Procuring medical devices to carry out HIV tests across the country has seen a series of back and forth turns in the process since 2012. On the Ministry of Health’s own admission, this has disrupted national HIV service delivery. The tests carried out on 6.3 million people over the past nine months were short of target owing largely to the unavailability of rapid HIV test kits.
Buying 11 million of these kits was challenged by disputes in standard setting, shifting procedures and techniques as the approach, despite clear guidelines in international and national policies and guidance. The country’s algorithm, a method employed to determine the precision of the kits, remained unchecked for close to 10 years, giving way to a single private company, Medica Pharma Plc, positioning itself as the sole supplier.
An attempt to revise the algorithm in 2012 ensued further disputes and a series of tenders and retenders on who is qualified to supply the kits that meet standards established by the World Health Organisation (WHO). This is a UN health watchdog which qualifies and prequalifies suppliers of medical and medicine supplies. Involved in the validation process are the US Centre for Disease Control (CDC), the Global Fund to Fight AIDS, TB & Malaria, and the Ethiopian Public Health Institute.
The Ministry, responsible for the procurement and distribution of the kits, had dropped its own endorsed field-tested algorithm in January 2015. Yet it went ahead with the purchase through an international agent, when the national procurement agency ordered cancellation of the announced supplier.
Subsequently, an order was placed with Premier Media Corporation First Response® HIV½ Card, a supplier the Ministry says had “lead-time and with 100pc specificity and sensitivity” when evaluated by WHO. It is the same kit tested in Zambia, Ghana, South Africa and India, having satisfactory results, the Ministry said.
Evaluation on local conformity, conducted on the imported kits by the Institute in its laboratory and in the field – in Debre Berhan and Dubti in Afar Region – showed 91.3pc sensitivity results short of the WHO’s requirement of 99pc. This led to the credibility of the Institute being questioned in three layers: non-observance of procedures, protocols, and supervision. But officials at the Ministry are certain that this has never happened and pledge it will not be repeated.
Consequently, the Ministry’s officials have resorted to using plasma testing, and a scientific method known as INNO-LIA, which is a supplemental HIV assay, meaning it determines quality. But INNO-LIA is not a kit or independent technique for proving adaptability. Neither are the lab-based plasma testing and field whole-blood tests replaceable – but complimentary to be certain.
The stirrings of procurement procedures have got so high, it has now reached a point of accusations and counter accusations of manipulating field test results. The Federal Ethics & Anti-Corruption Commission was involved to ensure corrective measures were taken. The nature of investigation promised remains vague.
The local bidder, largely owned by Dawit G. Egziyabher, has strong assumptions of why all this is happening and who is behind this. To Taye Tolera (MD), chief of the Office of the State Minister for Health, the incoherent and volatile decisions of his Ministry in the three-year procurement saga can be justified by its desire to break the monopoly in supply, and search for better deals which can fall within budget.
In these exclusive interviews, SAMRAWIT TASSEW, FORTUNE EDITOR-IN-CHIEF, unearths the facts as the officials try to clear the air around the disquieting challenges of the troublesome procurement. Here is the one with Dawit G. Egziyabher.
Q: How did you end up, with Medica Pharma Plc, being a lone supplier of Rapid HIV test kits to Ethiopia for close to a decade?
Dawit G. Egziyabher: I got into this business in the early 2000s when the Global Fund allocated 500 million dollars to Ethiopia to combat the disease. By pure coincidence, I met the person in charge, who came to talk at one of the lunch programmes of the Rotary Club, in which I give voluntary service.
He raised the subject and we did not pay attention. It was after the second coincidental meeting that I had a one to one talk with this person that I had seriously considered the issue as a business. In another venture, I knew Abbot Company in Dubai, which was a pioneer in manufacturing rapid HIV test kits. I connected all this and established Medica-Pharma to do the business. Later my network grew to meet KHB Company in China.
Since 2002, Medica Pharma was the leading company in the industry closely collaborating with the government in times of ups and downs. The crack in the relationship started when the government, after 10 years, decided to revise the algorithm of the country, without sufficient reasons. There was no change in technology and no indication of the need to revise the algorithm from the field experiences.
Q: The Ministry`s officials believe they have to make their options open for reasons of alternatives and budget. Why should that be wrong?
Our question was why, unless there was a hidden agenda? Medica Pharma, in 10 years, never revised prices, not even once despite the manufacturers’ complaints. The monopoly talk was a camouflage. Why was monopoly a problem if it was not dictating or abusing price and quality?
Q: Should the Ministry need to justify what it wants to buy to a supplier?
No; they do not and they could not when challenged to do so.
Q: Who challenged them?
I did. I saw the writing on the wall, and told them they were heading the wrong way.
Q: What do you believe was the wrong way?
I have evidences collected from the very beginning. It all started with the tender announcements. Conflicting announcements calling registered suppliers which were more than 12 were released on November 18 and 25, 2012. All representing a product in a WHO pre-qualified list. Suppliers registered at FMHACA did submit 1,000 specimens each.
While we were waiting for the results, there was another announcement on February 27, 2013. Again unexplained, but a confirmation of my suspicion; a hidden agenda driving an algorithm revision.
Q: Isn`t it a normal practice for government offices to have the discretion of canceling bids and rebid them after often changing the terms of reference?
I am not talking about bids here but submitted samples. Right there, the purpose, collecting specimens for the algorithm, was served. This led us to investigate things more deeply. Later, we realised an unregistered company had already submitted specimens, and its registration with FMHACA kept the process in the loop and led to repetitive calls.
The company was actually established in Ethiopia and the owner is a lady who resides in Geneva, Switzerland. The lady was married to a guy who is an employee of WHO at its headquarters.
Q: What does that prove to you?
Somebody’s interest is especially being promoted because of his association. My assumption is that the reason they had to float the tenders again and again was until the company got registration. The process was made to wait for the company to secure its licence.
Q: Even without its submitted specimen, couldn`t they continue with the process?
If the process started right away, this company would have failed automatically for not being registered. The technical evaluation was kept on hold. The field test was cancelled before it started by a letter dated on May 15, 2013. The letter read that there was no need for algorithm revision and all who had submitted their specimens could collect them all.
If a government responsible after 10 years reached a decision to revise the algorithm, why would it change its mind in six months was the question unanswered at the time. Later, in December 2014, the same call for specimens and the need to revise algorithm was sent out from the Ministry. A few days after the second round submission in December 2014, a letter signed by Kebede Worku (MD), state minister for Health, ordered a procurement agency to buy from selected suppliers. Five bidder were selected for screening test kit supply, one for conformity test, and one for tie breaker. There was no explanation.
The manufacturer, Premier Medical Corporation, was included among those shortlisted by the State Minister. Bio-Tech Plc, the agent for Premier Corporation, was registered in the meantime.
Q: Why did the Public Procurement Agency here in Ethiopia order cancellation and why has the Ministry not respected it?
The Public Procurement, after assessing the results, decided that the winner be dropped and the supply be done by one of the bidders, of which my company is one.
Q: Was the Ministry confronted on the matter?
Yes, and the top officials admitted discrepancy between the two documents. Ali Suleiman, the Commissioner for the Federal Ethics & Anti Corruption Commission, was involved to correct the matter. The manipulation was then corrected and a third document that goes back to the original numbers was released again in January 2015.
While processing the purchase, KHB was delisted from the WHO pre-qualified list. Its new products were dropped but such changes were done according to the recommendation of WHO.
The quality of KHB has always been the best, beating other competitors particularly in African settings. It was actually registered at least for 10 years, until it was recently delisted. It has a record of 100pc in both sensitivity and specificity, the two kinds of test kits, at WHO.
The next runner-up was again STAT-PAK, the manufacturer Medica Pharma represents.
The Ministry cancelled the second option under the pretext of price, which was actually 0.30 cents lower than what the Ministry used to pay. The product that they are actually saying expensive is not so new. They have bought it at 1.49 dollars. They have been buying it for so many years. In this case, the offer was 1.15 dollars, a decrease of 50 cents. It was all camouflage.
Q: How did you go about fighting these ‘inappropriate procedures’ as you put it?
I started with individuals before discrediting the whole system. I did confront EPHI’s Director, and the State Minister for Health. I appealed to other stakeholders like the HIV/AIDS Prevention & Control Office (HAPCO) that wrote questioning the confusing message the Ministry was sending out. I even went to the extent of sending SMS messages to alarm all who could make a difference – the ex-Minister, the current Minister and the State Minister at the Ministry of Health, to prevent the extra 50 million Br in additional cost. Nothing bore fruit.
Q: Why should you question the results given by EPHI, which the State Minister based his recommendations?
Why do we assume the game stops at the Ministry? Bio-Tech, a new supplier, was included in the screening section only, which is the most lucrative in terms of business.
Q: Has any bidder besides you raised their concerns?
We do not have an association so far, thus there was no concerted effort. But I know of some who had major misgivings.
Q: Things were done in an extraordinary manner due to the felt shortage. Shouldn`t that be understandable if human life has to come first?
What they should have done, for the sake of emergency, is to follow the regulation. There is a product which was recommended to them that has to be used as a screening since it has scored 100pc. If there was any purpose for emergency, they should have bought the one that passed, at any cost and not the failed product by national algorithm.
Q: But they felt due to emergency, they could not do field tests. They were pressed to stick to the laboratory tests, which CDC`s Atlanta office took part in the validation report. Wouldn`t that mean anything to you?
CDC does not have a laboratory. It does not have technicians. I am talking about field tests, which the country was capable of doing 10 years ago. The Institute’s decision was respected for so long, why question it now after all this drama?
Q: How do you see all the endorsements from international organisations about the validity of the whole process?
They are talking about CDC now. What mandate has CDC got to report on this?
Q: Have you had the opportunity to discuss the matter with the Ministry after the last result has been announced on May 6, 2016?
They do not have anything to say to me.
Q: What do you see as the way out?
Everyone should be given [the opportunity] to talk in the open. I have requested for a press conference, a platform to tell my story, to be arranged by the government. If the government wants democracy to prevail, the whole truth has to come out. Hence, we request an open, live opportunity, like the one given to MoH, to let the public know the truth. Justice has to prevail. Truth has to prevail.
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