World TB Day Memorandum: Step up the implementation of “Zero infections, deaths, stigma and discrimination from TB and HIV in my lifetime”!

Today, 22 March 2013, while we commemorate World TB day, we need to take stock of the progress we have made in fighting the disease.
Today, TB remains the number one cause of death in South Africa. Approximately 1% of the South African population develops TB disease every year. That is 500,000 people per year. Despite an improvement of the cure rate over the years, the treatment success rate of new TB infections is still below the global target of 85%. The epidemic is further compounded by MDR-TB with at least 13,000 new cases projected for 2013. South Africa continues to carry one of the highest TB burdens in the world.
We welcome the Department of Health’s effort in scaling up its campaign for testing and screening for HIV and TB. We sincerely hope that the DOH will reach the target of 30 million people screened by 2016 which it has set out in the NSP 2012-2016.
We furthermore welcome the considerable effort of the NDOH in making the GeneXpert available across the country. Today, more than 150 GeneXpert machines are installed and a further 125 are planned for 2013. With a sensitivity of 98% (55-77% in smear-negative cases) and a result within 90 minutes, GeneXpert should drastically reduce the time to diagnose active TB disease and especially drug-resistant TB (DR-TB). This should lead to faster initiation on effective treatment, less time for TB transmission in the community, less risk of resistance, and ultimately a decrease in the rate of new infections. However, Honourable Minister, GeneXpert can only make a difference if it leads to faster initiation on treatment. For this to happen, we need uninterrupted cartridge supply and capacity to manage DR-TB at primary care as soon as the patient is diagnosed, this includes adequate resource allocation, training of staff, continuous supply of TB and DR-TB drugs and adequate supervision capacity. Medicine stock-outs, as we saw in 2012, at depots, hospitals and pharmacies increase the risk of developing drug resistance and endanger the lives of many of South Africa’s people.
We welcomed the department’s policy framework on decentralised and deinstitutionalised management of DR-TB for South Africa in 2011. However, we have had to witness with sadness that two years later the policy framework has hardly been implemented. The provincial operational plans for decentralisation of MDR-TB care have not been drafted, nor have readiness assessments been conducted of all proposed decentralised MDR-TB units, satellite units and PHC facilities, nor have doctors and nurses been trained. We ask the honourable minister to report on the progress of the implementation of the MDR-TB decentralisation policy and assure us that clinically stable adults and children will be initiated and managed on DR-TB treatment in their local clinic in every province before the end of 2013.
 On 24 March 1882, Dr Koch announced that Mycobacterium Tuberculosis is the cause of Tuberculosis. Today, 131 years later, we are still treating patients with TB drugs that are 60 years old. Finally new drugs are being developed and tested. Bedaquiline is one example, and we welcome the open label trial to provide expanded access to Bedaquiline. However, currently there is only one primary care based site for initiation, in Khayelitsha; we need to increase the number of primary care based sites which are able to manage DR-TB adequately throughout South Africa to ensure our brothers and sisters elsewhere can access this potentially life-saving drug.
Bedaquiline alone will not be sufficient, it needs to be given in a regimen alongside other drugs.  We ask that other effective repurposed drugs be made affordable and therefore available. One such drug is Linezolid. This drug is highly effective against both MDR and XDR-TB but is extremely expensive in South Africa. Pfizer holds the patent in South Africa and sells Linezolid for R676 per tablet in the private sector and R287 per tablet to the government. Patients require one Linezolid tablet every day for many months.  As long as Pfizer holds a patent on this drug in SA, patients will not have access to a drug that, in combination with other effective drugs, could save their lives. Only recently in the Western Cape, the drug coding committee decided against coding Linezolid for treatment of DR-TB with cost playing a major role in the decision. Our government has the means to its disposal to allow for importation of this drug from a generic company in India at a price of R10 per tablet. A compulsory licence is authorised both by article 31 of the TRIPS agreement, as well as by the South African Patent Act of 1978 when “...  it is in the public interest that a licence or licences should be granted;”
The Department of Trade and Industry is currently devising a policy on intellectual property rights which will, amongst others, deal with trips flexibilities such as parallel importation, an examination office and compulsory licences. We urge the DOH to take an active interest in the development of this policy and not only protect the flexibilities that the DOH has to its disposal but build on them to actively advance the right to health for all South Africans. We need to prevent situations in which the pharmaceutical industry holds our health to ransom with monopoly prices on life-saving medicines, Linezolid being one of them. Despite the claim of the pharmaceutical industry that patents are necessary to stimulate innovation and economic development, “evergreening” through multiple concurrent patents on the same medicine violates patient’s rights to available treatment.
Let us commit to reach zero infection, deaths, stigma and discrimination from HIV and TB today!!