Global Health Issue: Access to Medicines

Hiroki Nakatani, MD, PhDBoard member, NCGM,Chair, Global Health Innovative Technology Fund

As an advisor

As a board member

As a teacher

1. Why CommunicableDiseases is stillimportant in GlobalHealth ?

2. Why Access to Medicine (ATM) matters in Global Health ?

3. Can Japan form Triple Win Global Health ?

Ten Great Public Health Achievements-Worldwide（2001-2010)

1. Reductions in Child Mortality

2. Vaccine-Preventable Diseases

3. Access to Safe Water and Sanitation

4. Malaria Prevention and Control

5. Prevention and Control of HIV/AIDS

6. Tuberculosis Control

7. Control of Neglected Tropical Diseases

8. Tobacco Control

9. Increased Awareness and Response for Improving Global Road Safety

10. Improved Preparedness and Response to Global Health Threats

資料 https://upload.wikimedia.org/wikipedia/commons/2/25/Universal_health_care.svg

Countries that have achieved UHC

UHCとは「すべての人が、適切な健康増進、予防、治療、機能回復に関するサービスを、支払い可能な費用で受けられる」こと

Source: WHO Information Session:Technical Report on Pricing of cancer medicines and its impacts, 25 April 2019

Essential Medicines Cancer Medicines

https://www.google.co.jp/search?q=funding+and+trend+HIV&hl=ja&rlz=1T4SKPT_jaJP396JP397&source=lnms&tbm=isch&sa=X&ved=0ahUKEwjZicOHtu_KAhWMGJQKHTYWA4YQ_AUICCgC&biw=1600&bih=701#imgrc=didzaoxpQ_zL2M%3A

Source; WHO; Global Health Response to HIV 2000-2015, http://apps.who.int/iris/bitstream/10665/198148/1/WHO_HIV_2015.40_eng.pdf

Distribution of HIV+ under Tx

Intensive Investment, Treatment Coverage and its Outcome

2000

2014

Remarkable Success

SourceWHO Media CentreThe top 10 causes of death, Fact sheet N°310, Updated May 2014http://www.who.int/mediacentre/factsheets/fs310/en/

0.8 Billion 2.5 Billion 2.5 Billion

1 Billion 7 Billion

SourceWorld Bank. World Development Indicators. Washington DC, World Bank 2013

8

Mortality/Morbidity Change: Top Ten Causes of Deaths by Income Category and Population

9

Source: World Bankhttps://data.worldbank.org/products/wdi-maps

Graduation from Developing Countries: Richer World（GNI per capita 2015 )

From MDGs to SDGs: More Diverse Global Agenda

From MDGs to SDGs: More Diverse Global Agenda

Cancer

UHC

SDG3

SDGs

Technical PillarNorms/Standard

Political PillarInternational And NationalCommitment

Practical PillarBudgeted National Action Plan

Intellectual Pillar Global Collaboration in Research and M/E

Access to

Medicine (ATM)

General Framework of ATM,UHC, SDGs and Four Pillars for Action

Goal 3: Ensure healthy lives and promote well-being for all at all ages

⚫ By 2030, reduce the global maternal mortality ratio to less than 70 per 100,000 live births

⚫ By 2030, end preventable deaths of newborns and children under 5 years of age, with all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births

⚫ By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases

⚫ By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being

⚫ Strengthen the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol

⚫ By 2020, halve the number of global deaths and injuries from road traffic accidents 3.7 By 2030, ensure universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes

⚫ 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

⚫ By 2030, substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination

⚫ Strengthen the implementation of the World Health Organization Framework Convention on Tobacco Control in all countries, as appropriate

⚫ Support the research and development of vaccines and medicines for the communicable and no communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance withthe Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all

⚫ Substantially increase health financing and the recruitment, development, training and retention of the health workforce in developing countries, especially in least developed countries and small island developing States

⚫ Strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks

産経新聞朝刊 2019年5月22日（水）

High Cost Medicines; Challenges for AllRecent announcement of Kymriah inclusion in Medical Care Insurance

Scheme in Japan

https://www.slideshare.net/MeTApresents/accountability-in-the-medicines-supply-chain

ATM is a very complex issue

1930 Informal Group

2315 Exhausted, Hungry and Terribly Cold

144 th Session of WHO Executive Board ( Jan 2019 )

11 PPs

5 OPs for Member Sates to do:Obligation in accordance with their national and regional legal frameworks and contexts• 1.1 prices and reimbursement• 1.2 human subject clinical trial• 1.3 details of price components• 1.4 Patent• 1.5 open dissemination of research

and know-how

7 OPs for WHO/DG to do:• 2.1 support MS in collecting and

analyzing information on prices• 2.2 support MS in policy

formulation• 2.3 support research and price

monitoring• 2.4 Analyze data• 2.5 Biennial Fair Price Forum• 2.6 Dissemination of patent status• 2.7 Report to 74th WHA in 2021

through EB 148 in Jan 2021

Intellectual Property Right

TRIPS

De-Link R/D Cost and Price

LIC/MIC’s View

HIC’s approach

Industry’s Approach

GHIT and Other PDPUNITAID

Government with ODA SupportGovernment,Industries NGOs

Few Examples of Best Practices

1. R&D2. De-Link of R&D cost and Price3. Patent Management → Work of MPP

( Mr.Charles Gore )4. Norm/Standard/Global Strategy: Global

Health Policy Cycle5. Access Accelerated : Industry’ s

List of type III, II, and I diseases based on Global Burden of Disease data

Source• Table:http://www.thelancet.com/pdfs/journals/lancet/PIIS0140

-6736(13)61046-6. • Concept:http://www.who.int/phi/3-

background_cewg_agenda_item5_disease_types_final.pdfpdf

Type I: 0.0 - < 3.0 i.e. the disease burden is approximately the same and no more than 3 timeshigher in low/middle income countries than high income countries

Type II: > 3.0 < 35.0 the disease burden is at a rate that is between 3.0–35.0 times higher inlow/middle income countries than in a high income

country. Type III: > 35.0 the disease burden is at a rate that is at least 35.0 times and up to more than a1000 times higher than is recorded in high income countries.

continue

Global R&D Panorama*(Lancet Rottingen論文の骨子）

• Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion.

• Of the US$214 billion (90%) invested in high-income countries

– 60% of health R&D investments came from the business sector

– 30% from the public sector

– about 10% from other sources (including private non-profit organizations.

– Only about 1% of all health R&D investments were allocated to neglected diseases in 2010..

• Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries.

• Conclusion

– Substantial gaps in the global landscape of health R&D remain, especially for and in low-income and middle-income countries.

– Too few investments are targeted towards the health needs of these countries.

– Better data are needed to improve priority setting and coordination for health R&D.

• Recommendation

– Ultimately to ensure that resources are allocated to diseases and regions where they are needed the most. The establishment of a global observatory on health R&D, which is being discussed at WHO, could address the absence of a comprehensive and sustainable mechanism for regular global monitoring of health R&D.

*source.:John-Arne Røttingen, Sadie Regmi, Mari Eide, Alison J Young, Roderik F Viergever, Christine Årdal, Javier Guzman, Danny Edwards, Stephen A Matlin, Robert F Terry: Mapping of available health research and development data:what’s there, what’s missing, and what role is there for a global observatory? Lancet 2013; 382: 1286–307

Source: https://msfaccess.org/our-wishlist-2019

MSF’s Wish List for R&D 2019

グローバルヘルス技術振興基金

R&D for NTD,TB andMalaria

International PPP Investments

Patent Management

23

Global Health Cycle- a case of HIV -

Global Consensus

Norm/

Standard

Global Strategy/

Action Plan

Resource

Mobilization

Monitoring

Eg; HIV UN Special Session 2001

WHO Treatment Guidelines

Treatment Targets WHO in consultation

with stakeholders

Financial and Technical Support for LICs

Annual Publication of Progress by UNAIDS and WHO

http://www.accessaccelerated.org/

+20 Big R&D Pharmas

https://accesstomedicineindex.org/overall-ranking/

Access toMedicine Index

NTDを中心とする途上国疾

患対応医薬品のアクセス向上への貢献をランキングしたもの

GHIT Fund | Management Team | 27

Contributions from pharmaceutical industry to combating NTDs

https://www.who.int/neglected_diseases/Medicine-donation-04-march-2019.pdf?ua=1

Company Medicine Commitment

Bayer

nifurtimox 2014–2019

nifurtimox 2012–2021

suramin Until November 2020

Eisaidiethylcarbamazine citrate (DEC)*

(100 mg scored tablets) in combination with albendazole

Seven-year period

2014–2020

EMS (Brazil) azithromycin 2018–2022

Gilead Sciences, Inc. liposomal amphotericin B (lyophilized 50 mg formulation) 2017–2020

GlaxoSmithKline albendazole (400 mg tablet)Since 1997 until the target of global elimination of

lymphatic filariasis is achieved Initial five-year period 2012–2016

Johnson & Johnson mebendazole (500 mg tablet) Initial five-year period 2012–2016

Merck praziquantel (600 mg tablet)Initial 10-year period 19 April 2007 – 19 April 2017

2017 for an unlimited period

Merck Sharp &

Dohme (MSD)ivermectin (3 mg tablet)

Since 1987 until the elimination of onchocerciasis in WHO’s African, Americas and Eastern

Mediterranean regions

Since 1997 until the elimination of lymphatic filariasis in Yemen and African countries where

lymphatic filariasis and onchocerciasis are coendemic

Novartis

multidrug therapy (rifampicin, clofazimine, dapsone) in blister packs

Loose clofazimine in capsules

2000-2020

2000-2020

triclabendazole 2016–2022

Pfizer azithromycin 1998–2020

Sanofi

eflornithine Until 2020

melarsoprol Until 2020

pentamidine Until 2020

GHIT Fund | Management Team | 28

Conclusion: Why does Japan engage global health?

Make healthier and

wealthier world

Be responsible as a

developed and

peaceful nation

Catalyze economic

revitalization

Devil Cycle vs Angel Cycle

New Social Model

International Partnership

Global

Standard

Health Care

Healthy

Longevity

Outbound Medicine and Products

Harmonizing Drug Regulation

International Clinical Trials

Global Health as a focal area of Economic Revitalization under Abe Cabinet: 3 Flagship Initiatives

30

SDGs Acceleration HQ chaired by PM Abe

Canada G7 2018Argentina G20 2018

France G7, August 25–27, 2019