By Clifford Akumu
Pharmacists have termed as needless the move to form a new agency to regulate drugs, which they say, will in turn scrap off the existing body Pharmacies and Poisions Board.
Pharmaceutical Society of Kenya (PSK) today expressed fears the new agency-Kenya Food and Drug Authority (KFDA), will be damaging for both healthcare and consumers.
Dr Louis Machogu, President of the Pharmaceutical Society of Kenya said it was unprecedented to move to create a body that was literally being abandoned elsewhere.
Instead, he called for improvement of the existing base saying the current regulators in both food and pharmaceuticals were fully operational.
“There is no reason to rush and create the country’s ‘next generation’ regulator. Our current regulators in both food and pharmaceuticals are fully operational. It is risky and completely unnecessary,” said Dr Machogu.
The idea to form KFDA, copied from United States’ Food and Drug Authorities, was reached in October 2014 by East African ministers and donors during a meeting in Arusha, Tanzania.
All East African Community countries were supposed to create similar authorities, which will make it easier for pharmaceutical companies to set up manufacturing businesses locally.
The KFDA Bill is under discussion between the Ministries of Agriculture and Health. The bill will be tabled in the National Assembly in February after Parliament resumes from recess.
The society, concerned that the draft bill is being drawn up without due consultations and without the involvement of pharmacists or Kenyan healthcare experts, also announced it was launching a committee to review the bill in full, and would be publishing the results of the review in January.
Machogu noted that rushed legislation without adequate and practical impact assessments constitutes a ticking time bomb.
“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 more serious concern is the decision to combine the regulation of medicines and medical equipment with the regulation of food, which is a completely different and a huge remit that has been shown to diminish the quality of regulation across all,” he said.
In the US, the White House announced in June 2018 the disbanding of its FDA, 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.
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