In a Tier 1 city in North India, Mrinalini, a house help, was very worried. Her 15-year-old son had been diagnosed with tuberculosis of a facial gland. The doctor at a private hospital had assured her that it could be cured, but the treatment was lengthy. A health ID that would give her subsidised treatment could be made only in her village, which she had no plans of visiting in the near future. Would she be able to afford the treatment was the thought that was giving her sleepless nights. On the other hand, in a Tier 2 city in South India, Basanti, a transgender person, was battling chronic stress and anxiety. That she had been advised to undergo regular screenings had her tensed.
Making health care and medicines affordable and accessible for all ran contrary to the economic interests of pharmaceutical and healthcare organizations that spent on research and development of new drugs and treatments and filed for patents, and was an area of debate for a long time amongst practitioners and policymakers. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and TRIPS-plus provisions have been found to benefit the developed nations by strengthening patent protection, thereby restricting access to affordable generic medicines to the least developed and developing countries. The lack of negotiating power that the developing countries had to avail legislative flexibilities offered under the TRIPS provision has also added to the problem. Apart from IPR provisions, the developing countries also suffer from a lack of research and development, manufacturing capacity and infrastructure to distribute medicines to patients in hard-to-reach geographical areas.
The challenge is how problems of Mrinalini and Basanti, may be addressed while still balancing the interests of the global innovators and the health care organisations.
- Scenario 1--IPR Provisions favourable for the innovators--Access to health care for all: In this scenario the health care ecosystem of a country balances the economic interests of the innovators and society at large. This may be possible through a tiered or differential pricing mechanism wherein the pharmaceutical companies and the health care providers charge based on the patients’ income level or the ability to pay. Such a model enables the companies to earn profits from wealthy markets and patients, which not only enables them to cover up for the subsidised health care to low-income patients but also gives them the incentive to invest in research for future drug development. The companies, however, need to be socially and legally responsible by following transparency in pricing and other monetary transactions.
- Scenario 2- IPR--Provisions favourable for the innovators--Absence of access to health care for all: In this scenario, the IPR provisions are favourable for the innovators, thus leading to a lack of affordable health care for all. In the case of patents held by global pharma companies, developing countries need to have the flexibility to interpret and apply rules regarding pharmaceutical patents to match the interests, needs, priorities, and levels of development of their respective nations. The need to develop legislative capabilities to use available exceptions, options, and defence mechanisms for disputing patents is critical. A South-South legal collaboration model wherein developing countries collaborate to develop a judicial system to interpret TRIPS in a way that is in accordance with human rights standards to promote access to medicine is advisable. A North-South collaborative model for building health care and manufacturing capacity would help developing countries to build the required technical capability as well as provide quality health care at competitive prices in developed markets. An ongoing negotiation between India and the US is an effort in that direction.
- Scenario 3--IPR Provisions unfavourable for the innovators--Access to health care for all: In this scenario, the IPR provisions are unfavourable for the innovators, with patents either being limited or expiring quickly, leading to access to health care for all. In this case, the market is dominated by generic players, thereby leading to affordable medicines and health care available to society. The government encourages domestic pharmaceutical production by funding R&D initiatives and providing manufacturing incentives and regulatory support. A quadruple-helix model wherein the government, pharmaceutical firms, universities, and society (NGOs) collaborate to develop medicines addresses the needs of society.
- Scenario 4--IPR Provisions unfavourable for the innovators--Absence of access to health care for all: In this scenario, although the medicines are not protected by IPR provisions, quality health care is still unavailable for all. In this case, governments must build a robust distribution network that reaches far-flung areas and different sections of society. Building manufacturing capacity through public-private partnership, developing a PAN-country digital ecosystem with records that can be accessed from anywhere in the country, educating society regarding the health care facilities available, and building trust in public health care would help to address problems of individuals like Mrinalini. Health care providers groomed and educated on inclusive and sensitive care have the opportunity to intervene and positively impact the experience of patients like Basanti.
The challenge is how problems of Mrinalini and Basanti, may be addressed while still balancing the interests of the global innovators and the health care organisations.
- Scenario 1--IPR Provisions favourable for the innovators--Access to health care for all: In this scenario the health care ecosystem of a country balances the economic interests of the innovators and society at large. This may be possible through a tiered or differential pricing mechanism wherein the pharmaceutical companies and the health care providers charge based on the patients’ income level or the ability to pay. Such a model enables the companies to earn profits from wealthy markets and patients, which not only enables them to cover up for the subsidised health care to low-income patients but also gives them the incentive to invest in research for future drug development. The companies, however, need to be socially and legally responsible by following transparency in pricing and other monetary transactions.
- Scenario 2- IPR--Provisions favourable for the innovators--Absence of access to health care for all: In this scenario, the IPR provisions are favourable for the innovators, thus leading to a lack of affordable health care for all. In the case of patents held by global pharma companies, developing countries need to have the flexibility to interpret and apply rules regarding pharmaceutical patents to match the interests, needs, priorities, and levels of development of their respective nations. The need to develop legislative capabilities to use available exceptions, options, and defence mechanisms for disputing patents is critical. A South-South legal collaboration model wherein developing countries collaborate to develop a judicial system to interpret TRIPS in a way that is in accordance with human rights standards to promote access to medicine is advisable. A North-South collaborative model for building health care and manufacturing capacity would help developing countries to build the required technical capability as well as provide quality health care at competitive prices in developed markets. An ongoing negotiation between India and the US is an effort in that direction.
- Scenario 3--IPR Provisions unfavourable for the innovators--Access to health care for all: In this scenario, the IPR provisions are unfavourable for the innovators, with patents either being limited or expiring quickly, leading to access to health care for all. In this case, the market is dominated by generic players, thereby leading to affordable medicines and health care available to society. The government encourages domestic pharmaceutical production by funding R&D initiatives and providing manufacturing incentives and regulatory support. A quadruple-helix model wherein the government, pharmaceutical firms, universities, and society (NGOs) collaborate to develop medicines addresses the needs of society.
- Scenario 4--IPR Provisions unfavourable for the innovators--Absence of access to health care for all: In this scenario, although the medicines are not protected by IPR provisions, quality health care is still unavailable for all. In this case, governments must build a robust distribution network that reaches far-flung areas and different sections of society. Building manufacturing capacity through public-private partnership, developing a PAN-country digital ecosystem with records that can be accessed from anywhere in the country, educating society regarding the health care facilities available, and building trust in public health care would help to address problems of individuals like Mrinalini. Health care providers groomed and educated on inclusive and sensitive care have the opportunity to intervene and positively impact the experience of patients like Basanti.
The Government of India, through the Ayushman Bharat programme launched in 2018, aims to provide free health care and tertiary services in empanelled hospitals. With 44 crore Ayushman cards created, 12 crore hospital admissions supported, and 1.5 lakh centres created to provide free essential drugs, diagnostic services, and teleconsultations, India is gradually progressing towards making universal health care accessible to all. Not only in India, but Indian drug-makers also operate more than 40 manufacturing facilities in the US.
(The views expressed are personal)
This article is authored by Meeta Dasgupta, associate professor, strategic management, MDI Gurgaon.