Emmanuel Mujuru Deputy Chairman Southern African Generic Medicines Association (SAGMA) BS5 Offering advocacy and member services The role of business associations in fostering Local Pharmaceutical Production International Conférence on Local Pharmaceutical Production in Africa Cape Town, April 5 2011 Introduction The Southern Generic Medicines Association (SAGMA) was inaugurated on 3 December 2009 following the adoption of its constitution by representatives drawn from companies and associations operating in SADC SAGMA was officially launched on April 4 2011 SAGMA is a Not for Gain Voluntary Association legally registered in RSA SAGMA is a legal entity with the capacity : to sue or be sued, own property, exist on its own right separate from its members & directors SAGMA is committed to the promotion of growth of pharmaceutical production and use of generic medicines in Southern Africa 2 1
Membership Membership is open to all who are committed to the production and promotion of generic medicines subject to a member applying for membership and being approved by the Board of Directors. Members should be natural persons and/or legal entities constituted according to the practice and laws of their countries of origin in SADC Category of membership include Ordinary Members and Associate Members. Ordinary Members have voting rights whilst associated members do not have voting rights. Subscriptions: Ordinary Membership USD$1,000 Associate Membership US$500 ; National Associations 5% of annual subscriptions to the association. Countries currently represented in SAGMA include Botswana, DRC, Malawi, RSA, Tanzania, Zambia & Zimbabwe with membership from Angola, Namibia, Swaziland, Mozambique, Mauritius expected by end of the year 3 Vision & Mission of SAGMA Our Vision is to create a vibrant, self sustaining generic pharmaceutical industry in the Southern African Development Community (SADC). Our Mission is to achieve self sufficiency and reliability in the local production and/or promotion of affordable, efficacious, quality generic medicines in the Southern Africa Development Community Our Strategic Intent is to make Africa internationally competitive in the Global Pharmaceutical Industry 4 2
Challenges Affecting Pharmaceutical Production Conflicting policies: Industrial Development vs. Health Needs ; Industrial Development vs. Tax Revenues Lack of Regional Regulatory Harmonization in SADC: Multiple Drug Registrations ; Prolonged delays in obtaining drug registration approvals; Regulatory Capacity International Patents Rights : IP vs. TRIPS ; ACTA vs. TRIPs Limited Markets: Small Population sizes; Low Health Budgets and expenditure on Medicines; High Donor Dependency ; Low Economies of Scale ; Low Pharmaceutical consumption per Capita Tariffs and Non-Tariff Barriers : Customs Duty and VAT on raw materials; Few Designated Health Ports; Porous & Uncontrolled Boarder Entry Points; Protective policies Financial Limitations: High cost Capital; Limited Access to Finance; Undeveloped capital markets Shortage of skills ; GMP compliance ; Old non compliant factories Supportive institutions for development of industry: CRO laboratories; API Industry; Research Laboratories ; Cost and availability of essential Utilities: Electricity; Water; Transport 5 Objectives of SAGMA Representing and supporting the common business, scientific & technical interest of its members Promoting access to safe, quality and efficacious generic medicines to patients in SADC. Facilitating economic growth of a viable and sustainable generic medicines industry Strengthening the local production of generic medicines Promoting excellence, facilitating networking opportunities, disseminating information and raising awareness regarding pharmaceutical & related matters Facilitating through collective advocacy active engagement on regional legislative and regulatory issues affecting healthcare and generic medicines Facilitating access to affordable financing Facilitating harmonization of regulatory and registration standards in SADC Addressing the improvement and retention of skills base, technical expertise and of GMP compliance in the generic industry Promoting the formation of very strong representative national associations Increasing the visibility of member companies and associations in global arena 6 3
Services and Benefits Offered by SAGMA Advocacy and lobbying strength in numbers Information sharing e.g. tenders, marketing, legal, regulatory, training, workshops, seminars etc. Facilitating access to national & regional markets, Networking opportunities Access to regional bodies, government authorities and donors Advocacy for removal of tariffs and non-tariff barriers Lobbying for participation and speedy implementation SADC pharmaceutical business plan & AU Pharmaceutical Manufacturing Plan Advocating for the harmonization of regulatory standards and registrations in the SADC region Facilitating access to training and skills development workshops, training, technical experts Access to pooled resources and facilities 7 Future Plans SAGMA s plans are captured in its Business Plan and include: Recognition & registration with SADC Membership with IGPA Increase membership to cover at least 10 members countries of SADC in the immediate term and all 14 in the medium term Achieve financial self sufficiency Partnering SADC in the implementation of pharmaceutical business plan. Engage the donor community to facilitate access of business from DFID; Global Fund ; UNICEF ; PEPFAR; UNAIDS Improve member benefits Developing and strengthening national associations in every SADC member country Obtaining NGO status with WHO etc. GMP training and skills development to increase the number of companies with WHO pre-qualification status Harmonization of regulatory standards and establishment of a regional regulatory authority Establishment of CRO s for bio-equivalency studies 8 4
Successes & Achievements In its just over a year of existence SAGMA has recorded the following achievements: Adoption of a new constitution and registration of SAGMA as a legal entity Setting up of a fully functional secretariat and adoption of a business plan Establishment and operation of a website which is providing an active platform for information sharing, recruitment of new members, marketing of services offered by SAGMA, Membership from 8 SADC Member Countries out of 15 In line with its advocacy role SAGMA held meetings with following: SADC Health Desk on implementation of SADC Pharmaceutical Business Plan; Official launch on 4 April 2011. Actively participated in various national and international conferences that included: SADC s workshop on the development of regional strategy and strategic framework for pooled procurement and production of essential medicines (13-17 December 2010); UNIDO IDB Meeting (24 November 2010) and Local National Association Meetings 9 Cooperation with Regional Associations In pursuit of its mandate SAGMA s interests is not only restricted to Southern Africa but also include relations globally and regionally in so doing the association will seek to: Establish membership with IGPA and working relationship with its regional affiliates. Foster closer cooperation and working relationships with regional associations that include: Western African Pharmaceutical Manufacturers Association (WAPMA) ; Federation of Eastern African Pharmaceutical Manufacturers (FEAPM) among others Recognition and registration with SADC and cooperation in the implementation of the SADC Pharmaceutical Business Plan Cooperation and working relationship with Global Fund, PEPFAR, DFID Close working relationship with WHO, UNICEF, UNIDO & UNCTAD Cooperation with AU in the implementation of pharmaceutical manufacturing plan for Africa. Participation in forums such as: WTO s TRIPS ; ACTA (Anti-Counterfeiting Trade Agreement); ALMA (Africa Leaders Malaria Alliance) 10 5
Thank you! 6