HIV Kits Arrive Amid Court Battle

The company has already delivered the first lot of tests containing close to three million HIV kits

While in the midst of a court battle between Medica Pharma and Pharmaceuticals Funds & Supply (PFSA) is adjourned until January, 2017 a Chinese manufacturer, Beijing Wanti Biological Enterprise, has delivered a first shipment of three million HIV kits. This was a $5.5 million worth of order for 11 million kits.

The second round of shipment, which is an eight million order of kits, is expected to arrive soon as PFSA has already begun a process to open a letter of credit.

The latest delivery will complement the 2017 HIV campaign that aims to reach 700,000 HIV patients and will run until June 2017, according to Kebede Worku (MD), state minister at ministry of Health.

For the latest purchase to compensate for the not yet established algorithm, tests were carried out on the kits, according to Kebede. “We have already done an evaluation on the kits by taking blood samples from blood banks and assisted by the Centers for Disease Control & Prevention (CDC) [US] assisted us in checking the kits.”

The process to bid for the kits started in June 2016, after a delayed purchase of six million kits. There was a complaint filed by Medica Pharma, who has been at loggerheads with the Ministry and the Agency after the ministry ordered to revise its algorithm. Algorithm is seen as the perfect combination of kits that gives higher quality of result in a setting.

While Beijing Wanti was awarded the contract, it was not a registered company with the Food, Medicine, and Health Care Administration & Control Authority (FMHACA). It was only after being awarded the contract; it was able to secure a registration license. However, it is listed in both Global Fund’s list of HIV diagnostic test kits and equipment and WHO’s pre-qualified companies list. Within Ethiopia, GeZ Chemicals & Pharmaceutical Plc represents it.

Beijing Wanti was registered by FMHACA on July 5, 2016, month after the award.

A number of allegations have surfaced on the awarding of the purchases in the last two years resulting in a severe shortage of HIV kits in the country. The shortage led PFSA to procure six million HIV kits prior to the latest purchase, not based on an established algorithm but on basis of pre-qualified status with the World Health Organization (WHO).

“It is okay to depend on WHO qualification for performance” Taye Tolera (MD) the outgoing advisor at the Ministry of Health told Fortune in an exclusive interview earlier this year. “Algorithms however are critical for logistics and management issues,” he added.

Taye also explained to Fortune then, how buying without an established algorithm is not a rule but an exception that sometimes works. The WHO advisory however recommends that countries to establish their own specific algorithm.

Regarding the latest purchases, on-site product oriented training will be given to health officers.

During the last fiscal year, eight million people have undergone testing for HIV in Ethiopia. Of these, over 45,000 individuals tested positive.

At Semien Health Post, in the north of Addis Abeba, Fortune has learned that HIV tests are only accessible to screened patients who are believed to be at risk only. These include new and prospective mothers, TB patients, patients with other sexually transmitted diseases and commercial sex workers. ”

“We have no choice as people come to check themselves and if they don’t fit in the group, we have to tell them that we can’t test them,” a health officer told Fortune. “The kits we are now using are more complicated than those that were in use before.

The rate of new HIV infection in Ethiopia has dropped from 0.29pc in 2001 to 0.03pc while the prevalence level of the virus in the country has also fallen to 1.2pc last year from 1.5pc in 2011. New HIV infections were projected to reach 14,405 by the end of 2016, according to the National AIDS Resource Center.


Published on Nov 22,2016 [ Vol 17 ,No 864]



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