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{
"id": 1104346,
"url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1104346/?format=api",
"text_counter": 96,
"type": "speech",
"speaker_name": "Endebess, JP",
"speaker_title": "Hon. (Dr.) Robert Pukose",
"speaker": {
"id": 1458,
"legal_name": "Robert Pukose",
"slug": "robert-pukose"
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"content": "technologies, control of clinical trials, conduct advertising and promotion, post marketing surveillance for quality, safety and disposal of health products and health technologies and regulate contractors for medical devices and physical security for products, including radioactive materials and biological products. The Health Act further provides that the legislation contemplated under Section 62 shall provide for the granting of marketing approval only by a technically competent body after appropriate assessment has established that such a product generally meets the recognised standards and approval made subject to conditions notably with respect to the conduct and content on promotion and advertising. Despite the proposed establishment of a single regulatory body to regulate the health products and technologies and the provision on the grant of marketing approval only by a technically competent body, under the Health Act 2017, the Bill under Clause 12 provides that the primary object of the proposed establishment of the Kenya Food and Drugs Authority, herein referred to as the Authority, shall, inter alia, provide for the regulation, investigation, inspection and approval of food, health products and technologies and related matters in the public interest, and to ensure adequate and effective standards and guidelines for regulation of health products and technologies. Additionally, the Bills prohibit, under Clause 79, the advertising of any health products and technology without the written permission of the Authority. Further, the Bill mandates the Authority, under Clause 113 to, inter alia, develop regulations with respect to the labelling, packaging and offering, exposing and advertising for sale of food, drugs, health products and technologies, and provide a manner and procedure in which clinical trials may be conducted in Kenya. Hon. Deputy Speaker, I know there have been expressions of fear from other quotas in as far as regulations of food products are concerned. We agreed as the Departmental Committee on Health that this Bill will not deal with matters that are not health-related. Those that are managed by other departments like agriculture are not going to be touched in this Bill. We are in concurrence with that. As I move this Bill, I want to ask those who are outside listening to this Bill not to fear because we will not interfere with other areas. We will only have what is health-related in this Bill; those that are managed by the public health officers within the Ministry of Health. We shall not touch anything that is not within the Ministry of Health in this Bill. This Bill will also have various departments within it; what we call advisory committees. Under the advisory committees, we will have medicines, medical devices, biological, therapeutic products and scientific advisory committees such as advisory committees on prescription medicines. We will have an advisory committee on the safety of medicines, medical devices, complimentary medicines, biological and safety of vaccines. As you may be aware, with COVID- 19 issues, vaccines are a major issue. We have other vaccines too. So, we will have an advisory committee on vaccines and for the scheduling of substances. We will have an advisory committee on medicines and advisory committee on chemical scheduling. For the regulations of clinical trials, a national health ethics committee… Right now, if you want to approve any trials, you seek for approval from the Kenyatta National Hospital Ethics Committee. However, we need to have a national advisory committee on ethics; what we will be calling a national health ethics committee that approves any clinical trials within our country. On combating anti-microbial resistance, we will have a national anti-microbial stewardship advisory committee. More often, you find people buying antibiotics over the counter without prescriptions. If you went to other countries like the United States, the European countries and even South Africa, you can never buy antibiotics over the counter. That is because it leads to anti- microbial resistance. The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
}