By Britain Eakin

Law360 (April 22, 2021, 7:46 PM EDT ) As debate rages about whether the World Trade Organization should waive global intellectual property rules to speed up equitable global distribution of COVID-19 vaccines, the chief patent attorney for Johnson & Johnson said Thursday the bigger problem is infrastructure.

Rather than hindering global COVID-19 efforts, intellectual property rights have enabled the development of safe and effective vaccines at record-breaking speed, Robert DeBerardine of Johnson & Johnson said during a webinar on the importance of intellectual property and health care innovation during COVID-19. The event was hosted by the Center for Strategic and International Studies.

DeBerardine said the company's intellectual property rights allow it to enter into agreements with appropriate partners to make and distribute its vaccine, which has been temporarily paused in the U.S. after the discovery of a small number of cases of severe blood clots in people who received the vaccine. But given that the new vaccines are difficult to produce, store and distribute, he said waiving intellectual property rights — even just for the duration of the pandemic — would raise safety issues.

"What we're able to do, because we have control of the IP, is to pick the best companies to help us supply the world. If you were to give everything to everybody, you may see a flood of vaccines, but you would have no idea if they're safe and effective," said DeBerardine.

Instead of pushing to waive intellectual property rights, he said the focus should be on boosting adequate health care infrastructure, vaccine education and medical personnel, some of the many pieces he said are required to get COVID-19 vaccines equitably and rapidly distributed.

"The issue has been, how do we get these safe and effective medicines that the patent system has generated to people that need them?" DeBerardine added.

The webinar came amid a six-month debate about whether the WTO should approve a proposal from India and South Africa, which has the support of more than 100 other mostly developing countries, that would temporarily suspend the enforcement of global IP rules. That would include patents, copyrights and trade secrets. Those countries argue that doing so would unlock key vaccine formulas, boost global production and improve access.

So far, WTO power players including the U.S., the European Union and the U.K. have blocked the proposal, which would waive provisions of the Trade-Related Aspects of Intellectual Property Rights, a global treaty governing international property rights, until widespread vaccination and immunity are achieved. Those countries have said waiving global IP rules could be counterproductive.

Backers of the proposal, meanwhile, say some requirements of the TRIPS Agreement create an unnecessarily burdensome process for importing and exporting medical products, and the proposal would remove those hurdles.

Last week, U.S. Trade Representative Katherine Tai signaled that the U.S. may be open to certain modifications to the proposal. But during an informal meeting of the TRIPS Council on Thursday, members were again deadlocked, differing over the degree to which intellectual property rights are hindering global vaccine efforts.

During Thursday's webinar, the WTO's former counselor for intellectual property, Jayashree Watal, said she doesn't think that intellectual property is the main barrier for COVID-19 vaccine distribution. Some organizations like Doctors Without Borders have suggested that, as the suspension of patent rights enabled the production of affordable, generic drugs during the HIV and AIDS epidemic, doing so could again meet the current global health challenge.

But Watal said unfortunately the current circumstances are different. The HIV and AIDS drugs could be easily copied, she said, but the COVID-19 vaccines are an entirely different matter.

"These are complex products to make. And so just waiving intellectual property — patents in particular — isn't going to help," she said.

The only immediate solution Watal said she can see is for wealthy countries, especially those that have already vaccinated large chunks of their populations, to donate vaccines or sell them at affordable prices to the global initiative COVAX, which is working to accelerate global COVID-19 vaccine distribution.

Watal said there are roughly 400 million people in low- and middle-income countries in priority groups who have yet to receive a single COVID-19 vaccine dose.

"That, I think, should be unacceptable to global leadership, to the international community," she said. "I do think that adolescents and children in the countries that have the doses already can surely wait a few months longer so that priority groups are vaccinated."

Following the TRIPS Council meeting Thursday, Márcio da Fonseca, the infectious disease adviser for Doctors Without Borders' access campaign, called again for WTO member states to approve the waiver.

"We have learned the hard lessons of the past of having to take a country-by-country and product-by-product approach of removing IP barriers impeding access to life-saving treatments," Fonseca said in a statement. "It is not sufficient and provides no expeditious option for this global pandemic. At a time when more than 3 million lives have already been lost to COVID-19, we urge countries to take all possible measures, including supporting this waiver, to be able to protect everyone, everywhere during this pandemic."

--Additional reporting by Kevin Stawicki, Andrew Karpan and Alex Lawson. Editing by Adam LoBelia.

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