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TWN Info Service on Trade, Intellectual Property and Health
26 June 2020
Third World Network

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.

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