ith the Kenya Food and Drug Authority (KFDA) Bill still in Parliament, stakeholders in the food and drug industry fear it could be implemented.
The private member’s bill, tabled in Parliament for the first reading in June 2018, proposed one regulatory body for food, medicine and health product by establishing the agency (KFDA).
The agency was expected to tighten import rules on food and medical products including equipment, so as to get rid of and prevent circulation of counterfeit in the country. Some players are opposed to the idea.
“I hear the proponents are still pushing for it. We want the focus to be separate because we risk losing control of drugs and food administration in the country,” said Dr Dominic Karanja from the Pharmaceutical Society of Kenya (PSK).
Experts said, instead, the legislation of and regulations on administration of the two should be strengthened. “The idea of lumping everything together is very dangerous. People want to do business at the expense of the citizens. Let us build the capacity of the Pharmacy and Poisons Board (PPB) instead,” he said.
This is despite the ministries of Health and Agriculture having agreed to go their separate ways following intense lobbying by the stakeholders in the industries. “It was agreed that food and drugs should be managed separately to avoid a clash in administration of the two. But, there are some overlapping roles that would need consultation,” said Fresh Produce Consortium of Kenya CEO Okisegere Ojepat.
“The government yielded that the two will now go separate ways. KFDA was not the way to go. It does not make sense to put administration of food and drugs together,” he said.
Although the way pesticides and pharmaceuticals are dispensed may look the same, the application is completely different and, therefore, the two cannot be put together, said Ojepat.
He said there are 22 regulating agencies that touch on food currently, and it would not be advisable to collapse them into one body because all their functions would be lost in the quagmire of a new body and compromise the safety of Kenyans.
According to him, each agency has some unique roles which could be lost if they are merged. “Kenya launched the KS1758 standard which covers flowers, ornamentals, vegetables and fruits and which will be operationalised starting this year,” he said, arguing the standards would be lost if KFDA became a reality. “We can’t have horticulture being regulated by KFDA.”
Ojepat said the standards will ensure complete coordination in the value chain from seed to food.
The bill proposes the disbandment of the PPB and replacing a single section of it’s functions around drug approvals. It also removes all requirements of pharmaceutical knowledge on the nine-member KFDA, an aspect that aroused anxiety among pharmacists.
According to the experts, there is no way drug regulation can be done without specialists in the field.
Combining the two is not practical because the roles of the concerned ministries may overlap and cause a breakdown of the administration of the two, they argued.
They said formation of the agency would instead endanger the lives of Kenyans. “You cannot have a law that pretends to address everything because the challenges are immense. Amalgamation is deadly because we will lose focus and the capacity within the structures (agencies) that deal with these issues,” said Dr Karanja.
He said instead of the forming one body, there must be regulation and management of drugs and food in a more organised, systematic approach that does not bring confusion. He added that KFDA will further disorient regulation of food and medical products.
Dr Karanja argued that KFDA borrows heavily from US Food and Drug Administration and Tanzania’s Food and Drugs Authority, two agencies the countries are abandoning due to their impracticability.