Abandoning vaccination alone will not solve India’s vaccine crisis

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India should never have been in this situation. The government is currently engaged in international disputes over waiver of vaccinations and intellectual property rights, while a The appalling and record rise in COVID-19 cases continues to destroy its population. The country’s recent vaccination policy – opening up vaccinations to anyone over the age of 18, while at a severe shortage, allowing the private sector to sell the vaccine at market prices and leaving states to procure the vaccines themselves – has been heavily criticized. public health experts and its the Supreme Court.

It is a strange resistance to one of the world’s largest suppliers of vaccines, a country that was ideally placed to rapidly increase vaccine production. But while some nations invested in the domestic development of vaccines and others received supplies from manufacturers, India showed no initiative increase their vaccine production capacity. Instead, it prematurely declared victory over the virus and roughly underestimated the amount of vaccine it needed.

“We are basically suffering the detrimental consequences of last year’s bad policy actions,” said economist R. Ramakumar, a professor at the Tumba Institute of Social Sciences in Mumbai, who writes about issues related to vaccine availability.

India made a small profit on 5 May when the United States announced its support for the liberalization of intellectual property rights from vaccines and agreed to participate in its negotiations. But while many celebrated the decision, others were cautious.

“I was surprised [at the decision] but then I read a great edition, ”Ramakumar said. He said it in tongue opinion, The United States did not seem in a hurry to give up intellectual property rights, anticipating that negotiations in the World Trade Organization (WTO) will be difficult and lengthy.

This lack of urgency is something that vaccine-hungry countries like India can afford. India plans to vaccinate more than 900 million adults, but has managed to vaccinate fully only 2.8 percent of the population.

Waiving intellectual property rights could provide vaccine manufacturers with the information they need to increase vaccine production so that more people in the world become infected. However, some experts like Ramakumar believe that it will take months for the international community to reach a consensus, and other experts believe that giving up alone will not help – not without adequate infrastructure and support to make vaccines.

India’s proposal to relinquish COVID-19 patents

For months, as COVID-19 cases and deaths rose, the world hoped the introduction of vaccines would end the pandemic. This did not happen. Of the approximately 1 billion COVID-19 vaccines given, only 0.3% meni low-income countries. Many rich western countries, such as the United States, bought enough vaccines to inoculate their populations many times, while countries ChadThere was none in sub-Saharan Africa.

India and South Africa in October 2020 proposed temporary waiver of intellectual property and patent rights for products that could prevent, contain and manage COVID-19. This would ensure that COVID-19 vaccines and medicines could be manufactured in facilities around the world – and not just in a small number of factories with the desired licenses.

First, the WTO should agree to waive intellectual property rights, which are currently protected by trade-related aspects of intellectual property rights (TRIPS). The agreement contains provisions on TRIPS flexibility, which allow countries to waive patent rights to ensure access to essential medicines.

COVID-19 vaccination station

Vaccination site in New Delhi, India.
Image by Raj K Raj / Hindustan Times via Getty Images

The exemption proposed by India and South Africa goes beyond TRIPS flexibility and requires pharmaceutical companies to disclose copyright material, trade secrets and information to regulators. This is because the preparation of vaccines is complex. Without this technical additional information, other manufacturers will not be able to produce vaccines quickly.

The Indian and South African proposal was supported by more than 100 developing countries, but was initially opposed by the US, UK, Canada, the EU and other Western countries, arguing that an intellectual property system is required to encourage new inventions in vaccines, diagnostics and treatment. At one point, billionaire-benefactor Bill Gates, a billionaire-benefactor, claimed the same thing, claiming that intellectual property rights support innovation and that repealing laws does not make vaccines available.

When the United States announced its support for IP exemptions, The Bill and Melinda Gates Foundation altered its position. The US decision also led the EU, France, Ireland and the United Kingdom to agree to participate in the WTO negotiations. However, Germany opposes the idea of ​​abandonment and the WTO is urging all 164 member states to reach a consensus.

“We expect large drug-led countries to use delaying tactics even before negotiations begin,” said Leena Menghaney, South Asia’s admission campaign manager, Doctors Without Borders. He also added that the world needs more than COVID-19 vaccines. It also needs more COVID-19 drugs and treatments, but the United States does not currently support the release of these products.

Given that it took the WTO five years to negotiate the 2001 Doha Declaration – which only clarified the flexibility of TRIPS – the fight for the current abandonment is likely to be fierce and lasting. “If the world does what it did about HIV / AIDS, it will take 20 years for COVID-19 treatment and vaccines to reach those in need,” Menghaney said.

Can India move forward without vaccine exemptions?

India does not own awaits the progress of the WTO agreement. Mandatory licensing allows manufacturers of generic products to produce a patented drug without the consent of the licensee.

“Even without WTO approval, India can grant a compulsory license to Covishield so that other Indian manufacturers can produce it,” Mengahney said.

Covishield is an Oxford / AstraZeneca vaccine known in India. The pharmaceutical company AstraZeneca authorized the Indian Serum Institute (SII) to produce the vaccine. SII is the largest manufacturer of vaccines in the worldand can produce 70 million doses of vaccine per month. But India needs at least 170 million servings a month vaccinate 80% of the country by the end of the year.

India launches world's largest vaccination against COVID-19

The vaccine is owned by the Institute of Indian Serum (SII) COVID-19 vaccine called Covishield.
Photo: Mayank Makhija / NurPhoto via Getty Images

While India may have the opportunity to bypass intellectual property rights, bypassing mainly pharmaceutical companies and licensing other factories to manufacture vaccines, it is unlikely to do so.

Mandatory licensing of vaccines can be cumbersome. The abolition of patents does not give manufacturers everything they need to know to make vaccines. “Technology and know-how need to be transferred along with the removal of patent rights,” Ramakumar said.

In addition to statutory rights, technology transfer is required, where companies help provide technical support to companies that receive technology. Therefore, countries including Vietnam, have encouraged pharmaceutical companies to cooperate and grant more voluntary licenses – such as those already granted by AstraZeneca to SII.

Even if there is support, the production of vaccines will take time. The indigenously produced Covaxin vaccine in India is licensed to three public sector vaccine manufacturers in India, but production has not yet begun and will continue for another 3-6 months.

Some vaccines are also more complex to produce than others. mRNA vaccines, such as those developed by Pfizer and Moderna, are new entrants the world of medicine. There is already a global shortage of raw materials for MRNA vaccines, including everything plastic bags for nanoparticles.

This is because before the pandemic, such vaccines were mostly produced in small batches – enough for academic research, but not for the global vaccination campaign. The new importance of these vaccines also means that there are very few production facilities and expertise needed to safely manufacture these vaccines. Those problems are not ones that giving up alone can solve.

“Deploying vaccine manufacturers with infrastructure, raw materials, skilled labor, and arrangements with vendors to begin manufacturing vaccines will take a considerable amount of time, a couple of months,” said Shivangi Mittal, a senior partner at Koan Advisory Group, a technology policy consulting firm.

This process is slower for other countries or other innovators who do not work closely with manufacturers under current commercial arrangements, Mittal said.

In addition to technical issues, diplomatic consequences alone have diplomatic consequences. Any country that has used compulsory licensing in the past has aroused strong mistrust from regions that are drug centers, such as the European Union, the United States and Japan, which have responded with the threat of sanctions and the removal of trade preferences.

“Even this [overriding of patent rights] is legally possible, it has been used infrequently, even in strong developing countries such as India, Brazil or South Africa, ”says Achal Prabhala, AccessIBSA project coordinator who campaigns for access to medicines in these countries.

Prabhala said smaller developing countries have almost never used these provisions because they are even more vulnerable to diplomatic pressure from economic presses like the US and the EU. Therefore, abandonment is a slower but still diplomatically tasty option in most countries, including India.

Exemptions are the beginning. They could theoretically help increase vaccine supplies, but the Indian government still needs to adopt good practices to facilitate the manufacture and distribution of vaccines to get shots in people’s arms. Globally, it would mean more collaboration and technology transfer from Western doctors to non-Western pharmaceutical companies.

“For India, that would mean declaring vaccines in the public interest, procuring them centrally and delivering them for free,” Ramamarar said.

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