Final Order Paper For Wednesday, 25th October 2023 - Morning Sitting

Thirteenth Parliament

Second Session

Morning Sitting

(No. 98)

(1529)

REPUBLIC OF KENYA

THIRTEENTH PARLIAMENT – (SECOND SESSION)

THE NATIONAL ASSEMBLY

ORDERS OF THE DAY

WEDNESDAY, OCTOBER 25, 2023 AT 9.30 A.M.

ORDER OF BUSINESS

PRAYERS

1. Administration of Oath

1. 2. Communication from the Chair
2. 3. Messages
3. 4. Petitions
4. 5. Papers
5. 6. Notices of Motion
6. 7. Questions and Statements
7. 8*. MOTION – EXPANSION OF DRUG AND SUBSTANCE ABUSE

REHABILITATION CENTRES

(The Hon. John Makali, M.P.) THAT, aware that, according to the National Protocol for Treatment of Substance Use Disorders in Kenya by the Ministry of Health, drug abuse has been increasing in Kenya especially among the youth with statistics indicating that more than half of drug users are aged between 10 and 19 years; further aware that, research released by the National Authority for the Campaign Against Drug Abuse (NACADA) in December 2022 placed western region as the leading region in alcohol and substance abuse at 23.8%, followed by the coast region at 13.9% and the central region at 11.9%; recognizing that, the high level of drug abuse in the western region is attributable to illegal entry points from neighbouring countries and unlicensed establishments especially in Bungoma and Busia counties with statistics indicating two out of every five establishments in Bungoma operate illegally; further recognizing that, a majority of the consumers of illegal substances are school-going children who end up dropping out of school; cognizant of the fact that the Alcoholic Drinks Control Act, 2010 established the Alcoholic Drinks Control Fund whose purpose is to,among other things, facilitate the dissemination of information on alcoholic drinks, and promote rehabilitation programmes in the country; this House urges the Government to institute intensive programmes for the dissemination of information on alcohol and substance abuse in line with the Alcoholic Drinks Control Act, 2010 and to increase the number of rehabilitation centres across the counties.

(Question to be put)

…...….……/9*

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1530)

1. 9*. MOTION – REGULATION OF THE SUGAR INDUSTRY TO

DISCOURAGE BRANDING OF SUGAR BY NON-

MILLERS

(The Hon. Peter Salasya, M.P.)

THAT, aware that, the importation and exportation of sugar is regulated by various laws including the Crops Act and the Agriculture and Food Authority Act, 2013; further aware that, the Agriculture and Food Authority is charged with the responsibility of regulating the importation and exportation of sugar in the country in accordance with the law; noting that, the importation of sugar is alsonegotiated within the regional trade blocs’ frameworks and agreements to enable the country to meet the demand for sugar; further noting that, individuals or entities are allowed to import sugar provided they obtain the necessary permits and meet the required standards; concerned that, despite these regulations, there have been instances of illegal importation of low quality sugar or adulterated sugar; further concerned that, unscrupulous traders have been found to rebrand the sugar which does not meet the standards of the Kenya Bureau of Standards specifications; deeply concerned that, this poses significant health risk to consumers as well as undermining the efforts to regulate and strengthen the sugar industry to protect local millers; acknowledging that, the country has the potential to produce enough sugar to meet its domestic demand as the sector has been a key driver of economic growth; further acknowledging that there is need for concerted efforts by stakeholders to discourage the branding of sugar by non- millers and promote the development of the local sugar industry; now therefore, this House resolves that the Government through the Ministry of Trade, Investments and Industry ensures strict operationalization of the regulatory frameworks governing sugar importation into the country.

(Question to be put)

1. 10*. MOTION – ACTION TO ADDRESS THE RECENT SURGE IN

ROAD ACCIDENTS IN THE COUNTRY

(The Hon. Naomi Waqo, M.P.)

THAT, aware that, the National Transport and Safety Authority Act 2012, provides for the establishment of the National Transport and Safety Authority (NTSA); further aware that, the Authority in line with section 4 of this Act plays a critical role in ensuring the provision of safe, reliable and efficient road transport services; concerned that, there has been an alarming surge in road accidents in the recent past resulting in loss of life, injuries and damage to properties; further concerned that, the Authority has not effectively and fully performed its functions of regulating safe and reliable transport service especially in dealing with public service vehicles; noting that, poor maintenance of motor vehicles and a lack of proper regulation are leading contributors to the marked increase in road accidents; deeply concerned that, school-going children are increasingly becoming victims of these road accidents; recognizing that, it is the responsibility of the Authority to ensure adherence to the road traffic rules, and to establish systems and procedures for, and oversee the training, testing and licensing of drivers; now therefore, this House resolves that the government …...….……/10*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1531)

through the Ministry of Roads & Transport undertakes a comprehensive overhaul of the transportation sector to provide for proper regulation of the sector and ensure strict operationalization of the Traffic regulations to provide a safer and more reliable transport sector.

(Question to be put)

1. 11*. COMMITTEE OF THE WHOLE HOUSE

(i) The Public Service (Values and Principles) (Amendment) Bill (National Assembly Bill No. 46 of 2022) (The Hon. Abdul Dawood, M.P.)

(ii) The National Construction Authority (Amendment) Bill (National Assembly Bill No. 59 of 2022) (The Hon. David Gikaria, M.P.)

(iii) The Kenya Drugs Authority (Amendment) Bill (National Assembly Bill No. 54 of 2022) (The Hon. (Dr.) Robert Pukose, M.P.)

(To resume from clause 23)

1. 12*. THE CANCER PREVENTION AND CONTROL (AMENDMENT)

(No. 2) BILL (NATIONAL ASSEMBLY BILL NO. 45 OF 2022) (The Hon. Abdul Dawood, M.P.)

Second Reading

1. 13*. MOTION – BANNING THE GROWING OF EUCALYPTUS TREES

IN THE COUNTRY

(The Hon. Moses Kirima, M.P.) THAT, aware that, the eucalyptus tree species are popular among large scale and commercial tree farmers in Kenya; noting that, these tree species are grown in most ecological zones in the country and in particular in the Western, Central Rift Valley, Central Kenya, parts of Eastern and the Coastal Regions of the country; acknowledging that, farming of the eucalyptus trees has been on the rise due to their fast growth, good economic returns and diverse commercial uses such as transmission poles, fuelwood, timber, plywood, pulp, fencing posts and building materials among others; concerned that, eucalyptus trees species are majorly cited as high water depleting agents through high consumption, transpiration and evaporation thus causing the drying up of streams, rivers and depletion of groundwater water sources; deeply concerned that, the high depletion of water by the said trees has caused adverse negative effects on soil fertility, land degradation and are a serious threat to the biodiversity; recognizing that, due to the serious threats paused by the Eucalyptus trees to the biodiversity, there is need therefore for their removal and replacement with other types of trees to improve conservation of water sources and the ecosystem; this House resolves that the National Government through the Ministry of Environment, Climate Change and Forestry – (i) orders absolute banning of planting eucalyptus trees and encourages planting of indigenous species across the country; …...….……/13*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1532)

(ii) orders the uprooting of all eucalyptus trees and replacement with other varieties of trees particularly, indigenous species to ensure conservation of water sources and preserve the ecosystem; and (iii) initiates the process of putting in place punitive measures against persons who defy the above orders.

1. 14*. MOTION – ESTABLISHMENT OF STRATEGIC GRAIN STORAGE

RESERVES AND SILOS IN CLOSE PROXIMITY TO

SMALLHOLDER FARMERS

(The Hon. Jessica Mbalu M.P.) THAT, aware that, agriculture is the backbone of the Kenya’s economy contributing approximately 33% of the GDP and employing more than 40 percent of the total population and 70 percent of the rural population; noting that the sector’s performance has been declining as a result of adverse effects of climate change, resulting in droughts, famine and food insecurity; further noting that Smallholder farming is predominantly rain-fed cereal grain farming and farmers experience boom harvest every time there is adequate rains; concerned that such farmers majorly lack proper post-harvest grain handling and modern storage facilities and resort to selling their harvest almost immediately after harvesting at low prices when market is flooded to reduce the risk of suffering losses through spoilage; cognizant of the fact that the current state of affairs exacerbates poverty in rural areas and there is need for instituting measures that boost local production to augment our grain reserves as stipulated under the National Food and Nutrition Security Policy, which would also lead to a reduction of grains imports in the country; this House now resolves that the Government through Ministry of Agriculture and Livestock Development establishes strategic grain storage reserves and silos in close proximity to smallholder farmers so as to address post-harvest inefficiencies.

1. 15*. MOTION – POLICY ON INTEGRATING A CURRICULUM FOR

ENVIRONMENTAL CONSERVATION IN PRIMARY

AND SECONDARY SCHOOLS

(The Hon. Umul Ker Kassim, M.P.) THAT, aware that, Article 42 of the Constitution accords every person the right to a clean and healthy environment and that Article 69(1)(d) of the Constitution also mandates the State to encourage public participation in the management, protection conservation of the environment; concerned that, the prevailing climate change and global warming has adversely affected our ecosystems and biodiversity causing unprecedented droughts, food insecurity and famine thus affecting livelihoods and our economy, further concerned that, there is a general lack of awareness or insensitivity among our citizens regarding the place of environmental conservation in preserving our biodiversity; noting that, there is need to inculcate a culture of environmental conservation practices to restore and maintain balanced natural ecosystems, and ensure protection of biodiversity, including reducing the effects of pollution and conserving natural resources for our future generations; this House resolves that the Government through the Ministry of Environment, Climate Change and Forestry develops …...….……/15*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1533)

and implements a policy on integrating a curriculum for environmental conservation in primary and secondary schools in the Country.

1. 16*. MOTION – POLICY FOR THE PROVISION OF MENTAL

HEALTH SERVICES IN ALL HEALTHCARE

FACILITIES

(The Hon. Mishi Mboko, M.P.) THAT, aware that Article 43(1)(a) of the Constitution provides that every person has the right to the highest attainable standard of health including the right to health care services; further aware that, mental health is a key determinant of overall health and socio-economic development; recognizing that, the Constitution assigns to the national government the responsibility of matters of health policy; concerned that, according to the World Health Organization (WHO), mental and neurological disorders are common and about ten (10) percent of the global population suffer from at least one mental health disorder at any given time; concerned that, psychiatric units are only available in a few facilities in the country and patients requiring psychiatric services have limited or no access to these facilities; acknowledging that, access to healthcare facilities would lead to improved overall health, increased economic productivity, social equity and improved quality of life for all; now therefore, this House urges the National Government, through the Ministry of Health, to collaborate with County Governments to develop a policy integrating mental health services in all healthcare facilities in the country.

1. 17*. MOTION – IMPLEMENTATION OF FIRST AID TRAINING AS A

CORE SUBJECT IN SCHOOLS

(The Hon. Caleb Amisi, M.P.) THAT, aware that first-aid training is a key component of Emergency Medical Response (EMR); further aware that first-aid response promotes a safer and healthier community by reducing accidents and injuries; noting that lack of first-aid training and skills among the general public has contributed to the aggravation of preventable injuries and accidents which, in some cases, has led to loss of lives; further noting that the current education system does not include first-aid training as a compulsory subject in the curriculum which deprives students of essential knowledge and skills necessary for their personal safety and that of persons around them; acknowledging that it is critical to equip students with the ability to assess and handle day-to-day emergencies in schools and at home; now therefore, this House urges the National Government through the Ministry of Education to develop and implement a comprehensive first-aid curriculum for schools across the country.

1. 18*. MOTION – ESTABLISHMENT OF A NATIONAL FUND TO

SUPPORT VICTIMS OF GENDER-BASED VIOLENCE

(The Hon. Mary Emaase, M.P.)

THAT, aware that Article 29 of the Constitution provides the right of every person to freedom from any form of violence; further aware that, gender- based violence (GBV) is a serious violation of human rights with records …...….……/18*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1534)

indicating that one in every three women will experience sexual or physical violence in their lifetime; noting that according to the UN Refugee Agency (UNHCR), gender-based violence includes sexual, physical, mental and economic harm inflicted in public or in private and may involve threats of violence, coercion and manipulation in the form of intimate partner violence, sexual violence, child marriage, and female genital mutilation; further noting that, timely response to and effective post- management of GBV incidences is critical in curbing the effects of these incidences to victims; concerned that at present, there are inadequate gender-based violence response centres and shelters in the country with limited resources being provided for victims seeking assistance; further concerned that, there are inadequate rehabilitation and reintegration programmes for victims and perpetrators of gender-based violence; recognizing that, victims of gender-based violence as well as perpetrators require specialized professional assistance for full reintegration into the community; this House therefore resolves that the Government through the relevant Ministry establishes a national fund to ensure all survivors of GBV have adequate, timely and unhindered access to quality services that meet their needs, and support victims of GBV to have access to timely and unhindered quality services.

1. 19*. MOTION – ADOPTION OF GOVERNMENT-TO-GOVERNMENT

(G2G) MODEL TO ACQUIRE AND SUPPLY

FERTILIZERS TO FARMERS AT SUBSIDISED COST

(The Hon. Geoffrey Ruku, M.P.) THAT, aware that, Kenya is an agricultural-based economy with a significant portion of its population relying on farming for their livelihood; noting that, the quality and quantity of crop yields in Kenya has been hampered to a large extent by lack of adequate and quality fertilizers leading to decreased agricultural productivity and economic losses; further noting that, the government has committed to improving agricultural productivity through various initiatives including provision of subsidized fertilizers; concerned that the cost, quantity and quality of fertilizers and subsequently the cost of production of food crops and cash crops including coffee, tea and Miraa has increased due to a number of factors, among them high cost of fertilizers due to markup by private suppliers of fertilizers; further concerned that, threat to food security is a threat to national security; recognizing that the Government-to-Government (G2G) model has been noted to lower cost of products; further recognizing that, there are countries willing to enter into a G2G agreements; appreciating that G2G has been proven to be effective in the provision of services that have a direct impact on citizens’ livelihood including the cost of living such as the supply of fertilizers, particularly in countries with similar agricultural conditions as Kenya; this House, therefore, resolves that, the government, through the Ministry of Agriculture and Livestock Development and its agencies adopts – (i) the Government-to-Government (G2G) model in the acquisition and supply of fertilizers by identifying potential partner countries that have surplus and quality fertilizers; (ii) a comprehensive programme for government-to-government (G2G) acquisition and distribution of fertilizers through among others, Kenya …...….……/19*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1535)

Farmers Association

(KFA),

Kenya Tea Development Agency (KTDA),Coffee Board of Kenya, Kenya Planters Cooperative Union (KPCU), Kenya Grain Growers Cooperation Union (KGGCU), Pyrethrum Board of Kenya among others for increased agricultural productivity.

1. 20*. MOTION – POLICY AND FUNDING FOR SUGARCANE

FARMING IN THE COUNTRY

(The Hon. Peter Nabulindo, M.P.)

THAT, aware that, commercial sugarcane production in Kenya was introduced in the early years of independence with an aim of eliminating dependence on sugar importation and contributing to economic transformation in the sugar belt and the country at large through agriculture; acknowledging that, at its pinnacle, the sugar industry significantly contributed to the country’s National Gross Domestic Product (GDP) and became one of the largest employers which supported livelihoods of many Kenyans both directly and indirectly; concerned that, over the last 25 years, sugarcane farming particularly in Western Kenya has been declining significantly, thereby dipping sugar production from over 600,000 metric tonnes per year in the 1990s to less than 300,000 metric tonnes in recent years; noting that, the decline in sugarcane farming has forced local millers to operate far below their milling capacities and pushed the country to over-rely on net importation of sugar, which negatively impacts on the balance of trade; noting that, the decline in sugar production is attributable to factors such as mismanagement, interference and unfair competition from cheap imported sugar; further concerned that, state-owned sugar millers like Mumias Sugar Company and Nzoia Sugar Company ceased milling while owing farmers hundreds of millions of shillings; appreciating that, the Government has been putting in place strategies, policies and regulations to define roles of millers and major players and stakeholders in the sugar industry in a bid to revamp the sector; concerned that, the acute shortage of sugarcane resulting from mass abandonment of sugarcane farming continues to roll back initiatives for reviving sugar milling; recognizing that, further investment in revamping sugar companies before reviving sugarcane farming would occasion loss of the invested public funds instead of yielding success; now therefore, this House resolves that, the National Government, through the Ministry of Agriculture and Livestock Development, reviews the sugar development policies to provide that every investor-miller sets aside definite funds for development of sugarcane farming, incentivizing farmers to embrace sugarcane growing and to enhance cane production in each of the respective zones.

1. 21*. MOTION – PROVIDING A SAFETY NET FOR CAREGIVERS OF

PERSONS WITH SEVERE DISABILITIES

(The Hon. Dorothy Ikiara, M.P.) THAT, aware that, Article 21(3) of the Constitution provides that all State Organs have the duty to address the needs of vulnerable groups within the society; further aware that the persons with severe disabilities cash transfer programme (PWSD-CT) is one of the four cash transfer programmes implemented by the government as part of the overall social protection …...….……/21*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1536)

interventions; noting that caregivers undertaking the immense responsibility of providing daily care and assistance to persons with severe disabilities (PWSD) are oftentimes the immediate family members of the PWSD; concerned that, this causes a disproportionate burden on these families as persons who would otherwise be engaged in gainful employment or other activities to provide for the families are limited by these immense responsibilities; further concerned that, this loss of income opportunities and resources exacerbates the challenges faced by these families; cognizant that, the government ought to take action to recognize the invaluable contributions of caregivers and support them in caring for individuals with severe disabilities; now therefore, this House resolves that the government, through the Ministry of Labour & Social Protection, recognizes primary caregivers of persons with severe disabilities (PWSD) as a distinct category requiring social protection and support, and further, develops and implements a cash transfer programme for these primary caregivers.

1. 22*. MOTION – NATIONAL SENSITIZATION AND SUPPORT FOR

COMBATING SICKLE CELL AND HAEMOPHILIA

DISEASES

(The Hon. Peter Nabulindo, M.P.) THAT, aware that Article 43(1) of the Constitution entitles every person to the right to the highest attainable standard of health, which includes the right to health care services; further aware that, every year, an estimated 14,000 children born in Kenya suffer from sickle cell and haemophilia diseases, with the highest prevalence rate being within Western, Nyanza and Coastal Regions; concerned that, failure to undertake sickle cell and haemophilia screening at birth hinders timely administration of appropriate treatment and other mitigation measures to forestall high infant mortality caused by preventable diseases like malaria; cognizant that, national population surveys does not include data on sickle cell and haemophilia diseases; concerned that, the dearth of data and information negatively hinders prioritization of resources and implementation of sickle cell disease management programs; recognizing that, the number infant deaths caused by the disease continues to grow as a result of underfunding due to lack of data on the number of cases of the killer disease; now therefore, this House resolves that the National Government, through the Ministry of Health, and in conjunction with county governments – (a) conducts awareness and sensitization programmes on sickle cell and haemophilia diseases and supports research and training for medical personnel on the two diseases; and (b) puts in place measures for mandatory screening of newborns sickle cell and haemophilia diseases in all public health facilities in the country in order to create a database to guide funding and other interventions aimed at curbing the diseases and reducing infant mortalities resulting from the diseases.

1. 23*. MOTION – DEVELOPMENT OF A SATELLITE-BASED CLIMATE

CHANGE MONITORING POLICY

(The Hon. Abdul Haro, M.P.)

THAT, aware that the Constitution recognizes the people’s respect for the …...….……/23*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1537)

environment as the country’s heritage and the commitment to sustaining the environment for future generations; further aware that the cyclic drought in the country has caused devastating effects and serious disruption to the economy; recognizing that climate change is a global problem with developing countries being the most affected as these regions are dependent on climate-sensitive sectors such as agriculture and forestry; further recognizing that the severe effects of climate change are already being experienced in the form of frequent droughts, flooding and other extreme weather occurrences; concerned that the current climate change monitoring mechanisms in the country are based on traditional methods which rely on ground observations and climate models which have limitations in terms of accuracy, timeliness and spatial coverage; noting that the country recently launched its first operational satellite to collect and transmit high- quality data; further noting that this technology can help in accurately monitoring and forecasting climatic and weather patterns; cognizant of the fact that other jurisdictions have made use of this technology to monitor climate change with marked positive impacts; appreciating that the use of technology especially satellite technology would allow enhanced monitoring that can have significant impact on sustainable environmental management; further appreciating that this technology would be useful in monitoring difficult-to-reach, expansive and unsafe areas; now therefore, this House resolves that the Ministry of Environment, Climate Change & Forestry develops a policy on IT that deploys the use of satellites in the monitoring and forecasting of climatic conditions with the objective of ensuring timely and accurate data collection to enhance the country’s capacity to respond to weather-related risks and vulnerabilities including climate change.

1. 24*. MOTION – ESTABLISHMENT OF A SCIENCE MUSEUM

(The Hon. John Kiarie, M.P.) THAT, aware that, Article 11(2)(b) of the Constitution provides that the government shall recognize the role of science and indigenous technologies in the development of the nation; further aware that the Vision 2030 provides for the integration of information, communication and technology in the country’s transformative agenda; concerned that, there exists no science museum for consolidating indigenous scientific and technological innovations, training and research purposes in the East Africa Region; appreciating that, integration of science and technology would greatly enhance Kenya’s economic and societal success; noting that there is potential for growth in the technology sector by establishing a science museum; further noting that, the informal science education plays a key role in the progression of Science, Technology, Engineering and Mathematics (STEM); acknowledging that science museums operate as the nexus between science practitioners, policy-makers and the public; cognizant of the fact that, a science museum in the country would greatly impact on the economy of the country in the quest to become an industrialized nation; now therefore, this House resolves that, the national Government through the relevant Ministries establishes and operationalizes a science museum in the country.

…...….……/25*

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1538)

1. 25*. MOTION – AFFIRMATIVE ACTION PLAN FOR THE PROVISION

OF WATER IN ARID AND SEMI-ARID AREAS

(The Hon. Mwengi Mutuse, M.P.) THAT, aware that, Article 43 of the Constitution as read together with section 9 of the Water Act, 2016 provide for the access to clean, safe and adequate water for all citizens; further aware that, access to water guarantees human and animal health, food security, clean and sustainable environment among other socio-economic drivers; acknowledging that, with a population of nearly 53 million, about 28 million Kenyans lack access to safe water while 41 million lack access to improved sanitation; further acknowledging the rising water demand in the country and the growing water scarcity due to climate change, population growth, urbanization, water pollution, and poor management of water resources; noting that, the lack of clean, safe and adequate water affects economic activities, food security, education, and health and that the effects are especially evident in rural areas and urban slums; further noting that, with recurring drought, the country experiences acute water shortage resulting in loss of lives, livelihoods, as well as environmental degradation with arid and semi-arid (ASAL) areas being the most affected; recognizing that this has led to economic decline in these areas partly due to successive marginalization and/or under investment in water; further recognizing that, during rainy seasons, these areas experience destructive immense surface water flow sometimes leading to flooding, and that with adequate supply of water, these ASAL areas can greatly contribute to food security, employment and wealth creation hence reduce poverty and accelerate national economic growth; this House therefore urges the National Government through the relevant Ministry, to – (i) institutionalize rainwater harvesting and storage in the country and particularly in the Arid and Semi-Arid areas; and (ii) develop an affirmative action programme for investment in water harvesting, purification, storage and distribution in the Arid and Semi-Arid areas.

1. 26*. MOTION – DEVELOPMENT OF A FRAMEWORK TO MITIGATE

FLOOD HAZARDS

(The Hon. Umulkher Harun, M.P.) THAT, aware that the Constitution recognizes the people’s respect for the environment and the determination to sustain it for the benefit of future generations; further aware that the country has been experiencing some of its worst flood events during the rainy season in recent years; concerned that the effects of climate change will exacerbate the frequency and intensity of these extreme flood events; further concerned that floods pose a direct threat to the safety and security of Kenyans causing significant loss of life and mass displacement which leads to severe economic setbacks; recognizing that there is need to take proactive measures by developing an actionable framework to implement strategic water harvesting techniques to mitigate against perennial flooding; acknowledging that rainwater harvesting would not only alleviate the destructive impacts of excessive runoff rainwater but also contribute to long-term …...….……/26*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1539)

water availability; now therefore, this House urges the national government through the Ministry of Environment, Climate Change and Forestry to develop a national framework providing for, among other things, the prevention and control of flooding in flood-prone areas in the country, emergency response coordination and evacuation, and long-term rainwater management systems through harvesting and storage.

1. 27*. MOTION – PROVISION OF APPROPRIATE ACCESS TO

MARKETS IN THE COUNTRY

(The Hon. Beatrice Kemei, M.P.) THAT, aware that, the Kenya Roads Act, 2007 mandates the various road authorities to, among other functions, control roads and road reserves, and access to roadside developments; further aware that, market centres are ordinarily constructed along road developments across the country; noting that, due to improper planning, some of the marketplaces have no access roads leading buyers and traders to encroach on the roads and road reserves; further noting that, there have been instances of accidents leading to multiple deaths due to this unregulated use of road development; appreciating that, proper access roads to market places would ease access by buyers and thereby avert accidents due to the converging of traders and buyers on roadsides, thus enhancing road safety and service delivery while providing opportunities for economic engagement for the traders; now therefore, this House resolves that the Government, through the Ministry of Roads & Transport, develops a framework to ensure that where market centres exist along road developments, appropriate access is provided including service lanes and access roads.

1. 28*. MOTION – SUPPORTING AND PROMOTING LOCAL

FERTILIZER MANUFACTURING INDUSTRIES

(The Hon. Samuel Atandi, M.P.) THAT, aware that, the Fertilizer and Animal Foodstuff Act, 2015 provides for the regulation of fertilizer importation in the country; further aware that, the Fertilizer and Animal Foodstuffs Board regulates the fertilizer and animal foodstuffs industry including the manufacture and production of fertilizers; noting that, the country currently relies heavily on imported fertilizer due to inadequate local production capacity; further noting that, the low local production leads to high costs for farmers, reducing their profits and results in an unhealthy reliance on imported fertilizer; concerned that, this scenario threatens the country’s food security in case of supply disruptions and discourages local production; recognizing that local fertilizer production could lead to improved fertilizer quality, increased crop yields and a reduction in environmental harm caused by the use of substandard fertilizers; recalling that the country has the potential to produce fertilizer that could meet the country’s domestic demand and also supply the regional market; further recognizing that there is need for the government to work with local producers to develop high quality fertilizer tailored to the needs of Kenyan farmers and crops; now therefore this House resolves that the National Government through the …...….……/28*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1540)

Ministry of Agriculture and Livestock Development, supports and promotes local fertilizer manufacturing industries by investing in research and development to bolster the domestic fertilizer manufacturing sector.

1. 29*. MOTION – REGULATORY FRAMEWORK FOR THE

MONEYLENDER INDUSTRY IN THE COUNTRY

(The Hon. Beatrice Kemei, M.P.) THAT, aware that the Consumer Protection Act, 2012 provides for the protection of the consumer and prevention of unfair trade practices in consumer transactions in line with Article 46 of the Constitution; further aware that there exists unregulated moneylenders, commonly referred to as ‘shylocks’, that provide loans outside the scope of formal financial institutions; noting that with the repeal of the Moneylenders Act in 1984, unscrupulous business people have exploited the loopholes to the detriment of the general public; concerned that these lenders operate outside of the formal financial sector and as such, engage in predatory practices such as high interest rates, hidden fees, unclear terms and conditions and aggressive loan recovery methods; further concerned that the absence of clear and enforceable regulations is untenable and requires immediate remedy; recognizing that the effects of these unregulated operations extend beyond financial implications but are also social and emotional with reports of depression, family breakups and even instances of suicide by borrowers due to excessive penalties and harsh recovery methods; now therefore, this House resolves that the government, through the National Treasury and Economic Planning develops a framework to regulate unlicensed money lenders to promote a fair and sustainable financial system.

1. 30*. MOTION – FORMULATION OF A GOVERNMENT-TO-

GOVERNMENT FRAMEWORK FOR IMPORTATION

AND DISTRIBUTION OF ESSENTIAL FOODSTUFF

AND GOODS

(The Hon. Geoffrey Ruku, M.P.) THAT, aware that, Kenya National Trading Corporation (KNTC) Ltd., a State Corporation in the Ministry of Industry, Trade & Investment; recalling that, KNTC was established under Session Paper No. 1 of 1965 in recognition of the importance of trade and industry in economic development of the then newly independent Kenya; noting that, among other functions, the corporation acts as the procurement agent for the government and participates in promotion of wholesale and retail trade with a view to strengthening and promoting supply chain of essential products in the country; appreciating that the corporation plays a crucial role in supporting Micro, Small & Medium Enterprises (MSME) sector through the supply of raw materials, provision of consultancy services and the identification of markets for their products; concerned that the price of foodstuffs and other essential basic commodities in the country have incredibly risen, causing majority of Kenyan households financial distress in the face of surging inflationary pressures, weakening shilling, high cost of fossil fuels, supply chain gaps, declining agricultural productivity orchestrated by high input prices, climate …...….……/30*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1541)

change and variability; concerned that, the decline in local food production has been progressively pushing Kenya to the edge of becoming a net importer of foodstuff; noting that the prices of foodstuff and other essential goods imported into the country by merchants have also been on the rise; acknowledging that Government-to-Government arrangements and frameworks are important divers in trade, economic integration and bears better outcomes in pushing downward pressure on costs for goods and stabilizing market supply conditions; now therefore, this House now resolves that the Ministry of Industry, Trade & Investment urgently establishes a framework for Government-to-Government contractual agreements for importation and distribution of foodstuff and other essential goods in the country through the Kenya National Trading Corporation Ltd. with a view to normalizing market supply conditions and prices for such basic food commodities.

1. 31*. MOTION – POLICY FRAMEWORK FOR GOVERNMENT-TO-

GOVERNMENT SOURCING OF ELECTRICITY

EQUIPMENT AND ON CONNECTION AND

BILLING OF ELECTRICITY INFRASTRUCTURE

(The Hon. Geoffrey Ruku, M.P.) THAT, acknowledging that, Kenya Vision 2030 identifies energy as an enabler to achieving social, economic and political pillars and that access to affordable, reliable and quality power is crucial for economic growth and development; aware that, prompt connectivity to affordable and stable electricity power is an essential enabler for spurring rural economies, thus contributing to national growth and development towards attainment of the Vision 2030; recognizing that, the Kenya Power Company Ltd. is the is national electricity utility company responsible for connection and billing of electricity to customers throughout the country and it also undertakes electricity licensing, metering, billing, offering emergency electricity services and customer relations; concerned that, the cost of electricity in the country has increased significantly over the years thus burdening households and industrial users with high costs of production; further concerned that the protracted chain of stages that characterize the processing of new electricity connections, coupled with delays in importation of critical electricity connection equipment such as transformers, conductors and meters overseas causes a red tape that results in inordinate delays in concluding new connections to electricity; considering that the convoluted process of connection to electricity and attendant management challenges that grapple the Kenya Power in managing electricity in the country bear serious implications on cost of living and retard economic growth by making businesses less competitive thereby diverting potential investments to other economies in the region; cognizant of the fact that, Government-to-Government procurement is an important factor in trading and efforts towards increased economic integration and bears better outcomes in curbing supplies hitches, in order to increase operational efficiency and impacting the overall prices of electricity, this House resolves that the Ministry of Energy to – (i) formulate a policy framework Government-to-Government agreements to facilitate local assembly of essential equipment for electricity …...….……/31*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1542)

connections such as transformers, conductors, meters and attendant equipment in order to address unwarranted supply hitches and to guarantee quality assurance of the equipment; and,

(ii) formulates management contracts with contractors with private entities to manage power connections and billing services on behalf of the Kenya Power with a view to enhancing efficiency.

1. 32*. MOTION – DEVELOPMENT OF MEASURES TO MITIGATE

DIGITAL EXCLUSION

(The Hon. Marianne Kitany, M.P.) THAT, aware that the Government of Kenya has prioritized digitization and automation of government processes and services as part of the Kenya Digital Master Plan (2022-2030), the blueprint for leveraging and deepening the contribution of information and communications technology (ICT) to accelerate the country’s economic growth; further aware that, the Government is committed to consolidating the industrial, academic institutions and other innovators to co-invest in emerging technologies to create high-quality jobs that leverage on artificial intelligence, robotics and other technologies; cognizant of the fact that, the Government intends to increase internet broadband connectivity across the country through construction of 100,000 km of national fiber optic connectivity network; concerned that, as the country rapidly digitizes services and processes, the high costs of data, internet services as well as purchase of internet-enabled digital devices may lead to digital exclusion of a majority of Kenyans; recognizing that, there is need to bridge the existing gap in ICT to ensure inclusivity in access to internet make Kenya a regional ICT hub while keeping pace with shifting technological changes; noting that, the Government’s plan for a digital superhighway may not be realized without deliberate interventions to lower data costs; now therefore, this House resolves that, the Government, through the Ministry of Information, Communication and the Digital Economy formulates a policy to: (a) regulate internet billing by Internet Service Providers (ISPs) by providing for metered billing of internet use based on consumption in order to mitigate exploitation and secure economic interests of internet users in line with Article 46 of the Constitution; and, (b) require Internet Service Providers to develop and deploy quality metered billing systems capable of monitoring customer usage, convert to readable details and creating invoices based on consumption and align their metrics with the value the customers get from various internet services.

1. 33*. MOTION – FORMULATION OF A REGULATORY FRAMEWORK

ON ARTIFICIAL INTELLIGENCE IN THE COUNTRY

(The Hon. Marianne Kitany, M.P.)

THAT, aware that the world is rapidly embracing Artificial Intelligence (AI), which is the use of a digital computer or computer-controlled robots to perform tasks commonly associated with intelligent beings; acknowledging that, …...….……/33*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1543)

the 2022 Government Artificial Intelligence Readiness Index report ranked Kenya fifth in Africa and 90th globally in readiness to adopt Artificial Intelligence (AI); further acknowledging that the Oxford Insights Survey 2022 pegged Kenya’s readiness to adopt AI at 40.3%; appreciating that AI has brought forth positive benefits that have increased efficiency in different sectors such as healthcare, manufacturing and robotics; concerned that, the exponential rate at which Artificial Intelligence is being embraced in the society without proper regulatory mechanisms has caused various negative consequences such as rising cases of disinformation and fake news; noting that there is need to protect Kenyans from the potential AI-instigated harms such as privacy breaches, AI- powered fake technology algorithms, algorithmic discrimination, autonomous weapons, job displacement and economic inequality, social manipulation and misinformation, financial market manipulation, and privacy invasion; now therefore, this House urges the Government, through the Ministry of Information, Communication and the Digital Economy to: (a) formulate a regulatory framework and ethical guidelines for implementation of Artificial Intelligence (AI) in the country to control its potential misuse; and, (b) develop and execute a public awareness programme on Artificial Intelligence to raise understanding of AI, foster transparency and promote responsible use of AI for the benefit of all.

1. 34*. MOTION – ESTABLISHMENT OF A NATIONAL POLICY TO

COMBAT OBSTETRIC VIOLENCE IN KENYA

(The Hon. Gathoni Wamuchomba, M.P.)

THAT, aware that, Article 43(1)(a) provides for the right of every person to access the highest attainable standard of health; further aware that, poor quality of health services especially maternal care has been a recurring concern among women in the country; noting that there is increased pre- and post-partum mistreatment and dehumanized care of women by healthcare providers, also known as obstetric violence; further noting that obstetric violence includes, but is not limited to, disrespectful and abusive behaviour, physical and verbal abuse, neglect, forced medical procedures, humiliation and assault in healthcare settings; concerned that sustained class-based disparities shape different maternal and infant health outcomes with women of low socio-economic status experiencing greater levels of obstetric violence; further concerned that these not only affect women’s physical and mental health, but also impact on the overall health outcomes of mothers and their newborns, significantly contributing to high maternal mortality rates; cognizant of the fact that there exists no national policy or framework to address and prevent obstetric violence; now therefore, this House resolves that the National Government, through the Ministry of Health, develops a policy on prevention of obstetric violence in healthcare facilities in the country and providing for a framework for regular monitoring and reporting of cases to curb incidences of pre- and post-partum mistreatment of women seeking health services.

…...….……/35*

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1544)

1. 35*. MOTION – ESTABLISHMENT OF A PRIORITY BOARDING

PROTOCOL FOR KENYA DEFENCE FORCES AND

KENYA SPECIAL FORCES PERSONNEL ON LOCAL

AIRLINES

(The Hon. (Capt.) Ruweida Obo, M.P.)

THAT, aware that, Article 239 provides for the National Security Organs, including the Kenya Defence Forces; further aware that, the Kenya Defence and Kenya Special Forces play an indispensable role in promoting and safeguarding national security in accordance with the Constitution; recognizing that, members of the Forces face life-threatening risks as they carry out their duties to protect our citizens, particularly in high-risk and volatile areas; noting that there is currently no token of appreciation for the remarkable dedication, service and sacrifices made by the Kenya Defence and Special Forces; acknowledging that it is important to accord special privileges and honours to our military and veteran personnel, akin to the practice observed in other countries including being allowed to access services like banking hall and boarding of flights ahead of the general public; further acknowledging that this practice would not only instill a sense of pride among the Kenya Defence and Kenya Special Forces personnel, but also enhance their morale and motivation, thereby boosting their performance and commitment to our national security; cognizant of the fact that there exists no national policy or framework to facilitate the implementation of such a practice; now therefore, this House urges that the National Government, through the Ministry of Roads and Transport, encourages local airlines to establish a priority boarding protocol for the Kenya Defence and Kenya Special Forces personnel which grants them the privilege to board local aircrafts before the general public.

1. 36*. MOTION – ESTABLISHMENT OF A REGULATORY FRAMEWORK

FOR CRYPTOCURRENCY

(The Hon. Irene Mayaka, M.P.) THAT, aware that Article 231(2) of the Constitution mandates the Central Bank of Kenya (CBK) to formulate monetary policy, promote price stability, and to issue currency among other functions; further aware that the National Payments Systems Act provides that Central Bank may, by notice in the Gazette, designate a payment instrument if the Bank is of the opinion that the payment instrument is of widespread use as a means of making payment and may affect the payment systems of Kenya; or to protect the interests of the public or of the integrity of the payment instrument; noting that use of cryptocurrency has gained traction in the recent past and has become an increasingly significant aspect of the modern financial ecosystem; further noting that Kenya is the amongst the leading countries in cryptocurrency ownership in Africa; concerned that the widespread use of cryptocurrency in the country without regulation could drive financial instability, market manipulation and potential illegal financial activities; further concerned that if left unregulated, cryptocurrencies may unofficially replace and devalue the domestic currency; cognizant of the fact that …...….……/36*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1545)

the Finance Act, 2023 introduced tax on income derived from the transfer or exchange of digital assets which include cryptocurrencies, digital documents, audible content, motion picture, and other related digital data; acknowledging that there is need to establish a regulatory framework to ensure mandatory registration of cryptocurrency and digital wallets; now therefore, this House urges the National Government, through the National Treasury & Economic Planning, to develop a framework for the establishment of a regulatory framework on the use of cryptocurrencies in the country and provide for licensing, governance and operations of cryptocurrency-related business.

*Denotes Orders of the Day*

…......./Notices*

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1546)

N O T I C E S

I. THE

PUBLIC

SERVICE

(VALUES

AND

PRINCIPLES) (AMENDMENT) BILL (NATIONAL

ASSEMBLY BILL NO. 46 OF 2022)

Notice is given that the Chairperson of the Departmental Committee on Labour intends to move the following amendment to the Public Service (Values and Principles) (Amendment) Bill, 2022 at the Committee Stage—

CLAUSE 2

THAT, the Bill be amended by deleting clause 2 and inserting the following new clause–

Amendment of section 16 of No. 1A of 2015.

1. 2. Section 16 of the principal Act is amended–

(a) in subsection (1) by inserting the words “and each public office” immediately after the words “each service Commission”; (b) in subsection (3) by inserting the following new paragraph immediately after paragraph (d)– “(da) details on the human resource establishment within the service Commission outlining the total number of employees and highlighting their gender, age, ethnicity and whether they are persons with disabilities;”

NEW CLAUSE

THAT, the Bill be amended by inserting the following new clause immediately after clause 1–

Amendment of section 2 of No. 1A of 2015. 1A. Section 2 of the Public Service (Values and Principles) Act (in this Act referred to as the “principal Act”) is amended by inserting the following new definitions in their proper alphabetic sequence– “authorized officer” means any officer appointed within the public service or service Commission to perform its delegated functions within the public service or service Commission;

“public office” has the meaning assigned in Article 260 of the Constitution;”

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1547)

II. THE NATIONAL CONSTRUCTION AUTHORITY

(AMENDMENT) BILL (NATIONAL ASSEMBLY

BILL NO. 59 OF 2022)

Notice is given that the Chairperson of the Departmental Committee on Housing, Urban Planning and Public Works intends to move the following amendment to the National Construction Authority (Amendment) Bill, 2022 at the Committee Stage—

CLAUSE 1

That the Bill be amended by deleting Clause 1.

CLAUSE 2

That the Bill be amended by deleting Clause 2.

III. THE

KENYA

DRUGS

AUTHORITY

BILL

(NATIONAL ASSEMBLY BILL NO. 54 OF 2022)

1) Notice is given that the Chairperson of the Departmental Committee on Health intends to move the following amendment to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

LONG TITLE

THAT, the Bill be amended by deleting the Long Title and substituting therefor the following new Long Title— “AN ACT of Parliament to establish a comprehensive legal framework for the regulation of Health Products and Technologies; to safeguard public health through development of a regulatory system to ensure safety, quality, efficacy, effectiveness and performance of health products; to establish the Kenya Health Products and Technologies Authority and for connected purposes”.

CLAUSE 1

THAT, Clause 1 of the Bill be amended by— (a) deleting the phrase “Kenya Drugs Authority Act, 2022” and substituting therefor the phrase “Kenya Health Products and Technologies Regulatory Authority Act, 2022”; (b) deleting the words “and commencement” in the marginal note.

CLAUSE 2

THAT, Clause 2 of the Bill be amended— (a) in the definition of “article” by– (i) inserting the words “dietary supplement” immediately after the words “therapeutic cosmetic” appearing in paragraph (a); and

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1548)

(ii) inserting the words “dietary supplement” immediately after the words “therapeutic cosmetic” appearing in paragraph (b); (b) in the definition of “Authority” by deleting the words “Kenya Drugs Authority” and substituting therefor the words, “Kenya Health Products and Technologies Regulatory Authority”; (c) in the definition of “chemical substance” by deleting the words “or detergent”; (d) in the definition of “drug” by deleting the word “if” appearing in paragraph (b)(ii) and substituting therefor the word “of”; (e) by deleting the definition of “enrolled pharmaceutical technologist”; (f) in the definition of “health products and technologies” by inserting the words, “dietary supplement” immediately after the words, “therapeutic cosmetics”; (g) by deleting the definition of “herbal medicine or product”; (h) by deleting the definition of “medical device”; (i) by deleting the definition of “medicinal substance”; (j) in the definition of “package” by inserting the words “dietary supplement” immediately after the words “therapeutic cosmetic”; (k) by deleting the definition of “pharmacy”; (l) by deleting the definition of “pharmaceutical technologist”; (m) by deleting the definition of “registered midwife”; (n) in the definition of “scheduled substance” by deleting the words “in the relevant schedule under this Act” and substituting therefor the words “in the list published by the Cabinet Secretary under section 37 of this Act”; (o) by deleting the definition of “therapeutic cosmetic”; and (p) by inserting the following new definitions in their proper alphabetic sequence— “active surveillance” means prospective measures taken to detect adverse drug reactions and adverse events and involves active follow-up during and after treatment of patients where the events may be detected by asking the patient directly or screening patient records; “adverse drug reaction” means a response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function and is characterized by the suspicion of a causal relationship between a medical product and an occurrence; “adverse event” means any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment; “biologicals” means a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies and includes products derived from human blood and plasma; “Board” means the Board of the Authority established under section 8; “Centre” means the National Pharmacovigilance Centre established under section 59B; “clinical trial” means any systematic study on pharmaceutical products in human subjects, whether in patients or other volunteers, in order to discover or verify the effects of, identify any adverse reaction to

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1549)

investigational products, study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety; “dietary supplement” means a product taken by mouth that is added to the diet to help meet daily requirements of essential nutrients, and which usually contains one or more dietary ingredient and includes vitamins, minerals and herbs; “enrolled pharmaceutical technologist” means a person enrolled as such by the body for the time being responsible for the enrolment of pharmaceutical technologists;”

“falsified medical product” means a product that is deliberately or fraudulently misrepresented in relation to its identity, composition or source; “Field Safety Corrective Action” means any action taken by a product owner to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device, and includes— (a) the return of a medical device to the product owner or its representative; (b) device modification which may include— (i) retrofit in accordance with the product owner’s modification or design change; (ii) permanent or temporary changes to the labelling or instructions for use; (iii) software upgrades including those carried out by remote access; (iv) modification to the clinical management of patients to address a risk of serious injury or death related specifically to the characteristics of the device; (v) device exchange; (vi) device destruction; or (vii) advice given by product owner regarding the use of the device. “health product” includes a medicine, medical product, medicinal substance, vaccine, diagnostic, medical device, blood or blood product, traditional and alternative medicine, therapeutic feed and nutritional formulation, cosmetic and related products; “health technology” means the application of organized knowledge and skills in the form of medicines, devices, vaccines, procedures, and systems developed to solve a health problem and improve the quality of lives; “herbal medicine or product” means a plant derived material or preparations with claimed therapeutic or other health benefits, which contain either raw or processed ingredients from one or more plants or material of inorganic or animal origin and includes herbs, herbal

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1550)

materials, herbal preparations, finished herbal products that contain active ingredients, parts of plants or other plant materials or combinations; “in-vitro diagnostics medical device” means a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes; “Inspector of Drugs” means a person who is competitively recruited by the Authority as a drug inspector and who holds a minimum of a diploma in pharmacy; “lot” or “sub-lot” means a defined quantity of starting material, packaging material or product, processed in a single process or series of processes so that the quantity is expected to be homogeneous; and in the case of continuous manufacture, the lot corresponds to a defined fraction of the production characterized by its intended homogeneity; “lot release” means the process of the evaluation of an individual lot of a licensed biological product by the Authority before giving approval for its release onto the market; “marketing authorization” means the certificate of registration issued by the competent health product regulatory authority in the country of origin for the purpose of marketing or free distribution of a health product after evaluation for safety, efficacy and quality; “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose of—

(a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (c) investigation, replacement, modification or support of the anatomy or of a physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; (g) providing information by means of in vitro examination of specimens derived from the human body; (h) disinfection substances; (i) aids for persons with disabilities; (j) devices incorporating animal or human tissues; (k) devices for in-vitro fertilization or assisted reproduction technologies,

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1551)

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means;

“medicinal substance” means a substance, the origin of which may be human, animal, vegetable or chemical including human blood and human blood products, micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, micro-organisms, plants, parts of plants, vegetable secretions, extracts, elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

“passive surveillance” means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns; “parallel importation” means importation into Kenya, by a licensed importer of a health product other than the marketing authorization holder or his or her technical representative, of the following health products which require marketing authorization in Kenya— (a) patented health products under section 58(2) of the Industrial Property Act, 2001; (b) non-patented health products; or (c) branded generic health products; “parallel imported medicinal substance” means a medicinal substance imported into Kenya under this Act; “pharmacovigilance” means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible health product related problem; “premise” includes any land, building, dwelling-place or any other place whatsoever; and includes stand-alone community retail pharmacy, private hospital pharmacy, public health facility pharmacy, wholesale pharmacy or distribution outlet, where health products and technologies are stored, handled or distributed; “scheduling” means, in relation to a substance, the determination of the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included; “substandard medical product” means a registered medical product that fails to meet either its quality standards or specifications, or both; “therapeutic cosmetic” means a cosmetic which— (a) offers an additional benefit to a person over an ordinary cosmetic; or (b) contains a bioactive product formulated from an animal ingredient that may have visible and measurable short or long- term effects on a person,

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1552)

and may include a product that may be absorbed through the skin or a mucous membrane; “unregistered medical product” means a product that has not undergone evaluation and approval by the Authority subject to permitted conditions under the Act and the rules therein; “vessel” means a truck, van, bus, minibus, car, trailer, aircraft, railway carriage, boat and other means that are used for purposes of conveying health products and technologies;

CLAUSE 3

THAT, Clause 3 of the Bill be amended by deleting sub-clause (1) and substituting therefor the following new sub-clause (1)—

“(l) This Act applies to the regulation of—

(a) medicines, medical products and technologies; (b) medical devices including radiation emitting products; (c) radiopharmaceuticals; (d) complementary, alternative or herbal medicines; (e) cosmetics and Borderline Products; (f) in-vitro diagnostics medical devices; (g) therapeutic feeds; (h) clinical trials; (i) nutraceuticals and dietary supplements; (j) digital health and technologies; (k) scheduled substances; (l) chemical substances; and (m) biological products for use in humans and the starting materials used in their manufacture.”

CLAUSE 4

THAT, Clause 4 of the Bill be amended in sub-clause (1) by deleting the words “Kenya Drugs Authority” and substituting therefor the words “Kenya Health Products and Technologies Regulatory Authority”.

CLAUSE 5

THAT, Clause 5 of the Bill be amended by deleting the words, “but the Authority may establish branches anywhere in Kenya” and substituting therefor the words “or in such other place as the board of the Authority may, by resolution, determine”.

CLAUSE 6

THAT, Clause 6 of the Bill be amended—

(a) by deleting sub-clause (1) and substituting therefor the following new sub- clause (1)—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1553)

“(1) There shall be a Director-General who shall be the chief executive officer of the Authority.”

(b) by deleting sub-clause (2) and substituting therefor the following new sub- clause (2)— “(2) The Director-General shall be appointed by the Board, through a transparent and competitive process, on such terms as may be specified in the instrument of appointment.”

(c) in sub-clause (3) by deleting the word “four” and substituting therefor the word “three”. (d) by deleting sub-clause (4) and substituting the following new sub-clause (4)—

“(4) A person shall be qualified for appointment as a Director-General if such person—

(a) holds a bachelor’s degree in pharmacy from a university recognized in Kenya; (b) holds a masters' degree in pharmacy, medicine or any relevant field from a university recognized in Kenya; (c) has at least ten years’ experience in pharmacy or its equivalent; (d) has served in a senior management position for at least five years; (e) is a member of a professional body; and (f) meets the requirements of Chapter six of the Constitution.”; and

(e) by deleting sub-clause (5).

CLAUSE 7

THAT, Clause 7 of the Bill be amended in paragraph (f) by deleting the words “Act. regulation under this” and substituting therefor the words “regulation under this Act.”.

CLAUSE 8

THAT, Clause 8 of the Bill be amended— (a) in sub-clause (1) by deleting the words “Kenya Drugs” and substituting therefor the words “Kenya Health Products and Technologies Regulatory’; (b) by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)–

“(2) The Board shall comprise— (a) a non-executive Chairperson appointed by the President and who shall─ (i) be a registered pharmacist of good standing with a degree in pharmacy; and

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1554)

(ii) have at least ten years' experience in the pharmaceutical sector, five of which shall be at senior management level; (b) the Principal Secretary in the Ministry for the time being responsible for health or a representative designated in writing; (c) the Principal Secretary the Ministry for the time being responsible for finance or a representative designated in writing; (d) the Director-General for Health or a representative designated in writing; (e) one person nominated by the Pharmaceutical Society of Kenya; (f) one person nominated by the Kenya Pharmaceutical Association; (g) one person nominated by the Kenya Medical Association; (h) one person, not being a Governor, with knowledge and experience in health products and technologies nominated by the Council of County Governors to represent the interests of counties; (i) one person, not being a public officer, representing consumer protection nominated by the Consumer Federation of Kenya; and (j) the Director-General of the Authority who shall be the secretary and an ex officio member of the Board.”; and (c) by deleting sub-clause (3) and substituting therefor the following new sub-clause (3)—

“(3) The Cabinet Secretary shall appoint the members of the Board under subsection (e), (f), (g), (h) and (i) by notice in the Gazette.”

CLAUSE 9

THAT, the Bill be amended by deleting Clause 9.

CLAUSE 10

THAT, Clause 10 of the Bill be amended in sub-clause (1) by deleting the words “section 12” appearing in paragraph (c) and substituting therefor the words “section 11”.

CLAUSE 12

THAT, Clause 12 of the Bill be amended by—

(a) inserting the following paragraphs immediately after paragraph (e)—

“(ea) regulate the disposal of health products and technologies; (eb) monitor the market for the presence of unregistered and illegal health products and technologies; (ec) conduct analytical tests of health products and technologies”;

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1555)

(b) deleting paragraph (f) and substituting therefor the following new paragraph (f) —

“(f) ensure continuous monitoring of the safety of health products and technologies regulated under this Act through analysis of reports on adverse reactions and events, including any other health product and technology use related issues and take appropriate regulatory actions when necessary”;

(c) deleting paragraph (g) and substituting therefor the following new paragraph (g)— “(g) regulate clinical trials and ensure that clinical trial protocols of health products and technologies are being assessed according to the prescribed ethical and professional criteria and defined standards including mandatory bioequivalence studies”;

(d) inserting the following new paragraphs immediately after paragraph (g)—

“(ga) approve the use of any unregistered medicinal substance for purposes of clinical trials, emergency use and compassionate use; (gb) carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements”;

(e) deleting paragraph (n) and substituting therefor the following new paragraph (n)—

“(n) appoint inspectors and order inspection of manufacturing premises, medical devices establishments, importing and exporting agents, wholesalers, distributors, pharmacies, including those in health facilities and clinics, retail outlets and any other premises and vessels subject to regulation under this Act”;

(f) inserting the following new paragraphs after paragraph (o)—

“(oa) conduct national regulatory authority lot release, official authority batch release of specified biologicals to ensure the quality, safety and efficacy of biological products through a regulatory release system in compliance with established approaches, policies, guidelines, procedures and in line with World Health Organization and internationally recognized guidelines; (ob) carry out and promote research related to medicines and health products”;

(g) inserting the following paragraphs after paragraph (q)—

“(qa) ensure that all health products and technologies manufactured in, imported into or exported from the country including through parallel importation conform to prescribed standards of quality, safety and efficacy;

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1556)

(qb) enforce the prescribed standards of quality, safety and efficacy of health products and technologies manufactured, imported into or exported out of the country; (qc) grant or revoke licenses and permits for the manufacture, importation, exportation, distribution and sale of health products and technologies; (qd) maintain a register of all authorized health products and technologies manually or electronically; (qe) regulate licit use of narcotic, psychotropic substances and precursor chemical substances in accordance with the Single Convention on Narcotic Drugs, 1961, the Convention on Psychotropic substances,1971 or the United Nations Convention against Illicit Traffic of Precursor Chemical Substances, 1988; (qf) inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies including those in hospitals and clinics and other retail outlets;”

CLAUSE 13

THAT, Clause 13 of the Bill be amended by— (a) deleting paragraph (a) and substituting therefor the following new paragraph (a)—

“(a) collaborate with such other bodies or organizations within or outside Kenya as it may consider desirable or appropriate for the furtherance of the purpose of the Act;”

(b) inserting the following new paragraphs immediately after paragraph (a)—

“(aa) adopt and implement any such internationally recognized good regulatory practices;

(ab) determine and implement effective and efficient reliance mechanisms;

(ac) issue, suspend, withdraw or revoke any license or compliance certificate granted under this Act;

(ad) levy, collect and utilize fees for services rendered;

(ae) grant or withdraw licenses and permits to manufacturers, wholesalers, retailers, importers, exporters and distributors; (af) develop guidelines on the manufacture, import and export, distribution, sale and use of medical products”.

CLAUSE 21

THAT, Clause 21 of the Bill be amended—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1557)

(a) by deleting sub-clause (1) and substituting therefor the following new sub-clause (1)—

“(1) The Board may establish such scientific advisory committees of the Authority, as may be necessary for the effective performance of the functions of the Authority”.

(b) in sub-clause (3) by deleting the words “Cabinet Secretary” and substituting therefor the words “Board of the Authority”; (c) in sub-clause (4) by deleting the words “Cabinet Secretary” and substituting therefor the words “Board of the Authority”; (d) by deleting sub-clause (9) and substituting therefor the following new sub-clause (9) — “(9) An advisory committee shall submit, at least once every six months, a report to the Board of the Authority, with respect to its activities and the Board shall submit a copy of each report to the Cabinet Secretary”.

PART IV

THAT, Part IV of the Bill be amended by deleting the title and substituting therefor the following new title–

PART III—HEALTH PRODUCTS AND TECHNOLOGIES

CLAUSE 22

THAT, Clause 22 of the Bill be amended—

(a) in the marginal note by deleting the word “medicines” and substituting therefor the words “health products and technologies”; (b) in sub-clause (1) by—

(i) deleting the words “sell any medicine” appearing in the opening sentence and substituting therefor the words “sell, manufacture, supply, distribute or dispense any health product or technology”;

(ii) deleting paragraph (d) and substituting therefore the following new paragraph (d)—

“(d) is falsified,”;

(c) in sub-clause (3) by—

(i) deleting the word “medicine” appearing in the opening sentence and substituting therefor the words “health product or technology”; and

(ii) deleting the words “pharmaceutical product” appearing in paragraph (b) and substituting therefor the words, “health product or technology”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1558)

CLAUSE 23

THAT, Clause 23 of the Bill be amended in sub-clause (1) by— (a) deleting the word “medicines” appearing in paragraph (a) and substituting therefor the words, “health products or technologies”; (b) deleting the word “medicine” appearing in paragraph (b) and substituting therefor the words, “health products or technologies”; and (c) deleting the word “medicine” appearing in paragraph (c) and substituting therefor the words, “health products or technologies”.

CLAUSE 24

THAT, Clause 24 of the Bill be amended—

(a) in the marginal note by deleting the word “medicines” and substituting therefor the words “health products and technologies”; (b) in sub-clause (1) by deleting the word “medicine” wherever it appears and substituting therefor the words “health product or technology”;

(c) by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)–

“(2) If a standard has not been prescribed for a health product or technology but a standard for the health product or technology is contained in any of the publications specified in the Fifth Schedule, any person who manufactures, labels, packages, sells or advertises any other substance or article in such a manner that is likely to be mistaken for the health product or technology having met any of the standards contained in any of the publications specified in the Fifth Schedule, commits an offence.”;

(d) in sub-clause (3)– (i) by deleting the word “medicine” wherever it appears in the opening sentence and substituting therefor the words “health product or technology”; and (ii) by deleting the word “drug” appearing in paragraph (b) and substituting therefor the words “health product or technology”;

(e) in sub-clause (4)— (i) by deleting the words “one hundred thousand shillings or to imprisonment for a term not exceeding three months” appearing in paragraph (a) and substituting therefor the words “one million shillings or to imprisonment for a term not exceeding three years”; and (ii) by deleting the words “two hundred thousand” appearing in paragraph (b) and substituting therefor the words “two million”.

CLAUSE 25

THAT, the Bill be amended by deleting Clause 25.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1559)

CLAUSE 26

THAT, Clause 26 of the Bill be amended by— (a) deleting the word “medicine” appearing in the marginal note and substituting therefor the words “health product or technology”; and (b) deleting the word “medicine” and substituting therefor the words “health product or technology”.

CLAUSE 27

THAT, Clause 27 of the Bill be amended—

(a) by deleting the words “medicinal products” appearing in paragraph (a) and substituting therefor the words “health products or technologies”; (b) by deleting the words “medicinal products” appearing in paragraph (b) and substituting therefor the words “health products or technologies”; and (c) by deleting paragraph (c) and substituting the following new paragraph (c)— “(c) the quality of the health products or technologies of each such description, according to the specification and the method or proposed method of manufacture of the health products or technologies, and the provisions proposed for securing that the health products or technologies as sold or supplied will be of that quality; and”

NEW CLAUSES 27A, 27B, 27C & 27D

THAT, the Bill be amended by inserting the following new clauses immediately after clause 27–

Application for product licence.

27A. (1) A person who intends to import, manufacture or sell a health product or technology shall apply to the Authority for the registration of the health product or health technology in the prescribed form. (2) An applicant under subsection (1) shall— (a) specify the particulars of the person with appropriate knowledge of all aspects of the health product or health technology who shall be responsible for all communication between the applicant and the Authority in the declaration page of the application form; and (b) where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, appoint a local representative who shall be a citizen of Kenya, a person who is or has permanent residence or a company incorporated in Kenya.

(3) The application made under subsection (1) shall be accompanied by— (a) a proposed label for use on the health product or technology; (b) a copy of the manufacturing licence of the health product or technology, where applicable;

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1560)

(c) a copy of the good manufacturing practice certificate from the Authority and the regulatory authority of the country where the health product or technology is manufactured;

(d) a copy of a certificate of analysis from a quality control laboratory recognized by the Authority, where applicable; (e) a copy of the marketing authorization or certificate of registration of the health product or technology from the regulatory authority of the country where the health product or technology is sold; (f) the available data on the quality, safety, efficacy and performance of the health product or technology submitted in a common technical dossier format; (g) a sample of the health product or technology; (h) proof of ownership of the site for the manufacture of the health product or technology, where applicable; (i) where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, a copy of the agreement appointing the local representative; (j) where the application relates to a health product or technology which is registered with a foreign regulatory body— (i) a copy of the certificate of registration; (ii) the professional information relating to the health product or technology; and (iii) the conditions of the registration of the health product or technology; (k) proof that the applicant holds— (i) a valid practicing licence issued by the body responsible for the profession of pharmacy; (ii) a valid wholesale dealer’s licence issued in accordance with this Act; (iii) a valid licence to sell poisons issued in accordance with this Act; or (iv) a valid manufacturing licence issued in accordance with this Act; and (v) proof of payment of the application fees as prescribed by the Authority. (4) An applicant shall notify the Authority of any variation to the agreement appointing the local representative within seven days of the variation Processing of application for registration of health product or technology.

27B. (1) The Authority shall consider the application made under section 27A, and, shall, if it is satisfied of the safety, efficacy, quality, performance and economic value of the health product or technology, register the health product or technology and issue a certificate of registration in the prescribed form.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1561)

(2) The Authority may, while considering the application, approve the details as supplied by the applicant or approve it with such amendments as it may consider appropriate in respect of the following particulars— (a) the name under which the health product or technology may be sold; (b) the labelling of the health product or technology; (c) the statement of the representations to be made for the promotion of the health product or technology regarding— (i) the claim to be made for the health product or technology; (ii) the route of administering the health product or technology; (iii) the dosage of the health product or technology; (iv) the storage conditions of the health product or technology; (v) the contra-indications, the side effects and precautions, if any of the health product or technology; and (vi) the package size of the health product or technology.

(3) When evaluating an application, the Authority may— (a) subject a sample of the health product or technology to an evaluation by an analyst; and (b) consider the evaluation report of the analyst that has evaluated the health product or technology.

(4) Where the Authority is not satisfied as to the quality, safety efficacy, performance or economic value of the health product or technology, it may, after providing an opportunity to the applicant to be heard, reject the application and inform the applicant the reasons for rejection in writing.

Registration during emergency.

27C. (1) The Authority may, where it considers it necessary to protect public health or in the event of a threat to life or health, issue a provisional certificate of registration for a health product or technology.

(2) A person who intends to obtain the provisional certificate of registration for a health product or technology under subsection (1) shall apply to the Authority in the prescribed form.

(2) Where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, the applicant shall appoint a

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1562)

local representative who shall be a citizen of Kenya, a person who is or has permanent residence or a company incorporated in Kenya.

(4) An application under subsection (2) shall be accompanied by─ (a) such documents as may be necessary to support the application; (b) where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, a copy of the agreement appointing the local representative; (c) proof that the applicant holds— (i) a valid practicing licence issued by the body responsible for the profession of pharmacy; (ii) a valid wholesale dealer’s licence issued in accordance with this Act; (iii) a valid licence to sell health products or technologies issued in accordance with this Act; or (iv) a valid manufacturing licence issued in accordance with this Act; and (v) proof of payment of the application fees as prescribed by the Authority.

(5) When determining an application under this section, the Authority shall consider the facts established from the valid marketing authorization for the health product or technology and the report on the assessment of the health product or technology obtained from the authority competent for health products and technologies, if available.

(6) The person to whom the certificate of registration is issued under this section, shall be responsible for the labelling, packaging, advertising and pharmacovigilance system of the health product or technology. (7) A provisional certificate of registration issued under subsection (1) shall be valid for two years from the date of issue or until the declaration made under section 35 of the Public Health Act is revoked.

(8) Any variation to the agreement appointing the local representative to the application made under subsection (2) shall be notified to the Authority within seven days of the variation.

Authorization of unregistered health product or technology. 27D. (1) The Authority may, in writing, authorize a person to import or distribute for a specified period to a specified person or institution

(No. 98)

WEDNESDAY, OCTOBER 25, 2023

(1563)

a specified quantity of a particular health product or technology that is not registered.

(2) A health product or technology distributed pursuant to authorization granted under subsection (1) may be used for such purposes and in such manner and during such period as the Authority may in writing determine.

(3) A person who intends to obtain the authorization under subsection (1), for purposes other than a clinical trial, shall apply to the Authority in the prescribed form.

(4) Where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, the applicant shall appoint a local representative who shall be a citizen of Kenya, a person who is or has permanent residence or a company incorporated in Kenya.

(5) The application made under subsection (3) shall be accompanied by— (a) a product brochure containing relevant chemical, pharmaceutical, pre-clinical pharmacological and toxicological data and where applicable, human pharmacological and clinical data related to the health product or technology for which authority is sought; (b) written consent of the applicant, where applicable; (c) details of registration or pending registration of the health product or technology with any other regulatory authority, where applicable; (d) evidence of compliance by the manufacturer of the health product or technology with good manufacturing practice standards as determined by the Authority; (e) reasons why a registered health product or technology cannot be used; (f) where the applicant is not a citizen of Kenya or is a company incorporated outside Kenya, a copy of the agreement appointing the local representative; (g) proof that the applicant holds— (i) a valid practicing licence issued by the body responsible for the profession of pharmacy;

(ii) a valid wholesale dealer’s licence issued in accordance with this Act;

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1564)

(iii) a valid licence to sell health products or technologies issued in accordance with this Act; or (iv) a valid manufacturing licence issued in accordance with this Act; and (v) proof of payment of the application fees as prescribed by the Authority.

(6) Where the Authority issues an authorization under subsection (1), the person to whom the authorization is issued shall submit to the Authority— (a) progress reports after every six months from the date of issuance of the authorization; (b) any adverse event report, where an adverse event occurred; and (c) a progress report within thirty days after the completion or termination of the use of the health product or technology.

(7) The Authority may, where it is of the opinion that the safety of any patient is compromised or where the scientific reasons for administering the unregistered health product or technology have changed— (a) impose any additional conditions; (b) request additional information; (c) inspect the site where the unregistered health product or technology is manufactured, stored or administered; or (d) withdraw the authorization to treat the patient.

(8) The Authority may, by notice in writing withdraw the authorization issued under subsection (1) if the any of purposes or the manner specified in subsection (2) is contravened.

(9) A health product or technology authorized under this section shall be labelled in accordance with this Act.

(10) An applicant shall notify the Authority of any variation to the agreement appointing the local representative within seven days of the variation.

(11) The requirements in this section shall apply to applications for donations of health products and technologies.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1565)

CLAUSE 28

THAT, Clause 28 of the Bill be amended—

(a) in the marginal note by deleting the words “medicines register” and substituting therefor the words “health products and technologies register”; (b) in sub-clause (1) by deleting the words “medicines register” and substituting therefor the words “health products and technologies register”; and (c) in sub-clause (2) by deleting the words “medicines register” and substituting therefor the words “health products and technologies register”.

CLAUSE 29

THAT, Clause 29 of the Bill be amended—

(a) in the marginal note by deleting the words “medicines and medical devices” and substituting therefor the words “health products and technologies”; (b) by deleting sub-clause (1) and substituting therefor the following new sub-clause (1)–

“(1) Every application for registration of a health product or technology shall be submitted to the Registrar in the prescribed form and shall be accompanied by the prescribed particulars and samples of the relevant health product or technology and by the prescribed registration fee.”

(c) in sub-clause (3)– (i) by deleting the word “medicine” appearing in paragraph (a) and substituting therefor the words “health product or technology”; (ii) by deleting the word “medicine” appearing in paragraph (b) and substituting therefor the words “health product or technology”; (iii) by deleting the word “medicine” appearing in paragraph (c) and substituting therefor the words “health product or technology”;

(d) in sub-clause (4) by deleting the word “medicine” appearing in the opening sentence and substituting therefor the words “health product or technology”;

(e) by deleting sub-clause (6) and substituting therefor the following new sub-clause (6)—

“(6) Where the Authority has approved the registration of any health product or technology if it is satisfied of the safety, efficacy, quality, performance and economic value of the health product or technology, the Registrar shall register that health product or technology and shall enter in the register such particulars in regard to the health product or technology as are required by this Act to be so entered and shall issue to the applicant a certificate of registration in the prescribed form in respect of that health product or technology.”

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1566)

(f) in sub-clause (7) by deleting the word “medicine” and substituting therefor the words “health product or technology”;

(g) in sub-clause (8) by deleting the word “medicine” wherever it appears and substituting therefor the words “health product or technology”;

(h) in sub-clause (9) by deleting the word “medicines” and substituting therefor the words “health products and technologies”;

(i) in sub-clause (10) by deleting the word “medicine” and substituting therefor the words “health product or technology”;

(j) in sub-clause (11) by deleting the word “medicine” and substituting therefor the words “health product or technology”;

(k) in sub-clause (12) by deleting the word “medicine” appearing in the opening sentence and substituting therefor the words “health product or technology”;

(l) in sub-clause (14) by deleting paragraph (a) and substituting therefor the following new paragraph (a) —

“(a)Kenya Essential Medicines List, Kenya Essential Diagnostics list and Kenya Essential Medical Supplies list' means the list of essential medicines, diagnostics and medical supplies included in the latest editions of the official publications relating to guidelines for standard treatment which is compiled by the state department responsible for Health;”

NEW CLAUSES 29A & 29B

THAT, the Bill be amended by inserting the following new clauses immediately after clause 29–

Authorization of health products and technologies.

29A. (1) A person shall not import any health product or technology unless— (a) the imported health product or technology has been authorized through issuance of an import permit or a written authorization by the Authority; and (b) the imported health product or technology is inspected and verified by an inspector of the Authority at the ports of entry prior to its release.

(3) No batch or lot of any registered product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product and official batch or lot release by the Authority in cases of biological therapeutics.

(No. 98)

WEDNESDAY, OCTOBER 24, 2023 (1567)

(3) Each applicable test conducted by the manufacturer under subsection (2) shall be made on each batch or lot after completion of all processes of manufacture and such test may affect compliance with the standard applicable to the product.

(4) The manufacturer or marketing authorization holder of any registered biological therapeutic shall submit lot summary protocol for each lot that contains registered tests and results of tests performed and, such manufacturer or marketing authorization holder may be required to submit samples of product from the specified lot to the Authority for official batch or lot release in accordance with the prescribed regulations.

(5) Every batch or lot of a registered biological therapeutic imported into Kenya or manufactured in Kenya shall be evaluated and, on being satisfied of conformity with prescribed standards and payment of prescribed fees, the Director-General shall approve its release into the market and issue a certificate of official batch or lot release in the prescribed format.

(6) The Authority may recognize and accept official lot release certificates issued by other national regulatory authorities of other countries for a specific batch or lots of biological therapeutic manufactured within the territories of those national regulatory authorities, in issuance of a certificate under this section.

(7) A person who contravenes this section commits an offence and shall on conviction be liable— (a) in the case of a first offence, to a fine not exceeding one million shillings or to imprisonment for a term not exceeding two years, or to both; or (b) in the case of a subsequent offence, to a fine not exceeding two million shillings or to imprisonment for a term not exceeding five years, or to both.

Parallel importation of health products and technologies.

29B. (1) A person shall not engage in the parallel importation of a health product or technology into Kenya unless— (a) the person is incorporated as a limited liability company under the Companies Act; (b) the person has been granted a certificate of parallel importation; (c) the person is licensed to parallel import the health product or technology; (d) the health product or technology has a valid registration in Kenya under this Act; and

(No. 98)

WEDNESDAY, OCTOBER 24, 2023

(1568)

(e) the health product or technology has a valid market authorization in the country of origin.

(2) A person who wishes to undertake parallel importation of a health product or technology shall apply to the Board for a certificate of parallel importation in the prescribed manner.

(3) The Board shall establish and maintain a system that ensures that a registered parallel imported health product or technology can be traced from its sourcing, manufacturing, packaging, storage, transport to its delivery to the health facility, institution or private practice where the health product or technology is intended to be used.

(4) A person who— (a) is the holder of a certificate of parallel importation or licensee and fails to comply with any requirement or obligation in this Act; (b) contravenes any prohibition prescribed by the Authority; or (c) fails to comply with any requirement imposed on that person by the Board pursuant to this Act, commits an offence and is liable, upon conviction, to a fine not exceeding one million shillings or to imprisonment for a term not exceeding two years, or to both.

CLAUSE 30

THAT, Clause 30 of the Bill be amended—

(a) in sub-clause (1) by deleting the word “medicine” wherever it appears and substituting therefor the words “health product or technology”; and (b) in sub-clause (3), by deleting the word “medicine” wherever it appears in paragraph (b) and substituting therefor the words “health product or technology”.

CLAUSE 31

THAT, Clause 31 of the Bill be amended—

(a) in sub-clause (1) by deleting the word “medicine” and substituting therefor the words “health product or technology”; and (b) in sub-clause (3), by deleting the word “medicine” appearing in paragraph (c) and substituting therefor the words “health product or technology”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1569)

CLAUSE 32

THAT, Clause 32 of the Bill be amended—

(a) by deleting sub-clause (1) and substituting therefor the following new sub-clause (1)– “(1) The Authority shall cancel the registration of a health product or technology if— (a) a licensee has failed to comply with a condition subject to which a particular health product or technology has been registered; (b) a particular health product or technology does not comply with a prescribed requirement; or (c) it is not in the public interest to make a particular health product or technology available to the public.” (b) in sub-clause (2) by deleting the words “medicine or medical device” wherever it appears and substituting therefor the words “health product or technology”; (c) in sub-clause (4)– (i) by deleting the words “medicine or medical device” appearing in the opening sentence and substituting therefor the words “health product or technology”; and (ii) by deleting the words “medicine or medical device” appearing in paragraph (b) and substituting therefor the words “health product or technology”; and (d) by deleting the words “medicine or medical device” wherever it appears in sub- clause (5) and substituting therefor the words “health product or technology”.

CLAUSE 33

THAT, Clause 33 of the Bill be amended in sub-clause (1) by deleting the words “medicine or medical device” and substituting therefor the words “health product or technology”.

CLAUSE 34

THAT, Clause 34 of the Bill be amended—

(a) by deleting the words “medicines” and “medicine” wherever it appears and substituting therefor the words “health product or technology”; and (b) in the marginal note by deleting the words “medicines” and substituting therefor the words “health products and technologies”.

CLAUSE 35

THAT, Clause 35 of the Bill be amended—

(a) by deleting the word “medicine” wherever it appears and substituting therefor the words “health product or technology”;

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1570)

(b) in sub-clause (1) by inserting the words “or an enrolled pharmaceutical technologist” immediately after the word “pharmacist”; (c) in sub-clause (2) by inserting the words “or an enrolled pharmaceutical technologist” immediately after the word “pharmacist”; (d) in sub-clause (3) by inserting the words “or an enrolled pharmaceutical technologist” immediately after the word “pharmacist”; and (e) in sub-clause (4) by inserting the word “or an enrolled pharmaceutical technologist” immediately after the word “pharmacist”.

CLAUSE 36

THAT, the Bill be amended by deleting Clause 36

NEW CLAUSE

THAT, the Bill be amended by inserting the following new clause immediately after clause 36—

Clinical trials.

36A. (1) A health product or technology shall not be used for clinical trial unless an approval is granted by the Authority with the approval of the relevant ethics body.

(2) A person who intends to commence a clinical trial on a health product or technology shall make an application to the Authority in the prescribed form and the application shall be accompanied by the study protocol in the prescribed format and the prescribed fee.

(3) The study protocol submitted under subsection (2) shall include a post-trial access program to ensure access of investigational medicinal substances by participants in the trial before grant of marketing authorization by the Authority.

(4) The Authority shall prescribe guidelines for evaluation of applications made under subsection (2) to be implemented for accelerated evaluations during emergency situations, epidemics and outbreaks.

(5) A person granted an approval under this section shall put in place a robust quality assurance system to ensure that the clinical trial is carried out in a manner that ensures the integrity of data generated and the safety and well-being of the participants of the study.

(No. 98)

WEDNESDAY, OCTOBER 24, 2023

(1571)

(6) The Authority shall carry out inspection of the clinical trials and monitor compliance of the clinical trials with the prescribed requirements.

(7) Any amendments to clinical trials protocols shall be submitted to the Authority for approval before implementation.

PART V

THAT, the Bill be amended in the title to Part V by deleting the expression “PART V” and substituting therefor the expression “PART IV”.

CLAUSE 37

THAT, Clause 37 of the Bill be amended—

(a) in sub-clause (2) by deleting the words “and dealers in mining, agricultural or horticultural accessories” appearing in paragraph (a); (b) by inserting the following new sub-clause (3) immediately after sub-clause (2)— “(3) The Cabinet Secretary shall publish the list of scheduled substances prepared under subsection (1) in the Gazette.”

(c) by renumbering sub-clause (3) as sub-clause (4); (d) by deleting sub-clause (4) and substituting therefor the following new sub- clauses —

“(5) The Authority shall at least once every two years, review the lists under subsection (3), or whenever necessary in the interest of public health and safety. (6) Any modification of the list of scheduled substances prepared under this section shall be subject to the procedure provided in subsection (1), (2) and (3).”

CLAUSE 38

THAT, Clause 38 of the Bill be amended— (a) in sub-clause (1) by— (i) deleting the words “the Limitations prescribed by this sub-section” and substituting therefor the words “the following limitations”; (ii) deleting paragraph (c) (b) by deleting sub-clause (2) and substituting therefor the following new sub- clause (2)—

“(2) A person who is in possession of a scheduled substance otherwise than in accordance with the provisions of this section commits an offence and shall on conviction, be liable to a fine not exceeding two million shillings or to imprisonment for a term not exceeding three years; or to both.”

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1572)

CLAUSE 39

THAT, Clause 39 of the Bill be amended by deleting sub-clause (5) and substituting therefor the following new sub-clause (5)—

“(5) A licence issued under this section shall be valid for a period of one year, renewable annually”.

CLAUSE 40

THAT, the Bill be amended by deleting clause 40.

CLAUSE 41

THAT, Clause 41 of the Bill be amended—

(a) in sub-clause (1) by deleting paragraphs (c) and (e); (b) in sub-clause (2) by deleting paragraph (b) and (c); and (c) by deleting sub-clause (3).

CLAUSE 42

THAT, Clause 42 of the Bill be amended— (a) in sub-clause (1) by deleting the words “paragraph (b) of Section 53(2)” appearing in paragraph (a) and substituting therefor the words “section 41(2)(b)”; and (b) in sub-clause (3) by deleting the words “three years” and substituting therefor the words “one year”

CLAUSE 43

THAT, Clause 43 of the Bill be amended in sub-clause (1)— (a) by deleting the opening sentence and substituting therefor the following new opening sentence—

“(1) A qualified healthcare professional may supply or dispense a Scheduled Substance with therapeutic value for the purpose of medical, dental or veterinary treatment, as the case may be, subject to the following provisions—"

(b) in paragraph (b) by— (i) inserting the word “and” immediately after the word “supplied” appearing in sub-paragraph (iii); and (ii) deleting the word “and” appearing in sub-paragraph (iv);

(c) by deleting paragraph (c).

CLAUSE 45

THAT, the Bill be amended by deleting Clause 45 and substituting therefor the following new clause 45—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1573)

Automatic machines.

1. 45. (1) An authorized seller may use an automatic machine to dispense

over-the-counter scheduled substances. (2) The Authority shall develop regulations on the— (a) classes of substances permitted; (b) quantities of substances to be dispensed; (c) records of substances dispensed; (d) location of automatic machines; and (e) registration of automatic machines.

CLAUSE 46

THAT, the Bill be amended by deleting Clause 46 and substituting therefor the following new clause 46—

Electronic sale of health products and technologies.

1. 46. (1) The Authority shall prescribe guidelines to provide for the

electronic supply and dispensing of scheduled substances including through e-pharmacy, telemedicine, medication therapy management and online pharmacy. (2) The regulations made under subsection (1) shall provide for— (a) licensure of e-pharmacies; (b) safety of patients; (c) verification of the identity and traceability of patients; (d) verification of the identity and traceability of prescribers; and (e) integrity, legitimacy and authenticity of prescriptions including avoidance of multiple use of the same prescription.

(3) The electronic supply and dispensing of scheduled substances shall be permitted provided that the supply of such health products and technologies conforms with all requirements for the particular health product or technology in terms of its scheduling status and any other requirements as may be specified in regulations in relation to such supply or dispensing. (4) In the case of a prescription-only medicine, the required prescription shall have been obtained as a result of at least one physical interaction between an authorised practitioner and the patient within a period of at least six months. (5) Any person who contravenes this section shall be guilty of an offence, and shall on conviction, be liable to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding one year, or to both.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1574)

NEW CLAUSE

THAT, the Bill be amended by inserting the following new clause immediately after clause 46— Dietary supplements. 46A. (1) A dietary supplement shall— (a) not contain scheduled substances; and (b) have a stated or implied therapeutic purpose.

(2) Where a dietary supplement contains folic acid, the maximum daily dose for the dietary supplement shall be as per the guidelines prescribed by the Board of the Authority.

PART VI

THAT, the Bill be amended in the title of Part VI by deleting the expression “PART VI—MANUFACTURE OF MEDICINAL SUBSTANCES” and substituting therefor the expression

“PART

IV—MANUFACTURE

OF

HEALTH

PRODUCTS”.

CLAUSE 47

THAT, Clause 47 of the Bill be amended—

(a) in sub-clause (1) by deleting the words “medicinal substance” and substituting therefor the words “health product”; (b) by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)—

“(2) A manufacturing licence issued under this section shall be valid for a period of one year, renewable annually.”

(c) in sub-clause (3) by deleting the words “medicinal substance” and substituting therefor the words “health product;

(d) in sub-clause (4) by deleting the words “medicinal substance” and substituting therefor the words “health product”;

(e) by inserting the following sub-clauses immediately after sub-clause (5)—

“(6) The Authority shall prescribe regulations setting out conditions for the qualifications of personnel involved in the production processes of a health product regulated under this Act.

(7) The personnel qualified to conduct lot release of vaccines and batch release of health products shall submit their qualifications to the Authority.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1575)

(8) Any person who commits an offence under this section is on conviction, liable to a fine not exceeding ten million shillings, or to imprisonment for a term not exceeding ten years, or to both.”

CLAUSE 48

THAT, Clause 48 of the Bill be amended—

(a) by renumbering the provision as sub-clause (1); and (b) by inserting the following new sub-clauses immediately after sub-clause (1)—

“(2) The Authority shall have power to enter and inspect manufacturing premises to confirm compliance with prescribed good manufacturing practices and issue a certificate of compliance in the prescribed format upon payment of prescribed fees.

(3) The Cabinet Secretary shall make regulations for the better carrying out of the provisions of this section.

(4) Without prejudice to the generality of subsection (3), the Authority shall make regulations on— (a) revocation and suspension of manufacturing licences; (b) withdrawal of revocation of manufacturing licences upon request; and (c) transfer of manufacturing licences.”

PART VII

THAT, the Bill be amended in the title of Part VII by deleting the expression “PART VII” and substituting therefor the expression “PART VI”.

NEW CLAUSES 51A & 51B

THAT, the Bill be amended by inserting the following new clauses immediately after clause 51—

Information that is required to be displayed on the pack. 51A. A person dealing in a therapeutic cosmetic shall indicate—

(a) the common name of the therapeutic cosmetic; (b) the net weight; (c) all the cosmetic ingredients in the order of prominence but not including flavours or fragrances; (d) the name and address of manufacturer of the therapeutic cosmetic; (e) a warning statement; and (f) a statement that the therapeutic cosmetic is capable of curing or treating any disease or medical condition.

(No. 98)

WEDNESDAY, OCTOBER 24, 2023 (1576)

Manufacturing of cosmetics. 51B. (1) The Cabinet Secretary shall make regulations for the effective implementation of this section.

(2) The regulations made under subsection (1) may— (a) require manufacturers of cosmetics to register with the Authority; and (b) impose restrictions, requirements or other conditions on manufacturers of cosmetics, if such restrictions, requirements or conditions are necessary to protect public health.

CLAUSE 52

THAT, Clause 52 of the Bill be amended by deleting the words “have a therapeutic effect or value” and substituting therefor the words “treat, diagnose or prevent disease, or affect the structure or functions of the body”.

CLAUSE 54

THAT, Clause 54 of the Bill be amended by— (a) deleting sub-clause (3) and substituting therefor the following new sub-clause (3)—

“(3) Any person who manufactures, sells, supplies, imports or exports a therapeutic cosmetic which contains a prohibited ingredient commits an offence and, on conviction, shall be liable to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding two years, or to both.”

(b) inserting the following new sub-clause immediately after sub-clause (3)—

“(4) The Authority shall make regulations exempting from any labelling requirement of this Part, therapeutic cosmetics which are, in accordance with the practice of the trade, to be processed, labelled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this Part upon removal from such processing, labelling or repacking establishment.”

PART VIII

THAT, the Bill be amended in the title of Part VIII by deleting the expression “PART VIII” and substituting therefor the expression “PART VII”.

CLAUSE 55

THAT, Clause 55 of the Bill be amended in sub-clause (1) by inserting the words “, in-vitro diagnostics medical devices register” immediately after the words “human medical devices register”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1577)

CLAUSE 56

THAT, Clause 56 of the Bill be amended in sub-clause (1) by inserting the words “falsified, falsely-labelled or counterfeited” immediately after the word “substandard” appearing in paragraph (c).

CLAUSE 58

THAT, Clause 58 of the Bill be amended—

(a) in sub-clause (2) by inserting the words “in accordance with the most recent World Health Organization’s prescribed guidelines on good manufacturing practice” immediately after the word “Authority”; (b) by inserting the following new sub-clauses immediately after sub-clause (2)—

“(3) The Authority shall receive from the Kenya Nuclear Regulatory Authority established under the Nuclear Regulatory Act, documented evidence of radiation required to enable a medical device perform its therapeutic and diagnostic functions and the intended purpose of the device, for issuance of a registration certificate for a medical device.

(4) An importer, distributor or dealer shall establish and implement documented procedures for the maintenance of importation or distribution records and shall maintain an importation or distribution record of each medical device to be submitted to the Authority.”

CLAUSE 59

THAT, Clause 59 of the Bill be amended in sub-clause (1) by inserting the words “unregistered establishments for medical devices and” immediately after the word “under”.

NEW CLAUSE 59A

THAT, the Bill be amended by inserting the following new clause immediately after clause 59—

Registration of medical devices establishment.

59A. (1) An application for registration of a medical devices establishment shall be submitted to the Authority in the prescribed format and shall be accompanied by the prescribed fees.

(2) An importer, distributor or dealer will establish a system of notification of field safety corrective action and shall notify the Authority of such system.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1578)

(3) Where the Authority is satisfied that the application under subsection (1) meets the prescribed requirements, the Director- General shall issue a registration certificate for the medical devices establishment in the prescribed format.

(4) A medical devices establishment registration certificate under this section shall be valid for a period of one year, renewable annually upon application in accordance with the prescribed conditions.

(5) The registration certificate for manufacturers shall be valid for five years following a successful reinspection.

(6) The Authority may refuse to issue a medical devices establishment registration certificate where— (a) an applicant has made a false or misleading statement in the application; (b) the Authority has reasonable grounds to believe that issuing the medical devices establishment registration certificate will constitute a risk to the health or safety of patients, users or other persons; or (c) an applicant has failed to meet the prescribed conditions for medical devices establishment registration.

(7) Where the Authority does not issue a medical devices establishment registration certificate under subsection (6), the Authority shall— (a) notify the applicant in writing of the reasons for refusing the registration of the establishment; and (b) give the applicant an opportunity to respond to the Authority and provide relevant documentation or evidence in support of the application.

(8) After the issuance of a medical devices establishment registration certificate, where there is a change to any of the information submitted at the time of application, the holder of the registration certificate shall submit the new information to the Authority within ten working days of the change.

NEW PART

THAT, the Bill be amended by inserting the following new Part immediately after the new clause 59A—

PART VIII-THE NATIONAL PHARMACOVIGILANCE SYSTEM

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1579)

Pharmacovigilance. 59B. (1) The Authority shall establish a National Pharmacovigilance Centre which shall set up and manage the national pharmacovigilance and post marketing surveillance system.

(2) The Centre established under subsection (1) shall receive and maintain all relevant information about suspected adverse drug reactions and adverse events to health products or technologies which have been authorized by the Authority.

(3) The Authority shall conduct both passive surveillance and active surveillance of health products and technologies.

(4) The Authority shall carry out pharmacovigilance audits and inspections in order to ensure compliance with good pharmacovigilance practices and the prescribed requirements.

(5) All entities responsible for placing a health product or technology in the market shall establish and maintain a pharmacovigilance system for managing safety information of health products and technologies.

(6) The entities referred to in subsection (5) shall submit safety information to the Authority in the prescribed manner.

(7) The consumers, general public and health care professionals shall report adverse reactions and adverse events to the Authority in the prescribed manner.

PART XI

THAT, the Bill be amended in the title of Part XI by deleting the expression “PART XI” and substituting therefor the expression “PART IX”.

CLAUSE 60

THAT the Bill be amended by deleting Clause 60 and substituting therefor the following new clause 60—

Establishment of the National Quality Control Laboratory.

1. 60. (1) There is established the National Quality Control Laboratory

of the Authority which shall be used as a facility for—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023

(1580)

(a) the examination and testing of health products and technologies including vaccines and biopharmaceuticals and any material or substance from or with which and the manner in which drugs may be manufactured, processed or treated and ensuring the quality control of drugs and medicinal substances;

(b) performing chemical, biological, bio-chemical, physiological and pharmacological analysis and other pharmaceutical evaluation;

(c) testing, on behalf of the Government, of locally manufactured and imported health products and technologies in the Kenyan market prior to marketing authorization, redistribution and post-distribution;

(d) field testing of regulated products using screening techniques;

(e) providing technical support to local manufacturers and building their capacity in matters pertaining to quality control of regulated products through on site and off site training and laboratory assessments;

(f) conducting investigations into the quality and safety status of regulated products developing and administering a data bank on quality assurance of all health products and technologies and generating scientific evidence and reports on the quality and safety status of the registered products;

(g) conducting research and training and providing high quality analytics and expert knowledge in the areas of medicinal products and active pharmaceutical ingredients; and

(h) developing and administering a data bank on quality assurance on behalf of the Authority.

(2) The National Quality Control Laboratory shall be the quality control laboratory of health products and technologies for the Authority.

(3) The Board of the Authority shall appoint a Director, National Quality Control Laboratory who shall be responsible to the Authority for the day to day management of the National Quality Control Laboratory.

(No. 98)

WEDNESDAY, OCTOBER 24, 2023 (1581)

(4) The Director National Quality Control Laboratory shall hold office on such terms and conditions of service as may be specified in the instrument of appointment by the Board of the Authority.

(5) The Director National Quality Control Laboratory shall be a registered pharmacist and shall possess a Master’s degree in a science related field from a recognized university.

(6) The Director of the National Quality Control Laboratory shall— (a) oversee and coordinate all operations and administration of the National Quality Control Laboratory and provide technical guidance on quality control; (b) ensure timely quality control testing of all samples in conformity with national and international standards; (c) co-ordinate and supervise the activities of the National Quality Control Laboratory including staff; (d) collaborate with other laboratories, regulatory and law enforcement agencies, manufacturers of pharmaceutical and other health products to ensure quality in health products and technologies; (e) handle appeals on test results; (f) where the laboratory lacks capacity, subcontract laboratory testing services; (g) advice the Authority on matters of testing and quality control over health products and technologies; and (h) perform any other duties assigned by the Authority from time to time.

(7) The funds to be used for the management of the Laboratory shall consist of all moneys received or recovered under this Part and a portion of the moneys appropriated by Parliament to the Authority.

(8) Subject to subsection (7), monies generated by the Laboratory in the course of the performance of its functions under this section shall be solely expended on the Laboratory.

CLAUSE 61

THAT, Clause 61 of the Bill be amended in sub-clause (1) by deleting the words “Director-General” and substituting therefor the words “Director of the National Quality Control Laboratory”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1582)

PART XII

THAT, the Bill be amended in the title of Part XII by deleting the expression “PART XII” and substituting therefor the expression “PART X”.

CLAUSE 63

THAT, Clause 63 of the Bill be amended—

(a) in sub-clause (1) by deleting the words “medicine, drug, appliance or article” wherever they appear and substituting therefor the words “health product or technology”; and (b) in sub-clause (2) by inserting the words “or enrolled pharmaceutical technologists” immediately after the word “pharmacists” appearing in paragraph (d).

CLAUSE 64

THAT, Clause 64 of the Bill be amended by deleting the words “a medicine, drug, appliance or article” wherever it appears and substituting therefor the words “health product or technology”.

CLAUSE 65

THAT, Clause 65 of the Bill be amended—

(a) in paragraph (a) by— (i) deleting the words “ or similar article”; and (ii) deleting the word “extravagant,”. (b) in paragraph (b) by deleting the word “ an article” and substituting therefor the words “health product or technology”.

CLAUSE 66

THAT, Clause 66 of the Bill be amended—

(a) in sub-clause (1)— (i) by deleting the words “drug, appliance or article” wherever they appear in paragraph (a) and substituting therefor the words “health product or technology”; and (ii) by deleting the words “drug, appliance or article” appearing in paragraph (b) and substituting therefor the words “health product or technology”;

(b) in sub-clause (3) by— (i) renumbering the provision as clause (2); and (ii) by inserting the words “, enrolled pharmaceutical technologists” immediately after the word “pharmacists” appearing in paragraph (ii).

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1583)

CLAUSE 67

THAT, Clause 67 of the Bill be amended—

(a) by deleting the word “articles” appearing in the marginal note and substituting therefor the words “health products and technologies”; (b) by deleting sub-clause (1) and substituting the following new sub-clause (1)–

“(1) Subject to this Act, a person shall not sell by retail a health product or technology consisting of or comprising a substance recommended as a medicine unless there is written so as to be clearly legible on the health product or technology or on a label affixed thereto, or if the health product or technology is sold or supplied in more than one container, on the inner container or on a label affixed thereto—

(a) the appropriate designation of the substance so recommended or of each of the active constituents, or of each of the ingredients from which it has been compounded; and (b) in a case where the appropriate designation of each of the active constituents or ingredients is written, the appropriate quantitative particulars of the constituents or ingredients; provided that this subsection shall not apply to a health product or technology made up and supplied for the use of a particular person, being an article prescribed by reference to the needs of that person.”

(c) in sub-clause (2) by deleting the word “article” wherever it appears in the definition of “appropriate quantitative particulars” and substituting therefor the words “health product or technology”; (d) in sub-clause (3) by— (i) deleting the word “ an article” appearing in sub-clause (3) and substituting therefor the words “ a health product or technology”; (ii) deleting the words “two hundred thousand” appearing in paragraph (a) and substituting therefor the words “one million”; (iii) deleting the words “three hundred thousand” appearing in paragraph (b) and substituting therefor the words “two million”.

CLAUSE 68

THAT, the Bill be amended by deleting Clause 68.

CLAUSE 69

THAT, Clause 69 of the Bill be amended by— (a) deleting the word “article” and substituting therefor the words “health product or technology”; and (b) deleting the word “articles” and substituting therefor the words “health products and technologies”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1584)

PART XIII

THAT, the Bill be amended in the title to Part XIII by deleting the expression “PART XIII” and substituting therefor the expression “PART XI”.

CLAUSE 71

THAT, Clause 71 of the Bill be amended— (a) in the marginal note by deleting the words “medicines or medical devices” and substituting therefor the words “health products and technologies”; and (b) in sub-clause (1) by deleting the words “or homoeopathic medicine, preparation or medical device” and substituting therefor the words “health products and technologies”.

CLAUSE 72

THAT, Clause 72 of the Bill be amended— (a) in the marginal note by deleting the words “medicine or medical devices” and substituting therefor the words “health products and technologies”; (b) in sub-clause (1) by inserting the words “including a health product and technology for emergency use” immediately after the word “technology”; and (c) in sub-clause (3) by deleting the words “medicine or medical device product” and substituting therefor the words “health product or technology”.

CLAUSE 73

THAT, Clause 73 of the Bill be amended—

(a) in the marginal note by deleting the word “goods” and substituting therefor the words “health products and technologies”. (b) in sub-clause (1) by deleting the words “drug, article” wherever they appear and substituting therefor the words “health product or technology”; (c) in sub-clause (2) by deleting the words “drug or article” wherever they appear and substituting therefor the words “health product or technology”; (d) in sub-clause (3) by deleting the words “drug or article” and substituting therefor the words “health product or technology”; and (e) in sub-clause (4) by deleting the words “drug or article” and substituting therefor the words “health product or technology”.

CLAUSE 78

THAT, Clause 78 of the Bill be amended in sub-clause (1) by inserting the words “or enrolled pharmaceutical technologist” immediately after the words “registered pharmacist” appearing in paragraph (b).

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1585)

CLAUSE 79

THAT, the Bill be amended by deleting Clause 79 and substituting the following new clause 79—

Inspection and verification of health products and technologies at the ports of entry.

1. 79. (1) A person who imports a health product or technology shall

notify the inspectors of the Authority at the ports of entry to conduct pre-clearance inspection and verification.

(2) Any person who imports a health product or technology and causes it to be released to the market without authorization under subsection (1) shall be guilty of an offence.

(3) Any person who commits an offence under this section is upon conviction, liable to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding two years, or to both.

CLAUSE 80

THAT, Clause 80 of the Bill be amended— (a) by deleting the words “article” and “articles” wherever they appear and substituting therefor the words “health product or technology” and “health products and technologies” respectively in sub-clause (6), (7), (8), (9), (10), (11) and (12). (b) in sub-clause (1) by— (i) deleting the word “article” wherever it appears and substituting therefor the words “health product or technology”; and (ii) inserting the words “or any other vessel” immediately after the word “vehicle” appearing in paragraph (b).

CLAUSE 81

THAT, the Bill be amended by deleting Clause 81.

CLAUSE 82

THAT, the Bill be amended by deleting Clause 82.

CLAUSE 83

THAT, the Bill be amended by deleting Clause 83.

CLAUSE 85

THAT, Clause 85 of the Bill be amended by deleting the word “article” wherever it appears and and substituting therefor the words “health product or technology”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1586)

CLAUSE 86

THAT, Clause 86 of the Bill be amended in sub-clause (1) by deleting paragraph (b) and substituting therefor the following new paragraph (b)—

“(b) in the case of a subsequent offence, to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding two years, or to both”.

CLAUSE 87

THAT, Clause 87 of the Bill be amended in sub-clause (1) by deleting the word “article” wherever it appears and substituting therefor the words “health product or technology” in paragraph (c)

PART XIV

THAT, the Bill be amended in the title of Part XIV by deleting the expression “PART XIV” and substituting therefor the expression “PART XII”.

CLAUSE 88

THAT, Clause 88 of the Bill be amended by deleting paragraph (a) and substituting therefor the following new paragraph (a)—

“(a) such monies as may be appropriated by the National Assembly for the purposes of the Authority”.

CLAUSE 91

THAT, Clause 91 of the Bill be amended by—deleting the words “Kenya National Audit Office” wherever they appear and substituting therefor the words “Auditor- General”.

PART XV

THAT, the Bill be amended in the title of Part XV by deleting the expression “PART XV” and substituting therefor the expression “PART XIII”.

CLAUSE 95

THAT, Clause 95 of the Bill be amended—

(a) in sub-clause 2 by— (i) deleting the word “drugs,” in paragraph (a)(i); (ii) deleting the words “any drug” in paragraph (a)(ii); (iii) deleting the word “product” and substituting therefor the word “products” in paragraph (d);

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1587)

(iv) deleting the word “drugs” wherever it appears and substituting therefor the words “health products or technologies” in paragraph (h); (v) deleting the word “article” and substituting therefor the words “health product or technology” in paragraph (k); (vi) deleting the word “articles” and substituting therefor the words “health products and technologies” in paragraph (m); (vii) deleting the words “drugs, medical devices” and substituting therefor the words “health products and technologies” in paragraph (o); (viii) deleting the word “medicines” and substituting therefor the words “health products and technologies” in paragraph (v); (ix) deleting paragraph (x) and substituting therefor the following new paragraph (x)—

“(x) governing administration of clinical trials of health products and technologies;”

(x) deleting the words “medicine, medical device” and substituting therefor the words “health product or technology” in paragraph (aa); (xi) deleting the words “medicines or medical devices” and substituting therefor the words “health products or technologies” in paragraph (bb); (xii) deleting paragraph (dd) and substituting therefor the following new paragraph (dd)—

“(dd) the compounding of health products and technologies and the dispensing of health products and technologies”

(xiii) inserting the words “,an enrolled pharmaceutical technologist” immediately after the word “pharmacist” in paragraph (bb); (xiv) deleting paragraph (ii); (xv) inserting the following new paragraphs immediately after paragraph (ii)— “(jj) on pharmacovigilance and post market surveillance; (kk) official regulatory lot release of vaccines and other biological products imported and manufactured in Kenya; (ll)pricing of health products and technologies; (mm) good practices in the regulation of medical products; (nn) inspections, licensure and certification of the manufacture of medical products by health facilities; (oo) inspections, licensure and certification of manufacture of medical products and other regulated products by facilities not directly regulated by the Authority including steel industries, sugar industries; (pp) inspection and recognition of pharmaceutical quality control laboratories; (qq) to regulate licit use of narcotic and psychotropic substances; and (rr) to regulate parallel importation of medicines;”

(b) by renumbering sub-clause (2) as sub-clause (3).

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1588)

CLAUSE 96

THAT, Clause 96 of the Bill be amended— (a) in sub-clause (1) by— (i) deleting the word “Board” and substituting therefor the word “Boards”; (ii) deleting paragraph (d) and substituting therefor the following new paragraph (d)—

“(d) all members and staff of the former Boards shall be deemed to be members and staff of the Authority, and subject to the provisions of any rules made under this Act, shall continue in office for the period for which they were appointed as members and staff of the former Boards.”

(b) by deleting the sub-clause (2) and substituting therefor the following new sub- clause (2)—

“(2) In this section, “the former Boards” means the Pharmacy and Poisons Board and the Board of Management of the National Quality Control Laboratory established under the Pharmacy and Poisons Act, Cap. 244.”

(c) in sub-clause (3) by deleting the word “twelve” appearing in the opening sentence and substituting therefor the words “twenty four”.

CLAUSE 97

THAT, Clause 97 of the Bill be amended by inserting the words “with reference to section 96 (3)” immediately after the words “that Schedule” in sub-clause (1).

SECOND SCHEDULE

THAT, the Bill be amended by deleting the Second Schedule.

THIRD SCHEDULE

THAT, the Bill be amended by deleting the Third Schedule.

FOURTH SCHEDULE

THAT, the Fourth Schedule of the Bill be amended by deleting paragraph (1), (2), (3), (4) and (5) and substituting therefor the following new paragraphs—

1. 1. Biologics Committee.
2. 2. Pharmacovigilance Committee.
3. 3. Complementary, Alternative or Herbal Medicines Committee.
4. 4. Radiopharmaceuticals Committee.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1589)

1. 5. Cosmetics and Borderline Products Committee.
2. 6. Clinical Trial Scientific Technical Advisory Committee.
3. 7. Health Technology Assessment Committee.
4. 8. Nutraceuticals and Dietary Supplements Committee.
5. 9. Digital Health and Technologies Committee.
6. 10. Medical Devices and Health Technologies Committee.
7. 11. Veterinary Medicines Committee.

SEVENTH SCHEDULE

THAT, the Seventh Schedule of the Bill be amended by—

(a) deleting the word “Board” in the paragraph on Cap. 244 (b) deleting the phrase “(s. 116) and substituting the phrase (“s.97”). (c) deleting the paragraph on Cap. 254.

2) Notice is given that the Member for Mathare (Hon. Anthony Oluoch) intends to move the following amendments to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

LONG TITLE

THAT, the Bill be amended by deleting the Long Title and substituting therefor the following new Long Title— “AN ACT of Parliament to establish the Kenya Health Products and Technologies Authority to ensure safety, quality and efficacy or performance of drugs, poisons, therapeutic and biological products, therapeutic cosmetics, herbal medicines and products, chemical substances, medical devices, veterinary products and other health technologies; to provide for the harmonization and administration of the laws relating to the regulation of, drugs, poisons, therapeutic products, therapeutic cosmetics, chemical products, veterinary products and medical devices and the control and safe handling of poisons; to safeguard the security of the supply chains for, therapeutic products, cosmetics and veterinary products; to provide for measures to optimize the use of therapeutic products in health care in Kenya and for connected purposes.”

CLAUSE 2

THAT, the Clause 2 of the Bill be amended— (a) in the definition of “authorized seller of scheduled substances” by inserting the words “and enrolled as a pharmaceutical technologist or registered as a pharmacist” immediately after the word “Act”; (b) in the definition of “pharmacy” by inserting the words “licensed and” immediately after the words “carried out by” appearing in paragraph (a); (c) deleting the definition of “chemical substance” and substituting therefor the following new definition—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1590)

“chemical substance” means any substance or mixture of substances prepared, sold or represented for use as a germicide, antiseptic, disinfectant, pesticide, insecticide, rodenticide, vermicide, detergent or any other substance or mixture of substances which the Authority may, declare to be a chemical substance; (d) deleting the definition of “therapeutic cosmetic” and substituting therefor the following new definition— “therapeutic cosmetic” means a product with the ability to trigger biological actions on the dermis, to target and repair skin issues, to prevent future damage and contains ingredients that are usually not found in regular cosmetics or at higher strengths than could be sold safely over the counter;”.

CLAUSE 6

THAT, Clause 6 of the Bill be amended in sub-clause (4) by deleting the word “ten” in appearing in paragraph (c) and substituting therefor the word “fifteen”.

CLAUSE 8

THAT, Clause 8 of the Bill be amended in sub-clause (7) by inserting the words “,fair representation of persons with disabilities” immediately after the words “regional balance.”

CLAUSE 23

THAT, Clause 23 of the Bill be amended in sub-clause (2) by —

(a) deleting the words “one million” appearing in paragraph (a) and substituting therefor the words “two million”; and (b) deleting the words “two million” appearing in paragraph (b) and substituting therefor the words “five million”.

CLAUSE 29

THAT, Clause 29 of the Bill be amended by deleting sub-clause (9).

CLAUSE 35

THAT, Clause 35 of the Bill be amended in sub- clause (2) by inserting the word “registered” immediately after the words “may prohibit a”.

CLAUSE 42

THAT, Clause 42 of the Bill be amended by—

(a) deleting sub-clause (1) and substituting therefor the following new sub-clause (1)—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1591)

“(1) An authorized seller shall enter a record of such particulars of the scheduled substance before delivery of the scheduled substance under this Act.” (b) inserting the following new sub-clause (2) immediately after the new sub-clause (1)— “(2) A record under subsection (1) shall be in the format prescribed by the Authority and shall indicate — (a) the date of the sale; (b) the name and address of the purchaser; (c) the quantity of the scheduled substances sold; and (d) the purpose for which it is stated by the purchaser to be required.”

(c) renumbering sub-clause (2) as sub-clause (3); and (d) renumbering sub-clause (3) as sub-clause (4).

CLAUSE 51

THAT, the Bill be amended in clause 51 by inserting the words “and, on conviction, shall be liable to a fine not exceeding one million shillings, or to imprisonment for a term not exceeding two years, or to both” immediately after the word “offence”.

CLAUSE 54

THAT, the Bill be amended by deleting clause 54.

CLAUSE 63

THAT, Clause 63 of the Bill be amended by deleting sub-clause (3).

3) Notice is given that the Member for Seme (Hon. (Dr.) James Nyikal) intends to move the following amendments to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

CLAUSE 2

THAT, Clause 2 of the Bill be amended by inserting the following new definitions in the proper alphabetic sequence— No. 21 of 2017.

“Director-General for Health” has the meaning assigned to it under the Health Act;

“wholesaler dealer” means a person who is licensed to carry out a business where health products and technologies are stored, distributed or sold in bulk to persons other than individual consumers and includes registration, importation, warehousing, good distribution practices and pharmacovigilance;”.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1592)

CLAUSE 12

THAT, Clause 12 of the Bill be amended by deleting paragraph (t).

CLAUSE 21

THAT, Clause 21 of the Bill be amended— (a) by deleting sub-clause (4); and (b) in sub-clause (9) by deleting the words “Cabinet Secretary, with respect to its activities and the Cabinet Secretary shall lay a copy of each report before Parliament” and substituting therefor the following words “Board of the Authority which shall submit a copy of the report to the Cabinet Secretary who shall transmit the report to Parliament”.

CLAUSE 22

THAT, Clause 22 of the Bill be amended in sub-clause (3) by deleting the words “sub- section (1)” and substituting therefor the words “The provisions of subsection(1)(a)”.

CLAUSE 29

THAT, Clause 29 of the Bill be amended by deleting sub-clause (4) and substituting therefor the following new sub-clause (4)— “(4) Where the Authority finds that an application for registration of a medicine or medical device does not satisfy the requirements provided in subsection (3), it shall notify the applicant in writing of the reasons why that medicine or medical device should not be registered and invite the applicant to make comments on its finding within a period of one month from the date of the notification.”

CLAUSE 31

THAT, the Bill be amended by deleting clause 31.

CLAUSE 35

THAT, Clause 35 of the Bill be amended— (a) in sub-clause (1) by inserting the words “upon consultation and concurrence with the person who prescribed the medicine,” immediately after the word “shall”; (b) by deleting sub-clause (2); (c) by renumbering sub-clause (3) as sub-clause (2); and (d) by deleting sub-clause (4).

CLAUSE 38

THAT, Clause 38 of the Bill be amended by deleting sub-clause (2) and substituting therefor the following new sub-clause (2)—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1593)

“(2) A person who is in possession of a scheduled substance otherwise than in accordance with the provisions of this section commits an offence and shall on conviction, be liable to a fine not exceeding one million shillings or to imprisonment for a term not exceeding three years; or to both.”

CLAUSE 39

THAT, Clause 39 of the Bill be amended in sub-clause (4) by inserting the word “and” immediately after the words “distribution of the Scheduled Substances”.

CLAUSE 42

THAT, Clause 42 of the Bill be amended in sub-clause (3) by deleting the words “one hundred thousand shillings or to imprisonment for a term not exceeding three years” and substituting therefor the words “five hundred thousand shillings or to imprisonment for a term not exceeding one year”.

CLAUSE 44

THAT, Clause 44 of the Bill be amended in sub-clause (3) by deleting the words “two hundred thousand” and substituting therefor the words “five hundred thousand”.

CLAUSE 79

THAT, the Bill be amended by deleting Clause 79.

CLAUSE 81

THAT, Clause 81 of the Bill be amended by deleting the words “Director of Medical Services” and substituting therefor the words “Director-General for Health”.

CLAUSE 83

THAT, Clause 83 of the Bill be amended by deleting the words “Cabinet Secretary” wherever they appear and substituting therefor the words “the Authority”.

CLAUSE 90

THAT, Clause 90 of the Bill be amended in sub-clause (2) by deleting the words “think fit” appearing in paragraph (f) and substituting therefor the words “deem appropriate”.

CLAUSE 92

THAT, Clause 92 of the Bill be amended in sub-clause (2) by inserting the words “with the approval of the Cabinet Secretary” immediately after the word “determine”.

FOURTH SCHEDULE

THAT, the Fourth Schedule of the Bill be amended—

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1594)

(a) in paragraph (1) by deleting the word “Coordination” appearing in sub- paragraph (4); (b) in paragraph (2) by inserting the following new sub-paragraphs immediately after sub-paragraph 2(e)—

“(f)a registered medical practitioner nominated by the Kenya Medical Association; (g)the Director-General for Health or a representative designated in writing;”

(c) in paragraph (4) by deleting the words, “in consultation with the Cabinet Secretary responsible for health,” appearing in sub-paragraph (2)(a).

4) Notice is given that the Nominated Member (Hon. Irene Mayaka) intends to move the following amendments to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

CLAUSE 37

THAT, Clause 37 of the Bill be amended — (a) by inserting the following new sub-clauses immediately after sub-clause (2)— “(3) The Cabinet Secretary shall publish the list prepared under subsection (1) in the Gazette. (4)The list published under subsection (3) shall include narcotic substances, prescription-only medications, pharmacist-only medications, pharmacy-only medications, over-the-counter medicines, hazardous substances and prohibited substances”. (b) by renumbering sub-clause (3) as sub-clause (5); and (c) by renumbering sub-clause (4) as sub-clause (6);

5) Notice is given that the Member for Ndhiwa (Hon. Martin Peters Owino) intends to move the following amendment to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

CLAUSE 72

THAT, clause 72 of the Bill be amended in subclause (1) by deleting the word “person” appearing immediately after the words “The Authority may authorise a” and substituting therefor the words “registered pharmacist”. 6) Notice is given that the Member for Homa Bay Town (Hon. Peter Kaluma) intends to move the following amendment to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

CLAUSE 3

THAT, the Bill be amended by deleting clause 3.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1595)

CLAUSE 4

THAT, the Bill be amended by deleting clause 4.

CLAUSE 5

THAT, the Bill be amended by deleting clause 6.

CLAUSE 6

THAT, the Bill be amended by deleting clause 6.

CLAUSE 7

THAT, the Bill be amended by deleting clause 7.

CLAUSE 8

THAT, the Bill be amended by deleting clause 8.

CLAUSE 9

THAT, the Bill be amended by deleting Clause 9.

CLAUSE 10

THAT, the Bill be amended by deleting Clause 10.

CLAUSE 11

THAT, the Bill be amended by deleting Clause 11.

CLAUSE 12

THAT, the Bill be amended by deleting Clause 12.

CLAUSE 13

THAT, the Bill be amended by deleting Clause 13.

CLAUSE 14

THAT, the Bill be amended by deleting Clause 14.

CLAUSE 15

THAT, the Bill be amended by deleting Clause 15.

CLAUSE 16

THAT, the Bill be amended by deleting Clause 16.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1595)

CLAUSE 17

THAT, the Bill be amended by deleting Clause 17.

CLAUSE 18

THAT, the Bill be amended by deleting Clause 18.

CLAUSE 19

THAT, the Bill be amended by deleting Clause 19.

CLAUSE 20

THAT, the Bill be amended by deleting Clause 20.

CLAUSE 21

THAT, the Bill be amended by deleting Clause 21.

CLAUSE 22

THAT, the Bill be amended by deleting Clause 22.

CLAUSE 23

THAT, the Bill be amended by deleting Clause 23.

CLAUSE 24

THAT, the Bill be amended by deleting Clause 24.

CLAUSE 25

THAT, the Bill be amended by deleting Clause 25.

CLAUSE 26

THAT, the Bill be amended by deleting Clause 26.

CLAUSE 27

THAT, the Bill be amended by deleting Clause 27.

CLAUSE 28

THAT, the Bill be amended by deleting Clause 28.

CLAUSE 29

THAT, the Bill be amended by deleting Clause 29.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1596)

CLAUSE 30

THAT, the Bill be amended by deleting Clause 30.

CLAUSE 31

THAT, the Bill be amended by deleting Clause 31.

CLAUSE 32

THAT, the Bill be amended by deleting Clause 32.

CLAUSE 33

THAT, the Bill be amended by deleting Clause 33.

CLAUSE 34

THAT, the Bill be amended by deleting Clause 34.

CLAUSE 35

THAT, the Bill be amended by deleting Clause 35.

CLAUSE 36

THAT, the Bill be amended by deleting Clause 36.

CLAUSE 37

THAT, the Bill be amended by deleting Clause 37.

CLAUSE 38

THAT, the Bill be amended by deleting Clause 38.

CLAUSE 39

THAT, the Bill be amended by deleting Clause 39.

CLAUSE 40

THAT, the Bill be amended by deleting Clause 40.

CLAUSE 41

THAT, the Bill be amended by deleting Clause 41.

CLAUSE 42

THAT, the Bill be amended by deleting Clause 42.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1597)

CLAUSE 43

THAT, the Bill be amended by deleting Clause 43.

CLAUSE 44

THAT, the Bill be amended by deleting Clause 44.

CLAUSE 45

THAT, the Bill be amended by deleting Clause 45.

CLAUSE 46

THAT, the Bill be amended by deleting Clause 46.

CLAUSE 47

THAT, the Bill be amended by deleting Clause 47.

CLAUSE 48

THAT, the Bill be amended by deleting Clause 48.

CLAUSE 49

THAT, the Bill be amended by deleting Clause 49.

CLAUSE 50

THAT, the Bill be amended by deleting Clause 50.

CLAUSE 51

THAT, the Bill be amended by deleting Clause 51.

CLAUSE 52

THAT, the Bill be amended by deleting Clause 52.

CLAUSE 53

THAT, the Bill be amended by deleting Clause 53.

CLAUSE 54

THAT, the Bill be amended by deleting Clause 54.

CLAUSE 55

THAT, the Bill be amended by deleting Clause 55.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1598)

CLAUSE 56

THAT, the Bill be amended by deleting Clause 56.

CLAUSE 57

THAT, the Bill be amended by deleting Clause 57.

CLAUSE 58

THAT, the Bill be amended by deleting Clause 58.

CLAUSE 59

THAT, the Bill be amended by deleting Clause 59.

CLAUSE 60

THAT, the Bill be amended by deleting Clause 60.

CLAUSE 61

THAT, the Bill be amended by deleting Clause 61.

CLAUSE 62

THAT, the Bill be amended by deleting Clause 62.

CLAUSE 63

THAT, the Bill be amended by deleting Clause 63.

CLAUSE 64

THAT, the Bill be amended by deleting Clause 64.

CLAUSE 65

THAT, the Bill be amended by deleting Clause 65.

CLAUSE 66

THAT, the Bill be amended by deleting Clause 66.

CLAUSE 67

THAT, the Bill be amended by deleting Clause 67.

CLAUSE 68

THAT, the Bill be amended by deleting Clause 68.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1599)

CLAUSE 69

THAT, the Bill be amended by deleting Clause 69.

CLAUSE 70

THAT, the Bill be amended by deleting Clause 70.

CLAUSE 71

THAT, the Bill be amended by deleting Clause 71.

CLAUSE 72

THAT, the Bill be amended by deleting Clause 72.

CLAUSE 73

THAT, the Bill be amended by deleting Clause 73.

CLAUSE 74

THAT, the Bill be amended by deleting Clause 74.

CLAUSE 75

THAT, the Bill be amended by deleting Clause 75.

CLAUSE 76

THAT, the Bill be amended by deleting Clause 76.

CLAUSE 77

THAT, the Bill be amended by deleting Clause 77.

CLAUSE 78

THAT, the Bill be amended by deleting Clause 78.

CLAUSE 79

THAT, the Bill be amended by deleting Clause 79.

CLAUSE 80

THAT, the Bill be amended by deleting Clause 80.

CLAUSE 81

THAT, the Bill be amended by deleting Clause 81.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1600)

CLAUSE 82

THAT, the Bill be amended by deleting Clause 82.

CLAUSE 83

THAT, the Bill be amended by deleting Clause 83.

CLAUSE 84

THAT, the Bill be amended by deleting Clause 84.

CLAUSE 85

THAT, the Bill be amended by deleting Clause 85.

CLAUSE 86

THAT, the Bill be amended by deleting Clause 86.

CLAUSE 87

THAT, the Bill be amended by deleting Clause 87.

CLAUSE 88

THAT, the Bill be amended by deleting Clause 88.

CLAUSE 89

THAT, the Bill be amended by deleting Clause 89.

CLAUSE 90

THAT, the Bill be amended by deleting Clause 90.

CLAUSE 91

THAT, the Bill be amended by deleting Clause 91.

CLAUSE 92

THAT, the Bill be amended by deleting Clause 92.

CLAUSE 93

THAT, the Bill be amended by deleting Clause 93.

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1601)

7) Notice is given that the Member for Rarieda (Hon. (Dr.) Otiende Amollo) intends to move the following amendment to the Kenya Drugs Authority Bill, 2022 at the Committee Stage—

CLAUSE 2

THAT, the Clause 2 of the Bill be amended by deleting the definition of “pharmacy” and substituting therefor the following new definition—

Cap. 244. “pharmacy” has the meaning assigned to it under the Pharmacy and Poisons Act.

CLAUSE 8

THAT, the Clause 8 of the Bill be amended in sub-clause (2) by deleting paragraph (j) and substituting therefor the following new paragraph—

“(j)one person, not being a Governor, who is a registered pharmacist of good standing, nominated by the Council of Governors”;

CLAUSE 39

THAT, the Clause 39 of the Bill be amended in the marginal note by deleting the words “Wholesale Dealer’s Licence” and substituting therefor the word “Local Technical Representative Licence ”.

…......./Notices*(Cont’d)

(No. 98)

WEDNESDAY, OCTOBER 25, 2023 (1602)

LIMITATION OF DEBATE

The House resolved on Wednesday, August 9, 2023 as follows— Limitation of Debate on Motions sponsored by Individual Members

IV. THAT, each speech in a debate on any Motion introduced by an Individual Member shall be limited in the following manner:- A maximum of one and a half hours with not more than ten (10) minutes for the Mover in moving and five (5) minutes in replying, and a maximum of five (5) minutes for any other Member speaking, including the Leader of the Majority Party and the Leader of the Minority Party; and that priority in speaking shall be accorded to the Leader of the Majority Party, the Leader of the Minority Party and the Chairperson of the relevant Departmental Committee, in that order.

The House resolved on Wednesday, February 15, 2023 as follows— Limitation of Debate on Individual Members’ Bills V. THAT, each speech in a debate on Bills NOT sponsored by a Committee, the Leader of the Majority Party or the Leader of the Minority Party shall be limited as follows: A maximum of three hours and thirty minutes, with not more than thirty (30) minutes for the Mover, in moving and ten (10) minutes in replying, a maximum of thirty (30) minutes for the Chairperson of the relevant Committee and a maximum of ten (10) minutes for any other Member speaking, except the Leader of the Majority Party and the Leader of the Minority Party, who shall be limited to a maximum of fifteen minutes (15) each; and that priority in speaking shall be accorded to the Leader of the Majority Party, the Leader of the Minority Party and the Chairperson of the relevant Departmental Committee, in that order.

.……. /Notice Paper*

NOTICE PAPER

Tentative business for

Wednesday (Afternoon), October 25, 2023 (Published pursuant to Standing Order 38(1))

It is notified that the following business is tentatively scheduled to appear in the Order Paper for Wednesday (Afternoon), October 25, 2023–

A. THE NATIONAL YOUTH COUNCIL (AMENDMENT) BILL

(NATIONAL ASSEMBLY BILL NO. 1 OF 2023)

(The Hon. Joshua Kandie, M.P.)

Second Reading (Question to be put)

B. THE LAND (AMENDMENT) BILL (NATIONAL ASSEMBLY BILL

NO. 40 OF 2022)

(The Hon. Simon King’ara, M.P.)

Second Reading (Question to be put)

C. MOTION - APPROVAL OF NOMINEE TO ONE NATIONAL

GOVERNMENT CONSTITUENCY DEVELOPMENT

FUND CONSTITUENCY COMMITTEE

(The Chairperson, NG-CDF Committee)

D. COMMITTEE OF THE WHOLE HOUSE

(i) The Insurance (Amendment) Bill (National Assembly Bill No. 18 of 2023) (The Leader of the Majority Party)

(ii) The Kenya Drugs Authority Bill (National Assembly Bill No. 54 of 2022) (The Hon. (Dr.) Robert Pukose, M.P.)

(If not concluded on Wednesday, October 25, 2023 – Morning Sitting)

E. THE

ASSISTED

REPRODUCTIVE

TECHNOLOGY

BILL

(NATIONAL ASSEMBLY BILL NO. 61 OF 2022)

(The Hon. Millie Odhiambo, M.P.)

Second Reading (Resumption of debate interrupted on Wednesday, October 18, 2023 – Afternoon Sitting) (Balance of time – 3 hours 7 minutes)

F. THE GERIATRIC BILL (NATIONAL ASSEMBLY BILL NO. 50 OF

2022) (The Hon. Gathoni Wamuchomba, M.P.)

Second Reading

G. THE PUBLIC SERVICE COMMISSION (AMENDMENT) BILL

(NATIONAL ASSEMBLY BILL NO. 6 OF 2023)

(The Hon. Benjamin Gathiru, M.P.)

Second Reading

H. THE

PUBLIC

PROCUREMENT

AND

ASSET

DISPOSAL

(AMENDMENT) BILL (NATIONAL ASSEMBLY BILL NO. 62 OF

2022) (The Hon. Benjamin Gathiru, M.P.)

Second Reading

I. THE

ANTI-CORRUPTION

AND

ECONOMIC

CRIMES

(AMENDMENT) BILL (NATIONAL ASSEMBLY BILL NO. 30 OF

2023) (The Hon. Peter Kaluma, M.P.)

Second Reading

J. THE

WILDLIFE

CONSERVATION

AND

MANAGEMENT

(AMENDMENT) BILL (NATIONAL ASSEMBLY BILL NO. 3 OF 2023)

(The Hon. (Capt.) Ruweida Obo, M.P.)

Second Reading

K. MOTION –

REPORTS OF THE AUDITOR-GENERAL ON THE

FINANCIAL STATEMENTS FOR THE NATIONAL

GOVERNMENT

CONSTITUENCIES

DEVELOPMENT

FUND

FOR

TWELVE

CONSTITUENCIES IN KAKAMEGA COUNTY

(The Chairperson, Decentralized Funds Accounts Committee) (Resumption of debate interrupted on Thursday, October 19, 2023)

L. MOTION –

1970 UNESCO CONVENTION ON THE MEANS OF

PROHIBITING AND PREVENTING THE ILLICIT

IMPORT, EXPORT AND TRANSFER OF OWNERSHIP

OF CULTURAL PROPERTY

(The Chairperson, Departmental Committee on Sports and Culture)

M. MOTION –

INSPECTION OF VARIOUS ONE-STOP BORDER

POSTS IN THE NORTHERN CORRIDOR IN THE

EAST AFRICAN COMMUNITY

(The Chairperson, Select Committee on Regional Integration)

N. MOTION -

SESSIONAL PAPER NO. 1 OF 2023 ON KENYA

NATIONAL

POPULATION

POLICY

FOR

SUSTAINABLE DEVELOPMENT

(The Chairperson, Departmental Committee on Finance and National Planning)

O. MOTION –

THE 4TH GENERAL ASSEMBLY OF THE EASTERN

AFRICA PARLIAMENTARY ALLIANCE ON FOOD

SECURITY AND NUTRITION (EAPA-FSN) HELD IN

KIGALI, RWANDA

(The Chairperson, EAPA-FSN Caucus)

P. MOTION –

LOANS

CONTRACTED

BY

THE

NATIONAL

GOVERNMENT BETWEEN MAY 2022 AND APRIL

2023

(The Chairperson, Public Debt and Privatization Committee)

Q. MOTION –

REPORTS

OF

THE

AUDITOR-GENERAL

ON

TWENTY-THREE

NON-COMPLIANT

STATE

CORPORATIONS

(The Chairperson, Public Investments Committee on Social

Services, Administration and Agriculture)

R. MOTION –

PROCEEDINGS OF THE SECOND ORDINARY

SESSION

OF

THE

SIXTH

PAN-AFRICAN

PARLIAMENT (PAP)

(Member of the Pan-African Parliament)

S. MOTION –

PROCEEDINGS OF THE 2023 UNITED NATIONS

HIGH

LEVEL

POLITICAL

FORUM

ON

SUSTAINABLE DEVELOPMENT

(The Vice Chairperson, Parliamentary Caucus on Sustainable Development Goals (SDGs) and Business)

T. THE

NATIONAL

GOVERNMENT

CONSTITUENCIES

DEVELOPMENT

FUND

(AMENDMENT)

BILL

(NATIONAL

ASSEMBLY BILL NO. 13 OF 2023)

(The Leader of the Majority Party and the Leader of the Minority Party) Second Reading

U. THE CONFLICT OF INTEREST BILL (NATIONAL ASSEMBLY BILL

NO. 12 OF 2023)

(The Leader of the Majority Party)

Second Reading

.….……../Appendix*

A P P E N D I X

NOTICE OF PETITIONS, QUESTIONS &

STATEMENTS

ORDER NO. 4 - PETITIONS

It is notified that, pursuant to the provisions of Standing Order 225, the following Petition will be presented –

No. Subject Petitioner(s) Relevant Committee

58/2023 Amendment to the Estate Duty Act to entrench taxation equality

To be reported by the Hon. Speaker on behalf of Mr. Godfrey Maina, Mr. Kevin Kiarie, Mr. Muhia Kagwi and Mr. John Wangai

Public Petitions

.….……../Appendix*(Cont’d)

ORDER NO.7 - STATEMENTS

It is notified that, pursuant to the provisions of Standing Order 44(2)(c), the following Statement will be requested–

No. Subject Member Relevant Committee

1. 1. Management of houses and

treatment of tenants on estates in Mombasa County owned by National Housing Corporation

Hon. Omar Mwinyi, M.P. (Changamwe Constituency)

Chairperson, D.C. on Housing, Urban Planning & Public Works