October 13, 2006 | Volume 3, Issue 2
Comprehensive Care for HIV/AIDS
The challenge goes beyond antiretroviral accessibility
The price of anti-retroviral treatment is prohibitive for most patients in developing countries, but a new integrated approach may succeed at reversing the pandemic by addressing more than just access to medication.
Introduction: The silent spread of the epidemic
Twenty-five years have passed since the first cases of Human Immunodeficiency Virus (HIV) were identified. Unlike other diseases, the progress up the learning curve for treating HIV has been very slow, and the spread of infections has doubled between 1995 and 2005 (Figure 1).
Figure 1: Evolution of the HIV/AIDS epidemic
Source: UNAIDS, 2006 Report on the global AIDS epidemic
Today 40 million people live with HIV worldwide; every six and a half seconds a person contracts HIV; and every 10 seconds a person dies from AIDS.1 Moreover, the spread of the pandemic is unevenly distributed between developed and developing countries. Sub-Saharan Africa, with 24.5 million people infected, has been devastated by the disease.2 In Asian countries, 1.8 million people are infected and growing epidemics in China, Indonesia and Vietnam are sure to increase this number.3 Likewise, there are 1.5 million people living with HIV/AIDS in Eastern Europe and Central Asia, with rapidly escalating infection rates in both Ukraine and Russia.4 Second only to Sub-Saharan Africa in scale and severity of the epidemic, the Latin America/Caribbean region is home to 1.9 million people living with HIV. In several Caribbean countries, HIV/AIDS has become the leading cause of death.5 All together, developing countries account for 73.5% (29.4 million) of the total population living with HIV, whereas developed countries in Western and Central Europe and North America are home to just 6% (2.0 million) of people living with HIV.
With these infections rates, today’s challenge is to find effective means to fight back the pandemic. This is particularly crucial in regions such as Sub-Saharan Africa, where an entire generation has been lost. Because the most promising vehicles to eradicate HIV-a vaccine or other forms of preventative medicine-remain out of reach, antiretroviral (ARV) treatment is the most effective mechanism that is presently available to combat the disease.
The combination of different ARV treatments can considerably delay the replication of HIV and reduce immune deterioration, and current research efforts concentrate on making better antiretroviral treatments.6 However, while key improvements in ARV treatments have been achieved since 1994, the main challenge to the success of ARV treatment remains one of access.7 Traditionally, the primary constraint to accessing ARV treatments has been cost. ARV treatments were developed and patented in developed countries where selling prices were set according to market forces, not social need. As a result, ARV treatments were available at very high prices in developing countries, and only those with the sufficient economic resources were able to receive adequate care. This partially explains the uneven distribution of the disease worldwide. However, Intellectual Property Rights (IPRs) and their impact on prices can no longer be seen as the primary barrier to accessible treatments. Instead, factors such as health infrastructure, human capital, and economic resources play a primary role in providing universal access. This paper will present the traditional policy approaches to improving access to ARV treatment before demonstrating how newer, more comprehensive policies are better able to address the problem.
Traditional approach to ARV treatment accessibility: Policies towards price reduction of ARV treatment
From 1994 to 2000, the global community concentrated its efforts on ensuring that developing countries are able to access ARV treatment at fair prices. In order to accomplish this, countries relied on three main strategies: (a) enforcement of local generic industries and compliance with the Trade Related Intellectual Property Rights (TRIPS) Agreement under the World Trade Organization (WTO); (b) the development of special HIV/AIDS laws that promote access to comprehensive care for people living with AIDS; and© the creation of global partnerships that increase awareness and gather funds necessary to pay for ARV treatment once fair prices were negotiated. Each of these strategies will be discussed in more detail below.
A. Enforcement of local generic pharmaceutical industries and implementation of the TRIPS Agreement
The TRIPS Agreement provides important mechanisms-such as compulsory licensing and parallel imports-that developing countries can use to ensure access to drugs. Compulsory licensing allows a government to grant a company, government agency, or other party the right to use a patent without the titleholder’s consent.8 Parallel importation occurs when a patented product sold legitimately on the market in one country is exported to and resold in another country without the consent of the owner.9
Compliance with the TRIPS Agreement has been erroneously perceived as a threat to ARV treatment accessibility. In this regard it is important to clarify the flawed assumptions that underlie developing countries´ resistance to IPRs. First, compliance with patents laws will not stop the production and exporting of generic medicines.10 The generic pharmaceutical business will continue as usual since product patents under the TRIPS Agreement are non-retroactive. Therefore, the production of existing generics will continue, and export activity to countries with insufficient or nonexistent production capacity will remain possible through the use of compulsory licensing.11 Second, IPRs are not the only determinant of high ARV treatment prices. Distribution, marketing and production are also part of the price equation.
Generic pharmaceutical industries in developing countries facilitate access to ARV treatments in two ways. First, they provide treatment at one-third the price of patented ARV treatments. Second, they introduce competition in the ARV treatment market, leading to reduced prices for brand-name ARV treatments. Brazil’s generic pharmaceutical industry has been a key player in ARV treatment universal access policy, supplying 40% of all ARV drugs used in Brazil and producing 7 of the 14 ARV treatments that the government distributes amongst its affected population.12
Success, though, has not come easily. Brazil has been under constant criticism from developed countries for implementing TRIPS provisions-like compulsory licensing-in order to boost its generic pharmaceutical market. Despite this outside pressure, the Brazilian government continues to argue that national legislation needs to allow for the use of compulsory licensing, because it (a) facilitates effective negotiations with patent holders, (b) prevents abuse of monopoly power, (c) protects prices from currency fluctuations, and (d) helps develop local industry and expertise.13
B. Development of special HIV/AIDS laws that promote access to comprehensive care for people living with AIDS
Local legislation that ensures access to comprehensive care has been an important factor in reducing the prices of ARV treatments. It forces health ministries and governments to partner with other countries in negotiating with the industry to arrange substantially reduced ARV prices. Through sub-regional negotiations, Latin American and Caribbean, ministries of health-with the support of PAHO, UNAIDS and other organizations-have managed to substantially reduce the price of ARV medicines.14
C. Creation of global partnerships that increase awareness of the situation and raise the funds necessary to purchase ARV treatment once fair prices are negotiated
According to the World Health Organization (WHO), the current cost of ARV treatments in least developed countries can range from $300 USD to $1,200 USD per annum, which remains a prohibitively high expenditure in countries with an average per-capita income below $745.15 Heightened awareness of the disease and of issues concerning ARV treatment accessibility has made it possible for international organizations, in conjunction with private and public sector entities, to develop a global partnership that is able to negotiate lower ARV treatment prices. This global partnership also guarantees that sufficient resources are available for ARV treatment acquisition once lower prices have been negotiated.
In short, the traditional approach used to improve access to ARV treatments has been successful in reducing ARV treatment prices by using cheaper generic substitutes; by negotiating in blocks with pharmaceutical companies; by developing local legislation that guarantees comprehensive health care and compliance with the TRIPS Agreement; and by forming global partnerships to increase awareness, share best practices, and collect the necessary funds to make treatment available for all.
Uganda provides a good example on how the traditional approach has made possible a decline in ARV treatment prices (Figure 2). In 1998, the average price of ARV treatment in Uganda was US$ 12,000; however, by the year 2000, the average price had fallen below US$ 2,000. As the government’s negotiation capacity benefited from the Accelerating Access Initiative (AAI), an 83.3% decline in price was possible.16 Further price reductions were also seen in 2001, as continued government discussion with the generic pharmaceutical industry increased competition in the Ugandan ARV treatment market.
Figure 2: Price reductions of ARV in Uganda
Source: World Health Assembly Technical briefing May 2002
As the traditional approach achieves its objective, new challenges arise as the price of ARV treatments becomes a secondary concern. Do governments have the necessary health infrastructure to deliver ARV treatment? Do they have enough doctors, nurses, clinics, and educational materials necessary to administer ARV treatment? Do they have the capacity to effectively manage large budgets tied to ARV treatment projects? Do they have the means to implement the provisions of the TRIPS Agreement? A new approach is needed to ensure that HIV policies are as complete as possible.
The recommended approach to ARV accessibility: Combination of policies targeting all aspects of the disease.
ARV treatment accessibility has been positively affected by the new approach developed at the World Summit in 2000. Under the Summit’s agenda for the new millennium, the international community agreed on eight Millennium Development Goals (MDGs) to be met by 2015. MDG 6 specifically targets HIV/AIDS, malaria, and other diseases, with the objective of halting the spread of the disease by 2015. Another of the Summit’s goals that has improved access to ARV treatments is MDG 8: Develop a Global Partnership for Development. It specifically calls for government cooperation with pharmaceutical companies to provide developing countries with access to affordable drugs.
Under this new organizational framework, the recommended approach is to target all the factors that surround the disease in order to combat it efficiently (Figure 3). Therefore, the most effective means of improving access to ARV treatments is a combination of policies that (a) facilitates the development of health infrastructure, (b) ensures investment in human capital, (c) promotes the efficient allocation of economic resources, and (d) complies with the TRIPS Agreement. Each of these policies will be discussed in more detail below.
Figure 3: New approach for ARV treatment accessibility: Is part of a major strategy to combat the disease
A. Investment in healthcare infrastructure
An integrated approach to HIV/AIDS treatment requires sufficient numbers of hospitals, clinics, laboratories, research facilities, and equipment. Linkages among these resources are also essential to promote operational effectiveness, sustainability, and overall coordination.17 Adequate healthcare infrastructure allows for better collection of health data, facilitates the development of logistical know-how, and improves healthcare management capabilities.
B. Investment in human capital
To administer ARV treatments and provide adequate service, training is necessary for doctors, clinical officers, nurses, social workers, laboratory technicians, pharmacists, counselors, and clerks. This requires economic resources, as well as a permanent collaboration with medical educational institutions. In 2006, low- and middle-income countries require $400 million USD to fund human resource training.18
C. Promotion of efficient allocation of economic resources
An integrated approach to combat HIV/AIDS requires efficient management of resources at all levels of the supply chain. The goal is to minimize administration expenses so that each major piece of the strategy can receive the funds necessary to efficiently deliver its services. An efficient practice to reach this objective is to distribute the funds as tied aid, which would restrict the application of HIV resources to predefined projects. For example, in 2005, Africa received 29% of the world’s total available funding earmarked for prevention and 55% of the total available funding earmarked for treatment and care.
Countries with low infection rates, in contrast, receive funds that are allocated more heavily to prevention rather than treatment. This is illustrated by Figures 4 and 5. Notice that the East Asia and Pacific region and the South and South-East Asia region received 26% and 21% respectively of total funding available for prevention, but only 16% and 4% respectively of the funding available to for treatment.
Figure 4: Distribution by region of the funding required for prevention
Source: UNAIDS (2005). Resource Needs for an expanded response to AIDS in low-and-middle-income countries.
Figure 5: Distribution by region of the funding required for treatment and care
Source: UNAIDS (2005). Resource Needs for an expanded response to AIDS in low-and-middle-income countries.
D. Compliance with the TRIPS Agreement and development of IPR Legal Frameworks
It is essential that developing countries have strong legislation that will promote the effective use of Intellectual Property Rights and provide comprehensive care for people living with HIV/AIDS. National policies need to support the use of compulsory licensing to import generic versions of ARV treatment that are already available on the market. Countries such as Nigeria and Cameroon have been able to acquire ARV treatments at a humanitarian price of $350 USD per month from an Indian pharmaceutical company, CIPLA. In June 2001, Kenya’s parliament unanimously passed a law allowing the government to suspend patent rights during times of emergency, thus clearing the way for importation of cheaper, generic AIDS drugs19 These examples illustrate the benefits of having patent laws that permit them to take advantage of TRIPS provisions.
Conclusion
The HIV/AIDS epidemic has affected the lives of nearly 40 million people around the world. There is currently no cure for HIV/AIDS, but a combination of ARV treatments can significantly improve patients’ quality of life. It took 14 years to develop ARV treatments, and the burden of the cost for research and development was automatically reflected in high prices when the drugs first came to market. Access to treatment became selective and only those with sufficient economic resources where able to receive it, leaving out those most in need.
A coordinated effort among development communities facilitated negotiation of lower group prices for ARV treatment. Other countries, like Brazil and India, focused on developing strong generic pharmaceutical industries that created competition in the ARV treatment markets. This enabled these countries to offer ARV treatment at one-third the price of brand-name medicines. In short, reducing prices was a process that absorbed most of the effort and resources available to fight the disease for 14 years.
In 2000, the declaration of MDGs provided a set of incentives and guidelines to combat HIV/AIDS as part of an integrated approach. Within this new perspective, treatment is just one aspect of the general policy used to reverse the pandemic. Important factors-such as healthcare infrastructure, human capacity, management of economic resources-were added to the efforts of developing a comprehensive regulatory framework. The results have been outstanding, and access to treatment has been enhanced by the existence of healthcare infrastructure that supports HIV/AIDS treatment and care.
This paper has demonstrated that an integrated approach has proven to be the most effective way to combat a disease that relies on treatment and prevention rather than a cure. It is a global responsibility to ensure that sufficient funds are available to combat HIV/AIDS, but ultimately, it is up to every country to provide the legal frameworks necessary to ensure free access to drugs and adequate healthcare infrastructure to reverse the pandemic. Countries’ policies need to prevent and treat the disease while ensuring that those most in need have access to the tools necessary for successfully fighting the disease.
1 United Nations Population Fund (UNFPA). “AIDS Clock.” http://www.unfpa.org/aids_clock/ (accessed July 2006).
2 Ibid
3 Joint United Nations Programme on HIV/AIDS (UNAIDS). “Number of women living with HIV increases in each region of the world.” Press Release. www.unaids.org (accessed July 2006).
4 Ibid
5 World vision international. “Aids in Latin America, facts in brief.”
http://www.wvi.org/wvi/aids/latin%20america_aids.htm (accessed July 2006).
6 World Health Organization (WTO). “Antiretroviral Therapy (ART).” http://www.who.int/hiv/topics/arv/en/index.html (accessed July 2006).
7 It took 14 years to launch the first highly active antiretroviral therapy (HAART) to inhibit the replication of HIV; United Nations Development Program (UNDP), Special Initiative HIV/AIDS. “TRIPS, HIV/AIDS and Access to Drugs.” New York: 2001
8 United Nations Development Program (UNDP), Special Initiative HIV/AIDS. “TRIPS, HIV/AIDS and Access to Drugs.” New York: 2001.
9 Ibid
10 United Nations Development Program (UNDP), Special Initiative HIV/AIDS. “Impact of India’s adoption of TRIPS: Access to medicines in the developing world.” New York: 2001.
11 Ibid
12 Ibid
13 Ibid
14 United Nations Population Fund (UNFPA). “Antiretrovirals: Efforts in Latin America and the Caribbean toward the universal access.” http://www.paho.org (accessed July 2006).
15 Sarath Rajapatirana,. “The Least Developed Countries, The Tyranny of a Definition.” Development Policy Outlook, AEI Online (Posted: Friday, July 14, 2006). http://www.aei.org/publications/filter.all,pubID.24661/pub_detail.asp (accessed July 2006).
16 The initiative involves a dialogue between the UN and the pharmaceutical industry with the intention of making HIV/AIDS medicines and diagnostic equipment more available and affordable in developing countries. AAI was launched in May 2000 by the Joint United Nations Programme on HIV/AIDS (UNAIDS).
17 Jack C. Chow. “Diplomacy Is Central to Building Public Health Infrastructure”. Deputy Assistant Secretary for International Health and Science, U.S. Department of State. http://usinfo.state.gov/journals/itgic/1201/ijge/gj02.htm (accessed July 2006).
18 Joint United Nations Programme on HIV/AIDS (UNAIDS). “2006 Report on global AIDS epidemic.” http://www.unaids.org/en/HIV_data/2006GlobalReport/default.asp (accessed July 2006).
19 United Nations Development Program (UNDP), Special Initiative HIV/AIDS. “TRIPS, HIV/AIDS and Access to Drugs.” New York: 2001.