2019-2023 ROAD MAP FOR ACCESS TO MEDICINES, VACCINES AND OTHER HEALTH PRODUCTS - Comprehensive support for access to
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ROAD MAP FOR ACCESS TO
MEDICINES, VACCINES AND
OTHER HEALTH PRODUCTS
2019–2023
Comprehensive support for access to
medicines, vaccines and
other health productsROAD MAP FOR ACCESS TO
MEDICINES, VACCINES AND
OTHER HEALTH PRODUCTS
2019–2023
Comprehensive support for access to
medicines, vaccines and
other health productsRoadmap for access to medicines, vaccines and health product 2019-2023. Comprehensive support for access to medicines, vaccines and other health products ISBN 978-92-4-151703-4 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Roadmap for access to medicines, vaccines and health product 2019-2023. Comprehensive support for access to medicines, vaccines and other health products. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Design and layout: L’IV Com Sàrl Printed in Geneva
Content
1 Introduction and rationale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2 General Programme of Work, 2019–2023. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3 How the road map was developed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4 Structure of the road map. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5 A health systems approach to improving access to health products. . . . . . . . . . . . . . . . 8
6 Strategic area: Ensuring the quality, safety and efficacy of health products. . . . . . . . . 11
7 Strategic area: Improving equitable access to health products.. . . . . . . . . . . . . . . . . . . 15
8 How WHO will collaborate on access to health products.. . . . . . . . . . . . . . . . . . . . . . . . . 25
9 How WHO will measure progress on access to health products. . . . . . . . . . . . . . . . . . . . 26
10 Estimated budget for implementing the road map. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Appendix 1
Key resolutions of the Health Assembly and regional committees, and regional committee
documents from the past 10 years relevant to access to safe, effective and quality
medicines, vaccines and health products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Appendix 2
WHO activities, actions, deliverables and key milestones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 11
Introduction and rationale
Equitable access to health products is collaboration with other sectors, partners
a global priority, and the availability, and stakeholders; they also need to be
accessibility, acceptability, and affordability aligned with legal and regulatory frameworks
of health products of assured quality need and cover the entire product life cycle,
to be addressed in order to achieve from research and development to quality
the Sustainable Development Goals, assurance, supply chain management
in particular target 3.8. 1 Every disease and use.
management strategy requires access to
health products for prevention, diagnosis, Primary health care services rely on
treatment, palliative care and rehabilitation. access to health products, including
medicines, vaccines, medical devices,
Access is a global concern, given the high diagnostics, protective equipment and
prices of new pharmaceuticals and rapidly assistive devices. These products must be
changing markets for health products of assured safety, efficacy, performance
that place increasing pressure on all and quality, as well as being appropriate,
health systems’ ability to provide full and available and affordable. Ensuring that
affordable access to quality health care. appropriate health products are available
The high percentage of health spending and affordable for primary care depends
on medicines (20–60% as demonstrated on policy decisions and processes related to
in a series of studies in selected low- the selection, pricing, procurement, supply
and middle-income countries) impedes chain management, maintenance (in the
progress for the many countries that have case of medical devices), prescribing and
committed to the attainment of universal dispensing (in the case of medicines) and
health coverage (1). Furthermore, it is known use of health products.
that a large proportion of the population in
low-income countries who spend for health WHO’s comprehensive health systems
do pay out-of-pocket for medicines. With approach to increasing access to health
the rise in noncommunicable diseases – products is guided by a series of Health
many of which are chronic conditions that Assembly and Regional Committee
require long-term treatment – the financial resolutions. These resolutions, nearly 100 in
burden on both governments and patients number (see Annex, Appendix 1) formed
will become even greater. the basis for the previous report by the
Director General on this topic (2). The present
Improving access to health products is a document responds to the Health Assembly’s
multidimensional challenge that requires subsequent request for WHO to develop a
comprehensive national policies and road map describing its activities, actions
strategies. These should align public and deliverables for improving access to
health needs with economic and social medicines and vaccines, for the period
development objectives and promote 2019–2023.
1
Achieve universal health coverage, including financial risk
protection, access to quality essential health care services,
and access to safe, effective, quality and affordable essential
medicines and vaccines for all.
2 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–20232
General Programme of Work, 2019–2023
The Thirteenth General Programme of Work, These strategic priorities are supported by
2019–2023 sets out three strategic priorities three strategic shifts: stepping up leadership;
for ensuring healthy lives and well-being for driving public health impact in every
all at all ages: achieving universal health country; and focusing global public goods
coverage, addressing health emergencies on impact (see Fig. 1).
and promoting healthier populations (3).
PROMOTE HEALTH – KEEP THE WORLD SAFE – SERVE THE VULNERABLE
MISSION
ENSURING
STRATEGIC HEALTHY LIVES AND PROMOTING WELL-BEING
PRIORITIES FOR ALL AT ALL AGES BY:
(AND GOALS)
ACHIEVING ADDRESSING PROMOTING
UNIVERSAL HEALTH HEALTHIER
HEALTH EMERGENCIES POPULATIONS
COVERAGE
1 BILLION 1 BILLION
1 BILLION more people better more people enjoying
more people benefitting protected from health better health and
from universal health emergencies well-being
coverage
STRATEGIC DRIVING PUBLIC HEALTH IMPACT IN EVERY COUNTRY
SHIFTS differentiated approach based on capacity and vulnerability
STEPPING UP Policy Strategic Technical Service FOCUSING
LEADERSHIP dialogue support assistance delivery GLOBAL
diplomacy PUBLIC
and advocacy; to develop to build high to build to fill critical GOODS ON
gender systems of performing national gaps in IMPACT
equality, the future systems institutions emergencies normative
health equity guidance and
and human Mature health system Fragile health system agreements;
rights; data, research
multisectoral and innovation
action; finance
Transform
partnerships,
ORGANIZATIONAL Reshape communications Strengthen
SHIFTS Measure impact
operating model and financing critical systems
Foster culture
to drive country, to resource the and processes
to be accountable change to ensure
regional and strategic to optimize
and manage for a seamless, high-
global impacts priorities organizational
results performing WHO
performance
Fig. 1. Overview of WHO’s Thirteenth General Programme of Work, 2019–2023: strategic priorities and shifts*
*Reprinted from the World Health Organization Thirteenth General Programme of Work 2019-2023
(https://apps.who.int/iris/bitstream/handle/10665/324775/WHO-PRP-18.1-eng.pdf)
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 3The planning framework for the Thirteenth access to essential medicines, vaccines,
General Programme of Work provides a diagnostics and devices for primary
structure for identifying priorities at the health care improved;
country level and for the planning and
budgeting of the work of WHO. It will ensure country and regional regulatory
that the programme budget reflects the capacity strengthened and supply of
needs of the countries and that work at all quality-assured and safe health products
three levels of the Organization is geared improved;
towards delivering country impact. This road
map for access to medicines, vaccines and research and development agenda
other health products, 2019–2023, aligns defined and research coordinated in line
with the following outputs that have been with public health priorities;
identified within this framework:
countries enabled to address antimicrobial
provision of authoritative guidance and resistance through strengthened
standards on the quality, safety and surveillance systems, laboratory capacity,
efficacy of health products, including infection prevention and control,
through prequalification services, essential awareness-raising and evidence-based
medicines and diagnostics lists; policies and practices.
4 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–20233
How the road map was developed
In May 2018, the Seventy-first World Health broadening of the scope to include
Assembly considered a report by the medicines, vaccines and health products
Director General on addressing the global and presented to the Executive Board at its
shortage of, and access to, medicines and 144th session (5).
vaccines (document A71/12) (2). The report
focused on a list of priority options for actions Following the 144th session of the Executive
to be considered by Member States and Board, further revisions were made. An
presented a comprehensive report by the Appendix was included to indicate the
Director-General on access to essential linkage between the Thirteenth General
medicines and vaccines. Programme of Work, 2019–2023 and the
activities, actions, deliverables and
Having considered the report, the Health milestones set out in the road map. The
Assembly adopted decision WHA71(8), in milestones were updated to reflect the global
which it decided to request the Director- goods planning process, and information
General to elaborate a road map report, in was added on the Organization’s mandate
consultation with Member States, outlining with regard to the actions required by the
the programming of WHO’s work on access road map and on the distribution of road
to medicines and vaccines for the period map activities across the programme
2019–2023, including activities, actions budget. The revisions included issues raised
and deliverables (4). The Health Assembly by the Executive Board relating to providing
also requested the Director-General to health products for primary health care,
submit the road map report to the Seventy- monitoring access, optimizing the use of
second World Health Assembly, through the biosimilars, addressing the challenges
Executive Board at its 144th session. faced by small island States, and supporting
countries transitioning from donor funding.
In July 2018, the Secretariat initiated a
process to consult Member States and an This document presents the draft road map
online consultation with Member States on that was noted at the seventy-second World
the zero draft road map was conducted Health Assembly (6). The previous report,
in the period July–September 2018, during document A71/12 proposed priority actions
which 62 countries provided feedback1. In based on the comparative advantage of
addition, a consultation with Member States WHO, whether the action provides value for
on the zero draft was conducted on 10 and money and if the actions lead to achievable
11 September 2018 in Geneva, preceded by and sustainable improvements. These
an informal discussion with representatives prioritized actions form the basis for the
of the United Nations and other international activities, actions and deliverables outlined
organizations and non State actors in official in this road map. It was developed based
relations with WHO. The zero draft report was on input from all levels of the Organization,
updated based on the feedback obtained taking into consideration existing governing
by these consultation processes, including body documents, the programme budget
2018–2019 and relevant departmental and
1
All written contributions from the survey and other written Regional Office strategies.
submissions are available on http://www.who.int/medicines/
access_use/road-map-medicines-vaccines/en/.
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 5The road map builds on the numerous on improving access to essential medical
regional and national initiatives and products in the South-East Asia Region,
commitments undertaken to improve access have been cited in the report by the
to safe, effective and quality medicines, Director-General on addressing the global
vaccines and health products, several shortage of, and access to, medicines and
of which, including the Delhi Declaration vaccines (2).
6 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–20234
Structure of the road map
The road map outlines the principles of WHO’s Under each strategic area, the road map
work on access to health products, including describes activities and puts forward the
essential health system components. It is specific actions and deliverables for the
structured around two interlinked strategic period 2019–2023.
areas that are necessary to support access
to health products: Fig. 2 shows the activities included under
each strategic area; the activities are listed
ensuring the quality, safety and efficacy in sequential order of the product life cycle.
of health products; Appendix 2 indicates the linkage between
the 13th General Programme of Work and
improving equitable access to health the activities, actions, deliverables and
products. short-, medium- and long-term milestones.
Ensuring quality, safety and efficacy
of health products Improving equitable access
Research and development that
meets public health needs and
Regulatory system strengthening improves access to health products
Application and management of
intellectual property to contribute to
innovation and promote public health
Assessment of the quality, safety
and efficacy/performance of health Evidence-based selection and fair
products through prequalification and affordable pricing
Procurement and supply chain
management
Market surveillance of quality, safety
and performance Appropriate prescribing, dispensing
and rational use
Fig. 2. Activities within the two strategic areas
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 75
A health systems approach to improving access
to health products
The six components of a well-functioning Countries that are transitioning away from
health system outlined in the WHO document receipt of donor funding, such as from
“Key components of a well-functioning the GAVI Alliance and the Global Fund to
health system” include: Leadership and Fight AIDS, Tuberculosis and Malaria, need
governance, health information systems, particular support to strengthen their health
health financing, human resources, essential systems, allocate resources more effectively
medical products and technologies, and and sustain financing.
service delivery (7). Ensuring access to
health products depends on all of these, in Activities in this road map support countries’
particular governance, health information, ability to allocate resources more effectively
financing and human resources. There is through evidence-based decisions to
no one-size-fits-all approach to ensuring ensure that cost-effective health products
a functional health system and tailored are included in a country’s essential
strategies are required to adapt them to medicines list, essential diagnostics lists
the local context. or reimbursement lists and through more
efficient procurement and supply processes
Four key health system components of and rational use of medicines. Support for
improving access to health products are fair pricing1 and policy implementation to
detailed below; specific actions to address reduce out-of-pocket expenditures will also
them are included in relevant activities be provided.
under the two strategic areas of the road
map provided in Sections VI and VII. Governance of health products
Financing of health products The need for good governance is increasingly
recognized as a major hurdle on the road to
Inadequate financing of health products, achieving universal health coverage. Weak
high prices of new health products and governance complicates access to health
ineffective policy interventions and products by fuelling inefficiencies, distorting
processes to manage expenditure, such as competition and leaving the system
the ineffective use of policies for generic vulnerable to undue influence, corruption,
and biosimilar medicines, contribute to waste, fraud and abuse. Given the large
the challenges facing the health system in role of health products in the provision of
achieving universal health care. Evidence health care and the proportion of health
indicates that up to one fifth of health spending they represent (as high as 60%
spending could be channelled towards for medicines in some countries), improving
better use by avoiding waste that occurs governance will help prevent the waste of
(a) when health products are priced higher public resources needed to sustain health
than is necessary, (b) when less expensive systems and provide quality and affordable
but equally effective alternatives are not care (8).
used and (c) when purchased products are
1
WHO’s working definition, based on input from the fair pricing
not used at all. initiative is that a fair price is one that is affordable for health
systems and patients and at the same time provides sufficient
market incentive for industry to invest in innovation and the
production of medicines.
8 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–2023There is a pressing need to improve access shortage concerns pharmacists, one of the
to timely, robust and relevant information specialized workforces required to ensure
concerning health products. Unbiased access to medicines and vaccines. There is
information that is free of any conflict of also a shortage of biomedical engineers,2
interest is vital for the sound selection, who play a crucial role in supporting the
incorporation, prescription and use of health best and most appropriate use of medical
products. Transparency of this information technologies. Both phar macists and
is central to accountability, strengthens biomedical engineers are essential to the
confidence in public institutions and improves development, production, procurement,
the efficiency of the system. Activities in distribution and appropriate use and
the road map address the transparency of maintenance of health products, as well as
clinical trials enabling support for clinical trial the supportive function of regulation.
registries and address price transparency
through the Market Information for Access The WHO Global Strategy on Human
to Vaccines (MI4A platform), for example (9). Resources for Health: Workforce 2030
addresses health workforce challenges.
The relationship between government and Many of the interventions needed
the private sector, such as pharmaceutical to improve the workforce are cross-
companies and medical device companies, cutting, such as mainstreaming relevant
requires particular attention. A question competencies in the pre-service education
of growing importance is how to support curricula of health personnel, scaling up
governments to work effectively with the the training of pharmacists, pharmacy
private sector and develop public policy assistants and biomedical engineers, and
while avoiding the risks of undue influence ensuring dedicated training for personnel in
and maximizing benefits. WHO supports administrative and management positions
improving practices in both the public within the supply chain. Some of the actions
and private sectors to ensure that national needed to strengthen the health workforce
policies reflect the central role of access to responsible for health products may be
health products in achieving universal health similar to – or implemented as part of –
coverage and in contributing to improved broader health workforce policies, including
accountability. improving public sector pay and incentives,
establishing mechanisms for access to
A health workforce that ensures education and training in rural areas and
access to health products1 reforming education strategies to reflect
current and emerging health system needs.
According to the High-Level Commission on
Health Employment and Economic Growth, Activities provided in the road map include
the global economy is projected to create support to ensure that the workforce is fit
about 40 million new health-sector jobs by for purpose in key areas such as regulatory
2030 (10). Most of these jobs, however, will be in capacity, where specific competencies
middle- and high-income countries, leaving are required to ensure the quality, safety
a projected shortage of 18 million health and efficacy of health products. Another
workers in low- and lower-middle-income key area is procurement and supply chain
countries. Part of the health workforce management, for which particular skills are
required to forecast needs, procurement
1
In line with resolution WHA69.19 (2016) on the global strategy
processes, warehousing and distribution,
on human resources for health: workforce 2030, a health
workforce impact assessment was carried out for the draft
road map for access to medicines, vaccines and other health 2
Specialists within the category of biomedical engineering
products, 2019–2023 (see https://www.who.int/hrh/documents/ include clinical engineers, biomedical engineering technicians,
WHA72_HRHlinks_160119-EMP.pdf, accessed 21 March rehabilitation engineers, biomechanical engineers and
2019). bioinstrumentation engineers.
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 9stock management and maintenance (of standards of reference for data compatibility
medical devices), for example. and to advance the harmonization and
modernization of data collection tools.
Information on health products for
decision-making WHO is working to develop agreed tracer
indicators to monitor the enablers to more
Infor mation is essential for decision- available and affordable medicines.
making, monitoring policy implementation To advance this, WHO convened an
and establishing accountability. To make expert meeting in February 2019 to review
accurate and useful decisions, timely and existing frameworks for monitoring the
accurate data and information are needed pharmaceutical system and to identify
in such categories as national expenditures indicators that reflect the performance
on health products; the procurement of each of the system’s components.
of health products, supply chain and These indicators will help countries to
distribution; pharmaco-vigilance and post- identify potential barriers to access and
marketing surveillance; health insurance corrective measures, and will contribute
coverage; prescription prices of health to the measurement of the Sustainable
products; and the availability of medicines, Development Goal indicator on access
vaccines and other health products in to medicines. Activities provided in the
health facilities. Monitoring access to health road map include support for platforms in
products is a complex endeavour that collecting a wide variety of data such as
requires gathering information from multiple the Global Observatory on Health Research
sources and ensuring the interoperability of and Development, the Global Surveillance
various data collection systems. Within the and Monitoring System for substandard and
framework of the Health Data Collaborative, falsified medical products, the shortages
WHO is supporting countries to improve their notification system and the global
capacity to collect, organize, analyse and programme on surveillance of antimicrobial
use quality data for policy-making, to create consumption.
10 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–20236
Strategic area: Ensuring the quality, safety and
efficacy of health products
National regulatory authorities in countries access, strengthen national health security
are responsible for the quality, safety and enhance industrial and economic
and efficacy of health products. A weak development. In most cases, low- and
regulatory system can have an impact on middle-income countries seeking to embark
patient outcomes and has the potential to on local production have limited regulatory
impair initiatives for improving access, for capacity to ensure the quality of products
example by taking too long to approve manufactured.
products for use in a country. Unfortunately,
the capacity of many low- and middle- The underreporting of adverse drug reactions
income countries to assess and approve and adverse events following immunization
health products remains limited, with as highlights the need for improved approaches
few as 30% of national regulatory authorities to post-marketing surveillance. In addition,
globally having the capacity to perform the rise in substandard and falsified products
all core regulatory functions for medicines in all markets is hampering efforts to ensure
(11). This lack of regulatory capacity in the quality, safety and efficacy of health
many countries hampers efforts to ensure products. A review showed that the observed
the quality, efficacy and safety of health failure rate of tested samples of substandard
products. and falsified medicines in low- and middle-
income countries is approximately 1 out of 10.
Key challenges include inadequate Substandard and falsified medical products
resources, overburdened staf f and endanger health, promote antimicrobial
incoherent policy frameworks. Differences resistance, undermine confidence in health
between regulatory systems cause delays professionals and health systems, create
for researchers and manufacturers, who distrust about the effectiveness of vaccines
must navigate multiple regulatory systems and medicines, waste the limited budgets
to register the same health product in of families and health systems and provide
different countries. The introduction of new income to criminal networks.
therapeutic classes, such as biotherapeutics
and similar biotherapeutic products, will The activities in this strategic area support
require new capacities and updating of countries to deliver regulation that protects
guidelines. the public while enabling timely access to,
and innovation of, quality products. Activities
A specific challenge has been highlighted focus on regulatory system strengthening,
by the recent public health emergencies assessment of the quality, safety and efficacy
requiring an urgent need for health of health products through prequalification,
products and decision-making in a and market surveillance of quality, safety
context that is different from “business as and efficacy.
usual”. Many countries do not have the
regulatory pathways in place to enable Regulatory system strengthening
rapid access to novel health products.
Another specific challenge is related to WHO develops international norms and
the growing interest in local production of standards so that countries worldwide
health products as a strategy to improve can consistently regulate health products.
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 11Through its expert committees, WHO international procurement and provide
provides detailed recommendations the extra assurance of quality, safety and
and guidance on the manufacturing, efficacy. Drawing on the expertise of some
licensing and control of health products, of the best national regulatory authorities,
including similar biotherapeutic products. prequalification provides a list of products
It supports countries, including those with that comply with unified international
local manufacturing or those seeking to standards. In parallel, WHO supports
develop local manufacturing, to strengthen countries in building national regulatory
regulation and regulatory capacity. Its capacity through networking, training and
action supports expanding reliance on information-sharing.
national regulatory authorities that meet
international performance benchmarks Market surveillance of quality, safety
(WHO listed authority) as assessed via the and efficacy/performance
Global Benchmarking Tool for assessment
of national regulatory systems. WHO This activity area supports countries to
facilitates work-sharing and convergence to strengthen post-market surveillance and
ensure greater efficiencies and more rapid monitor substandard and falsified health
registration of health products. The further products. It provides support for collecting
development of reliance networks will safety data to detect, assess and prevent
contribute to increased efficiency. Specific adverse drug effects. One strategic
actions proposed in this activity include approach relies on the introduction of
support for preparing regulatory procedures active surveillance of a limited number
for emergency and crisis situations. of priority health products (for example in
HIV, tuberculosis and malaria treatment
Assessment of the quality, safety programmes or new vaccines). This leads
and efficacy/performance of health to robust safety data for the specific
products through prequalification products in the short-term and a sustainable
pharmacovigilance infrastructure in the
Prequalification aims to ensure that long-term. The WHO global surveillance
diagnostics, medicines, vaccines and and monitoring system for substandard and
immunization-related equipment, falsified medical products collects data in
diagnostics and medical devices meet support of the prevention, detection and
global standards of quality, safety and response to substandard and falsified
efficacy. Products that have been assessed health products.
and prequalified by WHO are eligible for
12 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–2023ACTIVITY
Regulatory system strengthening
ACTION DELIVERABLES
Development and Guidelines, standards and biological reference materials to support
implementation decreased regulatory burden and support production and quality
of WHO technical control of safe and effective health products.
guidelines, norms
and standards for Support for increased uptake and utilization of guidance and
quality assurance standards by Member States.
and safety of health
products 1
ACTION DELIVERABLES
Support Smart regulation in an increasing number of countries by means
improvement of of collaborative approaches to registration including reliance and
regulatory systems, regulatory networks.
promoting reliance
and collaboration 2 Support for implementation of WHO quality standards3 to decrease
the regulatory burden.
Support for regulatory capacity strengthening towards WHO listed
authority status, especially in countries manufacturing products for
lower-middle-income countries or for local production to ensure
quality of products.
Support for the use of the Global Benchmarking Tool for the
formulation of country-specific institutional development plans and
related provision of technical advice, training and measures.
ACTION DELIVERABLES
Strengthen Support for strengthening regulatory procedures for risk-based
preparedness for evaluations during public health emergencies through the revision
entry of medicines, of regulatory procedures and standards for risk-based evaluations
vaccines and other during public health emergencies and the strengthening of
health products processes and services.
into countries
experiencing Support for the adaptation of regulatory requirements for public
a public health health emergencies and the use of networks for expedited
emergency or evaluations during such emergencies.
crisis 4
1
Corresponding mandate: WHA67.20.
2
Corresponding mandates: WHA62.15, WHA67.20.
2
www.who.int/medicines/regulation/tsn/en/.
4
Corresponding mandate: WHA64.19.
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 13ACTIVITY
Assessment of the quality, safety and efficacy/performance
of health products through prequalification
ACTION DELIVERABLES
Maintain and An efficient and effective prequalification programme maintained
expand the and optimized, in particular the prequalification of in vitro diagnostics
prequalification and vector control products.
service 1
Scope of prequalification expanded to include potential conditions,
such as noncommunicable diseases, based on an assessment of
specific needs from the essential medicines list and the essential
diagnostics list.
New routes to prequalification listing and new risk-based
approaches.
Post-prequalification product quality assured.
ACTIVITY
Market surveillance of quality, safety and efficacy/
performance
ACTION DELIVERABLES
Support Support for development of national capacity to ensure quality of
strengthening health products in the supply chain.
national capacity
to ensure the Support for development of national capacity for surveillance of
quality, safety and safety of health products on national markets.
efficacy of health Improved prevention, detection and response to substandard and
products 2 falsified health products.
1
Corresponding mandates: WHA67.20, WHA70.14.
2
Corresponding mandates: WHA61.21,WHA65.19, WHA67.20.
14 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–20237
Strategic area: Improving equitable access to
health products
Many people worldwide do not have Poor selection of health products,
adequate and regular access to health inadequate financing and ineffective
products. Many medical devices in resource- policy interventions and processes to
poor settings are broken, unused or unfit manage expenditure, including out-of-
for purpose. Access depends on having pocket expenditure, contribute to a lack of
appropriate products available at affordable access and unaffordable prices. There is an
prices. This is a particular challenge in small increasing need to ensure the sustainable
island States and for small markets, such as availability of health products through careful
children’s medicines. The introduction of management of affordable pricing for health
new medicines and other health products systems and fair pricing for producers.
and the rise of noncommunicable diseases
are putting increasing pressure on health Inefficient procurement and supply
care systems around the world and on chain management is another major
individuals who pay out-of-pocket in the challenge. The special skills required for the
case of lack of government financing. Lack procurement of quality assured products
of access can affect patient outcomes are lacking in many countries. The supply
if patients go undiagnosed or untreated chain requires a strong infrastructure and
or receive suboptimal treatment and accurate data management systems. This
can contribute to the rise in antimicrobial can be particularly complex for vaccines
resistance. Challenges for improving access and other temperature- or time-sensitive
occur throughout the system, ranging from health products that require careful
inadequate investment in research and handling and efficient cold chain systems.
development, lack of effective policies, Preventing, detecting and responding to
weak procurement and supply chain shortages of health products is complex
management, and inappropriate prescribing as well. In the case of infectious diseases,
and irrational use of health products. such shortages or stock-outs contribute to
growing antimicrobial resistance and have
Research and development investments an impact on health outcomes. Inefficient
in neglected diseases have shown an supply chain management can lead to
annual decline of 2–3% from 2012 (US$ 3.3 high levels of wastage, with significant
billion) (12). Neglected diseases and other consequences in terms of access. Waste
major global health problems cannot be management is also an emerging public
addressed with the health products that health problem, particularly for products
are currently available in markets, including such as antibiotics.
for emerging infectious disease pathogens,
and new antibiotic therapies. Some of the Local production of health products has
key challenges facing R&D include setting been proposed as a strategy to improve
priorities for research and development access, strengthen national health security
needs and incentivizing research and and enhance industrial and economic
development for health products that have development. There are a number of barriers
a potentially limited return on investment. to developing local production, however,
including policy incoherence, unreliable
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 15financing, lack of affordable, quality-assured Research and development that meets
materials and unavailable skilled workforce. public health needs. In line with the Global
strategy and plan of action on public health,
Particular challenges for medical devices innovation and intellectual property, which
include a lack of biomedical engineering recommends prioritizing needs for and
capacity to advise on their suitability promoting research and development,
for use in resource-poor settings such as WHO is playing a role in facilitating research
those with high temperature, fluctuating and development for neglected areas,
electricity or lack of clean water. Installation, where there is a compelling unmet public
maintenance services and user training health need for new products, including by
are also often lacking, leading to unsafe coordinating the efforts of different actors,
handling practices with potentially harmful setting research and development priorities,
consequences, such as misdiagnosis due to identifying associated gaps, defining
improper use or calibration of equipment. desired product profiles and facilitating the
development of affordable, suitable health
Estimates have shown that in low- and lower- products. The Global Observatory on Health
middle income countries, less than 40% of Research and Development is central to
primary care patients in the public sector setting priorities for product development
and less than 30% of primary-care patients in and contributing to coordinated actions
the private sector are treated in accordance on health research and development. The
with standard treatment guidelines (13). R&D Blueprint supports the development of
Factors that contribute to inappropriate a global preparedness plan for addressing
prescribing, dispensing and use include future epidemics. WHO, together with the
an inadequately trained workforce, Drugs for Neglected Diseases initiative, has
incorrect diagnoses, the prohibitive costs set up the Global Antibiotic Research &
or simple unavailability of medicines, and Development Partnership to develop new
activities related to product marketing treatments for bacterial infections.
and promotion. Policy approaches and
interventions have been identified to Application and management of
improve the use of health products but have intellectual property. Since the adoption
generally not been implemented over the of the Agreement on Trade-Related
past decade. Increasing burdens on health Aspects of Intellectual Property Rights
resources, the rise of antimicrobial resistance (TRIPS Agreement), many Health Assembly
to dangerously high levels and the rise in resolutions have requested WHO to address
noncommunicable diseases require a the impact of trade agreements and
renewed focus on appropriate prescribing intellectual property protection on public
dispensing and use. health and access to health products. The
Global strategy and plan of action on public
Activities under this strategic area will support health, innovation and intellectual property,
countries to achieve a continuous supply along with other relevant resolutions,
of quality, safe, effective and affordable constitutes the basic mandate for WHO’s
health products through research and work in this area. As requested by the plan of
development that meets public health action, WHO has intensified its collaboration
needs; the application and management with other relevant international
of intellectual property standards; evidence organizations, in particular through trilateral
based selection and fair and affordable collaboration with WIPO and WTO, as well as
pricing; procurement and supply chain with other organizations, including UNCTAD
management; and appropriate prescribing, and UNDP. Trilateral cooperation with WIPO
dispensing and rational use. and WTO is fostering a better understanding
16 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–2023of the linkage between public health and products and to build competencies for the
intellectual property policies and enhancing required skills, such as forecasting needs,
a mutually supportive implementation of procurement processes, warehousing
those policies. This activity area supports and distribution, stock management and
countries by fostering innovation and access maintenance (of medical devices). WHO
to health products through appropriate will contribute to the global understanding
intellectual property rules and management of supply and demand dynamics and to
and by providing technical support and platforms for collaborative approaches
capacity-building. to procurement and facilitating the
development of supporting policies and
Evidence-based selection and fair and guidelines for improved capacity. In addition,
affordable pricing. Procurement and the activity will contribute to support supply
reimbursement of health products is guided management in emergencies and crisis
by evidence-based selection (including situations which may create an urgent need
health technology assessment). Adoption for health products. Being prepared with
or expansion of national essential medicines the necessary products, plans and tools
or diagnostics lists requires the capacity is essential for manufacturers, regulators,
and competency at the national level to donor agencies, supply chain managers
translate findings from evidence to local and health workers.
contexts and to use findings for decision-
making. This activity area contributes directly Appropriate prescribing, dispensing and
to improving the availability and affordability rational use of medicines. This activity
of health products. Actions will be carried will contribute to ensuring health impacts
out to support countries for appropriate and the effective use of resources. This
selection of medicines, vaccines, diagnostics will require training of health care workers,
and other health products, transparent quality improvement processes and routine
and fair pricing, and implementation of monitoring of the use of medicines. WHO
policies, including on the use of generic and will support countries by consolidating
biosimilar medicines to reduce costs to both interventions to ensure that prescribers
governments and individuals while ensuring have the capacity to implement clinical
quality, safety and efficacy and sustainable guidelines and other proven strategies
supply. This will be particularly important for and that policy guidance is aligned, from
countries transitioning from donor funding. selection of medicines to prescribing
Additional work on support for evaluating practices. Work on responsible use will be
the benefit of future technologies as they are reinforced to guarantee the appropriate
developing will be carried out, in addition to prescription and use of medicines and
the advancement of strategic approaches other health products, including working
to ensuring supply security and other pricing with partners to improve health literacy.
and purchasing policies. WHO will support countries in implementing
stewardship programmes, with a focus on
Procurement and supply chain antimicrobials, and will support countries
management. Good procurement in developing policies and regulations to
practices play a key role in securing quality ensure access, appropriate prescribing,
products at affordable prices and ensuring dispensing and use of controlled medicines
adequate and timely supply, while good for the treatment of pain and palliative
supply chain management ensures that care while minimizing the risk of diversion
quality products are available at all levels and misuse. Capacity for monitoring will be
of the health system. WHO will continue to provided especially for the use of antibiotics
support collaborative efforts to optimize the in health facilities and in the community.
procurement and supply chain for health
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 17ACTIVITY
Research and development for health products that meet
public health needs
ACTION DELIVERABLES
Continue to set Information available through the Global Observatory on Health
priorities for health Research and Development: review of development pipelines;
research and research and development road maps; target product profiles for
development in missing health products to guide research and development priority-
areas of compelling setting for unmet public health needs in areas of market failure.
health need 1
Analysis of relevant information on the health research and
development needs of low- and middle-income countries through
the Global Observatory.
Continued development of the global development and
stewardship framework to combat antimicrobial resistance, jointly
with OIE and FAO and UNEP; support for the development of the
Global Antibiotic Research & Development Partnership.
ACTION DELIVERABLES
Coordinated Facilitated discussion on the development of unifying principles for
actions on health biomedical research and development.
research and
development 2 A harmonized WHO methodology for Target Product Profiles.
Establishment of new research and development initiatives, where
needed, and existing initiatives supported, including Global
Antibiotic Research & Development Partnership, to develop missing
health products in areas of market failure, including rare diseases
and neglected tropical diseases, based on core principles of
affordability, effectiveness, efficiency and equity.
Promotion of transparency in research and development costs;
development of incentive mechanisms that separate/delink the
cost of investment in research and development from the price
and volume of sales; and establishment of additional incentives for
research and development of new products where there are market
failures. Support for implementation of schemes which partially or
wholly delink product prices from research and development costs,
including actions recommended by the Consultative Expert Working
Group on Research and Development: Financing and Coordination
(see document A71/13, para. 30).
Promotion of new and existing research and development initiatives
that are complementary and well-coordinated.
1
Corresponding mandates: WHA61.21, WHA62.16, WHA69.23, WHA70.14, WHA71.2.
2
Corresponding mandates: WHA61.21, WHA62.16, WHA69.23, WHA70.14, WHA71.3.
18 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–2023A C T I V I T Y : Research and development for health products that meet public health
needs, continued
ACTION DELIVERABLES
Support improved Dissemination of and support for implementation of research and
capacity for development models that promote innovation and access in line
research and with principles of the Consultative Expert Working Group on Research
development and and Development: Financing and Coordination.
clinical trials in
countries 1 Support for clinical trial registries and improving policy mechanisms
for clinical trials, including capacity development.
Policies for prospective registration and public disclosure of the
results of clinical trials and support for the monitoring of registration
and results reporting.
Promotion of the transfer of technology and production of health
products in low- and middle income countries and support for
improved collaboration and coordination of technology.
Support for effective and innovative global health research by
strengthening the research capacity of disease-affected countries;
promotion of the translation of evidence into interventions that
reduce the burden of infectious diseases; and building resilience in
the most vulnerable populations through the UNICEF/UNDP/World
Bank/WHO Special Programme for Research and Training in Tropical
Diseases.
1
Corresponding mandates: WHA62.16, WHA61.21, WHA69.23, WHA70.14.
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 19ACTIVITY
Application and management of intellectual property to
contribute to innovation and promote public health
ACTION DELIVERABLES
Foster innovation Promotion of public health-oriented licensing agreements and
and access to transparency regarding the patent status of existing and new health
health products technologies.
by appropriate
intellectual Information provided on country experiences promoting public
property rules and health approaches in the implementation of health-related
management 1 provisions of the TRIPS agreements, including relevant TRIPS
flexibilities and intellectual property management.
A review of mechanisms and incentives for access to affordable
health technologies enabled by publicly funded research and
development.
Support for the expansion of the Medicines Patent Pool to patented
essential medicines and patented medicines included in WHO
treatment guidelines through identification of potential products
for licensing.
ACTION DELIVERABLES
Provide technical Technical support provided (as appropriate, upon request, in
support and collaboration with other competent international organizations),
capacity building 2 including to policy processes and to countries that intend to make
use of the provisions contained in TRIPS, such as the flexibilities
recognized by the Doha Declaration on the TRIPS Agreement and
Public Health and other WTO instruments related to TRIPS, in order
to promote access to pharmaceutical products.
Support for the consideration of public health implications when
negotiating bilateral or multilateral trade agreements.
Facilitation of the assessment of the patent status of essential health
products at national and regional levels, in collaboration with
competent partners.
Continued strengthening of the trilateral collaboration between
WHO, WIPO and WTO, including to implement this road map, as well
as with other relevant international organizations such as UNCTAD
and UNDP.
1
Corresponding mandates: WHA61.21, WHA62.16.
2
Corresponding mandates: WHA61.21, WHA62.16, WHA70.14.
20 R O A D M A P F O R A CCES S TO MEDI CI NES , VA CCI NES AND OT H ER H EALT H P RODUCT S, 2019–2023ACTIVITY
Evidence-based selection and fair and affordable pricing
ACTION DELIVERABLES
Support processes Normative guidance for the selection of essential health products
for evidence-based and the use of these in the development of national selection
selection, including processes, including model lists for essential medicines, diagnostics,
health technology medical devices and vaccines.
assessment
and their Capacity development for evidence-based selection and priority-
implementation 1 setting using various tools, including health technology assessment
in collaboration with relevant partners.
Information and knowledge exchange through global and
regional platforms to support country decision-making processes
on evidence-based selection and health technology assessment
of essential health products.
ACTION DELIVERABLES
Encourage more Policy guidance for more effective pricing policies to improve the
transparent and affordability of essential health products to health systems and
better policies and individuals.
actions to ensure
fairer pricing and Global and regional collaboration to increase price transparency,
reduction of out-of- support decision-making on pricing and reimbursement, facilitate
pocket payments 2 dialogue between public payers, government decision-makers and
industry, and improve capacity for price negotiation.
Pricing and financing policies to reduce out-of-pocket payments,
including the adoption of generics and biosimilars in the selection,
procurement and use of medicines; reimbursement schemes, where
appropriate, and control of mark-ups in the supply chain.
Support for national capacity for the regular monitoring and use of
price and availability information for decision-making.
1
Corresponding mandates: WHA60.29, WHA67.22, WHA67.23, WHA69.20.
2
Corresponding mandates: WHA61.21, WHA67.22, WHA68.6, WHA70.12.
Co mp re h e n sive support for a ccess to med icines, va ccines a nd ot her hea l t h produc ts 21You can also read
