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India, South Africa call for waiver of IP, patents under certain TRIPS provisions for COVID-19 therapeutics

There are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients, states a joint statement by these countries

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On October 2, 2020, India and South Africa jointly made their submission publicly to the WTO, seeking a time-bound waiver of intellectual property, patent, copyright and protection under the certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19. The next session of the TRIPS Council will take place between October 15-16, 2020.

Expressing the concerns related to COVID- 19 pandemic, both the countries through the submission have highlighted that the COVID-19 pandemic is now widespread, affecting most WTO members. As on October 1, 2020, there were about 333,722,075 confirmed cases globally with 1,009,270 confirmed deaths. To date, there is no vaccine or medicine to effectively prevent or treat COVID-19. All WTO members are struggling to contain the spread of the pandemic and provide healthcare services to those affected. Many developed, developing and least developed countries have declared a national emergency with the aim to curb the growing outbreak, and as advised by the WHO implemented social distancing measures with significant consequences for society and the economy. Notably, developing countries and least developed countries are especially disproportionately impacted.  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.

Therefore, the submission mentioned that given this present context of global emergency, 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 or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.

“The outbreak has led to a swift increase in global demand with many countries facing acute shortages, constraining the ability to effectively respond to the outbreak. Shortages of these products have put the lives of health and other essential workers at risk and led to many avoidable deaths. It is also threatening to prolong the COVID-19 pandemic. The longer the current global crisis persists, the greater the socio-economic fallout, making it imperative and urgent to collaborate internationally to rapidly contain the outbreak. And 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,” according to the joint statement.

According to the joint representation, the waiver should continue until widespread vaccination is in place globally, since the majority of the world’s population has developed immunity, however, the initial duration of years from the date of the adoption of the waiver will be decided, post the consultation meeting with rest of the member countries.

“There are several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients. It is also reported that some WTO Members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses,” the submission added.

Commenting on the development, KM Gopakumar, Legal Advisor, Third World Network (TWN) said, “The TRIPS waiver proposal if agreed by other WTO member countries would help the fight against COVID-19 by promoting local manufacturing of medical products required for the COVID- 19 response. In the absence of IP protection, it can facilitate the technology transfer more easily and facilitate local production. This would in turn bring competition in the market of medical products and bring down the prices. Such a move, in any way, will financially affect the companies because the R&D functioning for COVID-19 is predominantly through public funding.”

Gopakumar added, “Though Article IX of the Agreement Establishing, WTO allows taking decisions on waiver by three fourth of the majority, generally such decisions in the WTO are taken by consensus. Therefore, the consensus of other WTO members are required to give the legal effect to the proposal”.

“In 2001, at the height of the HIV epidemic when nearly 10,000 people a day were dying of AIDS, the Doha Declaration on TRIPS and Public Health affirmed that governments are free to take all necessary measures to address IP barriers to protect public health. Very simply, it puts governments in the driving seat to be able to put life before profit. The India and South Africa proposal to the WTO TRIPS Council does precisely that for COVID-19. This bold proposal, if accepted by WTO membership, will facilitate technology transfer for effective COVID-19-related vaccines, drugs or diagnostic tests as the waiver covers patents, copyright, industrial designs, and undisclosed information including know-how and trade secrets,” commented Leena Menghaney, Head, Médecins Sans Frontières’ (MSF) Access Campaign in India.

“WHO having declared COVID -19 as a pandemic and since all IP covenants such as Paris Convention, TRIPS and others including most National IP laws, include such provisions for overriding patents during pandemics and national emergencies, it is appropriate for the WTO to endorse such a resolution for waiving IP/Patent rights on all forms of medications related to the pandemic. A review may be undertaken in one year from the date of the waiver, informed Dr Gopakumar Nair, Patent Attorney and CEO, Gopakumar Nair Associates.

He said, “In the specific case of Anthrax thread, the US had waived patent rights on relevant antibiotics in 2001. Therefore, considering the present pandemic situation COVID-19, they should be considering it.”

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