•PSK said the Bill that has undergone the first reading seeks to overhaul health products and technologies regulation and might become law without the needed national dialogue.
•The society said the Bill purports to regulate ordinary food contrary to provisions of the Health Act 2017.
The Pharmaceutical Society of Kenya has called for the rejection of the Kenya Food and Drug Authority Bill, 2019.
In a statement on Monday, PSK said the Bill that has undergone the first reading seeks to overhaul health products and technologies regulation and might become law without the needed national dialogue.
The society said the Bill purports to regulate ordinary food contrary to provisions of the Health Act 2017.
“Therefore, in standing with public interest, professionalism and best practice, PSK calls for the total rejection of the 'KFDA' bill 2019 in its current form, in favor of a MOH-led single regulatory bill for regulating medicine, health products and technologies,” the PSK statement read.
The society questioned why the Ministry of Health was not leading the initiative, adding that passing the Bill blindly will result in an incoherent and out-of-touch law that will plunge the healthcare sector into chaos.
The pharmaceutical society cited the never ending amendments to laws governing medicines, health products and technologies in Kenya, as what has denied the country the needed direction in a sector as crucial as health.
“The ‘KFDA’ bill, 2019 is lacking crucial policy and regulatory law provisions around the following substantive areas: poisons Information Centre; cost effectiveness analysis mechanisms for medicines and health products (health technology assessment); clinical trials; biologic substances; scheduling of medicines and health product; and practice including levels of practice in handling medicines and health products,” PSK said.
The society noted that the Bill has not factored input from key stakeholders and risks exposing the public to great harm.
PSK called on President Uhuru Kenyatta, parliament and the public to act with urgency because the matter impacts on Kenya’s national interests and security.