Lesotho is among 12 African countries that adopted and implemented the African Union Model Law on Medical Products Regulation. The law was endorsed to improve access to quality, safe drugs and as well as fight the circulation of fake medical products on the continent. Such unregulated medicines resulted in the use of ineffective, poor quality and harmful medicines which lead to therapeutic failure, exacerbation of diseases, resistance to medicines and sometimes deaths. Lesotho has embraced and domesticated the AU Model Law.

Lesotho then enacted the Lesotho Medicines & Medical Devices Control Authority Act, 2023 a regulatory framework which envisages addressing the need to protect the public and ensure access to health. In terms of the newly enacted legislation, medicines and medical devices will now be regulated, medicines and medical equipment now require approval from the Board of the Authority prior to their registration. The criteria are safety, quality and therapeutic efficacy and the quality monitoring is performed at the National Pharmaceutical Quality Control Laboratory or any other accredited laboratory.

The Act seeks to establish the Authority which will be responsible for the regulation and control of medicine and medical devices, all medical products will be registered, premises used for manufacturing and selling of medical products as well as personnel handling medical products will also be licensed.

Prior to the enactment of the bill most medicines, in addition, it was indicated that such medicines might also lead to trafficking of substandard medical products, manufacturing of herbal medicines which have adverse effects on users, advertisements of medical products with false claims attached on the effects of medicines, malpractices in medicine outlets and unauthorized clinical trials. The Act therefore intends to address the said challenges by regulating and controlling the manufacture, sale, distribution, labelling, advertisement, and use of medical products to ensure that such products meet the required standard of safety, efficacy as well as quality in order to protect public health.

The Act appreciates the need for protection of health and further provides for Pharmacovigilance which is in relation to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The Board is charged with the recalling, non-dispensation and non-release of all the medicines it deems are unfit for consumption. The Act sets out fines and penalties for the non-compliance and contravention of the Act.

There will be inspectors, analysts and clinical trials in place to ensure that only the medicines fit for human consumption are sold and/or marketed. Any person who may be aggrieved by the decision of the Board is welcome to Appeal such a decision as outlined in the Act. There will be enacted guidelines and regulations pertaining to fees, forms, people who may apply for registration, minimum standards of good manufacturing e.t.c.