Sustainable Financing for Anti-Retroviral Therapy in Botswana

Concept Note

Sustainable Financing for Anti-Retroviral Therapy in Botswana 1.0 Introduction The GOB is currently financing 70% of the entire national response (NACA, 2010). The sustainability of the national antiretroviral (ARV) treatment program, known as MASA, is an important issue facing Botswana both now and in the future. The ability of government to sustain the ARV program in the future is directly connected to saving the lives of many Batswana. The life sustaining ARV treatment is also being proven to be an extremely important part of the HIV prevention strategy. Whilst the Government of Botswana (GOB) is committed to the management of the HIV and AIDS epidemic, it is, for a number of reasons, concerned with the long term sustainability of the national response. Reasons for such concern include:  The impact of the global financial crisis on the economy,  Decrease in diamond revenues,  Decreased global ODA aid funding commitments as reflected in the recent HIV/AIDS funding reduction and the resultant dilemma of low and middle income status countries,  International guidelines that recommend initiation of ARV therapy in HIV infected persons when their CD4 count is 350 – up from earlier criteria of CD4 count of 250.

1.1 Issues Surrounding Sustainability of the National ART Program Given the mounting fiscal pressures on Botswana and the disease burden from AIDS, it is imperative to explore avenues to sustain the national ARV program alongside other HIV and AIDS services. Therefore, it is important to seriously examine the costs associated with implementing the national ARV program and how these costs can be reduced in a sustained and equitable manner, as an urgent human rights principle. The issue of sustaining ART raises several issues pertaining to government’s capacity to relating to: 1. The cost of antiretroviral (ARV) drugs; 2. Structural capacity building issues including human resources; 3. Technical issues surrounding procurement of antiretroviral drugs embracing implementation of flexibilities enshrined in the DOHA declaration on the TRIPS Agreement and Public Health; and 4. Monitoring and evaluation of the antiretroviral treatment (ART) program.

1 The Cost of Antiretroviral Drugs for treatment of HIV Exploration of options to sustain the ARV program should be considerate of the fact that as the number of people in need of ARV treatment increases, the expenses associated with implementing the national ARV program will only continue to increase. For instance, as of 31st December 2011, there were between 300,000 – 350,000 estimated HIV infections, 178,684 HIV infected people were on HAART and 185,963 were estimated to be in need of ART (source: EPP Spectrum, MASA: Dec 2011). The figure of individuals eligible for ART will rise as the GOB has increased the treatment eligibility criteria from a CD4 count of 250 to a CD4 count of 350, effective from 1 st April 2012. This will significantly increase the burden on the current ART program as this change in treatment eligibility criteria will add about 23,000 people to the ART program, representing an increase of about 15% of those currently receiving ART by 2015. An analysis of the National Integrated ARV dataset suggests that around 42% (9,700) of the 23,000 would be diagnosed in the following year and be likely to start treatment. Thus between 9,700 and 17,000 new patients with CD4 counts from 150-350 are likely to receive ART by the end of 2012 as result of the guideline change. The increase will translate to an additional 254 million Pula by 2012 and 1,271 million pula for the 2012-2016 time period — an increase of 15%.

Structural Capacity Building Issues Including Human Resources In addition to the cost of maintaining the national ART program, another challenge is the availability of well-trained health professionals who can provide HIV treatment and care to patients with HIV. The brain drain in the field of health to other countries resulting from better pay and benefits promises places constraints on the national ART program’s ability to scale-up treatment to include more people. This places demands for capacity building efforts on the country to increase the number of health professionals who are knowledgeable about HIV and AIDS, who can help to ensure the sustainability of the program, among other structural requirements.

Technical Issues Surrounding Procurement of ARV Drugs Another issue that is critical to the discussion around the sustainability of the national ARV program in Botswana that has yet to be addressed by government, centers on the advantages and disadvantages of generics over brand name drugs. While there can be cost savings associated with procuring generics over brand name medications, pharmaceutical companies have been willing to sell HIV medications to resource poor countries at a reduced price or have simply given them away. In Botswana, for example, Merck has donated certain medications to the national ARV program. Where there is little or no advantage to procuring generics over brand- name medications, some health care professionals have preferred to use brand name medications. However, where there are clear advantages to using generics over brand name medications, it is important that government incorporate generics into the procurement process. Patent law issues often present challenges to procurement of the most cost effective drugs, whether generic or brand name. In Botswana, patent laws are covered under the Industrial

2 Property Act. As a result of a system in which it is usually more cost effective to buy ARV medications that are not patented, the patent laws of Botswana have important implications for the sustainability of the national ARV program. In order to ensure the sustainability of the national program, government must improve the current policy under the Industrial Property Act by clarifying and providing guidance where terms appear ambiguous or beyond the parameters of the flexibilities enshrined in the Doha Declaration of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) and Public Health (the ‘Doha Declaration’) that Botswana adopted. The TRIPS Agreement requires that patents “be available for any inventions provided that they are new, involve an inventive step and are capable of industrial application”. However, because the TRIPS Agreement does not specify what these terms mean, it is up to each member of the World Trade Organization (WTO) to determine what these terms mean. Botswana must insure that the meaning given to these terms meet the interests of Batswana within the parameters of acceded agreements. Another issue of importance regarding the sustainability of the ARV program and patents relates to the exclusion of new use and form patents that essentially allow patents to live on indefinitely. For example, if government grants a patent for the drug AZT, which was developed in the 1960’s as an anti-cancer drug but can now be used and an ARV drug, government would be issuing a new use and form patent for an “old” drug. Under international law, there would be no obligation for government to grant such a patent. The government must allow the public access to information about patents; revise the patent licensing requirements that encourage patent owners to grant voluntary licenses thus allowing generic products to be placed in the market without delay; and decriminalize patent infringements. There is no requirement under the TRIPS Agreement to make patent infringement a crime. These are but a few of the steps that government can take to ensure the sustainability of the national ARV program in the future in order to preserve the health and welfare of Batswana.

1.2 Monitoring and Evaluation of the ART Program The cost and critical nature of the ART program requires a monitoring and evaluation system in place to ensure an effective and efficient the procurement system to sustain ARV drug supply. There are logistical problems and challenges that can severely detract from the successful procurement of ARV drugs used in the national program, with delays that could result in changes to the ARV therapy regimen of established patients. Such changes may not only play havoc on the individual health and welfare of patients, but are also likely to be associated with additional costs that would undoubtedly become burdensome for the system when considered comprehensively.

2.0 Way Forward Based on the urgent nature of the AIDS treatment challenge for Botswana, it is critical for government to take forward the ground work that has already been carried out in the area. Efforts are currently ongoing in terms of government parties and some development agencies in this

3 regard. The GoB-POP has provisions to spearhead work in this regard in the Health and HIV and AIDS 2012 Annual Work Plan. Therefore, it is vital for all relevant sectors to convene and draw a road map for the country upon which a plan ensuring the sustainability of the national ART program can be developed. It is in this regard that a workshop on a Roadmap to Sustain the ART Program is proposed. The workshop should include treatment experts, pharmaceutical company representatives, representatives from the Ministry of Finance and National Development, Ministry of Trade and Industry, Attorney General’s Chambers, Ministry of Health, NACA, development partners (UNAIDS, UNDP, WHO etc), Central Medical Stores, CSO and other relevant stakeholders on the necessary steps that must be taken to ensure the sustainability of the ARV program.

2.1 Goal To review national past efforts aimed at attaining the sustainability of the national ART program with specific focus on ensuring access to WHO pre-qualified cheaper antiretroviral drugs.

2.2 Specific Objectives  Evaluate the current HIV burden and near-term trends (incidence, clinical progression and ART requirements), along with the scale, coverage, cost and quality of current and future interventions.  Identify mechanisms to ensure long-term financial sustainability of the ART program alongside other services in the national response to HIV.  Generate a national dialogue among key decision-makers and other stakeholders on the sustainability of the ART programme in Botswana that focuses on accessing WHO pre- qualified cheaper generic ARVs through either production or through sourcing.  Define a road map required to sustain the national response in particular on the ways of accessing WHO pre-qualified cheaper generic ARVs considering the global financial downturn and subsequent drying-up on overseas development aid, coupled with the national requirement to increase ARV coverage.