Why food and drug authority idea came a cropper

Monday, December 23rd, 2019 19:00 |
Parliament. Photo/File

Daniella Munene       

Members of Parliament are sometimes required to rule on some challenging proposals, with the private members’ Kenya Food and Drug Authority (KFDA) Bill a prime example.

Yet, as opinions unite around abandoning the idea of a joint medicine and food safety regulator, the bill has provided some lessons.

For one, it has shown the risk of failure to carry out impact assessments for bills. The KFDA idea emerged with the prospect of a very large price tag, but the very little sight of the envisaged benefits.

Initially, the KFDA bill was supposed to be a government bill. In 2018, the Office of the President announced the bill had been fast-tracked, and the ministries of Agriculture and Health would table it in Parliament within 100 days. The ministries never presented a draft. 

The challenge lay in structuring a viable joint authority spanning both ministries, across different interests and skills, besides multiple existing agencies, and with many similar, but also widely different touchpoints for data gathering, monitoring and evaluation.

With no government bill having emerged, Parliament was instead presented with a private member’s KFDA bill. 

The side-step into a private member’s bill meant that the bill in Parliament was no longer bound by the normal government process of due diligence. Any government bill must present a Regulatory Impact Assessment, covering the costs and benefits. But for the private bill, there was no such analysis. 

The potential spend was huge — more than Sh4 billion — to duplicate the roles of 10 of the 21 government agencies involved in national food testing, safety and quality control across the ministries of Health, Agriculture and Trade and Industrialisation. 

In fact, the bill proposed disbanding the Veterinary Services Board, the Pharmacy and Poisons Board and the Department of Public Health and wrapping them up into one and managing their roles together with the roles of 10 other agencies, which included the Kenya Bureau of Standards, the Kenya Plant Health Inspectorate Services and the Government Chemist’s Department. 

The rest, about seven, would have worked independently in the same space, but not under the KFDA. 

The transition would have cost a lot in diverted spending, with the setup, alone, costing 45 times more than the entire diabetes programme of Sh85.7 million, or the cost of setting up 300 new rural clinics. 

But its systemic replication of roles was also likely to have caused drug approval errors and increased food contamination, as well as extra spending in recurrent costs.

Tanzania was spending Sh13.2 billion a year with over 266 employees in its TFDA, and the government still reported that it had aggravated the food and health sector challenges due to duplicated roles with the Tanzania Bureau of Standards. TFDA was dissolved this year.

The US incurred double costs in food regulation by funding the Ministry of Agriculture one billion dollars with 9,200 full-time employees while at the same time the FDA spent $1.3 billion and employed 5,000 full-time employees.

Even so, rising health complications were reported due to drug approval errors and food contamination while endless cases of irrational agency divisions of responsibility, corruption, and food recall marred the authority and have led to its closure. 

Such a journey is not one that Kenya needed to take. The country has suffered a surge in food scares including aflatoxins in maize, antibiotics in meat, mercury in sugar, pesticide residues in fruits and vegetables and contaminated soft drinks. 

In 2017, the Ministry of Health reported 3,967 cholera cases and 76 deaths. There is an urgency to inject efficiency in our strained healthcare system to get the most value for every shilling spent.

As the Ministry of Agriculture unveils a single agency to oversee and ensure food safety, and the Ministry of Health reviews all aspects of medical regulation, we can now ensure that we all get the most gains for the associated government spending through thorough impact assessments from the very start. — The writer is the CEO Pharmaceutical Society of Kenya

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