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TRIPS and Public Health: Implications for the Pharmaceutical Sector in Africa

Update on Pharmaceutical Manufacturing Plan for Africa

Dr. Djoudalbaye Benjamin

Senior Health Officer

African Union Commission

Presentation outline Definition TRIPS Agreement TRIPS and Public Health About the PMPA Background & key milestones Philosophy Objectives Vision Conclusion

Definition

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.

The TRIPS agreement introduced intellectual property law into the international trading system for the first time and remains the most comprehensive international agreement on intellectual property to date.

In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal "to promote access to medicines for all."

TRIPS AGREEMENT

Background & Key Milestones PMPA: Born 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.

Philosophy 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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Core objectives 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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Imperative for success 1/2

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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Imperative for success 2/2

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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The key considerations

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 panacea

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Strategic Context; Africa’s Healthcare

Challenges

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Strategic Context Africa = 54 countries, >1 billion people (about 14%

of the global population) Highly heterogeneous context

Economic developmentDisease contextsStatus of pharma industry & quality systemsMultiple RECs and Trade blocs

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Significant challenges impacting on health outcomes

• 25% of the global disease burden• >50% of the global deaths of children under five• High infectious disease burden• Growing NCD

Disease burden

• Software –HR ~ 3% of the world’s deployed– inequitably distributed, Migration • Hard ware – clinics, hospitals, labs, inadequate, Supply chain

Infrastructure

•1% of global healthcare expenditure• Limited National budgets (by 2010 only 6 countries had met Abuja’s 15%)•Donor dependence

Funding

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African Pharma expected to grow dramatically in the next decade

The PMPA Business Plan Adopted approachMethodologyBP outline

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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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Adopted Approach Holistic & pragmatic

Current 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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Pharmaceutical ‘System’

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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- key principles

Implementation at the country level (RECs & continental). interconnectedness of key dimensions and requirements of

the manufacturing system No 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

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Systemic Orientation of solutions package

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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Conclusion

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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I thank you for your attention