Delivering as One UN to
Strengthen Regulatory Framework
for Medical Devices in Kenya
The case of condoms regulation in Kenya
Authors
1) Dr Regina Mbindyo, National Professional Officer- Health Technologies, WHO Kenya
2) Dr. Geoffrey Okumu, Programme Specialist – RH/HIV&AIDS UNFPA Kenya Office
Poster No K.14
Highlight of the Problem
• Specific Problem – Mandatory post-shipment testing of WHO/UNFPA pre-qualified
condoms supplied to Kenya (and 12 other countries in ESA) by UNFPA
– This testing (in-country) is done by non-accredited laboratories
(application of varying standards)
• Broader Problem – Lack of effective regulatory system for Medical Devices in Kenya
– Similar problem in the other 12 countries (from WHO assessment)
• Specific Experience/Best Practice – Collaboration between the two UN Agencies to support
Kenya in addressing the specific and the broader problems
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
UN Agencies Headquartered in Kenya United Nations Environment Programme (UNEP)
United Nations Human Settlements Programme (UN-Habitat)
United Nations Country Team for Kenya
Food and Agriculture Organisation for the United Nations (FAO)
International Civil Aviation Organization (ICAO)
International Labour Office (ILO)
International Maritime Organization (IMO)
International Monetary Fund (IMF)
United Nations Children's Fund - Kenya Country Office (UNICEF-KCO)
United Nations Development Fund for Women (UNIFEM)
United Nations Development Programme (UNDP)
United Nations Drug Control Programme (UNODC)
United Nations Educational, Social and Cultural Organization (UNESCO)
United Nations High Commission for Refugees (UNHCR)
United Nations Industrial Development Organization (UNIDO)
United Nations Office for Project Services (UNOPS)
United Nations Population Fund (UNFPA)
United Nations Programme on HIV/AIDS (UNAIDS)
United Nations Women (UNWOMEN)
World Bank
World Food Programme (WFP)
World Health Organization (WHO)
United Nations Centre for Regional Development (UNCRD)
• There are at least 23 UN
Agencies with major offices in
Kenya
• WHO and UNFPA are among
the UN agencies supporting
the health sector in Kenya
• Collaborative WHO/UNFPA
support on Medical Devices
emerged out of on-going
support (by the 2 agencies) in
HIV & RH (services & products)
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
UN Reform Status and the UNDAF - Kenya
• Kenya has formally initiated Delivering as One (DaO)
process as a self starter Country.
• The UN Development Assistance Framework (UNDAF):
2014 - 2018 is being developed in the context of DaO.
• The UNDAF is designed around three pillars:
– Governance, human capital, and economy.
• The Proposed Regulatory Reforms cut across the 3 Pillars
Each UN Agency is aligning its country support strategies
and frameworks to align with the DaO principles
The Collaborative approach applied by WHO & UNFPA is
consistent with DaO
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Medical Products Regulation: Kenya
• The Pharmacy and Poisons Board (PPB) is the
Medicines Regulatory Agency (MRA)
(http://pharmacyboardkenya.org/)
• Established in 1957
• Main challenge of PPB: Legal Framework – Narrow scope (not explicit on other medical products)
– Lack of independence from MOH
• The Health Policy (2013-2030) – Provides for establishment of Kenya Food & Drugs Authority (K-FDA)
– To regulate ALL Health Products & Technologies (HPTs)
– The result of sustained Advocacy by WHO and others
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Challenge: Many Regulatory Actors
Regulatory Body Date
Enacted Chair
Regulatory Scope (at Inception) Additional Scope
Profession ‘Tools of Trade’
1 Pharmacy and Poisons
Board (PPB)
1957 DMS Pharmacy
Profession
Trade in Drugs &
Poisons -
2 Nursing Council of
Kenya (NCK)
1983 Elected by
other Members
Nurses
-
NURSING COMMODITIES
REGULATIONS, 2012: Legal
Notice No. 17
3 Kenya Medical
Laboratory Technicians
and Technologists
Board (KMLTTB)
2000 Minister
appoints from
among Board
Members
Medical
Laboratory
Technicians &
Technologists
-
MEDICAL LABORATORY
(EQUIPMENT AND
REAGENTS VALIDATION)
REGULATIONS, 2011 Legal
Notice No. 113
Other Bodies – outside the Health Sector
1 Kenya Bureau of
Standards (KEBS)
1974 Appointed by
the Minister* -
Standardization of
specifications for
‘commodities’
Testing, Inspections and Pre-
Export verification of
conformity
Overriding Challenge: To rationalize and harmonize the fragmented regulatory mandates
Main Strategy: Advocacy to Government, RECs and Other Stakeholders (Multipronged)
Approach: Advocacy was from the perspective of the agency’s country support focus:
1) Overall Regulatory Strengthening (WHO)
2) Quality and Safety of RH Commodities (UNFPA)
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Kenya Health Policy Framework: 2013-30
• Kenya Health Policy Framework – Modelled on the WHO Health Systems Building Blocks
• Health Products and Technologies (HPTs) – one of the Building Blocks
• One Provision under the HPT Block – Establish a Harmonized Regulatory Framework for HPTs • Scope of HPTs: human drugs; vaccines, blood and its products; diagnostics, medical devices & technologies;
animal and veterinary drugs; food products, tobacco products, cosmetics and emerging health technologies).
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Position Paper: Post-Shipment Testing
Overall Stakeholder Recommendations:-
a) Pre-Qualification of manufacturers – Involve member state regulators in (as for medicines WHO-PQ)
b) Accreditation of condom testing laboratories – Member States should strive to achieve accreditation
c) Pre-shipment testing of condoms – Participation in pre-shipment verification of conformity (build confidence)
d) Post-shipment testing of condoms – Member states urged to waive post-shipment testing
– In case of test failure - verification to be done in accredited laboratory
e) Post-Marketing Surveillance of condoms – Establish post-market surveillance systems
– Harmonize QA standards for condoms among member states
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Critical Timeline: Key Health Related Events
<2010 2011 2012 2013 2014
Events related to
UNFPA
Events related to
WHO
CCS II – Kenya (2008-2013) CCS III -Kenya (2013-2019) -Draft)
Assessment of CCP and RHCS
Vision 2030 - Started in 06, Launched in 08, MTP to 2012; MTP II Launched July 2013
Const.
Referendum
(2009)
New Constitution: Kenya Constitution 2010
Election Devolved Governments
Key National
Events
Events related to
the health sector
Kenya Policy Framework, ‘94-10 Kenya Health Policy Review Review of draft by Counties
Two Ministries in Health (since 2008) One MOH
Draft Health Bill Review of draft by Counties
Draft KFDA Bill
Events related to
the UN
National Drug Policy 1994 Pharma. Policy Review (KNPP 2010) KNPP Cabinet Paper 2102
1st Global
Forum on MD
RECs Meeting
(Apr 2013)
Assessment of KEBS
UN Devolution TWG: UN Strategy on Devolution
SH Meeting on
KFDA (July)
HPT TWGs Pharmacy & Poisons Act (1957)
UN Delivering as One: various processes and consultations
UNDAF (2009-2013) UNDAF development (2014-2018) ongoing
Coalition Government (since 2008)
Baseline MD Survey (2010)
RECs Meeting
(Aug 2012)
2nd Global
Forum on MD
WHO Technical Guidelines on MD
User Complaints on MDs
Regional Integration: Kenya Actively participating in RECs processes
Position Paper on Post-shipment Condom Testing
Regulatory Reforms: Enabling Pillars
• UN Reforms – Delivering as ONE: Agency
refocussing; inter-agency
collaboration; coherence
• WHA60.29 (Ongoing
implementation) – Increased availability of technical
guidance, tools & expertise on HT
• Full-time staff in country
offices (WHO & UNFPA)
• New Constitution (2010) – All policies, laws and institutional
frameworks being revised to align
with the Constitution
– Extensive reforms across Govt.
– Devolution: Clear function
assignment
• Regional Integration – Fast tracking among RECs
– Kenya actively participates in East
African Community (EAC) &
African Union (AU) processes
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
UN Level Enablers Government Level Enablers
Enablers: Devolved Government System • 47 County Governments (CG)
• One National Government (NG)
• The 2 levels of Government are autonomous &
interdependent
• Each Level of Government has distinct Constitutional
Functions (Separation of Power)
• In the Health Sector: Health Policy & Regulation are
functions of the national Government (NG)
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Regulation of Health
Technologies is a function
assigned to the NG.
Implementation of the
Regulatory System should
be done in consultation
with CGs
WHO and UNFPA are
supporting stakeholder
engagements and capacity
building within this context
Key Achievements to-Date • Guidelines & Tools on regulation of medical devices
http://pharmacyboardkenya.org/downloads/?file=medical_devices_guidelines.pdf
• Government Policy Position adopted & clearly communicated
to stakeholders De-link product regulation from professional regulation
Harmonize product regulation under ONE legal & institutional framework
• RECs Position Paper on Post-shipment Testing (2012)
• Government leadership on regulatory reforms evident
• Stakeholder roles defined; consultative TWGs formed – 9 Technical Working Groups formed – Medicines, Devices, Traditional Med. , Blood & B. Products, Food Safety,
Chemicals, Radiation-emitting Products, Tobacco Products, Cosmetics
• Assessment of Laboratory Capacity & Gaps
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
Key Reference Documents
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013
• Support the ongoing Reform of HPT Regulatory System – Support to the TWG Consultations (Legal & Institutional)
– Institutional Capacity Strengthening • Standardized Assessments; Capacity strengthening plans
• Support towards accreditation of testing laboratories
– HR Capacity strengthening: Training, attachments
• Support regional harmonization thru RECs
NEXT
STEPS
Conclusion and Lessons • Regulation of Health Products and Technologies is complex and
resource-intensive
– Many actors, highly technical issues, complex interests, global scope, etc
• Regulatory issues affecting countries are similar, yet unique
• Government stewardship is critical in reforming regulatory systems
• Implementation of a new constitution offers many opportunities to
reform systems at all levels
– The health sector and the UN have seized the constitutional window of
opportunity to reform their respective systems
– NOT business as usual…opportunity to adopt best practice
• Collaboration between UN agencies is mutually beneficial
– Harnesses resources from each (financial & technical)
– Enables each agency to strategize within their mandate
– Strengthens the overall UN engagement & support to the country
– Enables better Government stewardship (coordination & leadership)
2nd Global Forum on Medical Devices: Geneva, 22-24 Nov 2013