Poster No K.14 Delivering as One UN to Strengthen ...2 Nursing Council of Kenya (NCK) 1983 Elected by other Members Nurses - NURSING COMMODITIES REGULATIONS, 2012: Legal Notice No.

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)


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


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


http://pharmacyboardkenya.org/

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)


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).


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


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


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)


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


http://pharmacyboardkenya.org/downloads/?file=medical_devices_guidelines.pdf

Key Reference Documents


• 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)
