The Challenge and Exploration of Children's Access to Medicines in BRICS Countries from the View of Achieving the MDGs: Taking China for Example ...
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The Challenge and Exploration of Children’s
Access to Medicines in BRICS Countries
from the View of Achieving the MDGs:
Taking China for Example
Lingli Zhang
West China Second University Hospital, Sichuan University
Chinese Evidence-based Medical Centre
INRUD, China
BRICS Medicines Alliance
2 Content The Millennium Development Goals Our efforts Recommendations
3 The MDGs and challenge of children’s access to medicines In 2000, 8 Millennium Development Goals were agreed by country leaders from 189 countries at the UN Millennium Summit The 4th Goal: Reduce child mortality by two thirds
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The progress and gap of the MDGs:Goal 4
15
Developed regions
6
99
Developing regions
53
81
BRICS countries
32
0 20 40 60 80 100 120
1990 2013 2015 target
Source: 1.United Nation. The Millennium Development Goals Report 2014. 2, UN data. http://data.un.
org/Default.aspx.2.
5
5
DALYs(Disability-adjusted life years) of
different ages in global
Source: Institute for Health Metrics and Evaluation (IHME).GBD Cause Patterns. Seattle, WA: IHME, University of
Washington, 2013
6 WHO proposes • Reaching the MDGs on reducing child mortality requires universal coverage with effective and affordable interventions • Medicine is one of the most important measures • Rational medicine treatment and prevention could avoid 8.1 million children under 5 years old from death each year Source：1.WHO.Target 4.A: Reduce by two thirds, between 1990 and 2015, the under-five mortality rate. http:/ /www.who.int /topics /millennium _development _goals/child_mortality/en/. 2. Levels & Trends in Child Mortality, Report 2014. The UN Inter-agency Group for Child Mortality Estimation. http://www.unicef.org/media /files/ Levels_and_Trends_in_Child_Mortality_2014.pdf
7 The current situation of children’s access to medicines • Lack of medicines exclusive for children:Many medicines for priority diseases are not developed for children; and when they are they are not reaching the children who need them most • Lack of children appropriate dosages and specifications: Medical staffs and guardians of children tend to use reduced-dose adult medicines, as well as crush tablets or dissolve capsules in water to prepare medicines for children • Lack of cost-effectiveness of medicines for children:The few existing paediatric fixed dose combinations developed for children are generally three times more expensive than the adult dosage form China for example: a survey of medicines used in pediatrics in 15 hospitals during 2011-2013 Total:1098,Medicines exclusive for chilidren:45, accounting for 4.1% Source:1.WHO, Background Information: Child-specific medicines, http://www.who.int/childmedicines/edia/ backgrounder/BG1/en/. 2.Zhang Lingli,Li Youping et.al, Pediatric Drug Shortage in China: Current Status and Reflection. Chin J Evid-based Med 2012,12(10):1159-1164
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Our efforts
Efforts in promoting children’s access to medicines in China
• 2011 National Program of Action for Child Development in China (2011 -2020)
• 2011 CFDA policy research project:Survey on the suggestion of legislation for packaging for
child medicines
• 2012 Established the new INRUD China Core Centreled by the Director of Medical
Administration of M.O.H., including the investigation on the management of vulnerables.
National actions • 2012 M.O.H. proposed "Healthy China 2020"
• 2013 China National Formulation for Children
• 2014 Proposed resolution of“Access to Essential medicines” to WHA,which was passed
• 2014 6 Ministries issued Several Opinions on Security of Medications in Children
• 2014 Established the Surveillance Network of Antibiotics Use in Children
Multi-department •2012 Symposium on Medication in Children led by the CPPCC, CFDA,MOH and the
State Administration of TCM
coordination • 2014 6 Ministries issued Several Opinions on Security of Medications in Children
•2011 Supplement Medicines Additional Catalogue of Sichuan Province in Primary
Policy support Care to National Essential Medicines
• 2012 National Essential Medicine List added medicines ,dosages and specifications for children
• 2013 CFDA Opinions on Deepening the Reform of Medicine Evaluation and Approval,
Further Encouraging MedicineInnovation
• 2014 Bidding programs of Medicine Policy of M.O.H on policy research of medication in Children:
Technical Support Survey on dosage and administration of children’s essential medicines; Investigation on priorly
encouraging the development of children appropriate dosages and specifications; Comparitive study of
appropriate dosages and specifications of children’s essential medicines at home and abroad
• 2014 Guiding Principles on Research Techniques of Pediatric Population's Pharmacokinetics
• 2014 Technical Guidelines for Clinical Trials of Pediatric Medicines
Continuous • 2014 M.O.H Major Project on Development and Production of New Medicines: children’s diseases
follow-up and • 2015 M.O.H Bidding Subject: Assessment of the Implementation of the WHA Proposal
improvement
9 WHA Resolution: Access to Essential medicines • In 2014, the Resolution of Access to Essential Medicines was proposed and passed at the WHA -Focus on medication in children Urges member states: to place greater emphasis on medicines for children and to promote the availability, affordability, quality and safety of essential medicines for access to these medicineschildren through the development and manufacture of appropriate paediatric formulations and to facilitate market -Highly praised by Margaret Chan, the Director General of the WHO
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2014 Security of Medications in Children
Drug Policy and Essential Medicine System
Department of National Health and Family
Planning Commission
Jointly issued by the National Health and Family
Planning Commission, the National Development Press conference of China Central
and Reform Commission, the Ministry of Industry Television and China National
and Information Technology, the Ministry of
Human Resources and Social Security, CFDA and Radio
the State Administration of TCM and focus on
encouraging R&D, accelerating application and
evaluation, guaranteeing production and supply,
improving the rational use of medicines in children11
Including Children’s Medicines in EML
• 2011, Supplement Medicines Additional Catalogue of Sichuan
to National Essential Medicines
Sichuan Department of Health firstly included 23 medicines and dosage
forms for children (29.5%) in provincial additional catalogue to national
EML
• 2012, National Essential Medicine List added medicines
dosages and specifications for children
-All National Immunization Programme Vaccines for children were
included
-200 medicines are available for children, 70 of which are exclusive dosage
forms and specifications for children
-Alleviated the shortage of children’s medication to some extent
Source:1.The announcement of Sichuan Health Department on publishing National Essential Medicines Sichuan
Province Primary Supplement Medicines Additional Catalogue. 2.National Health and Family Planning Commission
of PRC, the 2012 edition National Essential Medicine List published12
Evaluation of After Effect
• 2015 M.O.H. Bidding Subject: Assessment of the
Implementation of the WHA Proposal
Drug Policy and Essential Medicine
System Department of National Health
and Family Planning Commission
The Bidding of 2015 National Subject of
Drug Policy Department of M.O.H.
Project 7: The Assessment of the Implementation of the WHA Proposal13
National Research Platform for Rational Use of
Medicines in Vulnerables
• International Network for the Rational Use of Drugs (INRUD), China
Zongjiu Zhang, the Director of Medical Administration of M.O.H.,
served as the leader
• In 2012, Medication Management of People with Highest Risk of Drug
Exposure, INRUD, China
Prof. Lingli Zhang served as the group leader
Lead research and evidence production of rational medication in high-
risk people(children, pregnant women and old people) among more than
70 hospitals around China hospitals
14 13 12 13 13
12
9
10
8 6 7
6
4
2
0
April,2012 the conference of INRUD China The distribution of the High-risk People Medication
Management Group members14
Achievements
• What China has achieved by implementing relevant policies Essential
medicine system
-The essential medicine system has covered all government-run primary
medical institutions
-Established new purchasing mechanism for essential medicines
-Promoted the comprehensive reform of primary medical institutions
-The essential medicine system has been extended
-Initially formed the framework of the essential medicine system policies
• Several Opinions on Security of Medications in Children
-Present the first list of development-encouraging medicines for children
(Prof. Lingli Zhang’s team)
-Organize related institutions to investigate pilot children’s medicines, which
can be included into exclusive application and evaluation access, and be
given priority to package insert revision
-Study and improve consensus and guidelines on children’s medication, data
of children’s medication
-The CFDA is set to speed up the approval progress for some kinds of
children’s medicines15 Other BRICS countries • South Africa In 1998，released the first editon of Standard Treatment Guidelines and Essential Drugs List For South Africa Hospital Level Paediatrics, current 2006 edition Within 314 children’s medicines, only 1% is out of reach (3 medicines) • India In 2011,released the first editon of List of Essential Medicines for Children of India,which has not been updated
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The post-2015 sustainable development agenda
• Ensure healthy life,knowledge, and include both
women and children in it
-Eliminate preventable mortality and malnutrition
problems of maternals,neonatals and children
-Ensure the supply of essential medicines
The children’s access to medicines remians a major challenge
Source: UN.The road to dignity by 2030: ending poverty, transforming all lives and protecting the planet.201417 Recommendations Strengthen and expand the after effect of the Social Forum: Continuous attention and further follow-up to vulnerables’ health; Call for national actions among member states to arouse awarenesses Build international coorperation platform for rational use of medicines in vulnerables, focus on developing countries, pay attention to the unredeemed key indicators of the MDGs and key requirements of post- MDG based on the global perspective, produce evidences together, learn and share experiences, including: • Publicize and promote successful national medicine policies； • Provide resources and assistances to countries which need technical support: the development, production, supply of children’s medicine and reevaluation on their rational use • Produce, compose and convert evidence on children’s access to medicines Develop essential medicine list for children separately: to raise attention to medication in children
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Focus access to medicines strategy on developing countries including BRICS
EML
Including Medicines
for Children
Developing countries/regions
Country/Region%：65%
EMLc
Population%：82％
BIRCS
Country/Region%：2.3% EMLc
Population：42％
Source：1 UN. Developing regions：UN:http://unstats.un.org/unsd/methods/m49/m49regin.htm#ftnb.2.
Population Reference Bureau.2014 World Population Data Sheet.19 Poor health means poor policy. —— 2014,Global Symposium on Health Systems Research Good policy promotes good health! ——2015,Social Forum, United Nations “Every year millions of children die from preventable diseases. It’s not simply a cold statistic, they were flesh and blood human being with names.” ——2010, Secretary-general of United Nations Ban Ki-moon Source：United Nations Secretary-General Ban Ki-moon. Global Strategy for Women's and Children's Health. Available at: http://www.un.org/zh/ mdg/summit2010/ pdf/Global%20StategyCH.pdf.
20 Acknowledgment Prof. Youping Li of Chinese Evidence-Based Medicine Center Country leaders of BRICS Medicines Alliance Staffs of OHCHR Research team and colleagues from WCSUH-SCU
21 HAPPY CHINESE NEW YEAR！
22 Welcome to Chengdu, China Hot pot Giant Panda Jiuzhai Valley Face change
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Thanks for your attention
感谢聆听
Lingli Zhang, M.D.
Professor and Director of Pharmacy
West China Second University Hospital, Sichuan University
No.20,Third Section, Renmin Nan Lu, Chengdu, Sichuan, 610041, P.R.China
Fax:+86 28 85501012
E-mail: zhanglingli@scu.edu.cn
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