The Budget and Expenditure Monitoring Forum (BEMF), which draws together individuals and organisations from civil society, academia, government, organised labour and business, focuses attention on ensuring that sufficient money is budgeted for and appropriately spent on meeting the treatment and prevention targets of the national HIV & AIDS and STI Strategic Plan for South Africa 2007-2011 (NSP) as well as for health more broadly. BEMF held its first meeting on 21 August 2009. BEMF’s second meeting, which was held in Johannesburg on 5 February 2010, drew together over 40 people from 19 organisations, including legal experts, clinicians, economists, government officials, epidemiologists and trade union and civil society activists. The agenda focused on the upcoming antiretroviral (ARV) drug tender and the need to ensure that it is structured and run in a manner that enables the state to procure an adequate supply of appropriate medicines at the lowest possible prices.
A sustainable HIV treatment programme requires a competitive tender.
• government is able to procure sufficient quantities of medicines to meet demand;
• adequate funds have been budgeted;
• medicines are purchased at globally competitive prices; and
• all essential products – including appropriate paediatric formulations and fixed-dose combination pills (FDCs) – are available for procurement and use in South Africa.
The current ARV tender expires at the end of May 2010. Participants at the meeting were informed that the DoH, with the assistance of the Clinton Foundation Health Access Initiative (CHAI), has designed a tender process that appropriately addresses numerous issues, including the following:
• Enabling the state to purchase ARV medicines at globally competitive prices;
• Ensuring sufficient flexibility to allow companies to submit tender bids in respect of medicines that have yet to be registered for use in South Africa but in respect of which applications for registration have already been made to the Medicines Control Council (MCC); and
• Requiring companies to reduce prices in response to certain market shifts (such as significant drops in the prices of active pharmaceutical ingredients) so as to ensure that South Africa benefits from global price reductions.
Despite significant advances in ARV treatment, the 2004 treatment guidelines have yet to be revised. The meeting was informed of a process involving the South African National AIDS Council (SANAC) and the DoH to revise the guidelines. In calling for the most recent draft of the revised guidelines to be finalised and urgently published, the meeting recognised the need for future revisions to be guided by a transparent and well-defined process. In particular, the guidelines should be reviewed regularly to keep pace with advances in medical science. In addition, the process needs to take greater cognisance of the informed views of expert clinicians and people living with HIV.
For many reasons, the MCC has been notoriously slow and inefficient in registering medicines. Despite it having taken positive steps to address its backlog, too few ARV medicines have been registered in the past six months. This restricts the ability of the DoH to procure appropriate formulations of ARV medicines at competitive prices. In this regard, the meeting noted the need for the MCC to be allocated the necessary resources to carry out its work efficiently and effectively. In addition, it called for the MCC’s staff – all employees of the DoH – to prioritise the registration of those ARV products the state seeks to procure.
While generic versions of many ARV medicines are currently available for use in South Africa, a number of barriers still stand in the way of key products coming to market. Key products that ought to be available in South Africa include the following:
• Cheaper generic versions of the second-line ARV drug lopinavir/ritonavir (the only protease inhibitor included in the treatment guidelines);
• Appropriate formulations of paediatric abacavir, which are still awaiting registration by the MCC; and
• FDCs covering both first and second line ARV regimens in the new guidelines.
Monitoring and evaluation of the treatment and prevention programmes
The DoH has yet to implement an effective monitoring and evaluation system of its HIV treatment and preventions programmes. If and when done, this will enable it to report – with reasonable accuracy – on the following:
• Number of people initiated on ARV treatment;
• Number of people currently on treatment, including the number on second-line regimens;
• Baseline CD4 counts;
• The number of pregnant women at the various stages of the prevention of mother-to-child transmission of HIV (PMTCT) programme; and
• Number of infants tested and HIV prevalence amongst infants tested.
The meeting was informed that the Eastern Cape Health Department does not have the funds to pay the Occupational Specific Dispensation (OSD) to eligible health care workers. This confirms months of speculation that the OSD was not properly costed and concerns that there are insufficient funds for implementation.
The Money Bills Amendment Procedure and Related Matters Act 9 of 2009, which was assented to by former President Motlanthe and came into effect on 14 April 2009, gives Parliament wider powers over the budget process and outcome. No longer is Parliament confined to being able only to vote for or against the Budget. It now has the authority and statutory obligation, amongst other things, to consider the fiscal framework, the Division of Revenue Bill and the Appropriations Bill, and to make amendments were deemed appropriate and hold public hearings on all three.
The Free State AIDS Coalition briefed participants on ongoing concerns relating to ARV treatment access in that province. While the first BEMF meeting had been informed of shortages of ARV medicines in Free State health facilities, this second meeting heard about facilities that have adequate stocks of ARV medicines but are short-stocked on a range of other essential drugs.
The meeting also heard that the AIDS Law Project (ALP) and Health-e News Service have established a database to record incidents of drug shortages and other problems pertaining to the HIV treatment and prevention programmes. Any similar incidents should be reported to the ALP’s Agnieszka Wlodarski on 011 356 4100 or firstname.lastname@example.org. 5
Four formal presentations were made at the meeting. These are available at http://www.tac.org.za/community/bemf#meeting-2:
Nathan Geffen of the ALP described challenges to optimising the ARV treatment rollout.
Francois Venter, President of the Southern African HIV Clinicians Society, explained the new draft ARV treatment guidelines, including their advantages and shortcomings.
Jonathan Berger of the ALP explained the legislative framework for public procurement, with particular reference to the 2010 ARV tender.
Vishal Brijlal of the Clinton Health Access Initiative, who is advising the DoH on the 2010 ARV tender, explained the proposed tender process.