Health minister under fire over HIV test kits’ tender

A storm is brewing over how the government awarded a multimillion tender for the supply of new HIV/Aids testing kits just days after the high court issued orders stopping the tender until the matter is heard and detained.

In a statement Kitutu chache Kitutu Chache South MP Antony Kibagendi raised questions over how the Ministry of Health awarded the tender to Trinity Biotech Manufacturing to supply the kits.

Kibagendi claimed that certain potential suppliers who were qualified were dismissed allegedly through the influence of top officials at the Ministry of Health and Kemsa to ensure Trinity Biotech Manufacturing would get the tender.

He accused Health Cabinet Secretary Susan Nakhumicha of lack of leadership and disdainful treatment of Kenyans and health professionals in the country.

The tender worth Sh365,698,103, outlined in Circular Ref: MOH/ADM/1/1/12 dated August 22, 2023, was aimed at implementing a new testing algorithm.

The new aligorithim requires specific three-test algorithms for both general and antenatal populations, with a target for site-level implementation by January 2024, overseen by the National AIDS and STI Control Program (NASCOP).

The eight kits shortlisted by the Ministry of Health for consideration were One Step HIV ½ Whole Blood/Serum/Plasma manufactured by Guangzhou Wondfo Biotech Company Limited, Trinscreen HIV by Trinity Biotech Manufacturing, Determine HIV-1/2 (Abbott Diagnostics Medical Co.Ltd), Insti HIV-1/HIV-2 Antibody Test that is manufactured by BioLytical Laboratories Inc.

New algorithm

Others are the Standard Q HIV ½ Ab 3-Line Test made by SD Biosensor Inc., and the First Response HIV 1-2.0 Card Test (version 2.0) that is made by Premier Medical Corporation, Private Limited, Bioline HIV-1/2 3.0 (Abbott Diagnostics Korea Inc) as well as HIV ½ STAT-PAK that is made by Chembio Diagnostic Systems

 For the last 15 years, Kenya has been implementing a two-test strategy in HIV testing but was seeking to move to the new algorithm following recommendations from WHO which recommended all countries still using two consecutive reactive tests to establish a seropositivity diagnosis, to transition to three consecutives reactive tests.

 He said: “We urge the Principal Secretary of Medical Services, Harry Kimtai to shed light on the procurement and awarding of the tender to Trinity Biotech Manufacturing, without due process being followed.

“We also call on the management of the Kemsa led by the CEO Andrew Mulwa to clarify on the process and whether they conducted due diligence on the said company before awarding the contract,” he added.

False results

 Kibagendi claimed despite the Ministry of Health having expended public resources on conducting a pilot test, there were complaints of false results allegedly due to faulty HIV test kits

He accused both the Ministry of Health not only ailing to apply WHO standards while conducting suitability tests regarding the transition of HIV testing algorithms in Kenya but also failing to conduct proper background checks on the company’s operations and supply of commodities.

 He said: “It is evident that the procurement process was flawed in favour of unqualified cartels and cronies, marking yet another instance of malpractice within this government, aside from the ongoing fake fertiliser scandal within the Ministry of Agriculture.”

 The orders from the court came after two petitioners Kathambi Ruchiami and Guangzhou Wondfo biotech co. Ltd sued both the Attorney General Justin Muturi and Nakhumicha over the tender.

 In the documents filed in court, the duo claimed that a taskforce set up by the Ministry of Health to conduct an elaborate scientific study to assist the Ministry to move from the two-test algorithm to three-test algorithm as recommended by WHO violated Articles 35 and 46 (1) (b) of the Constitution of Kenya, by its failure to make known publicly the plan, existence and conduct of the whole verification process.

 The duo said that the pilot programme and the verification process ought to have been conducted in line with the provisions of Article 43 (1) (a) for the purposes of identifying, verifying and classifying the best Assay Kits in terms of their specificity, sensitivity, performance, rate of invalidity and affordability

Reads the petition: “The petitioners contend that every Kenyan, by virtue of Article 43 (1) (a) of the Constitution of Kenya, 2010 is entitled to the highest attainable standard of health care, including the access to the best HIV testing kits, of the highest standard and easily affordable, under the Ministry of Health’s recommendation. 

“Therefore, by the taskforce qualifying and recommending to the Ministry of Health, HIV test kits that are of lower sensitivity, specificity and performance as A1 kits while there exist commendable kits of higher specificity and less costly, it not only amounts to a denial and an infringement of the Petitioners’ rights under Article 43 (1) (a) by the taskforce but a violation and denial of the right under Article 43 (1) (a) to all Kenyans, in need of the HIV testing kits.”

 But in his replying affidavit MOH acting Director General Patrick Amoth opposed the petition saying the forum where Petitioners can challenge the decision to procure is from the Public Procurement Administrative Review Board established under Section 27 of the Public Procurement and Asset Disposal Act as it is the first instance jurisdiction to determine any issues raised concerning the procurement.

 He defended the Taskforce saying it conducted an elaborate scientific study to assist the Ministry to contextualise the adaptation process which included feasibility, acceptability and identification of operational issues as per WHO generic protocol.