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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Designing Vaccines for People, Not Profits

Source: ProjectSyndicate

For all the hope spurred by announcements of demonstrated efficacy in multiple COVID-19 vaccine candidates, there is still a long way to go to deliver on the promise of a universal, freely available “people’s vaccine.” As matters stand, national and private interests are trumping the principle of health justice.

LONDON – Recent announcements of demonstrated efficacy in COVID-19 vaccine trials have brought hope that a return to normality is in sight. The preliminary data for Pfizer/BioNTech and Moderna’s novel mRNA vaccines are highly encouraging, suggesting that their approval for emergency use is forthcoming. And more recent news of effectiveness (albeit at a slightly lower rate) in a vaccine from AstraZeneca and the University of Oxford has fueled optimism that even more breakthroughs are on their way.

In theory, the arrival of a safe and effective vaccine would represent the beginning of the end of the COVID-19 pandemic. In reality, we are not even at the end of the beginning of delivering what is needed: a “people’s vaccine” that is equitably distributed and made freely available to all who need it.

To be sure, the work to create vaccines in a matter of months deserves praise. Humanity has made a monumental technological leap forward. But the springboard was decades of massive public investment in research and development.

Most of the leading vaccine candidates prime the immune system’s defenses against the viral “spike protein,” an approach made possible through years of research at the US National Institutes of Health. More immediately, BioNTech has received $445 million from the German government, and Moderna has received $1 million from the Coalition for Epidemic Preparedness Innovations and more than $1 billion from the US Biomedical Advanced Research and Development Authority and the US Defense Advanced Research Projects Agency. The AstraZeneca-Oxford vaccine has received more than £1 billion ($1.3 billion) of public funding.

But for technological advances to translate into Health for All, innovations that are created collectively should be governed in the public interest, not for private profit. This is especially true when it comes to developing, manufacturing, and distributing a vaccine in the context of a pandemic.

No country acting alone can resolve this crisis. That is why we need vaccines that are universally and freely available. And yet, the current innovation system prioritizes the interests of high-income countries over those of everyone else, and profits over public health.

The first step toward a people’s vaccine is to ensure full transparency of the clinical-trial results, which would enable independent and timely assessments of safety and efficacy. The publication of scanty, preliminary data through corporate press releases is meant for financial markets, not the public-health community. This practice sets a bad precedent. While pharmaceutical share prices surge, health professionals and the public are left second-guessing the reported results. As more details about the flaws in clinical trial design and implementation for the AstraZeneca-Oxford vaccine emerge, so do the calls for open science and immediate sharing of protocols and results.

In addition, critical questions about the leading vaccine candidates remain unanswered. Responding to political and economic pressure in high-income countries, pharmaceutical companies are rushing their vaccine candidates across the finish line. Accordingly, they have designed their phase-three clinical trials to deliver the quickest possible positive read-out, rather than addressing more relevant questions such as whether the vaccine prevents infection or just protects against the disease. It also is unclear how long the protection will last; whether a given vaccine works equally well in young and old people, or in people with co-morbidities; and how the top candidates compare to one another (critical for designing effective vaccination strategies).

Moreover, national interests – especially those of developed countries – remain the dominant factor in vaccine rollout. While the international purchase and distribution platform COVAX represents a momentous step forward, its impact is being offset by massive bilateral advance-purchase agreements by rich countries that can afford to bet on multiple vaccines. For example, high-income countries have already bought close to 80% of the Pfizer/BioNTech and Moderna vaccine doses that will be available within the first year.

All told, rich countries have laid claim to 3.8 billion doses from different vaccine makers, compared to 3.2 billion (which includes around 700 million doses for COVAX) for the rest of the world combined. In other words, high-income countries have pre-ordered enough doses to cover their populations several times over, leaving the rest of the world with potentially too few to cover even their most at-risk communities.

At the same time, because the vaccine race is focused primarily on Western markets, some candidates are scarcely viable outside of a developed-country context. The Pfizer/BioNTech vaccine must be kept at -70ºC, which is colder than an Antarctic winter. Distributing this vaccine will create costly and complex logistical challenges, especially for low- and middle-income countries. Although other candidates – such as the AstraZeneca-Oxford vaccine – are stable at higher temperatures, it is notable that such glaring features of market discrimination are built into the first product to reach the approval stage.

Beyond national interest lurks the problem of even narrower private interests, which stem from an over-financialized biopharmaceutical innovation model. The business model for future vaccine development is already being sized up now that the pandemic has revealed the potential windfall for investors. But while they benefit from sky-rocketing stock pricessoaring capital gains, and dumping a company’s shares the same day it announces promising preliminary results in a clinical trial, delivering a people’s vaccine has become an afterthought.

The COVID-19 crisis is a perfect test of whether a more public-health-oriented approach to innovation and production will prevail in the years ahead. While Pfizer is sticking with the model of maximizing shareholder value, AstraZeneca has at least pledged not to profit from its vaccine “during the pandemic.” Yet, despite all the public investment that underwrote these innovations, the process will remain opaque, leaving one to wonder if AstraZeneca is actually ready to prioritize public health over profit and offer its vaccine at cost.

While the recent vaccine news has brought hope, it also has exposed the pharmaceutical industry’s broken business model, casting doubt on the prospects of delivering a people’s vaccine and achieving Health for All. Business as usual may allow us to scrape by in this crisis. But there is a better way to do things. Before the next pandemic arrives, we must recognize vaccines as global health commons, and start to reorient the innovation system toward symbiotic public-private partnerships governed in the public interest. 

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Opinion: WTO should waive TRIPS provisions during COVID-19

Source: Managing IP

The WTO should adopt India and South Africa’s proposal to lift IP restrictions to ensure access to COVID vaccines and therapies

The world received some good news this month. Two novel mRNA vaccines have shown to be over 90% effective against COVID-19, and a third vaccine from AstraZeneca looks like it might be close behind. These vaccines are the result of colossal efforts from the pharmaceutical industry to come together and find a solution to what has been one of the most dire public health crises the world has seen. But while discovering vaccines was a test of science, delivering them equitably is going to be a test of our humanity.

Already, global rights groups such as Human Rights Watch and Amnesty International are sounding the alarm that rich countries are pre-buying the bulk of COVID vaccines. Data from Duke University’s Global Health Innovation Centre shows that a handful of developed countries have already bought over 50% of the pre-pledged doses. A separate Oxfam report said that even if all five leading vaccine candidates in phase three clinical trials are approved, nearly two-thirds of the world’s population will not be vaccinated until 2022. Developing countries cannot wait that long.

In October, India and South Africa asked the World Trade Organization (WTO) to waive certain provisions of the TRIPS Agreement to help prevent, contain and treat COVID-19. The provisions in question are Sections 1, 4, 5, and 7 of Part II of TRIPS, which cover IP rights including designs and patents. This proposal would only cover COVID-19 vaccines and therapies, and would be only for the duration of the pandemic. 

After three hours of deliberation, a group of predominantly wealthy countries, including Canada, the US, EU member nations and the UK, signalled that they were against the proposal to lift IP restrictions, and instead argued that developing countries should take advantage of the so-called ‘TRIPS flexibilities’ that would allow for compulsory licensing. The problem is that right now the developing world does not need flexibility. It needs a giant bulldozer to make sure absolutely nothing will prevent the equitable distribution of vaccines.

The delegate from South Africa argued in October that the “product-by-product” approach of compulsory licensing under the TRIPS flexibilities would be restrictive during a pandemic. Many countries in the developing world would face hurdles in their national laws, and some lack the institutional capacity to implement the TRIPS flexibilities effectively. The representative specifically pointed to Article 31bis, which requires every product that has been issued a compulsory licence to be identified with specific packaging and quantities. This could lead to further delays to access.

History repeating itself?

It should be noted that these countries are not in uncharted territory when it comes to IP rights standing in the way of access to medicine. During the height of the HIV pandemic many developing countries could not afford patented antiviral medications and had to watch as their citizens died from lack of access. The developing world is also no stranger to vaccine hoarding. During the 2009 swine flu pandemic, many rich countries placed large pre-orders on vaccines that resulted in fewer available doses left for poorer countries. It looks like once again history is repeating itself with COVID-19.

Pharma innovators came forth with the argument that waiving IP rights would undermine the IP system, on which it relies to incentivise the important work of researching new medicines. While this is a fair argument in the abstract, the reality is that COVID-19 is not a typical pandemic in the way it has been funded. The public sector has poured huge amounts of resources into researching vaccines and therapies. The EU tracker of pledges counts nearly €16 billion ($19 billion) in government funds, and the US has also contributed billions with Operation Warp Speed. Some vaccine makers have made the decision to waive IP rights; Moderna has said it will not enforce its patents for the duration of the pandemic. This is fantastic especially as the company received nearly $1 billion in US government funding for its vaccine research.

Waiving IP rights alone will not be enough to ramp up manufacturing and ensure global access to vaccines, which are complex treatments to make. This means that even if patent rights are suspended, generic drug manufacturers need the technology and the know-how to produce enough for populations. In June the World Health Organization created the Covid-19 Technology Access Pool (C-TAP), in which pharma companies can voluntarily contribute their IP, trade secrets, and know-how. So far only 40 countries have pledged support of the C-TAP, and none of the pharma companies developing the vaccines have joined. It is not a reasonable position for developed countries and pharma companies to undermine the efforts of voluntary mechanisms with the C-TAP while simultaneously arguing that developing nations should resort to compulsory licensing.

It is important to keep in mind that how governments and the pharma industry choose to respond to this pandemic will be remembered for years to come. So far the world has already seen shortages of COVID therapies and personal protective equipment, as well as accusations of ‘vaccine nationalism’. This need not be the case. When COVID exploded on the global stage there were great cries for a ‘people’s vaccine’ that would be distributed equitably around the world. Science has prevailed to give us the tools to contain and prevent the spread of the virus, and our compassion should make sure those tools are distributed fairly.

As vaccines inch ever closer to market, the WTO should adopt India and South Africa’s proposal to lift IP restrictions during the pandemic.

Posted in Access to Medecines, COVID-19, TRIPS, TRIPS&IP rights | Leave a comment

India’s mRNA-based Covid vaccine won’t need ultra cold conditions for storage — Pune firm

Gennova Biopharmaceuticals CEO Sanjay Singh tells ThePrint their vaccine could be stored at around 2 to 8 degrees Celsius, and the trial is likely to be completed by March.

Source: The Print

13 Nov 2020, New Delhi: Pune-based Gennova Biopharmaceuticals Thursday said India’s very own messenger RNA (mRNA)-based vaccine against Covid-19 could be stored at around 2 to 8 degrees Celsius unlike American pharma giant Pfizer’s much-hyped vaccine candidate, which needs ultra cold storage technology.

Pfizer, along with German biotechnology firm BioNTech SE, had Monday announced that their experimental vaccine — made through the same mRNA technology — has shown more than 90 percent efficacy in stopping SARS-CoV-2 infections. 

Since the announcement, mRNA technology-based vaccines have taken the lead in the race for a Covid vaccine but alongside, it is being labelled as the “most fragile vaccine” as health officials are worried about its distribution process as they need to be stored at minus 75 degrees Celsius (plus-minus 15 degrees). 

But the Indian vaccine maker told ThePrint that while the emerging concerns about storage of mRNA vaccine are “genuine”, it added their technology would not require ultra cold conditions. 

“The concerns for the ultra cold storage of mRNA-based vaccines are genuine,” said Sanjay Singh, CEO, Gennova Biopharmaceuticals, in an exclusive interview to ThePrint. 

“The reason is that the ultra low temperature stabilises the mRNA against degradation. Since Gennova’s Covid-19 vaccine candidate is also an mRNA, it is also subjected to degradation,” he said.

Singh, however, added: “We focused our approach from day one, and scientists at Gennova are developing a novel technology to stabilise the mRNA at 2 to 8 degrees Celsius, which is much more amenable logistically for vaccine deployment.”

“There is no other alternative than to work towards an mRNA vaccine formulation that can be stored and shipped at 2 to 8 degrees Celsius.” 

He also said their preliminary results on the vaccine candidate’s stability at 2 to 8 degrees Celsius are promising. “And trying our best to circumvent this gargantuan logistics challenge through technological excellence,” Singh added.


Trial likely to be completed by March 

The trial for the vaccine, which was funded by the central government’s Department of Biotechnology, is likely to be completed by March. 

“Our vaccine candidate, HGCO19, developed in collaboration with our US partner HDT Bio Inc, is currently being reviewed by the Indian regulatory agency to whom we have asked permission for conducting human clinical trials in India. This will be the first mRNA-based Covid-19 vaccine trial in India. The trial is expected to be completed by March 2021,” Singh said. 

He said the human clinical trial’s consent is expected soon, and “we plan to start the clinical trial before the end of the year”.

Experts have welcomed the company’s efforts as a “positive step”.

“While there has been a lot of interest in the mRNA platform for Covid-19 vaccines, there have been many concerns, especially from a low-and-middle-income-countries’ (LMIC) perspective on the need for ultra cold chain requirements, which would be very difficult logistically to organise, as well as fairly costly,” said Anant Bhan, a researcher in global health, bioethics and health policy.

“In this light, the plans by Gennova to address this issue by working to keep their vaccine candidate stable at 2-8 degrees Celsius would be a positive step as this would make the cold chain maintenance and transport of the vaccine candidate more feasible.”

However, he added, “given this approach is under testing and would be a new innovation, it would need to go through adequate testing and quality checks, including in field conditions to inspire confidence”.

Using ‘self-amplifying’ mRNA giving company an edge

The company claimed it is using a “self-amplifying” mRNA, while others use a “non-amplifying” mRNA-based vaccine candidate against Covid-19. 

“Compared to the ‘non-amplifying’ mRNA, the ‘self-amplifying’ mRNA provides robust and sustained antigen release, thereby requiring a comparatively lower dose. The ‘self-amplifying’ mRNA gives Gennova an advantage both in terms of production and scalability,” Singh said. 

A government press statement issued in July on the Gennova’s vaccine candidate had stated the mRNA vaccine candidate demonstrated “safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models”. 

“The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of Covid-19, above the US-FDA recommended titre of 1:160 for neutralising antibodies,” the statement had added.

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

Third World Network reports on 20th Nov 2020 TRIPS Council discussion on the Waiver Proposal initiated by India and South Africa

24 Nov 2020

Source: TWN

On 20th Nov 2020, TRIPS Council had an informal meeting that was open only to members and Observers in WTO and discussed the Waiver Proposal initiated by India and South Africa. The discussion will continue at its next formal meeting to be held on 10 December. Third World Network (TWN) published the below report that summarises interventions/ responses made by the proponents during the meeting:


Developed countries continue to block TRIPS waiver proposal
(An earlier version was published in SUNS #9239 dated 24 November 2020)

Geneva, 23 Nov (D. Ravi Kanth) — As the global pressure grows by the day for a waiver to suspend various provisions of the WTO’s TRIPS Agreement in combating the COVID-19 pandemic, the United States, the European Union, Japan, and Switzerland among others have apparently adopted “stonewalling” tactics to block progress towards a General Council decision on this issue, negotiators told the SUNS.

Even as there is increasing recognition that there has been little progress in the world’s poorest securing access to COVID-19 vaccines, the US, the EU, Japan,and Switzerland continue to stubbornly oppose the large-scale gains for developing and poorest countries through the waiver, which would result in large-scale manufacture of therapeutics, diagnostic kits and equipment, and vaccines, said a negotiator, who asked not to be quoted.

At a virtual G20 leaders’ meeting on 22 November, German chancellor Angela Merkel warned that “progress was slow”, saying that “she would raise the matter with the global vaccines alliance (GAVI),” according to a BBC report late Sunday.

“We will now speak with GAVI about when these negotiations will begin because I am somewhat worried that nothing has been done on that yet,” the German chancellor said, according to the BBC report.

Speaking at the same G20 leaders’ meeting, the French President Emmanuel Macron urged his G20 counterparts to “go further and faster” in supporting poorer nations by donating doses, forging industrial partnerships and even sharing intellectual property, according to the BBC report.

These statements by the G20 leaders precisely reflect the concerns raised by the proponents of the TRIPS waiver – South Africa, India, Kenya, and Eswatini (formerly Swaziland) – in their interventions at the informal TRIPS Council meeting on 20 November, said a negotiator, who asked not to be quoted.

The problem with the TRIPS Agreement is that it is a double-edged sword, the negotiator said, suggesting that it acts on two fronts.

On the legal front, the TRIPS Agreement is burdened with stringent provisions that would make it almost impossible for any developing country to adequately use the flexibilities, including the compulsory license provision, the negotiator said.

And on the second front, the powerful members such as the US and the EU exert enormous pressure, including “arm-twisting” behind the scenes if any developing country wants to avail of the compulsory licensing and other flexibilities, the negotiator said.

Ironically, Brazil, which has now allied itself with the US against the waiver, was the first country to stand up to the US coercive tactics in 2000, when Brasilia launched a global movement against intellectual property rights (see the WTO US-Brazil IPR dispute no. 199). Brazil had passed an industrial law that established a “local working” requirement for the enjoyment of exclusive patent rights.

In the face of the international civil society movement and other pressure groups, the US quietly climbed down and withdrew its dispute panel request at the WTO, the negotiator said.

It is against this backdrop that the proponents have sought a waiver to suspend several TRIPS obligations as long as the ravaging COVID-19 pandemic lasts and until more than 7 billion of the world’s population are all vaccinated, said another negotiator, who asked not to be quoted.

At the informal TRIPS Council meeting held at the WTO on 20 November, the four proponents rebutted the criticisms levelled against their proposal, particularly against the questions raised by the US, the EU, Japan, Switzerland, and Brazil among others to confound the salient features of the proposal for a waiver, said another negotiator, who asked not to be quoted.

In their joint proposal (by South Africa, India, Kenya, and Eswatini) contained in document IP/C/W/669.Add.3 and now joined by Mozambique and Pakistan, the six proponents called for a General Council decision to suspend the implementation of TRIPS provisions concerning copyrights, industrial designs, patents, and protection of undisclosed information in relation “to prevention, containment or treatment of COVID-19” for a temporary period.

Due to the paucity of time following the sudden convening of the Doha Rules negotiating body meeting on 20 November, the participants at the TRIPS Council meeting could not discuss several issues, the negotiator said.

The chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter from South Africa, informed members that a formal TRIPS Council meeting will be convened on 10 December with the aim of adopting a report on this matter that can be submitted to the next General Council meeting, scheduled for 16-17 December.

The chair said that she will get in touch with delegations bilaterally, with group coordinators, and in small groups in the run-up to the 10 December meeting to get a sense of what the Council can likely agree on, said another participant.

During the meeting, the US, the EU, Japan, Switzerland, Brazil, the United Kingdom, and Canada among others raised many questions in an apparent attempt to divert attention away from the core objectives of the proposal.

QUESTIONS BY OPPONENTS OF TRIPS WAIVER

At the meeting, a US delegate said intellectual property rights (IPRs) encourage innovation and R&D, as well as manufacturing and access to medicines around the world, emphasizing that these core features are necessary for the global community to help and develop new medicines.

The US delegate said that IPRs are not an obstacle for addressing the pandemic and, if anything, they motivated countries to find treatment and medicines. The delegate argued that the joint proposal to waive off provisions on patents, copyrights, industrial designs, and undisclosed trade secrets in relation to the prevention, containment, and treatment of COVID-19, would be broad and be an unprecedented step.

The US described the waiver as a departure from the past WTO agreements, suggesting that the proposal “does not identify any specific measures for which it is requesting, instead, it says the waiver is meant for waiving TRIPS provisions for PCT (prevention, containment and treatment)”.

It argued that the waiver appears to be diametrically opposed to the G20 ministerial statement of 20 March, which states that “we agree that the emergency measures designed to tackle COVID-19 must necessarily be targeted, proportionate, transparent and temporary and that they do not create barriers to trade and disruptions to global value chains.”

Based on the G20 ministerial statement, the US posed several questions such as whether the proponents could explain how the waiver is a proportionate response to COVID-19, and whether the proponents could explain how members determine that their measure is related to prevention, containment and treatment of COVID-19, and so on. The US also sought to know from the proponents whether their measure is targeted against the COVID-19 pandemic during the implementation of the waiver.

The US delegate acknowledged government funding running into tens of billions of dollars for the development of therapeutics and vaccines but suggested that the governments do not manufacture the drugs or vaccines. The US said pharmaceutical companies take enormous risks for developing these medicines, arguing that they need to be supported through strong IPR protection.

According to the US, intellectual property has not been an obstacle in addressing the pandemic but rather has motivated global efforts to find treatments and cures. “Given the need to provide access to the entire global population, limits to manufacturing capacities and supply chain issues are currently the most significant concerns especially for vaccines,” the US said.

Japan argued that if “IP (intellectual property) (is) not properly protected, it will reduce investment in the medical field, especially in the Infectious Disease area.”

“It will also introduce a risk factor for the development of medical technology (which) will be hindered and essential products may not be developed in future crises,” Japan said.

Japan said that the proponents did not explain the basis for their proposal and why the current IP framework is not working, noting that companies and researchers are working to ensure access to effective medical products.

The European Union underscored the need for “a coordinated and multilateral public action to focus resources on the development of safe and effective therapeutics and vaccines to ensure rapid expansion of production of such vaccines and therapeutics as well as to ensure growth and equitable distribution including in low- and middle- income countries, safeguarding access for vulnerable populations across the world.”

Given the success stories of Pfizer and Moderna, which have developed vaccines for the COVID-19, the EU said that “these results show that the intellectual property system as a framework that provides incentives and the foundation for stakeholders to invest and innovate has delivered.”

The EU said that “the proposed waiver would put in question the ongoing investments and efforts undertaken by researchers to develop the vaccine at an unprecedented speed.” The waiver “could also undermine the ongoing public-private collaboration on the equitable access to affordable Covid-19 vaccines around the globe,” the EU said, without providing any concrete evidence.

The EU reluctantly agreed that “even though we do not foresee IP becoming a barrier to treatments or vaccines against Covid-19, we agree that members need to prepare for all eventualities in the times of crisis.”

The EU said that “this is why domestic legal frameworks should properly reflect the flexibility provided by the TRIPS agreement such as the possibility of issuing a compulsory license including for production for export to vulnerable countries that lack production capacity or including fast-track procedures that can be used in health emergencies.”

Brazil, which had fought against IPRs in 2000, has now joined forces with the US and chose to raise questions that are almost similar to the ones raised by the US delegate to stall progress on the waiver, said a negotiator, who preferred not to be quoted.

Brazil sought precise responses to its questions, including on issues such as the rationale for including industrial designs in the proposal.

Brazil, which is the second largest country in terms of the number of COVID-19 deaths, sought to know from the proponents the cases in which a waiver on copyright could be pertinent for preventing, containing or treating Covid-19.

Contrary to its earlier industrial law and positions taken at the WTO against IPRs, Brazil sought to know from the proponents how members are facing legal and institutional difficulties when using flexibilities.

Even before finalizing a decision on the waiver, Brazil sought “to hear from the proponents whether a waiver could reveal instead to be cumbersome and difficult to implement considering that most members would have to submit it to their national parliaments and (for) them to delve into the specific rights in each of the IP domains that would fall into the scope of the measure.”

Switzerland, Canada, Mexico, the UK, and Israel among others strongly supported the TRIPS flexibilities, and suggested that there is no need for a TRIPS waiver at this juncture.

Norway, which had opposed the waiver at the last meeting in October, did not join the opponents this time around, said a participant, who asked not to be quoted.

INTERVENTIONS BY THE PROPONENTS

The proponents offered detailed responses to the various issues raised by the US and other opponents.

Kenya, for example, said that “the narrow emphasis on maintaining intellectual property to increase resources for pharmaceutical companies, disregards the fact that rapid development of COVID-19 diagnostics, therapeutics and vaccines is the sum of public funding and global collaboration.”

According to work done by several think tanks, Kenya said that global committed funding was $9.1 billion for COVID-19, while pharmaceutical companies received both funding commitments for research and development totaling more than $3.9 billion (excluding funds identified as purely for manufacturing).

Kenya noted that the affected countries have shared digital sequence information and relevant public health information to enable researchers to track the evolution of this novel coronavirus and support the R&D (research and development).

“The current monopoly-based model of R&D puts the fruits of a collective effort into a single company, allowing it to dominate the market, dictate supply and charge high prices with governments and taxpayers once again footing the costs of the medical product,” Kenya said. “The co-sponsors,” said Kenya, “do not believe that such an outcome is in the interest of a solidarity-based collaborative approach to address COVID-19.”

Kenya said it is wrong to say that there is no evidence that intellectual property is a barrier to accessing vaccines, treatments or technologies for the COVID-19, suggesting that “cases involving potential intellectual property infringements emerged early on in the pandemic revealing the complex legal implications of producing copies of life-saving medical products or parts thereof as well as impact on access.” Kenya cited the example of the Gilead patent for Remdesivir, saying that Gilead has blocked access to generic alternatives until 2031.

SOUTH AFRICA’S INTERVENTION

Arguing that “ad hoc, non-transparent and unaccountable bilateral deals that artificially limit supply and competition cannot reliably deliver access during a global pandemic,” South Africa said “these bilateral deals do not demonstrate global collaboration but rather reinforce “nationalism”, enlarging chasms of inequality.”

It pointed out that, for vaccines, “bilateral deals are being signed by pharmaceutical companies with specific governments but the details of these deals are mostly unknown.”

While these bilateral agreements “are for manufacturing of limited amounts and solely supplying a country’s territory or a limited subset of countries,” many companies have not signed any agreements to expand manufacturing and supply, meaning that during the time of vaccine development when such supply bottlenecks could have been addressed, companies are refusing to share intellectual property in a responsible fashion, South Africa said.

“This (attitude of the pharmaceutical companies) turns countries against each other to compete for supply in lieu of working together to defeat the pandemic,” said South Africa, citing the example of the Pfizer/BioNTech vaccine, which has been “pre-booked by developed countries representing 14% of the global population, and no public commitment has been made in support of sharing its COVID-19 vaccine knowledge, technology and related intellectual property to boost supply, reduce price and enhance equity.”

Citing the pronouncements made by Moderna, which has developed the m-RNA vaccine for tackling the COVID-19, on the premise that it will not enforce its “COVID-19 related patents against those making vaccines intended to combat the pandemic,” South Africa said “the global pandemic response cannot be dependent on the possibility of such ineffectual, ad hoc announcements.”

South Africa said “voluntary licenses offered by patent-holding pharmaceutical corporations also tend to exclude millions of people from access to more affordable treatments.” It cited the example of Medicines Patent Pool licenses that normally exclude many developing countries and high-income countries from being supplied under the licenses.

The South African delegate offered concrete evidence to demonstrate that intellectual property is a barrier to access vaccines, treatments, or technologies in the global response to COVID-19.

South Africa said many of the monoclonal antibody candidate therapeutics such as tocilizumab, bevacizumab, and even the Regeneron’s monoclonal antibody treatment, which has just been granted license for emergency use authorization, pose huge problems due to the disparity in access unless concrete steps are taken to address intellectual property barriers.

With regard to diagnostics for the COVID-19, said South Africa, mass testing for the COVID-19 in Netherlands could not be done because of heavy dependence on Roche equipment and supplies of the liquid buffer to run the tests.

South Africa argued that “emerging intellectual property disputes already threaten the development and supply of COVID-19 medical products.” In one dispute, Regeneron and vaccine developers Pfizer and BioNTech are facing a lawsuit from Allele Biotechnology and Pharmaceuticals alleging that their coronavirus products were developed using Allele’s mNeonGreen fluorescent protein without the company’s permission, South Africa pointed out.

INDIA’S INTERVENTION

India suggested that while TRIPS flexibilities, including those confirmed in the Doha Declaration on TRIPS and Public Health, played a crucial role in promoting access to medicines, the present COVID-19 global pandemic presents exceptional circumstances.

India said that while “the TRIPS flexibilities do allow limited policy space for public health, they were never designed to address a health crisis of this magnitude (such as the COVID-19 pandemic).”

India explained some of the challenges in using TRIPS flexibilities in this current global crisis:

1. Understanding of TRIPS flexibilities is usually in the context of patents. However, as explained before, various types of intellectual property rights i.e. patents, copyrights, industrial designs and trade secrets pose a barrier towards an effective response to the COVID-19 as the pandemic requires access to various commodities, involving multiple IP rights. Flexibilities in other categories of IPRs than patents, are less understood and implemented before. Therefore, options available to Members through existing TRIPS flexibilities are limited.

2. Many countries lack the institutional capacities to utilize such flexibilities.

3. Moreover, compulsory licenses are issued on a country by country, case by case and product by product basis, where every jurisdiction with IP would have to issue compulsory license, practically making collaboration among countries for the development and manufacturing of medical products (where different components are sourced from different countries) extremely onerous.

4. Further, Article 31bis mechanism established to support countries with insufficient or no pharmaceutical manufacturing capacity has even in normal times been widely criticized for its cumbersome procedures. The mechanism includes procedures such as specific labelling or marking of products; special packaging and/or special colouring/shaping of products, making it practically meaningless. The procedure being used only once, since its inception in 2006, itself testifies to the difficulties associated with its use.

5. Finally, very often the implementation and use of flexibilities is accompanied by pressures from trading partners as well as other stakeholders.

India said countries such as the US, the EU, Japan, Canada, and Brazil – “who think that TRIPS flexibilities are enough for Covid-19 response and they do not need the waiver,” – “can choose to not implement the waiver in their domestic legislation, but they should not come in the way of international collaboration with respect to development, production and supply of needed healthcare products for Covid-19 that we seek to achieve through the TRIPS Waiver.”

“The waiver is more than just a legal mechanism, it is a statement of intent by all countries that they accord highest value to protecting human lives rather than protecting private profits,” India said.

As regards the use of initiatives such as ACT-Accelerator (ACT-A) and Covax Advance Market Commitment (AMC) including donations to these initiatives are sufficient to address the global need for vaccines and therapeutics, India said these initiatives would not be sufficient to ensure timely and equitable access to Covid-19 products and technologies.

The aim of ACT-A including the Covax AMC is to provide 2 billion vaccine doses (for 1 billion people if we consider a two-dose vaccine regimen) to the world by the end of 2021, India said, suggesting that “these initiatives are obviously inadequate to meet the medium- and long-term needs of the 7.8 billion people of this world.”

Given the disparity in access between the developed countries and the rest of the world, India said “developed countries have been able to leverage their financial position” to enter into bilateral deals.

“The global needs are massive and can only be addressed with global sharing of technology, knowledge and related IP, which is what our waiver proposal seeks to achieve,” India argued, pointing out that “it would be naive for any country to think that it can win over a virus, which knows no boundaries, by simply vaccinating their own population.”

Members “need to rise up to the demands of this crisis and show to the world that WTO is still relevant and very much capable of responding to the global need of saving lives and livelihoods, at least during a health crisis like COVID,” India said.

Pakistan, said “as custodians of the world trading order, I believe no one would like to be known for saving fish, but not human lives.”

On behalf of the ACP (Africa, Caribbean, and Pacific) group, Jamaica said there is agreement that “Covid-19 presents severe challenges to our health systems, our development, our individual lives and to global quick response in that regard.”

Jamaica said members “need equitable access to safe and effective vaccines” urgently, suggesting that “is why I can make or remain sympathetic with the proposal as it is seeking to respond to a pressing urgent international problem that confronts us all.”

Jamaica said “we believe the impact of the Covid-19 pandemic is unprecedented and requires extraordinary efforts.”

Moreover, the “WTO has a critical role to play in this process [and] saving human lives should always be our priority,” Jamaica said, suggesting that “the general objective of the proposal is in line with the urgency adopted by all our governments bilaterally and in other international fora including in the WHO and in New York.”

Therefore, said Jamaica, “we (the ACP group members) believe that there’s hope for WTO members to engage constructively on this initiative including suggesting any necessary amendments to the proposal to bring its provisions in line with what is mutually acceptable to the WTO membership.”

Nigeria said “the current TRIPS flexibilities, including compulsory licenses while they are good reference point, they are at most times difficult to implement especially in this emergency situation caused by the pandemic.”

Nigeria said the proponents for the waiver made it clear that the intention is for the waiver to apply temporarily and in relation to COVID-19 related materials and also based on the unique needs of different countries.

Tunisia urged members to “focus on the solidarity required to address this exceptional situation, and supports any initiative that can provide a rapid and effective and equitable response in order to contain this pandemic.”

Cuba, supporting the proposal, urged WTO members “to work together and to guarantee that intellectual property rights and patents, industrial designs, copyrights, and protection of undisclosed information do not create obstacles to access to affordable medical products, including vaccines and medicines to treat COVID-19.”

Ecuador adopted a somewhat ambiguous position by supporting the TRIPS flexibilities and the initiative taken by the six countries (South Africa, India, Kenya, Eswatini, Mozambique, and Pakistan) in addressing the COVID-19 pandemic.

Chile said it is important that the proponents clarify not just the technical aspects of their proposal but also “if it is the most adequate and relevant to address the concerns of the proponents given the comments that we have heard today.”

Singapore favoured the voluntary public-private partnerships and collaborations such as the COVAX facility to promote access to the diagnostics, vaccines, and therapeutics.

Bangladesh requested “a favourable consideration of the waiver proposal,” saying public health should not be seen from a narrow perspective. “Trade will fail to bring prosperity if we fail to save human beings from this global disaster,” Bangladesh warned.

Turkey said further consultations are needed on the waiver because of its “comprehensive nature”, emphasizing that “it is beneficial to have constructive discussions on this issue and we remain committed to work with all members to avoid further damage to human life.”

Ukraine thanked the proponents for their initiative and the information provided “for joint actions for global solidarity and putting in place collective response to COVID-19.”

In crux, the proponents took the battle for the waiver proposal to a global stage where it is increasingly becoming clear that the developing and least-developed countries are unlikely to get easy and affordable access for the new therapeutics and vaccines for COVID-19, as the US, the EU, Japan, Switzerland, and Brazil want to ensure that the profits of the big pharmaceutical companies take precedence over human lives, said several negotiators. +

Posted in Access to Medecines, COVID-19, Diseases/Therapies, TRIPS, TRIPS&IP rights | Leave a comment

Developing Nations Push for Covid-19 Vaccines Without the Patents

17 Nov 2020

Source: WSJ

South Africa and India plan to argue at the WTO that the usual protections should be suspended in light of the pandemic

ISLAMABAD, Pakistan—A group of developing countries, led by South Africa and India, say they will press at the World Trade Organization this week to free Covid-19 vaccines from patent protections so they can be more accessible and affordable for poor countries.

The pandemic requires a temporary suspension of the world’s usual intellectual property system, the countries say they will argue at a WTO council meeting this Friday. If poorer countries aren’t given special access to the vaccines, which are expected to hit the market by the start of next year, the group of developing nations say they will argue, they will continue to be devastated by the coronavirus even as it is stopped in the West. Committed number of Covid-19 vaccine doses to be purchased by top 10 countries ororganizationsSource: Duke UniversityConfirmedPotentialU.S.EUIndiaCovaxU.K.IndonesiaCanadaJapanBrazilVietnam0 billion12

The proposed waiver pits the developing nations against the U.S., the European Union, Japan and other wealthier countries, as well as Western pharmaceutical companies, which say respecting intellectual property rights is key to promoting the rapid development of the vaccines.

Developed nations have already struck deals with Western pharmaceutical companies to buy up enough vaccines to tie up most of the world’s production capacity until the end of 2021.

If the developed nations don’t relent, South Africa is prepared to try to force the issue through a rare contested vote at the trade organization, said Mustaqeem De Gama, counselor at the South African mission to the WTO. Decisions made at the trade organization are usually done on consensus.

“I don’t understand how governments of the world are able to outsource their responsibility for public health to a few companies that are able to hold them all ransom,” Mr. De Gama said.

The countries asking for a waiver from WTO members say there is unused manufacturing capacity in developing nations that could be harnessed to copy vaccines. Existing exemptions in trade law aren’t adequate to quickly allow countries to copy the vaccines or distribute them to other poor countries that have no manufacturing capacity, they say.

The most developed countries, which have fought for decades for better patent protection for pharmaceuticals, say the potential profits are an important driver of research and development, and ignoring patents could damage the engine of innovation that has helped develop vaccines so quickly.

“The United States is committed to helping to ensure the swift delivery of potential Covid-19 therapeutics and vaccines around the globe,” the Office of the U.S. Trade Representative said. “We believe that facilitating incentives for innovation and competition to develop, test, and produce safe and effective therapeutics and vaccines for the Covid-19 response, including by respecting intellectual property rights, will best achieve this objective.”

The European Union says intellectual property “is part of the solution rather than an obstacle,” while the U.K. also says it isn’t clear that patents are a barrier to supply, calling the proposal “an extreme measure to address an unproven problem.”

“Confiscating the intellectual property of innovators will only undermine our efforts to combat Covid-19,” said Brian Newell, a spokesman for BIO, a biotechnology industry association, which includes members developing Covid-19 vaccines.

China, which has four vaccines in final trials, has said it is open to discussions on a possible waiver.

Some of the emerging-market governments are complaining that words about solidarity and fair distribution from richer countries haven’t been matched by action. While the West is looking to vaccinate most of its population by the end of 2021, developing countries fear they may have to wait many years to access the vaccines and funding they will need to inoculate their populations.

A Duke University study this month found that mostly rich countries have purchased up to nine billion doses of Covid-19 vaccines. The U.S., which has bought the most, has deals for up to 2.6 billion doses, the report said, for its population of 330 million. Among the developing nations, India, the world’s biggest manufacturer of vaccines, has lined up the most: 1.6 billion doses, according to the Duke study.

The World Health Organization has set up a voluntary mechanism to share coronavirus-related intellectual property rights. So far, not a single pharmaceutical company has contributed to it.

South Africa successfully fought 20 years ago to have patent protections for HIV drugs lifted for poorer countries, allowing generic manufacturers to make much cheaper copies.

To succeed with Covid-19, South Africa and its allies will need the support of 75% of the member nations of the WTO.

“South Africa and India have a strong chance of winning if they can convince the supermajority of countries who are not benefiting from preferential advance purchase agreements and options for Covid-19 health products that their interest lies in bonding together rather than fall prey to threats from rich countries,” said Brook Baker, a professor of law at Northeastern University.

South Africa says its stance is gathering support since it floated the proposal in October. The proposed intellectual property-rights waiver would cover not only vaccines but also therapies, equipment and protective gear related to Covid-19, and last as long as the pandemic does.

Samples in a vaccine trial in South Africa. The country successfully fought 20 years ago to have patent protections for HIV drugs lifted for poorer countries.PHOTO: SIPHIWE SIBEKO/REUTERS

South Africa plans to convene the WTO’s council to debate the issue Friday. Mr. De Gama said given the urgency of the pandemic, there is only a small window of opportunity, for the next two or three months, for rich nations to change their positions, before the issue must be put to a vote.

Among countries backing the proposal are Kenya, Pakistan, Venezuela and Argentina. The initiative is also supported by UNAIDS, a specialist body of the United Nations tasked with tackling HIV/AIDS. Many more countries say they are considering support. So far, among developing countries, only Brazil has opposed it.

A global initiative known as Covax, backed by the World Health Organization, is trying to raise billions of dollars from richer nations to finance collective buying of Covid-19 vaccine for developing nations, while preserving intellectual property rights.

Under the Trump administration, the U.S. hasn’t supported Covax but says it has given $1.5 billion in Covid-19-related aid to poorer nations.

Covax says it has so far reserved around 450 million doses of vaccine for 92 developing countries, which have a combined population of 3.9 billion. The vaccine typically requires two doses, meaning this would cover around 225 million people. The nations supporting the WTO waiver welcome Covax but say it isn’t enough.

Posted in Access to Medecines, COVID-19, TRIPS, Vaccines, WTO | Leave a comment

A Global Covid Vaccine Heist

19 Nov 2020

Source: WSJ

India and South Africa want the WTO to vitiate private U.S. patents.

Breakthroughs on vaccines and new treatments are finally offering the world a path to end the Covid-19 pandemic. They’re a tribute to private U.S. corporate innovation, but now developing countries led by India and South Africa are making a damaging bid to waive patent protections for these life-saving advances.

The attempt will surface Friday when these countries offer a resolution at the World Trade Organization meeting to waive patent protections for Covid vaccines, therapies and other technologies. They say this is needed to ensure poor countries have equal access, but their effort would harm everyone, including the poor.This is a false choice. Private companies in the U.S. and to a lesser extent in Europe, with the financial support of their governments, have produced most virus breakthroughs. The Trump Administration’s Operation Warp Speed has spent more than $10 billion to advance vaccine clinical trials, manufacturing and distribution.

The U.S. government has also agreed to compensate private companies for vaccines and therapies in return for obtaining the earliest available dosages. For instance, the feds have allocated $1.5 billion to support the manufacturing and delivery of Moderna’s vaccine candidate in return for 100 million initial doses. America’s taxpayers have essentially paid for early access.

Nonetheless, companies plan to share the fruits of their investment and innovation with the world’s poor. A World Health Organization initiative funded by wealthy countries has reserved 450 million vaccine doses for 92 developing countries with populations of 3.9 billion. Gilead has voluntarily agreed to license its antiviral remdesivir royalty-free to developing countries.

Many companies are willing to license their IP at low or even no cost but want contractual agreements to ensure it is developed safely and not pilfered. But India and South Africa want to obtain this technology without paying for it and then use their generic-drug manufacturing base to produce, distribute and sell copycats worldwide.

This is theft, not sharing. Vitiating patents will stifle innovation and make it harder to end this pandemic and the next one. It’s not clear developing countries even have the ability to manufacture large-scale, complex technologies like Moderna’s mRNA vaccine or Eli Lilly’s monoclonal antibody cocktail—let alone distribute them.

The latter requires a strong health-care infrastructure and meticulous planning. Pfizer’s vaccine must be shipped and stored at ultra-cold temperatures. Even if governments of poorer countries were given free life-saving therapies and vaccines, most of their people wouldn’t get immediate access. Unlike the U.S. and Europe, most governments in the developing world also don’t provide liability protection to vaccine makers for adverse side effects. “Manufacturers won’t agree to procurement contracts or ship vaccine without liability protection,” a New England Journal of Medicine article recently explained.

Europe and the U.S. oppose the patent heist at the WTO, but they may be outnumbered at Friday’s meeting. China seems conflicted. It also wants access to the West’s vaccine technology. But it has developed vaccines of its own that it aims to distribute to poor countries to build goodwill.

Vaccines and therapies aren’t a free global good. They require billions of dollars in investment and years of risk-taking. U.S. companies are willing to share what they’ve developed but their patents deserve protection as an asset that is now helping the world eliminate the Covid scourge.

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COVID-19: The world needs to back India and South Africa’s call to remove TRIPS hurdles

New Delhi, 16 Nov 2020

Source: The Caravan

On 2 October, India and South Africa sent a joint communication to the Trade Related Aspects of Intellectual Property Rights Council of the World Trade Organisation, the multilateral institution formed to promote free trade between countries. The communication asked the body to recommend a waiver of major intellectual-property provisions of the TRIPS agreement for technologies to prevent, contain and treat COVID-19. The proposal was made in the middle of the global race to develop medicines and vaccines against the coronavirus. 

The communication said, “It is important for WTO members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”

At the heart of the debate about access to COVID-19 related vaccines, diagnostics and medicines are the contentious provisions of the TRIPS agreement. The WTO largely functions on the assumption that free trade helps increase the wealth of the nations and is thereby one of the pathways for poverty reduction. Intellectual-property rights or IPR recognised under the TRIPS agreement include patents, trademarks, and copyrights. These provisions provide monopoly rights to “innovator” companies, thereby preventing competition. Such monopolies, when applied to health-related products such as medicines, diagnostics, medical valves or even masks hinder accessibility and affordability by denying the early entry of generic products into the market. 

For example, in 2013 the United States approved a drug from Gilead Sciences called sofosbuvir meant to treat hepatitis C. The company got a patent in several countries including the US, granting it market monopoly up to 2024. As a result, a complete course of sofosbuvir cost $84,000 in the US. The same course is available as a generic in Egypt, where there was no patent, for just $1,900. The ostensible reason for granting patents to innovators is to encourage research and development and reward path-breaking innovations. However, patents have been used more as blanket commercial incentives resulting in the erosion of patient welfare. Moreover, most basic molecular research is not done by pharmaceutical companies themselves but in public universities funded by taxpayer money. Gilead Sciences got funding through the government-run National Institutes of Health in the US to develop sofosbuvir and still applied for a patent. 

Even before the COVID-19 pandemic, 50 percent of the world population lacked access to health technologies. Members of the WTO recognised public health barriers that intellectual property rights and TRIPS created at the organisation’s Doha ministerial summit in 2001. They agreed to allow TRIPS provisions to be interpreted in such a manner as to protect public health. The Doha Declaration that emerged from the summit allowed use of provisions like compulsory licensing, which allowed governments to suspend or revoke patent monopolies and allow generic manufacturing during emergencies like the current pandemic. 

India and South Africa’s recent communication to the TRIPS council echoes the Doha Declaration. It found support from most countries that identify themselves at the WTO as least developed and developing—Egypt, Indonesia, Bangladesh, Honduras, Tanzania on behalf of 43-member African Group, Chad on behalf of the 36-member Least Developed Countries group, Sri Lanka, Pakistan, Venezuela, Nepal, Nicaragua, Argentina, Tunisia, Mali, Mauritius and Mozambique. 

The WHO declared COVID-19 a pandemic on 11 March 2020. As of 1 October, there were more than 330 million confirmed cases globally and had more than one million deaths. Existing medicines that have been repurposed to treat COVID-19 such as remdesivir, heparin, dexamethasone and favipiravir have shown limited effectiveness. Ten months into the pandemic, there has been no COVID-19 specific drug or vaccine developed. 

The initial stages of the outbreak of disease saw attempts at global solidarity. China, the country where the pandemic originated, shared the coronavirus genome sequence with the WHO by early January 2020. Countries contributed to the WHO’s fund for a pandemic response. However, as the year progressed, things slipped to business-as-usual mode with international business resorting to its profiteering approach to COVID-19 technology development be it vaccines, diagnostics, medicines for treatment or related equipment such as personal protection equipment or machines for support. 

The World Health Organisation has deployed many tools to ensure fair and equitable access to biomedical technology that can combat the disease. In May 2020, the World Health Assembly, the decision-making body of the WHO, passed a resolution calling for the “removal of unjustified obstacles” to “Equitable Access to Covid19 Technologies”, known by its abbreviation EACT. The WHO set up the COVID-19 Technology Access Pool or C-TAP initiative to gather COVID-19-related technical and scientific information in an open-source environment for faster deployment of vaccines, medicines and other technologies. However, big pharmaceutical companies ridiculed this step. Albert Bourla, the chief executive of Pfizer, called the step “nonsense” and “dangerous”.

The world will need vaccines for the global population of nearly eight billion. Such a large number of doses cannot be manufactured immediately. Anticipating unequal access to COVID-19 resources, the WHO created an allocation framework for fair, ethical and equitable access to COVID-19 health products. The framework defined a ‘priority group’ that covered around twenty percent of the global population comprising frontline workers such as doctors, nurses, community health workers, sanitation and other essential workers, as well as the elderly and people with co-morbidities. This priority population will require about two billion vaccine doses. The world will still need a mechanism to manufacture, procure and equitably distribute the rest of the six billion vaccine doses—maybe more depending on whether more than one dose is required—to protect the global population.

The other global initiative around COVID-19 vaccines is the Access to COVID-19 Technologies accelerator. ACT-A is a collaboration of the WHO, the World Bank, the Bill & Melinda Gates Foundation which is a private philanthropic organisation, Gavi which is the vaccine-focussed global alliance, and global health organisations such as The Global Fund, Unitaid and Wellcome. One of the pillars of ACT-A is its vaccine mechanism called COVAX, which is a pooled procurement system for COVID-19 vaccines. It has identified certain eligible countries to which it will distribute vaccines at heavily subsidised prices. COVAX guarantees access to vaccines only to priority populations—around 20 percent of total population—in the groups of low and middle income countries called LMICs and least developed countries called LDCs. Countries will have to negotiate bilateral agreements with manufacturers for vaccine doses meant for people outside this target population at prices fixed by the company. Organisations like the BMGF command considerable power given their financial strength, relegating WHO to the margins in the COVAX partnership. This raises concerns of unequal access to the eventual vaccine. Public health experts around the world have raised questions about the BMGF’s accountability during the pandemic. The foundation played a role in Oxford University, which is a public university, handing over its vaccine technology to AstraZeneca, a private pharmaceutical company.

The UN general assembly has reiterated that EACT is a global priority. Oxfam, the international NGO, has called for a “people’s vaccine,” which should be available to all people in all countries free of charge. However, several high-income countries have entered into bilateral Advance Purchase Agreement or APAs with vaccine manufacturers after anticipating the need to look beyond COVAX for vaccine supply. This has given rise to a COVID-19 version of  vaccine nationalism. A case in point is the United States’ APA deals with seven vaccine manufacturers to secure 800 million doses at $10 billion and the United Kingdom’s deals for 340 million doses. Countries that have the capacity and companies working on COVID-19 tools are moving away from global solidarity, threatening huge inequity in access to COVID-19 treatment related tools, leaving LMICs and LDCs in the lurch.

High income countries will be able to buy vaccines for most of their populations beyond the designated priority populations. However, LMICs and LDCs that lack the same financial resources may not be able to afford so many vaccine doses by entering into APAs within a short period of time. For example, during the 2008 H1N1 crisis countries like France bought out a majority of H1N1 vaccines in the market. Meanwhile, LDCs had to wait for vaccine donations.This time too, LDCs may have to wait for the IPR of COVID-19 technologies to expire for competition to bring down prices of the vaccine or wait for donations. 

Not surprisingly, pharmaceutical conglomerates have enthusiastically participated in COVAX to safeguard their IPR and profit margins. The global pharmaceutical industry has also been hinting at differential pricing by which HICs will have to pay more and LMICs can pay less for medicines—a form of cross subsidisation. The global health system cannot rely only on the voluntary intent of pharmaceutical companies for COVID-19 drugs in LMICs to ensure equitable access. Even during this global health emergency, Gilead Sciences, which holds the patents for the drug remdesivir, entered into unfair voluntary licenses with generic companies. That restricted the number of countries the medicine can be supplied to and excluded Latin American countries.

The communication by India and South Africa to the TRIPS Council can trigger opening up access to COVID-19 related technical and scientific information. It can spur action that will allow countries to waive intellectual property protection on copyright, industrial design, patents and undisclosed information without the fear of sanctions for violation of international trade rules. It is a call for solidarity and cooperation, putting people before profits, during a health emergency that requires a global effort. Without relying solely on voluntary mechanisms of pharmaceutical corporations, LDCs and LMICs need to support the communication for the waiver to ensure that they can use COVID-19 related technology without fear or control by pharmaceutical corporations and thereby protect the health of their people. It will also allow countries like India and Brazil, which have production capacities, to quickly ramp up manufacturing and distribution of vaccines and medicines. This could potentially help supply other LMICs and LDCs. 

The WHO and the Joint United Nations Programme on HIV and AIDs, known as UNAIDS, have expressed their support for the waiver proposal. The TRIPS council received differing opinions from member states at their meetings on 15 and 16 October. Two countries fully supported the move, some provided general support seeking further negotiation on the proposal, and nine members—the United States, Switzerland, Japan, Norway, the United Kingdom, Canada, Australia, Brazil and the European Union—completely opposed the move. If other WTO member countries support the proposal, they will be effectuating the principles of EACT. They will also help speed up the response to the pandemic by removing barriers to technical and scientific information. The last two months of this year will be crucial as the WTO rules require the member countries to further consider this proposal within 90 days of receiving the application for waiver. The waiver proposal will expire on 31 December. 

Countries need to be proactive to break monopolies, move towards a people’s vaccine and allow open access to COVID-related tools. This is a better strategy than depending on voluntary commitments and appealing to the goodness of the pharmaceutical industry. The waiver proposal serves as a step towards building precedence within the WTO for pandemic situations and provide legal clarity for member states to develop policies that do away with the intellectual property protections for COVID-19 tools in these times of crisis. 

Prasanna S Saligram and Priyam Lizmary Cherian are associated with Equitable Access to Covid Technologies Project of the People’s Health Movement.

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