18 November 2017

Ethiopia: Nation Imports Subpar HIV Test Kits From China

Photo: Supplied
(File photo).

The Pharmaceutical Fund & Supply Agency (PFSA) procured an estimated five million HIV test kits worth 2.5 million dollars from Beijing Wanti Biological Enterprise, whose products were found to be below the standard in algorithm tests carried out by the Ethiopian Public Health Institute (EPHI) in August 2017.

This is not the first time when a controversy over the HIV test kits purchase has surfaced. There were constant accusations and claims amongst suppliers, PFSA, EPHI and Ministry of Health (MoH) since 2012, resulting in a shortage of kits in the middle of last year.

The kits, expected to arrive in a month, will be used to undertake HIV tests across the country for about four months.

The Agency opened a letter of credit (LC) at the Commercial Bank of Ethiopia (CBE) a month ago to process the procurement.

"It is not our mandate to check the quality and confirm how the kits fit the country's context," said Adina Berie, communications director of the Agency. "Our job is to process the procurement based on the instruction given by the MoH, and algorithm set by the EPHI."

The purchase is a part of the 55 million dollar contract awarded to the Chinese Company, Beijing Wanti, without an established algorithm- a test recommended to be undertaken to check whether the kit is compatible the environment of the country.

Beijing Wanti was given the contract based on the standards set by the World Health Organisation (WHO) although it is not locally registered by the Food, Medicine & Health Care Administration & Control Authority (FMHACA).

The Chinese company managed to win the bid to supply the kit after vying with Abon Biopharm, AHI (Avacare International) and Medica Pharma- a known supplier in the Ethiopian market for over a decade.

"This is like leaving the population in an uncertain situation," said Dawit G. Egziabher, a major shareholder of Medica. "Knowing that the company's products are risky, the Agency should have terminated the contract with the supplier to prevent false results."

After being dissatisfied with the PFSA's measures, Medica took the case to High Court. The Company filed a suit against MoH and PFSA in the first week of September 2016, on two accusations.

Medica, in its first charge, requested a suspension of the purchase and distribution process, claiming the kits were inefficient. However, the court rejected the claim for the lack of evidence.

Similarly, the company had also requested the termination of the contract given to the Company claiming that it had no presence in Ethiopia. The Court nonetheless declined the claims of Medica again.

However, in another algorithm test launched by EPHI four months ago, the test kits supplied by Beijing did not fulfil the minimum criteria.

Not only Beijing's products, but the products supplied by Prima Medica, dubbed as First Response Test Kit, in the mid-2016 were also found to have intolerable functioning quality, becoming cumbersome in practical testing procedures, according to EPHI's tests.

This comes a year and a half after PFSA selected Prima Medica to supply kits worth over seven billion Birr despite being far below the minimum standards, according to a test undertaken by EPHI at the moment.

A field test examined its effectiveness in Afar and Debrebirhan and revealed that the kits were 91.3pc efficient- 950,000 false negatives from the 11 million estimated to be tested in a year.

More than 718,000 people are living with HIV in Ethiopia, according to an estimate of the Federal HIV/AIDS Prevention and Control Office (FHAPCO). The number is expected to show an uptick as over half of the country's population has never been tested, according to the Demographic Health Survey (DHS) carried out by the Central Statistical Agency (CSA).

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