By MIKE MWANIKI
A lobby group has opposed a private members Bill seeking to merge the regulation of food and medicines by a new authority in Kenya.
The group, led by the Pharmaceutical Society of Kenya (PSK), describes as “retrogressive” the Kenya Food and Drugs Authority (KFDA) Bill by Endebess Constituency MP Robert Pukose which also wants tobacco and tobacco products to be regulated by the proposed authority.
The private members Bill was introduced after PSK and other stakeholders had submitted their amendments in the Government-sponsored KFDA Bill and were awaiting for public participation to begin.
Speaking during a press conference, PSK President, Dr. Louis Machogu warned: “It is essential that MPs consult widely as they examine this regulatory model that is being abandoned in the USA, South Africa and Tanzania because of the harm it has caused consumers.
He said the proposed authority has no medical or food experts to handle life-threatening issues of approvals in the vast and mismatched combination of food, medicines and tobacco.
“Food safety, requires experts who have mastered the risks posed by food hazards and understand the requirements necessary to manage them across the entire food chain.”
The new Bill has been introduced as the Pharmacy and Poisons Board has intensified the war against counterfeit medicines as well as quacks who have infiltrated the multi-billion shillings pharmaceutical industry.
If enacted, the new Bill—will repeal the Health sector’s Cap 244 (The Pharmacy and Poisons Act) and disband the Kenya Pharmaceutical and Poisons Board whose mandate is to regulate all clinical trials and pharmaceutical products, accreditation of pharmacists, licensing of pharmacies and regulation of manufacturing practices amongst others, in the multi-billion shillings pharmaceutical industry.
A former Health Ministry deputy chief pharmacist, Dr. Wilberforce Wanyanga says Kenya’s pharmaceutical industry is currently valued at more than $800 million annually.
In earlier interview, former chief pharmacist and Board registrar, Dr Kipkerich Koskei noted that Kenya’s pharmaceutical industry economy alone is bigger than all East Africa Community (EAC) countries combined—Uganda, Tanzania, Rwanda and Burundi.
If enacted, the new Bill will also repeal the Food Industry’s Cap 254, which is the Food, Drug and Chemical Substances Act as well as the regulation of tobacco and tobacco products which is undertaken by the Tobacco Control Board—which was established under the Tobacco Control Act 2017.
According to experts, “globally and scientifically, tobacco and tobacco products are not classified as health products…
“The inclusion of tobacco and tobacco products as part of health products is illegal as it contradicts both the Tobacco Control Act and the provisions of the World Health Organisation’s (WHO) Framework Convention for Tobacco Control (FCTC), which Kenya is a signatory (to).”
Speakers at the press conference accused multi-national pharmaceutical and food companies of sponsoring the new Bill in Kenya, driven by profit margins, while other countries which had merged the regulation of food and medicines under a single authority were abandoning the practice.
The lobby groups condemned the new Bill saying it “posed grave danger and was a risk to all Kenyans” and called for its immediate withdrawal.
The lobby groups opposed to the proposed Bill include PSK, Federation of Kenya Pharmaceutical Manufacturers (FKPM), Kenya Livestock Marketing Council, the Kenya Veterinary Association (KVA), Agricultural Industrial Network (AIN) and Fresh Produce Consortium of Kenya (FPCK).
Others are: Association of Public Health Officers of Kenya (APHOK), Kenya Health Professionals Society and the Kenya Veterinary Association (KVA).
On his part, the PSK chair (legal and ethics committee), Dr D Ngugi warned that the burden of Non-Communicable diseases (NCDs) was a big problem globally and there was need to tighten requirements on food safety.
Multi-national manufacturers, Dr Ngugi noted, wanted to use loopholes in the proposed food safety Bill to centralise “supermarket” legislation at the detriment of the public.
Instead of introducing a new legislative authority, the official observed, we should strive to strengthen the existing Pharmacy and Poisons Board and other legislative bodies.
According to pundits, the USA—which has been the leader on this model–is abandoning and dismantling its Food and Drugs Authority (FDA).
In June 2018, President Donald Trump announced that the country would be spending millions of dollars in dismantling the FDA as it has led to confusion, conflicts of interest, competition for resourcing and priorities and compromising of safety of both foods and medicines.
Tanzania, on its part, is currently drafting a Bill to dismantle its own Tanzania Food and Drugs Authority (TFDA) for similar reasons.
Health experts point out that currently, the world is focusing on the increased burden posed by Non-Communicable Diseases (NCDs) which are killing 38 million people annually.