Pharmaceutical Manufacturers Association PMA

Status of National Production Capacity of Generic Medicines – Private Sector

Perspective

Emmanuel Mujuru, PMA Chairperson

PMA Membership

• Pharmaceutical Manufacturing Companies• Advocacy – Enabling Economic, Regulatory & Policy

Environment• Nine Companies Namely1. CAPS

2. Datlabs

3. Graniteside

4. Gulf Drug Company

5. Ecomed

6. Pharmanova

7. Plus Five Pharmaceuticals

8. Varichem

9. Zimpharm

PMA

PMA OBJECTIVES

3

Create a vibrant, globally competitive and self-sustaining pharmaceutical manufacturing industry in Zimbabwe

Self-sufficiency and reliability in the local production of affordable efficacious and quality essential generic medicines

Promote access to safe, quality, efficacious medicines in Zimbabwe and region

Contribute positively to the economic and scientific development of the country

COMMON ASPIRATIONS

Access to medicines•Quality •Safety•Efficacy•Affordability•Availability

4

The eye sees not itself but by reflection – William Shakespeare

State of The Industry

• Serious viability problems • Low capacity utilisation < 40%• ≤45% of Essential Drugs EDLIZ down from

>75% • <15% Specialist Drugs SEDLIZ• Lack of investment in the past 10yrs• Old facilities in need of urgent upgrade • Product Development• Deindustrialisation • Competitiveness

5

Challenges Facing The Industry• Duties and VAT on raw materials and packaging• Collapse of public sector market ≤22% essential drug

availability of which > 90% donations• Policy incoherencies/Disharmony• Procurement policies• Funding• Donations• Non-Tariff Barriers e.g. exports to South Africa• Corruption• Regulatory and registration policies• Counterfeits• Cheaper Imports - India

Balancing Interests of Public Health Policy & Industrial Development Policy

Public Health Industrial Development

Pri

ce,

Qu

alit

y, E

ffic

acy

, A

va

ilab

ility

Em

plo

yme

nt,

Ec

on

om

ic

an

d S

cie

nti

fic

D

ev

elo

pm

en

tPatients Industry

Moving together

PolicyRegulationsRights issues

ConsumersProcurement agenciesHealth Facilities

Reg

ula

tors

Man

ufa

ctu

rers

Safe Effectiv

e

QualityAffordable

CASE STUDIES

• GHANA MODEL - $300Mln Market ; 32 Manufacturers; 44 restricted list; raw materials exempted from duty and VAT

• Tunisia – Importation banned as soon as product is locally produced >80% local

• SA – 75% of public sector requirements should be sourced locally

• India & China – benefit from a number of policy measures : protection from tariff regimes and procurement preferences as well as direct support : interest subsidies, export credits; cheap utilities; working capital credits and tax holidays

9

RALLYING POINTS

10

• Levelling of playing field – remove VAT and duty on pharma-raw materials

• Import restriction of commonly produced drugs – 40 products

• Capacitation of NATPHARM• Local preference on public tenders e.g.

Natpharm, NAC etc.• Establishment of local BE Centre• Fast track preferential registration – MCAZ• R&D collaborative drug development with

Universities, Traditional Healers etc.• Domestication of TRIPS flexibilities• Funding • Export competitiveness - $20bln African

Market growing >10% annually

Our Shared Vision

• Production of affordable, safe, efficacious and quality essential medicines

• Universal access to essential medicines• Positive public health outcomes• Employment, Economic and Scientific development

THANK YOU