Friday, May 29, 2020

To own the vaccine or not?

The United States and the UK were the only two holdouts in the World Health Assembly from the declaration that vaccines and medicines for COVID-19 should be available as public goods, and not under exclusive patent rights. The United States explicitly disassociated itself from the patent pool call, talking instead of “the critical role that intellectual property plays”—in other words, patents for vaccines and medicines. 

All other countries agreed with the Costa Rican proposal in the World Health Assembly that there should be a patent pool for all COVID-19 vaccines and medicines. All countries supported this proposal, barring the United States and its loyal camp follower, the UK. The United States also entered its disagreement on the final WHA resolution, being the lone objector to patent pooling of COVID-19 medicines and vaccines, noting “the critical role that intellectual property plays in incentivizing the development of new and improved health products.”

China and the EU have already agreed that any vaccine developed by them will be regarded as a public good. Even without that, once a medicine or a vaccine is known to be successful, any country with a reasonable scientific infrastructure can replicate the medicine or the vaccine, and manufacture it locally. India in particular has one of the largest generic drug and vaccine manufacturing capacities in the world. What prevents India, or any country for that matter, from manufacturing COVID-19 vaccines or drugs once they are developed—only the empty threat of a failed hegemon on breaking patents?

Most countries have compulsory licensing provisions that will allow them to break patents in case of epidemics or health emergencies. Even the WTO, after a bitter fight, accepted in its Doha Declaration (2001) that countries, in a health emergency, have the right to allow any company to manufacture a patented drug without the patent holder’s permission, and even import it from other countries. Why is it, then, that countries are unable to break patents, even if there are provisions in their laws and in the TRIPS Agreement? The answer is their fear of U.S. sanctions against them. Every year, the U.S. Office of the United States Trade Representative (USTR) issues a Special 301 Report that it has used to threaten trade sanctions against any country that tries to compulsorily license any patented product. 
 India figures prominently in this report year after year, for daring to issue a compulsory license in 2012 to Natco for nexavar, a cancer drug Bayer was selling for more than $65,000 a year. Marijn Dekkers, the CEO of Bayer, was quoted widely that this was “theft,” and “We did not develop this medicine for Indians… We developed it for Western patients who can afford it.” This leaves unanswered how many people even in the affluent West can afford a $65,000 bill for an illness. But there is no question that a bill of this magnitude is a death sentence for anybody but the super-rich in countries like India. Though a number of other drugs were under also consideration for compulsory licensing at that time, India has not exercised this provision again after receiving U.S. threats.
One issue is now looming large over the COVID-19 pandemic. If we do not address the intellectual property rights issue in this pandemic, we are likely to see a repeat of the AIDS tragedyPeople died for 10 years (1994-2004) as patented AIDS medicine was priced at $10,000 to $15,000 for a year’s supply, far beyond their reach. Finally, patent laws in India allowed people to get AIDS medicine at less than a dollar a day, or $350 for a year’s supply. Today, 80 percent of the world’s AIDS medicine comes from India. For big pharma, profits trumped lives, and they will continue to do so, COVID or no COVID, unless we change the world.

It is unlikely that a vaccine against SARS-CoV-2 will provide a lifetime immunity like the smallpox vaccine. Unlike AIDS, where the patient numbers were smaller and were unfortunately stigmatized in different ways, COVID-19 is a visible threat for everyone. Any attempt to hold people and governments to ransom on COVID-19 vaccines or medicines could see the collapse of the entire patent edifice of TRIPS that big pharma backed by the United States and major EU countries have built. That is why the more clever in the capitalist world have moved toward a voluntary patent pool for potential COVID-19 medicines and vaccines. A voluntary patent pool means that companies or institutions holding patents on medicines—such as remdesivir—or vaccines would voluntarily hand them over to such a pool. The terms and conditions of such a handover, meaning at concessional rates, or for only for certain regions, are still not clear—leading to criticism that a voluntary patent pool is not a substitute for declaring that all such medicines and vaccines should be declared global public goods during the COVID-19 pandemic.

During the anthrax scare in 2001, the U.S. Secretary of Health issued a threat to Bayer under “eminent domain for patents” for licensing the anthrax-treatment drug ciprofloxacin to other manufacturers. Bayer folded, and agreed to supply the quantity at a price that the U.S. government had set. And without a whimper. Yes, this is the same Bayer that considers India as a “thief” for issuing a compulsory license.


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