Support of Local Production in Africa The Tanzanian Experience

Transcription

1 Support of Local Production in Africa The Tanzanian Experience International Conference on Local Pharmaceutical Production in Africa Cape Town, April 4-6, 2011 German Medical Aid Organisation action medeor action medeor e.v. founded 1964 non-profit distribution of high quality low cost essential medicines and equipment headquarter and warehouse in Tönisvorst / Germany 45 employees customers (NGO hospitals) in approx. 130 countries comprehensive QA system => compliance with GMP 1

2 Pharmaceutical-medical projects Local production of ARV s and Malaria medicines TPI ARV project in Tanzania (EU funded) Artemisia annua cultivation and extraction in Kenya Capacity building for local manufacturers GMP / QC workshops in East Africa (Tanzania) since 2005 & West Africa (Ghana) since 2008 Training for pharmacy students & generic product development R&D lab at the Muhimbili University / Dar es Salaam (pharmaceutical technology & analytics) action medeor activities in the pharmaceutical sector in Tanzania Ministries Authorities/ institutions Manufacturers Wholesalers Health facilities 2

3 action medeor International Healthcare Tanzania Ltd. Non-profit drug supply organization located in Dar es Salaam 1st local branch of action medeor Germany Operating since 2005 Suppliers 2/3 of products from Tanzanian and Kenyan manufacturers other suppliers from Europe, India, South Africa Assured quality GMP complicance of suppliers => on-site audits random testing of products by certified laboratories Quality Assurance and Quality Control Manufacturer GMP, Registration Qualified Personnel Drug Regulatory Authority Registration and Control of the Products and the Manufacturing Facility Additional Quality Control: Audits, Product Analysis Hospital, Patient 3

4 Production of ARVs in Tanzania the TPI EU Project Overall objective: HIV/AIDS related socio-economic decline in Tanzania slowed down Specific objective: The demand of 100,000 HIV and AIDS patients for first-line antiretroviral treatment can be met by locally produced high-quality ARVs Result 1: Factory compliant with WHO GMP established Result 2: Sufficient production capacity of high-quality first-line ARVs according to the need installed and output achieved Result 3: Knowledge generation and capacity building programmes on GMP and TRIPS supported and/or conducted Technology transfer and local ARV production Financial Volume: 6.2 Million Euro Main Sponsor: European Union ca. 5 Million Euro Programme: Aid for poverty-related diseases (HIV/AIDS, Tuberculosis and Malaria) in developing countries European Partner: action medeor e.v. Tanzania Pharmaceutical Industries limited - Manufacturer of essential medicines - Production site: Arusha - Current staff: 92 - Former governmental Organization, privatized since 1997 (40% GRN) - Since 2005 ARV manufacturer of fixed dose combination 4

5 Main activities and target groups Main activities: Set up of a modern WHO GMP compliant pharmaceutical production facility in Arusha / Tanzania Planned production capacity: 100 million tablets/year for AIDS treatment => initiation of WHO prequalification Capacity building for personnel and strengthening of local structures Target groups: AIDS patients in Tanzania: ART for people in need Personnel of local pharmaceutical manufacturers and key persons from governmental institutions and non-governmental organizations => international workshops on GMP and TRIPS Project structure Project: Local Production of ARV action medeor EC EC Delegation Tanzania Tanzania Pharmaceutical Industries Local Partner Stakeholders 5

6 Stakeholders and clients Stakeholders Ministry of Health - support of local manufacturers (15% advantage in national tenders) TFDA (Tanzania Food and Drugs Authority) Ministry of Finance TACAIDS (Tanzania Commission for AIDS) NGOs TZ Potential clients Tanzanian Government Non-governmental organizations Church institutions Project Implementation Tendering/contracting Internal training for local staff Processing, QA, QC, GMP-Standards Pre-construction on site Plant construction Installation of modular plant/equipment Implementation of production Preparing dossiers for initiation of WHOprequalification process Carry out bioequivalence study for x products Production of needed 1st/2nd line ARV Procurement of equipment, vehicle, other supplies External training for governmental institutions/pharmaceutical personnel and manufacturers TRIPS/International regulations, ToT on ARV pharmacology/ Procurement/Store management 6

7 Aimed ARV range Efavirenz 600 mg, film-coated tablets (Pharm R&D Lab) Saquinavir 500 mg film-coated tablets (Pharm R&D Lab / Roche TTI) Fixed-dose combinations: Lamivudine 150 mg / Tenofovir 150 mg / Efavirenz 300 mg, filmcoated tablets (Pharm R&D Lab) Lamivudine 150 mg / Zidovudine 300 mg, film-coated tablets Current status Production Building and accessory buildings are ready built Cleanroom and Engineering company contracted Factory Acceptance Test of major production equipment performed The first 5 containers of the total of 40 have arrived in Dar and are subject to clearing Final acceptance of production rooms, equipment and utilities: September 2011 Drug Development according to new WHO treatment guidelines has started in collaboration with international senior experts and Muhimbily University Dar es Salaam 7

8 Project progress construction of the outer shell Inauguration ceremony (June 2010) 8

9 Next steps Procurement of QC lab equipment Training of further personnel Establishment of a Quality Assurance System Start of Qualification and Validation Start of pilot batches: October 2011 Start of commercial batches: April 2012 Registering of product with Drug Regulatory Authority: August 2012 Submission of Drug Dossier to WHO: November 2012 Sources of technology and access to know-how International team of (senior) experts Detailed URS (design qualification) for production plant and equipment Implementation of QA system incl qualification and validation processes Training of local personnel Assistance with product development at Pharm R&D Lab Experienced contractor from India construction of the clean-room system acc to URS Stringent supervision on-site by TPI / action medeor project management team Compliance with agreed international standards FAT, Qualification (IQ, OQ) 9

10 Challenges During project implementation: Infrastructure / utilities on-site Qualification of local personnel / recruitment (cost containment!) Intercultural interaction (European Asian African): different approaches and expectations, e.g. compliance of contractor with URS Stringent tendering requirements Product development for WHO prequalification (change of first-line recomm.) Budget limitations Project extension of 32 months was necessary Long-term: Maintaining the implemented standards Locational challenges (infrastructure/ utilities, skilled personnel, supply of materials, lack of support structures - like calibration, maintenance, repair - etc.) International competitiveness?! Capacity building and quality approach Training for DRAs and regional pharmaceutical manufacturers on GMP, QC and product developmement Workshop on TRIPS Implementation of a teaching and development laboratory Pharm R&D Lab in cooperation with Muhimbili University in Dar es Salaam (PPP GIZ action medeor MUHAS) => Good Manufacturing Practice Standard => WHO Prequalification 10

11 Final remarks Local Production is not automatically improving access to medicines: quality and affordability are pre-requisites Quality in East Africa is strongly improving due to investments in production, quality management and human ressources Key for quality are ongoing capacity building, strong regulatory authorities and a vivid competition between the manufacturers R&D capacities have to be strengthened (e.g. Pharm R&D Lab at MUHAS in Dar es Salaam) For improved access an effective distribution is essential Thank you for your attention! Christine Häfele-Abah Pharmacist / MScIH Head of Quality Assurance action medeor e.v. St. Töniser Str Tönisvorst / Germany Christine.haefele@medeor.org Tel