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IPC Meeting, World Bank, Washington D.C., 11-12 Dec 2012
Update on agencies’ achievements in past six months
Supporting local pharmaceutical production
(LPP) in developing countries:
UNIDO global project update
Juergen Reinhardt
Project Manager
Business, Investment and Technology Services Branch
UNIDO, Vienna
ACCESS TO DRUGS ‘UNIVERSE’
Quality
Affordability (price / income)
Availability (physical)
Accessibility(geographical)
Acceptability
drug
procurement
storage
distribution
pricing
rational use
regulatory
issues
low purchasing
powerfunding
constraints
stock outs
substandard
productscounterfeit products
limited human
resources for health
LPP increasingly acknowledged as one line of action which has a potential to reduce the access gap
4
WHY BOTHER ABOUT LOCAL PHARMACEUTICAL PRODUCTION (LPP)
� Mitigate supply shortages/stockouts and ad-hoc procurement
� Security/continuity of supply (incl. ‘beyond donations’)
� Potentially facilitates regulatory oversight
� Conduit to effectively combat substandard & counterfeit medicines
� Secure spillovers of as knowledge-intensive industry
� Strategic sector considerations
TitleStrengthening the local production of essential medicines in developing
countries through advisory and capacity-building support
Duration Start: 01/2006 Phase IV to start: 01/2013-02/2015
Budget EUR 8.0 m - Funded by Germany (EUR 6.98 m) & UNIDO (EUR 1.02 m)
Objective Increased capacity for the competitive local manufacturing of quality
essential medicines in target (L)DCs
Approach Improving the operating environment of pharmaceutical manufacturers
PremiseQuality LPP: potential to contribute to favourable public health (PH) and
industrial development (ID) outcomes (interface PH/ID)
Focus • Initially, medicines against three pandemics
• Meanwhile, essential medicines at large
Levels of
intervention
• Policy
• Institutions
• Sector/plant
5
UNIDO GLOBAL PROJECT
OPERATING CONDITIONS OF LPP: CHALLENGES AND DISCONNECTS
Capacity at medicines
regulatory authorities
Infrastructure
Import of raw
materials Human
resources
Access to technical
know-how/
technology
Access to
capital
Reliability & costs
of utilities
Sector
representation
Small market size &
fragmented
regional markets
Industrial policy
Health policy
Market environment
Health
funding
Limited
distribution
capacities
Limited access to
medicineIntellectual
property rights
regime
Regulatory
landscape
Import- / export-
regulations
Plant level challenges
Public
Private
UNIDO’S PROJECT ACTIVITIES (PHARMA) SINCE 2006
Kenya:
• Industry strategy development
& implementation support
• Sector scan
AUC:
• Partnership AUC-UNIDO
• Development of continental operational plan
(PMPA Business Plan)
• AU-UNIDO Conference on Ec. Diversification &
Manufacturing, Addis Ababa (June 2012)
Ghana:
• Industry strategy development
& implementation support
• Support to HR training
institutions
Tanzania:
• Sector development
strategy
• Support to St Luke
training institution
Southern Africa:
• Establishment of Southern
African Generic Medicines
Association (SAGMA)
Nigeria:
• Sector scan/profile
Uganda:
• Sector scan/profile
Zambia:
• Sector scan/profile
Zimbabwe:
• Sector scan/profile
Botswana, Cameroon, Ghana:
• Plant level pilot assistance
Accra, Cape Town, Lusaka, Nairobi:
• Regional LPP workshops &
conferences
BEYOND AFRICA:
• LPP Policy review & follow up
Viet Nam (with WHO)
• Sector scans: Cambodia, Lao PDR
Algeria, Tunisia:
• Preliminary industry/policy assessment
HIGHLIGHTS 2012
Pharmaceutical Industry Development Strategy formulation & early implementation (GHA &KEN)
� Holistic sector development approach
� Process orientation/multi-stakeholder dialogue/roundtable
� Implementation Plan
� Focus GHA 2012/13:
– GMP Roadmap
– Finance for companies
– Incentives
– MRA (FDB) capacity assessment
– HRD/technology transfer
� Phase 4: 2013-2015 Start process in two additional countries in Africa (out of Mozambique, Nigeria, Tanzania, Zimbabwe)
Policy level (national) Institutional level
� Strengthen industry associations:
– Southern African Generics Medicines Association (SAGMA)
– Federation of African Pharmaceutical Manufacturer Associations (FAPMA),Formal launch: Q1/2013
� HRD: Expanding support for Advanced Industrial Pharmacy Training program in URT (St Luke Foundation) for manufacturers and regulators
HIGHLIGHTS 2012 (cont’d)
� Analytical papers on incentives, economics of production, financing
� GMP Roadmap
� Improving manufacturing efficiency
� HRD: early concept note
� Business linkage platform/mechanism: concept stage
� Phase 4: 2013 – Further develop solution packages (in collaboration with partners)
Analytical work & tools development Other
� Assistance for leading companies: tailored training, business planning, advice on efficiency gains
� Business linkage promotion: AU-UNIDO Conference on Economic Diversification and Manufacturing, Addis Ababa, June 2012
– Pharma among priority sector
– B2B component
10
MAIN WORK LINE: BUSINESS PLAN FOR PMPA
� Strategic partnership AU-UNIDO
� PMPA BP vision:
To develop a competitive and enduring
integrated manufacturing pharmaceutical
industry in Africa, able to respond to the
continent’s need for a secure and reliable
supply of quality, affordable, accessible, safe
and efficacious medicines.
� Highest level political buy-in
– Approved at CAMH-6, May 2012
– Endorsed by AU Heads of State, July 2012
� Awareness-raising to include launch at high
level forum (AU-UNIDO side event at AU
Summit 2013)
STRATEGIC AU-UNIDO PARTNERSHIP ON PMPA BUSINESS PLAN
Original
PMPADevelopment
PMPA Business Plan
Implementation
PMPA Business Plan
� Abuja 2005: Original Heads of State decision to develop a PMPA
� Accra 2007: Initial Pharmaceutical Manufacturing Plan for Africa (PMPA) endorsed by Heads of State
� 2007, 2008, 2010: Technical Committee (TC) Meetings
� 2011: Proposal for expanded TC and development of Business Plan
� March 2011: CAMI 19 incorporation of sector in AIDA & PMPA as mechanism
� July 2011: Partnership Agreement AUC & UNIDO: Assistance to AUC inpreparation of the PMPA BP
� Sept. 2011: Inception WorkshopAUC & UNIDO
� Dec 2011: Inception Report for TC
� April 2012: presentation of draft PMPA BP to expanded TC
� May 2012: approval of draft PMPA BP by CAMH
� July 2012: Endorsement of PMPA BP by Heads of State at AU Summit
Implementation(post approval: time frame + 5 yrs)
2005 - 2010 2011 - 2012 2012 – 2017 (exp.)
Set up phase e.g.
� Formalization of consortium
� Resource mobilization
� Solution refinement
Full implementation e.g.
� Country implementation plan
� Solution implementation
Scale up phase e.g.
� Set up field representation
� Initial diagnostics and consultations with countries for strategy development
Key success factors
�Strong independent and predictable NMRAs
� Human capital development
� Increased and enhanced competition
� Reduced demand uncertainty and accurate forecasting
� Investment and access to affordable finance as well as provision of time-limited, easily understood accessible incentives
Fundamental aspects
�Recognition that there are organizations already engaged in various activities including regulatory harmonization, skills development, technology transfer –augment not supplant
�Coordination and integration of these various initiatives will be critical – avoid duplication & wasted effort
� PMPA not panacea
Imperatives
• Political support, policy coherence and planning for the future
• Recognize the limitations of access to medicines across Africa & seek out lasting solutions
• Government as a catalyst by making the important decisions
• African R&D and block-buster drugs (diasporaskills)
PMPA Vision
PMPA BP OBJECTIVES
Fundamental objective of PMPA BP is to develop
sustainable high quality manufacturing of essential drugs
Manufacturing
standards
WHOGMP
NOW
Product specific
requirements
TARGET
PQ
• In general, this requires raising the standard of
manufacturing on the continent
• However, to be sustainable the cost structure of the
industry needs to evolve
• To be achieved through a holistic approach
• Defragmented markets
(coordination with AMRH)
• Improved management of businesses
• Increased human resources
• Improved regulation
• Increased investment
• Time limited incentives
• Access to know how
• The approach will benefit both the economic
development and the public health of the continent
• But will require shared action from industry and
health portfolios, as well as many other players
Distribution of quality standards amongst companies
15
PMPA
BP
Holistic & pragmatic
Duration and implementation
period:
5 years
BP articulates clear strategies
Cognisant of country-specific
challenges
PMPA Approach
PMPA BP Solution Packages
17
KEY PMPA SUCCESS FACTORS
