Report of the Director General: Roadmap for access to medicines, - PowerPoint PPT Presentation

Report of the Director General: Roadmap for access to medicines, vaccines and other health products Information Session 4 December 2018, Geneva

Background WHA WHA 71 DG’s 71 (8) Report Decision Rep eport t by y the Dir Director-General on on ad addressin ing the he glo global l 1) elaborate a roadmap report, in sho shortage of of, , and and acc access to to, consultation with Member States, med edicines an and vacc accin ines. The outlining the programming of report focused on a list t of of WHO’s work on access to medicines and vaccines, including activities, priorit prio ity op opti tions for or ac acti tions to be considered by Member States actions and deliverables for the and presented a comprehensive period 2019−2023 report by the Director-General (2) submit this roadmap report to on access to essential medicines the Seventy-second World Health and vaccines Document A71/12. Assembly for its consideration in 2019, through the Executive Board at its 144th session . 2

Participation and Consultative Process ACTV TVITY DATE TE Member States Online Consultation, including good practices examples 9 July- 14 September 2018 62 62 countries s pr provided fee eedback 12 12 Goo Good pr practices examples s wer ere rec eceived Member States Consultation – Geneva (HQ) 10-11 September 2018 Informal Discussion with Stakeholders 10 September 2018 (Non-State Actors in official relations with WHO and UN and related organizations) ROADMAP DIS DISCUSSIONS - RE REGIONAL COMMITTEES AFRO (Dakar, Senegal) 27-31 August SEARO (New Delhi) (Ministerial Declaration) 3-7 September The draft report was updated based on the feedback obtained by these consultation processes, including broadening of the scope to include medicines, vaccines and health products. The contributions received are available on the Website at: http://www.who.int/medicines/access_use/road-map-medicines-vaccines/en/ 3

Structure of the road map: Activities within the two strategic areas Ens Ensuring qu quali lity, sa safety ty an and effic icacy of of hea health th Improvin Imp ing eq equit itable ac access pr products Research and development that meets public health needs and improves access to health products Regulatory system strengthening Application and management of intellectual property to contribute to innovation and promote public health Assessment of the quality, safety and Evidence-based selection and fair and efficacy/performance of health products through prequalification affordable pricing Procurement and supply chain management Market surveillance of quality, safety and Appropriate prescribing , dispensing and performance rational use 4

Strategic area: Ensuring the quality, safety and efficacy of health products • The activities in this strategic area support countries to deliver regulation that protects the public while enabling timely access to, and innovation of, quality products. • Activities focus on reg egula latory system str tren engthen ening, asses essmen ent t of of th the e qualit lity, safety and effic ficacy of of hea ealt lth products th through gh preq equalif ification, and market surveil illa lance of of quali lity, safety and effi ficacy. 5

Activity : Strengthening of regulatory system ACT CTIONS De Development and Str trengthen preparedness for or Support im improvement of of implementation of im of WHO HO entry en ry of of med edicines, vaccines tec echnic ical gu guidelines, norms regulatory ry systems, and oth other hea ealth products and standards for quality in into cou ountries exp xperiencin ing a promoting relia iance and assurance and safety of of col ollaboration public hea ealth em emergency health products (P (PHE) or or cri crisis 6

Activity : Assessment of the quality, safety and efficacy/performance of health products through prequalification ACT CTIONS Maintain and exp xpand th the prequalification ser ervice 7

Activity : Market surveillance of quality, safety and performance efficacy ACT CTIONS Support str trengthening nati tional l capacity to o en ensure th the quality, safety and efficacy of of hea ealth products 8

Strategic area: Improving equitable access to health products • Activities under this strategic area will support countries to achieve a continuous supply of quality, safe, effective and affordable. • Activities focus on research and development th that t meets public lic health lth needs; th the applic licati tion and management of of in intelle ellectu tual l property standards; evid vidence-based ed sele election and fair ir and affordable le prici ricing; procurement and supply ly ch chain management; and appropriate e pres escrib ibing, dis ispen ensing and rational use. 9

Activity : Research and development for health products that meet public health needs ACT CTIONS Continue to Con o set t pri riorities for Coordinated acti Co ctions on on Support im improved capacity health research and hea ealth research and for or R&D and clin clinical l tria trials in in development in in areas of of development cou ountries com ompelli ling hea ealth nee eed 10

Activity : Application and management of intellectual property to contribute to innovation and promote public health ACT CTIONS Fos oster in innovation and acc ccess to o hea ealth Provide tec echnical support and capacity products by appropriate IP IP rul rules and buil ilding management 11

Activity : Evidence-based selection and fair and affordable pricing ACT CTIONS Encourage more tr transparent and better Support processes for or evid vidence-based pol olicies and acti ctions to o en ensure fairer pri ricin ing sele election, in incl cluding hea ealth tech echnology assessment and th thei eir im implementation and red eduction of of ou out-of of-pocket payments 12

Activity : Procurement and supply chain management for quality-assured health products ACT CTIONS Im Improve capability Support for or Support cou ountries in in Support collaborative and capacity for or adeq equate supply effi ficient approaches to o detecting, preventing management and procurement and and res esponding to o appropriate use e of of str trategic supply ch chain procurement of of shortages of of hea ealth products in in management of of hea ealth products medicines and emergencies and health products vaccines cris crisis is situ ituations 13

Activity : Appropriate prescribing, dispensing and rational use of medicines ACT CTIONS In Interv rventions th that im improve use e of of hea ealth Support capacity for or monitoring products 14

Key Milestones “Key milestones” have been identified for each Strategic Area in line with the Pro rogramme Bu Budget 2018-2019 and th the e dra raft ft Glo lobal l Goods: 2019: Co Covered in in th the e Programme e of of Bu Budget 2018-2019 • • 2020 2020-2021: Dr Draft Glob lobal l Goo oods 2022 2022-2023: D Draft Glob lobal Goo oods • 15