SETBACK FOR KABATSI AS ACENG WRITES TO M7 EXPLAINING WHY NDA SHOULDN’T LOSE VETERINARY MEDICINES’ REGULATION MANDATE
By Mulengera Reporters
For some long time, Ministers Joy Kafura Kabatsi (Livestock) and Jane Ruth Aceng (Health) have been conflicting over control and regulation of veterinary medicines for livestock currently falling under the mandate of National Drug Authority (NDA). Whereas the livestock sub sector (which Kabatsi has been heading for the last 3.5 years) falls under Vincent Sempijja-led MAAIF (agriculture sector), the very lucrative NDA falls under Dr. Jane Ruth Aceng-led Ministry of Health. And it has always had the mandate to control and regulate the manufacturing, importation, sell, purchase, storage and consumption or use of both livestock and human medicines. This is called having a fused mandate which some at MAAIF have always been uncomfortable about.
And indeed, Kabatsi (herself a big-name livestock farmer in Sembabule where she lost stocks due to Acaricides drug-resistant ticks) has always been unconvinced that NDA is doing a good job to regulate the vet medicines sub sector. Convinced there was a lot of inefficiencies, corruption and indifference at NDA, Kabatsi determined to find a solution as soon as she became Minister for Animal Husbandry (livestock) in June 2016. Sources close to her say, on ascending office, Kabatsi made sorting out NDA a top priority as she was convinced the war against drug-resisting ticks would only be won with a prudent regulator in place.
Closely working with Dr. Charles Lagul who heads NAGRIC, Kabatsi convened many meetings to build consensus among livestock farmers that indeed the entire problem derived from inadequate regulation of the veterinary drugs’ importation. Even though invited, NDA seldom came for her meetings which became a platform for disgruntled livestock farmers from Kiruhura and other places to bash NDA like there was no tomorrow. Even in Cabinet, Kabatsi kept building her case against NDA each time she got the microphone. Being a livestock farmer himself, President Museveni was equally very much interested in having the vet drugs aspects of the sub sector sorted out.
In 2017, the process to diminish the NDA mandate began in Cabinet where Kabatsi managed to get it on the agenda and various steps were taken to “streamline regulation of veterinary medicinal products, chemicals and devices.” There was also the Moses Ali Cabinet subcommittee that was tasked to study the situation and advise on the legislative interventions that could be made to rectify the situation. The committee produced a report whose suggestions Kabatsi and the MAAIF leadership rejected as not going deep enough.
Kabatsi insisted on shifting of the veterinary medicines’ regulation mandate from NDA to MAAIF where the National Veterinary Drugs Regulatory Authority would be established and headed by people who are uniquely technical as vet scientists. It’s to have a secretariat operating as part of MAAIF. Mulengera News has seen a Kabatsi-induced Cabinet memo on financial implications indicating that operationalization of the new Authority would require Shs60.8bn spread out into 5 Financial Years. Of this, 70% would be generated from vet drugs registration, retention, verification, licensing and laboratory analysis. The remaining 30% would come from the treasury. Some suggested government initially meets 100% of the budget to avoid implementing the new Authority haphazardly.
Kabatsi also managed to get Cabinet to direct recentralization of everything to do with veterinary sub sector including removing district veterinary officers from the district local governments and bring them under the direct control of MAAIF so that regulation is approached in a better coordinated way. NDA was said to be overstretched with having to regulate both human and animal drugs. That NDA had over concentrated on human medicines leaving vet drugs inadequately regulated enabling rogue individuals to import into the country substandard products leading to tick resistance.
NDA maintained the problem was emanating poor farming practices which MAAIF and the vet personnel network across the country had to address rather than blaming the regulator. NDA critics insisted that the two mandates be separately suggesting creation of two distinct regulatory authorities namely National Human Drug Authority and National Veterinary Drug Authority. In October 2019, the AG William Byaruhanga was called upon to advise cabinet on the two options of amending the Act establishing NDA or coming up with new bills altogether.
A review of the available voluminous Cabinet literature, as exclusively undertaken by Mulengera News, shows that in her anti-NDA efforts Kabatsi was also strengthened by earlier Presidential directives ordering that regulation of vet medicines reverts to MAAIF from the MoH on grounds that streamlining regulation would ensure quality of Uganda’s livestock products and increased access to external markets.
Indeed, in a mid-October meeting Cabinet directed Kabatsi and Aceng to prepare an update on how far they had gone implementing the President’s most previous directive on the same that had been made two years earlier. Kabatsi proceeded and moved very fast to the extent she even created a small committee comprising of vet Professors from Makerere who came up with a document containing Cabinet Principles to very elaborately guide Cabinet on how to fast track the enactment, and operationalization of the proposed National Veterinary Drugs Authority (leaving Aceng-supervised NDA with a diminished mandate).
In a subsequent meeting, Cabinet discussed the advantages and disadvantages of intervening into the vet sub section in ways Kabatsi was suggesting. Ministers gave their reservations about recentralizing delivery of veterinary services with many arguing it would dilute decentralization which is a major policy shift by government. But in the end, it was agreed recentralization was necessary because the wide spread of livestock diseases and tick resistance amounted to an emergency whose resolution couldn’t wait until a comprehensive review of the entire decentralization policy takes place.
It was agreed that, besides enacting a law establishing the National Veterinary Drugs Authority, Shs182.2bn be availed to MAAIF to enable the implementation of “a comprehensive disease control program” that would result into better facilities being put in place and the over 2,000 vet cadres (130 DVOs & 2003 Sub County ones) facilitated better with motorcycles to more ably do their work.
In a subsequent letter dated 25th October 2019, Aceng protests to the President and demands a reversal of the anti-NDA gains Kabatsi had registered through Cabinet. She justifies her demands on a number of grounds including the fact that the pro-Kabatsi cabinet decisions were made in her absence otherwise she would have guided debate on the dangers of diminishing the NDA mandate by taking away the vet drugs regulation mandate. Aceng’s strictly confidential dossier is titled: “Decisions taken by Cabinet on Regulation of Veterinary and Human Drugs on 7th October 2015.”
Prime Minister Ruhakana Rugunda chaired that cabinet session and Aceng begins by saying it was anomalous for Cabinet to take such “major decisions affecting functionality of NDA” in her absence as the health sector Minister. Mulengera News understands she was in France executing one of the President’s assignments. In her absence cabinet discussed and voted on the need to repeal NDA Act and the enactment of a new Act/Bill establishing the National Veterinary Drugs Authority.
She says her exclusion was fatal because regulation of medicines is a very sensitive exercise requiring extreme caution. That repealing the relevant Act implies halting operations of NDA which is a risk to national security as Ugandans can’t do without human and animal medicines that are well regulated and well brought into the country. She demands that Museveni urgently intervenes to reverse the anti-NDA gains MAAIF had registered. That NDA should have been invited for the 7th October cabinet meeting to enable cabinet make an informed decision regarding repercussions of such decisions on health sector operations.
She attaches a copy of the Moses Ali committee report on vet medicines regulation and says it was a fatal mistake for Rugunda to lead cabinet into the 7th October resolutions without any reference to the Moses Ali committee report into which input was solicited from many key stakeholders.
She writes: “At the 31st Cabinet meeting (held 23rd July) which was chaired by Rt. Hon Dr. Ruhakana Rugunda, the report by the Committee of Rt. Hon Gen. Moses Ali was deterred to the next Cabinet meeting of 30th July pending your input and guidance. Unfortunately, this was not respected as decisions on this matter were made in your absence during the Cabinet meeting of 7th October 2019.” She says as Minister of Health, she is still waiting for a final position reflective of the H.E’s input and guidance. Apparently, that’s the only thing she will respect and comply with.
Aceng indicts MAAIF (whose officials are out to fault NDA and by extension her health sector leadership) by referencing on the scandalous importation of counterfeit Foot and Mouth Disease vaccines into the country by Mzee Xavier Kitaka-owned MTK (U) Ltd. Aceng refreshes the H.E’s mind on how this MTK scandal shamed government prompting the President to direct Rugunda to investigate and report back, an assignment the PM diligently executed. That 5th August 2019 Museveni directive to Rugunda seeking to expose MTK was recorded under Cabinet Minute 315 (CT 2019).
Aceng argues that the Rugunda committee report established that the problem of counterfeit vet drugs was deriving more from the way drugs are procured and supplied and not regulation by NDA (as is being deceptively portrayed to the President). She faults colleagues at the 7th October 2019 Cabinet meeting for not referencing at all on the PM’s Cabinet Committee report containing all these findings relating to the MTK scandal.
She says the same Rugunda Committee report rightly recommended for the immediate establishment of National Veterinary Medical Stores under MAAIF to carry out the procurement, storage and distribution of vet medicines as NDA concentrated on regulation. That, globally, distinguishing procurement, supply and distribution from regulation is a well-recognized best practice principle and that’s the way Uganda should proceed.
She says that this prudently is what happened in 1993 when NDA was established to strictly regulate as NMS too was established to handle procurement, storage and distribution of human medicines. That the omission back then was that no similar arrangements were made to establish the NMS equivalent to handle procurement and distribution of animal drugs. She argues that now is the time to rectify the anomaly by having in place the NMS equivalent to cater for procurement and distribution of vet drugs.
Aceng adds that even currently, there is no law preventing MAAIF from carrying out the mandate of procuring and distributing vet medicines under NDA regulation. That the MAAIF leadership should put their house in order to avoid loopholes that “unscrupulous entities like MTK (U) Ltd can exploit” to cause mayhem by importing counterfeit F&MD vaccines for government.
Aceng says instead of altering the law, government should consider increasing financial support to MAAIF to enable them adequately procure and stock essential livestock drugs and vaccines on good time rather than waiting for emergency disease outbreaks and begin acting in haste. That the current MAAIF approach of only waking up to respond to emergencies isn’t scientifically sound and plausible. That in most cases, MAAIF wakes up late only to “vaccinate already sick animals.”
She again refers to the Rugunda Cabinet Committee report that advised that in the interim period, MAAIF and her MoH work out modalities to use National Medical Stores (NMS) facilities and infrastructure in Entebbe “in case the Veterinary Stores in Wandegeya are not sufficient to handle the national vet supplies.”
Aceng then discusses why NDA is best suited to regulate both human and animal medicines. She refers to the capabilities the entity has built in the last 25 years. That there is plenty of multidisciplinary human resources including veterinary surgeons, human doctors, lawyers “and other support staff to perform all the regulatory functions spelt out in the National Drug Policy and Authority Act including veterinary drug regulation.”
Yet that isn’t all. Aceng says NDA has also been recognized as a “regional center of excellence in core functions of drug regulation like Good Manufacturing Practices (GMP) inspection among others.” That huge government investment has gone into NDA’s drugs analytical laboratory which sometime back attained WHO pre-qualification and ISO 17025 accreditation. That a new state of the art laboratory is nearing completion and it will increase NDA’s “levels of sophistication in the pharmaceutical industry.”
She persuasively argues it would be imprudent for the same government to begin scattering resources into entities like National Veterinary Drug Authority (NVDA) whose establishment the MAAIF officials are pushing for. She references on the Shs60.8bn MAAIF is demanding to establish the NVDA to directly duplicate NDA’s regulatory role. That this scattering of regulatory resources will only escalate inefficiency further constraining acceptability of Uganda’s livestock products on the global market. She suggests to the HE that it’s better to give that funding to NDA so that its regulatory processes are strengthened. “For instance, the proposed resources (Shs60.8bn) can be dedicated to straightening post marketing surveillance like setting up regional laboratories.”
That the global medicines regulation regime is tending towards “one health” combining both human and animal drugs and subjecting them to similar regulation standards and practices. Aceng argues that pulling in the opposite direction risks making Uganda misunderstood. “Therefore, the current fusing of human and veterinary drug regulation under one competent authority is in line with international best practices,” submits Aceng.
That globally, scientists are unanimously in favor of human drugs, veterinary drugs, blood products, food, cosmetics, medical devices and household chemicals of public importance being jointly regulated by one competent regulatory authority (under the Ministry responsible for health) which (in Uganda’s case) she maintains has to be NDA and not any other. She argues the same should happen with manufacture, importation, labelling, sale and advertisement of both human and veterinary medicines. That this is important because animal health outcomes directly impact on human life and economic growth of the country.
That in their 2018 assessment report, inspectors from World Animal Health Organization (OIE) reflected on performance of veterinary services in Uganda and strongly recommended for closer collaboration between MAAIF and MoH for better vet services outcomes. In the same report, Aceng says the global inspectors observed that NDA has the necessary structures and in-built systems to adequately regulate veterinary medicines.
Referencing on findings made by the Cabinet committee chaired by PM Rugunda, Aceng demands deepened fusion of human and veterinary medicines regulation because they have similar technical requirements. She also calls for increased clarity of the difference between NDA’s regulation mandate and the procurement and distribution mandate which is MAAIF’s. That to do even better, NDA should be financially supported to have a distinct Directorate charged with veterinary medicines to manage improved stakeholder linkages. The key stakeholders here would include MAAIF, Uganda Veterinary Board, Uganda Veterinary Association, Pharmaceutical Society of Uganda, Pharmacy Board, UNBS, PSFU and district LGs.
She also wants MAAIF to work more with NDA to ensure strict adherence to policy requirements on the rational use of veterinary drugs. That MAAIF should establish a Division on veterinary pharmaceutical services (charged with originating policy documents) to serve as the equivalent of pharmacy department at the MoH. That the NDA governance structure already provides for the different stakeholders (like MAAIF, Mak vet College etc) to all be represented on the NDA governing board (aka the Authority). This representation should ideally make it possible to have all the rising misunderstandings mitigated on good time.Aceng also says MAAIF’s animal diseases’ surveillance and diagnostic mandate be strengthened through the revitalization of the National Animal Disease Diagnostics & Epidemiological Center (NADD EC) which she suggests should be supported to acquire international accreditation so that it’s test results can be internationally recognized. She calls on the HE to disregard suggestions that majority shareholders are against fusion of human and veterinary medicines regulation into the hands of NDA. That those calling for separation are a minority whose views should be disregarded. Claiming some strange interests could be at play to selfishly undermine the work of NDA, Aceng says some time back Nyabushozi MP Col Fred Mwesigye unsuccessfully tried to champion his Veterinary Drugs & Feeds Bill.
She also refers to earlier cabinet efforts to strengthen NDA by transforming it into National Food & Drug Authority to enable it regulate many more things than just medicines for the safety of the Ugandan populace against all aspects of “bioterrorism.” Aceng reveals to the President that a lot of government finances and effort has already gone into consultations preparing for the NFDA Bill aimed at renaming and expanding the mandate of NDA.
Aceng ends her dossier with the following text: “Your Excellency sir I seek your intervention for Cabinet to reconsider its decision of repealing the NDPA Act Cap 206 and directing the Ministers of Health and Agriculture to prepare and submit cabinet principles to enact the National Human Drug Authority Bill and the National Veterinary Drug Authority Bill.” (For comments on this story, call, text or whatsapp us on 0705579994 or email us at email@example.com).