When Dr. Seima Dijeng stood before a room of pharmaceutical executives, medical-device manufacturers and industry lawyers on Wednesday, his ask was modest and, by the standards of government consultation, almost disarming: “Be blunt.”
The Chief Executive Offcier (CEO) of the Botswana Medicines Regulatory Authority (BOMRA) was not there to announce a finished product. He was there to share notes on a sweeping new medicines law; the most significant overhaul of the country’s pharmaceutical regulatory framework in over a decade; has been on the books since December. It is not yet in force.
The gap between those two facts is where Botswana’s pharmaceutical industry now lives, and it is the reason Dijeng spent his morning asking a roomful of stakeholders to help his agency write the rules that will make the law real.
“We are trying to build a regulatory system that Botswana can rely on and that our trading partners can recognise,” Dijeng said, closing the session at Travel Lodge in Gaborone.
A Law in Waiting
The Medicines and Related Substances Act, No. 29 of 2025, passed the National Assembly on December 11 and received presidential assent 13 days later. At 125 sections and 23 parts, it is a substantially larger and more ambitious statute than the 2013 law it will eventually replace; one that regulators and industry alike had outgrown.
But the new Act sits in a kind of legislative limbo. Under Section 1, read with Section 124, the law does not take effect until the Minister of Health appoints a commencement date by order in the Government Gazette. And the Minister, Dijeng made clear, will not commence an Act that has no working regulations beneath it.
Until that date arrives, the old 2013 statute and its 2019 regulations continue to apply in full. Which means the industry’s current licences, registrations and approvals remain valid; a point Dijeng was careful to emphasise in a room where anxiety about continuity tends to run high.
“We are the same Authority, operating under a modernised law,” he said. “That continuation is what preserves existing registrations and licences.”
Why the law had to change
The pressures that converged on the 2013 framework were not subtle. Whole product categories – traditional and complementary medicines, cosmetics, diagnostics – had outpaced the regulator’s legal perimeter. Botswana, a country heavily reliant on imported medical products, had no statutory basis for relying on the assessments of other regulators. Its appeal route ran through the courts. Its enforcement tools could not adequately deter repeat offenders.
By 2019, after several years of operation, the gaps were visible. Dr Dijeng explained that tghe Authority triggered a bill-drafting process shaped by three converging forces: the African Union’s model law on medical products regulation, the SADC Medicines Regulatory Harmonisation initiative and the African Continental Free Trade Area, and Botswana’s own national priorities.
The result was a deliberately slow legislative journey. Public comments were invited on a draft bill in 2021. Engagement sessions followed in 2023. The bill was revised, reissued and eventually passed in 2025. In April of this year, nine draft regulatory instruments were released for public comment. Wednesday’s consultation was the next step.
“Consultation has run alongside drafting at every stage,” Dijeng said, pushing back on any suggestion that the regulations had been sprung on industry. “2021, 2023, April to May 2026, and today.”
The scale of the change partly explains the timeline. The Act expanded from 13 parts to 23. Legislative drafting capacity in Botswana is limited. And, Dijeng argued, the Authority made a deliberate choice to consult properly at each stage rather than rush.
The Continental Architecture
Botswana is not legislating in isolation. The new Act is designed to slot into a continental and regional regulatory architecture that has been taking shape for years; one that Dijeng described as built on “recognition, reliance and harmonisation.”
At the continental level, the African Union’s model law provides a common legislative template so that national laws converge rather than diverge. The African Medicines Agency, a new continental body, offers common technical requirements and work-sharing across national regulators. Regionally, the SADC Medicines Regulatory Harmonisation programme allows a dossier assessed once to be relied on by several regulators.
For industry, the commercial appeal is obvious: faster registration timelines, pooled procurement, and the possibility of mutual recognition arrangements that let a product approved in one country move more easily through others. Section 109 of the new Act gives the Authority the power to adopt the decisions of another trusted regulator; a provision Dijeng acknowledged would be “taken as music to the industry, albeit with scepticism on implementation.”
He was careful not to over-promise. How reliance actually operates, which regulators are trusted, which product classes qualify, what abridged evidence is accepted; sits in the regulations and guidelines still being drafted. That, she told the room, is precisely what they should comment on.
The Benchmark Botswana Has Not Yet Met
Underpinning the legislative push is a more technical ambition: the World Health Organisation’s Global Benchmarking Tool, which measures regulatory maturity across nine functions and four levels. Maturity Level 3 – a stable, well-functioning regulatory system – is the standard the region is working toward and BoMRA’s foundational strategic goal.
But a country cannot reach ML3 without a legal framework covering every aspect of its regulatory system. The 2013 Act, regulators say, was the ceiling on how far Botswana could climb. Dijeng described ML3 as the objective, not something already attained. The legal instruments, she said, are the “gating dependency” for a large block of institutional development work – which is why the timeline matters.
A regulator that names its own gaps
In a move that is unusual for a government agency standing before the industry it regulates, Dijeng spent several minutes laying out BoMRA’s weaknesses.
The 2013 legislation constrains enforcement and deterrence for repeat offenders. Emerging product categories have outpaced regulatory capacity. A small market and rising inflows of unregistered medical products have stretched supply-chain oversight. Office and laboratory infrastructure remains constrained, though he said both are being resolved – laboratory capability, he noted, is central to regulating independently rather than by referral. And then there is the money.
The sustainability problem
BoMRA’s regulatory fees are the lowest in the region. They earn less than the system costs to run. Dijeng put the matter plainly: the Authority’s fee revenue covers roughly 17 percent of its operating costs. The strategic goal is to move meaningfully closer to 50 percent by 2030.
A new fee structure has recently been proposed. The Fees, Levies and Penalties Regulations have been drafted under the incoming Act and remain open for comment. Dijeng did not defend the proposed levels or promise a specific outcome. They are before the room, he said, precisely because they are open.
But he drew one firm line: subvention, the government’s direct funding of the Authority, will be preserved. The point, he said, was governance, not finance: regulatory independence must never become contingent on fee income from the entities BoMRA regulates.
“Under-funding shows up as delay,” she told the room. “Assessment capacity, laboratory testing, inspection cycles and turnaround times are all funded from the same base. A regulator that cannot resource its functions cannot deliver the timelines industry needs.”
What Comes Next
Wednesday’s consultation is part of a parallel process. The Authority’s draft regulations have been sent to the Attorney General’s Chambers so that formal legislative drafting can begin, a process that takes time and will produce its own draft for a further round of comment.
Dijeng addressed the inevitable question head-on: if the drafts are already with the Attorney General, why consult? Because the Chambers drafts language, he said, not policy. Comments received Wednesday feed into the drafting instructions.
His closing request was characteristically direct. The most useful thing stakeholders could give her agency was not agreement. It was honest, timely feedback – and, he added, written submissions. “Be blunt,” he said.
In a region where regulatory consultation can sometimes feel like theatre; the decisions already made, the comments already filed, the outcomes already settled; it was, at minimum, a credible opening bid.
Dr. Seima Dijeng is the chief executive of the Botswana Medicines Regulatory Authority. The MRS Regulations Stakeholder Consultation continues with further sessions. Written submissions can be directed to BoMRA at info@bomra.co.b