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The ‘Moonshot’: Access To World-Class Cancer Care, For All

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As in every year, February the 4th was celebrated as the ‘World Cancer Day’, across the world, in 2016, as well. Its main objective is to commemorate all the efforts done by the World Health Organization (WHO), the United Nations (UN), including the governmental and nongovernmental health organizations towards formulating a grand strategy to fight against cancer. The strategy is expected to span across cancer prevention, detection and treatment, for all. The key goal of this commendable initiative is to reduce illness and death caused by cancer by 2020, the world over.

The event also encourages to explore various ways to align individuals and groups to do their bit in reducing both the local and the global burden of disease related to cancer.

The last Thursday, the ‘World Cancer Day’ was celebrated in India too, albeit in a low key, as I could fathom, despite its alarmingly ascending trend in the country.

In this context, I would start with my first and a very small example of a sharply contrasting mindset to address the vexing issue of cancer between the largest democracy of the world – India, and the oldest democracy of the globe – America.

The United States (US) this year, like the previous five years on a trot, made this event visible for a large section of people to encourage them to think and act against cancer, in several different ways that they can. The imposing landmark in New York – the magnificent ‘Empire State Building’ was lit in blue and orange, the colors of the ‘Union for International Cancer Control (UICC’), the organizers of this annual event.

A brief recap:

Cancer is now one of the leading causes of death, not just in India, but across the world. Its rate is expected only to go up further in the years ahead, and that too at a brisk pace. Just as the disease is fast spreading across the socioeconomic spectrum, all over, so are the tough access barriers for effective cancer diagnosis, treatment and care, for all, increasing by manifold.

Urgent action is called for in most of the countries of the world by the respective Governments to save precious lives, by effectively overcoming most of these hurdles, soon.

With this backdrop, in this article, I shall explore what is happening on the ground in this direction, at present, drawing examples from the two greatest democracies of the world.

The largest democracy of the world:

Delivering affordable and equitable care for cancer to all, is one of greatest public health challenges of the largest democracy of the world – India. The country is required to face this challenge boldly and squarely, to mitigate the devastating socioeconomic and human costs that this disease is already costing our nation.

This point was reiterated by one of the lead authors of an article published by ‘The Lancet Oncology’ on April 11, 2014. The paper discussed the epidemiology and social context of the growing burden of cancer in India.

According to this paper, around 600,000 – 700,000 deaths in India were caused by cancer in 2012, with more than 1 million new cases of this life threatening disease being diagnosed every year.

Further, the World Health Organization (WHO) also reported that every year, around 145,000 women are diagnosed with breast cancer in India. Unfortunately, around half of them had succumbed to the disease, in 2008.

However, all these numbers should be taken into consideration carefully factoring in very low rates of early-stage detection and poor treatment outcomes in the country.

In this prevailing scenario, cancer is fast becoming a major public health concern in India, with the number of new cancer cases projected to nearly double within the next 20 years.

The average cost of cancer treatment in India:

According to the above ‘Lancet Oncology’ report, in India, the average cost of treating a typical patient with cancer at a government facility would come around US$593. Whereas, the average annual income per person is only U$ 1,219, with 27.5 percent of the population living on or below a daily income level of US$ 0.4.

Besides, most district hospitals, including the regional cancer centers do not have the requisite facilities required to provide quality cancer care to all those patients who need them.

Quoting experts, a newspaper report on June 19, 2014 also stated, around 50 per cent of the diagnosed cancer patients, who also commence their treatments, stop visiting hospitals after two or three cycles of chemotherapy, as they find the cost of treatment is not affordable to them. They also drop out from regular follow-up visits, say the doctors.

Low Government funding for healthcare:

As a result of abysmally poor public funding for healthcare in India, both by the Central and most of the State Governments, the cost of diagnosis and treatment of cancer is increasingly becoming out of pocket, and being catastrophically expensive, going beyond the reach of a large number of patients suffering from this serious ailment.

The socioeconomic impact:

This pathetic public healthcare system in India adversely affects not only the debt ridden poor and middle-class cancer patients, but also the welfare and education of several generations of their respective families.

Thus, cancer has a profound, both social and economic, consequences for the general population in India. This very often leads to family impoverishment and societal inequity, as the study points out.

The oldest democracy of the world:

The oldest democracy of the world – America, is one of the richest countries in the globe, having perhaps the best healthcare facilities and systems. All the latest drugs and diagnostics are also available there. Despite all these, there is a growing inequity in the cancer treatment in America too, with access to quality diagnosis and treatment for cancer patients becoming a major health, economic and political issue for the country.

‘Mayo Clinic Proceedings’ of August 2015, also expressed concern on the high prices of cancer drugs, which are affecting the care of cancer patients and eventually the American health care system.

The report does ring an alarm bell for high cancer care cost for many patients in America. The ‘Proceedings’ highlighted the following reasons, most of which are, quite interestingly, very similar to India: 

  • Cancer will affect 1 in 3 individuals over their lifetime.
  • Recent trends in insurance coverage put a heavy financial burden on patients, with their out-of-pocket share increasing to 20 percent to 30 percent of the total cost.
  • In 2014, all new US Food and Drug Administration (US FDA) approved cancer drugs were priced above US$ 120,000 per year of use. 
  • The average annual household gross income in the United States is about US$ 52,000.
  • For a patient with cancer who needs one cancer drug that costs US$120,000 per year, the out-of-pocket expenses could be as high as US$25,000 to US$ 30,000 – more than half the average household income and possibly more than the median take-home pay for a year.
  • Thus, cancer patients have to make difficult choices between spending their incomes and liquidating assets on potentially lifesaving therapies or foregoing treatment to provide for family necessities, such as, food, housing and education.
  • This decision is even more critical for senior citizens who are more frequently affected by cancers and have lower incomes and limited assets.
  • Because of costs, about 10 to 20 percent of patients with cancer do not take the prescribed treatment or compromise it. It is documented that the greater the out-of-pocket cost for oral cancer therapies, the lower the compliance. This is a structural disincentive for compliance with some of the most effective and transformative drugs in the history of cancer treatment. 
  • Given the rising incidence of cancer in the aging American population, high cancer drug prices will affect millions of Americans and their immediate families, often repeatedly. 

General public wants the US Government to act:

‘The Mayo Clinic Proceedings’ findings were vindicated by the October 2015 Kaiser Health Tracking poll, which reported, 76 percent of the public believes that a top priority for the American president and Congress should be making high-cost drugs for chronic conditions affordable. Yet another Kaiser poll found 72 percent of Americans believe drug costs are unreasonable and 74 percent think that pharma companies, in general, care more about profits than people.

General public expectations and belief do not seem to be any different in India too. 

I reckon, due to similar reasons in most countries of the world, an urgent action is required from the respective Governments to make cancer diagnosis and treatment affordable to all, sooner than later.

Different responses to the same problem:

Let me reiterate here again, that I am comparing India with America on this issue, not for any other reason, but just to give an example and a feel of how much the promised political intent, made for the benefit of the general population of the country, gets translated into reality in the world’s oldest democracy, as compared to the world’s largest democracy.

In India, despite high sound bytes emanating from various leaders of the principal party in power today, the fragile public healthcare system is still gasping for breath, starved by grossly inadequate resource allocations. This gets reflected on the details of national and state budgetary allocations for healthcare in India.

The delay in finalizing and then putting in place for implementation of the “National Health Policy”, which proposed making health a fundamental right and denial of health an offense, also seems to be of low priority for the national Government, at present. If so, this will indeed be quite contrary to its earlier firm promises on improving healthcare in India.

In the United States, as well, similar promises were made by senior politicians during the last national election campaign. The Presidential candidate for the party, which is now in power, created as much hype with matching sound bytes for healthcare reform in America, while seeking votes.

However, the sharp difference between the two similar situations is, having come to power on November 4, 2008 President Barack Obama, fulfilled his promise with a path breaking healthcare reform in his country. On March 23, 2010 he signed into law the ‘Affordable care Act’. It’s a different matter though, like most political decisions, this one also faced its own share of criticism from the American opposition.

The ‘Moonshot’:

Zeroing in specifically to address the agony of cancer patients in America, President Obama has recently initiated a ‘National Mission’ in this area. He has asked his Vice-President Joe Biden to spearhead this mission and get it done expeditiously. Biden enthusiastically accepted to lead this noble ‘National mission’ for mankind and termed it ‘A Moonshot for Cancer Cure’. The White House also announced a resource commitment of US$1 billion on this effort over the next two years.

In his ‘White House’ Blog Post of January 13, 2016 the Vice-President wrote about this project, very close to the ‘World Cancer Day’, which is basically symbolic, just as the ‘International Day of Yoga’, but this specific American ‘National mission’ against cancer does not appear to be so, by any stretch of imagination.

The key objective of this mission is indeed profound. With is effective implementation, the American Government wants to ensure that ‘the same care provided to patients at the world’s best cancer centers, is available to everyone who needs it.’

Joe Biden admitted, though several cutting-edge areas of research and care, including cancer immunotherapy, genomics, combination therapies and innovations in data and technology are revolutionary, all these are currently trapped in silos, preventing faster progress and greater reach to patients. 

It’s not just about developing game-changing treatments. It’s about delivering them to those who need them the most. The community oncologists, who treat more than 75 percent of cancer patients, have more limited access to cutting-edge research and advances, even in America, Vice-President Biden elaborated. 

Two key focus areas:

  • Increase resources, both private and public, to fight cancer.
  • Break down silos and bring all the cancer fighters to work together, share information, and end cancer, as we know it.

The goal of this initiative is to double the rate of progress by making a decade worth of advances in five years. He also outlined the details that he would follow to get this mission implemented on the ground within the set time frame.

“If there’s one word that defines who we are as Americans…” – Biden

Joe Biden concluded this announcement with his natural statesmanship, sans any drama, by saying: “If there’s one word that defines who we are as Americans, it’s ‘possibility.’ And these are the moments when we show up.”

The good news is, the project ‘Moonshot’, as the American Vice-President calls it, has already started with the full commitment of the American Government and backed to the hilt by none other than President Obama himself. The American President has already demonstrated to the world, from the very commencement of his Presidency, that he is a project implementer per excellence, as head of the Government.

Some key barriers to effective 'cancer care' in India:

Coming back to the Indian context, experts do indicate that one of the main barriers to cancer care, in the largest democracy of the world – India, is primarily lack of enough public facilities for early detection of cancer. Thus, even when it is detected considerable disease progression usually takes place. Moreover, most patients lack access to expensive cancer treatment and are compelled to give up the treatment for this reason. Consequently, as the data reveals, less than 30 percent of patients suffering from cancer in India survive for more than five years after diagnosis, while over two-thirds of cancer related deaths occur among people aged 30 to 69.

According to the data of the Union Ministry of Health, 40 percent of over 300 cancer centers in India do not have adequate facilities for advanced cancer care. It is estimated that the country would need at least 600 additional cancer care centers by 2020 to meet this crying need.

Conclusion:

It appears to me, even meeting this basic need for cancer care will be extremely challenging with frugal public healthcare spending in India. As I said before, it gets well reflected in the successive annual budgetary allocations for the same, both by the Central and most of the State Governments. Added to this, the ‘National Health Policy’, which was first drafted and released in December 2014 by the Ministry of Health for the stakeholders’ comments, is yet to be put in place. The draft policy recommended, among many others, making health a fundamental right of Indian citizens.

According to ‘The World Bank’ report, the public expenditure for health as a percentage of GDP of the oldest democracy of the world is already hovering over 8, against around just 1 of the largest democracy of the world. On top of this, the present American Government has committed, even more resources to usher in a new era of hope for all cancer patients with its latest ‘National Mission’ – ‘A Moonshot for Cancer Cure’.

There is a lot to feel good about it, even as an Indian, as this health mission, termed as ‘‘A Moonshot for Cancer Cure’ by the American Vice-President assures that ‘the same care provided to patients at the world’s best cancer centers, is available to everyone who needs it.’ Its overall benefits could possibly reach even the Indian patients…who knows?

Like 2016, and the previous years, the ‘World Cancer Day’ would come and go with the turn of every calendar year. Hopefully, things will be quite different sometime in future. India would possibly initiate the much awaited health care reform in the country and more specifically effective ‘cancer care’ for all, with requisite budgetary provisions in place. Till then, do the cancer patients in India have any other choice, but to eagerly wait for it, hoping for the best outcome?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Reverberations Around The Proposed New IPR Policy Of India

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“If the Obama administration succeeds in forcing India to strengthen its patent laws, the change would harm not only India and other developing countries; it would also enshrine a grossly corrupt and inefficient patent system in the US, in which companies increase their profits by driving out the competition – both at home and abroad. After all, generic drugs from India often provide the lowest-cost option in the US market once patent terms have expired.”

The above sharp, piercing and precise comment did not come from any health activist from India or elsewhere. It came from a team of highly credible academic experts working in the United States.

On February 10, 2015, Nobel Laureate in Economics – Joseph E. Stiglitz, who is also University Professor at Columbia University, former Chairman of President Bill Clinton’s Council of Economic Advisers and Chief Economist of the World Bank, made this comment in an article published in ‘The World Opinion Page’ of ‘Project Syndicate’.

The article is co-authored by Dean Baker, Co-Director of the Center for Economic and Policy Research in Washington DC and Arjun Jayadev, Professor of Economics at the University of Massachusetts, Boston.

The authors arrived at the above conclusion based on some sound arguments. I am highlighting below some of those important ones (may not be in the same order):

  • A patent that raises the price of a drug a hundred-fold has the same effect on the market as a 10,000 percent tariff.
  • India’s Patents and Act and policies allow drugs to be sold at a small fraction of the monopoly prices commanded by patent holders. For example, the Hepatitis-C drug Sovaldi is sold for US$84,000 per treatment in the US; Indian manufacturers are able to sell the generic version profitably for less than US$1,000 per treatment.
  • The threat of competition from Indian generics is partly responsible for major pharmaceutical companies’ decision to make some of their drugs available to the world’s poor at low prices. If the US compels India to tighten its patent rules substantially, so that they resemble US rules more closely, this outcome could be jeopardized.
  • Multilateral approach, using the World Trade Organization (WTO), has proved less effective than the major multinational pharmaceutical companies hoped, so now they are attempting to achieve this goal through bilateral and regional agreements.
  • In the view of America’s pharmaceutical industry, TRIPS did not go far enough. The Indian government’s desire to enhance its trade relations with the US thus provides the industry an ideal opportunity to pick up where TRIPS left off, by compelling India to make patents easier to obtain and to reduce the availability of low-cost generics.
  • In September 2014, during his visit to the US, Indian Prime Minister Narendra Modi agreed to establish a working group to reevaluate the country’s patent policy. The US participants in that group will be led by the Office of the US Trade Representative, which serves the pharmaceutical companies’ interests, rather than, say, the National Academy of Sciences, the National Science Foundation, or the National Institutes of Health.

Any comparable voice in favor of changes in Indian Patents Act?

I don’t seem to have heard or read as strong arguments from as credible sources as Nobel Laureate Joseph E. Stiglitz, Dean Baker and Arjun Jayadev – the authors of the above article, in favor of the changes that American pharma companies want in the Indian Patents Act.

India at the center stage in IPR debate:

In the IPR debate, India is continuously being seen at the center stage for various reasons. The key one being the size, scale and economic efficiency that the home grown Indian pharma players have attained to cater to the needs of a large number of global population, including those residing in the United States and Europe, with a wide range of high quality generic drugs at affordable prices.

Fast evolving scenario:

It is now absolutely clear that being rattled by several refusals of India’s granting product patent to very similar molecules with minor tweaking under section (3d) of the country’s Patents Act, together with the nation’s uprightness in issuing Compulsory License (CL) for an enormously expensive cancer drug reducing its price by over 95 percent, United States now intends to directly intervene into India’s IPR policy environment.

As Nobel Laureate Stiglitz wrote, keen desire of the new dispensation of the Indian government to enhance its trade relations with the US has provided a golden opportunity to American pharma companies and their paid lobbyists to jump into the fray. They have started exerting enormous pressure on their own Government to compel India, at bilateral discussions, dilute its well-balanced Patents Act, ignoring India’s sovereign right to play by the flexibilities as provided by the WTO to protect public health interest in the country.

Both the domestic and international civil society organizations, including public health activists have expressed their serious concerns on this aggressive intent of US and India’s seemingly vulnerable position in this regard.

“The US is pushing India to play by its rules on Intellectual Property, which we know will lead to medicines being priced out of reach for millions of people,” commented the Executive Director of MSF’s Access Campaign, according to media reports.

Non-pharma American Organizations reacted differently:

14 American organizations in a letter to their President Barack Obama dated January 20, 2015, just prior to his visit to India, asked him “to support India’s central role in providing high-quality, low-cost generic medicines -which are essential for health care around the world. Recent U.S. policy stances have sought to topple parts of India’s intellectual property regime that protect public health in order to advance the interests of multinational pharmaceutical corporations in longer, stronger, and broader exclusive patent and related monopoly rights. India’s laws fully comply with the WTO TRIPS Agreement. Millions around the world depend on affordable generic medicines that would disappear if India acceded to these proposals, including many beneficiaries of US-funded programs. Instead of using your trip to promote the narrow interests of one segment of the pharmaceutical industry, we ask you to support the interests of people who need affordable medicines, whether they live in the U.S., in India, in Africa or elsewhere. Our world is safer and healthier because of India’s pro-health stance and we ask you to say so publicly while you are there.”

The letter re-emphasized at the end:

“From Detroit to New Delhi, health is increasingly interconnected. Our world is safer when it is healthier, and it is healthier because India’s laws appropriately balance health and IP.” 

An interesting development:

It is interesting to note that after Winter Session of the Indian Parliament, the Modi Government announced a number of important policy changes at the end of December 2014.

Interestingly, one more critical policy – National Intellectual Property Rights (IPR) Policy has been left open for public comments and the final IPR Policy is yet to be announced despite enormous American pressure on India in this regard.

Without any specifics, the first draft of the National IPR policy just states that India will “review and update IP laws, where necessary, and remove anomalies and inconsistencies, if any.”  It does emphasize though, the need of “more innovation” in the country, unequivocally and quite justifiably.

I wrote on the draft National IPR Policy in my blog post of January 19, 2015, titled “New “National IPR Policy” of India – A Pharma Perspective”.

Conclusion:

It is generally believed that the National Intellectual Property Rights (IPR) Policy is undoubtedly a positive step to clarify the Government’s stand in maintaining a balanced IP regime in the country that would encourage innovation to add speed to the progress of the nation.

In just 10 years Indian IPR regime has, by and large, attracted enormous global attention mostly for balancing IP and public health interest, admirably. Experts like Nobel laureate Joseph E. Stiglitz sincerely hope that India will not change this course under pressure of any kind or form.

Be that as it may, several recent media reports also speculated, around the same time, that Government of India is probably considering putting in place ‘Data Exclusivity’ and ‘Patent Linkage’ through administrative measures, without making any amendments in the Patents Act of the country.

In my subsequent articles in this blog, I shall deliberate on these two contentious issues, keeping the evolving scenario in perspective.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

What President Obama And Prime Minister Modi Discussed On IPR And Healthcare In India

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During the recent visit of the US President Barack Obama to India from January 25-27, 2015, both the domestic and international media was abuzz with the speculation, whether or not India would concede some ground to America on the prevailing, generally considered, well balanced patent regime in India.

Many expected that the American delegation would succeed in getting some specific assurances from Prime Minister Narendra Modi to follow the line of the US style Intellectual Property Rights (IPR) in India, which would help the American pharma companies to maximize their financial returns in the country.

The assurances from India were expected mainly in areas involving grant of patents even to those pharma products, that do not quality for the same under section 3(d) of the Indian Patents Act 2005, dilution of provisions for Compulsory License (CL) and creation of a new provision for Data Exclusivity in the country, besides a few others.

As everyone noticed, just before the US President’s visit, interested groups both in India and also from abroad intensified lobbying and released op-eds to create pressure on the Indian negotiators, in general, and the Prime Minister Modi in particular.

Terming the Indian Patents Act weak, the lobby groups turned the Indian IPR regime on its head. Playing the role of India’s benefactor, they re-packaged their shrill collective voice into pontificating words while giving interviews to the Indian media by saying: “A strong IPR regime could allow the country (India) to make a major contribution to tackling health challenges, both domestically and around the world.”

Additional US interest in Indian IP regime from TPP perspective:

Exemplary demonstration of India’s resistance to intense external pressure, time and again, for dilution of the IP regime in the country, seems to have become a model to follow for the emerging economies of the world, in general. This trend now gets reflected even among some of the members of the 12-nation Trans-Pacific Partnership (TPP), which is a proposed regional regulatory and investment treaty.

According to reports, TPP members, such as, Brunei, Malaysia, Singapore and Vietnam are negotiating hard to get incorporated somewhat similar to Indian IP rules in the TPP agreement. Besides America, other members of the TPP are Australia, Japan and New Zealand, Canada, Chile, Mexico and Peru.

TPP negotiations are generally expected to follow the overall framework of American laws. However, according to media reports, based on the leaked draft of the TPP, the data exclusivity period for biologic medicines has already been negotiated down to 7 years, from 12 years under the US Affordable Care Act.

However, on January 27, 2015, US Senator Orrin Hatch, Chairman of the Senate Finance Committee reportedly said that he would oppose Senate approval of the TPP, if it does not provide 12 years of patent protection for biologics.

The same day, at a hearing before the House Ways and Means Committee, US Trade Representative Mike Froman reportedly reiterated, “The US is insisting on 12 years of IP protections, even though the Obama administration’s budget calls for 7-year exclusivity on biologic meds.”

It is also worth noting that Nobel laureate Joseph E. Stiglitz in an op-ed titled, “Don’t Trade Away Our Health”, published in The New York Times of January 30, 2015 commented as follows:

“TPP could block cheaper generic drugs from the market. Big Pharma’s profits would rise, at the expense of the health of patients and the budgets of consumers and governments.”

Clicking on this short video clip you will be able watch another similar viewpoint on TPP, its general perspective and what it encompasses.

Thus, the closely guarded ‘turf war’ on TPP is now heating up, making negotiations increasingly tougher to arrive at a consensus on the IP rules that would be applicable to pharmaceutical products in this trade initiative. Consequently, the evolving scenario has prompted the interested groups to keenly follow, with hopes, the outcome of Presidents Obama’s recent visit to India, especially in the pharma IP areas. This is because, many emerging economies of the world are now appreciative of the prevailing well-balanced patent regime in India.

After the 12-nation TPP agreement comes into force, probably following the lines of the US IP laws, it is quite possible that India may sometime in future would prefer to be a part of this agreement for greater trade facilitation, as the country comes closer to America…Who knows?

However, in that case the bottomline is, India would have to amend relevant provisions of its Patents Act in conformance with the requirements of mainly the US pharmaceutical companies and the IP laws prevailing in America, as this will be necessary to become a new member of this treaty.

Discussion in the summit meeting:

According to the Joint Statement on the summit meeting released by the White House, President Obama and Prime Minister Modi discussed the following subjects related to IPR and Healthcare in India, as detailed below:

  • Reaffirmed the importance of providing transparent and predictable policy environments for fostering innovation.  Both countries reiterated their interest in sharing information and best practices on IPR issues, and reaffirmed their commitment to stakeholders’ consultations on policy matters concerning intellectual property protection.
  • Reaffirmed their commitment to the Global Health Security Agenda (GHSA) and announced specific actions at home and abroad to prevent the spread of infectious diseases, including a CDC-Ministry of Health Ebola and GHSA preparedness training, expansion of the India Epidemic Intelligence Service, and development of a roadmap to achieve the objectives of the GHSA within three years.
  • Committed to multi-sectoral actions countering the emergence and spread of antimicrobial resistance (AMR), and cooperation in training of health workers in preparedness for infectious disease threats. The Leaders agreed to focus science and technology partnerships on countering antibiotic resistant bacteria and promoting the availability, efficacy and quality of therapeutics.
  • Welcomed further progress in promoting bilateral cooperation on cancer research, prevention, control, and management and agreed to continue to strengthen the engagement between the CDC and India’s National Centre for Disease Control.
  • Welcomed the upcoming completion of an Environmental Health, Occupational Health and Injury Prevention and Control MoU between the U.S. Centers for Disease Control and Prevention and the Indian Council for Medical Research to further collaborative efforts to improve the health and welfare of both countries’ citizens.
  • Agreed to expand the India-U.S. Health Initiative into a Healthcare Dialogue with relevant stakeholders to further strengthen bilateral collaboration in health sectors including through capacity building initiatives and by exploring new areas, including affordable healthcare, cost saving mechanisms, distribution barriers, patent quality, health services information technology, and complementary and traditional medicine.
  • Pledged to encourage dialogue between the U.S. Department of Health and Human Services and its Indian counterparts on traditional medicine.
  • Pledged to strengthen collaboration, dialogue, and cooperation between the regulatory authorities of the two countries to ensure safety, efficacy, and quality of pharmaceuticals, including generic medicines.
  • Agreed to accelerate joint leadership of the global Call to Action to end preventable deaths among mothers and children through a third meeting of the 24 participating countries in India in June 2015.  As host, India will showcase the power of new partnerships, innovations and systems to more effectively deliver life-saving interventions.
  • Also lauded the highly successful collaboration on a locally produced vaccine against rotavirus, which will save the lives of an estimated 80,000 children each year in India alone, and pledged to strengthen the cooperation in health research and capacity building through a new phase of the India-U.S. Vaccine Action Program.

As stated earlier, during this summit meeting, US lobbyists were reportedly nurturing a hope that Prime Minister Modi would eventually agree, at least in principle, to jettison section 3(d) on the patentability criteria enshrined in the Indian Patents Act 2005 and significantly water down the country’s Compulsory License (CL) provisions. This expectation increased, when the US President made the investment promise of U$4 billion in India.

That said, from the above points of discussion in the joint statement, it appears that no breakthrough on the part of the US was achieved especially in the IPR space, during the summit.

However, in other areas of bilateral healthcare co-operation, such as, science and technology partnerships in countering antibiotic resistant bacteria; cancer research and traditional medicines; the reaffirmations made by the two leaders are encouraging.

US pressure on IP to continue:

Going by India’s reaffirmation during the summit meeting of its commitment to consultations with America on policy matters related to IPR protection and US Trade Representative Mike Froman’s reported affirmation of the following to the US lawmakers during a Congressional hearing held on January 27, 2015, it is construed by the IP activists that the kettle has possibly started boiling:

- “We have been concerned about the deterioration of the innovation environment in India, and we have engaged with the new government since they came into office in May of last year about our concerns,”

- “We held the first Trade Policy Forum in four years in November. I just returned from India yesterday as a matter of fact … and in all of these areas, we have laid out a work program with the government of India to address these and other outstanding issues.”

- “We are in the process of providing comments on that draft policy proposal on IPR, and we are committed to continuing to engage with them to underscore areas of work that needs to be done in copyright, in trade secrets as well as in the area of patents,”

- “We’ve got a good dialogue going now with the new government on this issue, and we’re committed to working to achieve concrete progress in this area,”

Media reports also indicate that US pressure on IPR would continue, as they highlight:

“Threatened by free trade of high-quality and affordable medicines, US-based pharmaceutical companies and politicians friendly with the industry are using prominently placed op-eds, large advertisements on Washington, D.C. buses, and letters to President Obama to spread false information -claiming India’s rules are not legal or discourage innovation. The companies have been threatening to withhold investment if India does not adopt weaker patent laws that would extend pharmaceutical monopolies and stymie the country’s generic industry.”

I discussed some of these issues in my blog post of January 19, 2015, titled “New National IPR Policy of India – A Pharma Perspective”.

Conclusion:

Irrespective of whatever the US-India Joint Statement says on IPR, some experts do apprehend that Indian Government may now wilt under continuous intense pressure from the American Government. This is mainly because, India’s Commerce and Industry’s Minister has reportedly sought America’s inputs in the finalization process of the new National IPR policy of the country.

On this score, let me hasten to add that it may not be prudent to read too much into it, as seeking stakeholders’ comments on such matter is a practice that India has been following since long on various issues and policies.

However, at the same time, other groups of experts nurture a quite different viewpoint. They are confident that the nationalist Modi Government, under no circumstances would concede its long nurtured strategic ground on IPR to the US power play.

Emerging countries across the globe are keenly watching this intense game of  ‘Power Chess’, as they plan to emulate India in many of the pharmaceutical IP areas to uphold the public health interest, providing affordable healthcare to all.

These are still early days. Thus, in my view, on January 25, 2015, what President Barack Obama and Prime Minister Narendra Modi discussed on the IPR regime in India may not be as important as what they would eventually decide to agree, disagree or agree to disagree in this area, moving on from here.

Only time would prove…not just who is right, that is pretty obvious to many, but who wilts at the end of the day…and more importantly, why?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.