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Enforcement

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.

Key Highlights

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. 

Ms. Elizabeth Kelentse

Ms. Kelentse is the Pharmaceutical Care Improvement Specialist at the Botswana-University of Maryland School of Medicine Health Initiative.

She is an enthusiastic and hardworking Pharmacist who brings vast experience to the Board. Her career spans over 12 years from clinical pharmacy to community pharmacy, medicines regulatory experience in the evaluation of clinical trials protocols, and pharmacovigilance: health care management and public health programming.

She has served on the executive committees of the Pharmaceutical Society of Botswana, Botswana Health Professions Council, Young African Leaders Initiative Alumni as well as the National Adverse Events Following Immunisation.

She holds a Bachelor of Science (Pharmacy) University of West Indies St Augustine, Trinidad & Tobago.

Ms. Matshediso Matome

Ms. Matshediso Matome is a Faculty of Health Sciences lecturer at the University of Botswana. She is a seasoned academic who brings to the Board vast experience in the areas of research, health risk management, and delivery of innovative, quality, and cost- effective healthcare solutions for the public and private sectors.

Ms. Matome has previously served in various leadership and senior management positions, including Claims Manager and Head of Managed Care at the Associated Fund Administrators.

She holds a Master’s degree in Pharmacology and Toxicology from, the State University of New York Buffalo, NY, USA, and a Bachelor of Pharmacy, from Albany College of Pharmacy, Albany, USA

Dr Kobedi Segale

Dr. Segale is the Registrar of the Veterinary Surgeons Council. He is a passionate veterinary surgeon with intimate experience in the regulation of the veterinary profession. He has previously served as Deputy Director – Disease Control Division, in the Department of Veterinary Services, responsible for national animal health strategies, programs, and legislation. Dr. Segale brings to the Board a wealth of experience in monitoring and evaluating animal health programs veterinary public health, import and export controls, and animal traceability.

He holds a Master of Science in Tropical Animal Health, from the Institute of Tropical Medicine, Antwerpen, Belgium, and a Bachelor’s degree in Veterinary Medicine from the University College of Dublin, Ireland.

Ms. Mmama Mhlanga – Fichani

Ms. Mhlanga – Fichani is the Vice President, Human Resources and Communications, at Khoemacau Copper Mining. She is a human resources professional with an illustrious career, spanning over15 years in senior management positions. She has held senior leadership positions in diverse industries including, Director of Human Resources at Air Botswana and the Country Head of Human Resources at Standard Chartered Bank Botswana, Head of Human Resources at Be Mobile, Human Resources Manager at African Comprehensive HIV/AIDS Partnership and Human Resource Manager at Non-Bank Financial Institutions Regulatory Authority, respectively.

She brings to the Board vast experience in human resources and communication, organisational effectiveness, employee relations, and change management.

Ms. Mhlanga – Fichani holds a Master’s Degree in Business and Workforce Development from the University of Pennsylvania, USA, a Bachelor of Science in Business Management Human Resources Management, and Marketing Management, from Fairmont College, West Virginia USA, and a Degree of Associate of Science in Business Science- Human Resources Management, September, Calhoun State Community College, Decatur, Alabama, USA.

Mr. Modisa Kebonyemodisa

Mr. Kebonyemodisa is a Partner at Kebonyemodisa Law Office, he is admitted attorney of the High Court of Botswana. Before venturing into private practice, he worked as a Senior Prosecution Counsel at the Directorate of Public Prosecutions.

Mr. Kebonyemodisa is an accomplished legal advisor with over 15 years of experience providing legal counsel to businesses of all sizes. He brings to the Board vast experience in legal practice, corporate law, and extensive knowledge in the legal profession.

He holds a Bachelor of Law degree from, the University of Botswana and Trial Advocacy, Justice Advocacy Training (NITA) (Botswana)

Ms. Tiny Ralefala

Ms. Ralefala is a finance professional with a proven record of leadership, corporate governance, and risk management.

Her impressive professional track record spans over 26 years in finance, audit and accounting in reputable institutions as well as in civil service.

She previously worked as the Chief Finance Officer for Citizen Entrepreneurial Development Agency. Prior to her joining Citizen Entrepreneurial Development Agency she worked as the Finance Manager at the Motor Vehicle Accident Fund.

As a Chartered Financial Accountant, Ms. Ralefala brings to the Board a wealth of experience accustomed to managing projects in finance, audit and risk. She holds a Bachelor of Commerce degree from the University of Botswana. Ms. Ralefala is a fellow member of the Association of Chartered Accountants and the Botswana Institute of Chartered Accountants. She is the current Botswana Institute of Chartered Accountants Practice Review Committee Chairperson.

Dr. Lorato Mangadi-Mokama

 Dr. Lorato Mangadi- Mokama is the  Head of Operations at the Botswana Public Officers Medical Aid Scheme.
She has previously held other  leadership roles within the private healthcare industry, including Chief Operations Officer at the Botswana Medical Aid Society and Managing Director at MRI Botswana Limited. Prior to that, she practiced as a medical doctor in the public health sectors of Australia and Botswana.

Healthcare administrator and funding expert, with her extensive background in the private healthcare industry, she brings to BoMRA a wealth of experience and knowledge in business management and leadership.

She holds a Bachelor of Medicine from the University of Newcastle (Australia) and a Master of Business Administration from the University of Botswana.

She also has various leadership and professional certifications including Executive Leadership Program from Wits Business School and Healthcare Economics from Harvard Business School

Dr. Kegomoditswe Biki Maphane

Dr Kegomoditswe Biki Maphane is the Senior Manager – Safety and Sustainability Development at Debswana Diamond Company, Jwaneng Mine. He is a specialist in Occupational Medicine, Safety & Sustainable Development.

He has held various positions within the Debswana mines, including the Jwaneng Mine Hospital superintendent, and rose to executive leadership.

Dr Maphane provides leadership to the BoMRA Board and oversees the governance and strategic direction of the Authority. He holds a Bachelor of Medical Sciences, and Bachelor of Medicine / Bachelor of Surgery from the University of Melbourne, Australia