PART-I | Socialization of Medicine

Ensuring equitable access to healthcare and quality medicines to all sections of the society irrespective of their caste, creed, colour, religion or paying capacity is the hallmark of a just, humane and civilized society
PART-I | Socialization of Medicine
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Generally, the term "socialization" is used to indicate the process of making social. It can be defined as a process by which individuals acquire the knowledge, language, social skills and values to conform to the norms and roles required for integration into a culture or a community (Stefania & Marina, 2015). In general, it is a process of learning to behave in a way that is acceptable to the society at large. However, this term is used in an entirely different context in this write-up where it implies to make commodities like medicines easily available, affordable and accessible to all sections of the society irrespective of their caste, creed, colour, religion or even their paying capacity, without making them suffer impoverishment on account of catastrophic and spine-breaking expenditures on medicines and healthcare. Socialization of medicines is akin to universal health coverage though insurance component may not always be present in case of the former. Socialization of medicines can include a slew of measures like reducing their prices, simplifying their supply chains, minimizing the number of intermediaries, purchasing in bulk to achieve economies of scale, purchasing on generic names directly from the manufacturers and financing the medicine related expenditures through social security schemes and universal health coverage. Socialization may not always imply distribution of medicines among patients belonging to the lower strata of the society free of cost though it does include providing subsidies and financial coverage to them through government sponsored insurance schemes.

            On April 17th, 2021, on the intervention of the Govt. of India seven major manufacturers and marketers of Remdesivir, a drug that is used to reduce viral load among COVID-19 patients, reported voluntary reduction in maximum retail price of the major brands of this drug to the extent of 133 percent to 312 per cent. For instance Cadila Healthcare reduced the price of its brand Ramdac from 2800 rupees to 899 rupees whereas Cipla reduced the price of its brand Cipremi from 4000 rupees to 3000 rupees. This provides a glaring example of how drugs are often overpriced by their manufacturers and marketers as a result of which their access and affordability gets compromised and sometimes even blocked depriving a large section of the society from an equal opportunity of getting quality medicines and healthcare. As per World Health Organization (WHO) estimates one third of global population comprising of 1.3 to 2.1 billion people do not have adequate and equitable access to medicines. This percentage goes up to 50% in case of Asian and African populations whereas in India an estimated 65% population does not have an equitable and adequate access to medicines (WHO, 2011). A whole lot of examples can be cited in fact to demonstrate how life saving medicines are charged heavily by pharmaceutical companies as per their own whims and fancies at costs that are unimaginably unaffordable for the majority of the global population and thereby promoting indiscriminate profiteering and corporatization from lifesaving commodities like medicines. Few such examples are given as under to illustrate how indiscriminate profiteering on medicines is adversely impacting their affordability.

            Trastuzumab, sold under the brand name Herceptin is a monoclonal antibody that is used to treat breast and stomach cancers and was approved for medical use in US in the year 1998 at a whopping cost of 54000 USD per person per year (Harwart, 2008). Similarly Imatinib, an oral chemotherapy medication that is used to treat dreaded cancers like chronic myelogenous leukemia (CML) and acute lymphocytic leukemia (ALL) was approved for medical use in the US in the year 2001 at a stunning cost of 92000 USD per year. In the year 2003, pharmaceutical company Novartis launched beta crystalline version of this drug under the brand name of Gleevec in US costing 2200 USD (approx. Rs. 1.45 lakh) per patient per month whereas generic versions of the same drug were available in India for under 200 USD (approx. Rs. 14000) per patient per month. Another drug Sorafenib was co-developed and co-marketed by the pharmaceutical companies Bayer and Onyx under the brand name Nexavar for the treatment of advanced primary kidney cancer and advanced primary liver cancer in the year 2005. A kidney cancer patient had to pay 96,000 USD (£58,000) for a year's course of this drug, whereas the cost of the Indian version of the generic drug was around 2,800 USD (£1,700) (Bloomberg). Later a Hyderabad based generic drug company named NATCO manufactured and sold the same drug at the cost of Rs. 8800 only. In the year 2011, Bedaquiline, a medication used to treat multi-drug resistant tuberculosis was approved for medical use in the US at a cost of 30000 USD for a six-month course. Similarly, another drug named Sofosbuvir developed by Gilead Pharmaceuticals for treating Hepatitis C and approved for medical use in the United States in 2013 was sold under the brand name of Sovaldi and was costing 84000 USD per person for a twelve-week course whereas its actual production cost was estimated to be only 136 USD (Iyengar et al, 2016).

            Tocilizumab also known as Atlizumab, an immunosuppressive drug, mainly used for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children is also a monoclonal antibody, that was jointly developed by Osaka University and Chugai, and was licensed in 2003 by drug company Roche. This drug is useful for COVID-19 patients and is sold under the brand name Actemra. While the cost of a single vial ranges from Rs 40,000-50,000, black marketeers are offering a single vial for as much as Rs 2 lakh which is nearly four-five times the actual price (The Print). Since the pathogenesis of the acute pulmonary injury related to COVID-19 is related to a severe hyper-inflammatory state during which high amounts of pro-inflammatory cytokines are released inside the body, preliminary trial data has suggested that Tocilizumab may be effective in improving outcomes for patients severely affected by the SARS-CoV-2 virus. However its huge cost is restraining access to majority of the infected population in India as well as other developing countries like Brazil whereas minimum estimated costs of production were found to be US $0.93/day for Remdesivir, $1.45/day for Favipiravir, $0.08/day for Hydroxychloroquine, $0.02/day for Chloroquine, $0.10/day for Azithromycin, $0.28/day for Lopinavir/Ritonavir, $0.39/day for Sofosbuvir/Daclatasvir and $1.09/day for Pirfenidone whereas their actual costs of production ranged between $0.30 and $31 only per treatment course (10–28 days). Current prices of these drugs were found to be far higher than the costs of production, particularly in the US (Hill et al, 2020). Therefore all this direly needs to change and the world needs to move from corporatization to socialization of medicines shifting the focus from patents to patients and making the drugs affordable and accessible to large chunk of the world population.

            In its press release dated May 8, 2021 Indian Medical Association has appealed the Govt. of India to ensure equitable and affordable access to COVID-19 vaccination for all citizens above the age of 18 years and has termed the differential pricing of coronavirus vaccine for different age groups as unjustified. They have demanded free vaccination for the age group of 18-45 years too out of the central share of 50% burden of its cost. A bench of the Supreme Court of India, headed by justice D.Y. Chandrachud, maintained that "there are several aspects of the vaccine pricing policy adopted by the central government which require that policy be revisited," in particular the rationale behind letting the manufacturers determine the vaccine prices for states and other private entities. The court asserted that vaccinations being provided to citizens constitute a valuable public good and thus, discrimination cannot be made between different classes of citizens who are similarly circumstanced on the ground and that while the Centre will carry the burden of providing free vaccines for the 45 years and above population, the state governments will discharge the responsibility of the 18 to 44 age group on such commercial terms as they may negotiate (Hindustan Times). The Rajasthan High Court even issued notices to the central and state governments on a plea challenging differential pricing of the vaccine for the centre and the states. In this backdrop, the plea submits that once Serum Institute of India & Bharat Biotech decide to make available the vaccine doses for Rs. 150/- per dose to the Government of India, there was no occasion or reason to be charging exorbitantly high prices of Rs. 400/- (now 300/) and Rs. 600/- (now 400/-) from state governments and Rs. 600/- and Rs. 1,200/- from the other organizations. The plea calls it 'absurd' and rather "unjustified" as to how could vaccine manufactured by the companies be sold at three different prices in the same country without any cogent rhyme or reason and that too with the approval of the Government of India against the interest of the public at large ( NGOs like Global Justice Now, STOPAIDS and Just Treatment have recently despatched a letter to the British Prime Minister Boris Johnson that has been signed by more than 400 academics, public health experts, civil society organizations, parliamentarians, unions, healthcare workers and patients calling for waiving off the intellectual property rights over COVID-19 vaccines and treatments at the World Trade Organization.

(Author teaches at the Department of Pharmaceutical Sciences, University of Kashmir)

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