Main findings and recommendations from the UNIDO study on the pharmaceutical sector in Zimbabwe Domestication of TRIPs Flexibilities in National IP Legislation for Strengthening Access to Medicines in Zimbabwe 23 January 2014

Introduction and Background Main Findings Recommendations Presentation Outline Introduction and Background Main Findings Recommendations Current status 11/29/2018

Introduction and Background Study title: Pharmaceutical Sector Profile Zimbabwe Commissioned by the United Nations Industrial Development Organization (UNIDO) as part of the Global UNIDO Project: Strengthening the local production of essential generic drugs in least developed and developing countries Study was prepared in 2010 by UNIDO consultant, Chris Chitemerere, under the supervision of the UNIDO project team Study was published in 2011 11/29/2018

Introduction and Background The project produced a series of reports covering different countries The series of reports describe the local pharmaceutical industry in individual countries Main purpose was to provide a comprehensive picture of the status and operating environment of the pharmaceutical sector and are designed to assist national level stakeholders and inform discussions on how local production fits into the strategy for improved supply of medicines Also designed to feed into the ongoing debate among the international development community on the local manufacturing of generic medicines 11/29/2018

Introduction and Background The study profiled four local manufacturing companies: CAPS Private limited Datlabs Plus Five Varichem Others (not interested) Study had a strong emphasis on generic essential medicines used in the management of HIV/AIDS, malaria and tuberculosis 11/29/2018

Main Findings The pharmaceutical market in Zimbabwe is a relatively modest one with a balanced set of supply and demand fundamentals Although there is a huge need for medicines, there still remains a huge funding gap to meet the needs On the supply side, local generic medicines manufacturing companies have relatively balanced product portfolios and able to supply 47% of items on the Essential Drugs List for Zimbabwe However, product portfolios are aged and highly commoditized resulting in poor export performance and intense competition from foreign suppliers especially those of Indian origin 11/29/2018

Main Findings Perceived conflict between industrial policy, which aims to promote local manufacture, and health policy, which aims for maximum access to essential medicines (Now resolved) Business environment not conducive for the development of the local pharma manufacturing industry e.g. Funding Low disposable incomes Antiquated property, plant and equipment Unfavourable tariff structure High cost of inputs and utilities 11/29/2018

Main Findings The Patent Act of 1996, as amended in 2002, in need of a complete overhaul in order to safeguard interests of generic medicines producers Zimbabwe medicines regulatory machinery relatively strong when compared with that of its counterparts in the African region Funding of NatPharm almost non-existent, posing viability challenges for local manufacturers Pharmaceutical value chain weak especially in the area of R&D 11/29/2018

Key Recommendations Recommendations at national, sector and individual company level Policy issues need to be addressed urgently in order to create a conducive business environment for local pharma manufacturing industry Development strategy for the pharma sector Funding of the health sector Local pharma industry needs to embark on strategic partnerships in order to strengthen pharmaceutical value chain 11/29/2018

Key Recommendations Support of individual local pharma companies through development institutions for specific projects Support for industry at association level in the form of training and other capacity building initiatives 11/29/2018

Current Status MCAZ Register therapeutic profile Registrations as at August 2013 Essential Medicines Capacity/Deficits Importance of local funding – a South African Example Global Fund Purchases and Disbursements Patent Searches 11/29/2018

URL for Zim Pharma Profile http://www.unido.org/fileadmin/user_media/Services/PSD/BEP/Zimbab we_Pharma%20Sector%20Profile_032011_Ebook.pdf 11/29/2018

THANK YOU 11/29/2018