Good Procurement Practices for artemisinin-based antimalarial medicines

Transcription

1 Good Procurement Practices for artemisinin-based antimalarial medicines AMDS Partners and Stakeholders Meeting Geneva, 23 March 2010 Silvia Schwarte Medicines and Diagnostics Unit Global Malaria Programme

2 Complex ACT production cycle Growers Extractors Extraction (1 month) Seedling, nursery, plantation, growth and harvest (7 months) Manufacturers Derivatisation (2 months) API suppliers Co-formulation, tabletting, packaging and shipping (4 months) 2

3 Manufacturers and products 162 companies (last updated ) Multiple non-who recommended products: - oral artemisinin-based monotherapies - artemisinin + naphthoquine - artemisinin + PPQ - AS + sulfamethoxy-pyrimethamine - DHA + PPQ + trimethoprime - DHA + SP - DHA + PPQ + PQ + trimethoprime - arterolane + PPQ companies_marketing_oral_monotherapies.pdf 3

4 Levels of procurement Funding and procurement agencies: heterogeneous quality assurance criteria 4

5 ACT procurement and supply for public sector use Millions of ACT treatment courses GF appeal on ACTs WHO policy on ACTs months from adoption to implementation Forecast Cumulative number of countries ACT procured No countries: ACT 1st line No countries deploying 5

6 Manual for GPP Why needed? Challenges with artemisinin-based medicines API: plant origin, chemical instabilities Sub-standard ineffective and unsafe products in the markets Procurement channels: complex, fragmented Patients' health and lives Funding and procurement agencies: heterogeneous quality assurance criteria Manufacturers: GMP and documentation of quality Regulatory authorities: evaluation experience, control systems Increasing funding Credibility of health-care programmes Burden on the health care systems Resistance RMB PSM WG, 9-10 July 2007, Arlington, Virginia, USA: Expensive, high-profit medicines Need for guidance 6

7 Manual for GPP Development (I) April 2008, Woerden, Netherlands: Agreement on outline and content M. Assih (Centrale d Achat des Médicaments Essentiels et Générique du Togo), F. Blanco (UNICEF), A. Bosman (WHO), H. den Besten (I+ Solutions), E. Molari (UNOPS), R. Rack (JSI), and R. Shretta (MSH/SPS) December 2008: Document produced by collaboration between WHO/GMP and WHO/EMP, after consultation of national and international procurement agencies M. Assih (Centrale d Achat des Médicaments Essentiels et Générique du Togo), M. Sesay (UNOPS, India), IDA Foundation, UNICEF Initial draft: Monika Zweygarth, reviewed by Theo Dekker 7

8 Manual for GPP Development (II) June 2009: Review of WHO draft by Technical resource persons from the following agencies were invited to revise the manual and to attend the meeting: Senegal National Pharmacy, Kenya Medical Supplies Agency, Medical Stores Department United Republic of Tanzania, Centrale d Achat des Médicaments Essentiels et Générique du Togo, National Medical Stores Uganda, GFATM, I+Solutions, IDA Foundation, JSI, MSF, MSH/SPS, RBM, UNFPA, UNICEF, UNOPS, USAID, WB, WHO/EMP, WHO/GMP 6-7 July 2009: WHO Technical Consultation to finalize the manual August 2009: Revised version circulated by for a second round of comments 8

9 Launch: 9 March

10 Manual What's new? 1 st procurement guidance for artemisinin-based medicines Developed in cooperation with multiple national and international funding and procurement agencies Manual is based on new stringent internationally agreed quality standards as developed by GFATM, UNICEF, UNITAID, USPMI, WB, WHO 10

11 Inter-agency harmonized criteria for the selection of artemisinin-based antimalarials UNICEF/WHO tender criteria Restricted annual joint tender WHO Treatment Guidelines 2. PQ approved or SRA-registered 3. Dossier accepted by PQ or SRA 4. GMP compliance after inspection by WHO PQ or SRA Evaluation of IPPQ: - registration information, - regulatory (licensing) situation, Review of efficacy and safety - finished product specifications and compliance with International Pharmacopoeia standards, - stability data (in Zone IV), - labeling information, - API characteristics and certification. GFATM QA criteria Inclusion only in National Treatment Guidelines Dossier submission only to SRA

12 Compliance with all criteria required Harmonized selection criteria: Partial quality assurance criteria GMP compliance certified after inspection by WHO or by a SDRA for the dosage form concerned Submission of the Product Dossier to the WHO PQ Programme or to a SDRA and acceptance to review the dossier Acceptance of the product after technical review by an Expert Review Panel (ERP)" convened by WHO on the following: - registration information, - regulatory situation of finished pharmaceutical product and manufacturing facility, - finished product specifications and compliance with international pharmacopoeia standards, if available, - stability testing data (both accelerated and real time studies in Zone IV) as per ICH and/or WHO guidelines, - labeling information, - API characteristics and certification, - safety and efficacy data. 12

13 New GFATM QA policy and selection of finished pharmaceutical products (FPP) For ARVs, antimalarial and anti-tb FPPs Number of WHO-prequalified or SRA-authorized FPPs If 2 or more FPPs WHO prequalified or SRA authorized If 1 or 0 FPPs WHO prequalified or SRA authorized PR has to procure one of these FPPs PRs may procure a FPP recommended by the ERP If product not available* 13 * Inability to supply sufficient quantity of product within 90 days from date of order Courtesy of Dr. Sophie Logez, The Global Fund

14 Procurement Checklist (I) 16 steps to procure quality artemisinin-based medicines Step 1: Selection of medicines WHO guidelines, national guidelines, special situations Step 2: Estimation of requirements quantification, forecast Step 3: Securing funding national or donor funding Step 4: Model product specifications - Finished Pharmaceutical Product (FPP) - Manufacturing site - Active pharmaceutical ingredients (API) 14

15 Step 1: Selection of medicines Products available for procurement by WHO/UNICEF and GFATM (last updated ) WHOprequalified SDRAapproved GFATM ERP-approved 15

16 Procurement Checklist (I) 16 steps to procure quality artemisinin-based medicines Step 1: Selection of medicines WHO guidelines, national guidelines, special situations Step 2: Estimation of requirements quantification, forecast Step 3: Securing funding national or donor funding Step 4: Model product specifications - Finished Pharmaceutical Product (FPP) - Manufacturing site - Active pharmaceutical ingredients (API) 16

17 Step 4: Model product specifications FPP: e.g. product identification, packaging, labelling, product information, standards, stability, shelf-life, storage conditions, regulatory situation Manufacturing site: e.g. list of manufacturers, activities and licence numbers, GMP certificate API: e.g. list of API manufacturers, GMP certificate, Certificate of Analysis 17

18 Procurement Checklist (II) 16 steps to procure quality artemisinin-based medicines Steps 5-10: - Procurement method Open and restricted tenders, competitive bidding, direct procurement - preparation of documents (=> step 4) - Inviting tenders WHO PQ, SRA, special regulatory schemes, risk assessment mechanisms, sources of quality-assured products - Bid responses and evaluation Supplier, product quality (step 8), commercial aspects - Contracts 18

19 Step 8: Evaluating product quality Product types: - Innovators - Generic equivalents - New combinations/dosage forms Recommendable product Efficacy Safety Quality Bioavailability (BA) and bioequivalence (BE) Pharmaceutical specifications and analytical methods (identity, content, impurities, dissolution/disintegration, ), pharmacopoeial standards and manufacturer's specifications, control of API Stability testing, shelf-life and storage conditions 19

20 Procurement Checklist (III) 16 steps to procure quality artemisinin-based medicines Steps 11-14: Quality control (QC) - Pre-shipment QC - Port clearance, receipt - Post-shipment QC - Storage and distribution Steps 15-16: Monitoring - Supplier performance - Detection and handling of product variations 20

21 Step 11: Quality Control (QC) Pre-shipment QC for all non-a and non-b products Quality Control Test Multi Source Single and limited source products complying with option A or B Single and limited source products complying with option C Responsibility PR or sub recipient GF Secretariat Condition(s) When In accordance with the Good Procurement Practice After receipt of drugs at country level Notification submission by PR to GF No Objection by GF Before any shipment of drugs to the country Frequency At random, to be determined by the PR Mandatory for all Purchase Orders Laboratory Procedures and Assays To be selected by PR, laboratory recognized by NDRA, WHO prequalified lab when possible To be defined by the PR and selected laboratory SGS laboratory, contracted by GF Listed in SGS/GF contract All details 21 in FAQ:

22 Procurement Checklist (III) 16 steps to procure quality artemisinin-based medicines Steps 11-14: Quality control (QC) - Pre-shipment QC - Port clearance, receipt - Post-shipment QC - Storage and distribution Steps 15-16: Monitoring - Supplier performance - Detection and handling of product variations 22

23 Thank you 23