East African Nations Agree Declaration Promoting Regional Pharma Sector Investment 07/11/2016 by William New, Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Senior officials from East African nations last week agreed on a declaration on promoting investment in the region’s pharmaceutical sector, spelling out terms aimed at boosting investment in ways that are locally relevant and responsible. The declaration includes: steps to standardise and improve product quality and registration, boosting government procurement of local products, setting up research centres, adopting domestic laws on intellectual property and international trade flexibilities to IP, actions against counterfeit and substandard medical products, and increasing exports. The meeting comes as local pharmaceutical production is seen to be in decline in the region. Mr. Samuel Mwangi Kahenu, Senior Assistant Director, Regional Integration, Ministry of the East African Community Integration, Labour and Social Protection, Kenya addresses participants at the closing session Below is the declaration as agreed (the online version is available here): RESOLUTIONS: 1st International High Level Multi-Stakeholders Conference on Promoting Pharmaceutical Sector Investments in the East African Community 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. 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). 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. 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) [pdf] 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. Done at Nairobi, Kenya this 4th day of November 2016 ———— Below is an earlier press release from the event (press release available online here): Josiane Nijimbere, Minister of Public Health and the fight against AIDS in Republic of Burundi addresses the participants at the conference. East African Community Secretariat; Arusha, Tanzania; 02 November 2016:The 1st International High Level Multi-Stakeholders Conference on Promoting Pharmaceutical Sector Investments in the East Africa opened today at the Laico Regency Hotel in Nairobi, Kenya. The three-day conference brings together key stakeholders from EAC Partner States including Ministries of Health, Finance and Industry, National Medicines Regulatory Agencies (NMRAs), National Procurement Agencies (NMPAs), AU-NEPAD Planning and Coordinating Agency, World Health Organization (WHO), United Nations Conference on Trade and Development (UNCTAD), United Nations Industrial Development Organization (UNIDO) and the private sector (local and international pharmaceutical manufacturers) as well as international development partners and investors among others. The overall objective of the conference is to develop a common and shared vision for promoting investments in the regional pharmaceutical manufacturing sector. In her speech read by Mr. Barrack Ndegwa, the Integration Secretary, Kenyan Cabinet Secretary for East African Community Integration, Labour and Social Protection, Hon. Phyllis Kandie described the pharmaceutical sector is a critical area of cooperation in health matters within the EAC. Hon. Kandie said the conference was therefore significant as it provides a platform for stakeholders to have a conversation among the policy makers, industry players, the civil society, as well as social and development partners on how to deepen cooperation in the sector. She disclosed to the conference that in 2014, the pharmaceutical market of the EAC was valued at US$1.9 billion, adding that it was forecast to grow at a compound annual rate of 8.3% to reach US$4.2bilion in 2024. However, Kenya, which is the leading pharmaceutical producer in the region, with approximately 50% production and rising exports, supplies just 25% of the Kenyan market. The CS added that Tanzania supplies a declining share of its own domestic medicines market, down from 35% in 2009 to less than 10%-20% today. The Cabinet Secretary informed the participants that despite these developments, the Pharmaceutical manufacturers operating from within the EAC region generally produce at a cost disadvantage to larger generic product manufacturers internationally due to a variety of reasons including scale, expensive asset base coupled with older technology, higher financing costs plus a lack of integration with active pharmaceutical ingredients suppliers. “This situation makes domestically manufactured medicines uncompetitive compared to imports and the regional pharmaceutical market is therefore dominated by imports with domestic manufacturers only meeting less than 30% of the medicines demand.” She called for the Development Partners and other stakeholders to support the growth of the sector by engaging and addressing the concerns of the domestic pharmaceutical manufacturers and potential investors. On her part, Hon. Josiane Nijimbere, Burundi’s Minister of Public Health and the Fight Against AIDS, said medicines have become a very important and powerful tool, now more than ever, in improving the health status of populations and, in the long term, for reducing healthcare costs and ensuring sustainable development through health working human resource. “I am therefore delighted that the East African Community has decided to hold this conference in collaboration with our Development Partners here present and those who have not been able to make it, raise awareness of various stakeholders on the need to promote investment in pharmaceutical manufacturing.” She underscored the importance of the health sector for the citizens of East Africa as the EAC integration agenda aims at improving sharply standard of living the East African Citizenry. “To this effect, the development of the pharmaceutical sector and investments is equally critical if we want to achieve the objectives of the Community.” The EAC Deputy Secretary General in charge of Productive and Social Sectors, Hon. Christopher Bazivamo said that poor performance of the EAC health sector has contributed to shortage of essential medical products and health technologies, which could be produced within the region by EAC industrial sector. “About 75% of the EAC pharmaceutical market demand is met through importation of medical products and health technologies while 25% is covered by domestic pharmaceutical production,” said Hon Bazivamo. He urged Partner States to consider implementing incentive packages to promote domestic pharmaceutical production in the region which includes; a uniform preferential margin of 20% for all regionally produced medicines and medical devices in public tenders according to Article 35 of the Common Market Protocol; removal of duties for imported raw and packing materials, pharmaceutical manufacturing related equipment as well as spare parts for the equipment’s acquired by domestic manufacturers registered in the EAC; and classification and import restrictions for finished pharmaceutical products that can be produced within the region, based on regional capacity and quality audits of local manufacturers. The High Level Mult-Stakeholders Conference on Promoting Pharmaceutical Sector Investments conference provides an opportunity and a platform for stakeholders to discuss and agree on strategic areas and policy incentive packages that promote EAC domestic pharmaceutical manufacturers and foster dialogue between policy makers, regulators and pharmaceutical manufacturers. The Conference has been organized by the EAC Secretariat in collaboration with the EAC Partner States and Development Partners. 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