NATIONAL ASSEMBLY
FOR ORAL REPLY
QUESTION NO. 51
DATE OF PUBLICATION IN INTERNAL QUESTION PAPER: 05 MARCH 2013
(INTERNAL QUESTION PAPER NO. 5)
Questions Day: 13 March 2013
Mrs C Dudley (ACDP) to ask the Minister of Health:
(1) Why is the Tara Klamp still being used at hospitals despite reports that a clinical trial has shown it to be unsafe;
(2) what (a) is the Government paying per Tara Klamp and (b) amount has the Government spent on Tara Klamps to date;
(3) has the Tara Klamp been put out to tender?
NO405E
REPLY:
(1) The Tara Klamp (TK) is currently used in KwaZulu/Natal in addition to the forceps- guided surgical technique. The reason for using a device in addition to the surgical method is that KwaZulu/Natal Province has the highest prevalence of HIV according to the Antenatal Survey results. Reintroducing circumcision amongst males in KwaZulu/Natal had to be done in a manner that is clear and understandable by the clients, with clients having a choice in the method of circumcision.
The decision to use the TK was done from an informed perspective as a delegation from KwaZulu/Natal went to Malaysia to learn more about the practical use of the TK. Subsequently, a delegation from Taramed, made a presentation to the MEC, Head of Department, officials of the Department and Urologists from the University of KwaZulu/Natal. Furthermore, Malaysian trainers came to the Province to provide training on the use of TK.
The World Health Organisation (WHO)'s Department of Reproductive Health & Research (RHR) hosted a consultation to review manufacturing, clinical and regulatory requirements for male circumcision devices to support the programme expansion in high incidence settings in Africa in lieu of the lack of any pre-qualified devices. The group concluded that while rates of adverse events and device related incidents were of primary focus "it was agreed that they did not necessarily exclude the Tara Klamp device from further assessment in an adult African population, nor imply that similarly high complication rates would be see in younger men or adolescents".
(2)(a) The cost per unit item for the TK is R222.30 VAT inclusive depending on the rand/dollar exchange rate.
(b) The KwaZulu/Natal Department of Health has spent R48,544,916.75 from April 2010 to date on the purchase of the TK device.
(3) Departmental procurement processes were followed in line with Treasury Regulations. The TK device is solely manufactured by a Malaysian company and the sole distributor of the device for Africa is Intratrek. The Department procured the device from the sole distributor for Africa, it did not issue an invitation for public tender as there is a sole distributor.
Accordingly, and in terms of Treasury Regulation 16.A6.4 the KwaZulu/Natal Department of Health obtained approval to invoke Treasury Regulation 16.A6.4 and reasons for such deviation are a matter of record. This principle is further captured in the National Treasury Note 6 of 2007/8. On approval of the purchase of the device a Service Level Agreement was signed with the Service Provider.
Issued by Parliament, April 8 2013
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