The advancement health care and quality of life, not only in the developed nations but also in developing world including India, has made over the years can be described revolutionary. Today in India a person can live 64.4 years, whose life expectancy in 1951 was barely 36.7 years. Infant mortality has gone down from 146 to 70 per 1000 live births for the same period (Table 1). One of the key elements, provision of essential medicines is a strong indicator of health care system of any country. Therefore, the accessibility and affordability of essential medicines is vital for any noteworthy success in public health.
WHO estimated in 1999 that the percentage of Indian population had sustainable access to essential drugs was in 0-49 range, categorized as very low access country (Table 1). Roughly 1.42 billion people have inadequate or no access to live-saving essential medicines in the developing countries. The main obstacle to medicine access is economic constraint of these people, majority of whom resides in rural areas. The argument that India provides medicines to her people at low cost is not true in reality. This is required to be analysed by comparing purchasing power parity (PPP) of various countries. For example, cost of 100 paracetamol tablets represents income from 8 working hours (unskilled) in India, 1.3 hours in the USA and 1.5 in Switzerland. The fact that Karnataka High Court and subsequently Supreme Court stayed the implementation of pharmaceutical policy 2002 questioning the stand of Government over the exclusion of many essential drugs under the ambit of price control speaks the importance of price controlled essential drugs in India. The essential drugs, as defined by WHO, are drugs that satisfy the health care needs of majority of population and at a price that individuals can afford. An unnoticed feature of this definition is the conflict between need and affordability of a drug: whether or not a drug is considered essential must not depend on its price. Even in pre-TRIPS era, a life-saving anticancer drug imatinib mesylate cost between Rs 9,000 and Rs 12,000 per month treatment in its generic version. Leflunomide, an effective drug for rheumatoid arthritis is priced Rs 40 per tablet.
Post TRIPS scenario
Before the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement, India has not recognized product patent protection in drugs for the last 33 years. Patent Ordinance was introduced on December 26, 2004 to comply with WTO requirements. The Ordinance makes drastic changes to the existing Patent Act, 1970 and paves way for a minimum twenty years product patent regime to replace process patent system. Two categories of drugs will be affected (i.e. drug prices will rise) - first, post January 1, 2005 invented, patent protected drug. Secondly, generic drugs hitherto under Patent Act, 1970 but patent protected outside of India. India has been champion of world's leading generic low cost medicines manufacturer, with sizeable per cent of its export (including low cost HIV triple drugs) going to least developing countries. The supply of new affordable medicines will likely disappear in the new patent regime.
Table 1: Health status in select countries
| | HDI1 Rank | Public health expenditure (% of GDP)1 | Population with access to sustainable essential drugs (%)1 | Malaria cases (per lakh)1 | TB cases (per lakh)1 | Pop. with income of $ 1 a day 2 | IMR/10002 |
| India | 127 | 0.9 | 0-49 | 7 | 199 | 44.2 | 70 |
| China | 104 | 2 | 80-94 | 1 | 107 | 18.5 | 31 |
| UK | 13 | 5.9 | 95-100 | - | 5 | - | 6 |
| USA | 7 | 5.8 | 95-100 | - | 2 | - | 7 |
Source: 1-Human development report 2002, 2-National health policy 2002
An estimated 5.1 million people are currently living with HIV/and or AIDS in India, many of whom lack access to treatment. India is smitten with infectious and parasitic diseases, for which hardly any investments are made by MNCs for development of drug and therefore majority of people with tropical diseases do not have access to modern treatment. Everyone opines the same fate of post-TRIPS era in India - cost for AIDS treatment as well as treatment for cancer, diabetes and heart diseases will rise. On the top of it, it will be a luxury to have access to newer generics and better therapeutically active drugs.
However, TRIPS provides flexibilities in WTO rules to protect the rights of socioeconomic needs of its people. Everyone hopes that intelligent incorporation of necessary provision in pro-public health manner will be carried out in the patent ordinance before enacting it a full fledged patent law. Various NGOs across the developing world are closely following how these changes are being carried out, that has serious implications linked to access to affordable medicines.
The far-reaching impact is clear, medicines prices in India will continue to be high and will be higher. The obstacles to medicine access will definitely increase. Getting better anticancer, anti-arthritis or anti-hypertensive drug will never be same again. The efforts of international organizations in making medicines affordable and accessible to all may sound hollow to population lacks to the most basic essential drugs.
-- The author is Selection Grade Lecturer in Pharmacy Annamalai University, Annamalainagar 608 002 (TN). Email: cdl_scbasak@sancharnet.in