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

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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 DGs 71 (8) Report Decision Rep eport t by y the Dir


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Information Session

Report of the Director General: Roadmap for access to medicines, vaccines and other health products

4 December 2018, Geneva

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2

Background

Rep eport t by y the Dir Director-General

  • n
  • n ad

addressin ing the he glo global l sho shortage of

  • f,

, and and acc access to to, med edicines an and vacc accin

  • ines. The

report focused on a list t of

  • f

prio priorit ity op

  • pti

tions for

  • r ac

acti tions to be considered by Member States and presented a comprehensive report by the Director-General

  • n access to essential medicines

and vaccines Document A71/12.

WHA 71 DG’s Report

1) elaborate a roadmap report, in consultation with Member States,

  • utlining the programming of

WHO’s work on access to medicines and vaccines, including activities, actions and deliverables for the period 2019−2023 (2) submit this roadmap report to the Seventy-second World Health Assembly for its consideration in 2019, through the Executive Board at its 144th session.

WHA 71 (8) Decision

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Participation and Consultative Process

ACTV TVITY DATE TE Member States Online Consultation, including good practices examples 62 62 countries s pr provided fee eedback 12 12 Goo Good pr practices examples s wer ere rec eceived 9 July- 14 September 2018 Member States Consultation – Geneva (HQ) 10-11 September 2018 Informal Discussion with Stakeholders (Non-State Actors in official relations with WHO and UN and related organizations) 10 September 2018 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

  • f 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/

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Structure of the road map: Activities within the two strategic areas

Ens Ensuring qu quali lity, sa safety ty an and effic icacy of

  • f hea

health th pr products

Regulatory system strengthening Assessment of the quality, safety and efficacy/performance of health products through prequalification Market surveillance of quality, safety and performance

Imp Improvin ing eq equit itable ac access

Research and development that meets public health needs and improves access to health products Application and management of intellectual property to contribute to innovation and promote public health Evidence-based selection and fair and affordable pricing Procurement and supply chain management Appropriate prescribing, dispensing and rational use

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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

  • f th

the e qualit lity, safety and effic ficacy of

  • f hea

ealt lth products th through gh preq equalif ification, and market surveil illa lance of

  • f quali

lity, safety and effi ficacy.

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Activity: Strengthening of regulatory system ACT CTIONS

De Development and im implementation of

  • f WHO

HO tec echnic ical gu guidelines, norms and standards for quality assurance and safety of

  • f

health products Support im improvement of

  • f

regulatory ry systems, promoting relia iance and col

  • llaboration

Str trengthen preparedness for

  • r

en entry ry of

  • f med

edicines, vaccines and oth

  • ther hea

ealth products in into cou

  • untries exp

xperiencin ing a public hea ealth em emergency (P (PHE) or

  • r cri

crisis

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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

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8

Activity: Market surveillance of quality, safety and performance efficacy ACT CTIONS

Support str trengthening nati tional l capacity to

  • en

ensure th the quality, safety and efficacy of

  • f hea

ealth products

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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

  • f 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.

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Activity: Research and development for health products that meet public health needs ACT CTIONS

Con Continue to

  • set

t pri riorities for health research and development in in areas of

  • f

com

  • mpelli

ling hea ealth nee eed Co Coordinated acti ctions on

  • n

hea ealth research and development Support im improved capacity for

  • r R&D and clin

clinical l tria trials in in cou

  • untries
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Activity : Application and management of intellectual property to contribute to innovation and promote public health ACT CTIONS

Fos

  • ster in

innovation and acc ccess to

  • hea

ealth products by appropriate IP IP rul rules and management Provide tec echnical support and capacity buil ilding

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Activity: Evidence-based selection and fair and affordable pricing ACT CTIONS

Support processes for

  • r evid

vidence-based sele election, in incl cluding hea ealth tech echnology assessment and th thei eir im implementation Encourage more tr transparent and better pol

  • licies and acti

ctions to

  • en

ensure fairer pri ricin ing and red eduction of

  • f ou
  • ut-of
  • f-pocket payments
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Activity: Procurement and supply chain management for quality-assured health products ACT CTIONS

Support collaborative approaches to

  • str

trategic procurement of

  • f

hea ealth products Support cou

  • untries in

in effi ficient procurement and supply ch chain management of

  • f

health products Im Improve capability and capacity for

  • r

detecting, preventing and res esponding to

  • shortages of
  • f

medicines and vaccines Support for

  • r

adeq equate supply management and appropriate use e of

  • f

hea ealth products in in emergencies and cris crisis is situ ituations

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Activity: Appropriate prescribing, dispensing and rational use of medicines ACT CTIONS

In Interv rventions th that im improve use e of

  • f hea

ealth products Support capacity for

  • r monitoring
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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

  • f Bu

Budget 2018-2019

  • 2020

2020-2021: Dr Draft Glob lobal l Goo

  • ods
  • 2022

2022-2023: D Draft Glob lobal Goo

  • ods