India Delays COVID-19 Vaccine Supplies to WHO-Backed COVAX: Report

One of the sources said it was “frustrating” that India had yet to confirm any supply to COVAX, despite a promise by the health minister last month to meet the commitment to COVAX and others during the quarter to December.

New Delhi: India has delayed in committing supplies of vaccine to the COVAX global sharing effort, two sources told Reuters on Tuesday, a day after one of its key backers, the WHO, said the agency could not “cut corners” to approve a domestically developed vaccine.

The world’s biggest vaccine maker resumed exports of COVID-19 doses this month for the first time since April. It has sent about 4 million to countries such as neighbouring Bangladesh and Iran, but none to COVAX.

Delayed supplies to COVAX could disrupt inoculation drives in many African nations that rely on it for vaccines.

On Monday, in the run-up to an October 26 meeting on Covaxin, India’s first domestically developed COVID-19 vaccine, the World Health Organization (WHO) said it could not “cut corners” in the approval decision.

Also Read: ‘Naïvely Ambitious’: How COVAX Failed on Its Promise to Vaccinate the World

The sources, who have been briefed on the export talks, declined to be identified as they were not authorised to speak on the subject.

“We are still waiting for confirmation on when and how many doses we can expect when exports do resume, and are not aware of any specific delay,” COVAX co-lead GAVI, the Global Alliance for Vaccines and Immunization, said in an email.

“Indian vaccines have a powerful role to play” in ending the pandemic, it added.

India’s health ministry, WHO and the Serum Institute of India (SII), which is the world’s biggest maker of vaccines, did not respond to requests for comment.

SII, contracted to supply hundreds of millions of doses of a version of the AstraZeneca (AZN.L) vaccine to COVAX and countries such as Bangladesh, has more than tripled its output of the vaccine since April, to reach 220 million doses a month.

Indian government officials have said they are confident the WHO will soon approve emergency use of Covaxin, which accounts for 11% of the 990 million doses India has injected, with the rest mostly from AstraZeneca.

A few weeks ago, Adar Poonawalla, the chief executive of SII, told the Telegraph newspaper that the company would resume exports to COVAX in October.

“Initially these supplies will be small, but by January 2022, once we have satisfied domestic demands … we will see large volumes go to COVAX,” he added.

Before India halted overseas vaccine shipments in April to fill domestic demand, it donated or sold more than 66 million COVID-19 doses, including Covaxin.

Biden Announces Plan To Donate 500 Million Pfizer Doses, Urges Others To Join In

US drugmaker Pfizer and its German partner BioNTech will provide 200 million doses in 2021 and 300 million doses in the first half of 2022, which the US will then distribute to 92 lower-income countries.

St Ives, England: US President Joe Biden plans to buy and donate 500 million doses of the Pfizer coronavirus vaccine to more than 90 countries, while calling on the world’s democracies to do their part to help end the deadly pandemic, the White House said.

The announcement of the vaccine donation – the largest ever by a single country – comes before Biden meets leaders of the other Group of Seven advanced economies in England.

“The goal of today’s donation is to save lives and end the pandemic and will provide the foundation for additional actions to be announced in the coming days,” the White House said.

US drugmaker Pfizer and its German partner BioNTech will provide 200 million doses in 2021 and 300 million doses in the first half of 2022, which the United States will then distribute to 92 lower-income countries and the African Union.

The shots, which will be produced at Pfizer’s US sites, will be provided at a not-for-profit price.

“Our partnership with the US government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible,” said Pfizer chief executive Albert Bourla.

‘Superchage the global fight’

The new donations come on top of some 80 million doses Washington has already pledged to donate by the end of June, and $2 billion in funding earmarked for the COVAX program led by the World Health Organisation (WHO) and the Global Alliance for Vaccines and Immunization (GAVI), the White House said.

GAVI and the WHO welcomed the initiative but anti-poverty campaign group Oxfam called for more to be done to increase the global production of vaccines.

“Surely, these 500 million vaccine doses are welcome as they will help more than 250 million people, but that’s still a drop in the bucket compared to the need across the world,” said Niko Lusiani, Oxfam America’s vaccine lead.

“…we need a transformation toward more distributed vaccine manufacturing so that qualified producers worldwide can produce billions more low-cost doses on their own terms, without intellectual property constraints,” he added in a statement.

Biden has backed calls for a waiver of some vaccine intellectual property rights but there is no international accord on how to proceed.

The donation is meant to “supercharge the global fight against the pandemic,” the White House said. They will be part of the total US commitment of $4 billion to COVAX announced earlier this year, a White House official said.

The pandemic has killed about 3.9 million people around the world, with infections reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

Washington is also taking steps to support local production of COVID-19 vaccines in other countries, including through its Quad initiative with Japan, India and Australia.

“President Biden has been clear that borders cannot keep this pandemic at bay and has vowed that our nation will be the arsenal of vaccines,” the White House said.

Biden’s announcement comes amid mounting pressure for the United States, which has now given at least one shot to around 64% of its adult population, to boost donations of COVID-19 shots to other countries that are desperately seeking doses.

Amidst COVID-19 Surge in India, Serum Institute ‘Legally Bound’ to Supply Vaccines to COVAX

This complicates the Pune-based operation’s efforts to divert all production to the Indian market, amidst a significant surge in cases in the country.

New Delhi: Amidst growing demand at home, the Serum Institute of India is legally bound to ship doses of the coronavirus vaccine to COVAX, a spokesperson of Gavi which is co-leading the global vaccine-sharing facility told Reuters.

This complicates the Pune-based operation’s efforts to divert all production to the Indian market, amidst a significant surge in cases in the country.

India had slowed down all major exports last month to fill the demand at home. On April 9, the case tally reached 1,30,60,542. Chief ministers of two states have said stored vaccines are likely to run out amidst the demand, while others have requested a lowering of the minimum vaccine age.

SII is the world’s biggest COVID-19 vaccine maker and manufactures the Oxford University-AstraZeneca vaccine, locally marketed as ‘Covishield’.

Between February and May, SII was supposed to have supplied COVAX with more than 100 million doses, excluding supplies for India. However, it has only received about 18.2 million.

COVAX is an initiative that aims to ensure equitable access to COVID-19 vaccines. It is led by UNICEF, Gavi, the Vaccine Alliance (formerly the Global Alliance for Vaccines and Immunization, or GAVI), the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), and others organisations.

COVAX has delivered nearly 38.4 million doses of COVID-19 vaccines to 102 countries across six continents, six weeks after it began to roll out supplies, Gavi and WHO have said. It aims to deliver more than 2 billion doses this year.

Also read: Chart: Global Initiative to Provide Equitable Access to COVID-19 Vaccines Hits a Snag

Of the over 100 economies reached, 61 are among the 92 lower-income economies receiving vaccines funded through the Gavi COVAX Advance Market Commitment (AMC), PTI has reported.

“The agreement is legally binding and served as a basis for the first-round allocation document, which has been communicated to all participating economies,” a Gavi spokeswoman told Reuters.

The Reuters report notes that this agreement specified that Gavi would receive 1.1 billion doses of either the AstraZeneca vaccine or that of Novavax, with 200 million committed, and the rest on option, from SII.

AstraZeneca has already issued it a legal notice over delays to other shipments. The African Union’s disease control body said on April 7 that it had dropped plans to secure AstraZeneca COVID-19 vaccines for its members from SII, the world’s biggest vaccine supplier, amid global shortfalls of the shot.

Gavi told Reuters that its pact with SII took effect when the World Health Organization approved the AstraZeneca shot on February 15.

“SII has pledged that, alongside supplying India, it will prioritise the COVAX multilateral solution for equitable distribution,” Gavi told the news agency.

The report mentioned that neither SII nor Gavi gave comments on how this situation will be mitigated.

India could resume vaccine exports by June, SII’s chief executive, Adar Poonawalla, had told reporters this week. On April 7,  Poonawalla sought Rs 3,000 crore grant from the government to ramp up capacity of the Covishield COVID-19 vaccine beyond 100 million doses a month that it will reach by the end of May, Financial Express reported.

Meanwhile, asserting that India has not imposed any export ban on anti-coronavirus vaccines, the Ministry of External Affairs on April 8 said the supply of made-in-India vaccines abroad would continue while also taking care of the country’s domestic requirements.

Within the country, the topic of vaccine exports and the politics surrounding it amidst a shortage of doses has taken centre stage.

The Aam Aadmi Party on April 9 blamed the Centre for sending vaccines to Pakistan and Afghanistan when, allegedly, “Due to a shortage of the vaccine doses, 109 vaccination centres in Pune, 26 in Mumbai and more than 700 in Odisha have been shut down.”

India May Need To Spend $1.8 Billion on COVID-19 Vaccines in First Phase

India will have to spend $1.4 billion to $1.8 billion in the first phase of a coronavirus vaccination programme, even after getting support under the COVAX global vaccine-sharing scheme.

New Delhi: India will have to spend $1.4 billion to $1.8 billion in the first phase of a coronavirus vaccination programme, even after getting support under the COVAX global vaccine-sharing scheme, according to estimates by the GAVI vaccines alliance.

India, which has the world’s second highest caseload of coronavirus behind the US, plans to inoculate 300 million people over the next six to eight months, likely with vaccines from AstraZeneca, Russia’s Sputnik, Zydus Cadila and India’s own Bharat Biotech.

Documents reviewed by Reuters underline the scale of the funding challenge India faces to immunise its vast population, with 600 million shots required in the first wave alone for critical workers and people most at risk from COVID-19.

If India got 190-250 million shots of the vaccine under the COVAX facility – a best case scenario – then the government would need to line up about $1.4 billion to make up for the shortfall, according to an unpublished report prepared for GAVI’s three-day board meeting that began on Tuesday.

On the other hand, if India received a lower allocation of 95-125 million doses, then the cost to the government of procuring additional shots would go up to $1.8 billion.

By comparison, India’s 2020/21 federal budget allocated just under $10 billion to healthcare.

India’s health and finance ministries did not immediately respond to Reuters’ e-mail seeking comments.

Also Read: India Will Soon Have a Working Vaccine. We Must Start Now To Make It Work for All.

Support package

The COVAX plan, co-led by the World Health Organisation and GAVI, aims to provide poor and middle-income countries with diagnostic tests, drugs and vaccines through a fund known as the Access to COVID-19 Tools (ACT) Accelerator, set up last April.

The Indian government has not provided any estimate of the cost of its vaccine programme, though it has said all resources will be provided to protect the population.

GAVI, an alliance of governments, drug companies, charities and international organisations, said it was in discussions with the Indian government over a support package.

“Providing a low range of support would exacerbate the country’s ability to allocate enough resources to mitigate the risks of continued transmission of COVID-19,” the GAVI report said.

The GAVI report identified India’s economic burden due to the pandemic as “disproportionate” and suggested a donor-funded plan of $1.3 billion to secure 190-250 million doses. The plan needs to be approved by the GAVI alliance board.

According to a vaccination plan shared with international donors, India aims to inoculate 10 million frontline health workers by February, 20 million essential workers by the following month and then 270 million people by August, mostly people above the age of 50 and those with other health issues that make them more vulnerable.

India also needed $30 million to $80 million for the infrastructure to transport and store vaccines that must be kept at very low temperatures, the GAVI report said.

(Reuters)

World Leaders to Address a Special Session of the UN General Assembly on COVID-19 This Week

Serum Institute of India CEO Adar Poonawalla will also address the session virtually, apart from BioNTech co-founders Ugur Sahin and Ozlem Tureci, vaccine team leader at Oxford University Sarah Gilbert, among others.

United Nations World leaders, the top leadership of the UN and vaccine developers will address a two-day, special session of the UN General Assembly on COVID-19 this week. They are set to discuss the pandemic’s impact as well as the multi-faceted, coordinated response required to address the greatest global health crisis in decades.

The special session of the United Nations General Assembly in response to the coronavirus disease (COVID-19) pandemic will take place on December 3 and 4 at the UN headquarters.

The world organisation said that government leaders, UN’s principals and other relevant stakeholders would be able to engage in dialogue on the impact of the pandemic on people, societies and economies and discuss the multi-faceted, coordinated response required to address this crisis.

Serum Institute of India chief executive officer (CEO) Adar Poonawalla will also address the session through a pre-recorded video on December 4.

BioNTech co-founders Ugur Sahin and Ozlem Tureci, vaccine team leader at Oxford University Sarah Gilbert and CEO of GAVI (the vaccine alliance) Seth Berkley will address the special session virtually.

AstraZeneca and the University of Oxford are working on a COVID-19 vaccine, while global drugmaker Pfizer and BioNTech announced their vaccine candidate is 95% effective.

World leaders expected to address the session are Afghan President Ashraf Ghani, French President Emmanuel Macron, Nepalese Prime Minister K.P. Sharma Oli, New Zealand Prime Minister Jacinda Ardern and German Chancellor Angela Merkel.

President Donald Trump is not listed as a speaker for the session instead the US secretary of health and human services Alex Azar will address the high-level meeting.

The two-day special session will allow many stakeholders to share their experiences in fighting the pandemic, reflect on the global response to date, and forge a united, coordinated, and people-centered path forward.

The COVID-19 pandemic, which has claimed more than 1.3 million lives and infected more than 54 million people globally, “is not only the greatest global health crisis since the creation of the UN 75 years ago, it is also a humanitarian, socio-economic, security and human rights crisis,” the world body said.

The session’s first day will feature statements by the president of the general assembly Volkan Bozkir, secretary-general Antonio Guterres, president of the security council (for the month of December) South African ambassador Jerry Matthews Matjila and chair of the movement of non-aligned countries Ilham Heydar oglu Aliyev. The general assembly will then hear from world leaders.

According to the speakers list, there are 141 speakers inscribed, including 53 heads of state, 39 heads of government, four deputy prime ministers and 38 ministers. The second day will feature speeches from WHO director-general Tedros Adhanom Ghebreyesus and other UN and inter-governmental agencies.

Bozkir’s spokesperson Brenden Varma, replying to a question on whether it is too late to hold the special session on COVID-19, said the president of the general assembly agrees that it is already too late to have this meeting which should have been held in the summer as the coronavirus cases were rapidly increasing across the world.

Varma said member states have come together and decided to hold this special session on COVID-19. And the point of this is to recommit to multilateralism, he said.

“Currently there are a lot of responses to COVID-19, but the point of the session is to bring countries together, along with UN actors, the private sector and vaccine developers to work together to see where we are, to take stock and to identify gaps and challenges and then to move forward together so we have a unified response that actually makes sense and that can actually combat this pandemic,” he said.

(PTI)

India Pledges USD 15 Million for Global Vaccine Alliance GAVI

The amount was pledged as PM Modi addressed the virtual Global Vaccine Summit hosted by British Prime Minister Boris Johnson.

New Delhi: India on Thursday pledged USD 15 million to the international vaccine alliance GAVI, the Prime Minister’s Office said.

The amount was pledged as Prime Minister Narendra Modi addressed the virtual Global Vaccine Summit hosted by British Prime Minister Boris Johnson in which over 50 countries, business leaders, UN agencies, civil society, government ministers, heads of state and country leaders participated.

In his address, Modi said India stands in solidarity with the world in these challenging times, according to a statement from the PMO.

He said the COVID-19 pandemic, in some ways, has “exposed the limitations of global cooperation and that for the first time in recent history, the human kind faces a clear common enemy”.

Referring to GAVI, he said it is not just a global alliance but also a symbol of global solidarity and a reminder that by helping others we can also help ourselves, according to the statement.

Modi said India has a vast population and limited health facilities and that it understands the importance of immunisation.

India’s civilisation teaches to see the world as one family and that during this pandemic it had tried to live up to this teaching.

He said India did it so by sharing the country’s available stocks of medicines with over 120 countries, by forging a common response strategy in its immediate neighbourhood.

Modi said New Delhi also provided specific support to countries that sought it, while also protecting India’s own vast population.

He said one of the first programmes launched by his government was Mission Indradhanush, which aims to ensure full vaccination of the country’s children and pregnant women, including those in the remote parts of the vast nation.

Watch | ‘Our Aim Is to Get Millions of Vaccine Doses Out in the Next 6 Months:’

He said in order to expand protection, India has added six new vaccines to its National Immunisation Programme.

The prime minister elaborated that India had digitised its entire vaccine supply line and developed an electronic vaccine intelligence network to monitor the integrity of its cold chain.

These innovations are ensuring the availability of safe and potent vaccines in the right quantities at the right time till the last mile, he said.

India is also the world’s foremost producer of vaccines and that it is fortunate to contribute to the immunization of about 60 per cent of the world’s children, he pointed out.

Modi said India recognises and values the work of GAVI, that is why it became a donor to GAVI while still being eligible for GAVI support.

He said India’s support to GAVI is not only financial. India’s huge demand also brings down the global price of vaccines for all, saving almost USD 400 million for GAVI over the past five years.

He reiterated that India stands in solidarity with the world along with its proven capacity to produce quality medicines and vaccines at low cost.

India not only has the capacity to contribute to the global health efforts, but also has the will to do so in a spirit of sharing and caring, the prime minister noted.

GAVI, the Vaccine Alliance, helps vaccinate half the world’s children against deadly and debilitating diseases, according to its Twitter handle.

In a tweet, the alliance thanked Modi and the people of India for pledging USD 15 million.

Bharat Biotech’s Typhoid Vaccine Gets WHO Nod

The WHO pre-qualification makes the vaccine eligible for procurement by UN agencies such as UNICEF and Gavi, the Vaccine Alliance.

The WHO pre-qualification makes the vaccine eligible for procurement by UN agencies such as UNICEF and Gavi, the Vaccine Alliance.

Representative image. Credit: Reuters

Representative image. Credit: Reuters

New Delhi: The WHO has given its nod to Bharat Biotech’s typhoid vaccine Typbar TCV, which has longer-lasting immunity than existing vaccines, requires fewer doses and can be used on recipients over six months of age.

The WHO pre-qualification paves the way for health and humanitarian organisations such as UNICEF, GAVI and Pan American Health Organisation to procure it for public health vaccination programmes across the world.

“The fact that the vaccine has been pre-qualified by the WHO means that it meets acceptable standards of quality, safety and efficacy. This makes the vaccine eligible for procurement by UN agencies such as UNICEF and Gavi, the Vaccine Alliance,” the WHO said in a statement.

In October 2017, the Strategic Advisory Group of Experts (SAGE) on immunisation, which advises the WHO, recommended TCV for routine use in children over six months of age in typhoid endemic countries.

SAGE also called for the introduction of TCV to be prioritised for countries with the highest burden of typhoid disease or of antibiotic resistance to Salmonella typhi, the bacterium that causes the disease.

“Use of the vaccine should also help to curb the frequent use of antibiotics for treatment of presumed typhoid fever, and thereby help to slow the alarming increase in antibiotic resistance in Salmonella typhi,” the statement said

Typhoid is a serious and sometimes fatal disease spread through contaminated food and water. Symptoms include fever, fatigue, headache, abdominal pain and diarrhea or constipation.

For millions of people living in low- and middle-income countries, typhoid is an ever present reality. Global estimates of the typhoid burden range between 11 and 20 million cases and between about 1,28,000 and 1,61,000 typhoid deaths annually. Poor communities and vulnerable groups such as children are often the most susceptible.

With Pneumococcal Vaccine Patent, Pfizer Wins on Many Counts

Not only was Pfizer given a subsidy to ‘develop’ a drug that already existed, the profits they will make from the inefficient vaccine is much beyond what was originally stipulated.

Not only was Pfizer given a subsidy to ‘develop’ a drug that already existed, the profits they will make from the inefficient vaccine is much beyond what was originally stipulated.

A company logo is seen through branches at a Pfizer office in Dublin, Ireland November 24, 2015. Credit: Reuters/Cathal McNaughton

A company logo is seen through branches at a Pfizer office in Dublin, Ireland November 24, 2015. Credit: Reuters/Cathal McNaughton

New Delhi: Pfizer has been granted an Indian patent for its Prevenar 13 – a pneumococcal vaccine. The vaccine costs more than Rs 3,000 per dose and the three doses required to immunise a child cost more than Rs 10,000. The decision of the patent office bars other Indian companies from making a cheaper version of the vaccine. Although the vaccine is exorbitantly expensive, it has poor efficacy. Yet one is not surprised by the news of the patent, given the background story, nationally and internationally, of this vaccine. According to the petition by Prashant Bhushan in the Delhi high court, this vaccine has the distinction of being recommended even before it was manufactured, let alone tested, by the National Technical Advisory Group on Immunization, which is meant to evaluate and recommend vaccines for introduction in the country.

Vaccine with little efficacy

Pneumococcal bacteria are only one of a very large number of organisms that cause pneumonia. There are many other bacteria, mycoplasma and viruses that can also cause pneumonia. The pneumococcal bacteria itself has around 100 strains. The vaccine is against only 13 of those pneumococcal bacterial strains. It is clear that this vaccine impacts only a tiny fraction of the causes of pneumonia. Bacterial pneumonia is an eminently treatable condition, responsive to antibiotics with few long-term sequlae.

Before this vaccine against 13 strains was brought to the market, most pneumococcal pneumonia was caused by seven strains of the bacteria, which strains were responsive to inexpensive antibiotic like penicillin. A vaccine against the seven common strains was introduced in the US in 2000. It resulted in the near disappearance of these seven strains but other strains replaced the ones eliminated. The new strains caused more problems like pus collection in the chest and many were resistant to the first line penicillins. In short, the use of the vaccine was making the problem worse. This was followed by the development of a ten-strain vaccine and when that caused further strain shifts, the 13 valent vaccine was brought out. Other countries clearly had the opportunity to learn from these mistakes and grab the option not to introduce a vaccine that aggravates the problem. But such is the clout of the vaccine manufacturers and their international promoters like the WHO and GAVI, that the vaccine is being recommended in the poorest of countries that can ill afford to make such costly mistakes.

The vaccine has very poor efficacy. According to a WHO bulletin, the vaccine reduces the incidence of pneumonia by 3.6 cases per 1,000 children vaccinated. Preventing these four cases (a generous approximation) of pneumonia by vaccinating 1,000 babies with a vaccine at Rs 10,000 per child will cost a mind boggling Rs 100 lakh, whereas treating four cases of pneumonia with syrup Septran, as advised by the WHO, will cost Rs 40. Even if the vaccine is procured at a tenth of the market price, the vaccine will still cost Rs 10 lakh to reduce four cases of chest infection.

Adverse effects

The vaccine has other problems besides poor efficacy. A study published in the prestigious New England Journal of Medicine shows that the vaccination nearly doubled the incidence of asthma. For every two cases of pneumonia prevented, one child developed asthma. Pneumonia is a one-off transient disease. Asthma, on the other hand, has long0term implications. One is left to wonder what the trade-off is. In spite of all this evidence, this vaccine is being introduced in India to be given to every child.

The need for introducing this exorbitantly expensive vaccine that perhaps aggravates rather than alleviates respiratory morbidity in children and the need, now, to grant it a patent in India, has left organisations like Medecins Sans Frontiers (MSF) wondering about the clout that the manufacturer wields. We had evidence of this clout ten years ago when it the company hijacked the GAVI Advanced Market Commitment (AMC) funds. Professor Donald W. Light of Stanford University described this in lurid detail.

A woman walks past a chemist shop in Mumbai, India, on April 28, 2017. Credit: Reuters/Files

A woman walks past a chemist shop in Mumbai, India, on April 28, 2017. Credit: Reuters/Files

AMC hijacked

Pharmaceutical companies in general are keen to make drugs for the rich countries that they can sell at great profit. They have little interest in making vaccines for diseases like malaria that affected poor countries because the countries that needed the vaccine cannot afford their profit margins. In 2005, the Center for Global Development and the Bill and Melinda Gates Foundation came up with an idea to incentivise drug manufacturers to manufacture vaccines for neglected diseases like malaria. Donors made an AMC to make up the loss of revenue to the company that makes a drug for a neglected disease. The MSF estimates that profits for a breakthrough drug is approximately $400 million. The AMC agreed to buy upto a few hundred million doses of the new vaccine at what they called the ‘buyout price’ that ensured that the manufacturer made the profits it would make if the vaccine had been made for rich countries’ market. In turn, the manufacturer would commit to making the drug for low-income countries at $1-2, with no profit. Donors would not pay till the manufacturer came up with the breakthrough vaccine. The company that arrived there first would walk away with all the profits.

After the monies were collected from international donors for setting up the AMC, inexplicably the money was given to Pfizer for the Prevenar 13, which vaccine the company had already developed to replace their blockbuster seven-serovalent pneumococcal vaccine made for the rich market. Also, the buyout price was raised from $5-6 to $10 and the tail price (the no-profits price) was raised to $3.50 from the agreed $1-2. So in fact, no new vaccine for a neglected disease was developed. The company made profits in excess of $600 million, where the normal profits are $400 million according to calculations of the MSF. At the international level, this AMC killed off any interest other manufacturers may have had to make a cheaper vaccine. They could not compete against the huge subsidy given to Pfizer.

The last straw

India does not qualify for GAVI funding as its GDP per capita is in excess of $1,500 a year. It has to pay the full negotiated price for the vaccine. Indian manufacturers therefore had an incentive to make a cheaper vaccine for the local market and for other countries like India that have graduated out of GAVI aid. The present grant of the patent to Pfizer for Prevenar 13 kills that incentive all the way up till 2026.

Of course if the patent were not there, it may have helped the development of a less expensive vaccine and addressed the cost issue, but it would not alter the facts about the poor efficacy or the problem of asthma caused by the vaccine.

Jacob Puliyel is an expert member of the National Technical Advisory Group on Immunisation, an apex body that advises the government on immunisations, and is the head of paediatrics at St Stephens Hospital in New Delhi.

The Gates Foundation and the Anatomy of Philanthrocapitalism

Without adequate safeguards and greater debate about private aid, organisations like the Gates Foundation can provide only partial solutions and can even entrench the very systems whose symptoms they seek to address.

Without adequate safeguards and greater debate about private aid, organisations like the Gates Foundation can provide only partial solutions and can even entrench the very systems whose symptoms they seek to address.

Bill-gates-foundation

Bill Gates. Credit: Bill Gates Foundation

Price is one of the main barriers to medicine access in rich and poor countries alike. Solvadi, a drug that has revolutionised the treatment of Hepatitis C, costs $84,000 for a standard 84-day course. Ibane, a hugely effective breast cancer drug, is priced at $9850 per month. Oxfam estimates that more than 2 billion people across the developing world are unable to access life-saving drugs, despite their availability in the market.

India has long been considered the pharmacy of the world – its domestic intellectual property regime has allowed Indian pharmaceutical companies to create generic versions of existing drugs and supply them at a fraction of the cost to millions around the world. Not for much longer, however. The Narendra Modi government has been under sustained pressure from the US and European Union to amend its framework. Last week, India assured the United States Trade Representative that it would not issue compulsory licenses for commercial purposes. But this comes as no surprise given Modi’s eagerness to attract foreign investment, promote the Make in India program and strengthen ties with Washington. It is also not surprising in the context of the low priority given to healthcare by successive Indian governments – India’s spending on healthcare is among the lowest in the world, with just over 1% of GDP allocated to healthcare.

The question of patents

In much of the developing world, states have routinely under-invested in healthcare. The gap in healthcare provision is typically filled by informal health workers, non-governmental organisations and the private sector. The Bill and Melinda Gates Foundation (BMGF) has in recent years emerged as the largest player in global health. BMGF has disbursed approximately $32.9bn in grants to health programs around the world. To put these figures in perspective, the World Health Organization’s budget for 2014-15 was under $4 billion. Only the US and UK governments give more to global health today. It is necessary therefore to ask where BMGF stands on the issue of medical patents and what this might suggest for emerging global health paradigms.

Bill Gates has long stood for a strong and robust intellectual property regime, going even so far as to say that restricting intellectual property is tantamount to communism: “.. [O]f the world’s economies, there’s more that believe in intellectual property today than ever. There are fewer communists in the world today than there were. There are some new modern-day sort of communists who want to get rid of the incentive for musicians and moviemakers and software makers under various guises. They don’t think that those incentives should exist.” The Microsoft empire was in fact built on strongly protected patents – as recently as 2007, Microsoft was lobbying the G8 to tighten intellectual property protection. BMGF takes a similar stand. As Erik Iverson, Associate General Counsel of BMGF, clarifies: “[A] fundamental premise at the foundation is that we absolutely respect intellectual property rights.  We recognise their importance and we certainly recognize the importance of companies and their involvement in developing products and having them commercialised both in developed and developing countries.”

The irony should be obvious: on the one hand, BMGF is now the largest health agency in the world and on the other hand, it supports the very rules that prevent access to low cost health care. Health is both a fundamental right and a public good and it makes no sense that the same intellectual property rules that apply to Microsoft or the entertainment industry should be applied to the health sector.

Big Pharma maintains that the cost of medicines reflects their R&D investments; without adequate rewards and protection for medical invention, innovation in the sector will be stifled and even more people will be without access to necessary medication. However, numerous recent studies suggest otherwise. A 2013 article in The Caravan argues, for example, that Novartis spent under $100 million to develop cancer drug Gleevec – less than what Novartis makes from worldwide Gleevec sales every 13 days. Recently, The Wall Street Journal journalist Jonathan Rockoff reported that the price of Pfizer’s cancer drug Ibane – $9850 per month – was not a reflection of R&D costs but what the competition – Novartis – was charging for its own breast cancer drug and at what price point doctors and health insurance companies would stop supporting the drug. Anything more than $10,000 a month would be prohibitive.

The argument that patents fuel innovation is also problematic, for patents can only motivate innovation if the potential patent holders anticipate the developed drug can be sold at high prices. This explains why only 10% of global healthcare resources are spent on diseases that account for 90% of the global disease burden, affecting people mostly in the developing world; conversely, 90% of global health resources are spent on diseases affecting 10% of the population. There are numerous new drugs for acne and hair loss every year, but few for tuberculosis and sleeping sickness.

Gates contradictory stance

Leading thinkers around the world have thus called for a change to the medical patent regime, supporting alternatives such as the Health Impact Fund and Medical Innovation Prizes. Social justice must trump private profit in the case of health. What then explains Gates’ position – how is it that the new self-appointed guardian of global health supports an intellectual property regime that undermines his own stated objectives?

A recent study by Global Justice reports that as of 2014, the BMGF trust had investments in chemical and pharmaceutical corporations BASF, Dow Chemicals, GlaxoSmithKline, Novartis and Pfizer. The report thus argues that BMGF stands to directly gain from the profits of pharmaceutical companies. BMGF’s support for medical patents must therefore be seen in the context of its coziness with Big Pharma. BMGF maintains however that it has a global access policy whereby “knowledge and information generated by our projects will be promptly and broadly disseminated and that the developments created will be delivered at an affordable price to the people who need them most.” There seem to be no studies, however, that examine the functioning and outcomes of this policy.

But, to be fair, BMGF regularly funds research into diseases that have been neglected by the drug market for their close to zero-potential. It has also poured millions of dollars into the GAVI alliance – a public-private global health partnership that seeks to increase access to immunisation in poor countries. And, even though BMFG earmarks its contributions to the WHO, these are primarily for polio eradication and maternal newborn and child health in the developing world.

The coziness between BMGF and big pharmaceutical companies is perhaps more of concern in light of the huge influence BMGF, and Gates in particular, has on the global health agenda. In 2008 Dr. Arata Kochi, former head of WHO’s malaria program accused BMFG of acting as a “cartel” that suppressed the diversity of scientific opinion, that was “accountable to no-one other than itself,” and which “could have implicitly dangerous consequences on the policymaking process in world health”. A report by Global Health Watch similarly argues that while “[T]he Foundation has become the dominant actor in setting the frames of reference for international health policy,” there is a “fundamental lack of democratic or public accountability”.

There is also a broader systemic argument that must be considered when evaluating BMGF’s position on medical patents and its growing influence on the global health agenda, despite the seeming contradictions.

There is a growing expectation that private finance and philanthropy, rather than traditional aid, will be critical for meeting global development needs – this was brought out most recently by the global Financing for Development conference in Addis Ababa last year. Current thinking on development finance thus legitimises both the use of market solutions and business principles, as well as the idea that a profit incentive can help create sustainable and innovative solutions for global development. Similarly, BMGF’s approach makes sense if we see it not as a form of charity but as a form of ‘philanthrocapitalism’ or ‘venture philanthropy.’ That is, BMGF doesn’t simply donate money to global health but seeks to harness the power of the market to produce development outcomes, evaluating investments in terms of their probable returns and measuring performance using business metrics.

A problematic development paradigm

While such philanthrocapitalism undoubtedly injects the much-needed financial resources into global development programs, it is important to pay attention to the kind of development paradigm that is promoted as a result and the broader implications of such philanthrocapitalism.

BMGF’s philanthrocapitalism, like much of private sector investments for development, tend to promote vertical, issue-based solutions that are often rooted in new technologies and innovation. As the Global Health Watch report argues, “The Foundation’s corporate background and its demand for demonstrable returns on its investments appear to have resulted in a bias towards bio-medical and technological solutions.” Vaccination, for example, is considered a “catalytic” intervention that can simulate major progress in health.

However, this vertical approach does not contribute to building urgently needed health systems in the developing world. Responding to the criticism, in 2005, GAVI included a health system strengthening support window into its program portfolio. However, GAVI’s total commitments towards health systems between 2000 and 2013 are still only 10-11% of its overall spending.

Philanthropy is also fundamentally dependent on inequality and hierarchy. As Canadian sociologist Linsey McGoey argues, inequality provides both the reasons and resources of philanthropy. To illustrate the point, developing countries lose approximately $100 billion per year in revenues due to tax avoidance by large multinationals, monies that could go a long way in providing development solutions. A 2012 report from the US Senate found, for example, that Microsoft’s use of offshore subsidiaries enabled it to avoid taxes of $4.5 billion annually, a sum greater than the BMGF’s annual grant making ($3.6 billion in 2014). Neither Gates nor BMGF can be held accountable for the global rules and structures – for example, those of global taxation – that produce global inequalities, but there is surely an irony in looking to the benefactors of such structures for equitable and just development solutions.

The broader point is not to assign blame to a particular actor such as BMGF, but to consider the contradictions and limitations of the reliance of private finance, and global philanthropy in particular, for development solutions. It is also to highlight the need for close and regular scrutiny of their power and practice. Finally, it is to argue that without adequate investments and safeguards by states, and greater democratic debate about the nature of private aid monies and investments, organisations such as BMGF can provide at best, partial solutions and at worst, entrench the very systems whose symptoms they seek to address.

Dr. Urvashi Aneja is Associate Professor in International Relations, Jindal School of International Affairs.