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:
Kunda: So having distributed, were those safe for use? Yes Medical Stores.
Mbewe: Chair, I appreciate, I think from us, looking at the processes, because from our pharmacovigilance, this is a system where facilities report very specific issues to do with the integrity or the quality of the products. There was a pattern of complaints that by system were supposed to be submitted to ZAMRA and indeed facilities did report to ZAMRA and in that case I think if there is a product that is of suspected low quality then it’s not safe for use. I submit Chair.
Kunda: Yes, you said you started distributing the next day, did you undertake those tests that you are saying before you started releasing these products?
Mbewe: Chair, I did indicate the context under which this specific consignment was received at MSL and these events happened within 24 hours. So for us, part of the process is to make sure that we randomly pick the samples because eventually, the processes would have to be done over a specific period to inform the quality.
Kunda: So can you indicate to this committee that these products were not safe for use after coming across the results of these products that were tested, could you confirm?
Mbewe: Chair, I appreciate, you will guide on this. I did indicate that as a kit, you have about 60 different products. Where we have evidence…
Kunda: (interrupts) In terms of these condoms, in terms of the gloves, could you confirm whether you can safely say that there were not safe for use or for distribution? Of course you have mentioned that it happened within 24 hours and you started distributing, could you confirm?
Mbewe: Chair, we respect science and I think ZABS is a very credible institution, for me I can indeed confirm that they were not.
Kunda: Have these items been recalled? Yes Honorable Kasonso, and that is to the PS?
Kasonso: No, to the…
Kunda: On my question. Yeah, you can go ahead.
Kasonso: Yes Chair, I mean the witness, you are not being categorical in your responses. What we are asking is did you distribute these items which were not confirmed 100 per cent safe for the public use? Did you distribute them when you were aware that they were not 100 percent safe for public use? Why did you distribute them before you were aware that they were safe for public use?
Kunda: Maybe for clarity, yes you can address it again.
Mbewe: Chair, I did confirm that they were distributed and I did also explain the context under which they were distributed because there was a very specific directive to all the provinces to come and pick so in that context, they were distributed.
Kunda: Before Honorable Simbao comes in, I would like the PS to address that concern. Have those products been recalled or we have just looked the other side? PS.
Mulalelo: Honorable Chairperson, one of the mandates of ZAMRA is to ensure that there are safe drugs and medical supplies on the Zambian market and this is done through the national pharmacovigilance system. Like in the case of the paracetamol where batches of the paracetamol failed, ZAMRA issued a recall of all the paracetamol that was distributed and we received that report. Like I have said, as a ministry, we have not received any report on the condoms and the gloves so I cannot comment on the condoms and the gloves. I wish to direct that question to ZAMRA.
Kunda: Yeah, I have got another question but Honorable Simbao maybe you can ask.
Simbao: Yes, I think I have two questions, one goes to ZABS. ZABS, your testing methods, the condom deals with sperms and what’s the liquid called? I have forgotten. I am trying to look at ah, because I have been questioning all this time but I am trying to look at the liquid that the sperm swims in and the water that you are using, the two viscosities, would that give you the proper test for these condoms? Then second, Mr Mbewe, or Dr I don’t know, after you sent out these defective things, didn’t you put out a system for feedback as to the performance of these things? Thank you.
Kunda: Yes ZABS
Mutale: Thank you very much Honorable Simbao for that question. Like I said, whenever you are testing any products, you have a particular standard, it can be international standards or it can be a national standards and the standard for condoms which I made reference to which is an ISO standard also prescribes the method of testing. So these testing methods are agreed on a consensus basis and enshrined in the standards. So for you to be able to follow this accreditation or to attain the accreditation, you have to demonstrate that the equipment, your personnel and also the methods that you use. So in as far as you know, the condoms, like for the hang and roll, the prescription or the method is that you introduce in water and then basically what you are trying to detect, are there any holes because those holes can result into like you are saying, the sperms, you know because that’s supposed to be a barrier, you know the condom by use.
So, the method that we use is to ensure that there are no holes. Basically, you are trying to see to ensure that there is freedom of holes. All those, you know, there are some other methods that we can use to detect holes. We have got an equipment called an electronic hole tester where you know, it’s a much more even accurate method but if at all you know, using these visual method, you are also able to see water physically, by virtual visually coming out then that means that those condoms have failed but also in the method itself, it also prescribes the numbers, the thresholds, particular sample, how many are permitted for a sample for a batch to pass and how many should reach a certain threshold to be able to say, no, this batch has failed. So all these are enshrined in the, so it’s not ZABS which would come up with this approach, it’s enshrined in the international standards.
Kunda: Yes, PS, after hearing and seeing that these tests were conducted by ZABS, didn’t you, or have you not seen the need to recall these condoms and the gloves seeing that those tests that have been done by ZABS have been proved that it is not safe for use? PS.
Mulalelo: Honorable Chairperson, I did state that we haven’t received anything formally and our mandate lies, the mandate to recall lies with ZAMRA, hence Honorable chairperson I request that that question be referred to ZAMRA.
Kunda: Yes ZAMRA, why have you not informed the Ministry of Health on this very important issue that our people out there may, as a result of this lose lives? Yes ZAMRA.
Chilindi: Yes Chair, we are also getting information from here that these products were actually released out there but in terms of ZAMRA, we took…
Kunda: (interrupts) what do you mean? Just clarify the statement that you have made. You are just hearing from here that these products have been distributed to the citizenry, is that what you are saying?
Chilindi: Yes, because we never issued any instruction or validation of these products to be released, that’s why we took an approach to send these products to MCAZ in Zimbabwe for further analysis because our laboratory did not have requisite reference standards and the reagents to carry out the tests. Apart from the paracetamol that we issued a directive to the supplier on. In reference to the condoms, we wanted to get a second opinion of another lab before we actually issue the directive. This is, Chair, a practice in laboratory, it’s not unique to Zambia…
Kunda: (interrupts) but just there, how long is this supposed to take for you to make a decision that affects the people of this country. How long? Yes ZAMRA.
Chilindi: Chair, our desire is to make a quickest decision based on results that we have because we are dealing with science ourselves. We don’t make decisions without looking at the results. Chair, I must say that we have not up to now received results from MCAZ and we are still following up on our colleagues on the same matter. As indicated from the kits, apart from the paracetamol tablets which we did in our lab, we immediately issued a recall and that has been reported by the controlling officer.
Kunda: Medical Stores, when did you distribute, when did the distribution start? Please switch off your microphone ZABS.
Mbewe: Chair, thank you so much and again I appreciate the issues raised. Chair from our point of view, when we received the kits, the kits were distributed, the distribution started within 24 hours.
Kunda: When was it done? I want the time when it was done.
Mbewe: The specific date I might just need to recollect the specific date but the kits arrived on a Monday then we started the distribution the following day on a Tuesday. I might just need to get the specific date for the committee.
Kunda: Is it a month, is it two months ago, is it one year ago, how long?
Mbewe: Chair. I would say it’s more than three months ago but I would provide that information, very specific information.
Kunda: Okay, ZABS, when did you do these tests? Please use the microphone.
Mutale: Thank you very much, Chair, our test reports are dated 23rd of September, 2020. That’s the date of the test reports, 23rd September, 2020.
Kunda: September. Did ZAMRA get these results from yourselves as a client?
Mutale: Yes, these results like I said there were three samples, three test reports were issued to Medical Stores, thank you Chair. Three reports were issued to Medical Stores and then two reports were issued to ZAMRA who were the clients.
Kunda: What was that done?
Mutale: This was in uh, stamped with us, 23rd September, so they should have collected them I think two, three days after that.
Kunda: 23rd September…
Mutale: That’s right
Kunda: ZABS, last year 23rd September, and you are still waiting up to today you are still waiting for a second opinion for you to decide on whether you can recall those products or not? ZAMRA yes. How are we handling these matters that affect the people of Zambia? Surely do we have to wait for all these months for us to come and make a decision on a matter that concerns the well-being of individuals? Yes ZAMRA.
Chilindi: Chair, as indicated earlier, as ZAMRA, we wanted to look at another laboratory, to look at the results from another laboratory before we issue the validation on these products. As PS had…
Kunda: You don’t have faith in your institutions? Those institutions that you work with, does it mean that you don’t have faith in them for you to be waiting for months to make a decision that is, and I am repeating this, that is very important for the well-being of our nation?
Chilindi: Chair, we wish to state that we expeditiously sent these samples immediately we received the samples from ZABS to MCAZ and for us, we took it that we would receive these results within a shortest possible time.
Kunda: Who oversees this institution? Is it Ministry of Health or just independent that they work independently and there is no authority whatsoever that oversees this institution? Yes ZABS [ZAMRA]
Chilindi: Chair, ZAMRA is a creation of an Act of parliament, of course operating under the Ministry of Health that is the setup of the institution and it has a board that oversees it’s activities.
Kunda: Yes Honorable Mbulakulima then Honorable Simbao.
Mbulakulima: Thank you Chairperson although most of the items have been overtaken but just to follow up, maybe you can help me to understand. First of all, I am disappointed that controlling officer and the team have been very defensive, it’s the first time I am seeing this kind of a thing. This is a very serious matter, apart from ZABS, all of them are on the defensive. Now this issue is very critical. September last year up to now, since they sent the results or the samples to Zimbabwe, one would have thought they would have put a hold to it, which you have said Chairperson, have you issued a recall? Now, nothing has been done to articulate. This is a serious matter and the controlling officer must know, the buck stops at her, there must be ownership to this document, she is the one who has submitted under Ministry of Health. I want to find out from her, who will be answerable for the genocide committed, is it Ministry of Health or Medical Stores? Because people have died, September to date, it’s not a small issue. This is genocide, who will be answerable, who will be responsible. Don’t underplay these matters, it’s a serious matter. ZABS has indicated clearly, it was not fit for human use, why take this long and you are underplaying this matter, this is genocide and somebody must be responsible, I thank you.
Kunda: Yes Honorable Simbao.
Simbao: Thank you Mr Chairman, I have two questions, I still haven’t gotten the question I asked Mr Mbewe about feedback because this is an area where there can be feedback. There are people getting pregnant, irrespective of them wearing condoms or things like that. Now, this is about 4 months we are talking about, we haven’t had any feedback on these products. Second, ZAMRA, when you get a report from ZABS that these things are suspect, what is your procedure, what do you do? Do you have to wait for a second opinion or you immediately you say, hold these things until you get a second opinion?
Chilindi: Ideally Sir, we are supposed to….
Kunda: You will allow me to give you chance to speak. I am in charge here. Yes, you can go ahead address that issue.
Chilindi: Thank you Chair. As ZAMRA, we work hand in hand with ZABS in a lot of matters and this is not the only one. Once we receive results from our colleagues, like in this case for the condoms, ideally we were supposed to have immediately issued that stop for the distribution. That was an oversight for the institution, Honorable Chair.
Kunda: PS. Yes PS, you have heard these oversights, it was an oversight on the part of ZAMRA and you are still waiting for information to come from Zimbabwe for this long when there are these oversight, and in the meantime these are being used. PS, what is it that you say about this? I think that it is very important for us to hear what you say about this.
Mulalelo: Honorable Chairperson, issues to do with quality are technical and scientific in nature. I can only make a comment once, as a ministry, we can only make a comment once we receive a report from the respective authority, in this case ZAMRA or MSL…
Kunda: So you are taking away ZABS, whatever they found out…
Mulalelo: (Interrupts) I cannot take away ZABS Honorable Chairperson, I did state that we have never as a ministry received any report from ZABS. As such, I cannot comment on a report that I have not seen. The report was submitted to ZAMRA and not to Ministry of health.
Kunda: Who oversees this ZAMRA? I think you have not addressed that, PS.
Mulalelo: ZAMRA is a statutory organisation that reports to a board, the director there did state how ZAMRA was formed and it falls under the Mindustry of Health.
Kunda: So ZAMRA, you have not given a report to the Ministry of Health, is that the position?
Chilindi: As indicated earlier Chair, we were waiting for the results from Zimbabwe to issue that report.
Kunda: The report from ZABS, you have not given a report to the Ministry of Health?
Chilindi: No Chair
Kunda: A report that is very important, that has been sitting with you from September 23rd, you have not given that report to the Ministry of Health. Could you please clear that?
Chilindi: No Chair, we have not given a report.
Kunda: Medical Stores, aren’t you directly under the Ministry of Health? And also who authorised for the distribution of these products that knowing very well that the certificate of fitness was not provided? Medical Stores. Yes Honorable Mweetwa, let them first address that then you will follow up.
Mbewe: Chair, with your permission, thank you so much again… Chair…
Kunda: Who authorised? Yes we know that it is the ministry but there is a person who authorised, who is that person who authorised without the certificate of fitness for distribution? Yes Medical Stores.
Mbewe: I will submit that the PS maybe can comment on this one.
Kunda: Yes PS
Mulalelo: Honorable Chairperson, I think the comment to say that there was an authorization came from MSL, I am not very sure who the MD was making reference to in terms of authorization.
Kunda: MD, you are protected under Cap 12 of the Laws of Zambia and that nothing that you say will be used against you. What we require here it is the information so that it helps us to make proper recommendations so that our nation can be run in a way that in reference to issues to do with the health of people, this nation should be run properly. So, having said that, who authorised you? Obviously you are the director and therefore there should be somebody who authorised you to distribute and with those guidelines that provinces should come and self- collect, there should be somebody. Could you please state who authorised you to distribute?
Mbulakulima: Chairperson, because my battery is running low, kindly just under one minute…
Kunda: Honorable Mbulakulima…
Mbulakulima: Just to supplement on that effort…
Kunda: Okay, we will start with Honorable Mweetwa then we go to Honorable Mbulakulima. Yes Honorable Mweetwa.
Mweetwa: Thank you very much Chairperson, just as a rider to your question Chairperson. I wanted to find out if the controlling officer is in a position to confirm that actually, many other products were also defective unlike narrowing it down just to condoms. Just like I had given an example of erythromycin and others, that in fact, these other products were also defective and that they were distributed and consumed by unsuspecting members of the public and in line with the question Chair, you are insisting to illicit an answer for, who authorised such distribution because information reaching the desk of this committee Chair is that these products were delivered at 14:00 hours, the following morning at 08:00 hours they were destined for disbursement across the country for consumption. Thank you Chair.
Kunda: Honorable Mbulakulima
Mbulakulima: Thank you Chairperson, I am sorry, I said my battery is running low but you see, the procurement director is there and one thing that is technical here is what we call materials safety data sheet, materials safety data sheet or manufacturers quality certificate. The question is, if you can come out clearly, talking about who authorised the distribution, now me, I am going to, who received? I wanted to find out, if the consignment was delivered along with safety data sheet or manufacturers quality certificate and if not so, why did we even allow products to even be received in the first place? Can they come out clean on that. Let them clearly state those issues.
Kunda: Honorable Kasonso, you would want to…if you can.
Kasonso: Thank you Chair. Chair, I want MSL, Medical Stores also to be clear, when you received a report from ZABS, why haven’t you informed the ministry or the PS Ministry of Health about the report which can from ZABS because she is saying, she has no information from ZAMRA or ZABS, why didn’t you inform your ministry about it?
Kunda: Yes Medical Stores Limited, you can also address that issue raised by Honorable Simbao whether you have started getting feedback. Yes.
Mbewe: Thank you Honorable Chairperson and honorable members for the submissions on this. Indeed, I want to confirm that we do have a very specific pharmacovigilance system which looks at the use from the patients or from the hospitals and this is a well-documented process and with regards to this specific consignment, I think there were very specific submissions that were made and authority for this feedback mechanism is ZAMRA. Chair, in terms of our processes, as an institution, we have a very well defined quality assurance system which is also underpinned by very specific SOPs in terms of what we need to do. Chair, I did allude to the context of our submission on the latex products to Zambia Bureau of Standards and I did also allude to the fact that the only institution that tests latex products is only ZABS. It’s not only for Honeybee, we would do this for any supply that is coming to MSL and ZABS will be able to even testify to that.
Indeed, there have been, from specific suppliers, when products have failed and for us, always the journey is to make sure that we are able to communicate with ZAMRA in the most expeditious manner. So in terms of the specific SOP, our SOP, at MSL our quality control laboratory is not the law, the law is ZAMRA so once we have a very specific finding, this is an outsourced service from ZABS. Our SOP says once you get the results, you communicate to ZAMRA and our process are so well documented and I think from the discrepancies that were indicated on our goods acceptance certificate, there was a very specific statement that was read that please take note, that for the examination gloves, the condoms, we have submitted the samples to Zambia Bureau of Standards and indeed when the results came, we have a documented process and very time sensitive in terms of how we also communicate to ZAMRA. So, more than just the processes is the conscience that we have, if anything goes wrong about a condom, the consequences, we know the consequences are very difficult. Yeah, so in terms of our very specific process as an institution and it’s very important that as an institution, we work through a quality management system and underpinned by SOPs and for us ZAMRA is the only institution that can effect a products recall. So this is about respecting the way the system has been built.
Kasonso: Chair, you [Mbewe] have not answered my question. You, you deal with the Ministry of Health, don’t you? Why didn’t you inform the Ministry of Health about the results from ZABS? That’s my question.
Mbewe: Chair, I did indicate we have our SOP and according to our processes, immediately we get the results from ZABS, we are supposed to immediately communicate to ZAMRA because ZAMRA is the law, ZAMRA is the one that is going to make a decision.
Kunda: Okay, who authorised the distribution? Yes MSL
Mbewe: Chair, I did indicate that the distribution occurred within a context and the distribution started within a specific activity….
Kunda: Who authorised the distribution? That is the, I think it is a very simple question, I am sure you were contacted as the head of this institution that please start distributing, who is that?
Kasonso: No semantics!
Kunda: Honorable Kasonso please, if you want to speak, speak through the microphone, order! Yes MSL.
Mbewe: Chair, thank you so much, I would say that we received information through the office of the PS that we should, there will be a flagging off the following day by the Honorable Minister of the distribution.
Kunda. So PS, could you please confirm of what the MSL has just stated whether that authorisation came from your office or not.
Mulalelo: I do not recall, we have two permanent secretaries’ offices and that information did not come from my office.
Kunda: Okay. Yes, you can see the confusion. I just have, I have one issue on the issue of the power of attorney. I think this issue has not been conclusively dealt with. The director Honeybee, do you understand what a power of attorney is? Do you understand what a power of attorney is?
Zakir: Thank you Honorable Chair, yes I do understand what the power of attorney is.
Kunda: could you just shed light on what power of attorney is.
Zakir: Power of attorney is basically an authority given to a person to act on behalf of an entity or a business name.
Kunda: Who issues that power of attorney, in this case we are talking about the query that is saying that the lawyers did not provide the power of attorney. Yes.
Zakir: Thank you Honorable Chair…
To be continued in tomorrow’s edition.