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 Namely 1.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 Price, Quality, Efficacy, Availability Employment, Economic and Scientific Development PatientsIndustry

Moving together Policy Regulations Rights issues Consumers Procurement agencies Health Facilities Regulators Manufacturers Safe Effective Quality Affordable

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

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