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Life-Saving Drugs And The Intellectual Property Regime In India

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Over the years, the advancement in technology has led to innovation in the field of pharmacy, with new life-saving drugs being formulated every day. India, regarded as the pharmacy of the world, is on the threshold of becoming a major global market for pharmaceuticals by 2020. Pharmaceutical manufacturing companies in India are one of the world’s largest sources of generic drugs, exporting medicines worth of Rs 50,000 crore across the globe. However minuscule in comparison to the global players, India’s gross expenditure on R&D has more than tripled from Rs. 24,117 crore to Rs. 85,326 crore in the last decade.

Emerging lifestyle diseases in the last few decades have resulted in an immense increase in the availability of medicines in the marketplace, though accessibility is still an issue that needs to be resolved. According to the Global Burden of Disease (GBD) data published in the Lancet this year, heart disease is the leading cause of death, killing over 1.2 million people annually. Life-threatening diseases are on the rise and so is the profit-making by the pharmaceutical industry. A huge amount of research and development goes into discovery, development and clinical trials, before the commencement of the production. Every newly launched drug is thus very expensive, to begin with. Our country with its one-third population living below the poverty line, contracting a disease comes with a huge cost.

India has adopted the concept of Essential Medicines as pronounced by the World Health Organisation (WHO) while formulating the national list of essential medicines. National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency that controls the prices of essential pharmaceutical drugs in India, keeping in mind the overgrowing demand and affordability concerns. NPPA has the power to invoke Paragraph 19 of Drug Prices Control Order (DPCO), 2013, which gives it the power to fix and monitor the ceiling price or retail price of any drug.

Bayer Corporation vs. Union of India

Compulsory Licensing, a legal counterweight to combat the adverse effects of patents as a mechanism is allowed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – the international agreement which establishes intellectual property rights, including patent rights. In a one-of-its-kind case, the Intellectual Property Appellate Board (IPAB) in 2013, granted the first compulsory license (CL) to the Hyderabad-based Natco Pharma Limited, a generic drug maker, to produce and market Nexavar, an already patented cancer drug invented by Bayer Pharma, paving way for reduction in the prices of costly life saving drugs. Natco attained the license to manufacture and sell in India the patented drug under its brand name at a price of less than Rs.10,000/- per month as against the price of Rs.2,80,428/- per month charged by the Bayer Corporation. It was the first step towards fixing the price of life-saving drugs as Bayer failed to fulfil the reasonable requirement of the public with regard to the aforementioned drug.

Price Cap On Stents And Knee Implants

In July 2016, the government notified the inclusion of stents in the National List of Essential Medicines (NLEM), citing unethical profiteering and exploitative pricing. The National Pharmaceutical Pricing Authority (NPPA) brought down the prices of stents, a tiny wire mesh tube that is placed inside an artery in order to remove any blockages, from Rs 1.21 lakh to Rs 27,890. Paragraph 19 of the DPCO, 2013 inter-alia authorises the government, in extraordinary circumstances, to fix the ceiling price or retail price of any drug for such period, as it deems fit, keeping in view the essentiality of stents in a country where there are approximately 30 million heart patients.

A price cap on drugs or devices poses a major threat to the availability of the same in the marketplace, with pharmaceutical company arguing that although it is a responsible corporate citizen, it can’t provide vast quantities of the drug for less than its manufacturing cost. The drug in question — furosemide, sold under the brand name Lasix — is a medicine prescribed to babies with heart ailments. In 2017, National Pharmaceutical Pricing Authority cut its price from Rs 100 to Rs 10 per pack. Since then, the availability of this medicine in the market has come down drastically leaving parents of sick babies running from pillar to post. In the U.S, a new drug is launched in the market within two-three years of it getting approved, but in India, it takes around 6-8 years for the same drug to come out in the marketplace. Hence, as the price of the drug goes down, its availability in the market also gets massively affected.

The cost of bringing a drug to the market is higher than the actual cost of the drug itself. Inventing a drug takes years and years of research and is incredibly complex and extraordinarily expensive. Indian pharmaceutical companies or subsidiaries of multinational pharmaceutical companies in India often worry that lower drug prices, either through faster generic approvals or price control, would have a negative effect on the industry’s ability to bring innovations to patients in India. As a result of price control, Abbots Healthcare pulled the plug on two of its coronary stents, citing commercial unsustainability in India.

Is The High Cost Of Drugs To Offset R&D Costs Justified?

Research & development over life?

On an average, a pharmaceutical company invests millions of dollars into Research and Development and in order to recoup the amount, it raises the price of the drug and demands for ‘market exclusivity’ or patent, which is a right given to the inventor for a limited period of time over the product that it invented. The time period for which it gets a patent ranges from 15 to 20 years. During this time frame, no other company is allowed to manufacture the same drug, unless the license is granted either by the state or the company itself. Patent regime works well in the western countries where people are covered by health insurance. In an underdeveloped country like India, where only 18% of the population is covered under any kind of health insurance, and 276 million people are living below $1.25 per day, such strict patent system does not work.

According to healthdata.org – the major cause of disease burden over the last 26 years was diabetes (rate increased by 80%) and ischemic heart disease (up 34%). More than 60% of deaths, about 6.1 million, in 2016 were due to Non-communicable diseases (NCDs), up from about 38% in 1990. Hence, to address the issue of increasing drug prices affecting millions of people across the country, we should have a cost-based system, keeping in mind that the market-based system not only worsens the condition of poor people but also monopolises the market. Moreover, it is equally important that the drug companies reduce the profit margin to serve the need of the people in want of the life-saving medicine. The present predicament, of poor access to affordable healthcare amidst plenty of overpriced medicine, should not be allowed to continue to imperil the lives and health of Indians across the country.

 

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An ambassador and trained facilitator under Eco Femme (a social enterprise working towards menstrual health in south India), Sanjina is also an active member of the MHM Collective- India and Menstrual Health Alliance- India. She has conducted Menstrual Health sessions in multiple government schools adopted by Rotary District 3240 as part of their WinS project in rural Bengal. She has also delivered training of trainers on SRHR, gender, sexuality and Menstruation for Tomorrow’s Foundation, Vikramshila Education Resource Society, Nirdhan trust and Micro Finance, Tollygunj Women In Need, Paint It Red in Kolkata.

Now as an MH Fellow with YKA, she’s expanding her impressive scope of work further by launching a campaign to facilitate the process of ensuring better menstrual health and SRH services for women residing in correctional homes in West Bengal. The campaign will entail an independent study to take stalk of the present conditions of MHM in correctional homes across the state and use its findings to build public support and political will to take the necessary action.

Saurabh has been associated with YKA as a user and has consistently been writing on the issue MHM and its intersectionality with other issues in the society. Now as an MHM Fellow with YKA, he’s launched the Right to Period campaign, which aims to ensure proper execution of MHM guidelines in Delhi’s schools.

The long-term aim of the campaign is to develop an open culture where menstruation is not treated as a taboo. The campaign also seeks to hold the schools accountable for their responsibilities as an important component in the implementation of MHM policies by making adequate sanitation infrastructure and knowledge of MHM available in school premises.

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Harshita is a psychologist and works to support people with mental health issues, particularly adolescents who are survivors of violence. Associated with the Azadi Foundation in UP, Harshita became an MHM Fellow with YKA, with the aim of promoting better menstrual health.

Her campaign #MeriMarzi aims to promote menstrual health and wellness, hygiene and facilities for female sex workers in UP. She says, “Knowledge about natural body processes is a very basic human right. And for individuals whose occupation is providing sexual services, it becomes even more important.”

Meri Marzi aims to ensure sensitised, non-discriminatory health workers for the needs of female sex workers in the Suraksha Clinics under the UPSACS (Uttar Pradesh State AIDS Control Society) program by creating more dialogues and garnering public support for the cause of sex workers’ menstrual rights. The campaign will also ensure interventions with sex workers to clear misconceptions around overall hygiene management to ensure that results flow both ways.

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MH Fellow Sabna comes with significant experience working with a range of development issues. A co-founder of Project Sakhi Saheli, which aims to combat period poverty and break menstrual taboos, Sabna has, in the past, worked on the issue of menstruation in urban slums of Delhi with women and adolescent girls. She and her team also released MenstraBook, with menstrastories and organised Menstra Tlk in the Delhi School of Social Work to create more conversations on menstruation.

With YKA MHM Fellow Vineet, Sabna launched Menstratalk, a campaign that aims to put an end to period poverty and smash menstrual taboos in society. As a start, the campaign aims to begin conversations on menstrual health with five hundred adolescents and youth in Delhi through offline platforms, and through this community mobilise support to create Period Friendly Institutions out of educational institutes in the city.

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A student from Delhi School of Social work, Vineet is a part of Project Sakhi Saheli, an initiative by the students of Delhi school of Social Work to create awareness on Menstrual Health and combat Period Poverty. Along with MHM Action Fellow Sabna, Vineet launched Menstratalk, a campaign that aims to put an end to period poverty and smash menstrual taboos in society.

As a start, the campaign aims to begin conversations on menstrual health with five hundred adolescents and youth in Delhi through offline platforms, and through this community mobilise support to create Period Friendly Institutions out of educational institutes in the city.

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A psychologist and co-founder of a mental health NGO called Customize Cognition, Ritika forayed into the space of menstrual health and hygiene, sexual and reproductive healthcare and rights and gender equality as an MHM Fellow with YKA. She says, “The experience of working on MHM/SRHR and gender equality has been an enriching and eye-opening experience. I have learned what’s beneath the surface of the issue, be it awareness, lack of resources or disregard for trans men, who also menstruate.”

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A Computer Science engineer by education, Nitisha started her career in the corporate sector, before realising she wanted to work in the development and social justice space. Since then, she has worked with Teach For India and Care India and is from the founding batch of Indian School of Development Management (ISDM), a one of its kind organisation creating leaders for the development sector through its experiential learning post graduate program.

As a Youth Ki Awaaz Menstrual Health Fellow, Nitisha has started Let’s Talk Period, a campaign to mobilise young people to switch to sustainable period products. She says, “80 lakh women in Delhi use non-biodegradable sanitary products, generate 3000 tonnes of menstrual waste, that takes 500-800 years to decompose; which in turn contributes to the health issues of all menstruators, increased burden of waste management on the city and harmful living environment for all citizens.

Let’s Talk Period aims to change this by

Find out more about her campaign here.

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A former Assistant Secretary with the Ministry of Women and Child Development in West Bengal for three months, Lakshmi Bhavya has been championing the cause of menstrual hygiene in her district. By associating herself with the Lalana Campaign, a holistic menstrual hygiene awareness campaign which is conducted by the Anahat NGO, Lakshmi has been slowly breaking taboos when it comes to periods and menstrual hygiene.

A Gender Rights Activist working with the tribal and marginalized communities in india, Srilekha is a PhD scholar working on understanding body and sexuality among tribal girls, to fill the gaps in research around indigenous women and their stories. Srilekha has worked extensively at the grassroots level with community based organisations, through several advocacy initiatives around Gender, Mental Health, Menstrual Hygiene and Sexual and Reproductive Health Rights (SRHR) for the indigenous in Jharkhand, over the last 6 years.

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A Guwahati-based college student pursuing her Masters in Tata Institute of Social Sciences, Bidisha started the #BleedwithDignity campaign on the technology platform Change.org, demanding that the Government of Assam install
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Bidisha was selected in Change.org’s flagship program ‘She Creates Change’ having run successful online advocacy
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