Whose intellectual property is Bharat Biotech’s publicly funded Covaxin? India deserves an answer

If it turns out that the ICMR or the government owns the rights, the Indian public has the right to know how these were leveraged during a pandemic.

Source: Scroll

On Saturday, the pharmaceutical company Bharat Biotech officially announced the sale prices for its Covid-19 vaccine, Covaxin. State governments will have to pay Rs 600 per dose while private hospitals will have to pay Rs 1,200 per dose. These prices, fixed far above the corresponding rates announced by the Serum Institute of India for its vaccine, Covishield, has surprised observers for many reasons.

The Serum Institute could cite royalty payments to the Swedish-British firm AstraZeneca from which it has licensed its vaccine as a potential reason for higher prices. But Bharat Biotech does not have to pay any royalty for Covaxin. Covaxin is, in large measure, a product of publicly funded research in India.

It is based on the SARS-CoV-2 strain, which was isolated in the National Institute of Virology in Pune. This institute functions under the Indian Council for Medical Research. The ICMR had transferred this strain to Bharat Biotech for development and manufacture.

statement from the ICMR on May 10, 2020, had explained the collaboration in the following words:

“Work on vaccine development has been initiated between two partners. ICMR-NIV will provide continuous support to BBIL [Bharat Biotech] for vaccine development. ICMR and BBIL will seek fast-track approvals to expedite vaccine development, subsequent animal studies and clinical evaluation of the candidate vaccine, which will be fully indigenous to India.”

An ICMR official told the media, “ICMR and BBIL are jointly working for the pre-clinical as well as clinical development of this vaccine.” The ICMR also announced that it had selected 12 institutes to conduct clinical trials of the vaccine.

These are the only details available in the public domain on the collaboration between the ICMR and Bharati Biotech, but they demonstrated that Covaxin is the product of a close collaboration between the two entities.

However, we do not know anything yet about the extent of public investment in basic research, isolating the SARS-CoV-2 strain and other related interventions. As such, one is unable to gauge the share of public investment in the total amount spent to design, develop and manufacture the vaccine.

But there are a few other indicators that tell us that the ICMR’s involvement and control in developing the vaccine was indeed considerable. First, on July 3, the contents of a letter written by ICMR Director General Balaram Bhargava to the institutions managing the clinical trials, with a copy marked to Bharat Biotech, was reported in the press.

The letter said:

“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL [Bharat Biotech International Limited] is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project.”

The letter warned:

“Kindly note the non-compliance will be viewed very seriously. Therefore, you are advised to treat the project on highest priority and meet the given timelines without any lapse.”

Clearly, the government of India was interested in hastily releasing Covaxin on Independence Day 2020 even before it completed even the basic clinical tests. It was applying pressure on the partner institutions, including Bharat Biotech, to complete their tasks before a fixed date.

Many questions

On what authority did the ICMR director general write such a letter? Surely, the ICMR must have had some control over the processes leading up to the development of the vaccine. What was the exact nature of that control? Unfortunately, we do not know.

Secondly, on April 17 this year, the government of India allowed three new firms to produce Covaxin, including the Haffkine Institute in Mumbai. On what authority did the government of India provide licences to produce Bharat Biotech’s Covaxin to these entities? Was it a simple administrative approval from the government or was it a letter of permission from the owner of the vaccine’s intellectual property rights?

Surely, the government of India had some authority to give such an approval, especially when it had not invoked any provisions of compulsory licensing. What was that authority? Unfortunately, we do not know.

In sum, opacity marks the contracts and agreements surrounding the ICMR’s relationship with Bharat Biotech. There is no information in the public domain on who owns the intellectual property rights for Covaxin. In an important article on the subject, Anupriya Dhonchak and Anik Bhaduri ask this precise question.

They cite the provisions of the Union government’s General Financial Rules, 2017, for funding sponsored projects or schemes. The rules state that on the completion of the projects “…a stipulation should be made in such cases that the ownership in the physical and intellectual assets created or acquired out of such funds shall vest in the sponsor”. What was the stipulation in the contract between the ICMR and Bharat Biotech? Unfortunately, we do not know.

There is an indirect method we can use to judge if public money was involved in the research leading to the development of the vaccine. We could review the declarations of financial support in the research papers published on the vaccine till now. According to Bharat Biotech, there have been six international peer-reviewed journal publications on Covaxin till now. A summary of these six publications and the financial acknowledgements listed are given in the table below.

On reviewing these papers, we find that in four out of the six papers, financial support from either the Ministry of Health and Family Welfare or the National Institute of Virology, Pune, or the ICMR is clearly acknowledged. All the six papers were co-authored by scholars from Bharat Biotech and the ICMR/National Institute of Virology. In five of the six papers, the ICMR Director General Balaram Bhargava was himself a co-author.

These six papers did not provide any information on the amounts involved in the financial supports. However, they do provide unequivocal evidence that public money was indeed spent towards the research that resulted in the successful development of the vaccine.

PublicationJournalAcknowledgement of financial support
Phase 2 Human Clinical Trialhttps://doi.org/10.1016/S1473-3099(20)30942-7The LancetSupported and funded by BB; co-authored by scholars from BB and ICMR
Phase 1 Human Clinical Trialhttps://doi.org/10.1016/S1473-3099(21)00070-0
The LancetSupported and funded by BB; co-authored by scholars from BB and ICMR
Neutralization of UK Variant

Journal of Travel MedicineSupported and funded by Ministry of Health and Family Welfare, New Delhi and ICMR; co-authored by scholars from BB and ICMR
Hamster Efficacy Studyhttps://doi.org/10.1016/j.isci.2021.102054
CelPressSupported and funded by ICMR; co-authored by scholars from BB and ICMR
Non-Human Primate Efficacy Studyhttps://doi.org/10.1038/s41467-021-21639-wNatureSupported by BB and ICMR; co-authored by scholars from BB and ICMR
Preclinical Safety and Immunogenicityhttps://doi.org/10.1016/j.isci.2021.102298CelPressSupported and funded by BB and ICMR; co-authored by scholars from BB and ICMR
Source: https://www.bharatbiotech.com/images/covaxin/covaxin-publications.pdf. Note: All references to support from NIV, Pune, are represented as from ICMR in this table.

Given that taxpayer’s money was involved in the agreement, it is only appropriate that the Union government makes all the related documents public. If indeed the government or the ICMR holds the intellectual property rights for Covaxin, yet another question would arise. Despite the intellectual property rights being in public ownership, why was one company – Bharat Biotech – provided an exclusive licence for manufacture? Why was not non-exclusive licences provided to multiple manufacturers to produce the vaccine?

It is also important to note that Bharat Biotech later signed its own exclusive agreements with firms like Ocugen for the supply of 100 million doses of Covaxin in the United States. Does the ICMR get a share of Bharat Biotech’s profits from such arrangements if it has a stake in the intellectual property rights? Unfortunately, we do not know.

Indeed, the experience with the ICMR and Bharat Biotech reminds one of the ways in which the Oxford-AstraZeneca vaccine went from being a public vaccine to a private vaccine in the United Kingdom. Reports show that 97% of the funding for the Oxford-AstraZeneca vaccine came from public sources, such as the government departments of United Kingdom, scientific institutes in the United Kingdom and United States, the European Commission and various charities. Yet, Oxford University backed out of its pledge to maintain an open licence for the vaccine and signed an exclusive licence agreement with AstraZeneca.

As is well known, AstraZeneca went on to sign another exclusive agreement with the Serum Institute of India for the same vaccine to be distributed in India under the name Covishield. Thus, the Oxford-AstraZeneca vaccine became a tool for private profiteering out of public investments

India should not allow the same fate to befall Covaxin.

The immediate step in India should be a transparent publication of all agreements and intellectual property-related information on Covaxin. The ICMR and the Ministry of Health and Family Welfare should take a lead in this matter. If it turns out that the ICMR or the government of India owns the intellectual property rights over Covaxin, the Indian public has the right to know how these intellectual property rights were leveraged for public welfare amid the pandemic.

R Ramakumar is Professor, Tata Institute of Social Sciences, Mumbai.

Posted in Access to Medecines, COVID-19, IPR, Patents, Vaccines | Tagged , , | Leave a comment

[Economic Times] White House considering supporting India, S Africa move at WTO on COVID vaccines: Report

Originally Published here: https://economictimes.indiatimes.com/news/economy/foreign-trade/white-house-considering-supporting-india-s-africa-move-at-wto-on-covid-vaccines-report/articleshow/81718703.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

The White House is considering supporting a move by India and South Africa before the World Trade Organization on emergency temporary waiver of some Trade-Related Aspects of Intellectual Property Rights

(TRIPS) rules so that greater supplies of COVID-19 vaccines, treatment, and diagnostic tests can be produced globally, a media report has said.

Such a positive consideration by the Joe Biden administration comes after more than 60 lawmakers, mostly progressives, and a large number of rghts and non-profit pharma bodies have approached the White House to support the move of India and South Africa along with hundreds of other nations that have urgently gone to the WTO seeking a time-limited waiver of the TRIPS agreement.

The previous Trump administration had opposed such a move. The Indian Embassy here has also reached out to several lawmakers, including the members of the Indian Caucus, advocacy groups and administration in this regard. The temporary TRIPS waiver would allow countries and manufacturers to directly access and share technologies to produce vaccines and therapeutics without causing trade sanctions or international disputes.

“The White House is weighing whether to suspend intellectual property protections for Covid-19 vaccines and treatments, in response to pressure from developing nations and subsequent support from progressive lawmakers, according to three sources familiar with the matter,” CNBC news said.

According to the news report, the White House convened a meeting of deputy-level policymakers on March 22, but they reached no final decision. “The view is ‘We’re not safe until the world is safe,’ one of the sources said of the support from progressives on Capitol Hill.”

At a news conference early this month, Congressmen Rosa DeLauro, Jan Schakowsky, Earl Blumenauer, Lloyd Doggett, Adriano Espaillat, and Andy Levin urged President Joe Biden to support an emergency temporary waiver at the WTO as requested by countries led by India and South Africa.

The lawmakers said in the coming times more than 60 US representatives would collectively write to Biden to announce support for the TRIPS waiver proposed by India and South Africa at the WTO.

The temporary TRIPS waiver would allow countries and manufacturers to directly access and share technologies to produce vaccines and therapeutics without causing trade sanctions or international disputes, they said.

House Speaker Nancy Pelosi has also written a letter to Biden in this regard supporting the cause of the progressive members of her party, who now enjoy considerable influence in the Democratic Party.

CNBC said the move would allow other countries to replicate existing vaccines. The United States has so far approved three vaccine shots:

one developed by American company Pfizer and German-based BioNTech, another produced by U firm Moderna and the third made by American company Johnson & Johnson, it said.

“As part of rebuilding our alliances, we are exploring every avenue to coordinate with our global partners and are evaluating the efficacy of this specific proposal by its true potential to save lives,” USTR spokesman Adam Hodge told CNBC.

Pharma companies and the US Chambers of Commerce have opposed any move to support India and South Africa at the WTO.

Read more at:

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International Research Organizations Support WTO TRIPS Waiver for COVID-19

Over 250 organizations and prominent researchers and experts, representing millions of researchers, educators, libraries, and support organizations globally, call for reduction of copyright barriers to COVID-19 prevention, containment and treatment

Download the full statement (PDF)

Washington, DC — For the first time today, research and education organizations around the world are joining the call for the World Trade Organization (WTO) to temporarily suspend its rules on intellectual property where needed to support the prevention, containment and treatment of COVID-19. 

Their statement, released today, calls particular attention to the need to include copyright rules within the waiver. 

Supporters of the Statement are holding an online public event and press conference Monday March 22, 9am EDT / 1pm UTC ( Register to join). 

PIJIP is sponsoring this event as part of a program of activities exploring the human right to research and its application in international copyright law and policy, supported by the Arcadia Fund’s Open Access Program . 

Leaders in education, research and copyright 

Over 100 organizations and more than 150 international academics and other experts are releasing the statement, which is being delivered to the World Trade Organization today. The signatories include the largest library and education federations in the world. The sponsors include Education International, representing over 30 million teachers globally; and the International Federation of Library Associations and Institutions (IFLA), which represents over 1,500 library and research institutions in over 150 countries. 

Download the full statement (PDF)

Read a more detailed press release with statements from supporters

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Compulsory License instances and research synthesis

South Centre: Scope of Compulsory License and Government Use of Patented Medicines

South Centre has published a brief on various instances of compulsory licenses and government use licenses issued until March 2, 2021.

To meet public health needs, such as in the current COVID-19 emergency, governments can
use compulsory licenses and government use as a tool for procurement and import of
patented medicines.

These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement,
as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of
WTO members to grant compulsory licenses and their freedom to determine the grounds
upon which such licenses may be granted.

The South Centre Publication can be accessed here: https://www.southcentre.int/wp-content/uploads/2021/03/Compulsory-licenses-table-Covid-19-2-March.pdf

The table below from the above publication gives a list of compulsory licenses issued relating to COVID-19 medical technologies.

Instances of Compulsory License/Government Use License for COVID-19 related drugs

Knowledge Portal on innovation and access to medicines: Compulsory Licensing Research Synthesis

The literature on compulsory licensing in the pharmaceutical sector is rich. Although most of the literature provides information on legal provisions and discusses compulsory licensing from a theoretical perspective, knowledge portal’s research synthesis focuses on empirical studies of implementation of such licenses and their economic and political impacts, as well as on the possibilities associated with issuing compulsory licenses beyond the legal provisions contained in patent laws.

The research synthesis can be accessed here: https://www.knowledgeportalia.org/compulsory-licensing?j=70333283&jb=0&l=7745092_HTML&mid=181941&sfmc_sub=981275428&u=745545698

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[Jacobin] Finland Had a Patent-Free COVID-19 Vaccine Nine Months Ago — But Still Went With Big Pharma

Originally posted here: https://jacobinmag.com/2021/02/finland-vaccine-covid-patent-ip?fbclid=IwAR31pMbXYYeC12xCkGaals2FgzDrwqkm1MgVbqUop_RhHm8JzvPmFCmeHvg

Ilari Kaila and Joona-Hermanni Mäkinen

“We felt it was our duty to start developing this type of alternative,” says professor Kalle Saksela, chair of the Department of Virology at the University of Helsinki. “Back in the spring, I still thought that surely some public entity will get involved and start pushing it forward. Turns out that no situation is urgent enough to compel the state to start actively pursuing something like this.”

Saksela’s team has had a patent-free COVID-19 vaccine ready since May 2020, which they dubbed “the Linux of vaccines” in a nod to the famous open-source operating system that also originated from Finland. The work is based on publicly available research data and predicated on the principle of sharing all new findings in peer-reviewed journals.

The research team includes some of Finland’s scientific heavyweights, such as Academy professor Seppo Ylä-Herttuala of the A. I. Virtanen Institute, a former president of the European Society of Gene and Cell Therapy, and academician Kari Alitalo, a foreign associated member of the National Academy of Sciences in the United States. They believe their nasal spray, built on well-established technology and know-how, is safe and highly effective.

“It’s a finished product, in the sense that the formulation will no longer change in any way with further testing,” Saksela says. “With what we have, we could inoculate the whole population of Finland tomorrow.”

But instead of exploring the potential of intellectual property–free research, Finland, like other Western countries, has continued to follow the default policy of the last several decades: to lean fully on Big Pharma.

In the mainstream narrative, the first-generation COVID-19 vaccines from Pfizer, Moderna, and AstraZeneca are typically presented as an illustration of how markets incentivize and accelerate vital innovation. In reality, the fact that the profit motive is the overriding force shaping medical research has been devastating — particularly in a global pandemic. The Finnish vaccine provides a striking case study of the many ways in which the contemporary patent-based funding model has slowed down vaccine development, and how it currently hampers the possibility of conducting effective mass-inoculation campaigns.

Private Intellectual Property

The need to discover the next breakthrough proprietary product has many corrosive effects on research. It incentivizes companies to conceal their findings from each other and from the wider scientific community, even at the cost of human health. The intellectual property–free “open-source” model aims to reverse this and turn research into a multilateral collaborative effort rather than a race to invent and reinvent the wheel.

When it comes to COVID-19 specifically, the stalling impact of the contemporary funding model is felt most acutely at the final stages: getting the finished product approved and into use. Whatever time was lost during the early days of the pandemic due to lack of collaboration and trade secrets, virologist Saksela points out, is relatively insignificant. In fact, the development of all first-generation COVID-19 shots has been straightforward.

“The background research was finished in an afternoon, which then set the direction for all of them,” Saksela says. “Based on what we already know about SARS-1 and MERS, it was all quite obvious — not some triumph of science.” Instead of introducing an inactivated or weakened germ into the human body, the new coronavirus shots train our immune system to respond to a “spike protein” — in itself, harmless — which forms the characteristic protrusions on the virus’s surface.

The widely shared understanding of this mechanism predates the pharmaceutical companies’ contributions. This raises questions about the impact of patent-driven research on the end product. To what extent is the work guided by medical efficacy, and how much is based on the need to retain proprietary ownership?

“Different biotech firms would slap the spike protein onto some type of delivery mechanism, whether it was RNA technology or something else,” Saksela explains. “And typically, the choice is based on what applications they have a patent on, whether it’s the best option or not.”

The Finnish vaccine uses an adenovirus to carry the genetic instructions for synthesizing the spike protein. One of its practical advantages is that, unlike with RNA technology based on lipid nanoparticles, it can be stored in a regular fridge, potentially even at room temperature. This makes for easier and cheaper delivery logistics with no requirement for ultra-cold storage. Beyond its stability and the convenience of nasal administration, the vaccine may have other superior qualities to many currently on the market, Saksela’s team believes. “In order to fully stop the virus from spreading and to get rid of new mutations, we need to induce sterilizing immunity,” meaning that the virus no longer replicates within the body of an otherwise healthy person. Preliminary animal and patient trials seem to confirm that the nasal spray accomplishes this. “With about half the people who are exposed, even if they’re symptomless, you find that the virus is still present in the upper respiratory system. So even if it’s on the way out, it still gets to run amok through the front door, making your immune system into a training partner of sorts.”

But if the vaccine is as good as advertised, what’s holding it back? Outside of Big Pharma and venture capital, few mechanisms remain to secure funding for the large-scale patient trials necessary to carry a vaccine past the finish line. Patents are state-sanctioned monopolies that hold the promise of potentially massive returns on investment. The contemporary funding model of pharmaceutical research is almost entirely pinned on that expectation, and this is where an intellectual property–free medical product runs into serious roadblocks.

A Phase III clinical trial requires tens of thousands of human subjects and would cost around $50 million. But considering that despite Finland’s relative success in controlling the virus, the country has already had to borrow an additional €18 billion ($21 billion) to get by, the sum starts to look more like a drop in the ocean — adding up to about one quarter of a percent of the pandemic-induced public debt so far. The number becomes absurdly small when contrasted with the loss of life and economic devastation around the globe.

The State Paves the Way for Private Profit

This situation is especially absurd when we consider that so-called private pharmaceutical research is itself majority public funded. Moderna received $2.5 billion in government assistance and still attempted to fleece buyers with exorbitant prices. Pfizer has boasted not having taken any taxpayer money, but the PR campaign has little to do with reality: the vaccine is based on applications of public research developed by the German firm BioNTech, which has been additionally supported by the government to the tune of $450 million.

These numbers are only the tip of the iceberg when we consider the capital that countries pour annually into universities, scientific institutions, education, and basic research. This is how the body of knowledge and know-how that underlies all innovation is built.

“For instance, we have these new types of biological drugs, related to vaccines in a technical-scientific sense, produced with the same kind of DNA technology, where the pricing is comparable to extortion,” Saksela says. “It’s very sad. Whatever is the largest sum you can extort from a person or the state dictates the cost. And of course, they’re ultimately based on publicly financed research, just as is the case with vaccines.”

In other words, we are paying for the same shot twice: first for its development, then for the finished product. But there might be even a third price tag, since governments have agreed to assume responsibility for the potential side effects of coronavirus shots. This is a typical dynamic between large corporations and states: profits are private, risks are socialized.

“And yet, when I’ve tried to advocate for Finland to develop its own vaccine, this is the main argument I’ve kept hearing: that you need to have an entity with broad enough shoulders to take on the risk,” Saksela says. “But that’s all empty talk, turns out, since the companies are demanding, and receiving, freedom from any liability.”

The current patent monopoly–based system is a relatively recent development, not some unavoidable side effect of capitalism. Until as recently as the late 1940s, governments primarily funded medical research, while the role of pharmaceutical companies was confined mostly to manufacturing and selling drugs. Nowadays, governments support companies in the form of various subsidies and monopolistic privileges.

The damage goes well beyond shortages and high prices. For one, stopping a disease in its tracks is bad business. In one famous instance, the biotech company Gilead saw its profits fall in 2015–16 as a result of its new hepatitis C drug — because it ended up fully curing most patients. The same perverse incentive structure has sabotaged efforts to create preemptive vaccines, despite urgent calls from public health experts for the last twenty years.

By investing in predictive research, the outbreak could have been stopped in China. In an interview with the New York Times, professor Vincent Racaniello of Columbia University’s Department of Microbiology and Immunology puts it bluntly: “The only reason we didn’t is because there wasn’t enough financial backing.” Disease ecologist and public health expert Peter Daszak agrees: “The alarm went off with SARS, and we hit the snooze button. And then we hit it again with Ebola, with MERS, with Zika.”

Unfortunately, there aren’t many signs yet of political leaders waking up. There is a desperate shortage of vaccines, while pharmaceutical companies struggle to keep up even with their own production estimates. This is a direct result not only of the sanctity of patents, but of how the game is rigged against solutions created outside the profit-driven system. Because vaccines can only be produced in laboratories owned or authorized by the patent holders, most of the world’s pharmaceutical factories lie idle. An emergency solution proposed by India and South Africa, backed at the World Trade Organization by a majority of the world’s governments, sought to suspend intellectual property rights on COVID-19 shots. Rich countries, led by the United States and the European Union, categorically refused.

Meanwhile, wealthy nations have made the lion’s share of all vaccine preorders. Ethics aside, this is a catastrophic way to combat a pandemic. Inadequate amounts of vaccines are being produced to begin with and distributed based on wealth rather than a sane public health policy. Even the rich countries end up shooting themselves in the foot as the virus is allowed to keep spreading and mutating over most of the globe.

Inadequate amounts of vaccines are being produced to begin with and distributed based on wealth rather than a sane public health policy.

Within this global hierarchy, Finland is among the more privileged countries. But the bottleneck in vaccine production is having an adverse effect on everyone, Finns included. As Professor Saksela emphasizes, it is crucial to start taking preparedness seriously, both on the national and global levels. The world is far from getting the current pandemic under control, and the grim fact is that the next one is only a matter of time.

“That it’s all left up to market forces is a sign of the current times,” Saksela says. “Whether that’s a wholly wise approach should at least be carefully considered.”

Social-Democratic Paradise?

Finland is often portrayed in international media as a Nordic dreamland. During the pandemic, its new left-wing government has further boosted the country’s progressive image. One might expect such a government to be the most obvious advocate of publicly financed and freely shared vaccine technology. But the last few decades — the era of neoliberalism — have cast a long shadow.

Mirroring a general trend among its counterparts, the ruling Social Democratic Party began to remodel itself in the 1990s after Tony Blair’s New Labour and the Clinton Democrats. In 2003, Finland’s national vaccine development program was discontinued, after 100 years in operation, under a Social Democratic minister of health, making way for multinational drug companies.

Though the vaccine has received much attention in Finnish media, with an opposition much more hostile to the public sector than the parties in power, there is little debate about it within the political establishment. And in lieu of direct state funding, Saksela and his partners have received advice from the Ministry of Social Affairs and Health: to establish a startup and begin courting venture capitalists.

Saksela is hopeful they might yet secure the necessary funding. But it has meant embracing, at least in part, the topsy-turvy logic of market-driven medical research: however good or lifesaving your product is, unless you intend to make money, it will be very hard to get off the ground.

“A Phase III trial will still yield intellectual property around our vaccine that we believe to be potentially profitable,” Saksela says, “even if it’s not exploitatively profitable.”

Ilari Kaila is a Finnish-American freelance writer, journalist, and composer who currently teaches at the Hong Kong University of Science and Technology and blogs at Limited Hangout.

Joona-Hermanni Mäkinen is a Helsinki-based educator and writer researching economic democracy and economic history.

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Intellectual Property Rights protection provisions have encouraged the practice of knowledge monopoly which is fully controlled by the pharmaceutical industry in developed countries. This is a form of abuse of IPR protection by corporations applying IPR Law to prevent other people from producing and trading products whose technology is requested protection in an effort to keep profits in the hands of the IPR holder.

On the issue of health and medicine access, patent rights protection will establish uncertainty and increase costs, delay competition and keep prices high for low- and middle income countries, and ultimately block public access to medicines, medical equipment, including vaccines, which is urgently needed by the public especially in the course of a pandemic. Monopoly in patent rights must definitely be challenged by competition, hence production can be conducted on a larger and wider scale in order to produce cheaper and more affordable prices. With a patent right, there will be no other company that can produce generically for sure. Eventually, the IPR monopoly in the health sector will encourage open commercialization of basic needs in the people’s lives.

Access full briefing paper here: https://igj.or.id/wp-content/uploads/2021/02/BP-FEB-2021-ENGV2.pdf

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Vaccine export barriers during a pandemic are wrong. So are intellectual property barriers and vaccine nationalism

Rohit Malpani and Brook Baker

This piece was originally published here: https://romalpani.medium.com/vaccine-export-barriers-during-a-pandemic-are-wrong-fcde78811725

In the last few weeks, a global trade war has erupted over equitable access to COVID-19 vaccines. Yet it is the wrong one. High-income countries are fighting over who gets to be first in line for access to COVID-19 vaccines, even after having hoarded most of the world’s supply. In doing so, they are letting pharmaceutical corporations off the hook, and leaving the poorest countries out in the cold.

The European Union’s decision to pull up the drawbridge and potentially restrict exports of COVID-19 vaccines has been met with equal parts consternation and indignation by other wealthy countries. Protesting countries, such as Canada and Japan, have benefited handsomely from the current ‘free for all’ that is a defining feature of the pandemic — Canada ‘leads the world’ — having secured ten doses for every Canadian, with Japan having ‘only’ secured 4 doses per person. If politics, as they say, stops at the water’s edge, so does concern for a fair and equitable trading system.

In October 2020, faced with a likely reality that their own countries and their neighbours would be left with little to no access to COVID-19 vaccines, the governments of India and South Africa, now supported by nearly all low- and middle-income countries, petitioned the World Trade Organization to temporarily suspend all intellectual property rules for COVID-19 medical technologies for the duration of the pandemic. Their concerns about insufficient supplies have been borne out — only 55 doses of COVID-19 vaccines have been administered in low-income countries out of a total of more than 138 million doses administered worldwide.

This situation is not likely to improve. Rich countries with 14% of the global population had secured 4.2 billion vaccine doses, versus only 2.4 billion by low- and middle-income countries. These countries are also at the front of the line with options for over 4 billion additional doses still being negotiated. The COVAX facility, which is supposed to facilitate equitable vaccine access, has secured 1.1 billion doses with plans for an additional 1.2 billion, but some of those doses are reserved for upper-income countries, and most will arrive later this year, when many rich countries will have already reached herd immunity.

Intellectual property rights undermine supply, affordability, and equitable distribution to new COVID-19 vaccines by leaving total control of the knowledge and technology required for each vaccine in the hands of a small group of drug corporations that exclude other producers. We already know that no one company can supply all the vaccines needed to tackle the coronavirus and emerging variants, and we also know that given the choice, companies with limited supply will always sell to the highest bidder, whether that is wealthy countries, big companies, or individuals who want to cut the queue.

The proposed WTO IP waiver would remove an unnecessary barrier to the sharing of knowledge that is required to scale-up production of vaccines. It would allow any manufacturer willing to invest to make the vaccines for underserved markets. It is not as if intellectual property has played a major role in getting vaccines to market. Prior to the pandemic, coronavirus vaccine research programs were limited to a few academic consortiums, and in the midst of the pandemic, governments have spent over 90 billion Euros to pay for research and development, manufacturing and advanced purchases of new vaccines.

Yet even though intellectual property rights did not contribute to the rapid development of new COVID vaccines, IP rights are critical for those pharmaceutical corporations that now have exclusive rights and want to maximize profits this year and beyond. Pfizer is projecting US$ 15 billion in revenues in 2021, and expects to have a ‘durable’ revenue stream in the long-term due to the need for boosters against variants. In other words, our collective failure to control the pandemic and have enough supply is directly tied to the industry’s intent to retain its crown-jewel monopolies.

The European Union was right to criticize AstraZeneca, which signed an exclusive agreement with Oxford to manufacture a vaccine it had no hand in inventing, for not honoring its commitments. Yet instead of training its power upon rectifying the exclusive control of vaccines with a few multinational companies, they have decided to divide governments against one another, not to mention continuing to ignore the needs of the most vulnerable countries. Even now, the European Union has been antagonistic to India’s and South Africa’s request at the WTO, apparently willing to grant drug companies unfettered power to control these vaccines, if they can obtain enough doses for their own population.

It is not as if other high-income countries are any more virtuous. The same governments that are speaking out against EU export restrictions for depriving them of vaccines for their domestic populations have also been unwilling to support suspending IP rights on COVID-19 medical technologies. Some have been outright antagonistic — such as the case with Japan and the United Kingdom, while others such as Canada have been unable to commit to supporting the waiver. Of course, this stance reeks of a double standard.

Export restrictions had an immediate bite on the supplies provided to rich countries, and so they responded quickly. Yet these countries are happy to run out the clock on addressing intellectual property rights since they may believe their immunization programs can ‘outrun’ variants while avoiding supply disruptions in the future. These countries still have the chance to make the right choice, including at a meeting at the WTO in early March. Allowing the free movement of vaccines may allow the wealthiest countries to temporarily exit the pandemic this year, but only by allowing the free movement of knowledge will these countries rectify the inequity of access for which they are responsible, while also encouraging all countries to work with one another to end this pandemic.

Rohit Malpani is a public health consultant and advocate and represents non-governmental organizations on the Board of Unitaid.

Brook Baker is a professor at Northeastern University School of Law, USA; an honorary research fellow at the University of KwaZulu Natal; and a senior policy analyst with Health GAP (Global Access Project).

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Russia eyes total overhaul of pharma patent regulation

Russia needs a total overhaul of its patent regulation system with regard to pharmaceuticals, with the aim to ensure access for the local population to cheaper drugs, according to recent statements by local pharma analysts and some domestic media, reports The Pharma Letter’s local correspondent. 

As experts of the Russian Union of Industrialists and Entrepreneurs (RUIE) – a public association that unites representatives of Russian business, (including those in the field of pharmaceuticals) – said one of the most important goals that should be solved in the domestic pharmaceutical sector is putting an end to the practice of “evergreen patents” for drugs and their components in the Russian market.

According to Anatoly Semyonov, deputy head of the RUIE’s Committee on Intellectual Property and Creative Industries, the introduction of changes in legislation in this area will allow domestic companies to offer consumers their own, cheaper products compared to foreign analogues. Mr Semenov believes that any delay in conducting such reform may lead to a significant growth of mortality rate from certain serious diseases in Russia. 

According to him, most patents for drugs in the Russian market are currently owned by global drugmakers, most of which are not interested in strengthening of positions of domestic companies. In order to prevent this, foreign producers plan to more actively use the practice of evergreen patents and offer their Russian partners tougher conditions for licensing production of their drugs. 

Ending evergreening will see launch of more generics

According to analysts, the end of the practice of evergreen patents may create conditions for the more active launch of generics in the domestic market and contribute to the reduction of prices for the local range. 

Currently prices for a number of original drugs that are used for the treatment of some serious diseases, such as HIV and hepatitis C, remain very high in Russia, which limits their purchases both on a retail and state levels. That limits access of Russian patients to these drugs. 

For example, the Russian Patent Service (Rospatent) regularly extends the patent for hepatitis C drug sofosbuvir, which is sold under the brand name Sovaldi and produced by US biotech Gilead Sciences (Nasdaq: GILD) and Pharmstandard at the facilities of the Russian company. 

Pharmasyntez unable to gain permission for sofosbuvir generic

In recent years, an interest in the production of a generic version of the drug has been announced by a local drugmaker Pharmasyntez, however, so far, the company has been unable to receive all the needed permissions for the production of its analogue.

According to analysts at the Russian Izvestia business paper, the way Gilead uses in Russia does not work almost anywhere in the world. The point is that by the time the old patent expires for a drug as a mixture of active and auxiliary ingredients, the company applies for a new patent, but this time for a pure ingredient. In fact, the same ingredient is patented twice: the first time in the mixture, the second in pure form. Rospatent, after a series of proceedings in the Intellectual Property Rights Court, finds such an invention protectable, which has been criticized by local drugmakers. 

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Complete failure of the COVID-19 vaccination campaign in Ukraine: how was the country left behind the world in the fight against the pandemic

Head of the advocacy department at the 100 Percent Life Sergey Dmitriev has recently published an article about the problem with vaccination in Ukraine. The original article can be found here: https://life.pravda.com.ua/columns/2021/02/11/243902/

A translated version of the article is as below:

While the vaccination campaign is actively rolling out in the world and about 5 million doses of vaccines against COVID-19 are administered daily, Ukraine is still trying to sign at least some contracts for the supply of vaccines, waiting for the first deliveries from COVAX and enters into negotiations with Governments of foreign countries asking to share their surplus. People are not ready to be vaccinated and do not trust the vaccine purchased by the Ukrainian Government and National Anti-Corruption Bureau of Ukraine is launching an investigation regarding the corruption component in the only vaccine deal Ukraine’s managed to make. The risk groups prioritized by the MOH for receiving the vaccine do not comply with either the WHO recommendations or the national context. The vaccination process is not supported financially. This is the recipe for the complete failure of the campaign to immunize the Ukrainian population against COVID-19, to which Minister of Health Maksym Stepanov “successfully” has led the country.

“Ukraine should be among the first countries to be able to buy the vaccine. We need to think about this now. The whole world is lining up.” This statement of Volodymyr Zelenskyy was published on the President’s official website on July 25, 2020, and it provided optimistic forecasts for the timely immunization of Ukrainians against COVID-19. During the summer and fall, the head of the MOH also assured Ukrainians of active negotiations with international manufacturers, diplomats, etc., declaring Ukraine’s leadership role, timeliness, and effectiveness of state actions aimed at obtaining coronavirus vaccines as soon as the successful results of clinical trials of vaccine candidates were published.

As of February 12, 2021, according to Bloomberg, 159 million doses of the COVID-19 vaccine have been administered worldwide in 76 countries.

Thus, the vaccination campaign has been launched not only in such countries as Israel, the United States, and the United Kingdom but also in less wealthy countries, such as Morocco, Nepal, Egypt, Bangladesh, and others.

What about Ukraine? So far, only one agreement with the Chinese company Sinovac has been signed to supply 1.9 million vaccines to Ukraine. Meanwhile, Government still promises to sign a contract for the supply of AstraZeneca and Novavax vaccines (there are news about arrangements, confirmations of vaccine supply circulating on the internet, but still no official information about a contract singed) and it is still waiting for 3% of free vaccines to be provided to Ukraine from international COVAX initiative and making agreements with the governments of other countries to give their surpluses of vaccines to Ukraine. In parallel with these slow processes, the readiness of Ukrainians for vaccination is rapidly declining: while in November about 55% of the population were ready to be vaccinated under the condition of free immunization, according to the latest sociological research, this figure has dropped to 43%.

It should be noted that such an indicator of the vaccinated population is extremely insufficient to form so-called herd immunity because, according to the WHO, vaccination should cover at least 80% of people to protect the population from the transmission of such infectious diseases.

The question arises: what and when did it go wrong in Ukraine?

Unfortunately, the answer is simple and obvious: unacceptableinactivity and passivity of the Government. While most countries throughout the world have been concluding pre-order agreements for candidate vaccines since the spring and summer of last year (as of December, almost 7 billion doses were totally pre-ordered), Ukraine… has been just declaring its readiness to be among the first. When some countries (India, Bangladesh, and Egypt) prepared manufacturing facilities to produce licensed drugs and vaccines against COVID-19, they boastfully, long and loud talked in Ukraine about the semi-mystical Ukrainian vaccine nobody heard more about.

Thus, according to Bloomberg’s rating of contracts concluded by countries and the percentage of pre-ordered doses of vaccines per capita, Ukraine is at the bottom of the list (as of the end of January 2021 – 176th on the list), along with African and some Latin American countries. And The Economist Intelligence Unit‘s latest forecasts for Ukraine are extremely disappointing: mass access to the vaccine in the country will be possible only from 2023.

Let’s consider the main circumstances and problems Ukrainians face to have an access to immunization against COVID-19.

The issue of barriers to access to vaccination in Ukraine was widely analyzed in a study conducted by experts of 100 Percent Life in cooperation with the Committee of Medical and Pharmaceutical Law and Bioethics of Ukrainian National Bar Association in January this year. Details of the report in Ukrainian can be found here. Let’s focus on the key points.

First, despite all the declarations made by the Ministry and the President, Ukraine did not (and still does not, in part) had a regulatory framework for the procurement, import, and organization of the vaccination process. Secondly, a certain confrontation between the MOH and the State Enterprise “Medical Procurement of Ukraine” (which is the officially established procurement agency in Ukraine) played an important role and set our state back for at least a month in terms of negotiations and the conclusion of agreements with vaccine companies.

Thus, only on December 16 (when the vaccination campaign was already rolled out in the USA, Israel, and Europe), the Cabinet of Ministers finally authorized the SE “Medical Procurement of Ukraine” to carry out the relevant activities (negotiation, the conclusion of agreements to buy vaccines). On December 30, the only vaccine approved by Minister Stepanov with a rather strange justification was the Chinese Sinovac’s vaccine, although the MOH announced active negotiations with other leading development companies in October. In particular, according to an official announcement posted on the MOH website on October 15, the Ministry also held talks with such global companies as Pfizer, Moderna, and AstraZeneca, which, unlike the Chinese manufacturer, completed clinical trials of drugs at the end of December, and the US, UK and EU regulators even approved their vaccines for use.

Instead, the MOH concluded the first contract 1) to buy a not yet fully tested vaccine, 2) using the Ukrainian private company Lekhim as an intermediary  in this process (whose role is still a mystery, as well as the mechanism of introduction in this scheme) 3) considering that a vaccine price is one of the most expensive prices in the world – almost $ 18 per dose. Was it possible to buy a cheaper vaccine for Ukraine? Obviously, yes – because at the end of December 2020, SE “Medical Procurement of Ukraine” was in the final stages of negotiations with other manufacturers that offer more affordable prices, but the Ministry of Health simply did not agree to sign contracts with them. We could assume that the Chinese vaccine could be a good option considering it’s availability in terms of lower demand for it – therefore the Ministry of Health chose the vaccine which can be delivered to Ukraine the soonest. However, this is very much unlikely, since recently Lekhim adressed a request to the procurement agency to postpone the date of the first delivery of the Sinovac vaccine till April. 

Meanwhile, in continuation of the large-scale public response caused by the above-described events, National Anti-Corruption Bureau of Ukraine is opening a proceeding on this procurement. This whole situation clearly looks semi-surreal – because given the level of attention to these processes, their social significance and already existing failure of the Ministry of Health to ensure proper access to vaccines through the timely conclusion of relevant agreements, any abuses, schemes and machinations in these processes seem to have no chance for existence. But the reality remains quite dissappointing. 

Then, only in January, the process of amending the legislation on the registration of medicines, which would allow the import and use of vaccines against COVID-19 in Ukraine, actually began. The Law of Ukraine “On Medicinal Products” was amended in a hurry, without sufficient finalization and discussion with the public – and these amendments were made only on January 29.

For reference: because COVID-19 vaccines are being developed rather rapidly, the manufacturer cannot provide a complete list of clinical trial documents, as it is required by regular drug registration process; therefore, in Europe and other countries, there are the Emergency Use Authorization or Emergency Use Listing procedures for such cases, which simplify the authorization process introducing less requirements to the documents the applicant is obliged to provide as well as some different measures of medicines quality control assurance.

According to the original version of the draft law, the MOH could authorize the use of any vaccine that is at any stage of clinical trials (even initial) and has previous positive results of such trials. However, international experience in using such a procedure limits emergency use only to those drugs that are in the final (third) stage of studies because only these medicines can really demonstrate sufficient efficacy and safety.

Therefore, 100 Percent Life sent comments and recommendations to the relevant Committee on Public Health in Ukrainian Parliament to amend the draft, in particular, to expand the list of requirements for the vaccine or to limit the possibility of granting such use similar to the existing drug file authentication procedure in Ukraine: when such authorization is issued by a country with Stringent Regulatory Authorities (SRA)- the United States, Switzerland, Japan, Australia, Canada or the EU. Namely, if an authorization for use is issued in at least one of these countries, the MOH authorizes this drug for its use in Ukraine under a simplified procedure.

Unfortunately, despite the partial improvement of the proposed norms and the implementation of a similar procedure to recognize the authenticity of another country’s authorisation, the process proposed in the law has a lot of flaws. Despite the need for a rapid response by the state, it is clear that such changes to the legislation should not be made hastily, but considering the capabilities of the national expert institution and the specifics of the situation with vaccines against COVID-19, and there was time to do it smoothly at least since fall when the necessity of such changes was quite obvious.

However, it should be noted that despite the amendments to the law, a number of regulations on the procedure of pharmacovigilance, import control, etc. are still not finalized and may create barriers to vaccination. So the question is: even if the vaccines are physically delivered to Ukraine, will it be possible to start using them, will the batch of vaccines not be “quarantined” at the border, how will the conditions of their transportation and storage be controlled?

Another issue is the implementation of a vaccination program. On December 24, the MOH approved the Roadmap for vaccination from COVID-19 in Ukraine in 2021-2022. The document defines the target indicators of vaccination of Ukrainians during 2021, the main risk groups that have the right to priority vaccination and its stages, as well as the general concept of the immunization campaign against COVID-19. It is worth noting that both the document itself has a number of inconsistencies and a mechanism of its implementation, in our opinion, is virtually absent now.

First, the document sets a target to vaccinate 50% of the population during 2021. At the same time, according to the research cited by the Ministry in developing the Roadmap, at least 70% of the population (29,212,946 people) should be vaccinated to prevent epidemics (we remind that the WHO determined higher rates to form collective immunity). Therefore, the target of 50% for the whole year seems illogical because such coverage will not ensure the development of collective immunity and respectively undermines the effectiveness of vaccination in the country as a whole.

Second, the Roadmap provides official statistics on COVID-19 morbidity and mortality rates in Ukraine for 2020. In particular, the document states that the largest number of deaths from complications caused by COVID-19 was registered among people aged 60-69 (31.1%), in second place – the group aged 70-79 (28, 3%). Besides, 81.6% of people who died from COVID-19 had a history of comorbidities (cardiovascular, diabetes, neoplasms, kidney, liver, lung, and neurological diseases, malignancies, immunodeficiencies, etc.).

According to the latest results of the study of the effectiveness of coronavirus vaccines, their main action is aimed at preventing severe disease and reducing mortality, so it is the most expedient to immunize primarily people aged 60+, as well as people with comorbidities that increase the risk of death (which complies with WHO recommendations). Instead, according to the stages of the vaccination campaign set by the MOH, people aged 60 to 64, as well as people with comorbidities, will be fourth in line and all employees of law enforcement agencies (regardless of their age and health) – this is almost 600,000 people – should be vaccinated within the third stage. At the same time, according to the vaccination schedule approved and published by the Cabinet of Ministers on January 29, state security agencies will be vaccinated even earlier than the 65-69 age groups. Immunization of the highest mortality groups aged 65-69 and 60-64 is scheduled for mid-summer and late fall, respectively. The MOH plans to vaccinate people with comorbidities at the end of the year. It is rather difficult to understand the logic of this approach to prioritizing risk groups for primary vaccination.

After all, even according to the MOH scenario, the campaign to vaccinate the population of Ukraine against COVID-19 looks a bit illusory. As mentioned above, receiving the vaccine is a voluntary decision of every person. Given the fact that we do not have a register of patients and actual assessments of the need for vaccination, and negative attitude of the population majority to vaccination (considering many anti-vaccination ideas, and the delayed information policy of the MOH on this issue), it is unclear how this process will be implemented. If, for example, in the second stage there are people who do not will to be vaccinated, can persons from the third stage category have access to the vaccine, or will these vaccines simply be expired in warehouses? Will people have the right to choose a vaccine that will be provided free of charge? How will re-vaccination be monitored (most vaccines are designed for two doses)? This is quite difficult to understand now. For example, in some regions, doctors now personally call patients to make lists of people who will be vaccinated. But this is definitely not an effective example how to organize such a process.

To facilitate access to vaccination, the Roadmap in each region provides for the establishment of mobile teams which include a doctor, up to two healthcare workers (nurse assistants), and a record keepers to report according to approved forms. According to the MOH, 572 mobile teams (23 per region on average) will be required for vaccination against COVID-19. Some of these teams have already been created. It should be also understood that the work of such teams requires significant funding. However, there is virtually no regulatory framework to ensure their functioning, as well as to provide vaccination services in general.

The state budget of Ukraine currently stipulates an additional separate article “Vaccination of the population against acute respiratory disease COVID-19 caused by the SARS-CoV-2 coronavirus” allocating UAH 2.6 billion above the budget expenditures of the Ministry of Health, but there are not any normative act that provides for details how this item in the budget can be applied. The program of state guarantees for health care in 2020 and the first quarter of 2021 does not provide any additional packages for vaccination of the population against COVID-19. The existing Specification for the provision of medical services, in the area of ​​primary health care, provides for the payment of vaccination services exclusively according to the Schedule of preventive vaccinations and does not provide for the provision of vaccination services from COVID-19. So it is also unclear how the vaccination campaign will be funded and what the allocation of funds will look like.

Meanwhile, Ukraine plans to receive a new loan from the World Bank in the amount of USD 90 million in the framework of the “Emergency Response to COVID-19 and Vaccination in Ukraine” project. At the same time, if the target – 10 million people at risk is vaccinated – is achieved, Ukraine will be able to receive compensation of USD 30 million. Given that it is loan funds, the question arises as to the advisability of obtaining such a loan because when there is no adequate planning and efficient use of national budget funds, how will this loan use be justified and determined?

The choice of the Chinese Sinovac’s vaccine with a price of UAH 504 per dose (USD 17.8) is a clear example of irrational use of budget funds to buy the vaccine against COVID-19. As mentioned earlier, this is one of the most expensive vaccines available today. For comparison, let’s consider the prices of other vaccines for governments, which were previously posted on Twitter by the State Secretary for the Budget and Consumer Protection of Belgium Eva De Bleeker:

As we can see, in case of buying another vaccine, even one of the most advanced – such as BioNTech/Phizer – the purchase of a similar batch (1.9 million doses) of the vaccine could potentially save about 11 million dollars! This is an incredible amount in the Ukrainian healthcare budget.

Given the situation, it appears that attracting additional loan funds from the World Bank will only contribute to the further irrationality of the Ukrainian government’s decisions to respond to the COVID-19 pandemic and instead will only become a significant burden on the national health care system.

In retrospect: while vaccinations are actively carrying out in other countries, in Ukraine there are still more questions than answers. However, in such times as the pandemic, public health becomes a component of national security. And under these conditions, it is extremely important not only the proactivity of the government but also the openness of state bodies. Silencing and ignoring problems, inactivity, and reassuring that the situation is under control, when it is not true, is a road to nowhere. It is very important for the MOH to start a more open policy, ensure effective communication, and openly declare existing problems. This will create an opportunity to attract additional support, the reaction of patient-led organizations, donors, etc. 100 Percent Life has extensive experience in providing access to treatment for people living with HIV; we are adapting this expertise to COVID-19 and ready to support the state in the fight against the pandemic. Unfortunately, today we do not see that the MOH is interested and ready for a normal dialogue – all issues are resolved and all scenarios are written behind closed doors and we only have to respond to its decisions (or lack of them). We would very much welcome the change of the situation and then we can finally consolidate our efforts and effectively coordinate all the necessary actions to bring this pandemic to an end.

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The Delhi Network of Positive People write to 18 Ambassadors calling for supporting the COVID-19 waiver at the WTO

The Delhi Network of Positive People with support from civil society in India has written to 18 Ambassadors of EU and other countries in India for delivering on the pledge of global solidarity.

Countries at the World Trade Organization (WTO) is deliberating an important proposal that seeks a temporary waiver from implementing and enforcing certain intellectual property (IP) provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) for COVID-19 medical products and technologies.

The 18 countries has so far either opposed the waiver proposal at the WTO or have remained silent and not supported. The waiver proposal has been supported by more than 100 countries at the WTO.

The letter urges the Ambassador to call on their governments to express support for this important proposal during the formal and informal negotiations underway this month.

The copy of the letter as submitted to the Ambassadors is given below:

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