THIS is a continuation of verbatim from the Parliamentary Accounts Committee hearing, where the Ministry of Health PS, Honeybee Pharmacy, ZAMRA, Medical Stores and other government agencies appeared for questioning over the US$17 million drug supply scandal:
Chilindi: No Chair, I am not saying that. Because we follow these matters and we don’t leave clients because we have issued a license, we follow up on the clients to make sure that they attend to those identified deficiencies. Yes Chair.
Kunda: Honorable Mukosa
Mukosa: Thank you Chair. Director from ZAMRA, I wanted to find out, apart from Honeybee, has there been any other company that in the past you have issued a similar license to within a day or two?
Kunda: Yes ZAMRA.
Chilindi: Chair, it will be difficult to answer that question without looking at the records of our clients.
Kunda: Yeah, you are saying it can even be one day, have you had that opportunity to go through where you issue a licence within a day that you have referred to, yourself? From one day to one year, but the law is saying within 90 days, but you are saying from one day to one year. So the question from Honorable Mukosa is very clear. Based on your experience as a director at ZAMRA, have you had anytime where you have had to issue a license within a day, or two or three?
Chilindi: Chair, within a day, nothing really comes to my knowledge but within two days, there could be there, that’s my submission Chair. It’s difficult for me to answer…
Kunda: You know, we deal with facts here, we deal with actuals. So, are you in a position to tell us whether you have had an opportunity where you would have issued a license within a day or two?
Chilindi: Chair, I submit that I do not recall.
Kunda: But from your answer, you stated yourself that from one day to one year so why are you now saying that you have never gone through such kind of a thing?
Chilindi: Chair, I am not saying we have never gone through such kind of thing all that I am saying is I cannot recall exactly which one but given a chance to look through our records, maybe we could resubmit that information.
Kunda: Okay. Honorable Mukosa.
Mukosa: Yes Chair. With ZAMRA, I think me I am done, I wanted to also ask a question to PS and Honeybee.
Kunda: Yes, please go ahead.
Mukosa: PS, we have noted that from the three companies that were given the contracts to supply the health kits to Ministry of Health, two of three companies failed to supply or to deliver the contract of which I know that, one, you are undergoing the termination process and only Honeybee managed to supply about 21.5 percent or so which gives us about 9.5 percent of the total contract for the three companies. Considering that these health kits are needed in our health facilities, what are we going to do for those two companies that have failed to deliver? Are we planning to urgently procure from different entities or what are we going to do to ensure that we have stocks of the health kits in our health facilities.
Then, to the director of Honeybee, I am sure you are aware that you were contracted to supply the health kits under emergency conditions and there is need for contract to be filled. We are also aware that from the quantities that you were required to supply, you have supplied a percentage of what you are required to supply, about 21.5 percent of what you were required or there about. Considering that these health kits are urgently needed, when are you going to finish supplying the balance of the health kits and what assurance are you giving this Honorable committee that you are going to ensure that you supply within the timeframe that you are going to state. Thank you Chair.
Mweetwa: I have a rider Chair (interrupts)
Kunda: Yes Honorable Mweetwa, please unmute yourself.
Mweetwa: Thank you Chair for giving me the opportunity. I have three questions, just as a rider to what Honorable Mukosa has just asked. Number one, to the controlling officer, being where we are now and having looked at the transactions from the time of the contract up to date, would you confirm to this committee that Honeybee from the time of registration as a company in Zambia has actually been a retail supplier and not a wholesale supplier until this particular contract to the Ministry of Health. The second question is, the company that has been supplying you steadily with unquestionable quality of medicine, Missionpharma, was actually one of the lowest, I think they bid about US$11 to US$12 million, not withstanding, you could not consider them for this contract and interestingly, I have gotten it from the director of Honeybee that this particular company was holding government at ransom. When this particular information of holding government at ransom should have actually have come from yourself. Are you the one who told Honeybee directors that Missionpharma is holding government at ransom and also would you be in a position to confirm that Missionpharma was holding government at ransom unlike what the information we have that in fact, Missionpharma had actually given a payment plan to government of the monies that government is owing that particular company and even proposing translating the same into a loan at about 10 percent, is that what amounts to holding government at ransom? Lastly Chair, I would like the director of Honeybee, since you know we deal with facts at Parliament, to confirm what he has told this particular committee that their suppliers are actually WHO certified because I have information to the contrary, are they in a position to confirm to this committee that their suppliers are WHO certified so that I get that as being their current position. I thank you Chair.
Kunda: We start with Honeybee, director if you can address those concerns.
Mweetwa: And sorry Chair, my previous question which I had asked earlier on was never answered, if he can also take into account the question I had asked earlier on about the stimulus to why they had now to apply for that particular license. Thank you.
Kunda: Yes director.
Zakir: Thank you Honorable Chair, with regards to the need for the contract to be fulfilled since the Honorable member has mentioned that we have supplied 21.5 percent, we would like to confirm that our consignment of 12,500 kits is ready at the ports and we should be receiving this consignment very soon. With regards to the Honorable member’s question regarding whether our suppliers are WHO certified, we would like to state very clearly that yes, they are all WHO certified and we have received the documentation with regards the same. Thank you very much Chair.
Mulalelo: Honorable Chairperson, in response to the questions, there was one question regarding the status of the two contracts that were under termination. Yesterday [Tuesday], I did state that of the contracts, the one for Artemis, we did issue the termination notice to the supplier whilst the other contract, the one for Pharmanova wHere they are supposed to supply 5,000 kits. At the time when we received approval to terminate from the Ministry of Justice, the supplier gave us a copy of the performance bonds and thereafter we sought guidance from the office of the Attorney General as to whether we proceed to terminate and we were guided that we could proceed with the contract. So in terms of the status of the contract for Pharmanova, we are still awaiting delivery; this contract has not yet performed as rightfully observed by yourself.
With regards to the contract for Honeybee Pharmacy, as observed, Honeybee has supplied us with 5,000 kits and they are still owing a balance of 17,500 kits under their contract. We also still have an existing framework with Missionpharma where Missionpharma still has close to 40,000 kits under their framework contract that are yet to be supplied. So once we unlock the drug debt that is there, as well as the terms that Missionpharma has put on the table, we would have a steady supply of health centre kits. So the problem we have at the moment, like we have consistently been saying, is the issue of the drug debt. Missionpharma did write to us way back, I think from 2018, stating that they needed the Ministry of Health to pay them a certain amount of money before they started manufacture of any kits. This information was submitted to the Ministry of Finance, 2019 you heard in our submissions, the funding for 2019 was very poor and we were unable to settle the drug debt under the Missionpharma contract. In 2020 we managed to pay US$1 million to Missionpharma but this was not sufficient for them to start supply. So our appeal is that the drug debt is unlocked so that there is a steady supply of health centre kits. The Honorable member of parliament again referred to the terms that were used by the supplier in terms of holding government at ransom, again, I repeat Honorable Chairperson, we are not accountable to the terms that are used by the supplier. I submit.
Kunda: Yes Honorable…
Mweetwa: (interrupts) Rider Chair
Kunda: Yes Honorable Mweetwa
Mweetwa: Thank you Chair, the director Honeybee has indicated that their suppliers are WHO certified, are they in a position to adduce documentary evidence of such certification so that we are able to know for real that what is being said is actually the truth? Let them produce such evidence to this particular committee. My request Chair, thank you.
Kunda: Yes, director Honeybee.
Zakir: Thank you very much Honorable Chair, we have got, ummmm, we will present the documentation to prove that all our manufacturers are WHO certified and also, I would like to state that all the products that we received, they were accompanied by the COAs, certificates of analysis. Thank you very much Chair.
Kunda: Honorable Simbao.
Simbao: Thank you Chairperson, I recall, the other director in his response, he talked about condoms and I don’t know if there were gloves or something, so I just want to find out, who decided to take the condoms for the second testing in Zimbabwe, didn’t they believe what they saw here that the condoms were leaking? I mean, what do they expect to get from Zimbabwe apart from what they have seen here? So I wanted to, because they touched on that as something that they have performed or great, something like that. So I want him to address that.
Kunda: Yes director from Honeybee, joining via zoom. Could you please address that issue.
Abdullahim: Thank you so much Chair. Firstly, I would like to withdraw my statement of holding government to ransom. Be sure I was just coping the statements which I had heard earlier on as we were progressing when we were just hearing the report from the PS and also from, I believe it’s director for procurement. We haven’t sent any samples to Zimbabwe to correct his Honorable, we have just heard in this platform, I think the Ministry, I am quoting the Ministry saying they have sent the samples to Zimbabwe for verification. Thank you Chair.
Kunda: Yes, you would want to supplement (referring to Zakir who had his hand raised)? Yes please go ahead.
Zakir: Yes Honorable Chair, with regards to the products sent to Zimbabwe, that was not our responsibility and this was done by ZAMRA and we are still awaiting the results for these products that have gone to Zimbabwe. Thank you.
Kunda: I think that, that is why I had asked that ZABS take a seat, for issues to do with the same tests. Can ZABS clearly explain to this committee what tests you conducted for the benefit of everyone on the products that were supplied by Honeybee and were those tests reliable for now to hear that these are now being taken to Zimbabwe for more tests? You can deal with that and also, from your tests, were they fit to be distributed, for distribution to the populace of this country? You can address that.
Manuel Mutale: Thank you very much Chairperson for the opportunity to appear before your esteemed committee, I think the starting point for me is just to briefly highlight the mandate of ZABS because that informs Chairperson on the work that we did on the testing of the condoms. The Zambia Bureau of Standards…Our role is to promulgate standards, to be able to conduct tests on products and also to be able to offer what we call voluntary certification system. Previously, Chairperson, ZABS used to regulate, we were a regulator but at the moment, we are not carrying out any regulatory mandates. So, we are there to operate as a friend of industry.
Chair, we received samples for condoms and also for some inspection gloves, examination gloves from ZAMRA and the Medical Stores and under item point three in the report that I have just shared with you, we had three samples of the gloves from Medical Stores which were submitted to us and these were marked as having being supplied by Honeybee. We also had two samples of male latex condoms from Medical Stores again and the batches I have indicated in the reports and these again were supplied by Honeybee and we also later on, we received two samples of examination gloves from ZAMRA, again the other information in terms of the batch numbers, but these were also supplied by Honeybee. We conducted our tests, I should also mention that the Zambia Bureau of Standards testing laboratories currently enjoy a status of accreditation for a number of methods including the method that we use for testing condoms.
Accreditation is an independent attestation to say that the lab is competent to be able to test and issue reports for a particular method and in as far as the condoms are concerned, I have highlighted the standards against which we test them which is the ISO-4074, this is an international standard basically adopted for Zambia meaning that the requirements in that standards are the requirements which shall be in any other country because it’s an ISO standard so the same applies also for the inspection gloves, reference standard is the ISO-11193.
Chairperson, briefly in terms of our findings, the test results as reported and submitted to Medical Stores on their samples that they gave us, the latex examination gloves, two batches, the medium and the large sizes, they failed to comply to the requirements of ISO-11193, one batch complied. For the male latex condoms, both batches failed to comply with the requirements of the standards for the ISO-4074. I should also be able to indicate Chair, when we are doing the tests for condoms, the tests for the gloves for the inspection gloves because this is meant to give protection to the users of these gloves and some of the requirements that are specified against which we test is water tightness. It’s a test method Chair where you hang the glove on our equipment and then you introduce in water, you allow it to bulge. The expectation is that there should be no leakage as you visually look at it. So the standard will specify how many should be able to leak in a particular sample size and we have got these results and tests that were done and were shared with the client. According to ISO17025 which we comply to as a testing laboratory, our reporting is to the clients.
In as far as the condoms are concerned, again Chair, our area of interest in as far as these important products are concerned is what we call the hang and roll meaning you hang a condom on a test equipment, introducing water, you don’t expect the condom to have leaks in as far as water is concerned. There is also what we call a bursting volume…you introduce in pressure and allow it to balloon just like the young people will be able to pump a balloon and there are certain pressures which are specified at which a condom should be able not to burst because of course of their utilisation. The other tests that we carry out are package integrity meaning that once you have got a condom, it’s sealed in a package, you don’t expect to see some leakage of maybe some lubricating materials. So these are the type of tests Chair which we carry out, just on a sample basis to be able to highlight to the committee. So based on this Chair, our commitment as I said, as Zambia Bureau of Standards we are just a testing laboratory, once we test, our responsibility is to issue these test reports to the client and in this particular case, our clients were Medical Stores and ZAMRA and these are the ones who have the response maybe to be able to interpret this and maybe to make administrative and regulatory decisions. Chair, I submit.
Kunda: Yes Honorable Mweetwa
Mweetwa: Yes Chair, I would like to find out from the controlling officer if ZAMRA and Medical Stores actually did issue a validation certificate in report of the products that Honeybee provided, and not just paracetamol. Take for instance, erythromycin and other products, whether all these products were given a validation certificate before being made available for consumption to ensure that they were safe for use by members of the public and if the answer is in the negative, why? Thank you Chair.
Kunda: Yes PS
Mulalelo: Honorable Chairperson, we are still awaiting the test results from ZAMRA.
Kunda: Are you aware of these test results that were conducted by ZABS? PS
Mulalelo: Honorable chairperson like I said we have not yet received the validated test results from ZAMRA, we haven’t received any submission from ZABS.
Kunda: So you sending these tests, I mean these samples to Zimbabwe were based on what?
Mulalelo: Ministry of Health does not send, it’s ZAMRA that sends. ZAMRA is the one that is responsible for conducting…
Kunda: Yes, in your submission, you read yourself and you owned this submission, it is yours. You were saying…
Mweetwa: Sorry Chair for interrupting, my question is simple Chair, these products were already distributed to members of the public for consumption. At the time of disbursement, before these products are disbursed for consumption, for use by citizens, ZAMRA and Medical Stores should issue a validation certificate that these are fit for the purpose products for use, they are safe and secure. Did these two institutions issue a validation certificate on all the products that Honeybee provided to this particular ministry? That is the question that I would like the controlling officer to be able to answer because before you issue them for consumption, there must be certification or validation, was that process undertaken?
Kunda: Yes PS
Mulalelo: Honorable chairperson, I did respond and I did state that we have not yet received the certificate of analysis from ZAMRA, we are still awaiting and in my submission, I did state, on the, in reference to the various products that were queried, I did state that ZAMRA was still conducting tests and we are still awaiting results.
Kunda: Yes, were these condoms distributed, have they been distributed?
Mweetwa: And Chair I am sorry, in other words, the ministry allowed members of the public to begin to partake and consume of products which did not have validation certificate as to their safety.
Kunda: Yes, loud and clear. And also I am in receipt of a letter that was addressed to the Permanent Secretary, Ministry of Health on the procurement speciality. Goods Acceptance Certificate, invoice number 051, delivery note 001 005 006.
Contract number Ministry of Health SP/032/19/02. “We certify that Honeybee Pharmacy Limited has delivered the following products”. Manifest number, those numbers. 2,376 by each health centre kits, invoice value, US$1,896,380.64. Kindly note that as per MSL, which is the Medical Stores Limited procedure, Medical Stores Limited Zambia and ZABS are still conducting quality control procedures as the kits were not accompanied with certificates of analysis. Also, note that the Diazepam injection was missing from the kit” of course have been dealt with. Now, I want to find out, as far as I heard is that the certificate of analysis was provided, now, we have this letter from a department of government, of your Ministry. Why have you indicated that the certificate of analysis had accompanied these products, PS.
Mulalelo: Honorable Chairperson, the certificates of analysis that accompany those products may not have come together with the products, they may have come a couple of days after and they are included in our submission in the appendices for reference.
Kunda: But the letter is saying otherwise
Mulalelo: The letter is the goods acceptance certificate that is issued when the goods are delivered to Medical Stores.
Kunda: Okay, were those goods distributed to the citizenry for them to use?
Mulalelo: I believe Medical Stores can respond to that.
Kunda: Yes Medical Stores, I think that is why you are here. You can just draw a chair and sit there so that you can answer to that. Yes Medical Stores.
Mweetwa: Chair, as Medical Stores are preparing…
Kunda: Yes, is it in connection with Medical Stores?
Mweetwa: Yes Chair.
Kunda: Okay, you can go ahead
Mweetwa: I wanted to find out Chair whether Medical Stores do admit that in absentia of the validation certificates, it was irregular by themselves to have gone ahead to distribute those products that they did distribute that did not conform with the standard procedure of how such pharmaceutical products are supposed to be distributed to the end user, the citizenry after due consideration of validation of the processes that ensure safety of consumption of such products. Thank you Chair.
Kunda: I think that is why we have called Medical Stores to come and answer, they have not yet stated whether they distributed or not. You can answer to that question then if it is in the affirmative, then you can address that issue by Honorable Mweetwa. You can go ahead.
Mbewe: Honorable Chair, thank you so much for the opportunity to make this submission. Honorable Chair Medical Stores has a very important and strategic mandate whose mandate is storage and distribution of life saving medicines, the subject that we are privileged to submit on. Honorable Chair, as an institution, we do have a quality assurance system, part of the investment at Medical Stores is a quality control laboratory. We are not able to do quality control tests for all the products and in this case, Honorable Chair, the kit consists of about 60 items. We have specific capacities on certain items that we can do tests and indeed Chair, in that minute that we wrote to PS on the goods acceptance certificate, part of our internal protocol, the only institution in this country that has capacity to test latex products and latex products in our convention is products that include condoms, products that include the examination gloves; very, very important public health commodities. Now, Chair you already have shared the content of a very specific process that once we receive products and with regards to this very specific consignment is that we noted very important discrepancies that were noted and then Chair, I did allude to the fact that we have ZABS as an institution that has capacity to do the testing for the latex products. Chair, I must hasten to state that our laboratory is not law, so at Medical Stores, if indeed we have any detection of something that is not complying to quality, immediately, we have to communicate to ZAMRA and in this case, also as part of our protocol, is to immediately communicate to ZAMRA. So this was done. Chair, on the table there is also a question whether these products are delivered. I must state that indeed these products were delivered.
I also need to state the context under which this delivery happened. I might not be very specific on a date but the products arrived on Monday and there was a very specific decision that was made because of poor availability of supplies in the facilities that the following day, all our provinces were advised to a self-collection of the kits from our facility. So indeed that was done, so in principal, they were distributed. Chair, I also wish to submit before your committee that our very specific protocols to do with distribution and receipt of the products, what we do ourselves is that, like in this context, the fact that they were being distributed, our protocol is to ensure that we do our sampling and based on our sampling, whatever results otherwise that needs further investigation, we are able to refer to ZAMRA and all those due processes from our side, we think that we exhausted them and they are available on record.
To be continued in tomorrow’s edition.