Kenya Food and Drug Authority (KFDA) Bill - Pharmaceutical Society of Kenya (PSK)

The Pharmacy and Poisons Act, CAP 244 regulates the profession of pharmacy and the trade in drugs and poisons. It is administered by the Pharmacy and Poisons Board (PPB). PSK argue that Cap 244 is outdated, and is overdue for changes as envisioned in the enactment of the Health Act (HA), 2017. Section 62 of the HA states that there will be established a single regulatory body for health products and technologies.

In response to the HA, the MoH together with the MoALF have drafted the Kenya Food and Drug Authority (KFDA) Bill, 2018 which seeks to ensure that: 

  • food is safe and it is produced and handled using appropriate standards; risks to food safety are identified continuously and addressed expeditiously, and the labelling and marketing of food is truthful and supportive of healthy consumer choices;
  • medicines, medical devices and biological products (therapeutic products) are safe, perform as intended and are produced using appropriate standards, and the benefits to human health associated with their use is favourably balanced against the risks of harm from the use of such products;
  • veterinary medicinal products are safe, efficacious and of good quality, and they are used in a manner that promotes human and animal health goals; and,
  • cosmetics are safe and are produced using appropriate standards.

The proposed KFDA Bill creates a bloated governance structure and a scope that is too wide to be effective, to the detriment of the products that should be more stringently regulated – medicinal products. The proposed Bill is not aligned with the policy imperative to regulate health products and technologies but has expanded its scope to everyday food.

PSK argue that global approaches to the combined regulation of food and drugs are changing as seen in the USA where there is a proposal to separate the regulation of food from drugs (medicines and medicinal products). The US Food and Drug Administration (USFDA) is one of the bodies that the Office of Management and Budget (OMB) has proposed for restructuring to improve efficiency, effectiveness and accountability. The argument they have made is that food safety is now more complex than ever with the farm to fork approaches focusing more on traceability, nutritional value, labelling, and claims regarding health impacts. This they argue is important and needs to be regulated through a single agency, the US Department of Agriculture, and free up the USFDA to focus on its core responsibilities of drugs, devices, biologics and tobacco.

According to the Kenya Horticultural Council (KHC), who are preparing to advocate the development of an appropriate law on food safety, security and nutrition (separate BAF funding), in principle agree that the regulation of food should be separate to align to global agreements under CODEX Alimentarius, Food and Agriculture Organization (FAO) and the World Health Organization (WHO).

PSK seek BAF support to conduct a legal review of the proposed KFDA Bill and make proposals to remove the regulation of food from the KFDA Bill.

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