PSK announces January review, warns of health setbacks from rush to push ‘failing’ regulator model into Kenya, as it is abandoned in USA.
The Pharmaceutical Society of Kenya (PSK) has announced a review of the proposed Kenya Food and Drugs Authority (KFDA) Bill, which seeks to launch a combined regulator just as the USA, which created this duel regulation model, abandons its own FDA citing grave consequences from the conjoined regulation.
Commenting on the matter, Dr Louis Machogu, President of the Pharmaceutical Society of Kenya, said it was unprecedented to move legislation into the Rapid Review Initiative (RRI) to set up a body that was literally being abandoned elsewhere as damaging for both healthcare and consumers.
“PSK knows of no reason for rushing the creation of the country’s ‘next generation’ regulator. Our current regulators in both food and pharmaceuticals are fully operational, and the point of reforming the regulatory system is to improve it from an existing base. A 100-day hurtle to a model that is being abandoned elsewhere is creating huge risk completely unnecessarily,” said Dr Machogu.
The PSK, concerned that the draft bill is being drawn up without due consultations and without the involvement of pharmacists or Kenyan healthcare experts, also today announced it was launching a committee to review the bill in full, and would be publishing the results of the review in January.
“Rushed legislation without adequate and practical impact assessments constitutes a ticking timebomb,” said Dr Machogu.
“We are concerned to see the creation of a new regulator at all, rather than an upgrade in the scope and methodology of the existing and functioning pharmaceuticals regulator, the Pharmacy and Poisons Board (PPB). The one urgent action was to align the PPB’s remit with the Health Act and the needs of Universal Health Cover (UHC).
“However, of far graver concern is the decision to combine the regulation of medicines and medical equipment with the regulation of food, which is a completely different and huge remit that has been shown to diminish the quality of regulation across all,” he said.
In the US, the White House announced the reorganization of its FDA in June 2018, having determined that the current structure, formulated in the early 1900s, was outdated and creating greater risk, inefficiency, and inconsistency in ensuring safety for consumers.
The regulation of food and drugs is now being separated to deliver better results in each sector.