Réalité & Perspectives de la production pharmaceutique basée en Afrique: #PharmInAfrica
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Les médicaments produits en Afrique sont majoritairement des génériques et leur valeur ajoutée pour le système de soin est d'une importance cruciale à double titre : donner du travail de haute technologie à une population croissante ; permettre une indépendance stratégique du continent
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Réalité & Perspectives de la production pharmaceutique basée en Afrique: #PharmInAfrica
- 1. Réalité et Perspectives de la production pharmaceutique basée en Afrique #PharmIn@frica Dr NJAMBONG Guy, S.Anta Consulting – Cameroun Forum International sur la Qualité, 8-10 Nov 2017 Yaoundé, 16 novembre 2017
- 2. AGENDA de la Présentation : Préambule 1. Macro-Economie de #PharmIn@frica 2. Régulation de #PharmIn@frica 3. Perspectives & Conclusion pour #PharmIn@frica
- 3. 7 défis, en Afrique, pour l’amélioration des soins, qui est un marché créateur de valeur continental Capacité d'Électricité Limitée et trop peu d’Énergie renouvelable. Manque d'Infrastructure de Santé et Faible Production Pharmaceutique locale Logistique Intra-africaine limitée et Opérations de Distribution. Conditions de stockage et Qualité. Le lourd Fardeau des Maladies. Accessibilité de l'information. Régulation nationale et panafricaine de Santé. La lente mise en œuvre du PMPA Accroissement de la population versus la fuite des cerveaux. Enseignement limité dans le secteur santé L'accessibilité Limitée et l'intérêt d'Investisseur pour le secteur de Pharma. La fiscalité douanière. SOURCE : Dr NJAMBONG G; Enjeux & défis du marché pharmaceutique en Afrique; LEEM, 12 Jan 2017
- 4. I) CONTEXTE de #PHARMIN@FRICA 1. Sites de Production & de Recherche 2. Tactique d’émergence
- 5. #PharmExport@frica : en 2004, l'Afrique était un producteur pharmaceutique inconnu de l’OMS! SOURCE : WHO 2004
- 6. Intérêt individuel Influence collective #PharmInvestIn@frica : Le panafricanisme capitalistique pharmaceutique vient du Maghreb et d’Afrique Australe. Pharm@frica > 557 Usines ? 8 85 53 35 5 8 5 150 2 33 40 5 13 2 4 2 50 6 1 1 1 1 37 11 2 20 1 2 1 3 2 1. Accélération du transfert de technologie au niveau PanAfricain, Améliorer l'accès aux médicaments fabriquer localement, 2. Créer des emplois qualifiés, stimuler la compétitivité et la baisse des coûts, 3. Augmenter l'accessibilité à des médicaments abordables, supplanter la qualité inférieure et la contrefaçon 4. Participer à l'agenda politique de la Commission de l’U.A. 1. Création d'entreprises multinationales, 2. Une main-d'œuvre moins chère et une base de marché plus large, génèrent des revenus 3. Optimisation fiscales catalysant la compétitivité, 4. Limiter l'importation de la concurrence frontale par le lobbying local. SOURCE : Dr NJAMBONG G; Enjeux & défis du marché pharmaceutique en Afrique; LEEM, 12 Jan 2017 Sothema Pharma5 Medis Teriak Danadams Adcock Aspen Aspen Aspen Adcock Medis
- 7. #PharmIn@frica = #ResearchIn@frica : l’implantation de l’I.P. africaine est celle de la Recherche bien plus que de l’existence d’une formation pharmaceutique SOURCE: Solomon Nwaka.ANDI Director a.i. EAHIC London, March 26- 27, 2013 Libya Tunisia Algeria Morocco Western Sahara Guinea Bissau Mauritania Egypt Chad Niger Eritrea Sudan Central African RepublicNigeria Mali Senegal Liberia Togo Cameroon Ethiopia Somalia Djibouti Gambia Sierra Leone Guinea Ivory Coast Benin Zaire Uganda Gabon Kenya Burkina Ghana Equatorial Guinea Congo Rwanda Tanzania Mozambique Angola Zambia Burundi Malawi Madagascar Botswana Zimbabwe Namibia South Africa Lesotho Swaziland Cape Verde PharmIn@frica
- 8. Production de formes solides, liquide, semi-solide, via un protectionniste, #PharmIn@frica émerge SOURCE : Pharmaceutical Sector Profile: Nigeria – UNIDO https://www.unido.org/fileadmin/user_media/Services/PSD/BEP/Nigeria_Pharma%20Sector%20Profile_032011_Ebook.pdf Production locale de médicaments non parentéraux au Kenya selon le type de produit, 2007-2013 (en millions de dollars US) Average Annual National Production of Health Products on the Import Prohibition List Tablets Tablets Syrups (Litres) Paracetamol 76,862,821,591 2,258,474,114 Co-trimoxazole 1,446,797,876 193,796,390 Chloroquine 336,038,307 1,325,236,000 Metronidazole 1,295,122,945 1,400,000,000 Ferrous gluconate 666,855,000 Ferrous sulfate 1,272,000,000 Folic acid 1,316,508,717 Vitamin B Complex 2,805,506,155 Multivitamin 1,673,301,741 922,754,584 Acetyl salicylic acid 242,550,000 Mag. Trisilicate 620,337,000 13,955,983 Piperazine 200,000,000 6,667 Levamisole 50,000,777 Clotrimazole cream 100,068,221 Ampicillin/cloxacillin cap 1,184,586,740 8,235,000 Penicillin/gentamicin/oint 251,097,381 Pyrantel pamoate 1,692,607 750 Liste d'interdiction au Nigéria * (*) Government ban on imports of some essential medicines for which there is adequate domestic capacity and technical skills Des comprimés, la production de capsules vers le liquide, les crèmes, grâce à une protection de plus en plus, Pharm_frica est-elle prête pour la biotechnologie?litical Economy of Industrializing for Local Health. International Political Economy. London: Palgrave Macmillan.
- 9. Les prix douaniers applicables avant le Tarif Extérieur Commun dans la CEDEAO étaient différents par pays SOURCE : Dr Assane COULIBALY, Pr Amor TOUMI, « Etude pour le développement des industries pharmaceutiques locales (IPL) en cote d'ivoire »; ORGANISATION DES NATIONS UNIES POUR LE DEVELOPPEMENT INDUSTRIEL COTE D’IVOIRE - PROGRAMME D’APPUI AU COMMERCE ET A L’INTEGRATION REGIONALE (PACIR) ; Projet d’«Amélioration de la compétitivité des entreprises ivoiriennes des secteurs d’exportation non traditionnels» PROJET EE/IVC/010/001. Décembre 2014.
- 10. II) LA REGULATION DE PHARMIN@FRICA 1. DMF & Inspections 2. Harmonisation & Régionalisation
- 11. Le contrôle systématique de DMF et les inspections d’usines sont très faibles en Afrique SOURCE : Dynamics of Pharmaceutical Quality Systems for the Export of Pharmaceuticals from India to Africa - Empower School of Health; June, 2014 Exigence mondiale et africaine pour le DMF «Les fabricants changent souvent de sources d'API pour réduire les coûts ou remplacer les goulets d'étranglement, sans en aviser leurs régulateurs. Dans la plupart des pays africains, le changement de source de l'API n'implique pas automatiquement la soumission d'un dossier de «variation majeure». Reference: Frost & Sullivan 2013 India 61% Europe 18% China 14% USA 7% RAW MATERIAL WITH DMFS IN GHANA
- 12. La feuille de route WHO-GMP attise les convoitise en Afrique anglophone SOURCE : Dynamics of Pharmaceutical Quality Systems for the Export of Pharmaceuticals from India to Africa - Empower School of Health; June, 2014 SOURCE : Dr NJAMBONG G;, Enjeux & défis du marché pharmaceutique en Afrique; LEEM, 12 Jan 2017 New plant under construction Plant upgrade Plant upgrade New plant under construction New plant under construction New plant under construction Parmi les 10 premiers fabricants locaux du Ghana, 4 nouvelles usines sont en construction et 2 mises à niveau. L'ONUDI avec les parties prenantes kenyanes ont élaborés une feuille de route GMP lancée en décembre 2014. SOURCE : Supporting pharmaceutical production in africa – UNIDO, 2016 ; https://www.unido.org/fileadmin/user_media_upgrade/What_we_do/Topics/Business__investment_ and_technology_services/CUP/Pharma/PRINT_Pharma_Brochure_SPREADS.pdf
- 13. AMRH couvre 85% de l'Afrique & l’AMA sera lancé en 2018 – Mais Où sera-t-elle basée? « Le programme de réglementation et d'harmonisation des produits médicaux en Afrique est largement motivé par la nécessité d'accroître l'accès aux technologies essentielles de la santé et de renforcer l'innovation continentale ». SOURCE: Understanding the role of Regional Centres of Regulatory Excellence in strengthening medicines regulation in Africa; Margareth Ndomondo-Sigonda – NEPAD Agency Head of Health; Nov 2016. http://www.nepad.org/resource/understanding- role-regional-centres-regulatory-excellence-strengthening-medicines SOURCE : Supporting pharmaceutical production in africa – UNIDO, 2016 ; https://www.unido.org/fileadmin/user_media_upgrade/What_we_do/Topics/Business__investm ent_and_technology_services/CUP/Pharma/PRINT_Pharma_Brochure_SPREADS.pdf "La Commission de l’U.A. a invité l'ONUDI à prendre l'initiative d'élaborer le consortium pour mettre en œuvre le plan d'affaires de la PMPA"
- 14. En Afrique, 11 RCORE opèrent sur 8 segments technico-réglementaires, régi via une seule loi SOURCE: Understanding the role of Regional Centres of Regulatory Excellence in strengthening medicines regulation in Africa; Margareth Ndomondo-Sigonda – NEPAD Agency Head of Health; Nov 2016. http://www.nepad.org/resource/understanding-role-regional-centres-regulatory-excellence-strengthening-medicines Une loi cadre sur le règlement des produits de santé (janvier 2016) servira de guide pour les pays. Elle vise à assurer des processus réglementaires efficaces et transparents qui contribueront à la disponibilité des produits et technologies médicales de qualité, sûrs et efficaces, en tant que contribution à l'amélioration des résultats en matière de santé en Afrique.
- 15. III) CONCLUSIONS & PERSPECTIVES 1. L’Afrique de demain 2. A quand le leadership Pharm@fricain ?
- 16. L'Afrique doit être « pharmaceutiquement » plus industrialisée et en adéquation à ses maladies! Harvard Business Review 2016 http://www.hbrfrance.fr/magazine/2014/07/2687-le-temps-de-lafrique-est-venu/ KPMG > https://www.kpmg.com/Africa/en/IssuesAndInsights/Articles-Publications/General-Industries- Publications/Documents/Global%20Life%20Sciences%20sector%20report%202015.pdf Life Sciences in Africa with a focus on Sub-Saharan Africa La main-d'œuvre africaine augmentera de 163 m au cours de cette décennie et, en 2050, les Africains représenteront l'¼ des travailleurs dans le monde. La fabrication locale de médicament pour le traitement des maladies principales cause de décès en Afrique Sub-Saharienne n’existe pas.
- 17. Avec USP, l'OMS et les fabricants locaux, l'Éthiopie a adopté une feuille de route GMP de 5 ans. SOURCE : National strategy and plan of action for pharmaceutical manufacturing development in Ethiopia (2015–2025) ; Developing the pharmaceutical industry and improving access” written by the Ethiopian Ministry of Health and Ministry of Industry - http://www.who.int/phi/publications/Ethiopia_strategy_local_poduction.pdf Chaîne de valeur pharmaceutique éthiopienne projetée de 2015 à 2025 et matrice du passée
- 18. Un des modèles économiques dans Pharmin@frica est le P.P.P et le PMPA en est le cadre. Soutenir la revitalisation de l'industrie pharmaceutique du Zimbabwe SOURCE : Supporting pharmaceutical production in Africa – UNIDO, 2016 ; https://www.unido.org/fileadmin/user_media_upgrade/What_we_do/Topics/Business__investment_and_technology_services/CUP/Pharma/PRINT_Pharma_Brochure_SPREADS.pdf
- 19. … élargir et améliorer la disponibilité d’une bonne médication pour les Africains, par les Africains,… …et le #PharmIn@Cameroun doit reprendre son leadership dans la CEMAC … #PharmIn@frica c’est … … grâce à une meilleure qualité.
Notes de l'éditeur
- Before we jump into a discussion of these trends, I would like to put it in context with the challenges we are facing on the continent, and most likely will still face in 10-20 years from now. I am sure you are not unfamiliar with these challenges, so you may ask me why I am showing this slide, and the reason is that we believe the same challenges that we are facing currently will be the primary drivers of growth in Africa in the long term future. Disease management is defined as "a system of coordinated healthcare interventions and communications for populations with conditions in which patient self-care efforts are significant."[1][2][3] For people who can access health care practitioners or peer support it is the process whereby persons with long-term conditions (and often family/friend/carer) share knowledge, responsibility and care plans with healthcare practitioners and/or peers. To be effective it requires whole system implementation with community social support networks, a range of satisfying occupations and activities relevant to the context, clinical professionals willing to act as partners or coaches and on-line resources which are verified and relevant to the country and context. Knowledge sharing, knowledge building and a learning community are integral to the concept of disease management. It is a population health strategy as well as an approach to personal health. It may reduce healthcare costs and/or improve quality of life for individuals by preventing or minimizing the effects of disease, usually a chronic condition, through knowledge, skills, enabling a sense of control over life (despite symptoms of disease) and integrative care. 1/ Care Continuum Alliance. Care Continuum Alliance (CCA) definition of disease management. Retrieved 2011-05-24. 2/ Congressional Budget Office. An analysis of the literature on disease management programs. (PDF) 2004-10-13. Retrieved 2008-10-13. 3/ Coughlin JF, et al. (Apr 2006). "Old age, new technology, and future innovations in disease management and home health care" (PDF). Home Health Care Management & Practice. 18 (3): 196–207. doi:10.1177/1084822305281955.
- Pharmaceutical production occurs at three levels: The primary level includes the manufacture of active pharmaceutical ingredients and intermediates from basic chemical and biological substances. Secondary production includes the production of finished dosage forms from raw materials and excipients. The tertiary level is limited to packaging and labelling of finished products or repackaging of bulk finished products. Out of the 46 countries in the WHO-African Region[1] 37 have pharmaceutical industries, of them 34 have secondary level production and 25 have tertiary production. Only South Africa has limited primary production. Nine countries have no production capacity. Many countries in the continent rely mainly on India and in less measure on China for imports of affordable generics and raw materials. The fact that since 2005 India had to comply to the TRIPS and change its patent laws is seen as a potential threat to affordability and access to essential drugs in Africa. Patents often make drugs more expensive. Added to this is the fact that Indian producers target more and more rich countries markets and they are less orientated towards African countries diseases. African countries need to decide on alternatives for African specific diseases such as malaria. SOURCE: Towards greater production of medicines in Africa? Begoña Iñarra, AEFJN Brussels Secretariat - http://www.aefjn.org/index.php/358/articles/towards-greater-production-of-medicines-in-africa.html
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- Primary source > Kenya National Bureau of Statistics, Production data for the period 2007 to 2013, Government of Kenya, Nairobi, obtained 4 September 2014.
- Africa’s trade potential: Challenges and implementation of free trade agreements, Adefolake Adeyeye ; How we made it in Africa – Financial Time; '10 January 2017' Facilitating Africa’s intra- and inter-trade With this in mind, the Continental Free Trade Agreement (CFTA) expert meeting that took place in May 2016 to develop a draft of the Africa wide trade agreement, is welcome. The CFTA seeks to transform Africa’s economy by boosting intra-African trade and ultimately increasing Africa’s global trade. Of significance also is the Tripartite Free Trade Area (TFTA) between SADC, the East African Community (EAC) and COMESA, launched in 2015 and expected to pave the way for the CFTA. The TFTA involves 26 African countries spanning a combined market of 625 million. It addresses tariff and non-tariff barriers, transport infrastructure and industrial policy. If the TFTA is successfully implemented, many of the obstacles to intra-African trade could be resolved. The Economic Community of West African States (ECOWAS) has also started implementing the Common External Tariff that came into force in January 2015. Africa should also look into promoting its international trade in services as the services sector plays a major role in its economic development. As at the launch of the TFTA, trade in services was not addressed. Contrary to the long-held theories that countries develop by increasing agricultural productivity followed by manufacturing growth, Africa’s growth has been to a large part due to the services sector. Since services allow firms to participate in regional and global value chains, it has the potential to provide real trade opportunities for Africa. Moreover, international trade in services are less likely to be affected by slow economic growth and/or macroeconomic upheaval. Conclusion Africa needs to boost its trading prospects, both regional and global, by re-examining its intra-regional trade, RTAs and infrastructure development. The RTAs have not reached expected goals, with limited implementation of political commitments, high trade barriers, constraints and infrastructure deficits. In continents like Europe and Asia, RTAs have increased global trade, evidenced by the number of FTAs and position in world trade rankings. However, those continents have also established good trade infrastructure and policies. With Africa so fragmented, RTAs would still best serve the continent. It is hoped that the CFTA, TFTA, and ECOWAS CET will promote free trade among African nations, thereby potentially strengthening links in the global value chain, leading to increases in global trade and FTA implementation. The author, Dr Adefolake Adeyeye, is a Research Fellow of the NTU-SBF Centre for African Studies, a trilateral platform for government, business and academia to promote knowledge and expertise on Africa, established by Nanyang Technological University and the Singapore Business Federation. Dr Adeyeye can be reached at adefolake.adeyeye@ntu.edu.sg. Reminder : FTAs are agreements between two or more countries to lessen or eliminate trade barriers and effect closer economic integration. Basic areas of trade liberalisation typically covered by FTAs are trade in goods, trade in services and investments. FTAs can also include intellectual property protection, government procurement and other cooperation measures. FTAs help secure export markets, movement of investment and people, making it easier for companies to trade and invest in FTA partner markets.
- “The establishment of the AMA shall build upon already existing structures of the Regional Economic Communities (RECs) and Member States that have already started implementing the AMRH programs within the framework of the PMPA,” NEPAD Agency Pharmaceutical Coordinator, Margareth Ndomondo-Sigonda explained. The AMA implementation roadmap was also developed and participants elected the Chairperson and Vice Chairperson of the Task Team represented by Ms Gugu Mahlangu from Zimbabwe and Dr. Nadia Fenina from Tunisia respectively. “Our role is to facilitate the establishment and operationalization of institutions and systems to enhance access to good quality medicines and technologies for the people of our continent,” Dr Strijdom said. The main role of the Task Team is to build consensus on the key milestones towards the establishment of the AMA and work out detailed modalities, institutional framework, legal and financial implications.
- AMRH has launched the Regional Centres of Regulatory Excellence Initiative to fill the human resource gaps experienced by NMRAs and the pharmaceutical industry. The institutions will provide academic and technical training in regulatory science, exchange programmes and operational research. 8 Regional Economic Communities: Arab Maghreb Union (UMA), Common Market for Eastern and Southern Africa (COMESA), Community of Sahel Saharan States (CEN-SAD), East African Community (EAC), Economic Community of Central African States (ECCAS), Economic Community of West African States (ECOWAS), Intergovernmental Authority on Development (IGAD) and Southern Africa development Community (SADC)
- While success stories of local industry players exist, the majority have struggled to compete for two reasons. Firstly, the high costs of active pharmaceutical ingredients (APIs) in Africa has left most unable to compete on price with Asian generic manufacturers and unable to access the most in-demand therapy areas. Secondly, domestic manufacturers have struggled to implement good manufacturing practices (GMP) and ensure quality production. As a result, few companies have WHO prequalification status. For this reason, NGOs, which have historically been prime procurers of medicines on the continent, have refused to buy essential medicines (e.g., anti-infectives) from domestic manufacturers. Additionally, poor GMPs have been barriers for the International Finance Corporation (IFC), part of the World Bank Group, in its search to identify viable investment opportunities in the domestic industry market. Nevertheless, MNCs and the WHO are now working with local players to help them obtain WHO pre-qualification. For example, the WHO and UNITAID have been offering capacity building and technical assistance to local Nigerian drugmakers that has also resulted in progress towards achieving GMP standards and pre-qualification.
- With the establishment of FMHACA, Ethiopia moved to adopt WHO GMP standards. Consequently, after working with the United States Pharmacopeia/Promoting the Quality of Medicines (USP/PQM), WHO and local manufacturers in 2012, Ethiopia adopted the five-year GMP Roadmap (2013–2018). The roadmap was initiated with the aim of improving public access to sustainable, affordable, safe, efficacious and good-quality medicines produced in Ethiopia. The roadmap, in consideration of the challenges that the industry faces, adopted a pragmatic three-phased approach to ensuring all companies become compliant with WHO GMP standards by 2018. The Ethiopian pharmaceutical industry currently consists of 13 pharmaceutical and medical supply manufacturers; about 10 of these produce pharmaceuticals while the rest are engaged in producing medical supplies such as syringes, absorbent cottons and lab equipment. Almost all of these companies are owned by Ethiopian nationals. The industry is very small in size and has limited capacity; it serves only a small part of the domestic market (less than 20%) while imported drugs cover the rest of the market. The Ethiopian pharmaceutical sector is supported by the Engineering Capacity Building Program (ECBP) – a joint project by the Ethiopian government and the German development cooperative, GTZ. The ECBP supports manufacturers, institutions and associations in regard to the transfer of qualifications and know-how, as well as providing contacts to international buyers and investors. Pharmaceutical manufacturing is not a relatively attractive area for investors in Ethiopia, since there are, quite appropriately, stringent regulatory controls, and very high technical standards need to be met. The sector has been in difficulty over the past five years and four companies (ETAB Syringe factory and three IV fluid manufacturers (Biosol PLC, Bethlehem Pharmaceutical, Lifeline).) were foreclosed by two state-owned banks for failure to service their loan obligations.