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EXECUTIVE BOARD EB142/13 142nd session 12 January 2018 Provisional agenda item 3.6

Addressing the global shortage of, and access to,

medicines and vaccines

Report by the Director-General

BACKGROUND

1. The Seventieth World Health Assembly noted the report on addressing the global shortage of, and access to, medicines and vaccines and agreed to include an item on addressing this issue on the

agenda of the Executive Board at its 142nd session in January 2018. 1 The current report is based on a

review of: progress reports on related resolutions from across the Organization; reports considered by

Health Assemblies and sessions of the regional committees; work on access to medicines and vaccines

by other United Nations bodies, including the report of the United Nations Secretary-General’s

High-level Panel on Access to Medicines; 2 and work carried out by partners and non-State actors in

official relations with WHO. The attention of the Board is drawn to the Director-General’s report on

the overall programme review of the global strategy and plan of action on public health, innovation

and intellectual property. 3

2. This report contains three sections: (i) an executive summary (paragraphs 3–10) of the report on access to medicines and vaccines, focusing on a list of priority options for actions to be considered by

Member States; (ii) an update on the progress made in implementing those elements of

resolution WHA69.25 (2016) pertaining to the global shortage of medicines and vaccines

(paragraphs 11–14); and (iii) a comprehensive report by the Director-General on access to essential

medicines and vaccines (Annex), which includes the following appendices: a list of key resolutions of

the Health Assembly and regional committees, and regional committee documents from the past

10 years related to access to safe, effective and quality medicines, vaccines and health products

(Appendix 1); a list of documents reviewed for the purposes of preparing this report (Appendix 2); a

review of the recommendations of the report of the High-level Panel on Access to Medicines and

WHO’s activities in the area of access to medicines (Appendix 3); and a non-exhaustive list of United

Nations bodies and related organizations, WHO collaborating centres, partners and non-State actors in

official relations with WHO that carry out work on access to medicines (Appendix 4).

1 See document A70/20 and the summary records of the Seventieth World Health Assembly, ninth meeting, section 2.

2 Report of the United Nations Secretary-General’s High-level Panel on Access to Medicines: promoting innovation

and access to health technologies. Geneva: United Nations High-Level Panel on Access to Health Technologies; 2016

(http://www.unsgaccessmeds.org/final-report, accessed 20 December 2017).

3 See document EB142/14.

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EXECUTIVE SUMMARY

3. Access 1 to safe, effective and quality medicines and vaccines for all is one of the targets of the

Sustainable Development Goals. 2 Achieving universal health coverage requires access to safe,

effective, quality and affordable essential medicines and vaccines. Access is a global concern in view

of the: rising prices of new medicines that place increasing pressure on the ability of all health systems

to provide full and affordable access to health care; persisting problems of shortages and stock outs of

essential medicines, especially for noncommunicable diseases, and vaccines; and increasing numbers

of substandard and falsified medical products that pose an unacceptable risk to public health. In

addition, problems such as antimicrobial resistance and opioid misuse highlight the need to improve

appropriate use of medicines.

4. WHO plays a fundamental role in ensuring access to safe, effective and quality medicines and vaccines around the world through its strategic and normative work and technical support at the

global, regional and national levels. The Organization takes a comprehensive health systems approach

that addresses all stages of the pharmaceutical value chain, including: needs-based research,

development and innovation; public health-oriented intellectual property and trade policies;

manufacturing processes and systems; pricing policies; integrity and efficiency in procurement and

supply chain management; and appropriate selection, prescribing and use. WHO supports good

governance and strengthening of regulatory capacity, monitoring systems and workforce capacity, and

collaborates with a multitude of stakeholders.

5. Increasing access to medicines and vaccines is a complex issue. Although many activities contribute to improving access to medicines and vaccines, there is a need to prioritize and invest in

those where WHO has an advantage compared with other organizations and that provide value for

money, are fit for purpose, and lead to achievable and sustainable improvements. The Secretariat has

undertaken a comprehensive review of the major challenges to ensuring access to safe, effective and

quality medicines and vaccines and analysed progress made to date. On the basis of this review and in

accordance with the draft thirteenth general programme of work for the period 2019–2023, the

Secretariat has identified the actions listed below that could be prioritized for implementation. All

these actions fall under WHO’s existing mandate (see Appendix 1 to the Annex) and are all, to a

greater or lesser extent, currently being undertaken by the Secretariat. Confirmation of this approach

would enable the Secretariat to focus its activities on those actions with the greatest potential impact.

6. The scaling up of the following actions is considered by the Secretariat as having the greatest potential impact on access to safe, effective and quality medicines, with the least complexity and

requiring the fewest resources to implement.

• Engender and facilitate the development of political will at the national and regional levels to ensure the affordability and availability of safe, effective and quality medical products

through effective regulation and policy implementation, particularly the implementation of

1 “Access” is defined as the reliable and consistent availability of appropriate essential, quality medicines at health

facilities, the rational prescribing and dispensing of such medicines, and ensuring that they are affordable. Out-of-pocket

payments, if any, should be well within patients’ capacity to pay, and protection against catastrophic expenditure should be

ensured.

2 Target 3.8 of the Sustainable Development Goals (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).

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pricing and financing policies that encourage fair pricing and domestic investment in

universal coverage schemes that reduce out-of-pocket payments.

• Support increased interorganizational, regional and country collaboration, networking and training on specific topics such as: governance; regulation; quality and safety; intellectual

property and trade policies, including through WHO’s trilateral collaboration with WIPO and

WTO; pricing; procurement; reimbursement; and appropriate use.

• Consolidate and enhance the Secretariat’s contribution to product development across different diseases, including effective prioritization of research and development needs

through the Global Observatory on Health Research and Development and building on the

success of existing research and development models such as the Global Antibiotic Research

& Development Partnership. 1

• Support expansion of the Medicines Patent Pool to include all patented medicines on the WHO Model List of Essential Medicines and antimicrobial medicines.

• Build capacity, in collaboration with other partners, for the proper implementation of intellectual property laws that are in line with the Agreement on Trade-Related Aspects of

Intellectual Property Rights (TRIPS Agreement) and that make adequate use of its

flexibilities. 1

7. In addition, the continuation of WHO’s normative work to specify standards and guidance for the development, regulation, production, selection, pricing, procurement, distribution, prescribing and

use of medicines and vaccines is likewise considered as having a high impact on access to safe,

effective and quality medicines, with low complexity and requiring resources for implementation that

are mostly available.

8. The scaling up of the following actions is considered as having a potentially high impact on access to safe, effective and quality medicines, but involves greater complexity and requires additional

resources.

• Support the development and implementation of systems at the national level for collecting and monitoring key data on medicines and vaccines, such as availability, price, expenditure,

usage, quality and safety, and ensuring use of these data for better evidence-based

policy-making.

• Develop policies that promote transparency throughout the value chain, including the public disclosure of clinical trial data,

2 research and development costs, production costs,

procurement prices and procedures, and supply chain mark-ups. 1

• Provide support to Member States to develop collaborative approaches for strategic procurement based on existing models.

1 See also document EB142/14.

2 See recommendation 4.3.4.(b) in Appendix 3 to the Annex.

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• Develop a more systematic approach to providing technical support for improving the skills of the pharmaceutical workforce and monitoring its size, composition, skill sets, training

needs and performance.

9. The continuation of WHO’s support to ensure that regulatory systems have the capacity to provide access to safe, effective and quality medicines and vaccines in addition to support for the

development of international regulatory convergence and harmonization initiatives are considered as

having a potentially high impact on access to safe, effective and quality medicines and vaccines, but

involve greater complexity and require additional resources. WHO will continue to support the

availability of good-quality generic products for procurement by global agencies and countries through

its Prequalification of Medicines Programme, which will evolve to meet the changing health needs of

countries.

10. Lastly, there are a number of actions that have a potentially high impact, but are also highly complex and require significant additional resources. Examples of such actions are shown below.

• Support the development, implementation and monitoring of national medicines policies to reinforce strategies for the appropriate use of medicines.

• Tackling undue influence and corruption in the pharmaceutical system, particularly in procurement and supply chain management.

• Facilitate discussion on unifying principles for biomedical research and development. 1

PROGRESS IN IMPLEMENTING THOSE ELEMENTS OF RESOLUTION WHA69.25

PERTAINING TO THE GLOBAL SHORTAGE OF MEDICINES AND VACCINES

11. In May 2016, the Sixty-ninth World Health Assembly adopted resolution WHA69.25 on, inter alia, addressing the global shortage of medicines and vaccines. In the resolution, the

Director-General was requested “to develop an assessment of the magnitude and nature of the problem

of shortages of medicines and vaccines”, to develop “a global medicine shortage notification system

that would include information to better detect and understand the causes of medicines shortages” and

“to report on progress on, and outcomes of, the implementation of this resolution to the Seventy-first

World Health Assembly”.

12. In July 2017, the Secretariat hosted a technical consultation to review existing systems for reporting medicines shortages, including databases of regulatory authorities, as well as those for

substandard and falsified medical products and adverse events. This information will be used in the

design of a global reporting system for shortages and stock outs. Given that countries will rely on

different sources of information to contribute to a global reporting system, regulatory agencies,

national procurement authorities, manufacturers and those programmes that procure and deliver

medical products were identified among the entities who could contribute. Inclusion criteria, security

and interoperability with other reporting systems were also discussed. The global reporting system will

be limited to medicines included on the WHO Model List of Essential Medicines.

1 See also document EB142/14.

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13. In advance of a global reporting system, WHO has been assessing the magnitude and nature of the problem of shortages of medicines and vaccines through literature reviews, analysis of existing

national notification databases and interviews with stakeholders. In consultation with partners, WHO

is conducting various surveys to gather additional information, especially from countries without a

publicly available national reporting mechanism. 1

14. Regional work on causes of, and solutions to address, shortages has included discussions and a survey conducted in the Eastern Mediterranean Region in 2016, a survey conducted in the Western

Pacific Region in 2017 and a vaccines survey conducted in the European Region in 2016.

ACTION BY THE EXECUTIVE BOARD

15. The Board is invited to note this report, including the comprehensive report on access to essential medicines and vaccines (Annex), consider the priorities and strategic direction of the actions

listed above (paragraphs 6–10), and also note the update on the progress in implementing those

elements of resolution WHA69.25 pertaining to the global shortage of medicines and vaccines

(paragraphs 11–14 above).

1 A full report is planned for publication by May 2018.

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ANNEX

ACCESS TO ESSENTIAL MEDICINES AND VACCINES

Report by the Director-General

Overarching issues and context

1. Access to safe, effective, quality and affordable medicines and vaccines for all is a specific component of target 3.8 of the Sustainable Development Goals.

1 Access to safe, effective and quality

medicines has been recognized as a crucial element for solving numerous important public health

problems and features in many Health Assembly resolutions covering work across the Organization

(see Appendix 1). Achieving universal health coverage requires access to safe, effective, quality and

affordable essential medicines and vaccines.

2. Access to medicines and vaccines is of global concern. There is increasing pressure on health systems to provide affordable access to health care, particularly with the introduction of new

high-priced medicines and health products. Up to 90% of the population in developing countries

purchase medicines through out-of-pocket payments, making medicines the largest family expenditure

item after food. 2 With the rise in noncommunicable diseases – many of which are chronic conditions

that require long-term treatment – the financial burden for patients and governments will become even

greater. Some countries are reporting difficulties in obtaining both traditional and new vaccines in the

quantities needed, as well as in accessing sufficient financial resources to meet the increasing costs of

paying for vaccines and their delivery.

3. The availability of medicines and vaccines is still poor in some countries, particularly for noncommunicable diseases. Data collected by the Secretariat over the past two years show that less

than 10% of facilities in some countries have a complete “basket” of essential medicines for treating

noncommunicable diseases. 3 The supply chain system in many countries continues to underperform,

leading to stock outs and the inability to deliver quality services. In addition, increasing numbers of

substandard and falsified medical products pose an unacceptable risk to public health.

4. The rise of antimicrobial resistance and opioid misuse has highlighted the need for appropriate prescribing and dispensing to ensure appropriate use. The serious lack of new antibiotics under

development to combat the growing threat of antimicrobial resistance calls for greater investment in

the research and development of innovative medicines.

1 Target 3.8 of the Sustainable Development Goals (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 WHO guideline on country pharmaceutical pricing policies. Geneva: World Health Organization; 2015

(http://apps.who.int/iris/bitstream/10665/153920/1/9789241549035_eng.pdf?ua=1, accessed 23 October 2017).

3 Improving access to medicines in the South-East Asia Region: progress, challenges, priorities. New Delhi: World

Health Organization Regional Office for South-East Asia; 2017

(http://apps.who.int/iris/bitstream/10665/258750/1/9789290225904-en.pdf, accessed 23 October 2017).

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5. Access to safe, effective and quality medicines and vaccines requires above all sufficient political will at the national level. It also requires a comprehensive health systems approach that

addresses all stages of the pharmaceutical value chain, including: needs-based research, development

and innovation; public health-oriented intellectual property and trade policies; manufacturing

processes and systems, including strategic and sustainable local production that ensures quality

products; pricing policies and coverage schemes that contribute to the attainment of universal health

coverage; integrity and efficiency in procurement and supply chain management; and appropriate

selection, prescribing and use. Strong regulatory systems to oversee the quality, safety and efficacy of

medicines and vaccines are also required, as well as an effective monitoring system to inform policy.

Strong governance is needed to ensure accountability and tackle vulnerabilities to corruption. In

addition, a well-trained workforce is needed throughout the system, as well as collaboration with all

stakeholders involved.

6. Access to other health technologies, 1 including medical devices and assistive technologies, is

also essential for a well-functioning health system and for achieving the health-related Sustainable

Development Goals. Health technologies are essential for screening, diagnosis, treatment,

rehabilitation and even palliative care, and are often required for appropriate medicine delivery. Many

of the barriers to improving access to medicines are similar to those for medical devices. However, the

selection process, training for proper use, maintenance (where appropriate) and infrastructure support,

and ensuring sustainable access to medical devices are even more complex. Nevertheless, proposals

for the way forward for improving access to medicines and vaccines may be relevant and research and

support for improving access to other health technologies has to be further developed.

Progress in improving access

7. WHO plays a fundamental role in ensuring access to safe, effective and quality medicines and vaccines around the world through its strategic and normative work and technical support at the

global, regional and national levels. The following is a summary of the main challenges related to

access and the activities carried out by WHO to address them, based on a review of progress reports

and other documents (Appendix 2).

(a) Political will and governance

8. Political will is essential for securing the resources required for sustainable access to safe, effective and quality medicines and vaccines and is reflected in the development and implementation

of national medicines and immunization policies. The high percentage of health spending on

medicines (20–60% in low- and middle-income countries) impedes progress for the many countries

that have made a commitment to universal health coverage. 2,3

Strong policies must reflect both an

increasing need for financial coverage for health services and the need to ensure equitable access to

quality care. Robust processes, including transparency and civil society participation, are needed to

decide which services to provide, which patients receive health services, how to reduce out-of-pocket

1 The term “health technologies” refers to the application of organized knowledge and skills in the form of devices,

medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives. See

resolution WHA60.29 (2007) on health technologies.

2 Reich MR, Harris J, Ikegami N, Maeda A, Cashin C, Araujo EC, et al. Moving towards universal health coverage:

lessons from 11 country studies. Lancet. 2016;387:811-16. doi: 10.1016/S0140-6736(15)60002-2.

3 WHO guideline on country pharmaceutical pricing policies. Geneva: World Health Organization; 2015

(http://apps.who.int/iris/bitstream/10665/153920/1/9789241549035_eng.pdf?ua=1, accessed 23 October 2017).

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payments and how to fund health care. Strong governance not only ensures efficient use of funds, but

also improves trust in the health care system and contributes to the proper use of quality medicines and

vaccines.

9. Weak governance leaves the pharmaceutical system vulnerable to ineffective management, undue influence, corruption, waste, fraud and abuse. Corruption is estimated to lead to losses of up to

6% of the annual global health expenditure, or US$ 300 billion. 1 In addition, weak governance in the

pharmaceutical system continues to be an issue for countries due to a lack of transparency and

accountability, unclear roles and responsibilities, and a lack of oversight. Experience in some countries

with decentralized health systems showed five or more years of prolonged confusion over roles and

responsibilities within their immunization programmes, with inadequate accountability mechanisms

and oversight to control how resources were spent and prioritized, making it impossible to achieve

improvements in immunization coverage. 2 A question of growing importance is how to manage

interactions between governments and the private sector to avoid risks of undue influence. In recent

years, there has been an increase in the number and scope of access initiatives being carried out by

pharmaceutical companies and there is a need to ensure that public health interests remain at the centre

of such initiatives.

10. The Secretariat has supported the development of strong policies, as outlined in the following sections of this report. More work is required to update policy guidance and support countries to

develop and implement national policies that reflect the need to improve access to medicines and

vaccines as essential to achieving universal health coverage.

11. In October 2017, WHO published a policy brief on responding to industry initiatives to increase access to medicines and other health technologies in order to support Member States in this respect.

3

The Secretariat has field-tested a revised version of the pharmaceutical system transparency and

accountability assessment tool. 4

12. WHO plays a leadership role in the improvement of transparency with regard to immunization and vaccine safety through the establishment of National Immunization Technical Advisory Groups

5

which provide independent, evidence-informed advice to health authorities on policy issues related to

immunization and vaccines. Regional and country collaboration platforms have been established in all

WHO regions to share experiences, document evidence and develop a policy dialogue on how

countries can use national medicines policies to improve access to essential medicines.

1 The world health report 2010. Health systems financing: the path to universal coverage. Geneva: World Health

Organization; 2010 (http://apps.who.int/medicinedocs/documents/s20169en/s20169en.pdf, accessed 23 October 2017).

2 Strategic Advisory Group of Experts on immunization. 2016 Midterm review of the global vaccine action plan.

Geneva: World Health Organization; 2016

(http://www.who.int/immunization/sage/meetings/2016/october/1_Draft_GVAP_Assessment_report_2016_for_Yellow_Boo

k_28_Sep_2016.pdf, accessed 23 October 2017).

3 Policy brief: responding to industry initiatives to increase access to medicines and other health technologies in

countries. Geneva: World Health Organization; 2017 (http://apps.who.int/iris/bitstream/10665/259359/1/WHO-EMP-

2017.04-eng.pdf, accessed 26 October 2017).

4 The pharmaceutical system transparency and accountability assessment tool is scheduled for publication in

February 2018.

5 For further information on National Immunization Technical Advisory Groups, see http://www.nitag-resource.org/

(accessed 23 October 2017).

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13. Country support for governance has been provided through WHO’s Good Governance for Medicines programme, which aims to: raise awareness of the impact of corruption in the

pharmaceutical sector; increase transparency and accountability of pharmaceutical systems; and

institutionalize good governance in pharmaceutical systems. The Eastern Mediterranean Region has

been particularly active in the Good Governance for Medicines programme, and support has been

provided to countries in the Region to: establish policies for implementing codes of conduct; manage

conflicts of interest; increase public availability of information; develop membership guidelines for

committees; develop standard operating procedures for decision-making processes; establish

independent complaints mechanisms to improve protection for whistle-blowers; and increase civil

society engagement.

14. Key considerations are as follows.

• More work is required to engender and facilitate the development of political will at the national and regional levels to ensure access to medicines and vaccines, particularly with

regard to the implementation of pricing policies and domestic financial investment in

coverage schemes.

• Strategies for reducing undue influence and tackling vulnerabilities to corruption need to be included in support provided to countries for developing and implementing medicines and

vaccines policies.

(b) Workforce

15. While population changes and growth are expected to create 40 million new health worker jobs by 2030, there is currently an estimated shortfall of 18 million health workers required in order to

achieve the health-related Sustainable Development Goals. 1 The development, production,

procurement, distribution and appropriate use of medicines, as well as the supportive functions of

regulation, all require a competent, equitably distributed pharmaceutical workforce. However, low-

and lower-middle-income countries continue to have a very low density of pharmacists compared to

high- and upper-middle-income countries. 2 It has been found that countries with a lower number of

pharmacists per capita are more likely to have reduced access to medicines, as pharmacists are needed

at every stage of the pharmaceutical supply chain. 3

1 Working for health and growth: investing in the health workforce. Report of the High-Level Commission on Health

Employment and Economic Growth. Geneva: World Health Organization; 2016

(http://apps.who.int/iris/bitstream/10665/250047/1/9789241511308-eng.pdf?ua=1, accessed 23 October 2017).

2 Global pharmacy workforce intelligence: trends report. The Hague: International Pharmaceutical Federation; 2015

(http://www.fip.org/files/fip/PharmacyEducation/Trends/FIPEd_Trends_report_2015_web_v3.pdf, accessed

23 October 2017).

3 Bates I, John C, Bruno A, Fu P, Aliabadi S. An analysis of the global pharmacy workforce capacity. Hum Resour

Health. 2016;14(1):61. doi: 10.1186/s12960-016-0158-z.

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16. WHO’s Global Strategy on Human Resources for Health: Workforce 2030 1 sets out

four strategic objectives and policy options to improve the health workforce (applicable to all

occupations) including: the optimization of the existing workforce; anticipating and planning for

future workforce requirements; strengthening institutional capacity to plan and manage the workforce;

and building and utilizing data and evidence to drive workforce policies and strategies. The

International Pharmaceutical Federation’s Pharmaceutical Workforce Development Goals, 2 developed

in alignment with WHO’s Global Strategy, provide detailed guidance specific to the pharmaceutical

workforce, including on addressing the workforce supply, retention, working conditions and

remuneration, education and training capacity, and comprehensive data and evidence to inform

workforce planning.

17. WHO, in partnership with African, Caribbean and Pacific island countries and the European Union, has trained over 3500 health workers since 2012 to strengthen pharmaceutical systems and

improve access to quality medicines. 3 The training has covered a broad range of topics, from the

acquisition of additional skills to assess and register medicines to training on how to conduct surveys

of consumption of antimicrobial medicines. Over 250 regulatory authority personnel from all

WHO regions have been trained on a range of regulatory issues. Support from donors such as the

European Commission has allowed the continuation of the work of a network of WHO national

professional officers, particularly in Africa, with expertise in medicines and health technologies, which

is key to supporting this work effectively in country offices. Numerous training and capacity-building

efforts have also been carried out at the regional and country levels on all topics, as reported

throughout this document.

18. Key considerations are as follows.

• A more systematic approach to providing technical support for improving the skills of the pharmaceutical workforce and monitoring the size, composition, skill sets, training needs and

performance of the pharmaceutical workforce could be developed.

• National professional officers with expertise in medicines and health technologies play a key role in WHO country offices and should be supported.

(c) Needs-based research, development and innovation

19. The shortcomings of the current market-driven innovation system have been the subject of intensive discussion. The problem of commercial research and development not meeting public health

needs was first highlighted in 2001 with respect to neglected diseases. 4 Today, it is widely

1 Global strategy on human resources for health: workforce 2030. Geneva: World Health Organization; 2016

(http://www.who.int/hrh/resources/pub_globstrathrh-2030/en/, accessed 22 November 2017).

2 Pharmaceutical workforce development goals. The Hague: International Pharmaceutical Federation; 2016

(https://fip.org/files/fip/PharmacyEducation/2016_report/2016-11-Education-workforce-development-goals.pdf, accessed

23 October 2017).

3 Annual report 2016: WHO essential medicines and health products. Geneva: World Health Organization; 2017

(http://www.who.int/medicines/publications/annual-reports/WHO_EMP_Report_2016_Online.pdf?ua=1, accessed

23 October 2017).

4 Fatal imbalance: the crisis in research and development for drugs for neglected diseases. Brussels: Medicines Sans

Frontières International; 2001 (http://www.msf.org/sites/msf.org/files/old-cms/source/access/2001/fatal/fatal.pdf, accessed

26 October 2017).

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acknowledged that there is a similar problem with the research and development pipeline for

pathogens with pandemic potential such as Ebola virus or Middle East respiratory syndrome

coronavirus, 1 as well as for antibiotic treatments.

2 Research and development investments in neglected

diseases have shown an annual decline of 2–3% since 2012 (US$ 3.3 billion). 3 In addition,

advancements in vaccine formulations have increased the need for innovative technologies that

simplify vaccine delivery.

20. A lack of sharing of clinical trial data can not only create unnecessary duplication, but also introduce publication bias that can potentially distort regulatory and public health decision-making.

4 In

addition, a lack of regulatory capacity and/or inadequate regulatory pathways for clinical trials has an

impact on the development of new medical products, for example for emergency preparedness and/or

for specific populations, such as medicines for children.

21. The global strategy and plan of action on public health, innovation and intellectual property and the Consultative Expert Working Group on Research and Development: Financing and Coordination

5

have provided the overarching framework guiding the work on research and development by the

Secretariat and Member States. The Secretariat has reviewed the recommendations from the overall

review of the global strategy and plan of action 6 that will be presented to the Board at its

142nd session and has reviewed the recommendations from the report of the United Nations

Secretary-General’s High-level Panel on Access to Medicines 7 (see also section (d) below and

Appendix 3) and compared them with progress made by WHO on needs-based research and

development and innovation.

22. Key progress made by the Secretariat on research and development priority-setting has been the establishment of the Global Observatory on Health Research and Development

8 and the establishment

of the Expert Committee on Health Research and Development. Progress on strategic work to promote

1 WHO publishes list of top emerging diseases likely to cause major epidemics. Geneva: World Health Organization;

2015 (http://www.who.int/medicines/ebola-treatment/WHO-list-of-top-emerging-diseases/en/, accessed 23 October 2017).

2 Organisation for Economic Co-operation and Development, World Health Organization, Food and Agriculture

Organization of the United Nations, World Organisation for Animal Health. Tackling antimicrobial resistance: ensuring

sustainable R&D. Paris: Organisation for Economic Co-operation and Development; 2017

(http://www.oecd.org/g20/summits/hamburg/Tackling-Antimicrobial-Resistance-Ensuring-Sustainable-RD.pdf, accessed

23 October 2017).

3 R&D funding flows for neglected diseases (G-FINDER), by disease, year and funding category. World Health

Organization, Global Observatory on Health Research and Development; 2017 (http://www.who.int/research-

observatory/monitoring/inputs/neglected_diseases/en/, accessed 23 October 2017).

4 Hudson KL, Collins FS. Sharing and reporting the results of clinical trials. JAMA. 2015;313(4):355-6. doi:

10.001/jama.2014.10716.

5 Research and development to meet health needs in developing countries: strengthening global financing and

coordination. Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination.

Geneva: World Health Organization; 2012 (http://www.who.int/phi/CEWG_Report_5_April_2012.pdf, accessed

23 October 2017).

6 See document EB142/14.

7 Report of the United Nations Secretary-General’s High-level Panel on Access to Medicines: promoting innovation

and access to health technologies. Geneva: United Nations High-Level Panel on Access to Health Technologies; 2016

(http://www.unsgaccessmeds.org/final-report, accessed 20 December 2017).

8 For further information on the Global Observatory on Health Research and Development, see

http://www.who.int/research-observatory/en/ (accessed 23 October 2017).

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innovation, research and development and product development includes the establishment of the

research and development blueprint for action to prevent epidemics. 1 Applying the blueprint to Zika

virus vaccine development has allowed research and development to progress at an unprecedented

speed. 2 For Middle East respiratory syndrome coronavirus, WHO has developed a global research and

development road map as well as vaccine target product profiles, and a vaccine is now in clinical

testing. WHO has collaborated on numerous product development partnerships. For example, WHO

has established jointly with the Drugs for Neglected Diseases initiative the Global Antibiotic

Research & Development Partnership 3 and provides support for the Coalition for Epidemic

Preparedness Innovations, 4 among others.

23. WHO has made progress on normative work to guide product development and has recently published several key reports on: antibacterial agents in clinical development;

5 prioritization of

pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial

infections, including tuberculosis; 6 and a proposal for financing and operation of a health product

research and development fund. 7 The Secretariat is actively engaged in a number of ongoing activities

to promote research availability and transparency, such as through the International Clinical Trials

Registry Platform, 8 the publication of a formal position on the timing of reporting,

9 and a statement on

public disclosure of clinical trial results. 10

To foster an enabling environment for research on vaccines,

medicines and diagnostics for outbreak response, a number of tools have been developed, including

1 An R&D blueprint for action to prevent epidemics: funding & coordination models for preparedness and response.

Geneva: World Health Organization; 2016 (http://apps.who.int/medicinedocs/documents/s22472en/s22472en.pdf, accessed

23 October 2017).

2 Current Zika product pipeline. Geneva: World Health Organization; 2016 (http://www.who.int/blueprint/priority-

diseases/key-action/zika-rd-pipeline.pdf?ua=1, accessed 23 October 2017).

3 For further information, see the Global Antibiotic Research & Development Partnership website

(https://www.gardp.org/, accessed 23 October 2017).

4 For further information, see the Coalition for Epidemic Preparedness Innovations website (http://cepi.net/, accessed 23 October 2017).

5 Antibacterial agents in clinical development: an analysis of the antibacterial clinical development pipeline, including tuberculosis. Geneva: World Health Organization; 2017

(http://www.who.int/medicines/news/2017/IAU_AntibacterialAgentsClinicalDevelopment_webfinal_2017_09_19.pdf,

accessed 23 October 2017).

6 Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis. Geneva: World Health Organization; 2017

(http://www.who.int/medicines/areas/rational_use/PPLreport_2017_09_19.pdf?ua=1, accessed 23 October 2017).

7 Health product research and development fund: a proposal for financing and operation. Geneva: World Health Organization; 2016 (http://apps.who.int/iris/bitstream/10665/204522/1/9789241510295_eng.pdf?ua=1, accessed

23 October 2017).

8 For further information on the International Clinical Trials Registry Platform, see http://www.who.int/ictrp/en/ (accessed 23 October 2017).

9 Moorthy VS, Karam G, Vannice KS, Kieny M-P. Rationale for WHO’s new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS Med. 2015;12(4):e1001819. doi:

10.137/journal.pmed.1001819.

10 WHO statement on public disclosure of clinical trial results. Geneva: World Health Organization; 2015 (http://www.who.int/ictrp/results/reporting/en/, accessed 23 October 2017).

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Material Transfer Agreements 1 for sample sharing, and an agreement with stakeholders for rapid

sharing of data.

24. The Secretariat provides technical support to countries to enhance clinical trial oversight, especially in low- and middle-income countries. This includes facilitating the acceleration of clinical

trial and market approvals through work with national regulatory authorities and regulatory and other

networks such as the African Vaccine Regulatory Forum (see section (e) below). Other regional

activities include the establishment by the Regional Office for the Western Pacific of a health research

portal, 2 national health research/clinical trial registries

3 and an Ethics Review Committee

4 to provide

ethical review of research involving human participants.

25. Key considerations are as follows.

• The Global Observatory on Health Research and Development and the research and development blueprint for action to prevent epidemics will play a key role in contributing to

priority-setting mechanisms for product development.

• WHO could strengthen the understanding of its own role in product development partnerships and scale up successful approaches.

• A standardized approach to target product profile development may be useful to improve efficiencies in the use of time and resources, ensure alignment of objectives, accelerate

product development timelines, minimize product development risks, and lead to an optimal

product.

• The recommendations resulting from the overall review of the global strategy and plan of action on public health, innovation and intellectual property

5 are in line with WHO’s work in

this area.

• The work of the Secretariat covers many of the recommendations in the report of the United Nations Secretary-General’s High level-Panel on Access to Medicines.

• WHO could support the development of a code of principles for research and development in order to provide a public health target for funders of research and development.

1 For further information on the Standard Material Transfer Agreements 2 (SMTA2), see

http://www.who.int/influenza/pip/benefit_sharing/smta2/en/ (accessed 23 October 2017).

2 For further information on the health research portal of the Regional Office for the Western Pacific, see

http://researchportal.wpro.who.int/index.php/whorrp (accessed 26 October 2017).

3 For further information on national health research registries, see http://www.wpro.who.int/health_research/nhrr/en/

(accessed 23 October 2017).

4 For further information on the Ethics Review Committee of the Regional Office for the Western Pacific (WPRO-

ERC), see http://www.wpro.who.int/health_research/ethics/wproresearchethics/en/ (accessed 23 October 2017).

5 See document EB142/14.

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(d) Public health-oriented intellectual property and trade policies

26. Since the adoption of the TRIPS Agreement in 1994, the implications of the WTO intellectual property regime for access to medicines in developing countries have been the subject of robust

discussion. Countries have implemented and used the flexibilities provided in the TRIPS Agreement,

as restated by the 2001 Doha Declaration on the TRIPS Agreement and Public Health, to varying

extents. In addition, the use of compulsory licences has been limited. Concerns remain that

“TRIPS-plus” provisions in trade agreements that further strengthen and prolong patent regimes

beyond the TRIPS Agreement standards create additional challenges for ensuring the availability of,

and access to, medicines and other health products. 1

27. The report of the High-level Panel on Access to Medicines echoes the conclusions of previous reports prepared under the auspices of WHO (in particular the reports of the Commission on

Intellectual Property Rights, Innovation and Public Health 2 and the Consultative Expert Working

Group on Research and Development: Financing and Coordination 3 ). It also reiterates elements of

WHO’s global strategy and plan of action on public health, innovation and intellectual property, in

particular the call for greater policy coherence between public health, development and trade. The

Secretariat has reviewed the recommendations from the overall review of the global strategy and plan

of action on public health, innovation and intellectual property that will be presented to the Board at its

142nd session and the recommendations from the report of the High-level Panel on Access to

Medicines and compared them with progress made by WHO (see also section (c) above and

Appendix 3).

28. The global strategy and plan of action on public health, innovation and intellectual property constitutes the basic mandate for WHO’s work in this area. WHO closely collaborates on this topic

with other relevant international and regional organizations, in particular through the trilateral

collaboration with WIPO and WTO, 4 as well as with other organizations, including UNCTAD and

UNDP.

29. Highlights regarding recent progress in normative work on the relationship of innovation, intellectual property and access to medical products include the publication of the report on access to

hepatitis C treatments, 5 and the report on the role of intellectual property in local production in

1 Public health related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and

implementers in the WHO Eastern Mediterranean Region. Cairo: World Health Organization Regional Office for the Eastern

Mediterranean; 2010 (http://apps.who.int/medicinedocs/documents/s21391en/s21391en.pdf, accessed 23 October 2017).

2 Commission on Intellectual Property Rights, Innovation and Public Health. Public health, innovation and

intellectual property rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva:

World Health Organization; 2006 (http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf,

accessed 23 October 2017).

3 For further information, see the webpage of the Consultative Expert Working Group on Research and Development:

Financing and Coordination (http://www.who.int/phi/cewg/en/, accessed 23 October 2017).

4 For further information on the trilateral cooperation, see

http://www.who.int/phi/implementation/trilateral_cooperation/en/ (accessed 23 October 2017).

5 Global report on access to hepatitis C treatment: focus on overcoming barriers. Geneva: World Health Organization;

2016 (http://apps.who.int/iris/bitstream/10665/250625/1/WHO-HIV-2016.20-eng.pdf?ua=1, accessed 23 October 2017).

Annex EB142/13

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developing countries. 1 In addition, WHO published the patent situation for all new hepatitis

treatments 2 as well as for other treatments, including for noncommunicable diseases. WHO has

published two guides: one on trade and health, 3 which provides guidance on how to harness and

maximize opportunities to promote public health and minimize the risks and threats of trade policies;

and another for negotiators and implementers on TRIPS-plus provisions in the Eastern Mediterranean

Region. 4 WHO supports innovative approaches to overcoming patent barriers such as the Medicines

Patent Pool.

30. Training and technical support has been provided by the Secretariat, in collaboration with other relevant international organizations, to numerous Member States and regions on how to facilitate

access to affordable treatments, including on the appropriate use of the flexibilities provided in the

TRIPS Agreement and the effective promotion of health production innovation. 5

31. Key considerations are as follows.

• The recommendations of the overall review of the global strategy and plan of action on public health, innovation and intellectual property are in line with WHO’s work in this area.

• The work of the Secretariat covers many of the recommendations in the report of the High-level Panel on Access to Medicines.

• The Medicines Patent Pool should be expanded to include all patented medicines on the WHO Model List of Essential Medicines.

• The Secretariat should continue to provide technical support and training to Member States in this area.

(e) Regulation to ensure quality, safety and efficacy

32. Despite significant investment over the past decade by many partners, it is estimated that only 60 regulatory authorities in all WHO regions have well functioning and integrated regulatory systems.

Weak regulatory capacity limits the ability of national regulatory agencies to ensure the quality, safety

and efficacy of medicines and vaccines and regulate new products such as biological products and cell

and gene therapies, 6 thus delaying advancements in research and market entry of these products. Long

1 The role of intellectual property in local production in developing countries: opportunities and challenges. Geneva:

World Health Organization; 2016 (http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-

challenges.pdf, accessed 23 October 2017).

2 For further information on patent information on treatments for hepatitis C, see

http://www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/ (accessed 23 October 2017).

3 Trade and health: towards building a national strategy. Geneva: World Health Organization; 2015

(http://apps.who.int/iris/bitstream/10665/183934/1/9789241565035_eng.pdf?ua=1, accessed 23 October 2017).

4 Public health related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and

implementers in the WHO Eastern Mediterranean Region. Cairo: World Health Organization Regional Office for the Eastern

Mediterranean; 2010 (http://apps.who.int/medicinedocs/documents/s21391en/s21391en.pdf, accessed 23 October 2017).

5 For further information on technical cooperation programmes relating to the implementation of the TRIPS

Agreement, see http://www.who.int/phi/wto_communications/en/ (accessed 23 October 2017).

6 Milstien J, Belgharbi L. Regulatory pathways for vaccines for developing countries. Bull World Health Organ.

2004;82(2):128-33.

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lead times and differing regulations among countries also lead to delays in market entry of new

products, as evidenced in a study reporting a delay of four to seven years between the first regulatory

submission (in a high-income country) and the final regulatory approval in sub-Saharan Africa. 1 Weak

national regulatory capacity creates a risk that poor-quality or substandard and falsified medical

products enter markets. In 2013, more than 200 people died and around 1000 became seriously ill in

Pakistan after taking contaminated cardiac medicines. 2 As at November 2017, 100 Member States had

reported over 1500 suspect substandard and falsified medical products in their supply chains through

the WHO Global Surveillance and Monitoring System. 3

33. WHO develops international norms and standards, so that countries worldwide can consistently regulate health products and technologies. The Secretariat supports countries to strengthen regulation,

including post-market surveillance, and eliminate substandard and falsified medicines. WHO also

facilitates access to quality-assured, safe and effective health products by assessing medicines,

vaccines and medical devices for priority diseases.

34. Progress by the Secretariat on normative work includes: the recent development of draft good regulatory practices, consisting of a compendium of international standards, guidelines and “smart”

legislation (that delivers results in the least burdensome way) to establish effective regulatory

systems; 4 the publication of good data and record management practices,

5 which helps regulators to

identify insufficient or false data about health products; and the publication of the global model

regulatory framework for medical devices, 6 including in vitro diagnostic medical devices, which

recommends guiding principles and harmonized definitions for effective regulation of medical

devices. In 2016 and 2017, WHO further developed the national regulatory authority global

benchmarking tool that will be used to evaluate regulatory systems that oversee medical products in

Member States. The Secretariat is also working to revise the WHO emergency use assessment and

listing procedure developed in 2015, 7 which is used in the event of a public health emergency to assess

the quality, safety and efficacy of the available products with fewer data than usual regarding potential

use.

35. The Secretariat has provided support to countries for regulatory system capacity strengthening, targeting specific areas such as registration, inspections, good manufacturing practices, reviews of

1 Ahonkhai V, Martins SF, Portet A, Lumpkin M, Hartman D. Speeding access to vaccines and medicines in low- and

middle-income countries: a case for change and a framework for optimized product market authorization. PLoS One.

2016;11(11):e0166515. doi: 10.1371/journal.pone.0166515.

2 Deadly medicines contamination in Pakistan. Geneva: World Health Organization; 2013

(http://www.who.int/features/2013/pakistan_medicine_safety/en/, accessed 23 October 2017).

3 WHO Global Surveillance and Monitoring System. Geneva: World Health Organization

(http://www.who.int/medicines/regulation/ssffc/surveillance/en/, accessed 23 October 2017).

4 To be published in 2018.

5 Guidance on good data and record management practices. Annex 5 to the WHO Expert Committee on

Specifications for Pharmaceutical Preparations: fiftieth report. Geneva: World Health Organization; 2016 (WHO Technical

Report Series, No. 996; http://apps.who.int/medicinedocs/documents/s22402en/s22402en.pdf, accessed 23 October 2017).

6 WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices.

Geneva: World Health Organization; 2017 (http://apps.who.int/medicinedocs/documents/s23213en/s23213en.pdf, accessed

23 October 2017).

7 For further information on the WHO emergency use assessment and listing procedures for medical products during

public health emergencies, see http://www.who.int/medicines/news/public_consult_med_prods/en/ (accessed

23 October 2017).

Annex EB142/13

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legislation and pharmacovigilance, and has provided support on the development of regulatory

authority institutional development plans. Intensive support has been provided to regulatory authorities

in key producing countries to enhance regulatory oversight of products exported to the global market

and to countries with strategic development plans for local production. Support has also been provided

to strengthen networks and in the convergence and harmonization of medicines regulation at the

international, regional and subregional levels. Technical support has been provided at all levels of the

Organization. The Regional Office for South-East Asia supported the establishment of the South-East

Asia Regulatory Network and the Regional Office for Africa has been supporting countries with

collaborative initiatives such as the African Vaccine Regulatory Forum, which has been expanded to

include medicines, and the African Medicines Regulatory Harmonization initiative. In the Eastern

Mediterranean Region, WHO held a regional meeting on strengthening pharmacovigilance systems, in

which harmonization and strengthening of post-market and vigilance regulatory functions for

medicines, vaccines and medical devices were specifically promoted. Consultation workshops with

national tuberculosis programmes, national medicine regulatory authorities and technical partners were

also organized in the Western Pacific Region to establish priorities and strategies for strengthening and

harmonizing the regulation of tuberculosis medicines. Progress has also been made on the creation of

regulatory networks for work-sharing to enhance smart regulation (the delivery of results in the least

burdensome way) and disseminate good regulatory practices.

36. WHO’s Prequalification of Medicines Programme has helped to ensure access to quality-assured products for global procurement. In 2014 alone, the Prequalification of Medicines

Programme enabled sales of medicines and vaccines worth more than US$ 3 billion. In addition, the

Prequalification of Medicines Programme provides capacity-building activities for regulatory systems

strengthening that include rotating staff fellowships and joint reviews of products with the regulatory

authorities of collaborating Member States. Following requests from Member States and procurement

agencies as well as current donors, the Secretariat is developing a strategic plan to expand the

Prequalification of Medicines Programme to include many of the products on the WHO Model List of

Essential Medicines: vector control products, medicines for hepatitis C, diagnostic tests for hepatitis C

virus and biological products. The Secretariat is also proposing to devolve the assessment of as many

products as possible to benchmarked and well functioning national regulatory authorities. Similarly,

the Secretariat is working with Member States and regional networks to promote reliance on products

included in the WHO list of prequalified medicinal products as another pathway to regulatory

approval.

37. To support Member States to improve the quantity, quality and analysis of accurate data concerning substandard and falsified medical products, the Secretariat established the Global

Surveillance and Monitoring System and has provided training for Member States on detection and

reporting. The Regional Office for the Western Pacific worked with Interpol on annual campaigns to

identify substandard and falsified medical products and strengthen enforcement to curb the sale of

such products. The Regional Office for Africa developed a regional plan of action (2014–2017) to

minimize the spread of substandard and falsified medical products, which included the establishment

of a regional working group on substandard and falsified medical products. The Regional Office for

South-East Asia also provided strategic policy support to countries in that region for setting up the

pharmacovigilance systems required for implementing the use of bedaquiline, which is used

specifically to treat multidrug-resistant tuberculosis.

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38. WHO continues to gather information on suspected adverse events resulting from medicinal products through the VigiAccess global database for reporting on adverse drug reactions,

1 which is

currently used by 127 countries and contains over three million reports.

39. Key considerations are as follows.

• Political will at the national and regional levels is required to ensure access to safe, effective and quality products through effective regulation.

• The success of the Prequalification of Medicines Programme can be built upon through strategies such as expansion to other products and promoting reliance on Programme-listed

products.

• The increasing number of substandard and falsified medical products requires additional efforts to detect, prevent and respond to such products effectively.

• There is also much scope for improving regulation by pooling resources among Member States, for example by pursuing regional harmonization initiatives.

(f) Strategic and sustainable local production

40. Many middle-income countries have established sizeable pharmaceutical industries, built vaccine production capacity and are diversifying into other areas of health technology manufacturing.

As at June 2017, the number of vaccine-producing countries was 43, of which 36 have a functional

national regulatory authority. Local production is also being pursued in low-income countries, as

demonstrated for example by the Pharmaceutical Manufacturing Plan for Africa and the ASEAN

vaccine security and self-reliance initiative for improving vaccine security.

41. The current interest in local production of medicines and vaccines is significant both as a strategy to improve access and for industrial and economic development. Nevertheless, the success of

industrial development that has been experienced in larger economies is difficult to replicate in smaller

markets. Many countries may lack a sufficient market that could justify such investments in terms of

economies of scale. 2 In some settings, the economic and development agendas are currently

overwhelming the capacity of the health system, especially the ability of countries’ national regulatory

authorities to respond effectively. Major barriers to developing local production include: a lack of

fundamental infrastructure; the lack of a well-trained workforce; lack of access to appropriate and

long-term sustainable financing; a lack of collaborative linkages and policy coordination between

ministries and institutions; high costs of finance; and low production standards. 3

42. The Secretariat, with support from the European Commission and the Bill & Melinda Gates Foundation, has carried out a number of studies with respect to local production, in collaboration with

1 For further information on the VigiAccess database, see http://www.vigiaccess.org/ (accessed 23 October 2017).

2 The changing landscape on access to medicines. Geneva: International Federation of Pharmaceutical

Manufacturers & Associations; 2012 (https://www.ifpma.org/wp-content/uploads/2016/01/ChangingLandscapes-Web.pdf,

accessed 23 October 2017).

3 Local production for access to medical products: developing a framework to improve public health. Geneva: World

Health Organization; 2011 (http://www.who.int/phi/publications/Local_Production_Policy_Framework.pdf, accessed

23 October 2017).

Annex EB142/13

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UNIDO, UNCTAD and other partners. The lessons learned from this work are outlined in a Secretariat

report 1 and include the need for greater consideration of the long-term investments (over a period of

15–20 years) involved in increasing local production.

43. Progress on normative guidance in this area includes publication of the report on the role of intellectual property in local production in developing countries

2 and a set of guidelines for developing

policy frameworks on local production that meet public health needs. 3 An inter-agency consultation is

planned for January 2018 to discuss the development of an assessment tool to evaluate the readiness of

manufacturing facilities and feasibility for local production. 4 The Secretariat is also enhancing

interagency collaboration between WHO, UNCTAD, UNIDO and other partners to define roles and

responsibilities for supporting local production.

44. The Secretariat has provided technical support to strengthen manufacturing capacity in countries. For example, in 2015, under the leadership of the Government of Ethiopia, the Secretariat

supported the development and launch of the National Strategy and Plan of Action for Pharmaceutical

Manufacturing Development in Ethiopia (2015–2025), and is now facilitating the implementation of

this strategy. In addition, the Secretariat has provided support to the ASEAN vaccine security and

self-reliance initiative to develop a strategy for vaccine security through guaranteed production and

financing. Support has also been provided to countries to improve regulatory capacity (as described in

section (e) above) and to individual manufacturers through the Prequalification of Medicines

Programme. The Secretariat has also worked on supporting local production capacity for influenza

vaccine manufacturing in a number of Member States, as well as supporting technology transfer

initiatives for biological products such as monoclonal antibodies. 5

45. Key considerations are as follows.

• Strong regulatory capacity is essential before investing in local production.

• Increasing local production to improve access to medicines requires the alignment of countries’ development agendas with health plans and an understanding of the conditions

under which such local production could lead to improved access.

1 Report of the interagency consultation on local production of essential medicines and health products. Geneva:

World Health Organization; 2017 (http://apps.who.int/medicinedocs/documents/s23255en/s23255en.pdf, accessed

23 October 2017).

2 The role of intellectual property in local production in developing countries: opportunities and challenges. Geneva:

World Health Organization; 2016 (http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-

challenges.pdf, accessed 23 October 2017).

3 Local production for access to medical products: developing a framework to improve public health. Geneva: World

Health Organization; 2011 (http://www.who.int/phi/publications/Local_Production_Policy_Framework.pdf, accessed

23 October 2017).

4 Draft to be finalized by the end of 2017.

5 Improving access to safe blood products through local production and technology transfer in blood establishments.

Geneva, World Health Organization; 2015 (http://www.who.int/phi/publications/blood-prods_technology_transfer.pdf,

accessed 23 October 2017).

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(g) Pricing policies

46. Inadequate domestic or government financing of medicines is a major contributor to lack of access to medicines and vaccines and high out-of-pocket expenditure. The extent to which health care

systems cover pharmaceutical expenditure is a crucial measure of the adequacy of the benefits package

offered under universal health coverage. 1 One particular concern at present is the evolving donor

priorities for funding. As countries transition away from donor support for globally purchased quality

products, the question is how to implement sustainable financing mechanisms to avoid disruptions in

medicine and vaccine availability, particularly in middle-income countries that no longer receive

support but do not have the required resources.

47. Ineffective policy interventions and processes to manage expenditure also contribute to a lack of access and high out-of-pocket expenditure. Medicines and vaccines need to be selected through a

rigorous selection process based on clinical evidence of safety, efficacy and cost-effectiveness, in

order to avoid risks of higher expenditure, poor procurement practice and irrational use of medicines

that results from the high variety of available products. 2 As much as 70% of all medicines currently on

the market are duplicative or non-essential, and newer medicines are nearly always more expensive

than existing ones. 3

48. Owing to their lower prices, generic medicines and vaccines offer an opportunity for significant savings for health budgets and for lowering out-of-pocket expenditure. However, developing and

implementing policies for the procurement and use of generic medicines is complex and requires many

different policy components to be in place, such as: the establishment of systems that facilitate market

entry of generic medicines; the existence of a functioning and transparent medicines regulatory

agency; and adequate training of prescribers and dispensers.

49. Countries need additional capacity to negotiate prices effectively, or to take better advantage of their position to negotiate with manufacturers. A lack of transparency regarding costs of production,

research and development, and prices paid by other Member States and procurement agencies results

in a lack of power to negotiate and a reliance on mechanisms for comparison such as international

reference pricing, which is likewise opaque. Capacity to effectively negotiate prices is limited even in

some high-income countries. As a result, countries are forced to limit access to high-priced but

effective medicines and vaccines, the most well described example being the direct-acting antiviral

medicines for the treatment of hepatitis C. Collaborative approaches for strategic procurement offer

possibilities to improve negotiation, as discussed in section (h) below.

50. Supply chain mark-ups are uncontrolled in many countries, resulting in the price-to-patient being many times that of the ex-manufacturer price. There have been several well documented

examples of rapid and extreme price rises leading to reduced access. There are also challenges in

collecting and monitoring pricing information that could inform policy-setting.

1 Tracking universal health coverage: first global monitoring report. Geneva: World Health Organization; 2015

(http://apps.who.int/iris/bitstream/10665/174536/1/9789241564977_eng.pdf?ua=1, accessed 23 October 2017).

2 Laing R, Waning B, Gray A, Ford N, Hoen ET. 25 years of the WHO essential medicines lists: progress and

challenges. Lancet. 2003;361(9370):1723-9. doi: 10.1016/S0140-6736(03)13375-2.

3 Managing medicine selection. In: Managing access to medicines and health technologies, third edition. Arlington,

VA: Management Sciences for Health; 2012 (http://apps.who.int/medicinedocs/documents/s19630en/s19630en.pdf, accessed

23 October 2017).

Annex EB142/13

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51. WHO is working closely with national and global immunization partners to advocate for increased domestic financing to sustain immunization gains once donor support ends. In 2016–2017,

an assessment for new immunization financing was added as a module in the new WHO guidance on

conducting a national immunization assessment review. 1 The testing of this module has been carried

out in several countries over the past five years: in low-income countries; countries transitioning from

support from the GAVI Alliance; and middle-income countries that are not eligible for support from

the GAVI Alliance. This improvement to the Expanded Programme on Immunization review will

allow countries to assess immunization financing and financial sustainability bottlenecks prior to the

development of a comprehensive multiyear plan for immunization.

52. The Secretariat has contributed for many years to normative work on medicine selection, including through the development of standard treatment guidelines and the WHO Model List of

Essential Medicines. In 2017, the Expert Committee on the Selection and Use of Medicines undertook

an important review of antibiotics for treatment of infectious diseases, sexually transmitted infections

and paediatric indications, as well as medicines for treatment of noncommunicable diseases such as

cancer and diabetes. 2

53. The Secretariat has started collecting evidence for a fair-pricing 3 model that could be adapted by

countries according to the national context. The Secretariat has made substantial progress on the

vaccine product, price and procurement initiative, which now provides access to procurement prices of

vaccines across more than 80% of countries, with the goal of increasing price transparency and

informing vaccine introduction and procurement. The Secretariat is building on the work carried out in

collaboration with Stichting Health Action International on the tool for measuring and monitoring

medicine price and availability 4 through the use of a smartphone application. The Secretariat is also

providing support to Member States to collect data on medicine price and availability and explore

methods for price negotiation.

54. Detailed regional-level discussions on how to manage the complex process of selection and pricing of medicines and health products in the context of universal health coverage have taken place

over the past three years. In the Region of the Americas, a Health Technology Assessment Network of

the Americas (Red de Evaluación de Tecnologías en Salud de las Américas), has been established to

strengthen and promote the evaluation process of technologies and enable the exchange of

information. In the South-East Asia Region, the Secretariat has helped countries to revise essential

medicines lists as part of the revision of the package of essential health services and has helped

countries to introduce health technology assessments as a routine part of the decision-making process

for adding medicines to their national benefit packages. In the Western Pacific Region, WHO has

1 Guidance and tools. Geneva: World Health Organization

(http://www.who.int/immunization/programmes_systems/financing/tools/en/, accessed 28 October 2017).

2 WHO updates Essential Medicines List with new advice on use of antibiotics, and adds medicines for hepatitis C,

HIV, tuberculosis and cancer. Geneva: World Health Organization; 2017

(http://www.who.int/mediacentre/news/releases/2017/essential-medicines-list/en/, accessed 30 November 2017).

3 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. In this context, fairness implies

positive incentives/benefits for all stakeholders, including purchasers and those involved in the research and development and

manufacture of medicines.

4 Measuring medicine prices, availability, affordibility and price components, second edition. Geneva: World Health

Organization; 2008 (http://www.who.int/medicines/areas/access/OMS_Medicine_prices.pdf?ua=1, accessed

23 October 2017).

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supported countries with evidence-based revisions of national essential medicines lists and the

selection of new cost-effective therapeutic options based on health technology assessments. Regional

efforts by the regional offices for Africa and South-East Asia include assessments of medicine pricing

policy, best practices and lessons learned for price control. The Regional Office for the Western

Pacific relaunched the Price Information Exchange for Selected Medicines to provide comparative

information across the region on procurement prices for medicines. In the European Region, the

Secretariat conducted a technical briefing in 2016 that resulted in recommendations calling on the

regional office to promote collaboration among Member States and support the development of

regional and subregional networks to address topics such as horizon scanning (that is, examining how

emerging trends and developments might affect current policy and practice), health technology

assessment, the willingness to pay for innovation, and the delinking of medicine prices from research

and development costs.

55. Platforms for price information exchanges (such as the Price Information Exchange for Selected Medicines) and for discussions on strategies to facilitate sustainable access to essential medicines

(such as the Asia Pacific Network on Access to Medicines) have been established. In the European

Region, best practices for pricing and reimbursement policies were shared during a summer school

and two pharmaceutical pricing and reimbursement information network meetings were held for

Member States.

56. Key considerations are as follows.

• There is a need for increased political will and support to enable countries to develop domestic financial investment in coverage schemes and implement policies that reduce

out-of-pocket payments such as generic policies, control of supply chain mark-ups and other

pricing control methods, including reviewing intellectual property legislation, and

implementation and use of the flexibilities provided in the TRIPS Agreement.

• Support is needed in countries to improve evidence-based selection of medicines, including selective use of health technology assessment techniques in order to achieve universal health

coverage.

• There is a need to establish a fair-pricing model that ensures sustainability for health systems and access for patients as well as sufficient profit to sustain the production of quality

products.

• Support to countries is needed to facilitate the transition away from donor support for globally purchased quality products in order to implement sustainable financing mechanisms and

avoid disruptions in medicine availability.

• Platforms for sharing procurement price information, including the Global Price Reporting Mechanism and the vaccine product, price and procurement initiative, offer opportunities for

better price negotiation.

• Routine monitoring of data on medicine prices and availability is essential to inform decision-making.

Annex EB142/13

23

(h) Procurement and supply chain management

57. Good procurement practices play a key role in securing competitive prices, ensuring adequate supply of quality products and contributing to appropriate use. Three main challenges to good

procurement practice are: limited negotiating power (also discussed in section (g) above); inaccurate

quantification of the demand for medicines; and corrupt procurement practices and procedures.

Limited negotiating power stems from a lack of information on how prices are derived, what price

other Member States and procurement agencies are paying, and small economies of scale. Inaccurate

quantification is common in the absence of reliable data on needs, stocks and usage, while corruption

occurs in the absence of transparent procurement processes. In the light of several notable cases of

failure of governance, such as the theft and resale on the black market of malaria medicines purchased

with donor funds and accounts of donations from pharmaceutical companies during emergency relief

operations that fail to meet recipients’ real needs, there has been recognition by global health partners

and donors of a need for change.

58. Good supply chain management ensures the availability of quality products at all levels of the health system and encompasses storage and inventory management, physical distribution and tracking

of products. The supply chain is frequently weakened by inadequate infrastructure and the lack of

effective management information systems. As immunization programmes expand to include new

vaccines and strive to reach more people, they are increasingly constrained by outdated supply chains.

This is of particular concern for the delivery of new vaccine formulations, as it is projected that

by 2020, four times the cold-chain capacity will be needed compared with 2010. 1 The information

systems for tracking stock and associated documentation may also be poorly managed, leading to the

oversupply of unnecessary products, the undersupply or stock outs of medicines and vaccines, the

inability to monitor supply chain leaks, and the infiltration of substandard and falsified medical

products into the supply chain.

59. Normative work by the Secretariat has mainly focused on providing guidance to countries to improve coordination and quality of donations and on the development of pre-packaged medical kits

(for example, the Interagency Emergency Health Kit and the piloting and expanding use of

noncommunicable diseases kits). To determine which vaccines are needed for crisis-affected

populations, in 2013 WHO published a framework for vaccination in acute humanitarian

emergencies. 2 WHO, UNICEF, Médecins Sans Frontières International and The Save the Children

Fund also jointly developed and launched a Humanitarian Mechanism 3 in May 2017 for more effective

and efficient vaccine procurement during emergencies.

60. WHO has also played a role in the coordination of the Interagency Supply Chain Group, an informal coalition of partners, which was established following the work of the United Nations

1 For further information on the immunization supply chain, see the GAVI Alliance website

(http://www.gavi.org/support/hss/immunisation-supply-chain/, accessed 23 October 2017).

2 Vaccination in acute humanitarian emergencies: a framework for decision making. Geneva: World Health

Organization; 2013 (http://www.who.int/hac/techguidance/tools/vaccines_in_humanitarian_emergency_2013.pdf, accessed

23 October 2017).

3 Accessing affordable and timely supply of vaccines for use in humanitarian emergencies: the Humanitarian

Mechanism. Geneva: World Health Organization; 2017

(http://www.who.int/immunization/programmes_systems/sustainability/The_Humanitarian_Mechanism_ToRs.pdf?ua=1,

accessed 23 October 2017).

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Commission on Life-Saving Commodities for Women and Children with the aim of coordinating and

collaborating at the global level to strengthen countries’ supply chains.

61. Support has been provided to Member States for the establishment of appropriate policies and good practices, as well as capacity-building for improving governance, efficiency and the quality of

procurement and supply-chain management, both in ordinary and emergency situations. In the Eastern

Mediterranean Region, the Secretariat has collaborated closely with countries to strengthen good

governance and tackle vulnerabilities to corruption through the Good Governance for Medicines

programme (see section (a) above).

62. At the regional and country levels there have been enhanced efforts to: increase intercountry collaboration on procurement of medicines and vaccines to enhance transparency; facilitate

cross-country learning; strengthen bargaining power; and mitigate high transaction costs. For example,

PAHO’s Revolving Fund for Strategic Public Health Supplies 1 was used by 41 Latin American and

Caribbean countries and territories in 2015 to purchase goods worth over US$ 70 million. The

Organisation of Eastern Caribbean States reported an average cost saving of 37% for buying

25 selected medicines over a five-year period by using a regional pooled procurement mechanism. 2

The Nordic Forum, the Beneluxa group, the European Union’s Joint Procurement Agreement to

Procure Medical Countermeasures, and the Baltic Partnership Agreement are examples of joint

procurement efforts that have helped to facilitate procurement in the European Region. In May 2017,

eight European countries signed the Valletta Declaration as a commitment to explore areas for

cooperation in procurement such as information sharing, joint procurement and price negotiations. The

Regional Office for South-East Asia held a regional consultation in August 2017 with 11 countries in

the region, United Nations bodies and international partners such as the Global Fund to Fight AIDS,

Tuberculosis and Malaria to discuss options for intercountry and regional collaboration on public

procurement and pricing.

63. WHO regional offices have also been providing technical support to Member States to: improve the accuracy of national vaccine forecasts; enhance demand-consolidation activities (such as the

harmonization of product requirements across countries); and improve procurement legislation and

practices. A number of countries have introduced more strategic public procurement practices such as

longer-term contracts, central bargaining and e-procurement, which have contributed to lower prices

and fewer stock outs. Countries that currently self-procure vaccines have been supported to consider

procuring through alternative mechanisms, such as that developed by UNICEF, for enhanced access to

affordable vaccines. Following a call for action as a result of the review in 2016 by the Strategic

Advisory Group of Experts on immunization of the global vaccine action plan 3 to redesign supply

chains and information systems, WHO and UNICEF have been working in collaboration with other

1 For further information on the PAHO Strategic Fund, see

http://www.paho.org/hq/index.php?option=com_content&view=article&id=12163%3Apaho-strategic-

fund&catid=8775%3Aabout&Itemid=42005&lang=en (accessed 23 October 2017).

2 Multi-country regional pooled procurement of medicines: identifying key principles for enabling regional pooled

procurement and a framework for inter-regional collaboration in the African, Caribbean and Pacific Island countries. Meeting

report. Geneva: World Health Organization; 2007 (http://www.who.int/medicines/publications/PooledProcurement.pdf,

accessed 23 October 2017).

3 2016 Midterm review of the global vaccine action plan. Geneva: Strategic Advisory Group of Experts on

immunization, World Health Organization; 2016

(http://www.who.int/immunization/sage/meetings/2016/october/1_Draft_GVAP_Assessment_report_2016_for_Yellow_Boo

k_28_Sep_2016.pdf, accessed 23 October 2017).

Annex EB142/13

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partners to support countries to improve their vaccine supply and cold-chain systems with

transformative solutions through the WHO/UNICEF Effective Vaccine Management initiative. 1

64. Key considerations are as follows.

• Joint or pooled procurement at the national, regional and global levels has proved an effective means to secure lower prices and offers promise for expansion. The scaling up of

collaborative approaches for strategic procurement should be supported.

• Increased transparency of procurement procedures offers an opportunity to curb corrupt procurement practice.

(i) Appropriate prescribing, dispensing and use

65. It has been reported that worldwide, more than 50% of all medicines are prescribed, dispensed or sold inappropriately, while 50% of patients fail to take their prescribed medicines correctly.

2

Medicines continue to be inappropriately prescribed and dispensed in many countries due to an

inadequately trained workforce, poor-quality diagnosis and medication errors. The impact of

marketing and promotional activities on doctors’ prescribing patterns may also be a contributing factor

to irrational prescribing and use. 3 On the patient side, the inability to pay and the unavailability of

medicines lead to patients not seeking treatment or reverting to harmful treatments. 4 Furthermore, the

overuse and misuse of antimicrobial medicines is leading to increased antimicrobial resistance, while

challenges remain in establishing a balance between increasing access to palliative care to those who

need it and minimizing misuse and abuse of opioids. Improving appropriate prescribing, dispensing

and use requires implementing behaviour change policies, monitoring and commitment to quality of

care – a series of complex activities that may currently be beyond the capacity of many health systems.

66. Resolution WHA60.16 (2007) on progress in the rational use of medicines identified the interventions that had been shown to be effective at that time. It also identified some policy

approaches, such as national advisory committees on rational use of medicines, that have generally not

been implemented over the past decade. However, the commitment to the achievement of the

Sustainable Development Goals, the rise of antimicrobial resistance and the move away from vertical

disease-management programmes offers an opportunity to re-evaluate what is most likely to be

effective in promoting appropriate use of medicines and thus to update WHO’s recommendations in

this area.

67. For health care workers, WHO has now established robust methods for developing standard treatment guidelines that can be adapted at the national level, but there needs to be greater emphasis on

ensuring that these guidelines are implemented.

1 For further information on the Effective Vaccine Management initiative, see

http://www.who.int/immunization/programmes_systems/supply_chain/evm/en/, accessed 23 October 2017.

2 Promoting rational use of medicines: core components. Geneva: World Health Organization; 2002

(http://apps.who.int/iris/bitstream/10665/67438/1/WHO_EDM_2002.3.pdf, accessed 23 October 2017).

3 Vancelik S, Beyhun NE, Acemoglu H, Calikoglu O. Impact of pharmaceutical promotion on prescribing decisions

of general practitioners in Eastern Turkey. BMC Public Health. 2007;7(1):122. doi: 10.1186/1471-2458-7-122.

4 Global health community slithers away from snakebite crisis as antivenom runs out. Geneva: Médecins Sans

Frontières International; 4 September 2015 (http://www.msf.org/en/article/global-health-community-slithers-away-snakebite-

crisis-antivenom-runs-out, accessed 23 October 2017).

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68. The Secretariat is leading work on surveillance of the consumption and use of antimicrobial medicines. Training and survey implementation began in 2016. The Secretariat developed a protocol

for WHO’s hospital point prevalence survey on use of antimicrobial medicines on the basis of that

issued by the European Centre for Disease Prevention and Control. The pilot phase of surveys on the

use of antimicrobial medicines in hospitals is November and December 2017 in the African Region

and the Region of the Americas: the surveys will be scaled up in 2018. When considering

antimicrobial resistance, it is important to note the role of diagnostic devices and infection prevention

and control measures in health facilities.

69. In the Region of the Americas, guidance has been published on developing, implementing and monitoring national medicines policies to reinforce strategies for the rational use of medicines. In the

African Region, 17 countries have worked to improve the selection, prescribing, dispensing and use of

medicines. Activities have included: the revision of national essential medicines lists and/or standard

treatment guidelines; training on prescribing and use; and surveys to assess prescribing and use of

medicines. The Regional Office for Europe collaborates with partners in order to support community

pharmacists to promote greater engagement in issues related to the responsible use of medicines and

has co-convened a course to provide guidance to countries on understanding how multifaceted models

can improve adherence to recommendations on quality care with respect to the use of medicines. The

Regional Office for the Eastern Mediterranean has provided training for eight countries on addressing

barriers to access to opioid medicines and their use, on topics such as conducting surveys on

accessibility, availability, affordability and use, and estimation of future needs. The Regional Office

for South-East Asia has provided support to enable countries to establish medicines and therapeutics

committees at the health facility level to improve rational use of medicines and national medicine

supply systems and increase compliance with national essential medicines lists in prescribing. More

than 115 Member States have formed independent National Immunization Technical Advisory Groups

to guide decision-making on vaccine introductions, immunization schedules and immunization

policies.

70. Key considerations are as follows.

• WHO’s recommendations for improving prescribing, dispensing and use of medicines should be updated to include effective strategies that are within the capacity of health systems.

• Technical support is required to implement and monitor national medicines policies for the appropriate use of medicines.

• Strategies for effective implementation of the ethical criteria for medicinal drug promotion need to be updated.

(j) Monitoring of pharmaceutical systems

71. Routine monitoring of access to medicines and vaccines and other key data such as expenditure on medicines and vaccines, shortages, consumption, immunization, safety and detection of

substandard and falsified medical products is essential to inform policy decisions and improve

accountability. The lack of methods for collecting immunization data, for example, has created

difficulties for locating unimmunized pockets and assessing the success of immunization

Annex EB142/13

27

programmes. 1 The lack of fully computerized systems and variabilities in how data are collected and

validated create discrepancies in reporting and limit the ability of countries to conduct analyses and

make well informed decisions. 2 Although survey-based methods such as the service availability and

readiness assessment 3 will be used for some time to monitor progress on the indicators of the

Sustainable Development Goals, countries need to move towards much more routine data assessment

methods.

72. WHO has started working on the development of the newly approved Sustainable Development Goal indicator on access to medicines that includes the proportion of health facilities that have a core

set of relevant essential medicines available and affordable on a sustainable basis. 4 This indicator is

similar to the one that was selected for target 8.E of the Millennium Development Goals 5 and that,

after failing to establish a reliable and consistent data collection and measurement method, was

dropped from the formal reporting on the Millennium Development Goals for the years 2009–2014.

WHO has already started engaging with relevant international agencies and experts on monitoring

indicators of the Sustainable Development Goals to ensure that reliable, measurable and available

metrics are developed for this newly approved indicator.

73. The Secretariat’s work to strengthen monitoring includes the development of monitoring and reporting mechanisms and the provision of technical support to Member States on data collection and

the development of strong information management systems. Key areas of work mentioned throughout

this report include: collection of information on suspected adverse events resulting from medicinal

products (section (e)); collection of data concerning substandard and falsified medical products

through the Global Surveillance and Monitoring System (section (e)); development of a smartphone

application for measuring medicine price and availability (section (g)); surveillance of the

consumption and use of antimicrobial medicines (section (i)); and development of a global medicine

shortage notification system to track and monitor medicine shortages (summarized in the report on the

progress of resolution WHA69.25 below). In addition, the WHO/UNICEF joint reporting process 6

provides data on performance, planning, financing and quality indicators for immunization to all

Member States on an annual basis and has helped to avoid the publication and dissemination of

discrepant immunization system performance data.

1 2016 Midterm review of the global vaccine action plan. Geneva: Strategic Advisory Group of Experts on

immunization, World Health Organization; 2016

(http://www.who.int/immunization/sage/meetings/2016/october/1_Draft_GVAP_Assessment_report_2016_for_Yellow_Boo

k_28_Sep_2016.pdf, accessed 23 October 2017).

2 Núñez-Núñez M, Navarro MD, Palomo V, Rajendran NB, del Toro MD, Voss A, et al. The methodology of

surveillance for antimicrobial resistance and healthcare-associated infections in Europe (SUSPIRE): a systematic review of

publicly available information. Clin Microbiol Infection. 2017. doi: 10.1016/j.cmi.2017.07.014.

3 For further information on Service availability and readiness assessment, see

http://www.who.int/healthinfo/systems/sara_introduction/en/ (accessed 23 October 2017).

4 Indicator 3.b.3 (Proportion of the population with access to affordable medicines and vaccines on a sustainable

basis).

5 Target 8.E of the Millennium Development Goals: In cooperation with pharmaceutical companies, provide access to

affordable essential drugs in developing countries.

6 For further information on the WHO/UNICEF joint reporting process, see

http://www.who.int/immunization/monitoring_surveillance/routine/reporting/en/ (accessed 23 October 2017).

EB142/13 Annex

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74. Key considerations are as follows.

• A new emphasis on data and monitoring is required in order to support policy decisions and improve accountability, particularly for key indicators such as access, expenditure, claims

data and usage.

(k) Collaboration

75. The pharmaceutical system includes myriad stakeholders including pharmacists, health care workers, patient groups and consumers, wholesalers, academic institutions, donors, policy-makers,

regulatory authorities, United Nations bodies, nongovernmental organizations and the private sector.

The challenge at the global, regional and country levels is to coordinate and harness the contributions

of the many different entities to improve access to safe, effective and quality medicines and vaccines.

WHO collaborates with stakeholders in a multitude of ways, some of which are mentioned in this

report. A non-exhaustive list of entities working on access to medicines (WHO collaborating centres,

United Nations bodies and related organizations, partners and non-State actors in official relations

with WHO) is provided in Appendix 4.

76. Key considerations are as follows.

• WHO can use its convening power and advantage compared with other organizations to support increased interorganizational, regional and country collaboration in order to network,

share best practices and improve information sharing.

Annex EB142/13

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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

Resolution 1 (year) Title

Health Assembly

WHA70.7 (2017) Improving the prevention, diagnosis and clinical management of sepsis

WHA70.12 (2017) Cancer prevention and control in the context of an integrated approach

WHA70.14 (2017) Strengthening immunization to achieve the goals of the global vaccine action plan

WHA70.16 (2017) Global vector control response: an integrated approach for the control of vector-borne

diseases

WHA69.1 (2016) Strengthening essential public health functions in support of the achievement of

universal health coverage

WHA69.11 (2016) Health in the 2030 Agenda for Sustainable Development

WHA69.20 (2016) Promoting innovation and access to quality, safe, efficacious and affordable

medicines for children

WHA69.21 (2016) Addressing the burden of mycetoma

WHA69.23 (2016) Follow-up of the report of the Consultative Expert Working Group on Research and

Development: Financing and Coordination

WHA69.25 (2016) Addressing the global shortage of medicines and vaccines, and the safety and

accessibility of children’s medication

WHA68.2 (2015) Global technical strategy and targets for malaria 2016–2030

WHA68.6 (2015) Global vaccine action plan

WHA68.7 (2015) Global action plan on antimicrobial resistance

WHA68.15 (2015) Strengthening emergency and essential surgical care and anaesthesia as a component

of universal health coverage

WHA68.18 (2015) Global strategy and plan of action on public health, innovation and intellectual

property

WHA68.20 (2015) Global burden of epilepsy and the need for coordinated action at the country level to

address its health, social and public knowledge implications

WHA67.1 (2014) Global strategy and targets for tuberculosis prevention, care and control after 2015

WHA67.6 (2014) Viral hepatitis

WHA67.14 (2014) Health in the post-2015 development agenda

WHA67.19 (2014) Strengthening of palliative care as a component of comprehensive care throughout the

life course

WHA67.20 (2014) Regulatory system strengthening for medical products

WHA67.21 (2014) Access to biotherapeutic products, including similar biotherapeutic products, and

ensuring their quality, safety and efficacy

WHA67.22 (2014) Access to essential medicines

1 Unless otherwise indicated.

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Resolution 1 (year) Title

WHA67.23 (2014) 1 Health intervention and technology assessment in support of universal health

coverage

WHA67.25 (2014) Antimicrobial resistance

WHA66.7 (2013) Implementation of the recommendations of the United Nations Commission on

Life-Saving Commodities for Women and Children

WHA66.12 (2013) Neglected tropical diseases

WHA66.22 (2013) Follow up of the report of the Consultative Expert Working Group on Research and

Development: Financing and Coordination

WHA65.3 (2012) Strengthening noncommunicable disease policies to promote active ageing

WHA65.4 (2012) The global burden of mental disorders and the need for a comprehensive, coordinated

response from health and social sectors at the country level

WHA65.5 (2012) Poliomyelitis: Intensification of the global eradication initiative

WHA65.17 (2012) Global vaccine action plan

WHA65.19 (2012) Substandard/spurious/falsely-labelled/falsified/counterfeit medical products

WHA65.21 (2012) Elimination of schistosomiasis

WHA65.22 (2012) Follow-up of the report of the Consultative Expert Working Group on Research and

Development: Financing and Coordination

WHA64.5 (2011) Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines

and other benefits

WHA63.1 (2010) Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines

and other benefits

WHA63.12 (2010) Availability, safety and quality of blood products

WHA62.10 (2009) Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines

and other benefits

WHA62.16 (2009) Global strategy and plan of action on public health, innovation and intellectual

property

WHA61.1 (2008) Poliomyelitis: mechanism for management of potential risks to eradication

WHA61.15 (2008) Global immunization strategy

WHA61.21 (2008) Global strategy and plan of action on public health, innovation and intellectual

property

WHA60.1 (2007) Smallpox eradication: destruction of variola virus stocks

WHA60.13 (2007) Control of leishmaniasis

WHA60.16 (2007) Progress in the rational use of medicines

WHA60.20 (2007) Better medicines for children

WHA60.28 (2007) Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines

and other benefits

WHA60.29 (2007) Health technologies

WHA60.30 (2007) Public health, innovation and intellectual property

Regional Committee for South-East Asia

Document SEA/RC70/7 Hepatitis

Document SEA/RC70/8 Tuberculosis: ‘Bending the curve’

Document SEA/RC70/9 Access to medicines

1 Unless otherwise indicated.

Annex EB142/13

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Resolution 1 (year) Title

Document SEA/RC69/9 1 Antimicrobial resistance

SEA/RC68/R3 (2015) Antimicrobial resistance

SEA/RC68/R5 (2015) Cancer prevention and control – The way forward

SEA/RC66/R7 (2013) Effective management of medicines

SEA/RC65/R3 (2012) Consultative Expert Working Group on Research and Development: Financing and

Coordination

SEA/RC65/R6 (2012) Regional strategy for universal health coverage

SEA/RC64/R3 (2011) 2012: Year of Intensification of Routine Immunization in the South-East Asia Region:

Framework for increasing and sustaining coverage

SEA/RC64/R5 (2011) National essential drug policy including the rational use of medicines

SEA/RC63/R4 (2010) Prevention and containment of antimicrobial resistance

SEA/RC62/R6 (2009) Measures to ensure access to safe, efficacious, quality and affordable medical

products

SEA/RC61/R5 (2008) Dengue prevention and control

SEA/RC60/R5 (2007) The new Stop TB Strategy and its implementation

SEA/RC60/R8 (2007) Challenges in polio eradication

Regional Committee for Africa

AFR/RC66/R2 (2016) Regional strategy on regulation of medical products in the African Region,

2016–2025

AFR/RC64/R4 (2014) Regional Strategic Plan for Immunization 2014–2020

AFR/RC63/R4 (2013) Addressing the challenge of women’s health in Africa: Report of the Commission on

Women’s Health in the African Region

AFR/RC63/R6 (2013) Regional strategy on neglected tropical diseases in the WHO African Region

AFR/RC63/R7 (2013) The WHO consolidated guidelines on the use of antiretroviral drugs for treating and

preventing HIV infection; recommendations for a public health approach –

implications for the African Region

AFR/RC62/R2 (2012) HIV/AIDS: Strategy for the African Region

AFR/RC62/R7 (2012) Consideration and endorsement of the Brazzaville Declaration on noncommunicable

diseases

Regional Committee for the Eastern Mediterranean Region

EM/RC63/R.3 (2016) Improving access to assistive technology

EM/RC63/R.5 (2016) Strategic framework for blood safety and availability 2016–2025

EM/RC59/R.3 (2012) Health systems strengthening in countries of the Eastern Mediterranean Region:

challenges, priorities and options for future action

Regional Committee for the Western Pacific

WPR/RC66.R1 (2015) Viral hepatitis

WPR/RC65.R5 (2014) Expanded programme on immunization

WPR/RC64.R5 (2013) Hepatitis B control through vaccination: setting the target

WPR/RC63.R4 (2012) Regional action plan for neglected tropical diseases in the Western Pacific

(2012–2016)

1 Unless otherwise indicated.

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Resolution 1 (year) Title

Regional Committee for Europe

EUR/RC66/R5 (2016) 1 Strengthening people-centred health systems in the WHO European Region:

framework for action on integrated health services delivery

EUR/RC66/R9 (2016) Action plan for the health sector response to HIV in the WHO European Region

EUR/RC66/R10 (2016) Action plan for the health sector response to viral hepatitis in the WHO European

Region

EUR/RC65/R5 (2015) Priorities for health systems strengthening in the WHO European Region 2015–2020:

walking the talk on people centredness

EUR/RC65/R6 (2015) Tuberculosis action plan for the WHO European Region 2016–2020

EUR/RC64/R5 (2014) European Vaccine Action Plan 2015–2020

Directing Council of the Pan American Health Organization

CD55.R5 (2016) Plan of action for the prevention and control of HIV and sexually transmitted

infections 2016–2021

CD55.R7 (2016) Plan of action for malaria elimination 2016–2020

CD55.R8 (2016) Resilient health systems

CD55.R9 (2016) Plan of action for the elimination of neglected infectious diseases and

post-elimination actions 2016–2022

CD55.R12 (2016) Access and rational use of strategic and high-cost medicines and other health

technologies

CD54.R7 (2015) Plan of action for the prevention and control of viral hepatitis

CD54.R9 (2015) Strategy on health-related law

CD54.R15 (2015) Plan of action on antimicrobial resistance

CD52.R10 (2013) Chronic kidney disease in agricultural communities in Central America

1 Unless otherwise indicated.

Annex EB142/13

33

Appendix 2

DOCUMENTS REVIEWED FOR THE PURPOSES OF

PREPARING THIS REPORT

A70/17 Review of the Pandemic Influenza Preparedness Framework

A70/20 Addressing the global shortage of, and access to, medicines and vaccines

A70/21 Evaluation and review of the global strategy and plan of action on public health, innovation

and intellectual property

A70/22 Follow-up of the report of the Consultative Expert Working Group on Research and

Development: Financing and Coordination

A70/23 Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit

medical products

A70/25 Global vaccine action plan

A70/38 Progress reports: Health systems: I. Progress in the rational use of medicines

(resolution WHA60.16)

A70/38 Progress reports: Health systems: J. Regulatory system strengthening for medical products

(resolution WHA67.20)

A69/22 Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and

other benefits

A69/24 Global action plan on antimicrobial resistance

A69/34 Global vaccine action plan

A69/42 Addressing the global shortages of medicines, and the safety and accessibility of children’s

medication

A69/43 Progress reports: Promoting health through the life course: C. Strengthening of palliative

care as a component of comprehensive care throughout the life course

(resolution WHA67.19)

A69/43 Progress reports: Health systems: G. Access to essential medicines (resolution WHA67.22)

A68/36 Progress reports: Health systems: N. Progress in the rational use of medicines

(resolution WHA60.16)

A68/36 Progress reports: Preparedness, surveillance and response: O. Pandemic influenza

preparedness: sharing of influenza viruses and access to vaccines and other benefits

(resolution WHA64.5)

A67/30 Access to essential medicines

A67/31 Strengthening of palliative care as a component of integrated treatment throughout the life

course

A67/32 Regulatory system strengthening

A67/40 Progress reports: Health systems: I. Global strategy and plan of action on public health,

innovation and intellectual property (resolution WHA61.21)

A66/19 Global vaccine action plan

A66/27 Progress reports: Health systems: L. Progress in the rational use of medicines (resolution

WHA60.16)

SEA/RC70/2 The work of the WHO in the South-East Asia Region 2016: Report of the Regional

Director, 1 January–31 December 2016

SEA/RC70/9 Access to medicines

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34

SEA/RC70/13

Rev.1

Progress reports on selected Regional Committee resolutions: antimicrobial resistance

(SEA/RC68/R3)

SEA/RC70/13

Rev.1

Progress reports on selected Regional Committee resolutions: Consultative Expert

Working Group on Research and Development (CEWG): Financing and Coordination

(SEA/RC65/R3)

SEA/RC69/2 The work of the WHO in the South-East Asia Region: Report of the Regional Director,

1 January–31 December 2015

SEA/RC69/9 Antimicrobial resistance

SEA/RC69/13 The Decade for Health Workforce Strengthening in the SEA Region 2015–2024: the first

review of progress, challenges and opportunities

SEA/RC69/18 Progress reports on selected Regional Committee resolutions: 2012: Year of Intensification

of Routine Immunization in the South-East Asia Region: Framework for increasing and

sustaining coverage (SEA/RC64/R3)

SEA/RC68/2 The work of the WHO in the South-East Asia Region: Report of the Regional Director,

1 January–31 December 2014

SEA/RC68/11 Policy and technical topics: Antimicrobial resistance

SEA/RC68/16 Progress reports on selected Regional Committee resolutions: Effective management of

medicines (SEA/RC66/R7)

SEA/RC67/2 The work of the WHO in the South-East Asia Region 2013: Biennial report of the Regional

Director, 1 January 2012–31 December 2013

SEA/RC66/15 Progress reports on selected Regional Committee resolutions: National Essential Drug

Policy Including the Rational Use of Medicines (SEA/RC64/R5)

AFR/RC67/2 The work of WHO in the African Region 2016–2017: Biennial report of the Regional

Director

AFR/RC67/INF.

DOC/1

Progress report on implementation of the Regional Strategic Plan on Immunization

AFR/RC66/2 The work of WHO in the African Region, 2015–2016: Report of the Regional Director –

illustrative report

AFR/RC66/13 Regional Strategy on Regulation of Medical Products in the African Region, 2016–2025

AFR/RC66/19 Sixty-sixth session of the WHO Regional Committee for Africa: Final report

AFR/RC65/2 The work of WHO in the African Region: Biennial report of the Regional Director,

2014–2015

AFR/RC65/14 Sixty-fifth session of the WHO Regional Committee for Africa: Final report

AFR/RC65/INF.

DOC/7

Progress report on the establishment of the African Medicines Agency

AFR/RC64/14 Sixty-fourth session of the WHO Regional Committee for Africa: Final report

AFR/RC63/7 Strengthening the capacity for regulation of medical products in the African Region

AFR/RC63/16 Sixty-third session of the WHO Regional Committee for Africa: Final report

EM/RC64/INF.

DOC.4

Progress report on the implementation of the Eastern Mediterranean vaccine action plan

2016–2020

EM/RC63/3 The work of WHO in the Eastern Mediterranean Region: Annual report of the Regional

Director 2015

EM/RC62/2 The work of WHO in the Eastern Mediterranean Region: Annual report of the Regional

Director 2014

EM/RC61/4 The work of WHO in the Eastern Mediterranean Region: Annual report of the Regional

Director 2013

EM/RC60/2 The work of WHO in the Eastern Mediterranean Region: Annual report of the Regional

Director 2012

Annex EB142/13

35

EM/RC59/2 The work of WHO in the Eastern Mediterranean Region: Annual report of the Regional

Director, 1 January–31 December 2011

WPR/RC67/2 Report of the Regional Director: The work of WHO in the Western Pacific Region

1 July 2015–30 June 2016

WPR/RC67/10 Progress reports on technical programmes: 15.5 Antimicrobial resistance

WPR/RC67/10 Progress reports on technical programmes: 15.6 Essential medicines

WPR/RC66/2 Report of the Regional Director: The work of WHO in the Western Pacific Region

1 July 2014–30 June 2015

WPR/RC66/9 Progress reports on technical programmes: 14.6 Regulatory systems strengthening

WPR/RC64/9 Progress reports on technical programmes: 15.7 Expanded Programme on Immunization

WPR/RC63/11 Progress reports on technical programmes: (7) Expanded Programme on Immunization

EUR/RC67/5 The work of WHO in the European Region in 2016–2017: Interim report of the Regional

Director

EUR/RC67/11 Strengthening Member State collaboration on improving access to medicines in the WHO

European Region

EUR/RC66/5 Moving from vision to action: Report of the Regional Director on the work of WHO in the

European Region in 2014–2015

EUR/RC65/5 Rev.1 The work of WHO in the European Region in 2014–2015: Interim report of the Regional

Director

EUR/RC64/5 Realizing our vision: Report of the Regional Director on the work of WHO in the

European Region in 2012–2013

EUR/RC64/15

Rev.1

European Vaccine Action Plan 2015–2020

EUR/RC64/19 Progress reports: E. The European strategic action plan on antibiotic resistance

EUR/RC63/5 The work of WHO in the European Region in 2012–2013: Interim report of the Regional

Director

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Appendix 3

RECOMMENDATIONS OF THE REPORT OF THE UNITED NATIONS SECRETARY-GENERAL’S HIGH-LEVEL

PANEL ON ACCESS TO MEDICINES 1 AND WHO’S ACTIVITIES IN THE AREA OF ACCESS TO MEDICINES

2. INTELLECTUAL PROPERTY LAWS AND ACCESS TO HEALTH TECHNOLOGIES

No. Recommendation 2

Entities

concerned 3

WHO’s activities, including those carried out in collaboration

with WTO and WIPO

2.6.1

World Trade Organization (WTO) Members should commit

themselves, at the highest political levels, to respect the letter

and the spirit of the Doha Declaration on TRIPS and Public

Health, refraining from any action that will limit their

implementation and use in order to promote access to health

technologies.

WTO

Members

• WHO provides technical support to countries to build capacity to develop and implement intellectual property policies and

management, including guidance on how to develop

health-sensitive patent legislation and patentability standards.

• On request, WHO also provides technical support to countries to improve access to affordable medicines, including through the

use of the flexibilities provided in the Agreement on

Trade-Related Aspects of Intellectual Property Rights

(TRIPS Agreement).

• WHO also supports initiatives to increase access to patent information.

• The Directors-General of WHO, WIPO and WTO have established a trilateral cooperation arrangement that includes

annual symposia and training workshops 4 and a trilateral study on

promoting access to medical technologies and innovation, 5 which

1 Report of the United Nations Secretary-General’s High-level Panel on Access to Medicines: promoting innovation and access to health technologies. Geneva: United Nations

High-Level Panel on Access to Health Technologies; 2016 (http://www.unsgaccessmeds.org/final-report, accessed 20 December 2017).

2 As stated in the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines.

3 As specified in the recommendation of the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines.

4 For further information, see http://www.wipo.int/policy/en/global_health/events.html (accessed 25 October 2017).

5 Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade. Geneva: World Health Organization, World Intellectual

Property Organization, World Trade Organization; 2013 (http://www.who.int/phi/promoting_access_medical_innovation/en/, accessed 25 October 2017).

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is available in all six official United Nations languages, as well as

an online course.

• WHO has published a range of guidance documents, including: Global report on access to hepatitis C treatment: focus on

overcoming barriers 1 (2016); The role of intellectual property in

local production in developing countries: opportunities and

challenges 2 (2016); Increasing access to HIV treatment in

middle-income countries: key data on prices, regulatory status,

tariffs and the intellectual property situation 3 (2014); Using

TRIPS flexibilities to improve access to HIV treatment 4 (2011);

and Guidelines for the examination of pharmaceutical patents:

developing a public health perspective 5 (2007).

• WHO contributed to the consideration of the report of the High-level Panel on Access to Medicines by WTO Members at

the WTO TRIPS Council meetings in November 2016 and

March 2017.

2.6.1.(a)

WTO Members must make full use of the policy space

available in Article 27 of the TRIPS Agreement by adopting

and applying rigorous definitions of invention and

patentability that curtail the evergreening to ensure that

patents are only awarded when genuine innovation has

occurred.

WTO

Members

• WHO provides technical support to countries to build capacity to develop and implement intellectual property policies and

management, including guidance on how to develop

health-sensitive patent legislation and patentability standards.

• On request, WHO provides technical support to countries to improve access to affordable medicines, including through the

use of the flexibilities provided in the TRIPS Agreement, and

1 Global report on access to hepatitis C treatment: focus on overcoming barriers. Geneva: World Health Organization; 2016 (http://apps.who.int/iris/bitstream/10665/250625/1/WHO-

HIV-2016.20-eng.pdf?ua=1, accessed 25 October 2017).

2 The role of intellectual property in local production in developing countries: opportunities and challenges. Geneva: World Health Organization; 2016

(http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-challenges.pdf, accessed 23 October 2017).

3 Increasing access to HIV treatment in middle-income countries: key data on prices, regulatory status, tariffs and the intellectual property situation. Geneva: World Health

Organization; 2014 (http://www.who.int/phi/publications/WHO_Increasing_access_to_HIV_treatment.pdf?ua=1, accessed 25 October 2017).

4 Using TRIPS flexibilities to improve access to HIV treatment. Joint United Nations Programme on HIV/AIDS, United Nations Development Programme, World Health Organization;

2011 (http://apps.who.int/medicinedocs/documents/s18392en/s18392en.pdf, accessed 25 October 2017).

5 Guidelines for the examination of pharmaceutical patents: developing a public health perspective. International Centre for Trade and Sustainable Development, United Nations

Conference on Trade and Development, World Health Organization; 2007 (http://apps.who.int/medicinedocs/documents/s21419en/s21419en.pdf, accessed 25 October 2017).

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guidance on how to negotiate trade agreements insofar as they

have an impact on public health.

• WHO has provided technical support and training to numerous countries and regions over the past 10 years.

1

• WHO also supports initiatives to increase access to patent information.

• WHO has published a range of guidance documents, including: The role of intellectual property in local production in developing

countries: opportunities and challenges 2 (2016); Promoting access

to medical technologies and innovation: intersections between

public health, intellectual property and trade 3 (2013); and

Guidelines for the examination of pharmaceutical patents:

developing a public health perspective 4 (2007).

2.6.1.(a)(i)

The United Nations Conference on Trade and Development

(UNCTAD), the United Nations Development Programme

(UNDP), the World Health Organization (WHO), the World

Intellectual Property Organization (WIPO) and the World

Trade Organization (WTO) should cooperate with one another

and with other relevant bodies with the requisite expertise to

support governments to apply public health-sensitive

patentability criteria.

UNCTAD,

UNDP, WHO,

WIPO, WTO

• The International Centre for Trade and Sustainable Development, UNCTAD and WHO have developed the following guidance for

the examination of pharmaceutical patents: The role of

intellectual property in local production in developing countries:

opportunities and challenges 5 (2016).

• A WHO/WIPO/WTO technical workshop on patentability criteria was held in 2015.

• WHO and UNCTAD submitted a grant proposal to UNITAID in 2017 to expand work in this area.

1 For further information, see an overview on technical cooperation programmes relating to the implementation of the TRIPS Agreement

(http://www.who.int/phi/wto_communications/en/, accessed 25 October 2017).

2 The role of intellectual property in local production in developing countries: opportunities and challenges. Geneva: World Health Organization; 2016

(http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-challenges.pdf, accessed 23 October 2017).

3 Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade. Geneva: World Health Organization, World Intellectual

Property Organization, World Trade Organization; 2013 (http://www.who.int/phi/promoting_access_medical_innovation/en/, accessed 25 October 2017).

4 Guidelines for the examination of pharmaceutical patents: developing a public health perspective. International Centre for Trade and Sustainable Development, United Nations

Conference on Trade and Development, World Health Organization; 2007 (http://apps.who.int/medicinedocs/documents/s21419en/s21419en.pdf, accessed 25 October 2017).

5 The role of intellectual property in local production in developing countries: opportunities and challenges. Geneva: World Health Organization; 2016

(http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-challenges.pdf, accessed 23 October 2017).

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2.6.1.(a)(ii)

These multilateral organizations should strengthen the

capacity of patent examiners at both national and regional

levels to apply rigorous public health-sensitive standards of

patentability taking into account public health needs.

UNCTAD,

UNDP, WHO,

WIPO, WTO

• On request, WHO provides technical support to countries to build capacity to develop and implement intellectual property policies

and management, including guidance on how to develop

health-sensitive patent legislation and patentability standards.

• On request, WHO provides technical support to countries to improve access to affordable medicines, including through the

use of the flexibilities provided in the TRIPS Agreement, and in

negotiations of relevant chapters of free trade agreements.

• WHO also supports initiatives to increase access to patent information.

• The International Centre for Trade and Sustainable Development, UNCTAD and WHO have developed the following guidance for

the examination of pharmaceutical patents: The role of

intellectual property in local production in developing countries:

opportunities and challenges 1 (2016).

2.6.1.(b)

Governments should adopt and implement legislation that

facilitates the issuance of compulsory licenses. Such

legislation must be designed to effectuate quick, fair,

predictable and implementable compulsory licenses for

legitimate public health needs, and particularly with regards to

essential medicines. The use of compulsory licensing must be

based on the provisions found in the Doha Declaration and the

grounds for the issuance of compulsory licenses left to the

discretion of governments.

Governments

• On request, WHO provides technical support to countries to improve access to affordable medicines, including through the

use of the flexibilities provided in the TRIPS Agreement, and in

negotiations of relevant chapters of free trade agreements.

• WHO has published the following guidance on implementing the flexibilities contained in the TRIPS Agreement: Promoting access

to medical technologies and innovation: intersections between

public health, intellectual property and trade 2 (2013).

• An annual Geneva-based training workshop has been organized in collaboration with WIPO and WTO (the WTO annual

Workshop on Trade and Public Health).

1 The role of intellectual property in local production in developing countries: opportunities and challenges. Geneva: World Health Organization; 2016

(http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-challenges.pdf, accessed 23 October 2017).

2 Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade. Geneva: World Health Organization, World Intellectual

Property Organization, World Trade Organization; 2013 (http://www.who.int/phi/promoting_access_medical_innovation/en/, accessed 25 October 2017).

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• WHO has also published the following guidance: Guide for the

application and granting of compulsory licenses and authorization

of government use of pharmaceutical patents 1 (2009); and

Remuneration guidelines for non-voluntary use of a patent on

medical technologies 2 (2005).

2.6.1.(c)

WTO Members should revise the paragraph 6 decision in

order to find a solution that enables a swift and expedient

export of pharmaceutical products produced under

compulsory license. WTO Members should, as necessary,

adopt a waiver and permanent revision of the TRIPS

Agreement to enable this reform.

WTO

Members

• At the TRIPS Council meeting on 30 January 2017,

WTO Members took note of the entry into force of the amended

TRIPS Agreement. They also requested capacity-building to

make the compulsory licensing system work effectively as a

procurement tool.

2.6.1.(d)

Governments and the private sector must refrain from explicit

or implicit threats, tactics or strategies that undermine the

right of WTO Members to use TRIPS flexibilities. Instances

of undue political and commercial pressure should be

formally reported to the WTO Secretariat during the Trade

Policy Review of Members. WTO Members must register

complaints against undue political and economic pressure, and

take punitive measures against offending Members.

Governments

and the private

sector

• NA

2.6.1.(e)

Governments engaged in bilateral and regional trade and

investment treaties should ensure that these agreements do not

include provisions that interfere with their obligations to fulfil

the right to health. As a first step, they must undertake public

health impact assessments. These impact assessments should

verify that the increased trade and economic benefits are not

endangering or impeding the human rights and public health

obligations of the nation and its people before entering into

Governments

• WHO advocates for and provides support to countries to align health, development and trade policies with one another and

provides technical support on request in collaboration with other

relevant United Nations entities.

• WHO has published the following guides: Trade and health: towards building a national strategy

3 (2015), which provides

guidance on how to harness and maximize opportunities to

promote public health and minimize the risks and threats of trade

1 Guide for the application and granting of compulsory licences and authorization of government use of pharmaceutical patents. Geneva: World Health Organization; 2009

(http://apps.who.int/medicinedocs/documents/s19902en/s19902en.pdf, accessed 25 October 2017).

2 Remuneration guidelines for non-voluntary use of a patent on medical technologies. Geneva: World Health Organization; 2005

(http://www.who.int/hiv/amds/WHOTCM2005.1_OMS.pdf, accessed 25 October 2017).

3 Trade and health: towards building a national strategy. Geneva: World Health Organization; 2015 (http://apps.who.int/iris/bitstream/10665/183934/1/9789241565035_eng.pdf?ua=1,

accessed 25 October 2017).

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commitments. Such assessments should inform negotiations,

be conducted transparently and made publicly available.

policies; and Public health related TRIPS-plus provisions in

bilateral trade agreements: a policy guide for negotiators and

implementers in the WHO Eastern Mediterranean Region 1

(2010).

2.6.2.(a)

Public funders of research must require that knowledge

generated from such research be made freely and widely

available through publication in peer-reviewed literature and

seek broad, online public access to such research.

Public funders

of research

• In May 2017, 20 funders and nongovernmental organizations made a commitment to implement WHO standards on

dissemination of research results. 2 These entities have made a

commitment to develop a publicly available policy, making

specific framework commitments on research registration,

methods and results disclosure, and embedding dissemination

standards as a quality criterion for future grant-funding decisions.

2.6.2.(b)

Universities and research institutions that receive public

funding must prioritize public health objectives over financial

returns in their patenting and licensing practices. Such

practices may include publication, non-exclusive licensing,

donations of intellectual property and participation in public

sector patent pools, among others. Sufficient incentives must

be in place in these practices to make it attractive for

developers to underwrite the cost of bringing a product to

market at affordable prices that ensure broad availability.

Universities

and research

institutions

• Universities Allied for Essential Medicines is publishing scorecards that provide transparency on performance of

universities on prioritization of public health objectives.

Following input from WHO, Universities Allied for Essential

Medicines has included research results metrics in its scorecard.

2.6.2.(c)

Universities and research institutions that receive public

funding should adopt policies and approaches that catalyse

innovation and create flexible models of collaboration that

advance biomedical research and generate knowledge for the

benefit of the public.

Universities

and research

institutions

• Universities Allied for Essential Medicines is publishing scorecards that provide transparency on performance of

universities on prioritization of public health objectives.

Following input from WHO, Universities Allied for Essential

Medicines has included research results metrics in its scorecard.

1 Public health related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and implementers in the WHO Eastern Mediterranean Region. Cairo: World

Health Organization Regional Office for the Eastern Mediterranean; 2010 (http://apps.who.int/medicinedocs/documents/s21391en/s21391en.pdf, accessed 23 October 2017).

2 For further information, see the joint statement on public disclosure of results from clinical trials (http://www.who.int/ictrp/results/jointstatement/en/, accessed 27 October 2017).

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NEW INCENTIVES FOR RESEARCH AND DEVELOPMENT OF HEALTH TECHNOLOGIES

No. Recommendation 1

Entities

concerned 2

WHO’s activities

3.4.(a)

It is imperative that governments increase their current levels

of investment in health technology innovation to address

unmet needs.

Governments

• WHO will continue research and development prioritization efforts through the Global Observatory on Health Research and

Development, the research and development blueprint for action

to prevent epidemics and the global priority list of

antibiotic-resistant bacteria to guide research, discovery, and

development of new antibiotics. 3

• WHO is in the process of establishing an Expert Committee on Health Research and Development, which will provide technical

advice on the prioritization of health research and development

that, if sufficiently funded, will help to address the current

underfunding in research and development for areas of critical

unmet needs.

3.4.(b)

Stakeholders, including governments, the biomedical

industry, institutional funders of health care and civil society,

should test and implement new and additional models for

financing and rewarding public health research and

development (R&D), such as the transaction taxes and other

innovative financing mechanisms.

Governments,

the biomedical

industry,

institutional

funders of

health care

and civil

society

• The Consultative Expert Working Group on Research and Development: Financing and Coordination has provided

overarching guidance on this work.

• WHO and the Drugs for Neglected Diseases initiative have established the Global Antibiotic Research & Development

Partnership and WHO has supported the creation of the Coalition

for Epidemic Preparedness Innovations.

1 As stated in the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines.

2 As specified in the recommendation of the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines.

3 Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. Geneva: World Health Organization; 2017

(http://www.who.int/medicines/publications/global-priority-list-antibiotic-resistant-bacteria/en/, accessed 22 November 2017).

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3.4.(c)

Building on current discussions at the WHO, the United

Nations Secretary-General should initiate a process for

governments to negotiate global agreements on the

coordination, financing and development of health

technologies. This includes negotiations for a binding R&D

Convention that delinks the costs of research and

development from end prices to promote access to good

health for all. Such a Convention should focus on public

health needs, including but not limited to, innovation for

neglected tropical diseases and antimicrobial resistance and

must complement existing mechanisms.

United

Nations

Secretary-

General

• The Consultative Expert Working Group on Research and Development: Financing and Coordination recommended the

development of a research and development treaty in 2012.

• WHO will continue research and development prioritization efforts through the Global Observatory on Health Research and

Development, the research and development blueprint for action

to prevent epidemics and the global priority list of

antibiotic-resistant bacteria to guide research, discovery, and

development of new antibiotics.

• WHO is in the process of establishing an Expert Committee on Health Research and Development, which will provide technical

advice on the prioritization of health research and development

that, if sufficiently funded, will help to address the current

underfunding in research and development for areas of critical

unmet needs.

3.4.(d)

As a preparatory step, governments should form a Working

Group to begin negotiating a Code of Principles for

Biomedical R&D. The Principles would apply to public R&D

funds and should also be adopted by private and philanthropic

funders, product development partnerships, universities, the

biomedical industry and other stakeholders. Governments

should report annually on their progress in negotiating and

implementing a Code of Principles as a preparatory step to

negotiating the Convention in the United Nations General

Assembly.

Governments

• WHO support for the definition of the scope and requirements needed for the development of a code of principles for biomedical

research and development is currently under consideration.

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GOVERNANCE, ACCOUNTABILTY AND TRANSPARENCY

No. Recommendation 1

Entities

concerned 2

WHO’s activities

4.3.1.(a)

Governments must review the situation of access to health

technologies in their countries in light of human rights

principles and States’ obligations to fulfil them, with

assistance from the Office of the United Nations High

Commissioner for Human Rights (OHCHR) and other

relevant United Nations entities. The results of these

assessments should be made publicly available. Civil

society should be financially supported to submit their

own shadow reports on innovation and access to health

technologies. Such national reviews should be repeated at

regular intervals.

Governments NA

4.3.1.(b)

Governments should strengthen national level policy and

institutional coherence between trade and intellectual

property, the right to health and public health objectives by

establishing national inter-ministerial bodies to coordinate

laws, policies and practices that may impact on health

technology innovation and access. Appropriate member/s

of the national executive who can manage competing

priorities, mandates and interests should convene such

bodies. The deliberations and decisions of such groups

should operate with a maximum of transparency. Civil

society should be financially supported to participate and

submit their shadow reports on innovation and access to

health technologies.

Governments

• WHO advocates for and provides support to countries to align health, development and trade policies with one another. In that

connection, WHO has published the following guidelines for

negotiators and implementers on TRIPS-plus provisions: Public

health related TRIPS-plus provisions in bilateral trade

agreements: a policy guide for negotiators and implementers in

the WHO Eastern Mediterranean Region 3 (2010).

• Training activities that WHO organizes or to which it contributes, such as the WTO annual Workshop on Trade and Public Health,

call for a holistic, coherent and inclusive approach that is based

on coordination among all competent government departments.

1 As stated in the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines.

2 As specified in the recommendation of the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines.

3 Public health related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and implementers in the WHO Eastern Mediterranean Region. Cairo: World

Health Organization Regional Office for the Eastern Mediterranean; 2010 (http://apps.who.int/medicinedocs/documents/s21391en/s21391en.pdf, accessed 23 October 2017).

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4.3.2.(a)

The United Nations Secretary-General should establish an

independent review body tasked with assessing progress

on health technology innovation and access. Challenges

and progress on innovation and access to health

technologies under the ambit of the 2030 Agenda, as well

as progress made in implementing the recommendations of

this High-Level Panel, should be monitored by this body.

Membership should comprise of representatives from

United Nations and multilateral organizations, civil

society, governments, academia and the private sector.

United

Nations

Secretary-

General

NA

4.3.2.(b)

The United Nations Secretary-General should establish an

inter-agency taskforce on health technology innovation

and access. This taskforce, operating for the duration of

the SDGs, should work toward increasing coherence

among United Nations entities and relevant multilateral

organizations like the WTO. The taskforce, charged with

overseeing the implementation of the High-Level Panel’s

recommendations, should be coordinated by the United

Nations Development Group and report annually to the

United Nations Secretary-General on progress made in

enhancing United Nations system-wide coherence.

United

Nations

Secretary-

General

Extensive cooperation between WTO and the other relevant United

Nations entities is already in place, including an annual coordination

meeting that is convened by WHO as the United Nations specialized

agency for health.

4.3.2.(c)

The United Nations General Assembly should convene a

Special Session no later than 2018 on health technology

innovation and access to agree on strategies and an

accountability framework that will accelerate efforts

towards promoting innovation and ensuring access as set

out in the 2030 Agenda. Civil society should be financially

supported to participate and submit their reports on

innovation and access to health technologies at this Special

Session.

United

Nations

Secretary-

General

NA

4.3.3.(a)

Biomedical private sector companies involved in health

technology innovation and access should report, as part of

their annual reporting cycle, on actions they have taken

that promote access to health technologies.

Biomedical

private sector

companies

• WHO will continue research and development prioritization efforts through the Global Observatory on Health Research and

Development, the research and development blueprint on action

to prevent epidemics and the global priority list of

antibiotic-resistant bacteria to guide research, discovery, and

development of new antibiotics.

• WHO is in the process of establishing an Expert Committee on Health Research and Development, which will provide technical

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advice on the prioritization of health research and development

that will assist in outlining a comprehensive set of needs as

targets for needs-driven research and development. This could

form the basis for reporting by companies on how their actions

are related to global health research and development needs.

4.3.3.(b) Private sector companies should implement the following: Private sector

companies NA

4.3.3.(b)(i)

A publicly available policy on their contribution to

improving access to health technologies setting out general

and specific objectives, timeframes, reporting procedures

and lines of accountability; and

Private sector

companies NA

4.3.3.(b)(ii)

A governance system that includes direct board-level

responsibility and accountability on improving access to

health technologies.

Private sector

companies NA

4.3.4.(a)

Governments should require manufacturers and

distributors of health technologies to disclose to drug

regulatory and procurement authorities information

pertaining to:

Governments NA

4.3.4.(a)(i)

The costs of R&D, production, marketing and distribution

of health technology being procured or given marketing

approval with each expense category separated; and

Governments • WHO advocates for increased transparency regarding the costs of

research and development and production.

4.3.4.(a)(ii)

Any public funding received in the development of the

health technology, including tax credits, subsidies and

grants.

Governments • WHO advocates for increased transparency regarding the costs of

research and development and production.

4.3.4.(b)

Building on the Global Price Reporting Mechanism

(GPRM), V3P and others, WHO should establish and

maintain an accessible international database of prices of

patented and generic medicines and biosimilars in the

private and public sectors of all countries where they are

registered.

WHO

• WHO provides support to maintain existing and develop new platforms for sharing procurement price information, including

the Global Price Reporting Mechanism and the vaccine product,

price and procurement initiative.

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4.3.5.(a)

Governments should require that the unidentified data on

all completed and discontinued clinical trials be made

publicly available in an easily searchable public register

established and operated by existing mechanisms such as

the WHO Clinical Trials Registry Platform,

clinicaltrials.gov or in peer reviewed publications,

regardless of whether their results are positive, negative,

neutral or inconclusive.

Governments

• In May 2017, 20 funders and nongovernmental organizations made a commitment to implement WHO standards on

dissemination of research results. 1 These entities have made

specific framework commitments on research registration,

methods and results disclosure, and on embedding dissemination

standards as a quality criterion for future grant-funding decisions.

WHO advocates that all public sector funders of clinical trials

sign the WHO joint statement on public disclosure of results from

clinical trials.

4.3.5.(b)

To facilitate open collaboration, reconstruction and

reinvestigation of failures, governments should require

that study designs and protocols, data sets, test results and

anonymity-protected patient data be available to the public

in a timely and accessible fashion. Those undertaking

clinical trials must not prevent researchers from publishing

their findings.

Governments

• WHO advocates for all funders of research and development to align their reporting of clinical trial results with WHO standards.

• In May 2017, WHO called for access to methods (in the form of protocols) to be made available at the time of results disclosure in

order to assess outcome switching.

• WHO is initiating a mapping process of the status of individual participant data sharing from clinical trials as a basis for agreeing

on a set of global standards in this area. One focus of the process

is to ensure that developing country perspectives are fully

addressed in the development of WHO standards.

4.3.6.(a)

Governments should establish and maintain publicly

accessible databases with patent information status and

data on medicines and vaccines. This information should

be periodically updated and consolidated by WIPO in

collaboration with stakeholders to develop an international,

easily searchable database which should include:

 standard international common names for biological products;

 international non-proprietary names for products, either as known at the time of application or after the

granting of a patent; and

 dates of grant and expiry.

Governments

• WHO supports efforts to establish and maintain publicly accessible databases containing patent information.

• WHO has published patent information on the treatment for hepatitis C and other treatments, including for noncommunicable

diseases.

• WHO has published the following guidelines for conducting patent searches: How to conduct patent searches for medicines: a

step-by-step guide 2 (2010).

1 For further information, see the Joint statement on public disclosure of results from clinical trials (http://www.who.int/ictrp/results/jointstatement/en/, accessed 27 October 2017).

2 How to conduct patent searches for medicines: a step-by-step guide. World Health Organization Regional Office for South-East Asia and Regional Office for the Western Pacific;

2010 (http://apps.who.int/medicinedocs/documents/s17398e/s17398e.pdf, accessed 25 October 2017).

NA: not applicable.

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Appendix 4

ENTITIES THAT CARRY OUT WORK ON ACCESS TO MEDICINES 1

WHO collaborating centres 2

– WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance (Ghana)

– WHO Collaborating Centre for Antimicrobial Resistance (South Africa)

– WHO Collaborating Centre for Biological Standardization (United States of America)

– WHO Collaborating Centre for Clinical Laboratory Standards and Accreditation (United States of America)

– WHO Collaborating Centre for Drug Information (Malaysia)

– WHO Collaborating Centre for Drug Quality Assurance (Australia)

– WHO Collaborating Centre for Drug Quality Assurance (China)

– WHO Collaborating Centre for Drug Statistics Methodology (Norway)

– WHO Collaborating Centre for Evidence Synthesis for Infectious and Tropical diseases (United Kingdom of Great Britain and Northern Ireland)

– WHO Collaborating Centre for Evidence-Based Research Synthesis and Guideline Development (Italy)

– WHO Collaborating Centre for Gonorrhoea and other sexually transmitted infections (Sweden)

– WHO Collaborating Centre for Governance, Transparency and Accountability in the Pharmaceutical Sector (Canada)

– WHO Collaborating Centre for Health Technology (Mexico)

– WHO Collaborating Centre for Health Technology Assessment (Argentina)

– WHO Collaborating Centre for International Drug Monitoring (Sweden)

– WHO Collaborating Centre for International Laboratory for Biological Standards (United Kingdom of Great Britain and Northern Ireland)

– WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity (Canada)

– WHO Collaborating Centre for Medicines Quality Assurance (Singapore)

– WHO Collaborating Centre for Monitoring of Anthelminthic Drug Efficacy for Soil-transmitted Helminthiasis (Belgium)

– WHO Collaborating Centre for Pharmaceutical Policies (Brazil)

– WHO Collaborating Centre for Pharmaceutical Policy (United States of America)

– WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies (Austria)

– WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting (Netherlands)

– WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services (India)

– WHO Collaborating Centre for Prevention and Control of Chronic Respiratory Diseases (Japan)

– WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy (India)

– WHO Collaborating Centre for Quality Assessment in Haematology (United Kingdom of Great Britain and Northern Ireland)

– WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices (Germany)

– WHO Collaborating Centre for Quality Assurance of Medicines (South Africa)

– WHO Collaborating Centre for Rational Use of Medicines (Argentina)

– WHO Collaborating Centre for Regulatory Control of Pharmaceuticals (Malaysia)

1 This list is non-exhaustive.

2 The country of each WHO Collaborating Centre is shown in parentheses.

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– WHO Collaborating Centre for Research and Training in Pharmacoepidemiology (Spain)

– WHO Collaborating Centre for Research on Bioequivalence Testing of Medicines (Germany)

– WHO Collaborating Centre for Standardization and Evaluation of Biologicals (Canada)

– WHO Collaborating Centre for Standardization and Evaluation of Biologicals (Japan)

– WHO Collaborating Centre for Standardization and Evaluation of Vaccines (Germany)

– WHO Collaborating Centre for Strengthening Pharmacovigilance Practices (Morocco)

– WHO Collaborating Centre for Training and Policy on Access to Pain Relief (India)

– WHO Collaborating Centre for Training and Research in Essential Medicines and Rational Use of Medicines (India)

– WHO Collaborating Centre for Training on Medical Product Registration and Regulation (Tunisia)

Partners and non-State actors in official relations with WHO

– Bill & Melinda Gates Foundation

– Council on Health Research for Development

– Drugs for Neglected Diseases initiative

– Global Diagnostic Imaging

– Healthcare IT and Radiation Therapy Trade Association

– Ecumenical Pharmaceutical Network

– Foundation for Innovative New Diagnostics

– Health Technology Assessment International

– Interagency Pharmaceutical Coordination Group

– International Alliance for Biological Standardization

– International Association for Hospice and Palliative Care Inc.

– International Association for the Study of Pain

– International Diabetes Federation

– International Insulin Foundation

– International Network for Cancer Treatment and Research

– International Pharmaceutical Federation, Foundation for Appropriate Technologies in Health

– International Union Against Tuberculosis and Lung Disease

– International Union of Basic and Clinical Pharmacology

– Knowledge Ecology International

– Medicines for Europe

– Medicines for Malaria Venture

– Medicines Patent Pool Foundation

– Médecins Sans Frontières International

– Organisation for Economic Co-operation and Development

– OXFAM

– Public Services International

– Stichting Health Action International

– South Centre

– The Commonwealth Pharmacists Association

– The GAVI Alliance

– The Global Fund to Fight AIDS, Tuberculosis and Malaria

– The Save the Children Fund

– The Worldwide Hospice Palliative Care Alliance

– Union for International Cancer Control

– United States Agency for International Development

– World Hepatitis Alliance

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Bodies of the United Nations system and related organizations

– UNCTAD

– UNDP

– UNFPA

– UNHCR

– UNICEF

– UNIDO

– UNITAID

– United Nations Office for Project Services

– UNODC

– World Bank

– WIPO

– WTO

= = =