Controversy over procurement of HIV testing kits

Controversy has hit procurement of HIV/Aids test kits with accusations of malpractice in the award of the multi-billion tender.

A member of the National Assembly departmental committee on Health has come out to cast the first stone claiming the procurement procedure was flawed.

Kitutu Chache MP Antony Kibagendi said the tender was not advertised by the Kenya Medical Supplies Authority (Kemsa), and the manufacturers were allegedly handpicked by the Health Ministry.

The Ministry of Health has however refuted claims of irregularities in the procurement of the said test kits saying it used a direct method and not through open tender.

The tender, outlined in circular Ref: MOH/ADM/1/1/12 dated August 22, 2023, is aimed at implementing a new HIV testing algorithm.

The algorithm mandated by the ministry, requires 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).

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In the last 15 years, Kenya has been implementing a two-test strategy in HIV testing.

Following World Health Organisation (WHO) recommendations, Kenya in 2022 started a process of adopting three testing algorithms which means all persons that are tested in the country are subjected to a three-step test for one to be certified as tested of the virus.

But Kibagendi claims certain potential suppliers were seemingly disqualified, while an overwhelming 80 percent of the supply was awarded to one of the companies, allegedly through the influence of top officials at the ministry and Kemsa.

“We urge the Principal Secretary of Medical Services, Harry Kimtai, to shed light on the procurement and awarding of the tender, without due process being followed,” Kibagendi told The Standard in an interview.

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

The PS yesterday dismissed the claims saying the ministry used a direct tendering method as opposed to the open tender one.

Direct tender does not require advertisement and listing of qualified bidders.

The ministry according to Kimtai formed a taskforce and developed testing criteria that developed standards to arrive at the testing kits.

The procedure he said involved validation of ethical standards.

The procedure for selecting the supplier he said was guided by the World Health Organisation (WHO) set protocols.

“Basically the tender is not a normal tender, it is pre-qualified through a process, The names were submitted to Kemsa. The names came from the ministry based on report from the taskforce, they had recommended,” said the PS.

Eight companies were shortlisted for the tender among them BioLytical Laboratories, Inc., Abbott Diagnostics Medical Co. Ltd, Trinity Biotech Manufacturing Ltd, Abbott Diagnostics Korea, SD Biosenser, Chembio Diagnostic Systems Inc., Premier Medical Corporation Private Limited and Guangzhou Wondfo Biotech Co., Ltd.

Based on the recommendation by the task force during the pre-qualification stage, only three were selected namely Trinity Biotech Manufacturing Ltd, Sd Biosensor Inc and GuangzhouWondfo Biotech Co, Ltd.

But after picking on three, Kimtai said previous suppliers of the HIV testing kits went to court challenging the process.

Further, Kibagendi is accusing the Ministry of Health of failing to apply WHO standards while conducting suitability tests regarding the transition of HIV testing algorithms.

He is also accusing top officials at the Ministry of Health of failing to conduct proper background checks on the company’s operations.

He claims this oversight has put the lives of Kenyans at risk.

‘‘We are not a stand-alone counter. We consult WHO to ensure suppliers, whom are pre-qualified, maintain the standards,” said Kimtai.

The PS added, “Training on the testing kits is ongoing with support of WHO. Anytime we get notification on their quality status, the government will stop the supply”

The ministry according to Kimtai is in the process acquiring the kits with support from Global Fund, The US President’s Emergency Plan for AIDS Relief (PEPFAR).

The government is also co-funding the procurement of the testing kits expected to be fully rolled out in July.

Kimtai explained that Kenya is among 10 countries transitioning to the three testing algorithm and this is the reason why there is need to procure the kits.

Previously, individuals testing for HIV using two HIV testing algorithm could not be subjected to ARV treatment because of challenges of accuracy of the results.

“WHO guided member states to move to three tests algorithm because of the need to have accurate results,” said the PS.

“I want to inform the country that the ministry has taken a bold step to take the country to the three testing algorithm to ensure HIV cases are reduced. The kits being procured meet WHO standards. These are products satisfied by highest health body globally. As a country, we shall ensure the kits meet the standards. I know there are those aggrieved.”

On his part, Kemsa CEO Dr Andrew Mulwa distanced himself from any dispute regarding the kits.

Speaking to The Standard, Mulwa said the testing algorithm is developed by the Ministry of Health.

“Adoption of testing algorithms is a policy process. Kemsa has no role in the process,” said Mulwa.

Mulwa dismissed claims of Kemsa influencing qualified bidder.

“Kemsa cannot influence a policy process in the ministry. The ministry is not involved in even in the remotest way,” said the CEO.

Additionally, Mulwa said the change of algorithm is not a tendering process.

“As far as we are concerned, the kit is WHO pre-qualified. Safety of kits is under the purview of the ministry,” he said. The two test algorithms done previously, according to Kimtai, provided accurate results but some people doubted the results.

“If you doubt results you are always asked to go back for another test. What guides us now is the new algorithm. If the first and second tests are doubted, you should go for third test which is your HIV status,” he said.

About 1.3 million Kenyans are on ARVs. “We want continuous tests to stop rise of HIV, if we do not, it means we shall have more people on ARVs,’’ the PS said.