OUR

Enforcement

The unit was charged with driving strategic objective 7 which has changed from “ensure compliance to legislation” to “Strengthening Enforcement”. The initiatives carried out as per the annual work plan were guided by the existing enforcement framework which is a policy document comprising proactive and reactive enforcement activities.

The unit was charged with driving strategic objective 7 which has changed from “ensure compliance to legislation” to “Strengthening Enforcement”. The initiatives carried out as per the annual work plan were guided by the existing enforcement framework which is a policy document comprising proactive and reactive enforcement activities.

The unit was charged with driving strategic objective 7 which has changed from “ensure compliance to legislation” to “Strengthening Enforcement”. The initiatives carried out as per the annual work plan were guided by the existing enforcement framework which is a policy document comprising proactive and reactive enforcement activities.

Enforcement team

Key Highlights

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1. By District/Town Council:- Southern, Kweneng, Lobatse, South East, Kgatleng, Gaborone, Central, Selibe-Phikwe, Francistown, North East, Chobe, North West, Ghazni, Jwaneng.

2. Ports of entry and border:- Ramatlabama, Pioneer, Tlokweng, Martins Drift, Ramokgwebana, Kazungula and Dibete Gate.

1. Between 2020/21 and 2021/2 trained 147 Law enforcement representatives from other organisations on understanding the control of human medicines in “greater” Gaborone, Francistown, North East, Kasane, Maun, ports of entry in southern parts, in North East, Sir Seretse Khama Airport, PG Matante International airport, Ramokgweban, Botswana Post International Exchange Centre (in Gaborone) Mamuno and Mohembo.

2. A cumulative of nine (9) stakeholder organisations participated in the Joint operations with Botswana Police Service, Ministry of Investment, Trade and Investment, BURS, Botswana Post, Wildlife and Parks, Environmental Health, Competition, and Consumer Protection as well as Local administrative authorities. A total of 13 joint operations varying in duration have been conducted between 2020/21 and 2021/22.

1. Most infringements were as is translated from the number of offenders and the economic value of the offences.

2. Unregistered and/or imported with an import permit.

3. Common offences committed against MRSA in 2013 related to possession and selling of unregistered medicine. Unlawful dispensing of medicines has increasingly come to light in 2021/22 hence offences stated herein against section 38.

4. Informal traders were the most likely to contravene sections 23 and 28.

5. Illegal manufacturing of hand sanitiser products was the main driver for the Infringement of MRSA section 27.

6. One counterfeit case is under processing for which penalties are not accounted for in this summary.

1. The fines imposed averaged 1% of the potential monetary penalties as provided in the MRSA of 2013.

2. The figure below summarizes a contrast between penalties stipulated by MRSA in 2013 against the actual fines which were imposed.

3. The remainder of the offenders comprised entities licensed by other authorities.

4. The figures below summarise offender types and the number of offences identified.

1. The Authority is unable to impose and collect fines, as it is hamstrung by the current Medicines and Related Substance Act of 2013. Therefore BoMRA, as a contingency intervention, relies on strategic partners for this enforcement sanction such as Botswana Police Service and BURS.

2. The fines imposed through the Botswana Police Service are not deterring. This explains the continued unlawful possession and selling of unregistered medicines.

3. During this formative stage, the Enforcement Unit is not optimally resourced to cover the breadth of the country and to keep up with the frequency of offences.

4. Between three groups of (i) historically regulated entities such as community pharmacies and pharmaceutical wholesales (ii) newly regulated such as medical practitioners and veterinary retailers as well as (iii) unregulated such as street vendors and other informal traders, there are claims of ignorance of the MRSA.

5. Inability to keep up with social media marketing for borderline complementary medicines, advertising of unregistered medicines and off-label use of registered medicines.

6. Ineffective border control between Botswana and her neighbours results in the smuggling of unregistered medicines.