Update on Pharmaceutical Manufacturing Plan for Africa
Dr. Djoudalbaye Benjamin
Senior Health Officer
African Union Commission
1









Definition
TRIPS Agreement
TRIPS and Public Health
About the PMPA
Background & key milestones
Philosophy
Objectives
Vision
Conclusion

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."
 PMPA:
Born out of the recognition by African Heads
of state of the tremendous challenges facing African
healthcare systems;
 Original
 Initial
decision to develop a PMPA – Abuja 2005;
Plan endorsed by Heads of State – Accra
2007;
 Series
of technical
dialogues undertaken;
workshops
and
political

 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.
6

Support local pharmaceutical manufacturing:
Increased access to affordable quality medicines;
Sustainable supply of essential medicines;
Improved public health outcomes;
Industrial and economic development.
7
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).
8
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,
accessible incentives.
easily
understood,
and
9
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
10
11
11
 Africa
= 54 countries, >1 billion people (about 14%
of the global population)
 Highly heterogeneous context
Economic development
Disease contexts
Status of pharma industry & quality systems
Multiple RECs and Trade blocs
12
Disease
burden
• 25% of the global disease burden
• >50% of the global deaths of children under
five
• High infectious disease burden
• Growing NCD
Infrastructure
• Software –HR ~ 3% of the world’s deployed–
inequitably distributed, Migration
• Hard ware – clinics, hospitals, labs,
inadequate, Supply chain
•1% of global healthcare expenditure
Funding
• Limited National budgets (by 2010 only 6
countries had met Abuja’s 15%)
•Donor dependence
13
14
15
“No Indian company can
make an API that meets
our specifications”
Global R&D company in letter to an Indian Pharma company in 1984
 Holistic
& pragmatic
Current model
unsustainable.
of
Stand-alone
solutions
is
Urgent need to coordinate and align the activities of
various organizations
 Cognisant
of country-specific challenges
Highly heterogeneous contexts
development of the pharmaceutical
&
stages
of
 Legal-regulatory frameworks and institutional capacities;
 North Africa and Sub-Saharan Africa.
17
National Medicines Regulatory Authorities
e.g. oversight of
clinical trials and
GLP
Inputs
e.g. dossier review,
plant inspection,
GMP certification &
monitoring
Local
Manufacturing
Trade Associations*
Business partners
-access to formulations
and know how
-Supply agreements
-etc
e.g. Pharmacovigilance and
adverse events
reporting system
e.g. oversight and
enforcement of GDP
and GWP
Distribution
Market
National Markets
Public procurement
Private market
NGO procurement
Distribution
-array of public &
private systems
Material inputs (e.g.
API, excipients)
Utilities
Other supporting
industries e.g.
Maintenance and repair
of equipment
Clinical research for
BA/BE
Sub-regional exports
• Public procurement
• Private market
• NGO procurement
Manufacturers
Formulation
development
Final formulation
Packaging
Distribution
-range of
mechanisms
including national
systems and donor
operated supply
chains
National Standards
Board e.g. calibration of
equipment
e.g. Tariffs on Inputs,
FDI incentives
e.g. Incentives to
support industry
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
External
Players
Products from other
countries
particularly India as well
as intra African Trade
Other NMRAs
Other MoF
Other MoH
International regulatory
bodies e.g.
- WHO prequalification
prorgamme
- Stringent regulatory
authorities (e.g. FDA)
Prequalified products
from other countries
largely from India
e.g. content of EML, national
drug policy, export incentives,
inclusion of TRIPS flexibilities in
national legislation
e.g. procurement
policies and functions
of the CMS
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.
18
African Pharma Value Chain
19
Key PMPA Success Factors
20
Proposed package of solutions
21
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

Development of Human Capital
Development of a GMP road map
Legislative and policy advice tools for developing - Incentives,
regulatory structure etc
Technical assistance to Regulators
PMPA Business linkages platform
Product development (FDC’s paediatric, new FF, delivery
platforms)
Strengthening trade associations
Assistance with developing market data collection capabilities
 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.