PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA 6 TH TECHNICAL COMMITTEE MEETING 28-29 NOVEMBER 2015 ADDIS ABABA, ETHIOPIA CONCEPT NOTE THEME: PMPA +10: WHERE ARE WE?
P a g e 1 1. Background Over the past decade Africa intensified its efforts to strengthen its pharmaceutical manufacturing capacity and contribute to the improvement of public health outcomes as well as socioeconomic and industrial development. The Pharmaceutical Manufacturing Plan for Africa (PMPA) business plan under the Africa Health strategy and the Accelerated Industrial Development in Africa (AIDA) is the framework within which this agenda is being promoted on the continent. Significant progress at a continental, regional and national level has been made since the commitment by the Heads of State and Government Assembly Decision 55madein Abuja in 2005 and other subsequent decisions to promote the development of a sustainable pharmaceutical manufacturing industry on the continent taking full advantage of the TRIPS flexibilities and bolstering of research and development. Supported by development partners and various stakeholders, the AU has continued to provide leadership in facilitating the implementation of a package of solutions to the myriad of challenges confronting the pharmaceutical industry as well as the medical product regulatory systems proposed in the PMPA Business plan. Efforts to create an enabling regulatory and legislative environment for medical products regulations, including the African Medicines Regulatory Harmonisation (AMRH) programme(2009), African Medicines Agency (2014) and a AU Model Law on Medical Products Regulations (2015) have been developed as continental frameworks for adoption and adaptation to support regional economic communities and member states initiatives. Platforms such as the African Medicines Regulators Conference (AMRC) and AMRH governance structures to encourage dialogue among regulators have been established. The manufacturing perspective continues to be strengthened through fostering dialogue and partnerships involving both public and private actors aimed at creating a coherent policy environment across various sectors including trade, finance, health, academia among others. The Federation of African Pharmaceutical Manufacturers Association (FAPMA) consisting of members of West African Pharmaceuticals Manufacturers Association (WAPMA), Federation of East African Pharmaceutical Manufacturers Association (FEAPMA), Southern African Generic medicines Manufacturers Associations (SAGMA) launched in 2012;the AMRH Biennial Scientific Conference as well as the proposed African Pharmaceutical Manufacturers forum are useful platforms for enhancing dialogue and advancing both regional and national interests. Meanwhile dialogue through international cooperation platform such as Africa-EU, Forum on China Africa Cooperation (FOCAC), US-Africa, India-Africa and other multilateral cooperation s continues to deliver some promise results e.g. some multinational pharmaceutical companies have shown keen interest to invest in Africa. Despite the challenges that continue to hamper speedy progress, Africa is making strides in the right direction in its manufacturing capacity and is poised to harness the opportunities. In the North African countries and Southern African region, the status of local manufacturing of pharmaceutical products has gained a sturdy foothold. For example, Egypt and Tunisia produce most of their national requirements for essential medicines. Morocco, the second largest African pharmaceutical producer, after South Africa, has 40 pharmaceutical industrial units supplying 70% of domestic demand and exporting 10% of their production, particularly to neighboring African countries. WHO estimates that Ghana s pharmaceutical sector is one of the healthiest in Africa. As part of the efforts to develop its pharmaceutical industry, the country has made significant
P a g e 2 strides in the previous years. For example, backed by partners, efforts are underway to reform legislations, policies and incentives governing the sector to make it more attractive to potential investors. In addition, evidence produced by development partners on the need to strengthen pharmaceutical regulation is getting significant attention by policy makers in the country. A draft GMP roadmap has been developed in conjunction with the FDB, discussions with the industry have taken place regarding business linkages and work is ongoing to develop the platform. Training modules have been developed to raise the awareness of domestic companies on the importance of business partnership and help them develop their business skills. In Ethiopia, efforts by the government to support the sector as part of its growth and transformation plan was recently demonstrated by the launch in July 2015 of the country s national 10-year strategy and plan of action to increase access to medicines by transforming local pharmaceutical industry and optimizing the manufacturing value chain including focus on production of APIs and strengthening Research and Innovation sector. Private sector engagement and public sector efforts in other countries across the continent e.g. Tanzania, Kenya, Uganda, and Nigeria have continued to grow- seeking to enhance production capacity, expand product portfolio, and secure international standards of GMP. Despite the challenges, the AU continues to pursue the local manufacturing agenda taking full advantage of the political commitment at the highest level of leadership of its decision and policy making organs as well as harnessing the existing opportunities that come with its rapidly growing population size and combined GDP growth, increasing urbanization and disposable income of households, patent expiry of many leading medicines in the world, growth of pandemics and increasing number of people on treatment, ageing population, increase in lifestyle diseases, improved health insurance and coverage environment among others. Against this background, the PMPA technical committee (TC) was established in 2007 to provide technical guidance to African Union Commission (AUC) on the strategic approach to promoting the development of the African pharmaceutical sector. To provide guidance and oversight on the implementation of the pharmaceutical manufacturing plan for Africa, the TC is scheduled to meet for its 6th technical session from 26 to 27 November 2015 in Addis Ababa, Ethiopia. The TC is composed of 12 member states from across the five regions of the AU namely: East (Kenya, Ethiopia), West (Ghana, Nigeria, Senegal), North (Libya, Egypt), Central (Cameroon, Burundi), South (South Africa, Angola, Mozambique); representatives from 8 regional economic communities and representing steering committees on AMRH; academia and African pharmaceutical manufacturers associations (FAPMA). 2. General Objective The objective of this meeting is to review the progress made so far on the implementation of the PMPA, identify challenges and opportunities to further advance the sector for improved access to much needed medical products on the continent and pave the way forward for the future of the pharmaceutical industry and related sectors.
P a g e 3 3. Specific Objectives The objectives of the technical committee meeting are as follows: To take stock of progress in the implementation of the PMPA; To strengthen collaboration and networking among policy makers, regulators, industry, academia, scientific community and civil society; To consider the Roadmap for implementation of the recommendations of the first specialized technical committee on health, population and drug control (STCHPDC-1) held from 13-17 April 2015; To consider the Terms of reference and work plan of the AU PMPA Joint secretariat; To endorse the 3 year work-plan of the PMPA consortium. 4. Expected outputs The following are expected to be the outputs of the deliberations of the technical committee: PMPA Situation analysis report considered Roadmap for implementation of the recommendations of the first specialized technical committee on health, population and drug control (STCHPDC-1) held from 13-17 April 2015 adopted. Terms of reference and the annual work plan of the AU PMPA Joint secretariat considered The 3 year work-plan of the PMPA consortium endorsed 5. Expected Outcomes Improved awareness of the progress made and challenges that continue to hamper sustained progress, opportunities that could be harnessed to advance implementation of the PMPA. Increased awareness among national governments, regional and international organizations of the need and feasibility of local production Consensus will be reached on an approach to support the current national, regional and continental level efforts in the implementation of the PMPA. A declaration/communiqué developed at the conclusion of the meeting 6. Participants The meeting shall be attended by the following: Members of the technical committee AU PMPA Joint secretariat Resource persons Other stakeholders (only for the open session(s))
P a g e 4 7. Structure and design The meeting shall be conducted in both French and English. Sessions shall be conducted in plenary and closed sessions. The technical committee shall choose a chair, and rapporteur to preside over and facilitate the proceedings at the closed sessions. The AU PMPA joint secretariat shall provide secretarial, logistical and coordination support. 8. Information For any information or enquiries on the meeting, participants are advised to contact the following: Names Email Phone Technical : Janet Byaruhanga ByaruhangaJ@africa-union.org +251115182226 (Addis Margareth Ndomondo-Sigonda mnsigonda@nepadst.org +27 12 841 2980 (Midrand) Logistics: Senait Yirgu SenaitY@africa-union.org +251115182224 (Addis Kidu Hailu kiduhailu@yahoo.com +251911925251 (Addis Imene Chergui imene.chergui@gmail.com +251943296081(Addis