A healthcare organization, not commercial lawyers, “should decide on access to patents” – Eurasia Review

Eight months ago, South Africa and India proposed a trade-related waiver for COVID-19 vaccines, treatments and diagnostics. Calling for a temporary suspension of intellectual property protections on COVID-19 products and technologies, it was a bold move to tackle global inequality of access.

“As new diagnostics, therapies and vaccines for COVID-19 are developed, there are significant concerns [about] how these will be made available quickly, in sufficient quantities and at an affordable price to meet global demand, ”states the proposal, submitted to the World Trade Organization Council for Intellectual Property Rights Aspects Affecting to trade (TRIPS).

Developing countries have been disproportionately affected by the pandemic, and intellectual property rights hamper the provision of affordable medical products to patients, according to the communication.

While the proposal has garnered global support from Nobel Prize winners, international rights organizations and civil society, more than half of all WTO members have yet to show their support. As of May 17, 62 countries have registered as co-sponsors, including the 35 members of the WTO’s Least Developed Countries Group.

This opposition took a significant turn in early May, however, when U.S. Trade Representative Katherine Tai announced her government’s support for lifting intellectual property protections for COVID-19 vaccines.

“The administration strongly believes in intellectual property protections, but in the service of ending this pandemic, supports waiving such protections for COVID-19 vaccines,” Tai said in a statement. “We will actively participate in the textual WTO negotiations necessary to make this happen.”

“Having the United States at the table means that many other countries will take it seriously and join the negotiations,” said Leena Menghaney, global intellectual property advisor for the Doctors Without Borders access campaign.

“But we have to be careful of the American position. Their statement is very narrow, only mentioning vaccines when we also need treatment and diagnosis. “

Even if the waiver were adopted immediately, global production of these much-needed medical supplies would still be a long way off, as developing countries need important and critical infrastructure, capacity and skills.

Unexploited capacity

With only two percent of the 700 million doses worldwide having been sent to African countries and the number of cases increasing in parts of the continent, there is a particular sense of urgency around vaccines.

The proposed India-South Africa waiver would allow technology transfers, knowledge sharing and logistical know-how, and allow African partners to contribute to the global fight against COVID-19.

Africa is teeming with untapped and underutilized capacity, says Fatima Hassan, founder of the South Africa-based Health Justice Initiative.

The African Centers for Disease Control and Prevention has identified six vaccine manufacturing sites on the continent with potential for expansion, including two in Nigeria and South Africa.

“Opponents say that no one in the Global South can make safe and effective vaccines. If there is cooperation and knowledge transfer, it is possible, ”said Hassan.SciDev.Net.

In April, the World Health Organization launched a call for expressions of interest for its mRNA technology hub, which aims to expand production capacity in low- and middle-income countries. WHO says it has received around 50 applications from entities that are either willing to be seen as a center for technology transfer or able to provide knowledge, training and intellectual property rights.

Once knowledge is shared, companies can assess whether they are able to modernize or build facilities capable of manufacturing drugs and vaccines. This scaling up potential encourages government funding and investment.

But some say it wouldn’t have an immediate impact on COVID-19 management strategies.

“We have an infrastructure that would be essential for the manufacture of vaccines, but which would require substantial development for mRNA and live viral vector vaccines, because they are new technologies,” says Salim Abdool Karim, director of the Center for the AIDS Program of Research in South Africa (CAPRISA).

“In South Africa, if we started now, it would take over a year to be able to manufacture vaccines locally. “

More broadly in Africa, there are concerns about the ability to produce quality vaccines, says Kelly Chibale, director of the Drug Discovery and Development Center (H3D) at the University of Cape Town. More specifically, it notes the lack of essential technical skills and technologies, as well as limited local and regional regulatory capacities to ensure quality.

“However, the waiver is a step in the right direction with medium to long term benefits in terms of acquisition and manufacturing development,” said Chibale.

Quality control

The political will needed to increase vaccine production in Africa is intensifying, according to analysis by consulting firm McKinsey, citing the launch this year of the African Continental Free Trade Area (AfCFTA) and the African Agency for nascent medication.

While there are challenges surrounding the regulation of COVID-19 vaccines, Andy Gray, pharmacist and lecturer at the University of KwaZulu-Natal in South Africa, says they are similar to the global pressure to put the products to market quickly.

“It is quite unusual, for example, to see trial phases one, two and three run almost in parallel, with conditional regulation given for vaccines even before the end of phase three,” he said. declaredSciDev.Net. “Regulatory approval in general must be done with incomplete data.”

Arguments about vaccine safety must also be considered in the global context, says Gray, who is also a consultant pharmacist for the WHO Collaborating Center for Drug Policy and Evidence-Based Practice.

Johnson and Johnson, for example, lost 15 million potential doses of the vaccine after an American subcontractor failed to meet quality standards.

In Brazil, authorities have announced they are rejecting the import and use of Russia’s Sputnik V vaccine over concerns over the lack of reliable data and potential health risks. Sputnik V says the move was politically motivated and contradicted an earlier decision by Brazil’s science ministry, which recognized the vaccine as safe.

“Lower quality products that come out of legitimate factories but without quality control are a challenge for any newcomer to the market,” says Gray. “We should avoid calling it an African problem when it can happen in the best of places. “

Extreme urgency

With the world’s fastest growing population and ongoing crises related to HIV, measles and Ebola, Africa’s ability to produce its own vaccines could have vast benefits for public health and the economy. According to McKinsey, the African vaccine market could grow from $ 1.3 billion today to between $ 2.3 billion and $ 5.4 billion by 2030.

While the TRIPS waiver can help kickstart this development, it is not intended to be a panacea for the continent.

“The intention of the waiver is to open access to all COVID-19 related technologies, including vaccines, for the duration of the pandemic,” said Hassan of the Health Justice Initiative. “It’s for a limited period of time and within TRIPS rules.”

According to Hassan, this is not the first time that a waiver has been requested and granted for a specific period. And the Doha Declaration on the TRIPS Agreement and Public Health, adopted by WTO members in 2001, specifically allows flexibility to the TRIPS Agreement in emergencies.

“[P]Public health crises, including those related to HIV / AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency, ”the statement said.

More than 167 million cases of COVID-19 have been confirmed worldwide, including nearly 3.5 million deaths, according to the WHO. If this is not an extreme emergency, some epidemiologists ask, what would?

“We are facing a global public health crisis, and all the reasons why you would be allowed to have a waiver or use the Doha Declaration are there,” Hassan said. “It’s a real moment of crisis, but here we are negotiating with trade delegations, lawyers and diplomats.”

Ultimately, Hassan says, the status quo regarding access to life-saving medicines and vaccines through a commercial body must change. “There is a certain gap which is not sustainable. We need a health organization that makes these decisions.

Focus on the future

The sponsors of the TRIPS waiver are expected to start text-based negotiations with their WTO colleagues in June. Hassan and Menghaney of Doctors Without Borders fear these will be built around a watered-down version of the US-backed proposal.

“Our hope is that India and South Africa will live up to their initial terms. It will be a big turning point, but we expect a setback, ”Menghaney said.

The negotiations risk dragging on and on. As time is running out, some – including the Independent Panel for Pandemic Preparedness and Response, which issued a damning report that said the deadly pandemic could have been avoided – have suggested setting concrete deadlines if the results fail. not materialize.

The panel called on major vaccine-producing and manufacturing countries to meet within three months to immediately relinquish intellectual property rights and agree to voluntary licensing and technology transfer, if they cannot agree to do so voluntarily.

Although there is no legal obligation for this guidance, panel member Precious Matsoso said SciDev.Net: “There is a monumental moral and ethical constraint to save lives not in one or a few countries, but across the world. “

This emergency goes beyond controlling COVID-19, to preparing the world for the next pandemic threat.

“We want to see an evolution towards a model where innovation is an inclusive and truly global model aimed at delivering global public goods,” Matsoso said. “When, not if, the next pandemic arrives, we should be ready, and this global system should be up and running.”

* About the Author: Laura Owings, With a background in science and international media, Laura has been a writer for over 10 years spanning health, science and technology. Having lived in New York, Amsterdam and now Cape Town, her interest is to cover these issues from a local perspective. In addition to writing, Laura also enjoys reading the news, doing yoga and hiking in the beautiful landscapes of South Africa.

Source: This article was published by SciDev.net

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