1. Update on prequalification of essential medicines for reproductive health Dr Hans V. Hogerzeil Director Medicines Policy and Standards WHO, Geneva Reproductive Health Supply Coalition October 2006 1

2. 2 Department of Medicines Policy and Standards Prequalification of essential medicines  The UN prequalification program is an action plan for expanding access for the hardest hit by  HIV/AIDS  Tuberculosis  Malaria  Reproductive Health  for ensuring quality, efficacy and safety of medicines all the way through the medicines supply chain.

3. 3 Department of Medicines Policy and Standards Why the prequalification of RH items is needed  Problems Over 200 million of people do not have access to the RH items they need and want Increasingly decentralized funding and procurement of RH medicines; more reliance on national procurement Weak national regulatory and quality assurance systems No harmonized quality assurance system available  Risks Sourcing of poor quality products or even counterfeit medicines  risk to patients, treatment failure, resistance, reputation

4. 4 Department of Medicines Policy and Standards Prequalification: basic principles  Voluntary for participating manufacturers  Legitimate - Procedure and standards approved through WHO Expert Committee system, involving all Member States and governing bodies  Widely discussed FIP Congress, Nice 2002 ICDRA 2002 and 2004 (>100 national drug regulatory authorities)  Transparent: all information on http://mednet3.who.int/prequal/ http://mednet3.who.int/prequal/  Open to innovators and multi-source/generic manufacturers  No cost for applicants

5. 5 Department of Medicines Policy and Standards Expected outcomeof prequalification  List of products and manufacturers approved for UN procurement Meeting international norms and standards on quality, safety, and efficacy  Better access to treatment Fair procurement mechanisms (e.g. tender, competition)  Harmonization DRAs, NGOs, procurement organizations Ongoing monitoring of quality, safety & efficacy of essential medicines  Capacity building DRA's: life-time learning experience in assessment and inspection Manufacturers: free feed-back on performance and advice how to improve

6. 6 Department of Medicines Policy and Standards How prequalification is organized  Role of WHO: Manage the project on behalf of the UN Provide technical and scientific support and guarantee that international norms and standards are applied all through the process of assessment, inspection and quality control  Partners: UNICEF, UN Population Fund (UNFPA), UNAIDS and with the support of the World Bank Anti-malarial and anti-TB products: Roll Back Malaria and Stop TB (Global Drug Facility); HIV/AIDS Department  Actors: Assessors and inspectors of National DRAs as well as National Quality Control Laboratories of PIC/S and ICH member countries Increasing involvement of end-user countries

7. 7 Department of Medicines Policy and Standards Experiences with HIV/AIDS, tuberculosis and malaria  Good news ä Many products and suppliers comply with the standards ä Many suppliers appreciate feedback and are willing to improve ä Unique technical knowledge obtained about products, especially about generic antiretrovirals and antimalarials  Bad news ä Only limited number of products have met the required standards ä Takes time to get into compliance: data to be generated tests to be carried out GMP upgrade needed ä Bad quality generics undermine public confidence in generics ä Quality has its price (e.g. TB)

8. 8 Department of Medicines Policy and Standards Quality can not be assessed, tested or inspected into the product BUT it has to be built into it! More technical help to manufacturers in developing countries is needed

9. 9 Department of Medicines Policy and Standards Update on prequalification of RH items (Oct 2006) n 3-year funding received from Gates Foundation (July 2006) n RHSC selection of priority items: ä Ethinylestradiol + levonorgestrel, tablet, 30/150 microgram ä levonorgestrel, tablets, 30, 750, 1500 microgram ä medroxyprogesterone acetate (DMPA) depot injection, 150mg/ml n 5 staff recruited / under recruitment (programme manager, heads assessment and inspection teams, inspectors) n Expression of Interest issued and on the web n Dossier assessments from Nov 2006; inspections from early 2007

10. http://mednet3.who.int/prequal/

11. 11 Department of Medicines Policy and Standards http://mednet3.who.int/prequal/

12. 12 Department of Medicines Policy and Standards What is now expected from RHSC members? n Encourage your suppliers to participate in the WHO/UN prequalification programme and submit dossiers n Inform all your suppliers officially that you will only procure prequalified products as soon as two products have bee prequalified n Inform your local suppliers that they can also receive technical advice from WHO in order to prepare for prequalification and improve quality where needed n Main message: Prequalification is a global support mechanism to improve their quality production, and will establish their international export potential

13. 13 Department of Medicines Policy and Standards Interagency List of Essential Medical Devices for Reproductive Health Medicines Policy and Standards Health Technology and Pharmaceuticals Cluster RHSC meeting, Bonn 19-20 October2006 13

14. 14 Department of Medicines Policy and Standards Background n The development of an interagency list of essential medical devices for RH was agreed at the 1st Interagency Consultation on the Selection and Delivery of Reproductive Health Medicines and Commodities in December 2003 n Availability of various lists of RH medicines and commodities ä UNFPA/UNAIDS/WHO medicines and commodities list ä Draft UNFPA/WHO essential drugs and other commodities for RH services list ä 13 th WHO Model List of Essential medicines n Medical devices on the lists ä discrepancies in terminology and content were identified.

15. 15 Department of Medicines Policy and Standards The Interagency List of Essential Medicines for Reproductive Health, 2006 n Include 148 medicines n Two proposed presentations: ä by therapeutic group based on the WHO model list classification ä by clinical group following previous interagency lists ä Available in English and French n Approved by International Planned Parenthood Federation (IPPF), John Snow, Inc (JSI), PATH, Population Services International (PSI), UNFPA and the World Bank

16. 16 Department of Medicines Policy and Standards Interagency list of essential medical devices for RH n Achieving consistency in the minimum list of medical devices and supplies for common interventions in maternal and RH, including HIV/AIDS commodities n Drafted after 4 interagency consultations: ä By group of items, according to MNH interventions* ä Use UNICEF nomenclature (UNCCS) n Sent for final review process to major partners n final draft prepared in June 2006 in collaboration with UNICEF n The interagency list includes special notes and specifications for each group of items * WHO/Making Pregnancy Safer document

17. 17 Department of Medicines Policy and Standards Interagency list of essential medical devices for RH: special notes Technical comments to facilitate procurement selection, review lists and support technical review of tender offers ä Special note for units and biomaterials used for medical devices ä Special note on packaging and labelling ä Special note on injection safety ä Special note on health care waste management ä Special note on surgical sutures ä Special note on standard precautions for health workers ä Special note on wearing protective equipment ä Special note for textiles used for linen and clothing ä Special note on surgical instruments stainless steel

18. 18 Department of Medicines Policy and Standards Interagency list of essential medical devices for RH Product specifications UNICEF technical specifications (80% of the list) Development of additional specifications for 49 items Specifications will be available on: n WHO/RHR website n UNICEF website: http://www.supply.unicef.dk/catalogue/

19. 19 Department of Medicines Policy and Standards http://www.supply.unicef.dk/catalogue/

20. 20 Department of Medicines Policy and Standards Interagency list of essential medical devices: Next steps Receiving any comments on the final draft Proposing endorsement of the interagency list Posting on the websites