A contentious law that seeks to restructure two of Kenya’s most-prominent industries has sparked debate among industry stakeholders.
This is the result of a Kenyan Member of Parliament’s (MP’s) plans to reshape approval process for all of the country’s food and medicines. The move has caused alarm among the nation’s professional bodies.
His proposed Kenya Food and Drug Authority (KFDA) Bill is currently being scrutinised by the country’s Parliamentary Health Committee following its first reading in Parliament.
The Bill proposes that the regulation of food and medicines be merged and regulated by a single body.
In Kenya, food and drugs have different regulatory requirements. Also, experts have argued that the regulatory requirements and processes for research, manufacture, distribution and sale of medicine and health products are completely different.
The proposed law comes at a time when the World Health Organisation (WHO) already classifies Kenya’s regulatory and institutional framework for medicines and health products as WEAK.
Critics of the b=Bill say adding food regulation to this institution equals an overloaded, inefficient and ineffective regulatory system and structure.
“It is essential that parliamentarians now consult widely as they examine this regulatory model that is being abandoned in the USA, South Africa, and in Tanzania, because of the harm it has caused to consumers,” said Dr Louis Machogu, President of the Pharmaceutical Society of Kenya.
“Indeed, the Kenyan version is far worse than elsewhere, proposing a new authority with neither medical or food experts to handle life-threatening issues of approvals, in regulation across some vast, mismatched combination of food, medicines, and even tobacco,” he continued.
The Bill has been tabled by the Dr Robert Pukose, the MP for Kenya’s Endebess Constituency in Trans-Nzoia County, who is now intent on ending the separation of food and medicine approvals and removing the requirements for expertise on the approval authority.
“But 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,” said Andrew Edewa Food Safety Specialist at the United Nations Industrial Development Organisation (UNIDO).
“It is an extremely grave mistake to regulate food and medicines as if they have some common need or crossover and as if the regulation of each requires no knowledge,” he argued.
The prospect of Kenya flying in the face of the global trend towards specialist approvals overseen by experts has drawn together a growing alliance of professionals and industry bodies.
Briefing the media in Nairobi this week, the Pharmaceutical Society of Kenya (PSK), the Fresh Produce Consortium of Kenya (FPCK), Association of Public Health Officers of Kenya (APHOK), Kenya Health Professionals Society, and Kenya Livestock Marketing Council (KLMC) all condemned the private Bill as a danger and a risk to all Kenyans and urged for its rapid abandonment.
The Agricultural Information Network (AIN), the Kenya Veterinary Association (KVA) and the Federation of Kenya Pharmaceutical Manufacturers (FKPM) have also joined the growing alliance of stakeholders opposed to the Bill, as have the Livestock Council and other bodies.
“Rarely in Kenya’s history have we seen such a potentially catastrophic Bill, and yet it is now hurtling through its moment of public participation virtually unseen by the public,” said Dr Machogu.
“In this, we would like to thank the parliamentary health committee for its collaboration in seeking public feedback in recent days and we hope for a fruitful engagement on this, ensuring that we get the best for Kenyans,” he said.
The Bill’s detractors said that it removes multiple regulatory functions from Kenya’s statutes. They argue that it requires zero medical and food specialists’ qualifications for the authority board.
The Bill had its first reading prior to stakeholders being notified of its existence.
Major stakeholders include Kenya’s Horticulture Crop Development, the Agriculture and Food Authority, the Kenya Dairy Board and many others.
Critics of the Bill have concluded that food is a multi-sectoral area, which requires wider stakeholder participation.
“We believe it is our duty to raise the alarm and ensure that the public and representatives in parliament are not hoodwinked into a collective, non-expert approval process that will surely cost Kenyan lives,” said Dr Machogu.