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Update on Pharmaceutical Manufacturing Plan for Africa

Presented By Dr. Marie Goretti HARAKEYE Department of Social Affairs

Background & key milestones Philosophy Objectives Imperative for success Key Considerations Strategic Context; Africa’s Healthcare Challenges The PMPA Business Plan ;Adopted approach

Methodology and BP outline Conclusion

PMPA: Borne out of the recognition by African Heads of state of the tremendous challenges facing African healthcare systems

Original decision to develop a PMPA – Abuja 2005 Initial Plan endorsed by Heads of State – Accra

2007 Series of technical workshops and political

dialogues undertaken Development and adoption of Business plan – 2012

Access to quality healthcare is a fundamental Human Right

The promotion of industrial development and the safeguarding and protection of public health are not mutually exclusive priorities

The production of quality medicines and the development of an international GMP compliant industry in Africa are possible, desirable and eminently doable

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Support local pharmaceutical manufacturing:

Increased access to affordable quality medicines;

Sustainable supply of essential medicines;

Improved public health outcomes;

Industrial and economic development.

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Political support & Policy coherence;

Recognizes the on-going human tragedy on our continent resulting from limited access to medicines & the dire need for lasting solutions;

Demands courage, foresight and the willingness to take tough decisions (govt. catalytic role);

African R&D and blockbuster drugs (Diaspora skills).

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Strong independent and predictable NMRA’s;

Human Capital development;

Increased and enhanced competition;

Reduced demand uncertainty and accurate forecasting;

Investment and access to affordable finance;Provision of time-limited, easily understood,

and accessible incentives.

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Recognition of on-going efforts (REC / country level);

Recognition that there are Organizations already engaged in various activities including regulatory harmonization, skills development, technology transfer and so forth – Augment not Supplant;

Coordination and integration of these various initiatives will be critical – avoid duplication & wasted effort;

PMPA not panacea8

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Africa = 54 countries, >1 billion people (about 14% of the global population)

Highly heterogeneous contextEconomic developmentDisease contextsStatus of pharma industry & quality

systemsMultiple RECs and Trade blocs

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“No Indian company can make an API that meets our

specifications”

Global R&D company in letter to an Indian Pharma company in 1984

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Holistic & pragmaticCurrent model of Stand-alone solutions is

unsustainable.

Urgent need to coordinate and align the activities of various organizations

Cognisant of country-specific challengesHighly heterogeneous contexts & stages of

development of the pharmaceutical Legal-regulatory frameworks and institutional capacities; North Africa and Sub-Saharan Africa.

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Inputs Local Manufacturing

Distribution Market

Tra

de

Asso

cia

tion

s*

National Medicines Regulatory Authorities

e.g. oversight of clinical trials and GLP

e.g. dossier review, plant inspection, GMP certification & monitoring

e.g. oversight and enforcement of GDP and GWP

e.g. Pharma-covigilance and adverse events reporting system

Material inputs (e.g. API, excipients)

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

Utilities

Business partners-access to formulations and know how-Supply agreements-etc

National Standards Board e.g. calibration of equipment

ManufacturersFormulation developmentFinal formulationPackaging

Distribution-array of public & private systems

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

National MarketsPublic procurementPrivate marketNGO procurement

Sub-regional exports • Public procurement• Private market• NGO procurement

Donor funded market for pandemics (both national and export), e.g.• Global Fund• PEPFAR• PMI

e.g. dossier review, plant inspection and GMP certification and monitoring

Other NMRAs Other MoFOther MoH

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

Prequalified products from other countries largely from India

Products from other countriesparticularly India as well as intra African Trade

External Players

Various National Ministries including Health, Finance, Industry, Trade

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

* - 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.

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African Pharma Value Chain

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Key PMPA Success Factors

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Proposed package of solutions

Implementation at the country level (RECs & continental).

interconnectedness of key dimensions and requirements of the manufacturing system

No one organization has the breadth of expertise to deliver the full package of solution

Vertical stand-alone solutions not enough – need a systemic approach

Partnership & Collaboration – alignment and coordination of various interventions critical --- but need for a central depository of expertise, knowledge, skills for deployment where required 20

Development of Human CapitalDevelopment of a GMP road mapLegislative and policy advice tools for developing

- Incentives, regulatory structure etcTechnical assistance to Regulators PMPA Business linkages platform Product development (FDC’s paediatric, new FF,

delivery platforms)Strengthening trade associationsAssistance with developing market data collection

capabilities

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The production of quality medicines and the development of an internationally GMP compliant industry in Africa is not only possible, but necessary (desirable) and eminently doable.

Local production has huge potential to not only contribute to improved healthcare provision, but also to stimulate economic growth, self reliance and develop skills and increase the knowledge base.

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THANK YOU