KENYA FOOD AND DRUGS AUTHORITY BILL

Cost of law void of regulatory impact assessment

Introduction of Kenya Food and Drugs Authority Bill shows why we need impact assessments for all legislation.

In Summary
  • This transition was certain to have cost lives in diverted spending, with the set up, alone, costing 45 x more than the nation’s entire diabetes programme of Sh85.7 million.

Our parliamentarians are sometimes required to rule on some challenging proposals, with the private members’ Kenya Food and Drug Authority (KFDA) Bill a prime example from 2019: yet as opinions now unite around abandoning the idea of a joint medicine and food safety regulator, the bill has raised some clear lessons.

Above all, it has shown the risks of paths to Parliament that do not include impact assessments. For the KFDA idea emerged with the prospect of a very large price tag, but very little sight of the envisaged benefits from all the spending. Indeed, at its inception, the KFDA Bill was to have been a government bill. In 2018, the President’s office announced the bill had been fast tracked, and the ministries of Agriculture and Health were together working to place it before Parliament within 100 days.

The ministries never presented a draft, for the same reasons as other nations have disbanded FDAs that had already been established. The challenge lay in structuring a viable joint authority spanning both ministries, across different interests and skills, beside multiple existing agencies, and with many similar, but also widely different touch points for data gathering, monitoring and evaluation.

With no government bill having emerged, Parliament was instead presented mid-year with a private member’s KFDA Bill, even as government officials continued to research, investigate and conceptualise the best possible ways to achieve food safety and high quality medicines.

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

That’s a thought-provoking gap when the potential spend was huge, at more than Sh4bn, in a bid to duplicate the roles of 10 of the 21 government agencies involved in national food testing, safety and quality control across the Ministry of Health, Ministry of Agriculture and the Ministry of Trade and Industrialisation.

As the Ministry of Agriculture now unveils a single agency to oversee and ensure food safety for us all, and the Ministry of Health, likewise 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.

In fact, the bill proposed disbanding the Veterinary Services Board, the Pharmacy and Poisons Board and the Department of Public Health, 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 been left to work entirely independently in the same space, but not under the new KFDA.

This transition was certain to have cost lives in diverted spending, with the set up, alone, costing 45 x more than the nation’s 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 again in recurrent costs.

Indeed, Tanzania was spending Sh13.2 billion a year with more than 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 (TBS). TFDA was dissolved this year.

Likewise, the USA incurred double costs in food regulation by funding the Ministry of Agriculture $1 billion 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 recalls marred the authority and have, likewise, led to its closure.

The country has suffered a surge in food scares, spanning aflatoxins in maize, antibiotics in meat, mercury in sugar, pesticide residues in fruits and vegetables and contaminated soft drinks among others. In 2017, the Ministry of Health reported 3,967 cholera cases, causing 76 mortalities. There is an urgency to inject efficiency in our strained health care system to get the most value for every shilling spent.

As the Ministry of Agriculture now unveils a single agency to oversee and ensure food safety for us all, and the Ministry of Health, likewise 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.

Such a journey was not one that Kenya needed to take.

CEO of Pharmaceutical Society of Kenya