KEPSA Agriculture, Livestock & Fisheries Sector Board participated in the stakeholders meeting on Kenya Food and Drugs Authority (KFDA) Bill organized by the Pharmaceutical Society of Kenya (PSK) on 6th June 2019 at Silver Springs Hotel. The Bill was introduced by new private member in May 2019 and which has been tabled for first reading. The objective of the meeting was for the private sector to discuss and get a common position on macro issues around the KFDA Bill.
During the meeting PSK made a presentation on their interpretation of what is wrong with the bill. Key contentious issues included:
- Proposes to merge the regulate food and medicine & health products together into one act and by a new single body called the Kenya Drug and Food Authority (KFDA).
- The bill proposes the disbanding of the Kenya Pharmacy and Poisons Board (KPPB) and only replaces a single section of the KPPB’s several functions like those around drug approvals.
- The bill removes all requirements for pharmaceutical expertise on the new nine-member KFDA, stating that no professional knowledge is necessary to achieve safe and satisfactory regulation of Kenya’s drugs.
- The bill includes control of tobacco and tobacco products as part of health products to be regulated by the new body. Globally and scientifically, tobacco and tobacco products do not qualify to be classified as health products. Inclusion of tobacco and tobacco products as part of health products contradicts both the Tobacco Control Act and the provisions of WHO Framework Convention for Tobacco Control (FCTC), which Kenya is a signatory to, and which is domesticated through the Tobacco Control Act.
During plenary discussion it was highlighted that the Ministry of Health and the Ministry of Agriculture were in the process of developing a similar bill to KFDA and that the private member’s Bill was poorly crafted. It was also noted that the amalgamation of institutions in the agriculture sector through Agriculture and Food Authority (AFA) had not led to the achievement of intended objectives. Confusion and competition for resources has increase which has derailed the agriculture sector. It was observed that Fisheries and livestock subsectors have since moved out of AFA and more subsectors are looking to do the same.
Members felt that Food and medicine and health products do not belong in the same regulatory policy fields as their regulatory process are different. At the same time, Under WHO, Kenya is classified as having a weak regulatory framework for medicines and health products. If food regulation is added to the regulatory institution dealing with medicines and health products, it will result in burdened regulatory system and structure leading to inefficiency and ineffective regulation for medicines and food products.
It was also noted that globally, countries such as America, being the world leader for the FDA model through its Food and Drugs Authority, are abandoning it. In June 2018, USA announced that it would spend million to dismantle the body as it realized that the structure led to confusion, conflicts of interest, and competition for resourcing and priorities thus compromising on safety of foods and medicines. Other nations like South Africa, UK, EU have consistently regulated the two areas separately. The African Union has also modelled its medical products regulation law provides a framework for African countries to regulate medical products in a single entity from food. Closer home Tanzania is also looking to dismantle its TFDA.
Having considered input from members, it was agreed the stakeholders will engage with the Parliamentary Departmental Committees on Health and Agriculture on the private sector concerns.