'The Pharmaceutical M f t i Pl f Manufacturing Plan for

African - pathway to Local African pathway to Local Production of Generic Medicines in Africa??

IP FORUM – Gallagher Estate, MidrandDr Skhumbuzo NgozwanaDeputy CEO: Cipla Medpro

26th F b 2013

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26th February 2013

Outline Overview of Africa’s healthcare

h llchallenges Overview of African pharma industryp y The Pharmaceutical Manufacturing

Plan for Africa (PMPA) – the RoadPlan for Africa (PMPA) – the Road Ahead

Hi t Obj ti Vi io History, Objectives, Vision

o PMPA Solutions to Grow Africa-based Industry

Conclusion2

Overview of state of Overview of state of Africa’s Healthcare

systems

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High Disease Burden (current)High Disease Burden (current)

25% of the global disease burden 25% of the global disease burdeno 75% of the global HIV/AIDS pandemic

o 90% of the malaria cases and deaths

o 9 countries (excluding North Africa) among the 15 countries with the highest TB burden in the worldcountries with the highest TB burden in the world.

o MDR-TB and XDR-TB rated among the highest in the worldworld.

o Significant child mortality – diarrhoeal, measles, URTI etc

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High Disease Burden (2030 Projections)

Diseases Number 

Hypertension 60 milyp

Diabetes 18.6 mil

Cancer 1 mil (new cases annually)Will surpass HIV / AIDS as

Other (CNS, CVS, Resp.)Will surpass HIV / AIDS as leading cause of death

Source: WHO AFRO, Colin D Mathers & Dejan Loncar. Projections of Global Mortality and Burden of Disease from 2002-2030. PloS Medicine Nov 2006, Vol. 3, Issue 11

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Significant Healthcare challengesSignificant Healthcare challenges

Poor healthcare infrastructure Poor healthcare infrastructureo Software – Shortage of healthcare HR

Hard ware clinics hospitals labs supplyo Hard ware – clinics, hospitals, labs, supply chains inadequate

o Inadequate quality systems limited accesso Inadequate quality systems -- limited access

Limited healthcare fundingo Limited National budgetso Donor dependence (? fatigue)

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State of African Pharma - Challenges

d O t itiand Opportunities

Pharmaceutical Production ProcessProcess

Plants N

Synthesis

Plants

Animal i

Extraction

ATER

IALS

Isolation

DIAT

ES

I RMULA

TION

F l tiytissue

Chemical Fermentation RA

W M

A

Purification INTE

RME

AP

NISHED

 FORFormulation 

& packaging

FIN

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Source: Metanoia Consulting Pty Ltd (SA)

State of African Pharma

Africa imports more than 95 percent of API and roughly 75 percent of finished formulations.

~38 countries have pharmaceutical manufacturing Only 2 with limited API production

o API Production is the source of Security of Supply Various global players active through agencies /

distributorships etc Big pharma moving plants to centres of excellence

globally

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African Pharma Challenges g Policy Incoherence

o Health vs Industrial vs Finance / Treasury priorities: Technocrats ino Health vs. Industrial vs. Finance / Treasury priorities: Technocrats in key support ministires have limited knowledge of the pharma sector

Lack of Regulatory capacityo Lack of resourceso Lack of autonomy, financial independence & frequent

incidences of political interferenceincidences of political interference Lack of Regulatory Harmonization

o Varying legal and regulatory frameworkso Varying legal and regulatory frameworkso Delayed registrationso Increased costs due to need to customise regulatoryo Increased costs due to need to customise regulatory

processes10

African Pharma Challenges Counterfeit and Substandard medicines

o USP (2011) - 30 to 50 percent of malaria medicines ino USP (2011) - 30 to 50 percent of malaria medicines in some markets are counterfeit and as many as 84 percent in countries sampled on the continent were substandard.

o WHO (2011) - 28.5 percent of the medicines sampled failed to comply with specifications (anti-malarials)

o Direct consequence of the lack of adequate regulatoryo Direct consequence of the lack of adequate regulatory capacity and proper enforcement

Lack of Specialised Pharmaceutical Skillspo Unresponsive training – institutions mostly offer generalist

science and retail oriented Pharmacy degreeso Challenges with external recruitment – e.g. permits

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African Pharma Challenges

Access to technologyo Absence of home grown - and difficulty in accessing

foreign technologieso Lack of academia / R&D institute & industry interfaceo Lack of academia / R&D institute & industry interfaceo The Indian experience – government’s catalytic

role!!!!! The Pandemic blindside

o Priority given LARGELY to the three pandemicso Local production prejudiced by the perceived ease with

which African countries can access affordable quality medicines from low cost producers in the east – albeit onlymedicines from low cost producers in the east albeit only for the epidemics

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African Pharma Challenges

Lack of affordable Finance and Incentive S hSchemeso Commercial banks reluctant to offer loans to the industry -

interest rates ~ 25-30%interest rates 25 30% o Absence of well developed stock markets o Investors have little appetite for the pharmaceutical pp p

industry - amounts made available often insufficient for pharmaceutical upgrades (counterfeits / weak regulation / Asian tigers / uncompetitive against local non-GMP firms)Asian tigers / uncompetitive against local non GMP firms)

o Unreasonable lending requirements e.g. IFC demands WHO PQ before they can advance a loan – yet loan necessary to assist companies to upgrade for international GMP (? agenda)

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African Pharma Challenges g

Governance and business cultureFounders reluctant to give up control or dilute theiro Founders reluctant to give up control or dilute their influence.

o Poor record keeping – challenges with business p g gevaluations

o Poor governance Lack of market data / intelligence and

informationL k f k t d t lti l d l l t do Lack of proper market data - multiple and poorly regulated channels through which products enter and leave the market & unofficial/unlicensed dispensing pointsp g p

o Public procurement data non existent14

Supporting industries &industries &associated 

infrastructureinfrastructure

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African Pharma Challenges g

Weak or non-existent related and supporting Industrieso Raw materials, tooling and machine spare partso CRO’s and BE centerso Unregulated, fragmented and grossly inefficient g g g y

pharmaceutical distribution chains o Utilities unreliableo Underdeveloped and unresponsive financial and

legal infrastructure

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About the PMPA

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PMPA Background & Key MilestonesYear Place Milestone

2005, July Abuja Original decision to develop a PMPA 

2007, July Accra Initial Plan endorsed by Heads of State2011, March Algiers CAMI Roundtable on local production and 

incorporation of sector in AIDAincorporation of sector in AIDA 

2011, Sep to 2012, April

Vienna Inception workshop, data gathering, country visits  & strategic plan development

2012 M G Ad d b h C f f Af i Mi i ’2012, May Geneva Adopted by the Conference of  African Minister’s of Health (CAMH) – wide support from stakeholders, UN Agencies, other potential partnerspartners

2012, July Addis Endorsed by Heads of State of State and Government

2012, Oct /Dec Vienna / CT

High level meeting with Heads of Agency, AUC, Donors, Political leadership, FAPMA etc

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Core objectivesCore objectives

Support local pharmaceutical Support local pharmaceutical manufacturing to:o increase access to affordable quality

medicineso ensure sustainable supply of essential

medicines i bli h l ho improve public health outcomes

o promote industrial and economic development

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PMPA VisionPMPA Vision

To develop a competitive and enduringTo develop a competitive and enduring integrated pharmaceutical f t i i d t i Af i blmanufacturing industry in Africa, able

to respond to the continent’s need for a secure and reliable supply of

quality, affordable, accessible, safe q y, , ,and efficacious medicines.

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PMPA Package of gSolutions for Growing the

Africa based Industry

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Pharmaceutical ‘System’Pharmaceutical SystemNational Medicines Regulatory Authorities

e.g. oversight of li i l t i l d

e.g. dossier review, plant inspection, e.g. oversight and

f t f GDP

e.g. Pharma-covigilance and

e.g. dossier review, plant

Inputs Local Manufacturing

Distribution Market

clinical trials and GLP

GMP certification & monitoring

enforcement of GDP and GWP

adverse events reporting system

Business partners-access to formulations and know how National Markets

inspection and GMP certification and monitoring

Products from other countries

External Players

ation

s*

Material inputs (e.g. API, excipients)

Utilities

and know how-Supply agreements-etc

ManufacturersFormulation

Distribution-array of public & private systems

Public procurementPrivate marketNGO procurement

Sub-regional exports • Public procurement• Private market

Other NMRAs Other MoFOther MoH

countriesparticularly India as well as intra African Trade

Trad

e Ass

oci

Other supporting industries e.g.Maintenance and repair of equipmentClinical research for BA/BE

Formulation developmentFinal formulationPackaging

Distribution-range of mechanisms including national systems and donor operated supply chains

• NGO procurement

Donor funded market for pandemics (both national and export), e.g.

International regulatory bodies e.g.- WHO prequalification prorgamme- Stringent regulatory authorities (e.g. FDA)

National Standards Board e.g. calibration of equipment

chains p ), g• Global Fund• PEPFAR• PMI

Prequalified products from other countries largely from India

e.g. Tariffs on Inputs, FDI incentives

e.g. Incentives to support industry

e.g. procurement policies and functions of the CMS

e.g. content of EML, national drug policy, export incentives, inclusion of TRIPS flexibilities in national legislation

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Various National Ministries including Health, Finance, Industry, Trade

* - Note trade associations can perform a range of functions on behalf of their members to influence the business environment, such as dissemination of best practice, partnership brokering, lobbying

Key: = Material flows= supply of services/access to knowledge= influence, including through regulatory oversight, policy, lobbying etc.

PMPA Package of Solutions

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HR Development HR Development

Key Interventions: Training of:NMRAs (all aspects of Quality  ‐ GMP, GDP, GLP, GWP, policy etc.) Pharmaceutical companies (e.g. formulation, GMP, Lean manufacturing, business management plant operations)

Key objective:To build capacity to meet skills requirements for local  management,  plant operations)

Govt policy makers (e.g. policy development & coherence)

Facilitate the review & reorientation of

qproduction of affordable and 

safe quality medicines

Facilitate the review & reorientation of science/pharmacy/engineering curricular at institution of higher learning

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HR Development HR Development Professional & short courses (< 1 year)Professional & short courses (< 1 year)

o Who - Industry experts, International organisations (e.g. USP, WHO, SRAs)

o How - Trade associations & NMRA’so Where - Centres of excellence

Long term courses (> 1 year)o Specialised tertiary institutions (e.g. St Lukes,

University of Ibadan, UZ, UCT etc)o Centers of Excellence (e.g. ANDI)

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Access to Products & T h lTechnology

Key interventions:

Working with CoEs, develop formulations and diffuse technology to GMP compliant gy pcompaniesWorking with UNDP/UNCTAD/ARIPO etc., exploit TRIPS flexibilities to supply donor 

Key objective: Assist African companies to access 

d i b t i lp pp y

funded markets in LDC’sNegotiate directly with patent holders for voluntary licences

and acquire best in class technology & improve product 

portfolioso u ta y ce cesFacilitate access to technology through partnerships; e.g. WHO/EGA/KEMRI/NIPRD etc.

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etc.

Access to funding & incentivesAccess to funding & incentives

Key interventions:

Advisory and technical assistance to governments on development of policies including incentive programmes that are supportive of the 

th f th h i d t

Key objective: Assist African companies to access 

ff d bl it l d d i growth of the pharma industryMobilise enthusiasm for pharma 

sector and lobby for review of funding / d i i i ( l l

affordable capital, and advise governments on conducive 

incentives

/and investment criteria (e.g. local banks and international finance organisations)

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Regulatory systems t th istrengthening

Key interventions:

Offer technical assistance toDevelop legislative framework for the NMRA produce organisational development plans, policies and procedures

Key objective: Assist NMRAs to develop the capacity to fulfil their mandate policies and procedures

NMRA’s and partnership with AMRH for regulatory harmonisation

Establish a “GMP road map” & an audit

capacity to fulfil their mandate – ensuring that the products on the market are safe, efficacious 

and of good quality Establish a  GMP road map & an audit tool to establish baseline for industry & Enhance capacity of NMRA’s to enforce

and of good quality

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Facilitating partnerships & b i li kbusiness linkages

Key interventions:

Create a web portal with corporate profiles and a B2B facilitation platformFacilitate bi‐annual matchmaking meetings and fairs with global counterparts

Key objective: Promote business linkages and t hi t f ilit t t Strengthen linkages with ANDI and other CoE’s

Strengthen industry associations & partner with them to foster internal partnerships (e.g. Pooled procurement of products and services)

partnerships to facilitate access to products, finance, and skills & 

know how

Pooled procurement of products and services)Monitor and track deal flow & and the aspirations of global and African pharma

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Enhancing market data ll ti & collection & access

K i t tiKey interventions:

Identify & partner with reputable research organisations to collect market data and i lli

Key objective: f ilit t th ll ti f k t intelligence

TA to government procurement agencies to develop forecasting and data collection abilities

facilitate the collection of market data

abilities

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Facilitating access tok tmarket

Key interventions:Key interventions:

Facilitate acquisition of international GMP standards, product and technology to s ppl f nded markets

Key objective: Assist companies to improve d t lit & tf li th b supply funded markets

Promote regulatory harmonization and intra‐regional trade

Exploit TRIPS flexibilities

product quality & portfolio thereby strengthening  their access to local 

& funded markets

Exploit TRIPS flexibilities

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Conclusion

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EndEnd

thank youthank you…Dr Skhumbuzo Ngozwana

skhumbuzo@ciplamedpro co zaskhumbuzo@ciplamedpro.co.za+27 82 829 3832