Making Africa a competitor in the Global Pharmaceutical Industry: Implementation of the Pharmaceutical

Manufacturing Plan for Africa AWA Consultative Experts’ Committee Meeting of

Commission of the African Union, Nouakchott, Mauritania

27-28 May 2014

Dr Paul Lartey, FAPMA Chairperson

Africa’s Public Health Challenges

• Heavy burden of HIV/AIDS: top cause of morbidity and mortality in Sub-Sahara Africa;

• Upsurge in tuberculosis and other opportunistic infections;• Future disease burden

– 60 million people with hypertension by 2020– 1 million cases of cancer annually– 18.6 million people with diabetes by 2020– Other CVS, chronic respiratory diseases (COPD / asthma) and

neuro-psychiatric conditions – NCD’s will have surpassed infectious diseases as the leading

cause of death in Africa by 2030.Source: WHO, WHO AFRO, Frost & Sullivan analysis

Pharmaceutical Manufacturing Plan for Africa - PMPA

• African Heads of State recognized the need for a sustainable strategy with treatment as central point

• This in turn implies the need for readily available efficacious, high quality and affordable medicines

• AU Heads of State meeting of July 2012 accepted the PMPA Business Plan

PMPA Vision

To develop a competitive and enduring integrated pharmaceutical manufacturing 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.

4

Key Issues and Package of Solutions

6

Active in Entire Pharma Value Chain

Research into Neglected Diseases

Date/Place Agreement Objective/Declaration

June, 2007Noordwijk-aan-Zee, Netherlands

The Noordwijk medicines Agenda adopted by the Organization for Economic Cooperation and Development.

Encourage a model for the innovation and development of medicines for neglected and emerging infectious diseases affecting developing countries.

May, 2008Geneva, Switzerland 

61st World Health Assembly adopted the Global strategy and plan of action on public health, innovation and intellectual property.

All UN member states should promote technological innovation and the transfer of technology to developing countries, as supported by intellectual property rights.Strengthen the innovative capacity of developing countries as an essential response to the needs of public health.

March, 2009Yaoundé, Cameroon

Strengthening health innovations: from agendas to action

Encourages a broader African perspective on health innovations.

PMPA: Partnering for Implementation

• World health Organization (WHO) and United States Pharmacopeia convention’s Promoting the Quality of Medicines program. – These organizations are assisting with capacity development in

regulation and GMP. • The United Nations Industrial Development Organization (UNIDO) is

playing a much-needed coordinating role in the implementation of the PMPA BP, through a consortium comprising representation from all stakeholders.

• Other partners are the United Nations Development Program (UNDP), the Joint United nations Program on HIV/AIDS (UNAIDS), United Nations Population Fund (UNFPA) and the African Development Bank.

Federation of African Pharmaceutical Manufacturers Associations

9

Member Organizations:

•Federation of East African Pharmaceutical Manufacturers

•Southern African Generic Medicines Association

•West African Pharmaceutical Manufacturers Association

FAPMA Membership

10

FAPMA231 manufacturers

11

FAPMA Objectives

To promote excellence in the pharmaceutical industry

Promote access to safe, quality, efficacious medicines in Africa

To strengthen local production of medicines so as to meet needs of the continent

Facilitate economic growth through development of a sustainable, self-sufficient and viable pharmaceutical industry in Africa industry

Factors impacting on industry capacity

• Unfair competition from fake and substandard imported medicines

• Price competition against imported highly subsidized medicines from Asia

• Inadequate patronage by African governments

Way Forward

• Aligned visions of PMPA BP and FAPMA demonstrates commitment

• Mix of capacity development measures, incentives and patronage, strengthen of 236 Africa-based pharmaceutical manufacturers

Global competitiveness is imminently possible