Entry Instance

HTTP 200 OK
Allow: GET, PUT, PATCH, DELETE, HEAD, OPTIONS
Content-Type: application/json
Vary: Accept

{
    "id": 1336959,
    "url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1336959/?format=api",
    "text_counter": 171,
    "type": "speech",
    "speaker_name": "Endebess, UDA",
    "speaker_title": "Hon. (Dr) Robert Pukose",
    "speaker": null,
    "content": " Hon. Deputy Speaker, this Bill establishes the Kenya Drugs Authority that is responsible for the regulation, investigation, inspection and approval of health products and technologies, and related matters. Having gone through this Bill, the Committee made the following observations. The Bill expands the current Pharmacy and Poisons Board and re-engineers the new regulator based on international best practice in regulation of human health products and technologies, including therapeutic cosmetics. This re-engineering will enable the country to attain the recommended WHO maturity of level 3. The level 3 maturity is where a national regulatory authority can be trusted and be in a position to control the manufacture of products to world-class standards. The Bill strengthens the functions of the National Quality Control Laboratory so as to improve the quality of test analysis and research for quality control. This will in turn ensure that the health products and technologies used in the country meet international quality standards, thereby guaranteeing patient safety. Therefore, the Bill fulfils the country’s obligation in the war against poor quality medicines, in line with its commitment under the recently ratified African Union (AU) Establishment of the Africa Medicines Agency Treaty, which this House ratified. This Bill strengthens the regulation of medicines by providing a comprehensive regulatory framework which enables the country to comply with good manufacturing practices as envisaged under the AU Model Law on Medical Products Regulation. This ensures that health products and technologies used in the country are safe and effective, in line with Section 66 of the Health Act (No.21 of 2017). This Bill also encourages local manufacture of health products and technologies as espoused in the Kenya Universal Health Coverage Policy, 2020–2030. Therefore, the Bill is in line with the Government’s plan of promoting local manufacturing, especially in the pharmaceutical sector, a key contributor to Kenya’s economy. The Bill will hasten the attainment of the Government’s vision for national economic transformation. Lastly, this Bill further improves the availability of health products and technologies and enhances access to priority health products and technologies. It also improves the efficiency of operations, quality and pricing of medicines and vaccines which are key components and enablers for the successful realisation of universal health coverage. The Committee, having considered this Bill, approved it with amendments. Those amendments shall be moved during the Committee of the whole House. I urge members of the public, especially those in the pharmaceutical industry, the Pharmaceutical Society of Kenya (PSK), Kenya Pharmaceutical Association and pharmaceutical manufacturers, to hold their horses. The amendments which had been proposed will be considered by the Committee during the Committee of the whole House. Hon. Deputy Speaker, with those few remarks, I move and ask the Vice-Chairman, Hon. Patrick Ntwiga Munene, Member for Chuka/Igambang’ombe, to second. I know Hon. (Dr) Nyikal is here to contribute to this Bill."
}