Tag Archives: Summit

At The Indian IPR Front: ‘Ground Control, There’s No Major Storm’

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The incessant pressure of the developing countries on India, from 2005 to date, to include various restrictive conditions in the Indian Patents Act 2005, still continue. This demand spans across the inclusion of even those provisions, which many experts term as TRIPS-Plus, as these are not required by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. More interestingly, the pressure group also insists on the simultaneous deletion or dilution of some existing important provisions in the statute that guarantee public health interest of the nation.

This pressure is expected to mount in the G20 summit of September 4-5, which is now being held in China.

Refreshingly, on 30 August 2016, just ahead of this summit, the eminent economist Dr. Arvind Panagariya, who is also the incumbent Vice Chairman of Niti Aayog of India, and India’s Sherpa at the G20 summit reiterated, as follows, in an interview to a leading National English Business Daily:

“India has strongly opposed the language of the draft on Intellectual Property Protection (IPR) to be taken up at the upcoming G20 meeting in Beijing.”

In the interview, having re-emphasized the critical point that “there is a certain flexibility that we have under the TRIPS agreement and anything that dilutes that flexibility is not acceptable to India,” Dr. Panagariya clearly reaffirmed, yet again that ‘Indian IPR laws and policies are absolutely TRIPS compliant’.

This statement indeed sends a very positive signal to all on the ground, regarding the robust position maintained by the Government, to ward off any move by the overseas vested business interest to derail the flexibility that Indian well-balanced patent regime offers today, not just for public health, but also to foster innovation ecosystem in the country.

At the same time, India’s Sherpa at G20 summit also reportedly clarified that the IPR framework being proposed at the G20, in its strictest sense, cannot be construed as TRIPS-Plus. Nevertheless, some language used in the proposed G20 draft could be subject to interpretation, and India feels that it should not leave any room for ambiguity that has the potential to stretch this demand further, as we move on.

According to Dr. Panagariya: “Right now, these documents have some language where people in the Department of Industrial Policy & Promotion (DIPP) feel that it impinges a bit. We have to fight it out at the summit.”

The basis of apprehension:

There are many reasons for the recent apprehension that India may buckle under the US pressure to dilute its IP laws and policies. One of the reasons could well be a possibility that India has come to an understanding with USTR in this area.

An interesting article published in the ‘spicyip’ on March 14, 2016 also captured this scenario pretty well. I am reproducing below in verbatim a paragraph of this paper, just as an example:

“Last month, the Indian government privately assured the US-India Business Council (“USIBC’’) that it would not invoke compulsory licensing for commercial purposes, as reported in their submissions (available here) to the United States Trade Representative (“USTR”) for the 2016 Special 301 Review. The USIBIC stated that it would be “further encouraged” if the government of India were to make a public commitment, or a written declaration to only issue compulsory licenses in the event of public health emergencies, and not for commercial purposes. This, in their eyes, would “greatly enhance legal certainty for innovative industries”. While such a private assurance doesn’t give rise to any legal commitments, it may well be indicative of a policy shift.”

Prior to this, among many others, a March 3, 2016 ‘The Wire’ report captioned “India Assures the US it Will Not Issue Compulsory Licenses on Medicines”, also raised the same red flag.

The pressure continues even post engagement:

Be that as it may, America has been, repeatedly, raising its concerns over India’s patent regime, driven by its powerful pharma lobby groups.

To keep the kettle boiling, the Office of the United States Trade Representative (USTR) in its 2016 Special 301 Report released this year on April 12, continued to keep India, along with 11 countries, on the Priority Watch List (PWL) for the current year.

USTR reportedly expressed serious concern about Indian IP policies stating that the regime apparently ‘favor’ indigenous manufacturing or Indian innovators. It also alleged that such direction ‘damages’ the patent infrastructure not just in India, but across the world.

It is believed by many that the Special 301 Report is, in fact, a formal posturing of the country on their unilateral IP related business hurdles for the year, exhibiting the power to implement unilateral trade sanctions when the US demands are not met.

In that context, the 2016 Special 301 Report caught many by surprise, as the Indian ‘IPR Think Tank’ (a body of the Union Government-selected experts) was also working closely with the United States to identify and address their issues of concern, such as, patent system, copyright infringement, trademark and counterfeiting, among others.

At that time, this discussion was possibly in its final stage as, just a month after, on May 12, 2016, the Union Cabinet approved the National Intellectual Property Rights Policy (IPR) of India, as proposed by the ‘Think Tank’, in consultation with, among others, especially the United States, which reportedly expressed its overall satisfaction with the final IPR policy.

Key concerns:

From the pharma industry perspective, the key IP concerns are centered, primarily, in the following three areas, besides a few others:

  • Patentability
  • Compulsory Licensing (CL)
  • Data Exclusivity

I would, therefore, concentrate briefly on these three areas to argue how reasonable is the Indian Patents Act 2005 to create a win-win situation both for the patients and the industry while fostering pharma innovation in the country.

Patentability:

One of their key concerns on patentability, revolves round an important provision in the statute – Section 3 (d).

Pharma Multinational Corporations (MNCs), and their trade associations have been going overboard, since long, to lobby hard to make all concerned believe that section 3 (d) is a stumbling block for pharma innovation, as it does not allow patent protection on known chemical substances lacking any significant improvement in clinical efficacy.

This provision of the statute prevents ever-greening of patents with frivolous incremental innovation. Consequently, it blocks the possibility of pricing such ‘me too’ new molecules, exorbitantly, and persuading the prescribers of the existing molecule switching over to the new brand, backed by contentious marketing campaigns, adversely impacting affordability and access to the majority of the patients in India.

Notwithstanding the shrill voices of vested interests, Section 3 (d) has been upheld by the Supreme Court of India in the famous Glivec case of Novartis against Cipla.

The Submission of the Federation of Indian Chambers of Commerce and Industry (FICCI) to USTR for the Review of ‘2016 Special 301 Report’, categorically also states that the Indian Patent Act prescribes a higher threshold on inventive step for medicines, which is in keeping with the TRIPS Agreement, Paris Convention and the Doha Declaration. Hence, Section 3 (d) is sound in terms of the TRIPS, Public policy and Health policy.

Compulsory License (CL):

Besides the hard fact that India has, so far, granted just one CL in a span of more than the last ten years, the Doha Declaration on the TRIPS Agreement related public health clearly provides the flexibility to all its member states to decide on the necessary grounds for granting CL. It is noteworthy that for public health interest, TRIPS flexibilities for CL has been used even by the developed countries, such as, Canada, United States and Germany, in the not too distant past.

Data exclusivity:

The terminologies ‘Data Exclusivity’ and ‘Data Protection’ are quite often used interchangeably by many, creating a great deal of confusion on the subject. However, in a true sense these are quite different issues having a critical impact on the public health interest of a nation.

In an article published in ‘ipHandbook’, titled “Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals”, the author Charles Clift, a former Secretary, Commission on Intellectual Property Rights, Innovation and Public Health, World Health Organization; differentiated these two terminologies as follows:

Data Protection (DP): Protection of commercially valuable data held by the drug regulator against disclosure and unfair commercial use.

Data Exclusivity (DE): A time bound form of Intellectual Property (IP) protection that seeks to allow companies recouping the cost of investment in producing data required by the regulatory authority.

According to Charles Clift, Article 39.3 only articulates widely accepted trade secret and unfair competition law, and is not an invitation to create new IP rights, per se, for test data. Nor does it prevent outside parties from relying on the test data submitted by an originator, except in case of unfair commercial practices.

Some developed countries, such as the United States and the European Union have argued that Article 39.3 of TRIPS requires countries to create a regime of DE, which is a new form of time-limited IP protection. However, it is worth noting that in both these countries DE regime was adopted prior to the TRIPS Agreement. Hence, many experts construe such approaches and pressure, thus created for DE, as ‘TRIPS-Plus’.

In its new IPR Policy, India has successfully resisted the demands of TRIPs-Plus provisions, such as, data exclusivity, patent linkage and patent-term extension.

Even the draft IPR policy had reiterated that India accepts: “Protection of undisclosed information not extending to data exclusivity.”

Any near-term possibility of a change in the statute?

While the new IPR Policy of India focuses on consolidating institutional mechanisms to create a robust IPR ecosystem in the country, besides resolving some pressing issues, such as, expediting approval processes involving patents or trademarks, it does not indicate any possible change in the important provisions in the Patents Act 2005, including the much talked about Section 3 (d) and compulsory licensing, despite concerns expressed by the US and pharma companies.

Moreover, a May 13, 2016 Press Trust of India (PTI) report on the Union Cabinet approval of Indian IPR Policy quoted a Government official, as follows, negating the apprehensions that the government may yield to the pressure of developed countries with regard to its IR regime:

“India will never go beyond its current commitments in the TRIPS. Section 3 (d), patent linkage, data exclusivity and compulsory licensing are red lines.”

On the same day and in the same context, Union Finance Minister Arun Jaitley also reportedly stressed that India’s IPR policies are TRIPS-compliant and encourage invention of life-saving drugs, while at the same time, “we must also be conscious of the need to make it available at a reasonable cost so that drug cost does not become prohibitive as has become in some parts of the world”, he articulated, unambiguously.

Conclusion:

Despite all these developments, reiterations and interpretations, a lurking fear on India’s diluting the current patent regime of the nation was refusing to die down in the country.

Many experts were also quite apprehensive about what would be India’s stand on IP in the G 20 summit on September 4-5, currently being held in China.

Is it, then, just a storm in a tea cup on the ground?

This is not a very easy question to answer, though, as many industry watchers sense. Nonetheless, yet another emphatic statement on the subject coming from a top Government echelon and none other than Dr. Arvind Panagariya, the Vice Chairman of Niti Aayog and India’s Sherpa at G20 summit, possibly sends a clear message, at least for now, to all those holding ground in the Indian IPR front:

‘Ground Control, There’s No Major Storm’.

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. 

Worsening Health Effect Of Climate Change In India: A Perspective

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At present, out of the top five most pressing global and local environmental challenges, ‘Climate Change’ features at the top.

It has been broadly defined as, “a change in global or regional climate patterns, in particular a change apparent from the mid to late 20th century onwards and attributed largely to the increased levels of atmospheric carbon dioxide produced by the use of fossil fuels.” 

The impact of Climate Change’ is so profound that, if not addressed immediately, it would most likely to cause extinction of human life from the planet Earth and that too in the most agonizing and painful way, lasting over a long period of time.

The Paris Summit and its objectives: 

To effectively address the ‘Climate Change’ issue, nearly 150 world leaders of 196 countries, including Prime Minister Modi, deliberated in the Paris summit earlier in December 2015. Their representatives and negotiators ultimately succeeded, at the fag end of the ‘Paris Summit’ to arrive at a global consensus for inking a new ‘Climate Change’ agreement.

Prior to this, a report titled, “Paris 2015: Getting a global agreement on climate change”, published in August, 2014 by the Green Alliance Trust, United Kingdom stated that the agreement, expected to be signed in this Paris summit should ensure a meaningful united global action on climate change, covering the following key points:

  • A strong legal framework and clear rules
  • A central role for equity
  • A long term approach
  • Public finance for adaptation and the low carbon transition
  • A framework for action on deforestation and land use

Experts opined that a strong deal will make a significant difference to the ability of individual countries to tackle climate change by ensuring the following:

  • Give a clear signal to business for desired environmental protection and pollution control
  • Guide investment toward low carbon outcomes
  • Create a simpler, more predictable framework for companies operating in different countries
  • Help meeting international development aims, which are at increasing risk from rising global temperatures.
  • Help reducing poverty
  • Help improving health and building security
  • Fetch huge benefits to the natural environment by helping to avoid biodiversity loss and the degradation of ecosystems upon which the existence of human life depends

India’s position on ‘Climate Change’:

India’s position on ‘Climate Change’ has been clear and is well captured in Prime Minister Modi’s reiteration in the Paris summit as follows:

“Climate change is not of our making. It is the result of global warming that came from an industrial age powered by fossil fuel. Yet, we face its consequences today, and that is why the outcome in Paris is so important and we are here today. We want the world to act with urgency. Agreement must lead us to restore balance between humanity and nature. We want a comprehensive equitable and durable agreement in Paris.”

Worsening health effect:

‘Climate Change’ could even drive the human race to extinction in its final outcome. Meanwhile, besides its devastated environmental impact on the planet Earth, it would gradually but surely worsen human health conditions.

In this article, I shall focus only on human health perspective on ‘Climate Change’. 

Direct and indirect health impact:

I would classify the adverse impact of ‘Climate Change’ on health basically into two categories:

- Indirect

- Direct

Indirect impact: 

Many of the indirect health impact events of ‘Climate Change’ either go unnoticed or are still considered as an ‘Act of God’. Although this issue relates to our ultimate survival, even today in India not many debates are taking place on the subject, mostly in the Television Channels. This amazing medium continues to remain obsessed with competitive high decibel shouting and slanging matches to strengthen the viewers’ appetite, even more, mostly on trivial sensationalism.

Fortunately, global awareness of the disastrous impact of ‘Climate Change’ is increasing, slowly but surely. 

I shall give below just a few examples of indirect health impact of this change:

- Extreme weather events, such as floods, droughts, tsunamis, heat-waves and other disasters would keep increasing the mortality rate. Many experts attribute the cause of the recent deluge in Chennai to ‘Climate Change’, though there are other view points too. 

- Extreme weather conditions have also started causing frequent crop failures, especially in the developing world like India. As a result, many people go hungry and children suffer from malnourishment, mostly in rural areas, precipitating adverse health consequences.

- The impact of all these on mental health is also at times devastating and should in no way be ignored. Frequent incidences of farmers’ suicide in India due to crop failures could possibly be due to their deteriorating mental health, which needs to be studied in detail.

Direct impact:

According to ‘Big Picture’ – a free and impartial educational resource that explores the innovations and implications of cutting-edge science, rising temperatures and pollution levels may act together to directly worsen various health conditions, a few examples are as follows:

- Researches say, air temperature is more likely to affect cardiovascular function, when ozone levels are high, including the heart’s electrical activity and airflow into the lungs.

- A recent review has established that air pollution sets off nearly as many heart attacks as physical exertion, alcohol or coffee. Belgian researchers examined 36 studies conducted in various countries between January 1960 and January 2010 to examine the percentage of heart attacks attributable to the common risk factors and found that air pollution increased a person’s heart attack risk by 5 percent.

- Higher temperatures may also make the body more sensitive to toxins, such as ozone.   

- Studies show allergies are on the rise in developed countries, including the United States, which could partly be rising carbon dioxide levels and warming temperatures. 

- A number of notorious diseases, such as, malaria and cholera, thrive with the increase in temperature and rainfall. To give an example, the mosquitos that carry the malaria parasites grow rapidly in hot and humid conditions. The increasing prevalence of such weather conditions in climate change is likely to spread these diseases in a much wider population.

Is there any upside for ‘Climate Change’? 

Available information also points out towards some possible, but limited benefits for ‘Climate Change’, as follows: 

- Reduced risk of dying of the elderly persons from extreme cold in the winters of the temperate countries.

- Longer summers in those countries are likely to improve agricultural yields of the farmers.

Let me hasten to add, all these upsides, if at all, may not help the developing and poorer nations of the planet Earth, as such climatic conditions are mostly prevalent in the developed nations of the world.

Need for further research:

A report titled, “A Human Health Perspective On Climate Change”, published on April 22, 2010 by ‘Environmental Health Perspectives’ and the ‘National Institute of Environmental Health Sciences’, identified the following major research areas that need to be further explored and understood in the ‘Climate Change’ perspective:

The above outcome of the study is exactly in the expected line, which was “to identify research needs for all aspects of the research-to-decision making pathway that will help us understand and mitigate the health effects of climate change, as well as ensure that we choose the healthiest and most efficient approaches to climate change adaptation.”

How can we all contribute individually?

On this subject, by a release on November 26, 2011, ‘The National Aeronautics and Space Administration (NASA)’ of the United States recommended some very easy to follow steps for all of us.

It said, each individual can help in this matter by using less energy and water. For example, one may consider turning off lights and TVs when one leaves a room. Turn off the water, when brushing teeth.

It suggests, another way to help is by learning about Earth and its climate. The more we know about how Earth’s climate works, the more we shall be able to help solve problems related to climate change and that is also the purpose of this article.

In addition, besides many others, we may consider lesser use of our private cars and more of available public transports. Smokers may consider to quit smoking. We can also help by planting trees, which absorb carbon dioxide from the atmosphere.

India’s high stake:

A December 9, 2015 article published in ‘The New York Times’, titled “For Indians, Smog and Poverty Are Higher Priorities Than Talks in Paris” reiterated as follows:

At the climate talks in Paris, “few countries have so much at stake as India. For the last month, the front pages of major newspapers have been dominated by one environmental crisis after another: City-dwellers are up in arms about hazardous levels of air pollution, which has already damaged the lungs of about half of Delhi’s schoolchildren. And last month brought torrential rains and flooding in the southern city of Chennai, evoking the erratic weather that climate experts warn about.”

India’s consistent stand in various ‘Climate Change’ talks is drawing a fine balance between rapid development of the nation, with commensurate new job creation and health safety & environment. However, the apprehension that is being expressed now by many, whether that is feasible on the ground at all, for holistic measures in the right direction, with the adequate funds flow for the same.

Thus, the key concern of the Indian negotiators was, signing of any global agreement to support a strong climate regime, without requisite funding, could seriously impede India’s economic growth and development agenda. The developing nations, such as India, therefore, expect adequate and committed funding from the developed nations for generation of clean energy to drive inclusive economic prosperity of the respective emerging economies.

Developed nations still not quite on the same page?

The developed nations, even in the final text of the deal, do not seem to be quite on the same page, with firm financial commitments. As a result, a ‘Tug of War’ of objectives, as it were, surfaced in the final negotiation process – mainly between sustained economic development and stringent global measures with fund commitment to contain possible extinction of the human race in the world.

The impact of an effective implementation of the agreement is expected to last almost in perpetuity.

Conclusion:                                                                              

Finally, on the last Saturday, December 12, 2015 a new global deal to address the pressing issue of ‘Climate Change’, was agreed in Paris. Unquestionably, this is a critical step forward for all countries to save the planet Earth.

Intriguingly, the deal still does not provide for a binding commitment towards adequate funding by the developed countries, which is so essential for the developing nations to adopt clean and renewable energy to contain the devastating impact of the ‘Climate Change’.

Although, the agreement does talk about funding of US$ 100 billion a year from 2020 to 2025, this is not the legally binding part of the deal, as many people had expected.

In my view, if there is just one statesman who could be singled out for taking exemplary initiative to make the deal come through, it would be President Barack Obama of the United States. He spoke several times to the heads of the several developing nations, including India, China and Brazil, many times to iron out the differences till the last moment, for this key global issue – indeed a statesman par excellence, at least to me.

Be that as it may, the deal has now been inked, Indian Government also has expressed its satisfaction and happiness with the final text of the agreement. Still, a key question haunts: Would it produce the desired results, as expected? Well, that depends on how effectively and time bound manner the global commitments get translated into reality, with required fund flowing smoothly, to contain environmental disasters, leading to natural calamities and jeopardizing human health-safety.

Let’s all keep our finger crossed, as the saying goes, “The proof of the pudding is in the eating.”

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.