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{
    "id": 1104084,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1104084/?format=api",
    "text_counter": 93,
    "type": "speech",
    "speaker_name": "Endebess, JP",
    "speaker_title": "Hon. (Dr.) Robert Pukose",
    "speaker": {
        "id": 1458,
        "legal_name": "Robert Pukose",
        "slug": "robert-pukose"
    },
    "content": " Thank you, Hon. Deputy Speaker. The purpose of the KFDA Bill is to safeguard the health and safety of consumers with regard to broad categories of products which they routinely consume. Those are food and medicines. The measures outlined in the Bill seek to ensure that food is safe and of adequate nutrition and the medicines and other products used in health care are safe, efficacious and of acceptable quality. The Bill is expected to address chronic weaknesses in the existing regulatory and control systems. In as far as drugs are concerned, Kenya has a national regulatory authority for assuring the quality, safety and efficacy of medicines - and this is the Pharmacy and Poisons Board. However, the current enabling law, the Pharmacy and Poisons Act, done in 1957 through Cap244, is outdated and presents numerous challenges to the functionality of the Pharmacy and Poisons Board and I will give examples. The Pharmacy and Poisons Board regulates the profession of pharmacy and medicines. Although this model was common practice in the 1950s, the health landscape and health sciences involved have changed dramatically and consequently the regulatory approaches have evolved. In today’s world, regulating the competences of health professionals and pharmacists is very different from regulating the quality or efficacy of a medical product like medicine. Therefore, there is need for harmonisation and adoption of the agreement between the East African Community (EAC) partner states, that each country adopts a Food and Drugs Authority (FDA) institutional model of regulation. The regulation of medical devices including diagnostic devices has been, perhaps, the most fragmented. Until the late 90s, there was no clear global framework for regulating medical devices, although they were deemed to be medical products. Initial attempts by the Pharmacy and Poisons Board to implement a regulatory framework for medical devices were met with resistance and conflict from other professions, particularly nurses and laboratory technicians and technologists. 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."
}