[Ip-health] TWN Info: COVID-19: South concerned over TRIPS barrier to access affordable vaccines

Thiru Balasubramaniam thiru at keionline.org
Fri Jun 26 00:58:57 PDT 2020


<SNIP>


The developing countries – India, Indonesia, South Africa, and the
coordinator of the ACP (Africa, Caribbean, and Pacific) group among others
– further called for the convening of a regular TRIPS Council meeting to
discuss the IP measures put in place following the Covid-19 pandemic, said
participants after the meeting.

In the face of the proliferating IP-related measures, representatives of
the developing countries said that it is important to convene the regular
TRIPS Council meeting for sharing information on measures adopted by
various countries so as to understand their implications, said a
participant from a developing country, who asked not to be quoted.

The developing countries also called for a standing agenda item on
IPR-related measures for addressing the Covid-19 pandemic, the participant
said.

But the United States, the European Union and Switzerland flatly opposed
the demand for an urgent TRIPS Council meeting, saying that there is no
need for such a meeting until October, the participant added.

<SNIP>

The regular TRIPS Council meeting should have taken place in March but was
cancelled due to complete lockdown of the WTO for the past three months.

The TRIPS Council chair, according to the participants, held consultations
to explore the way forward for convening the regular meeting for sharing
information and for discussing other issues.

But the US, the EU, and Switzerland said there is no need for the regular
TRIPS Council meeting at this juncture, insisting that the next regular
meeting must take place in October.

“The EU supported the resumption of the work of the TRIPS Council, in a
digital format, if required, as planned in October, until the situation
allows all WTO Members to travel safely from capitals to Geneva so as to
allow the TRIPS Council to meet in its usual format,” an EU official told
the SUNS.
“The EU also supported continuing the transparency exercise regarding IP
measures taken in the context of COVID-19,” the EU official said, adding
that “as some delegations proposed earlier resumption of work of the TRIPS
Council, this matter will be subject to further consideration and
consultations.”

Surprisingly, the EU is ready to discuss all the Covid-19 measures without
any delay in other committees, including restarting the fisheries subsidies
negotiations without any delay, said a South American trade official, who
asked not to be quoted.

---
TWN Info Service on Intellectual Property Issues (Jun20/04)
26 June 2020
Third World Network
https://twn.my/title2/intellectual_property/info.service/2020/ip200604.htm

COVID-19: South concerned over TRIPS barrier to access affordable vaccines
Published in SUNS #9145 dated 24 June 2020

Geneva, 23 Jun (D. Ravi Kanth) – Many developing countries have expressed
sharp concerns over the barriers imposed by the WTO’s TRIPS Agreement on
affordable access to vaccines and therapeutics that are being currently
developed for combating the Covid-19 pandemic, as well as the likely
emergence of so-called “vaccine nationalism”.

At an informal virtual meeting of the TRIPS Council on 19 June, the
developing countries also called for “multilateral cooperation” for
ensuring an effective response to the Covid-19 pandemic, cautioning that
the so-called “unilateral” initiatives are inadequate and will not address
the IP (intellectual property) barriers.

The developing countries – India, Indonesia, South Africa, and the
coordinator of the ACP (Africa, Caribbean, and Pacific) group among others
– further called for the convening of a regular TRIPS Council meeting to
discuss the IP measures put in place following the Covid-19 pandemic, said
participants after the meeting.

In the face of the proliferating IP-related measures, representatives of
the developing countries said that it is important to convene the regular
TRIPS Council meeting for sharing information on measures adopted by
various countries so as to understand their implications, said a
participant from a developing country, who asked not to be quoted.

The developing countries also called for a standing agenda item on
IPR-related measures for addressing the Covid-19 pandemic, the participant
said.

But the United States, the European Union and Switzerland flatly opposed
the demand for an urgent TRIPS Council meeting, saying that there is no
need for such a meeting until October, the participant added.

Despite the convening of regular virtual meetings of the Committee on
Agriculture on 18 June and various other WTO committee meetings, the
opposition to a virtual TRIPS Council meeting from the US, the EU and
Switzerland exposed their “double-standards,” the participant said.
Ahead of the informal TRIPS Council meeting on 19 June, the chair-designate
for the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter from South Africa,
circulated on 8 June the agenda on the two items that would be discussed at
the informal virtual meeting.

The two items include exchanging of views on the COVID-19 implications for
the work of the Council, and sharing of information on IP measures adopted
in the context of COVID-19.

Members were also invited to “share information and best practices on IP
measures taken in the context of the COVID-19 pandemic.”
Prior to the meeting on 19 June, the WTO TRIPS Council Division also issued
a detailed chart of “Covid-19 measures regarding TRIPS” that were in place
until 17 June.

According to the chart, Argentina, Australia, Brazil, Canada, Chile, China,
Ecuador, European Union, Germany, Hungary, India, Israel, Italy, Korea, the
Philippines, Saudi Arabia, Singapore, Switzerland, Thailand, United
Kingdom, and the United States had adopted various IP measures over the
past four months.

Germany and Italy among others adopted IP measures that could constitute
compulsory licensing. Other countries also informed about the measures
their respective IP authorities took in the context of the Covid-19.

Germany, according to the WTO chart, announced that “an amendment to the
German Act on the Prevention and Control of Infectious Diseases in Humans
grants the Parliament the competence to determine the existence of an
epidemic situation of competent authority to allow the use of
patent-protected inventions to ensure the supply of various health
technologies, including medicines, diagnostics and personal protection
equipment.”

In a similar vein, the US Patent Office (USPTO), for example, said that it
“considers the effects of coronavirus to be an “extraordinary situation”
within the meaning of 37 CFR 1.183 and 37 CFR 2.146 for affected patent and
trademark applicants, patentees, re-examination parties, and trademark
owners. Therefore, the USPTO is waiving petition fees in certain situations
for customers impacted by the coronavirus.”
The US also announced other measures such as: (1) “the United States Patent
and Trademark Office has extended certain deadlines for patent and
trademark matters”; (2) “the USPTO is waiving the requirement of 37 CFR
1.4(e)(1) and (2) for original handwritten signature for certain
correspondence with the Office of Enrollment and Discipline and certain
payments by credit card”; (3) the USPTO has launched a website called
Patents 4 Partnerships, which lists patents and published applications
relating to COVID-19 that the owners have indicated are available for
licensing, along with contact information; and (4) “the USPTO will accept
plant patent applications and follow-on documents through the USPTO patent
electronic filing systems (EFS-Web or Patent Center).”

According to the WTO Secretariat’s list of measures, “the United States
Patent and Trademark Office launched the COVID-19 Prioritized Patent
Examination Pilot Program under which it will grant requests for
prioritized patent examination for applicants which qualify for small and
micro-entity status with respect to applications that cover a product or
process that is subject to US Food and Drug Administration (FDA) approval
for use in the prevention and/or treatment of COVID-19.”

The European Union, for example, announced that “the European Committee for
Standardization and the European Committee for Electrotechnical
Standardization, in collaboration with their members, agreed to make freely
available certain copyrighted European standards for certain medical
devices and personal protective equipment.”

Against this backdrop, representatives of the developing countries
underscored the need for a virtual regular meeting for sharing information
and the impacts of these measures on the TRIPS Agreement.

The regular TRIPS Council meeting should have taken place in March but was
cancelled due to complete lockdown of the WTO for the past three months.

The TRIPS Council chair, according to the participants, held consultations
to explore the way forward for convening the regular meeting for sharing
information and for discussing other issues.

But the US, the EU, and Switzerland said there is no need for the regular
TRIPS Council meeting at this juncture, insisting that the next regular
meeting must take place in October.

“The EU supported the resumption of the work of the TRIPS Council, in a
digital format, if required, as planned in October, until the situation
allows all WTO Members to travel safely from capitals to Geneva so as to
allow the TRIPS Council to meet in its usual format,” an EU official told
the SUNS.
“The EU also supported continuing the transparency exercise regarding IP
measures taken in the context of COVID-19,” the EU official said, adding
that “as some delegations proposed earlier resumption of work of the TRIPS
Council, this matter will be subject to further consideration and
consultations.”

Surprisingly, the EU is ready to discuss all the Covid-19 measures without
any delay in other committees, including restarting the fisheries subsidies
negotiations without any delay, said a South American trade official, who
asked not to be quoted.

The coordinator for the ACP (Africa, Caribbean and Pacific) group argued
that “the unprecedented global health crisis caused by COVID-19 represents
a challenge to the essential security interests of all countries and the
most vulnerable are those living in developing and least developed
countries, like ours, with less equipped health systems,” said
participants, who asked not to be quoted.

“Access to affordable medicines, vaccines, diagnostics and medical
equipment, as well as access to the technologies to produce them, are
indispensable to the fight against this pandemic,” the ACP emphasized,
suggesting that “such technologies should be broadly available to
manufacture and supply what is needed to address this pandemic.”

“The existence of patents on products or processes generally prevents the
acquisition of pharmaceutical products at low prices or in sufficient
quantities,” the ACP argued.

“The ACP Group wishes to emphasize that the TRIPS Agreement should continue
to be interpreted and implemented in a manner supportive of WTO members’
right to protect public health and, in particular, to promote access to
medicines for all.”

“In respect of the commercial aspects of intellectual property rights, the
WTO has a vital and ethical role to play in striking an acceptable balance
between, on the one hand, preserving the health of our populations and on
the other, saving the lives of our people,” the ACP argued.

“To this end it might prove useful for the Council to give consideration to
facilitating a webinar/seminar on the now very relevant issue of “TRIPS and
Public Health in the context of COVID-19″.”

In its intervention, the South African trade official spoke about the
alarming trends of the spread of Covid-19 across Africa, suggesting that
“South Africa is the most affected, accounting for 25% of the continent’s
total cases.”

“A recent analysis by the Western Cape Department of Health (South Africa)
indicate that health outcomes of 12, 987 people with COVID-19 indicates
that people living with HIV and people with past or current tuberculosis
infections have a two- to three-times greater risk of dying of COVID-19,”
the South African official said.

“These data, the first to come from a country with a high burden of HIV and
tuberculosis” and these co-morbidities “are likely to make the task of
controlling the impact of COVID-19 so much more difficult,” the South
African official told the meeting, according to participants, who asked not
to be quoted.

“Given this present context of global emergency,” the South African
official argued that “it is important for WTO Members to work together to
ensure that intellectual property rights such as patents, industrial
designs, copyright and protection of undisclosed information do not create
barriers to the timely access to affordable medical products including
vaccines and medicines.”

The South African official emphasized that “an effective response to
COVID-19 pandemic requires rapid access to affordable medical products
including diagnostic kits, medical masks, other personal protective
equipment and ventilators, as well as vaccines and medicines for the
prevention and treatment of patients in dire need.”

Further, the Covid-19 outbreak, according to the South African official,
“has led to a swift increase in global demand with many countries facing
acute shortages, constraining the ability to effectively respond to the
outbreak.”

Unsurprisingly, “shortages of these products has put the lives of health
and other essential workers at risk, and is also threatening to spread
COVID-19 further.”

Therefore, “Members should assess to what extent TRIPS flexibilities can be
useful to deal with the pandemic,” the South African official argued.
“The Doha Declaration on the TRIPS Agreement and Public Health (Doha
Declaration) reaffirms the right of WTO Members to protect public health,”
the South African official said.

The Doha declaration clearly states that “the TRIPS Agreement does not and
should not prevent members from taking measures to protect public health.”

While reiterating its commitment to the TRIPS Agreement, South Africa said
that “the Agreement can and should be interpreted and implemented in a
manner supportive of WTO members’ right to protect public health”.

Nonetheless, “many developing country Member States may also face legal,
technical and institutional challenges in using TRIPS flexibilities,” the
South African official cautioned, arguing that “national patent laws may
not even have the necessary provisions to issue compulsory licenses in the
public interest or government use licenses or where such a possibility
exists.”

“Sometimes, provisions on compulsory licensing in national legislation are
subject to specific processes and as such, the issuance of compulsory
license may involve lengthy processes that are time-consuming”, the South
African official argued.

More disturbingly, the “lack of domestic manufacturing capacity to produce
COVID-19 related pharmaceutical products, diagnostics and other PPEs is
lacking in most countries of the world, making them dependent on imports to
meet their medical needs,” the South African official said.
Further, “access to Article 31bis of the TRIPS Agreement many not be
effective in securing access to much needed pharmaceuticals, medical
devices, diagnostics and therapeutic technologies to address the health
impact of COVID-19,” the official added.

It is in this context that “IP rights may constitute a barrier to the
diagnosis, treatment and overall management of COVID-19 and co-morbidities.”
“Multilateral cooperation is going to be critical in ensuring an effective
response to the pandemic and may require drawing from both current and past
experiences in finding an innovative solution to this unprecedented
crisis,” the South African official said, arguing that “in anticipation
that intellectual property may pose a barrier to access, several ad-hoc
unilateral initiatives have emerged.”

“However, these initiatives, while commendable, are simply inadequate to
address the IP barriers,” South Africa argued, adding that “holders of
protected technologies that are crucial in the battle against COVID-19 may
not participate in such initiatives and voluntarily surrender their IP.”
“Licenses granted under such schemes tend to limit the number of countries
that can be supplied by the licensee; upper-middle-income countries are
often excluded,” South Africa argued.

More importantly, “the role of governments acting in the public interest
will be important to address possible obstacles to access to medicines and
medical technology that could be posed by IPRs,” South Africa argued.

During its intervention, India said that “it is important to provide
maximum flexibility to Member countries in the implementation of the TRIPS
Agreement, so as to enable them to face the extraordinary challenge posed
by COVID-19.”

“It is imperative that IPRs do not become a barrier to access to medicines,
vaccines, medical equipments, treatments and technologies, critical for
countries’ response to the ongoing pandemic,” India said.

India also reiterated “the pressing need to remove the procedural
complexities in effective implementation of paragraph 6 system or Article
31bis of the TRIPS Agreement.”

New Delhi urged “Members to constructively engage on this issue to improve
the effectiveness of this provision and to ensure that it could benefit
Members with insufficient or no manufacturing capacities in the
pharmaceutical sector.”

In sharp opposition, Switzerland, the US, and the EU argued that the TRIPS
Agreement does not pose barriers for affordable supplies of vaccines and
therapeutics for fighting Covid-19, according to the participants present
at the meeting.


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


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