The Bill and Melinda Gates Foundation's new headquarters occupies 900,000-square-feet and cost $(US)500 million

The Bill and Melinda Gates Foundation’s new headquarters occupies 900,000-square-feet and cost $(US)500 million

by Sandhya Srinivasan

“There is no better place to have an impact than India.” – Bill Gates1

How much money does the Bill and Melinda Gates Foundation (BMGF) spend in India?

urban-poverty-in-india-1

According to World Bank figures, 68% of India’s population live on less than $US2 a day

BMGF has a substantial presence in India, directly funding projects totaling at least $1 billion from 2003, when it entered, to 2012.2 Apparently, this does not include funds given to international non-governmental organisations (NGOs) that run projects in India. (For example, BMGF has donated a total of almost $1 billion to a single international NGO, Program for Appropriate Technology in Health (PATH), to conduct and fund various projects; indeed PATH has been described as an agent of the foundation more than a grantee.3 PATH in turn runs projects in India.) In India, BMGF’s activities are largely in the fields of health and nutrition, where it co-funds government programmes, non-governmental organisations’ activities and pharmaceutical companies’ ventures here.

However, BMGF’s funds are small compared to India’s public health expenditure. The latter was $18.3 billion in 2010-11 alone.4 Thus BMGF’s funds as such cannot make a major contribution to meeting the health needs of India. Rather, if BMGF funds were withdrawn or declined, even a small (in percentage terms) increase in allocations by the Central and state governments would more than compensate for the loss.

What are BMGF’s objectives?

Key elements of the BMGF strategy5 – as described on the Foundation website – are as follows:

(i) using partnerships to leverage public and private resources to influence policy;
(ii) using State projects as ‘incubators of innovation’; and
(iii) underscoring the role of technology.

The BMGF strategy (as described on a website page that has since been changed but is available as an archived6 page) says:

“The foundation does not invest in delivering health or education services. Instead, we identify ways to leverage systems and innovate so these services achieve better outcomes for people.
All strategies leverage our partnerships to achieve impact…
All strategies underscore the role of technology.” (emphasis added)

In other words, BMGF’s objective is to influence Government policy. The foundation’s memorandum of understanding with the Bihar government (Bihar and Uttar Pradesh are the two states where the foundation’s work is concentrated, according to the foundation website) elaborates on this strategy: to use the foundation’s resources to “leverage public and private resources” for its objectives, and use “the state as an incubator of innovation”to influence national-level programmes and policy.

What are Product Development Partnerships (PDPs), and how does BMGF employ them to pursue its objectives?

The Gates Foundation has played a key role in promoting ‘Product Development Partnerships’ (PDP), a form of public-private partnership. PDPs bring industry and government together through what is described as a non-profit venture to develop technologies for health.

According to the website of the International AIDS Vaccine Initiative7 (a Gates grantee), the PDP is meant to “accelerate product development”, working in collaboration with “academia, large pharmaceutical companies, the biotechnology industry and governments in developing countries”.  The products are vaccines, drugs, diagnostics, pesticides etc. For example, the PDP Innovative Vector Control Consortium (also a Gates grantee) is a “not for profit company and registered charity to overcome the barriers to innovation in the development of new insecticides for public health vector control … .”8

The last job of its chief executive officer was at Bayer CropScience.

The PDP’s job includes taking the product through clinical trials and regulatory approvaland getting country governments to introduce it into their programmes. While the proponents of PDPs justify them on the ground that they focus on disease areas without viable commercial markets, in fact an examination of PDPs indicates that one of its jobs is to identify the market. A study by the Boston Consulting Group9 commissioned by PATH’s Malaria Vaccine Initiative (with funding from USAID and BMGF) looks at the public and private markets for a malaria vaccine at various prices, what donors would fund, the US military as a market, and so on.PDPs are essentially ways for industry to influence the decision-making process and get entry into the large and relatively untapped markets of public health programmes in developing countries. A presentation10 by representatives of the Global Alliance for TB Drug Development and PATH’s Malaria Vaccine Initiative describes what it calls “country decision making”. Globally, PDPs work with multilateral agencies. Locally, “PDPs, WHO, pharma and other actors can assist in the generation of a public health case for and against adoption.”  They may also need to assist in the “definition of disease burden; establishment of new decision-making bodies; support for local advocacy; and Phase IV studies.”

Not only does the product have to be developed and brought to market; the demand for this vaccine or drug needs to be created; organisations – including advocacy groups and the media – need to lobby for its inclusion in the country’s programmes. Phase IV studies, sometimes described as demonstration projects are conducted to establish the product can be introduced into a government programme. The PDP is also advised to assist in the establishment of “new decision-making bodies”. It is not clear what these new decision-making bodies could be, who they would represent, and how they would be established.

What role do contract research organisations (CROs) play in BMGF’s activities?

The Gates Foundation’s strategy of blurring of the distinction between public and private is also apparent in its support of private as well as ‘non-profit’ contract research organisations to carry out trials of the products developed by PDPs. Family Health International (FHI)11 describes itself as a “non-profit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions.”12 It provides “technical assistance”, partly through contract research, to corporate, governments and NGOs, and its donor base13 includes BMGF, USAID, Centers for Disease Control and Prevention (CDC, US), and Department for International Development (DFID, UK) – and Bayer Pharmaceuticals, GlaxoSmithKline (GSK) and Pfizer.  In 2011, FHI,14 Quintiles,15 Pharmaceutical Product Development,16 and GVK Biosciences17 were named ‘preferred providers’ for contract research to a consortium of 14 ‘global health product development partnerships funded by BMGF, government agencies, private companies and “other sources”, that is expected to run 12818 clinical trials of vaccines and drugs in 2011-13. All four CROs run trials in India for pharmaceutical companies – in essence, they are commercial entities working (in this case) for what is described as a kind of non-profit sector.

To give another example, Aeras is a “global non-profit biotech” developing TB vaccines. The Aeras Global TB Vaccine Foundation is a PDP testing TB vaccines. Most of its board of directors19 were drawn from the pharmaceutical industry, and at least one is currently the president of a privately held biotech company. Its funding20 includes grants, “investments from industry partners”, and co-investments with other organisations, governments and institutions. The industry partners include Sanofi Pasteur, GSK and the biopharmaceutical companies, Okairos in Switzerland, and Crucell in the Netherlands.

In March 2011,21 Aeras and Crucell conducted a Phase 1 trial of a TB vaccine in Bangalore (it had already started Phase 2b trials in Kenya and South Africa) supported by the Research Council of Norway and the Indian government’s department of biotechnology. In 2012, the company announced plans to conduct, in India, the trial of another TB vaccine, being developed with GSK.22

What projects does BMGF fund in India?

In an Addendum we have compiled a partial list of BMGF-funded projects in India. From this list it can be seen that BMGF funding travels across a vast web of connections, including international institutions, Central and state governments, NGOs, educational and research institutions, public sector establishments, private corporate sector firms, and so on. This vast web provides it virtually unmatched reach, which can be translated into influence.

 What are the implications of BMGF collaborations with the Government?

We can get an idea of BMGF’s method of operation, and its influence, through some examples. One example of BMGF’s influence with the government is Grand Challenges India launched in April 2013.23 This is a collaboration between BMGF, India’s Department of Biotechnology (DBT) and its Biotechnology Industry Research Assistance Council. According to a BMGF press release,

Under the Memorandum of Understanding that was signed last year, the DBT and the Gates Foundation have agreed to invest up to $25 Million each over 5 years in innovations in vaccines, drugs, agricultural products, and interventions related to malnutrition, family and child health.

Among the ‘grand challenges’ are: to create new vaccines and improve existing ones; to develop genetic and chemical strategies to control vector-borne diseases; and to improve nutrition by creating a “nutrient-rich staple plant species”.

A director at DBT is quoted24 as saying that the collaboration would ensure that India has access to the medicines developed from this funding. The very fact that a Government department has felt it appropriate to take funds from a private institution indicates the extent of influence BMGF wields. It is not that the Government needs $50 million to run a grant programme of this kind. Nor does the Government need such collaborations to get access to the patents to manufacture the medicines – it is legally entitled to issue compulsory licensing for the manufacture of essential drugs.

For BMGF, however, the Grand Challenges India collaboration, with foundation board members on the advisory board, is a way to gain access to decision making in public health research in India – to choose the subjects and focus of research.

Of course there is no reason to believe that any drugs and vaccines – and even ‘nutrient-rich’ staple plant species – developed through the Grand Challenges will improve people’s health.

Another instance of BMGF influence is its substantial funding25 with the government, of the Public Health Foundation of India (PHFI). BMGF’s funding includes $15 million to set up public health schools across the country. This gives Gates a say in the functioning and direction of these institutions – the type of research they conduct, and the academic programmes they run.

What is BMGF’s impact on India’s vaccination programme?

Gates assigns technology a central role in addressing questions of public health; vaccinations are a prime instance of such technology.

India’s public health priorities, including which diseases to focus on tackling, need to be determined independently of pressure from foreign and private interests. These priorities need to be addressed in a comprehensive way, with nutrition, sanitation, drinking water, and preventive measures and curative care. However, in fact the priorities are influenced to a large extent by international and private pressures, which also try to dictate the methods of tackling those priorities.

An important example of this is the polio eradication campaign, which has been heavily promoted by the Gates Foundation, Rotary International, the World Health Organisation, and others. In fact, Bill Gates treats it as a test case to prove the efficacy of interventions of this nature in public health.26 Under external pressure, the Government of India ignored the fact that polio eradication is not a public health priority for India. It gave polio, in effect, precedence over all other questions of public health, mobilising vast numbers of its employees (including 2.3 million vaccinators) to vaccinate 170 million children.27 In this it showed a zeal, urgency, and liberality of funding woefully lacking in its overall public health efforts, or indeed its efforts to improve the living conditions which breed disease. (Bill Gates mentions proudly how polio vaccinators “found children in the poorest areas of Uttar Pradesh and in the remote Kosi River area of Bihar—an area with no electricity that is often flooded and unreachable by roads.28) By focusing on one disease and ignoring all others – the polio vaccine is the only vaccine recognised by people all over India – as well as the conditions which breed disease, the polio campaign diverts human and material resources from other pressing needs, and in fact contributes to weakening even the existing universal immunisation programme. Further, the repeated doses of live attenuated vaccine are responsible for cases of vaccine-derived polio paralysis – something the campaign initially denied but finally admitted. This also raises questions of the harm it causes to children who contract polio in spite of vaccination – children who are forced into the programme and not even compensated for the harm caused to them.29

Finally, this focus on polio eradication ignores other water-borne infections which would be prevented if people had access to clean water and sanitation. One critic points out that India received a token donation of just $0.02 billion for its polio programme, but wound up spending $2.5 billion on it: “It is tempting to speculate what could have been achieved if the $2.5 billion spent on attempting to eradicate polio were spent on water and sanitation and routine immunisation. Perhaps control of polio, to the level of elimination, may well have been achieved as it has been in more developed countries.”30 The Gates view is that other infections will be addressed by other vaccines.

Thus, for example, BMGF has been pressurising the Government to introduce the hepatitis B vaccine and a pentavalent vaccine (against diptheria, pertussis, tetanus, hepatitis B, and haemophilus influenza b). It has funded trials of human papilloma virus (HPV) vaccines. And it is funding the development of, and actively promoting, a rotavirus vaccine. In all these efforts, BMGF has consistently disregarded serious concerns raised by senior public health professionals regarding these vaccines’ relevance, public health value, safety, and cost/affordability for India, as well as the ethics related to their trials.31 In none of these cases have BMGF and its partners been able to convincingly refute the criticisms made. Despite this, the Government seems to be moving along the lines indicated by BMGF.

What is the overall impact of BMGF in India? Are there no benefits?

No one would claim that everything BMGF funds is bad. Many things are unexceptionable. But these could as well be funded by the public sector. The fact is, BMGF’s funding of useful activities provides it credibility and influence to promote a broader agenda.

As we said at the outset, BMGF’s funds are not large in relation to India’s total public health expenditure. The real impact of BMGF is to further a major shift in health policy which has taken place during the last two decades. Earlier, there was at least formal adherence to a comprehensive approach to public health including nutrition, sanitation, drinking water, preventive health care, and an appropriate and universal system of curative care. Since the 1990s, this was progressively replaced with a World Bank-promoted model, which plays down the public sector and tries to involve the private sector in delivery of health care; imposes user fees for public services; and focusses on specific interventions rather than a comprehensive approach.

This approach has reached its zenith with the entry of Gates and his foundation. Their aim is to install a public health model driven by private corporations, and revolving around the use of privately-owned technological interventions, a ‘magic bullet’ for each disease. While such a model is incapable of delivering public health, it is geared to deliver a private profit.

[For a detailed discussion on BMGF’s role in influencing India’s vaccine policy, please see: Srinivasan S. Shift in directions of medical research. Social Development Report 2014. Forthcoming.]

Sandhya Srinivasan is a consulting editor of the Indian Journal of Medical Ethics; the article above is taken from the blog of Research Unit on Political Economy, here.  RUPE is also on our lists of links.

 

 

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