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Medicines and Health Products Division
Access to medicines –WHO perspective
SDG 3. Goal 3: Ensure healthy lives and promote well-being for all at all ages
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Access to essential medicines - proportion of health facilities that have a core set of
relevant essential medicines available and affordable on a sustainable basis
SDG Indicator 3.b.3.
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• available → medicine is available in a facility when it is found in this facility by the interviewer
on the day of data collection
• affordable → medicine is affordable when no extra daily wages are needed for the lowest paid
unskilled government sector worker to purchase a monthly dose treatment of this medicine after
fulfilling basic needs represented by the national poverty line
No access =
available + not affordable
not available + affordable
not available + not affordable
𝑆𝐷𝐺3.𝑏.3 =𝐹𝑎𝑐𝑖𝑙𝑖𝑡𝑖𝑒𝑠 𝑤𝑖𝑡ℎ 𝑎𝑣𝑎𝑖𝑙𝑎𝑏𝑙𝑒 𝑎𝑛𝑑 𝑎𝑓𝑓𝑜𝑟𝑑𝑎𝑏𝑙𝑒 𝑏𝑎𝑠𝑘𝑒𝑡 𝑜𝑓 𝑚𝑒𝑑𝑖𝑐𝑖𝑛𝑒𝑠 (𝑛)
𝑆𝑢𝑟𝑣𝑒𝑦𝑒𝑑 𝐹𝑎𝑐𝑖𝑙𝑖𝑡𝑖𝑒𝑠 (𝑛)
GPW13
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72nd World Health Assembly: some highlights
• Approval of “Access Roadmap for Access to Medicines, Vaccines and other Health Technologies, 2019-2023”
http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17-en.pdf
• Resolution on Transparency “Improving the transparency of markets for
medicines, vaccines, and other health products”http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf
• Launch of Interagency statement on “Promoting Local production of
Medicines and other Health Technologies”https://www.unaids.org/en/resources/presscentre/pressreleaseandst
atementarchive/2019/may/20190524_local-production-medicines
• Launch of a “Strategy for prevention and control” of snakebite envenominghttps://www.who.int/snakebites/resources/9789241515641/en/
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72nd WHA: Resolution on Transparency Adopted
• Improving the transparency of markets for medicines, vaccines and other
health products in an effort to expand access
• The resolution urges Member States to enhance public sharing of
information on actual prices paid by governments and other buyers for
health products, and greater transparency on pharmaceutical patents,
clinical trial results and other determinants of pricing along the value chain
from laboratory to patient
• It requests the WHO secretariat to support efforts towards transparency
and monitor the impact of transparency on affordability and availability of
health products, including the effect of differential pricing
http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf
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Fair Pricing Forum: April 2019 Johannesburg
Working definition:
A fair price is one that is affordable for health systems and patients and that at the same time provides sufficient market incentive for industry to invest in innovation and the production of medicines.
• More than 200 participants
• Key topics:
o pricing transparency
o Incentives for innovation, private public partnerships
www.who.int/sdg/global-action-plan
A Joint Initiative of:
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ACCELERATE: 7 cross-cutting areas
1.Sustainable financing
Global Fund, World Bank,
Gavi
Improve the generation,
allocation, and use of
funds for health.
2. Primary Health Care (PHC)
UNICEF & WHO
Support and reform the
PHC system
4.Determinants of health
UNDP & UN Women
Collectively advocate for a
new multisectoral
paradigm to address the
determinants of health
5.R&D, innovation & access
WHO (supported by Wellcome Trust)
Invest and support new
innovations to reach those
most in need at country
level
6.Data and digital health
UNFPA and WHO
Better harness technology
to gather, store and
analyze data to improve
health decision making
3.Community & civil society
engagement
UNAIDS and WHO
Establish mechanisms to
improve CSO engagement
in global health
7.Innovative programming in
fragile settings/outbreaks WFP and WHO
Strengthen the
humanitarian-development
nexus
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72nd WHA: Access Roadmap
• Aims to assist in achieving the Sustainable Development Goals by ensuring “availability, accessibility, acceptability and affordability” of health products of assured quality
• Based on existing WHO mandates in key Health Assembly resolutions of the last 10 years related to access to safe, effective and quality medicines, vaccines and health products
• Outlines the programming of WHO’s work on access to medicines and vaccines for the period 2019–2023, including activities, actions and deliverables
Improving equitable access
• R&D that meets public health needs and improves access to health products• Application & management of IP to contribute to innovation & promote public health• Evidence-based selection and fair and affordable pricing• Procurement and supply chain management• Appropriate prescribing, dispensing and rational use
Ensuring quality, safety and efficacy of health products
• Regulatory systems strengthening• Assessment of the quality, safety and efficacy of health products through
prequalification• Market surveillance of quality, safety and performance
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http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17-en.pdf
Access Roadmap - Activities and Actions
• Development and implementation of WHO technical guidelines, norms and standards for quality assurance and safety of health products
• Support improvement of regulatory systems, promoting reliance and collaboration
• Strengthen preparedness for entry of medicines, vaccines and other health products into countries experiencing a public health emergency or crisis
• Maintain and expand the prequalification service
• Support strengthening national capacity to ensure the quality, safety and efficacy of health products
Ensuring quality, safety and efficacy of health products
• Regulatory systems strengthening• Assessment of the quality, safety and efficacy of health products through
prequalification• Market surveillance of quality, safety and performance
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Access Roadmap - Activities and Actions
• Continue to set priorities for health research and development in areas of compelling health need
• Coordinated actions on health research and development
• Support improved capacity for research and development and clinical trials in countries
• Foster innovation and access to health products by appropriate intellectual property rules and management
• Provide technical support and capacity building
• Support processes for evidence-based selection, including health technology assessment and their implementation
• Encourage more transparent and better policies and actions to ensure fairer pricing and reduction of out-of-pocket payments
Improving equitable access
• R&D that meets public health needs and improves access to health products• Application & management of IP to contribute to innovation & promote public health• Evidence-based selection and fair and affordable pricing
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Access Roadmap – Activities and Actions
• Support collaborative approaches to strategic procurement of health products
• Support countries in efficient procurement and supply chain management of health products
• Improve capability and capacity for detecting, preventing and responding to shortages of medicines and vaccines
• Support for adequate supply management and appropriate use of health products in emergencies and crisis situations
• Interventions that improve use of health products
• Support capacity for monitoring
Improving equitable access
• Procurement and supply chain management• Appropriate prescribing, dispensing and rational use
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Access Roadmap - Actions
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Strategic area
Improving equitable access to health products
Activity
Appropriate prescribing, dispensing and rational use of medicines and health products
Action
Interventions that improve use of health products
Action
Support capacity for monitoring
Access Roadmap - Deliverables
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Action
Interventions that improve use of health products
• Support for strengthening national structures and capacity for the regular development and revision of national treatment guidelines that are aligned with both the national essential medicines list selection process and prescribing practices.
• In collaboration with partners, support for regional/national capacity development of the pharmacy and allied workforce to strengthen the medication-use process, ranging from improving adherence to regulations and guidelines to ensuring patient safety.
Access Roadmap - Deliverables
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Action
Interventions that improve use of health products
• Support for implementing stewardship programmes, with a focus on antimicrobials; guidance on alignment of standard treatment guidance, with resistance pattern and national action plans for antimicrobial resistance; and support for using the Access, Watch and Reserve (AWARE) and the AWARE Index for quality improvement and stewardship interventions.
• Support for the development of national policies and regulations to ensure access, appropriate prescribing, dispensing and use of controlled medicines, including guidance on optimizing relevant legislation and support for strengthening the capacity of prescribers and dispensers to ensure access and quality of service and minimize the risk of diversion.
Level of engagement depends on local context and maturity of health system
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Service delivery • Provide guidance and information on maintenance of medical devices and assistive products
Technical
Assistance
• Provide guidance and information on the pricing of health products, supporting countries in monitoring
prices of these products, and working with countries to put in place national strategies and policies on
prices of medicines, including the use of generic medicines.
Strategic
support
• Support the strengthening of regulatory systems of medicines, vaccines and other health products that
contributes significantly to i.) the availability of efficacious, good quality, and safe medical products,
and ii.) the prevention and detection of SF medicines.
• Implement the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual
Property, including policies on local production of health products, and stimulating a public-health
driven research and development agenda.
Policy dialogue • Provide policy guidance and support to countries to develop, implement, monitor and evaluate
national policies and strategies on medicines and health products that aim to expand access within the
wider framework of UHC.
• Promote networking, coordination of partners in the field and collaboration with a number of WHO
collaborating centres.
To enhance access to generic medicines WHO develops - with the help of labs - a list of
medicines for which clinical studies can be waived:
• WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on
registration requirements to establish interchangeability (revision)
Annex 6, WHO Technical Report Series 1003, 2017 – includes chapter on “biowaiver”,
i.e. criteria how clinical studies can be waived
• Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential
Medicines immediate-release, solid oral dosage forms
Annex 8, WHO Technical Report Series 937, 2006:
Please see Annex 6, WHO TRS 1003, 2017 for the current policy regarding biowaivers.
The table with BCS classifications is currently being revised
Example 1
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• to facilitate deliveries in the supply chain, update of the WHO GOOD STORAGE AND
DISTRIBUTION PRACTICES FOR MEDICAL PRODUCTS
• Setting out steps to assist in fulfilling the responsibilities involved in the different stages
within the supply chain and to avoid the introduction of substandard and falsified
products into the market.
• The relevant sections should be considered as particular roles that entities play in the
storage and distribution of medical products.
Example 2
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Following discussions relating to establishing policy for remaining shelf life (RSL) of medical
products upon delivery, and considering the discussion between the IPC group
representatives, it was decided to initiate a project to establish a policy on remaining shelf
life for procurement and supply of medical products.
The aims of this policy document are to:
• ensure that there is a balance between enforcing the remaining shelf life policy and
ensuring availability of medical products
• facilitate the national authorization of importation of medical products where
applicable
• promote and support the efficient processing of medical products in the supply chain at
all levels and thus prevent wastage because of delays
Example 3
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• assist in ensuring that there is sufficient stock of medical products, with acceptable
remaining shelf life, in-country
• prevent dumping of medical products
• ensure that barriers to access and supply of medical products are addressed;
• prevent stock-outs
• prevent receiving donations of medical products that are not in accordance with this
guideline
• prevent having expired stock of medical products
Example 3 (cont.)
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A world where every child, man and woman has access to
the quality essential medicines, vaccines and other health
products they need to lead a healthy and productive life.
Thank you
Sabin Kopp
Group Lead
Medicines Quality Assurance
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