Patient-Groups Worldwide Press India to Issue Compulsory Licenses for TB Drugs

“So many lives depend on it,” a letter submitted to the government, signed by 60 organisations from around the world that work on TB, said.

New Delhi: Last night, Prime Minister Narendra Modi tweeted about a major international tuberculosis (TB) summit India is hosting – that he would launch the ‘Tuberculosis Free India Campaign’ on the occasion. This campaign plans to take the activities of the National Strategic Plan for TB elimination forward in mission mode.

Earlier in the day yesterday, 60 organisations from around the world wrote in a letter to Modi of the urgent need for him to issue a compulsory license for two experimental lifesaving drugs (bedaquiline and delaminid) for drug-resistant TB patients in India.

A compulsory license on the patent for these drugs will allow generic companies to legally make cheaper drugs available. The 60 organisations, many of whom are patient-groups, say this could bring the price of bedaquiline and delaminid down by 95%.

“We are writing to appeal to the Indian government to continue to play its crucial role in global health by addressing the urgent treatment needs for drug-resistant tuberculosis,” the letter says.

Beginning today, the ‘Delhi End TB’ Summit 2018 will see various world leaders deliberate on strategies to tackle the disease, which killed 17 lakh people around the world in 2016. Modi and Tedros Ghebreyesus, the World Health Organisation’s (WHO) director-general, are set to address the summit today.

But even as these deliberations go on, about 1.3 lakh drug-resistant TB patients in India will need access to drugs like bedaquiline and delaminid – both of which have a reputation as ‘breakthrough drugs’ because they were discovered after about 40 years of little advancements in treating drug-resistant TB.

Lack of treatment for drug-resistant TB

TB is the world’s top infectious killer disease. The WHO has specified that TB will need to be “eliminated” by 2030. However, even with the world’s largest number of TB patients, India has declared it will eliminate TB five years earlier.

The Delhi summit is being hosted by the Ministry of Health and Family Welfare, the WHO and the ‘Stop TB Partnership’. The summit and events around it will demonstrate India’s “resolve to fast-track efforts to end the killer disease,” a press release from the WHO said.

Yet the Indian government has been conservative in dispensing the drugs. For example, India has not been purchasing the drug, instead choosing to rely on donations from the manufacturers: Janssen (US) and Otsuka Pharmaceuticals (Japan).

Moreover, the drugs’ access is restricted only to government centres since the government has been trying to monitor the substances’ side effects. This is because phase-three trial data has not been made available for the drug globally. “Bedaquiline and delaminid are cardio-toxic and side effects associated need to be strictly monitored,” Arun Kumar Jha, a senior health ministry official, said on Twitter. “Sans phase three trials, regulatory authority only permitted conditional access.”

It is against this backdrop that the 60 organisations submitted their letter to the prime minister, demanding immediate access to this drug for Indian drug-resistant TB patients. Another letter on the same issue had been sent to the government earlier this week by doctors in Karnataka.

A compulsory license on bedaquiline and delaminid in India is crucial because India has about 1.3 lakh drug resistant TB patients. Bedaquiline and Delamind offer hope here.

So far India’s programme to reach these patients has been getting by on “donations” from Jannsen and Otsuka, which has come from USAID. Once the small stock of these donations run out, India will have to begin purchasing the two drugs from these companies to ensure patients have a constant supply. Activists have estimated that, for a six-month course per patient, the Indian government will have to pay Rs 1 lakh for delaminid and Rs 58,000 for bedaquiline.

But given the scale at which India has to deal with ‘regular’ TB and its drug-resistant variety, these numbers won’t be feasible. The price of bedaquiline and delaminid will have to be brought down. As the letter said, “So many lives depend on it.”

India also has had a strong generics industry capable of producing cheaper versions of the drugs. However, this will not be possible for as long as Jannsen and Otsuka hold the patents. As it happens, the companies have thus far not shown any indication of issuing a voluntary license – which is when patent holders license their drugs to other companies, who will in turn pay royalties.

In this scenario, patient-groups from around the world have been asking the Indian government to step in and use such legal provisions as are available to induce competition and bring the prices down.

The specific mechanism they have their eyes on is compulsory licensing (CL) – which is when a government directs a patent-holder to license the drug out to others. India’s patent act allows the government to issue CLs for public, non-commercial use – a criterion the government-controlled TB programme would fulfil.

India has issued only one compulsory license so far, which was given in 2012 to Natco, for Bayer’s cancer drug Nexavar. Here the price crashed from Rs 2.8 lakh per month to Rs 8,880 when the CL was issued. Natco payed Bayer a 6% royalty on sales.

Phase three trial data for bedaquiline is awaited globally. India has not conducted its own phase three trials but has instead given approval to this drug based on the decisions to give access by the US Food and the European Medicine Agency.  Even while waiting on this, bedaquline and delaminid for adults, were added to WHO’s Essential Medicine List in 2015. Delaminid for children, was added in 2017.

The Gates Foundation and the Anatomy of Philanthrocapitalism

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

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

Bill-gates-foundation

Bill Gates. Credit: Bill Gates Foundation

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

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

The question of patents

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

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

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

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

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

Gates contradictory stance

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

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

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

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

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

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

A problematic development paradigm

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

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

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

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

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

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

India Assures the US it Will Not Issue Compulsory Licences on Medicines

The government appears bent on decisively abandoning the earlier consensus of adherence to public health goals.

The government appears bent on decisively abandoning the earlier consensus of adherence to public health goals.

India has 'assured' the US it will not issue compulsory licences on medicines. Credit: Carl Milner/Flickr, CC BY 2.0

India has ‘assured’ the US it will not issue compulsory licences on medicines. Credit: Carl Milner/Flickr, CC BY 2.0

In what is widely being hailed as an extraordinary victory for the multinational pharmaceutical industry over the Indian government, the US-India Business Council (USIBC), in its submission to the United States Trade Representative (USTR), reports that the Indian government has “privately assured” the industry that it would not use compulsory licences (CLs) for commercial purposes. Since it came to power in 2014, it has been speculated that the NDA government is keen to accommodate objections of the USTR and the US based pharmaceutical industry regarding the use and implementation of a number of health safeguards in domestic laws on intellectual property rights designed to promote affordable access to medicines in India. We now have confirmation that the government is willing to travel the extra mile in order to placate the US and that the Big Pharma’s vicious campaign after the first CL was granted in India has been a success.

Striking at the heart of India’s Patent Act

Mukesh Aghi, president of the USIBC that claims to represent “more than 350 of the largest global companies investing in India”, writes in his submission to the office of the USTR on February 5, 2016, “Overall, the U.S.-India Business Council believes there have been important developments related to the Intellectual Property policy in the last 12 months in India that have paved the way for substantive improvement in India’s IP environment”. He further adds, “…the level and frequency of engagement between the U.S. and Indian governments was encouraging and many have noted that they had not seen this level of engagement with the Government of India before”. Aghi goes on to compliment Prime Minister Narendra Modi for “several public statements reaffirming his commitment to a strong and robust intellectual property regime” and also notes with approval that “(the) Government of India has denied several compulsory license applications”. Particularly disturbing is his assertion that “the Government of India has privately reassured India would not use Compulsory Licenses for commercial purposes”. Curiously, David Hirschmann, the senior vice president of the US Chamber of Commerce, uses exactly the same phrase regarding “private reassurance” in his submission to the USTR.

That these are not isolated reactions becomes clearer when similar sentiments are echoed in the deposition by Patrick Kilbride of the US Chamber of Commerce’s Global Intellectual Property Centre. Kilbride in his deposition to the USTR on March 1, 2016 notes, “The U.S. and Indian governments have re-opened a formal dialogue through the bilateral Trade Policy Forum, with the creation of an Intellectual Property Working Group as a core element”. He goes on to say, “The election of Indian Prime Minister Sri Narendra Modi in 2014 provided an important opportunity to re-establish a collaborative and productive working relationship on intellectual property issues between India and the United States”.

One may legitimately ask if it is bad news that the US and India are talking to each other. The issue is not that they are talking but what the substance of their talks indicate. Let us not forget that the US and India are traditional adversaries in the area of IP protection and India has been on the USTR’s Special 301 ‘watch list’ for over a quarter of a century. In such a situation, a ‘private’ assurance that compulsory licences will be denied is abject surrender, not dialogue. The compulsory licensing provisions in the Indian Patents Act are a critical part of India’s attempt to prevent monopolies and assure access to new medicines of public health importance. A compulsory license allows domestic companies to produce cheaper generic versions of drugs under the patent monopoly of MNCs (many of them US based). When CL provisions are used, prices decreases can range from 50% to 97%, resulting in massive cost savings to governments and patients, and a significant increase in the number of patients able to access the medicines. This is the option, embedded in our national law, which is being gifted away by the ‘private assurances’. It is a disingenuous attempt to strike at the very heart of the legislative intent embodied in the Indian Patents Act.

Why is compulsory licensing important?

A recent study identified 140 patented products being marketed in India. Information about if they were manufactured in India was available for 92 products, but only four of these were manufactured in India and the remaining 88 were being imported. Thus, we see a growing trend of imported drugs forming a significant portion of the domestic market. The table below provides the prices of some of these.

Cost of patented protected drugs

Molecule Brand/Unit Clinical Use MNC Unit Price Treatment frequency
Ixabepilone Ixempra

45 Mg Injection

Breast Cancer, being investigated for other cancers BMS 71175.00 1 unit weekly for 4  weeks; cycle may need to be repeated
Goserelin Zoladex

10.8 Mg Injection

Cancer of Prostate Astra Zeneca 28320.00 Every 12 weeks
Zoledronate Aclasta

5 Mg Infusion

100 ml

To prevent fractures  and bone pains in some forms of cancers Novartis 19516.00 Every 3-4 weeks
Pegylated

Interferon Alpha 2a

Pegasys

180 Mcg Injection

10 ml

Hepatitis C Roche 18200.00 1 unit every week for 8 weeks
Ibandronate Bondronat

6 Mg Injection

To prevent fractures  and bone pains in some forms of cancers Roche 13950.00 Every 4 weeks
Erythropoietin

Products

Mircera

100 Mcg Injection

0.3 ml

Treatment of anemia in kidney failure Roche 8821.00 Every 2 weeks
Sunitinib Sutent

50 Mg Capsule

Cancers of kidney and Gastrointestinal tract Pfizer 8714.78 Daily for 4 weeks; may need to be repeated after two weeks
Everolimus Afinitor

10 mg Tablet

Cancers of kidney, breast and brain Novartis 7217.60 Daily for 24 weeks
Liraglutide Victoza 

6 mg Injection 3 ml

Diabetes Novo Nordisk 4315.00 9 units a month
Erlotinib Tarceva

150 mg Tablet

Cancers of lung, pancreas Roche 4030.00 Daily for 3-4 months
Dasatinib Sprycel

50 mg Tablet

Chronic Myeloid Leukemia BMS 3287.30 2 units daily
Long acting insulin (Ultra Lente) Novorapid

100 IU Injection 10 ml

Diabetes Novo Nordisk 2211.65 Variable

Attempts to regulate the prices of these patented medicines have yet to bear fruit. A ‘Committee on Price Negotiation of Patented Drugs’ was set up to recommend ways in which the prices of patented drugs could be controlled. The committee’s report, submitted in 2013, suggested the ceiling prices of patented drugs be fixed by factoring in their prices in a select group of reference countries (a practice known as reference pricing), and the comparative per-capita GNP of India and the reference countries. No headway has been made since as the industry, especially the Organisation of Pharmaceutical Producers of India (OPPI) – representing drug MNCs in India – has opposed the formula suggested. Concerns have also been raised that reference pricing would push up costs enormously given that patented drugs are exorbitantly priced in all countries and have no relation to real manufacturing costs.

The best method of controlling the prices of patented drugs would be by breaking the monopoly of the patent holder through the grant of CLs to domestic generic manufacturers. The ‘assurance’ to eschew the grant of compulsory licences for ‘commercial’ use is at variance with the Make in India rhetoric of the current government. The Indian generic industry, now a 200,000 crore rupees commercial enterprise, was a product of the Patents Act of 1970, which rejected the high patent protection enshrined in the British patent regime and did not allow patents on pharmaceutical products. Since 2005, with the implementation of the India’s commitments under the World Trade Organisation’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), India now grants 20-year product patents on pharmaceuticals. The TRIPS Agreement incorporates the right of all WTO members, including India, to issue CLs on any grounds, a right that was re-iterated in the 2001 Doha Declaration on TRIPS and Public Health that signed by all WTO members, including the US thus: ” Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.”

By promising not to grant CLs for commercial purposes, the only possible lifeline to keep the domestic industry competitive and capable of challenging the monopoly power of foreign companies over patented medicines is sought to be denied. Possibly this is a sneak peek into the real intentions of the Make in India campaign – opening up Indian infrastructure and technological capacities for foreign companies to exploit our cheap labour and lax regulations, and repatriate super profits to their home countries. The Indian Patents Act provides clearly that CLs can be issued if commercial activities in India are prejudiced. Clause 84.7 a (iv) states: “…the reasonable requirements of the public shall be deemed not to have been satisfied if the establishment or development of commercial activities in India is prejudiced”. International legal experts have confirmed that CLs can indeed be issued to ensure local working of a patent.

Compulsory Licence provisions remain unused

It is noteworthy that the CL provisions in the Indian law have remained virtually unused and only one CL has been issued till date. In contrast, several low income countries – Zambia, Zimbabwe, Eritrea, Ghana, Mozambique – have issued CLs to promote the access to high-priced patented medicines. The only CL issued in India (to NATCO in 2012 for Sorafenib, an anti-cancer drug marketed by Bayer as Nexavar) indicates the power of a CL. NATCO’s price for Sorafenib is 8,800 rupees for a month’s treatment, in contrast to 2,80,000 rupees for Nexavar.

Although several patented drugs have started entering the Indian market, there have been few CL applications. Intuitively this would indicate a link between the new strategy of domestic Indian companies to ‘collaborate’ rather than to ‘oppose’ pharmaceutical MNCs. In large measure, this is related to the chilling effect of the government’s overt manoeuvre directed at appeasing foreign drug companies and the USTR. As submissions to the USTR indicate, CL applications are being actively discouraged, especially over the last two years. The most recent case is the denial of a CL for anti-diabetic drug Saxagliptin.

Abandoning popular consensus to safeguard public health

The pursuit of market-based reforms has brought about changes in the industrial climate. Indian generic drug companies are increasingly tying up with foreign MNCs, given their interest in developed country export markets. While domestic demand for medicines has stagnated due to poor public investment in healthcare, the major source of expansion for large Indian companies is this export market in the EU and the US. Given this backdrop, it should come as no surprise that the present government appears bent on decisively abandoning the earlier consensus of adherence to public health goals, which the previous UPA government had nominally retained.

The latest revelation on the ‘private assurances’ is another link in a long chain of events heralded by the installation of the NDA government. The shift in stance of the Indian government’s policy towards IP was signaled by the joint communiqué at the end of Modi’s visit to the US in 2014, which agreed to “establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the Trade Policy Forum”.

In January 2015, the government unveiled its Draft Intellectual Property Policy. The draft policy enunciates a vision that proactive promotion of IP protection is in harmony with India’s developmental goals and claims that it is designed to “Stimulate large corporations, both Indian and foreign, that have R&D operations, to create, protect and utilize IP in India”. Nary a mention of the possible negative effective of strong IP protection on the access to health services and other basic needs, or of the benefits of open innovation systems and non-exclusive licences.

India is now perched on a slippery slope where decades of effort to promote a liberal IP regime, which allowed easier access to medical products, stands to be frittered away. It will really be a sad day for millions across the world if India continues to walk this talk and succumbs to the designs of Big Pharma. At stake are poor patients in three continents, who look towards India with hope for medicines that are cheap and effective. Surely ‘national interest’ demands that public health be privileged over the interests of foreign governments and foreign corporations.

Amit Sengupta is Associate Global Co-ordinator, People’s Health Movement.

India Must Resist US Pressure on Generic Drugs, African Leaders to Tell Modi

So far, the NDA government has been a mute spectator to the US pharma strategy of forcing Indian generics manufacturers to produce only what is required for Indian consumers and abandon the export of cheap drugs to Africa.

So far, the NDA government has been a mute spectator to the US pharma strategy of forcing Indian generics manufacturers to produce only what is required for Indian consumers and abandon the export of cheap drugs to Africa

Anti-retrovirals from Indian in the customs warehouse at the airport in Accra, Ghana. Credit: David Baron/PRIs World

Anti-retrovirals from India in the customs warehouse at the airport in Accra, Ghana. Credit: David Baron/PRIs World

In his ‘Mann ki baat‘ radio show on Sunday, Prime Minister Narendra Modi proudly spoke about how India will host 54 heads of state from Africa for the first time to reinforce “our nation’s historical and cultural links’ with African countries.

However, invoking this very spirit, the visiting African leaders will place before the Prime Minister an issue of life and death for their peoples in which India can play a critical role – the export of cheap and affordable generic medicines for the cure of AIDS and other deadly diseases. The African heads of state will urge Modi to resist growing pressure from the United States government and Western drug multinationals on India to stop exporting cheap generics to Africa.

Kenya’s ambassador in India, Florence Imisa Weche told this writer in an interview for RSTV that the issue of affordable medicine imports from India – especially for treating AIDS – is a matter of great concern for African nations. Weche indicated that the visiting African leaders will urge Modi not to dilute India’s current status as the “Pharmacy of the Third World”. This comes after the South African health minister expressed similar apprehensions a few months ago. The India-Africa summit will provide an opportunity to address this question.

The US pharma lobby wants India to limit the production of affordable generics to only what is required for Indian consumers under a “voluntary licensing scheme” and not produce drugs for third country patients. Some Indian companies, lured by higher profits, are already striking cosy deals with US pharma giants. The NDA government has shown a tendency to assist this collaboration through the back door, by signalling its willingness to dilute India’s pro-public health intellectual property policy which has been widely hailed in the developing world. India’s existing policy has enabled the price of HIV drugs to fall 99% – from $10,000 per person per year in 2000 to $100 per year today. Other diseases like tuberculosis, hepatitis and malaria which afflict millions of people in Africa also need affordable generic medicines exported from India.

The Modi government has publicly said that it is not willing to dilute India’s IPR law – whose provisions on compulsory licensing and the ‘evergreening’ of patents make it difficult for Western pharma companies to earn super-profits from essential formulations – but at the same time it has made some non-transparent moves like setting up a committee to look at the implementation of the IPR guidelines, especially in the pharma sector. Prime Minister Modi had publicly assured American CEOs in President Obama’s presence in India last January that he would “address all their concerns on Intellectual Property Rights”.

This assurance had caused apprehension about the NDA’s continued commitment to the current IPR policy. There is a fear that the law may remain the same but cumbersome procedural guidelines could make it costlier for domestic pharma companies to export cheap drugs to other developing countries.

Inspite of the big boost for a pro-public health policy which the Supreme Court delivered through its judgement against the US MNC Novartis some years ago, it appears American and other Western pharma companies have mounted a massive offensive against their Indian rivals through clever, procedural tweaking. So far, the NDA government has been a mute spectator.

For instance, a US multinational company, Gilead, launched an anti-Hepatitis C drug and entered into a deal with seven Indian companies to make the drug cheaper, but still unaffordable, thus offering higher profits to the Indian counterparts. The Indian pharma companies agreed to be co-opted because the alternative would be to get into long drawn and costly litigation against Gilead in order the make the same drug much cheaper in India – both for Indian patients and for export to developing regions like Africa. Given the critical importance of affordable drugs, it could be argued that a pro-active government ought to help its domestic pharma industry in the litigation process and even put price caps on such life saving drugs to ensure that public health objectives are met. This is precisely what the African heads of State will be urging Modi to do.