generic, haart, hiv, india, policy
B Kanna. Access To Highly Active Anti-Retroviral Therapy (HAART) For HIV Infection In India. The Internet Journal of Law, Healthcare and Ethics. 2006 Volume 4 Number 2.
The focus of this document is to analyze viable policy alternatives to generic drug manufacturing, an issue that is currently under debate. Policy options that improve access to HAART for HIV patients in India will be discussed based on a methodical approach to policy analysis proposed by Eugene Bardach (
Problem Definition & Background
Of the millions of HIV infected individuals in the world, more than 90% live in developing countries of Africa and Asia. In India alone in year 2006, an estimated 5.7 million people have HIV/AIDS that is more than any other country in the world. Almost every state in India has reported HIV cases. (2)
Highly active antiretroviral therapy (HAART) has led to a dramatic decline in AIDS-related morbidity and mortality. (3) However, such advances in HIV therapy have not benefited those suffering from HIV/AIDS in the developing countries. (4) One of the important reasons has been the high cost of antiretroviral therapy (HAART). Although, more than 600,000 individuals in India are in need of antiretroviral therapy, less than 30,000 are currently on HAART.
Generic manufacture of drugs in developing nations has led to price reductions of HAART and has made these drugs accessible to the poor patients suffering from HIV/AIDS. However there are several concerns among pharmaceutical companies and the medical community regarding the proper manufacturing and distribution of such antiretroviral drugs. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), pharmaceutical companies depend on patents to protect their huge investments in new pharmaceutical inventions. Pharmaceutical companies incur enormous costs in the research and development of new drugs. Estimates show that it takes approximately 10-15 years and costs roughly $800 million to introduce a new medicine to market. (5) While, generic producers do not contribute towards research into new drugs, they can produce low-cost drugs that are easily affordable. However, generic manufacturing would seriously impact the pharmaceutical companies' ability to reclaim their costs and reinvest in other research projects.
The World Trade Organization (WTO) developed an international agreement of patent protections for drugs across the world. This agreement called Trade-Related Aspects of Intellectual Property Agreement (TRIPS Agreement) requires patent protection for pharmaceutical inventions for a period of 20 years, preventing generic competitors from producing cheaper alternatives. (6) However, this TRIPS Agreement has some provisions that allow the delay of enforcement of TRIPS agreement for several years after initial application by a member country. As one of the first TRIPS member, India has made full use of these provisions to manufacture generic drugs disregarding patent regulations of TRIPS. However, India's utilization of provisions of the TRIPS agreement to manufacture generic HAART has certainly helped the people of India to access HIV/AIDS therapy at affordable costs. From January 2005, India will have to provide patent protection for medicines as part of its obligation under TRIPS. India's parliament passed a bill in March 2005 that changed the patent laws to prohibit the production of generic versions of patented medicines, including antiretroviral drugs. (7) Therefore, new HIV drugs discovered after 1995 will be sold in India at international prices unaffordable to Indian HIV patients. Also a recent proposal allows compulsory licensing of HIV drugs in countries only with capability to manufacture those medications, which certainly limits import of HIV medications to nations without this manufacturing capability. Due to emerging controversies concerning access to HIV drugs, the 2001 DOHA Ministerial conference was convened to specifically address the concern of public health among developing countries within the TRIPS agreement. This DOHA declaration formed provisions for an acceptable interpretation of the TRIPS treaty for member countries and recognized that intellectual property rights issues cannot be discussed separate from public health concerns. However, several other barriers to an acceptable HIV Drug pricing policy exist in developing countries.
National governments, international voluntary organizations and other bilateral donors and foundations have pledged just over US$ 2 billion towards antiretroviral treatment access by the year 2005. This aid falls short by US$ 3.5 billion with large variations at the country level. International aid has declined disproportionately compared to the increase in HIV disease burden in developing countries like India where more than 4 million HIV infected people live today. Even though financial resources are rising, in many heavily affected countries several barriers prevent effective spending of the money. These blockages include lack of provider and institutional resources, social stigma and discrimination, societal commitment and inconsistent funding processes of the international donor community. (8)
The major stakeholders in HIV Drug pricing policy are:
Alterative Policy Options
Alternatives to generic drug manufacturing have been suggested that may enable better access to HAART by the needy in developing nations.
1. Government-Pharmaceutical company partnerships: Pharmaceutical companies and developing countries can work together to purchase huge quantities of essential drugs. The combined purchasing power of all these countries may lead to price reductions allowing wider access to HAART.
2. Low cost HAART: Pharmaceutical companies can reduce the prices of their patented HAART drugs and improve access to them among the needy patients in the developing world. Such an option is limited by quantity of products that can be subsidized as well the period for which this will be in effect. Further, it is feared that the health care of HIV patients in these countries will become dependant on support of the pharmaceutical industry.
3. Compulsory licensing: Compulsory licensing is a legal provision within TRIPS that allows manufacturing of generics at competitive prices by copycat pharmaceutical companies. Despite competitive pricing of HAART, it could still be unaffordable for developing nations.
4. International funding: Although several barriers to access of HAART exist in the developing world, lack of funds to improve health care infrastructure and delivery above all is a major contributing factor.
The main outcome expected due to the HIV/AIDS Drug Pricing policy is to enable availability of HIV drugs in India at affordable costs. However, one would like to achieve this outcome under a fair cost reimbursement scheme for the US pharmaceutical companies who invest in research & development (R & D) of such high cost drugs. The following are the specific outcomes desired from any policy that addresses these issues.
A. Availability of HIV drugs to HIV patients in India at affordable cost (Best outcome)
B. Enforcement of TRIPS or other agreements among Indian companies and world market
C. Better R & D in HIV treatment
Projected outcomes & trade-offs
All policy alternatives are ranked based on evaluative criteria in a ranking matrix given below. (Table1) These alternatives are chosen to achieve the projected outcome namely, to improve availability of HAART to HIV infected patients in India at affordable cost. All policy options suggested in the ranking matrix have trade-offs as suggested by low scores for different criteria. The scores of 1 to 3 (1 =poor; 2= moderate; 3=better) denote the degree to which a specific alternative satisfies particular evaluative criteria. The trade-offs are the least for the International aid option (score 13/18) and the most for Compulsory licensing option (score 6/18)
Policy Recommendation And Rationale
International Aid has declined disproportionately compared to the increase in prevalence of HIV disease in developing countries. Lack of finance is now a serious barrier in the progress against AIDS. Even though World Bank, WHO and other philanthropic organizations provide financial assistance, the HIV pandemic in India remains out of control. This is partly due to the enormity of the disease burden affecting millions of people. At present approximately 5.7 million people are affected with the HIV virus. This estimate is projected to increase in the next few years. India is home for 10% of all HIV infected persons in the world and 60% of the Asian HIV infected population. India has the largest number of HIV infected individuals in year 2006 in the whole world. The pandemic is essentially out of control with HIV infection crossing over from high-risk groups to the general population now. An urgent need exists to improve infrastructure and personnel to provide adequate screening, prevention and therapeutic services for this huge number of HIV infected individuals. In view of rapid spread of HIV infection, there is a compelling need for appropriate treatment of HIV infected individuals to decrease mortality. HAART is well known to decrease mortality due to HIV infection. However, access to HAART is poor in several areas in India. Lack of infrastructure, lack of political will, costs of HAART and lack of funding are some main reasons for poor access to HAART. Based on a study published in Journal of American Medical Association by Attaran et al. (10) lack of funding was found to be most serious problem as opposed to popular belief that patent regulations prohibit access to drugs in developing countries.
Rationale for the recommendation
‘Increase in International Aid to India to improve structure and function of regional health care system to enable screening, diagnosis of HIV infection and administration of HAART therapy
An initial increase in health care treatment costs due to use of health care by more numbers of HIV infected individuals will be balanced indirectly by subsequent improvement in their overall health status due to availability of HAART. The International funding will also directly aid initial costs of improving health care delivery and access to HAART. More need for HAART will drive up healthy competition among pharmaceuticals and lead to drug price control through a market driven approach.
In light of an ever increasing threat of the uncontrolled spread of HIV infection to pandemic proportions in populous developing countries like India, International cooperation and aid is extremely important to tackle this enormous disease burden and improve access to health care for millions of HIV infected patients in the Indian subcontinent. The urgent need for international aid to improve access to HAART is best articulated by Attaran et al (10) who conclude from their study on access to HIV drugs in Africa as quoted below, “a variety of de facto barriers are more responsible for impeding access to antiretroviral treatment, including but not limited to the poverty, the high cost of antiretroviral treatment, national regulatory requirements for medicines, tariffs and sales taxes, and, above all, a lack of sufficient international financial aid to fund antiretroviral treatment. We consider these findings in light of policies for enhancing antiretroviral treatment access in poor countries”. Improving health care of HIV infected individuals will increase the demand for therapeutic HIV drugs that in turn can stimulate the international market to competitively drive down cost of these medications especially if local governments can buy drugs in bulk from pharmaceutical companies. (11)
Balavenkatesh Kanna MD MPH FACP Lincoln Hospital 234, E 149th ST Bronx NY USA Office: 718-579-5000 ext 5016 Fax: 718-579-4836 Email: email@example.com