Advocates were pleased by Katherine Tai, U.S. Trade Representative’s May announcement that the U.S. will not prevent the waiver of intellectual property rules related to the COVID-19 vaccination.
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In May, the Biden administration was in hot water when U.S. Trade Representative Katherine Tai made headlines announcedThe U.S. supports a temporary waiver of intellectual property laws that prevent generic drugmakers mass-producing COVID-19 treatments and vaccines.

However, soon after, it was clear that the European Union, headed by Germany, could still exist. block a waiver of the World Trade Organization’s agreement on trade-related aspects of intellectual property rights, or TRIPS. The elimination of intellectual property restrictions is an essential condition for the availability of expensive vaccines in the developing world. Global health advocates argue that this will help to reduce costs and make them more affordable.

Because the waiver requires unanimous approval of all the WTO 164 member countries, any objection of one of them would stop it from moving forward.

In advance of the critical WTO negotiations, some EU negotiators are being invited to Brussels by developing nation negotiators. This new EU text reaffirms certain exceptions to TRIPS, but does NOT give up on the EU’s monopoly in determining where and how vaccines are made. The waiver by developing nations and allies is necessary to increase COVID-19 vaccine manufacturing and distribution.

HuffPost is now a copy of the draft text that the EU’s directorate-general for trade has shared with at least one WTO member nation with whom it is negotiating.

The proposal’s core follows a framework outlined by the EUThis June’s WTO procedure was to be reaffirmed. It required companies to license their patents in the event of a public emergency.

“Ensuring that all WTO Members can make effective use of the TRIPS Agreement is crucial and consequently a waiver with respect to certain requirements related to granting compulsory licenses for the production and export of COVID-related pharmaceutical products, allowing for their rapid supplies, could be considered,” the proposal states. “The objective would be to lift or simplify the key requirements related to exporting COVID-related pharmaceutical products under a compulsory license to the Members in need.”

“The EU’s counter-proposal is a delaying tactic that is not designed to solve the problem but to obstruct any workable resolution.”

Graham Dutfield University of Leeds professor

Notably, while the EU text uses the word “waiver,” it explicitly does not waive the TRIPS agreement’s requirements that countries provide extended monopolies for drug firms holding patents, copyrights, trade secrets and other forms of intellectual property.

Instead, this draft text describes the possible procedures used by countries to issue mandatory licenses. These details were clarified in 2001 Doha Declarationon TRIPS and Public Health that could create exceptions from the regular TRIPS rules.

HuffPost was told by two experts in intellectual property who support greater access to affordable medicine. They said that this proposal will not do much to address the lack of COVID-19 vaccination doses in developing countries.

South Africa, India and the United Kingdom initially suggested that WTO intellectual Property Protections be temporarily suspended. The existing WTO rules allow countries to issue mandatory licenses. However, India and South Africa are already allowed to do so. According to Tahir Amin (an intellectual property lawyer who founded the I-MAK affordable medicine group) and Graham Dutfield (a Professor of International Law at the University of Leeds who specializes on intellectual property regimes), Tahir Amin and Graham Dutfield both co-founded I-MAK.

“This clearly shows that either the E.U. does not understand how intellectual property systems work in developing generic/biosimilar drugs and vaccines or they are deliberately being deceptive about their intentions with this proposal and wasting valuable time to block the full intellectual property waiver,” said Amin, who helped India develop its groundbreaking 2005 patent law. “I believe it’s the latter.”

Dutfield made a similar scathing assessment.

“The EU’s counter-proposal is a delaying tactic that is not designed to solve the problem but to obstruct any workable resolution,” he said. “It will protect corporate profits without significantly challenging the artificial scarcities that intellectual property rights are designed to sustain.”

That’s because, as the vaccine’s developers are fond of boasting, the vaccines are complex. These vaccines are the result of many inputs, most of which have been protected by intellectual property that grants the owners of the intellectual property an exclusive right to use them. Those protections include dozens of patents, but also a host of trade secrets ― from technological know-how to lipid recipes, copyrighted manuals and clinical trial data ― needed to actually make use of the patented components of the COVID-19 vaccine.

Getting compulsory licenses on each element would take years and may not cover the thicket of intellectual property rules restricting replication of those nonpatented-but-still-proprietary elements of vaccine production.

South African trade minister Ebrahim Patel met with Ambassador Tai on Tuesday. South Africa and India lead a group of developing nations seeking an IP waiver for the COVID-19 vaccine.
Ebrahim Patel, South Africa’s trade minister met Ambassador Tai Tuesday. India and South Africa lead the group of countries seeking to obtain an IP waiver in respect of COVID-19.
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The EU’s counter-proposal comes to light ahead of important WTO negotiations. Ambassador Tai met with South Africa’s trade minister, Ebrahim PatelTuesday Conducting is her job. unspecified meetings with other WTO counterparts at the WTO’s headquarters in Geneva, Switzerland, on Wednesday. TRIPS supporters hope the WTO members will reach a deal before the year ends.

The disagreements over TRIPS waiver have forced the U.S. to form an unlikely alliance of developing countries with the U.S. This has triggered a discussion among rich nations on the best way to combat the spread COVID-19.

Acknowledging the entire world’s continued vulnerability to the persistence of the COVID-19 pandemic in the developing world, the governments of the US., EU and other developed nations have sought to donate vaccine doses through an international program called Covax.

Covax is unable to meet the demand for COVID-19 vaccinations in developing countries. At the September end, 56 countries with low income had been vaccinated less than 10%According to the World Health Organization, they represent a quarter of all their population.

In order to avoid such an outcome, the WTO was petitioned by a group consisting of India and South Africa. October 2020TRIPS waiver is available for COVID-19 vaccinations and the treatments that are associated with them. The group of countries ― some of which are home to big generic drugmakers ― argues that rapid vaccination of the global population requires a significant increase in vaccine production that only temporarily waiving intellectual property rules can enable.

They argue that even though the waiver is in effect, pharmaceutical giants and their supporters from wealthy nations claim that it would be impossible for the developing world to produce the vaccine on a mass scale.

But developing nations ― and the affordable medicine advocates in their corner ― insist that a TRIPS waiver is a prerequisite for acquisition of that know-how and capacity without fear of devastating legal consequences.

A waiver might also allow brand-name pharmaceutical firms that are reluctant to broker license agreements with generic drugmakers to come to the table. This could increase the likelihood that companies from developing nations will ultimately reverse-engineer the products of their clients without any legal repercussions.

The pharmaceutical companies that make brand names have been happy to restrict their sales to rich countries capable of spending top dollars, while forcing the poorer nations to buy less. “Hunger Games”-style bidding warThe remaining doses can be found here.

If the EU gets its way, however, waiver proponents fear that the WTO will simply buy additional time for brand name pharmaceutical companies to scale up their production capacity so they can sell vaccine doses to developing countries at sky-high prices, on their own prolonged timetable ― without changing the global intellectual property regime that protects pharmaceutical industry profits.

“By kicking the can down the road, the Pfizers and the Modernas can get more efficient and more to scale, and they’ll say, ‘Oh look, the current supply is going to meet demand,’” Amin suggested.


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