Globally, healthcare experienced far-reaching changes and people are living longer, healthier lives than before with the Indian pharma playing saviour. With the World Bank and the World Health Organization (WHO) assessing more than 1 billion still have no access to health services and modern medicine, challenges remain. While targeting holistic India-centric healthcare, the byproduct has been affordable healthcare for poor nations globally. Among essential components of healthcare—medical infrastructure, human resource and medicines—the last is crucial where India’s role is laudable.
Pfizer is a global leader representing patent-owner pharma companies that led “Profits versus Patients” debate over two decades, with India on the defensive. Pfizer misled the world with tall claims on its much touted Covid mRNA vaccine, with the Moderna back-to-back. Both escalated their vaccine’s success rates frequently in December 2020. With the price and storage requirement at -70°C, India realized it wasn’t for us. That became a blessing-in-disguise. We eventually got better, cheaper and made-in-India vaccines. Pfizer’s villainous role with recent disclosures is in the public domain.
The power-wielding multinational companies (MNCs), especially pharmaceuticals, are known to even influence US presidency. They invest in Research and Development (R&D) and have their original global patents. But they also buy patents from researchers at a pittance and make billions. They aren’t interested in volume, but in higher revenues, so jack up the prices manifold for R&D cost-recovery. They target “classes”, but generic manufacturers have to reach the “masses”. It is important to protect intellectual property, but more important to reach out the fruits of inventions to the masses. Without that, the “they” and “we” divide will get wider, leading to anarchy. As doctors, we need to be creative, watchful and mindful that the well-being of our patients is prime that makes us successful doctors.
INDIA’S SECOND FREEDOM STRUGGLE
India’s role in mitigating HIV and Hepatitis-C Virus (HCV) is unprecedented. The AIDS epidemic has completed 42 years of its devastating presence, killing over 37 million. India has brought hope by making HIV a chronic, manageable and affordable disorder. Resultantly, more lives are saved, thanks to Indian pharma that startled the world by providing affordable generic ART, which can be described as India’s second freedom struggle.
Indian pharmaceuticals took the lead, braved risking litigations, fighting patents and pseudo-patents, circumvented patents by producing generic copies using reverse engineering and brought down the cost to 1% of the innovator’s cost, yet with 100% matching bio-equivalence. This compelled MNCs to reduce prices for developing countries and offer voluntary licences to Indian pharma, which has the capacity to meet the global demand. Currently, 92% of people living with HIV (PLHIVs) globally are on India-made ART priced at US$69 yearly per patient, against US$10,439 from MNCs.
Ditto with medicines for Hepatitis-C, a fatal viral infection that is commonly spread among drug users. Innovator’s medicine costs around US$1,000 per tablet,US$84,000 for an 84-day full course. Gilead, the MNC with a human face, issued Voluntary Licences to 11 Indian pharmaceuticals to manufacture and sell anti-HCV medicines at US$1,000 for a full course, expanding the accessibility. Inter-pharma competition got it down to $250 (0.3% of MNCs). This resulted in HCV-tourism: HCV patients from rich countries come to India for treatment, with an 84-day tourism at a fraction cost.
Treating HIV-HCV is a public health imperative to prevent new transmissions, morbidity and mortality and delay has grave public health consequences globally. Imagine a scenario of the developing world ridden with HIV, HCV, TB, infections and cancers, minus India. Millions more would have died, pushing the African continent towards extinction.
India invented the fixed-dose combination (FDC) for anti-tuberculosis three decades back, with the WHO making it standard-of-care for their global programme. On our suggestion, Indian pharma devised FDC for HIV, that made ART cheaper, safer, easier and with better patient compliance. Wary, the MNCs took made in India medicine samples in 2003, carried out experiments in their labs and kept quiet, as they didn’t find any lacunae.
Impressed with India’s initiative, MNCs made similar combos as standard-of-care globally in HIV management. Ironically, when we copy patents, we were termed “copy-cats”, but when they copied this from India never credited India. Why apply different yardsticks? Indian generics meet not only ART demand but also of drugs for other health conditions globally.
THIS WASN’T AN EASY BATTLE
When the HIV epidemic was peaking with Africa’s PLHIVs succumbing in hordes, Cipla chairman, Dr Yusuf Hamied raked up a controversy in 2000 by offering ART at a dollar-a-day, 3.5% of the global cost, defying patents. That ended up in the South Africa Supreme Court. Almost 64 MNCs ganged up against Cipla. Treatment Action Group (TAG) and Médecins Sans Frontières (MSF) and a few doctors rallied behind Cipla. Sensing hostility, the industry withdrew the case against the South African government in April 2001. The US government, siding with MNCs, also dropped its complaint against Brazil on the same issue at the World Trade Organisation (WTO) in June 2001. This jolted the MNCs’ businesses in the developing world and encouraged countries to adopt liberal interpretation on Trade Related Intellectual Property Rights (TRIPS), to override patents. We were supported by the World Intellectual Property Organization (WIPO) that agreed patients’ rights are more important than patents. Under pressure, the WTO convened TRIPs council meeting in Geneva in June 2001. Surprisingly, the developed nations were willing to let the developing countries use TRIPS agreement flexibility.
HOW CAN PATENT VIOLATION BE LEGAL?
It is done through legal recourse in two ways: Compulsory Licence and Voluntary Licence. Compulsory Licence is government’s prerogative under the General Agreement on Tariffs and Trade (GATT), if the innovator company is unable/unwilling to offer life-saving medicines at affordable costs. It is the key public-health and social-justice safeguard that allows governments to use, produce, and import/export patented technologies in public interest. The Doha Declaration on TRIPS Agreement and Public Health confirms that countries are free to determine grounds for compulsory licences as an international legal agreement between WTO member nations. They include remedying anti-competitive practices, when the patented medicine is unaffordable or unavailable making it inaccessible to patients and when public health is at stake like emergency, extreme urgency, epidemics and public non-commercial use.
When confronted with intellectual property barriers, the governments of India, Thailand, Brazil, South Africa, Malaysia among others used compulsory licensing to ensure lifesaving medicines reach those most-in-need. Compulsory Licence can be issued under Section 84 of Indian Patents Act, 1970. Here, the copy-maker pays innovator 5% of trade cost.
Voluntary Licence, on the contrary, is issued free of charge by innovators to generic manufacturer(s), to prevent litigations and compulsory licensing to protect their own markets, with the undertaking: “copy-makers will not advertise and market generic products in patent-respecting countries”. Indian pharmaceuticals make excellent comparable generics using either Compulsory or Voluntary Licence that are sold in Asia, Africa and Latin America, in demonstration of south-south collaboration.
The TRIPS agreement doesn’t directly affect accessibility to drugs and is flexible. But many countries are unable to use because of diplomatic influence and political blackmail from developed countries protecting MNCs. Initially, the poor countries were compelled to buy ART from patent-holders, but even their preferential pricing was exorbitant. MSD announcing price reduction said “we are reducing price of anti-HIV drug Indinavir by 95% for Africa, on which we will not make any profit”, thus admittedly was 1900% profit.
In 2019, the United States Trade Representative (USTR)’s “Special 301 Report” slammed India: “While it may not be possible to determine an exact figure, studies have suggested that up to 20% of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety.” We successfully convinced the poor nations that they shouldn’t get carried away by US propaganda.
WAY FORWARD
One of the lessons from the global public health emergency is that profiteering from illness has to end. It’s an essential cog in the wheel of sustainable development; where no one is left behind so that all healthcare services reach every human being in a rights-based manner and is not dependent on her/his capacity to pay. This global village requires symbiosis. Many Indian pharmaceutical plants are approved by FDAs of different governments, including USFDA. Many MNCs get their products manufactured in India for cost-saving, market at exorbitant costs. Attack on low cost generic medicines is an attack on the survival of millions of gullible, un-affording people globally. The world recognized the Indian pharma strength in saving millions for decades from a range of health issues. In patents versus patients, the balance tilts towards patients to bridge the enormous gap. It’s a herculean task and will be possible only by intensive joint efforts of all including innovators. India continues humanitarian mission to make life-saving medicines affordable and accessible. India also produces some vanishing “orphan drugs” that no one wants to produce because of thin trade margin.
Consultant in HIV in Infectious Diseases, President of AIDS Society of India, Secretary General of Organised Medicine Academic Guild-OMAG and Governing Council Member of International AIDS Society, gilada@usa.net, www.unisonmedicare.com