RESOLUTIONS: 1st International High Level Multi-Stakeholders Conference on Promoting Pharmaceutical Sector Investments in the East African Community

Posted in Official Statement

1. The 1st International High Level Multi-Stakeholders Conference on Promoting Pharmaceutical Sector Investments in the East African Community (EAC) was held in Nairobi, Kenya at Laico Hotel on 2nd to 4th November 2016. The Conference was officially opened by Hon Christopher Bazivamo, EAC Deputy Secretary General Productive and Social sectors, Hon. Phyllis Kandie, Cabinet Secretary, East African Community, Labour and Social Protection of the Republic of Kenya and Hon. Dr. Josiane Nijimbere, Minister for Health and Fight against AIDS, Republic of Burundi.
2. The conference was jointly organized by the East African Community Secretariat (EAC), Ministry of East African Community, Labour and Social Protection of the Republic of Kenya, GIZ/GFA Project on Pharmaceutical Sector promotion, Federation of East African Pharmaceutical Manufacturer’s Association (FEAPM), Bill and Melinda Gates Foundation, World Bank, African Union NEPAD Planning and Coordinating Agency, the World Health Organization (WHO), United Nations Industrial Development Organization (UNIDO), United Nations Conference on Trade and Development (UNCTAD) and German Metrology Institute (PTB).
3. The conference was attended by domestic and international pharmaceutical manufacturers, stakeholders from Ministries of Health, Finance, Trade and Industry, National Medicines Regulatory Authorities (NMRAs), National Medicines Procurement Agencies (NMPAs), and development partners including UNAIDS, and Swiss Tropical Institute and experts from the cooperating partners.
4. The conference made the following resolutions on this date 4th November 2017:

i) Investment in development of EAC domestic pharmaceutical manufacturing sector has an important role in achieving economic transformation goals, access to medicines goals and Sustainable Development Goals (SDGs) and enhances inclusive growth in the health sector and economy at large. The EAC and FEAPM to develop a robust Incentive Framework that will lead to significant investments in regional pharmaceutical manufacturing.

ii) EAC to ensure policy coherence across the sectors of health, industry, trade, commerce, customs and enhanced market access at regional and national levels in the EAC Pharmaceutical Manufacturing Plan of Action (EACRPMPOA 2017-2027) and the EAC Medicines and Health Technologies Policy and Strategic Plan (2016-2021) currently under preparation.

iii) The EAC to undertake a stepwise approach towards the implementation and domestication of the EAC Harmonized Good Manufacturing Practice (GMP) Standards to ensure domestic pharmaceutical industry stays competitive at regional and international levels. Basing on the experience and benefits of the Kenya GMP roadmap the region commits to implementation of the roadmap within 5 years.

iv) In order for the EAC Pharmaceutical manufacturing sector to capitalize on the available market and ensure medical products produced domestically are safe, efficacious and of acceptable quality standards to build customer trust and confidence, the EAC domestic pharmaceutical manufacturers to utilize the EAC-Medicines Regulatory Harmonization scheme including the single application for registration of medical products to be marketed in all the five Partner States and joint GMP inspections which reduces duplication of efforts, costs and time to the Pharma sector.

v) Preferential treatment of locally produced pharmaceutical products in government procurement is key to creating the necessary demand for locally manufactured products and thus more investments. To this end the government of East African Partner States and the private sector are called upon to give a preferential margin of up to 30% to the domestic manufacturers.

vi) For purposes of resolution No. (v) the region undertakes to operationalize Article 35 of the EAC Common Market Protocol , which clearly defines, ‘local’ in a regional content to ensure that preferential treatments accorded to nationals are extended to all suppliers within the East Africa Community.

vii) Noting that the low level of domestic production of essential medicines and health technologies leads to shortage of essential medicines and health technologies, the EAC and FEAPM to prepare a list of essential medicines that can be produced within the region. The region will then undertake classification and import restrictions for these finished pharmaceutical products based on regional capacity and quality audits of local manufacturer.

viii) Noting the importance of finance to investments in the sector, the EAC undertakes to explore innovative mechanisms for financing domestic pharmaceutical manufacturing.

ix) EAC in collaboration with FEAPM to formulate a regional skills development and partnership programme based on the assessment needs in pharmaceutical manufacturing and research centres.

x) Noting the importance of innovation, research, technology and development to the sector, the EAC to undertake networking research centres and build synergies among researches taking place within EAC in biotechnology and pharmaceutical. Further they are to increase participation of EAC research institutions in researches taking place outside EAC including public-private product development partnerships on diagnostics and treatment of tropical and communicable disease.

xi) Noting the importance of Intellectual Property Rights, the governments of the EAC Partner States are called upon to implement the recommendations of the Regional Intellectual Property Policy on utilization of Public Health Related WTO- Trade Related Aspects of Intellectual Property Rights (TRIPS) under their domestic laws.

xii) EAC undertakes to implement the EAC Competition Policy to improve coordination, to combat substandard, spurious, falsely labelled, falsified and counterfeit products. Further the region commits to undertake pharma covigillance and post market surveillance activities.

xiii) Noting the importance of enhancing market access for EAC products in other regions, the region undertakes to include pharmaceutical exports in regional and bilateral trade negotiations.

xiv) The EAC commits to strengthen the existing multi sectoral regional and national steering committees for the implementation of the EAC Regional Pharmaceutical Plan of Action.

xv) The EAC welcomes the, ‘Nairobi Statement on Investments in Access to Medicines’ signed by UNCTAD, AUC, MOH Kenya, MOITI SA and UNAIDS and calls upon EAC Partner States to join in the commitment to promote local pharmaceutical production in support of SDG goals and emphasize policy coherence and market integration.

xvi) The stakeholders recommended that the multi sectoral conference will be biennially to take stock of the development of joint activities and progress.