The Ministry of Health’s decision to halt unregulated parallel importation of medicines and health technologies marks an important step in strengthening Kenya’s pharmaceutical regulatory system.
More than a policy shift, it is a reaffirmation that improving access to medicines should never come at the expense of patient safety, quality or public confidence.
Parallel importation has long divided opinion. Supporters argue it can improve access and lower costs by allowing medicines to be sourced from alternative markets.
Critics, however, caution that medicines are not ordinary consumer goods.
They require strict oversight of manufacturing, storage, transportation, labelling, traceability and post-market surveillance. A cheaper medicine that cannot be verified, traced or monitored may ultimately impose far greater costs on patients and the healthcare system.
The real issue, therefore, is not whether parallel importation should exist, but whether it can operate within a robust regulatory framework. Every product entering the Kenyan market should be authorised, quality-assured, traceable and compliant with local regulatory requirements. Affordability should never be pursued independently of safety, quality and efficacy.
Weak oversight creates opportunities for substandard or falsified medicines to enter legitimate supply chains, undermining public trust and fragmenting accountability. This makes strong regulation indispensable.
Kenya has made significant progress in strengthening pharmaceutical oversight, including the Pharmacy and Poisons Board’s pursuit of the World Health Organization’s Maturity Level 3 benchmark.
The planned rollout of medicine serialisation and track-and-trace systems will further enhance transparency by enabling regulators to monitor products throughout the supply chain and respond quickly to quality or safety concerns.
The next challenge is implementation. Regulators, manufacturers, importers, distributors and healthcare professionals must consistently apply the 2019 parallel importation framework.
Greater transparency is equally important. The public should be able to identify which products have been authorised for parallel importation, who is responsible for them and how compliance will be monitored.
Ultimately, the success of the policy will not be measured by the volume of medicines imported or the prices achieved. It will be judged by whether Kenyan patients receive safe, effective and quality-assured medicines through a regulatory system they can trust.
The writer is a Pharmaceutical Industry Expert
