, they called for a waiver
from the implementation, application and enforcement of Sections 1, 4, 5
and 7 of Part II of the TRIPS Agreement or the provisions in Part III of
the TRIPS which enforce those Sections.

The waiver would not get rid of patents or any other intellectual property
type, and it would not change national laws. The waiver would only suspend
obligations to abide by the WTO TRIPS rules, and even then, be limited to
one virus, COVID-19, limited to a specified number of years, and subject to
annual reviews by WTO Members.

The primary benefits of the waiver would be the suspension of TRIPS Article
31(f) and Article 31bis, both relating to exports under a compulsory
license, and Article 39, on the protection of undisclosed information.
Although, there may also be additional benefits in waiving Articles 30 and
certain copyright and design provisions.

Articles 30 of the TRIPS Agreement places a set of restrictions on the
exceptions to patent rights. The boundaries of Article 30 were explored by
the WTO in WT/DS114/13, regarding Canada’s early working exception for
pharmaceutical drugs. Thereafter, Canada was required to make a regulatory
amendment to make the pre-marketing stockpiling of patented medicines an
infringement.

Article 31 of the TRIPS provides for (other) uses of a patent without the
authorization of the right holder. These other uses are frequently referred
to as compulsory licenses, although the specific terms in national laws
vary.

Within Article 31 is subparagraph f, which limits exports under a
compulsory license to less than 50 percent of would could be produced
nationally. This provision, 31(f), is designed to limit the use of
compulsory licenses by preventing manufacturers from achieving an efficient
scale of production. It has a discriminatory impact against countries with
smaller national markets, is protectionist, inefficient by design, and
massively inappropriate for a pandemic, where exports and expanded scale of
manufacturing are both desperately needed.

Following negotiations conducted in 2003, the WTO adopted an exception to
31(f) for “pharmaceutical products,” which were defined to include active
ingredients and related diagnostic kits (but not items like respirators or
N95 masks). This was later adopted by the WTO as Article 31bis, which
itself has been criticized as protectionist and inefficient.

Article 31bis permits exports under a compulsory license that exceed the 50
percent threshold of national production, but only when several measures
are taken that require considerable foresight, coordination between
governments and manufacturers, and the involvement of the WTO TRIPS
Council; forcing both importing and exporting governments to coordinate
with multiple departments or agencies. The provisions of Article 31bis are
set out in more than 1800 words, compared to the 643 words used for Article
31, or the mere 20 words in Article 31(f), which Article 31bis was intended
to fix. Canada, despite having experienced shortages of some products,
including vaccines today, has elected to be ineligible to import products
under Article 31bis but is eligible to export.

Overall, both Article 31(f) (plainly) and 31bis (practically) are toxic
measures designed to limit exports and would be lifted by a TRIPS waiver.

Article 39 of the TRIPS Agreement deals with undisclosed information
including, for example, secret manufacturing know-how, and information
given to regulators of pharmaceutical products. The TRIPS waiver would
reduce risks to countries that undertake measures to force the sharing of
manufacturing know-how.

The references to copyrights and designs in the waiver were motivated, in
part, by reports of threatened litigation over attempts to use 3D printers
to make emergency ventilators.

Opposition to the waiver

Drug companies (and allies, like the Center for Global Development) have
offered a number of arguments in defense of the WTO TRIPS rules.
Rightsholders have hired more than 100 registered lobbyists to oppose the
waiver in the United States, making contradictory claims that the waiver
would not work, and yet work too well for countries like China or India.

As both a legal and a political measure, the waiver can be seen as a
weakening of intellectual property norms for the pandemic. With massive
government subsidies for R&D, and manufacturing companies unable to meet
demand, the case against the waiver has come down to claims that the waiver
is particularly ineffective for scaling up vaccine manufacturing. This
remains to be seen, of course, and many of the narratives about the
futility of inducing entry into vaccine manufacturing are awkward given the
surprisingly short term entirely new vaccines to have reached the market,
the widespread use of emergency regulatory authorizations, and the roughly
six months it has taken for the steady stream of new outsourcing contracts
to enter into production (See:
https://www.keionline.org/covid-19-vaccine-manufacturing-capacity).

What opponents of the waiver want is for developers to fully privatize
control over publicly subsidized vaccines in the middle of the pandemic,
and restrict the sharing of both intellectual property and know-how to
arrangements that suit commercial objectives. The harm from hoarding
intellectual property and know-how has been considerable, but the full
dimensions of these policy failures will not be known for a while, and
depend upon the duration of the pandemic, the durability of vaccine
immunity, the risks of exposure to new variants, and the promised future
hikes in vaccine prices.

The Canadian Access to Medicines Regime (CAMR)

At the WTO, Canada has asked for examples of where compulsory licensing was
difficult to use, mentioning that Canada is the only country to have
successfully used the special compulsory licensing mechanism. In their 20
December 2020 statement at the WTO TRIPS Council, Canada stated:

-------------
“Canada remains the only Member to have used this special compulsory
licensing system under Article 31bis and can thus observe on the basis of
concrete experience that this system has worked as intended. Article 31bis
only used once does not suggest that the system is inadequate rather Canada
believe that this suggests that the overall TRIPS regime works as part of a
broader international framework that provides Member with sufficient
latitude and flexibility such as there has been limited or no need to
issues compulsory licenses under Article 31bis.”[1]
-------------

The object and purpose of the Canadian Access to Medicines Regime (CAMR) is
to enable generic or biosimilar pharmaceutical manufacturers to obtain a
compulsory license to manufacture a product and export it to a country that
is unable to manufacture on its own.

Since CAMR’s implementation nearly 17 years ago, there have been five
separate attempts to use the special compulsory license regime to export
patented pharmaceutical products to lower-income countries. Only one, by
Apotex, was successful, and the process took nearly four years.[2] To date,
Apotex’s experience with the special compulsory license for export is the
only time that Article 31bis flexibility has been used, not just in the
Canadian context but also globally.

Knowledge Ecology International has examined the five attempts to use the
special compulsory licensing regime in Canada, each of which indicates that
the system is laborious and has fundamental flaws limiting its feasibility
of use and expeditiousness.[3] NGOs, experts and generic manufacturers have
echoed the conclusion that the system, as it stands, is onerous and the
government has discouraged its use.[4] The experiences of those attempting
to use the regime stand in stark contrast to Canada’s 20 December 2020
statement at the WTO that the system in question does work as intended.

Only products listed on Schedule 1 of the Patent Act are eligible for
export pursuant to CAMR. At the moment, no COVID-19 therapeutic or vaccine
is included in Schedule 1. Knowledge Ecology International is working
alongside Biolyse Pharma in their efforts to amend Schedule 1 and can
comment firsthand on the difficulty in pushing forth a simple amendment to
a Schedule, whose purpose is to remain current with public and global
health needs.

Products as Public Goods

It is not enough to lift the WTO TRIPS obligations during a pandemic.
Governments need to collaborate to ensure that COVID-19 pandemic
countermeasures, including but not limited to, therapeutics, vaccines and
diagnostic tests can be developed so that the inventions, data, know-how
and working cell lines are treated as global public goods. The public
cannot rely upon for-profit corporations, who answer to shareholders, to
make critical decisions that determine the speed of manufacturing and the
prices of countermeasures.

Recommendations

1. Add ‘COVID-19 Vaccines’ to Schedule 1 of the Patent Act.

2. Support the WTO TRIPS waiver in its present form or engage in text-based
negotiations to find a feasible version that, at a minimum, will suspend
the toxic effects of Article 31(f) and 31bis and does not block government
measures to expand access to manufacturing know-how.

3. Providing funding to support the WHO proposed technology transfer hub
for vaccine manufacturing, as a global effort.

4. Ask the WHO C-TAP to create contractual agreements that enable vaccine
manufacturers to share rights in regulatory filings.

5. Support proposals to create a WTO agreement for the supply of public
goods.

6. Propose or support provisions in the WHO negotiations on a pandemic
treaty for cross border sharing of rights in inventions and know-how for
publicly funded R&D.

————————
Knowledge Ecology International is a not for profit non-governmental
organization that searches for better outcomes, including new solutions, to
the management of knowledge resources. KEI undertakes and publishes
research, engages in global public interest advocacy and provides technical
advice.
______________

Notes

[1] Intervention by Canada, Item 15 – Waiver from certain provisions of the
TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19,
Government of Canada (10 December 2020).

[2] Review of the Canadian Access to Medicines Regime Submission to the
Government of Canada, Médecins Sans Frontières (24 January 2007).

[3] Schouten, A. Canadian Experience with Compulsory Licensing under the
Canadian Access to Medicines Regime, Knowledge Ecology International (31
March 2021).

[4] Lexchin, J. Canada and access to medicines in developing countries:
intellectual property rights first, Globalization and Health (3 September
2013); Kohler, J. C., Lexchin, J., Kuek, V., & Orbinski, J. Canada’s Access
to Medicines Regime: Promise or Failure of Humanitarian Effort? Healthcare
Policy (February 2010); Elliott, R. & Morrison, C. Making CAMR Work:
Streamlining Canada’s Access to Medicines Regime, HIV/AIDS Legal Network
(21 October 2010); and Goodwin, E., P. Right Idea, Wrong Result – Canada’s
Access to Medicines Regime, American Journal of Law & Medicine (6 January
2021).


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