Lead Authors: Kate Armstrong and Professor Paul Hoffman and Jacinta Sherlock,
Organization: CLAN (Caring & Living As Neighbours) and APPES (the Asia Pacific Paediatric Endocrinology Society).
Country: Australia; New Zealand
*The authors would like to acknowledge members of the APPES-CLAN Equity (ACE) Working Group who assisted not only with the development of this paper but also the actions underpinning the case studies. The deep commitment of these health practitioners to achieving equitable access to medicines and healthcare for the many thousands of children they care for in the Asia Pacific region informed this contribution. We would ask that the expertise, insights and achievements of the grassroots practitioners that is shared in this paper be considered by the High Level Panel members in their deliberations.
This contribution to the United Nations Secretary General’s High-Level Panel (UNSG HLP) on Access to Medicines is respectfully submitted by CLAN (Caring & Living As Neighbours) and APPES (the Asia Pacific Paediatric Endocrinology Society).
CLAN and APPES will speak to the inequitable access to medicines, equipment, diagnostics and health technologies experienced by children and adolescents living with non-communicable diseases (NCDs) in low- and middle-income countries (LMICs) specifically in the Asia Pacific region, and the enormous and preventable morbidity and mortality that results. We offer specific examples relating to children affected by common childhood endocrine NCDs such as Congenital Hypothyroidism (CH), Type 1 Diabetes Mellitus (T1DM), Congenital Adrenal Hyperplasia (CAH) and Osteogenesis Imperfecta (OI) to inform this contribution.
CLAN and APPES invites the UNSG HLP to consider what has been accomplished to date for children living with endocrine conditions and other NCDs through the multisectoral collaborative implementation of CLAN’s strategic framework for action using “the five pillars” (http://www.clanchildhealth.org). This human rights-based, community development approach offers practical solutions for the sustainable and scalable change for children and adolescents living with NCDs in LMICs.
Background to the authors
CLAN is an Australian-based non-government organization (NGO) committed to equity for children and adolescents living with chronic health conditions in resource poor countries. CLAN is formally associated with United Nations Department of Public Information (UNDPI/NGO) and delivered successfully on commitments to the UNSG’s Every Woman Every Child (EWEC) movement. CLAN is founding secretariat and governing council member of global coalition NCD Child (www.ncdchild.org). NCD Child endorses this contribution.
APPES is the peak body for paediatric endocrinology societies in the Asia Pacific region, representing around 500 specialist paediatricians working across almost twenty countries (including Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Korea, Laos, Malaysia, Myanmar, New Zealand, Oman, Pakistan, the Philippines, Singapore, Thailand and Vietnam).
A. Executive Summary
CLAN and APPES respectfully calls upon the UNSG HLP to consider our experiences redressing inequities for children living with endocrine conditions in LMICs of the Asia Pacific region through systematic and collaborative action around childhood NCD community priorities by a range of multisectoral partners.
Our specific recommendations to the UNSG HLP include a request for urgent and high-level support for:
1. Coordinated action towards equitable access to medicines, technologies, diagnostics and healthcare for #EVERYchild living with endocrine conditions and other NCDs. Maslow’s Hierarchy of Needs conceptualises the fundamental importance of affordable access to essential medicines and healthcare if rights to fulfilling lives are to be respected. Urgent humanitarian donations must be secured for those living in LMICs whilst medium and longer term solutions (including local registration of drugs; Universal Health Care and innovative financing mechanisms) are explored;
2. A human rights-based, person-centred and community development approach to improving equity for children living with NCDs in LMICs;
3. Universal newborn screening for Congenital Hypothyroidism in all LMICs;
4. Development of paediatric NCD patient registers and data disaggregation to identify and monitor the actual burden NCDs place on children and families in LMICs; and
5. Encouragement of technology and private sector partners to engage with grassroots childhood NCD communities and practitioners to fast-track change.
B. The rights of EVERY child to access medicines and healthcare
The United Nations Convention on the Rights of the Child (UNCRC)1 recognises the rights of all children to live an individual life in society, raised in the spirit of happiness, love, understanding, peace, dignity, tolerance, freedom, equality and solidarity.
Specifically, UNCRC addresses the rights of children who are living with special health needs such as NCDs and other chronic health conditions (see Table 1). UNCRC affords all children the right to “enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health” and holds the international community responsible for ensuring countries “strive to ensure that no child is deprived of his or her right of access to such health care services”.
Table 1 – The rights of EVERY child to essential medicines and equipment (as outlined by UNCRC)
• Governments shall undertake all appropriate legislative, administrative and other measures for the implementation of the rights recognised in the present Convention ... to the maximum extent of their available resources and where needed, within the framework of international co-operation (Article 4)
• The inherent right to life (Article 6)
• Governments shall ... ensure the development of institutions, facilities and services for your care (Article 18)
• Governments recognise that a child living with a mental or physical disability should enjoy a full and decent life, in conditions which ensure dignity, promote self-reliance and facilitate active participation in the community ... and ensure access to health care services and rehabilitation services… in a manner conducive to achieving the fullest possible social integration and individual development… (and) the right of a child living with a disability (and those responsible for the child) to special care, subject to available resources (Article 23)
• The right to the enjoyment of the highest attainable standard of health and facilities including the provision of necessary medical assistance and health care (Article 24)
• The right to benefit from social security, including social insurance (Article 26)
• The right to a standard of living adequate for physical, mental, spiritual, moral and social development... including through material assistance and support programs (Article 27)
C. Child health inequities in the Asia Pacific region
With the rights of every child so clearly articulated by the UNCRC, the gross inequities experienced by children and adolescents living with endocrine conditions2 and other NCDs3,4 in resource poor settings represents a significant misalignment of policy, public health goals and actions.
Specific examples of this inequity relevant to four major NCDs affecting children and adolescents in the Asia Pacific region are:
i. Congenital Hypothyroidism (CH) – access to diagnostics
CH is the most common inherited endocrine condition of childhood and affects 5.02:10,000 children5. Undiagnosed and untreated, CH results in severe developmental delay (historically called “cretinism”). This outcome is rarely seen anymore in high-income and middle-income countries due to implementation of universal newborn screening (NBS – also called heel-prick testing) and the affordable availability of thyroxine tablets for treatment.
By comparison, in many LMICs of the Asia Pacific region preventable morbidity associated with CH is high. Although thyroxine tablets are relatively affordable and available in all countries, failure to screen EVERY newborn baby in EVERY country for CH6 results in irreversible developmental delay that affects thousands of babies by the time a diagnosis is made. The consequent burden of preventable disability on affected children, families and the economic fabric of their countries is extreme7.
ii. Type 1 Diabetes Mellitus (T1DM) - access to medicines, diagnostics, technologies and health care
It is estimated 100million people globally require insulin (an estimated 490,100 for T1DM)8,9, with around half facing challenges with access. In high-income countries children with T1DM can expect to be diagnosed and managed so that their diabetes does not significantly reduce their lifespan. Secure access to medicines (insulin and glucagon) and new technologies (such as insulin pumps) are reducing the burden on young people and families alike.
For children living in LMICs of the Asia Pacific the experience of T1DM is very different10. Misdiagnoses are frequently fatal (ketoacidosis is commonly mistaken for pneumonia); insulin and glucose monitoring strips are unaffordable and in many cases unavailable; glucagon is unavailable in most LMICs (increasing the risk of fatal hypoglycaemic episodes); and, inequitable access to new technologies is commonplace (eg 30-60% use of insulin pumps by children in Australia versus 0% use in Pakistan). These factors all contribute to the inequitable burden of preventable morbidity and mortality in the region11.
Whilst successful humanitarian aid programs (such as the International Diabetes Federation’s Life For A Child program12) are doing much to reduce mortality, there is a need for strong political will to drive secure, sustainable long-term solutions in-country that will protect and promote the rights of children. Insulin was discovered in 1921 and both insulin and glucagon are included within the World Health Organisation’s Essential Medicines List for Children (WHO EMLc)13, yet misalignment of the rights of inventors and children, trade regulations and public health objectives intensifies inequities.
iii. Congenital Adrenal Hyperplasia (CAH) – access to medicines, diagnostics and healthcare
CAH is the most common adrenal condition of childhood. The incidence of CAH is known to vary significantly (incidence figures of 1:18,000 in the USA and 1:6,000 in the Philippines7 have been established through documented NBS programs). With appropriate maintenance treatment (affordable hydrocortisone and fludrocortisone tablets) and sick day care (hydrocortisone for emergency injection) the life expectancy for children born with CAH in HICs is not reduced.
By comparison, mortality associated with CAH in LMICs in the Asia Pacific is known to be significant and largely attributable to unaffordable access to essential medicines, diagnostics and quality health care. Like insulin, hydrocortisone (tablets and vials for injection) and fludrocortisone are included on the WHO EMLc13, yet this proves little help to health professionals striving to secure local registration and availability. Compounding the issue, high mortality rates reduce prevalence numbers and the demand for drugs remains low. As orphan drugs with competing cheap generics in the market, there is minimal financial incentive for pharmaceutical companies to push ahead with registration of the drugs in-country (often at significant cost to have a portfolio approved). The black market is consequently the only source of CAH medications in many countries, with negative impact on quality and security of supply.
iv. Osteogenesis Imperfecta (OI) – access to medicines, technology and healthcare
OI is a genetic disorder of collagen production that results in fragile bones that fracture easily and often. Fortunately, treatment with intravenous bisphosphonates is affordable and effective, and since it was introduced in 199414 has revolutionized care for children living with OI by reducing fracture rates and optimizing mobility and health outcomes.
Unfortunately, in many LMICs, bisphosphonates for injection are neither available nor registered for legal use in children. As a result, OI in these countries is still associated with very high rates of preventable disability, morbidity and mortality. Access to morphine (for pain relief) and effective management of fractures are additional problems for OI communities in many LMICs. Most usually the telescopic high quality steel rods used to stabilise long bone fractures in HICs and MICs are not affordably available in LMICs, and this further contributes to the high rates of disability, pain and suffering that are reported by APPES members15.
D. A human rights-based, community development model to fast-track equity for children living with NCDs in LMICs
CLAN and APPES respectfully share their experiences utilizing CLAN’s strategic framework for action to drive multisectoral collaborative action to redress inequities for children and adolescents living with endocrine conditions in the Asia Pacific region. Based on successes so far, we offer it as a model for driving sustainable and scalable change for children living with NCDs in LMICs more broadly.
Since 2004 CLAN and members of APPES have worked in partnership to implement a human rights-based, person-centred, community development approach to redressing the inequities experienced by children and adolescents living with endocrine conditions in the Asia Pacific region.
Empowering individuals to become communities
CLAN identifies all children and adolescents in a country who are living with the same chronic health condition as members of a united local, national and global “community”. For example, a child presenting with Diabetes at the National Institute of Child Health in Karachi, Pakistan is automatically a member of the Pakistani Diabetes community and also the international Diabetes community.
Having shifted from an individual to a community based focus, CLAN and APPES members then commit to working collaboratively with a range of multisectoral partners and stakeholders to drive human rights-based, Strategic Framework for Action (known as the “Five Pillars”) focused on community priorities:
1) Affordable access to medicines and equipment;
2) Education (of children, families, health professionals, and local, national and international communities), research and advocacy;
3) Optimal medical management (with a holistic approach and commitment to primary, secondary and tertiary prevention);
4) Encouragement of family support groups; and
5) Reducing financial burdens and promoting financial independence.
These Five Pillars were first developed in 2005 following detailed consultation with the CAH community of Vietnam16, and have since been used to inform collaborative action across multiple chronic conditions (including Diabetes, Autism Spectrum Disorders, Nephrotic Syndrome, Rheumatic Heart Disease, Asthma, Osteogenesis Imperfecta and Duchenne Muscular Dystrophy) and countries (Pakistan, the Philippines, Indonesia, Nigeria, Kenya and Algeria).
Practical examples of CLAN’s model redressing inequity in the Asia Pacific
Regional achievements are presented as brief case studies:
i. Impact on remedying policy incoherence
a) Rapid change for the CAH and Diabetes communities in Vietnam
CLAN was invited by APPES members to work with the CAH (since 2004) and Diabetes (since 2007) communities in Vietnam. Access to medicines (Pillar 1) was identified by families as their greatest priority15. Urgent humanitarian donations of hydrocortisone (Alphapharm Australia), fludrocortisone (Bristol-Myers Squibb) and insulin (Insulin For Life) were arranged to secure the lives of all affected children whilst medium term solutions to registration barriers were explored.
A partnership with the International Insulin Foundation was established, resulting in collaborative implementation of the RAPIA (Rapid Assessment Protocol for Insulin Access) survey across three paediatric hospitals in Vietnam (Pillar 2 – research). The Diabetes RAPIA17 was then adapted for use by the CAH community and the resultant CAH RAPIA report18 identified clear recommendations to benefit the communities which were then implemented (including successful inclusion of hydrocortisone and fludrocortisone tablets in the WHO EMLc in 2008)19, resulting in the registration of hydrocortisone and fludrocortisone tablets in Vietnam and their inclusion in the national insurance scheme. APPES members assisted with translation of educational resources (Pillar 2); gave educational talks for families at support group meetings (Pillars 2 and 4) to help families learn how to use the drugs optimally; and supported training for health professionals to strengthen medical management (Pillar 3).
b) FOSTEO impacts legislation in Indonesia
CLAN was invited by APPES members to support efforts for the OI community in Indonesia in 2012. At that time quality of life for children with OI was very poor; there were only 25 children known to be alive. Most children with OI died painful, fracture-related deaths within the first few years of life because it was illegal for doctors to prescribe intravenous bisphosphonates to children, despite extensive evidence internationally that such treatment strengthened bones and offered increased mobility and survival for those receiving it (Pillar 1, 2, 3).
An official launch of the national OI community (called FOSTEO) was held in Jakarta (Pillar 4) with celebrity endorsement resulting in significant media coverage of the challenges the community faced (Pillar 2 – advocacy)20. Within 6 months national legislation was changed and bisphosphonates could be legally prescribed (Pillar 1). A patient register was developed, and in the following 6 months more than 100 children were registered due to the increased awareness of the condition across the archipelago (Pillar 2). Strong community participation (using Watts App and other means) supports ongoing action and fundraising for the community21, with all children receiving treatment and many now mobilizing and achieving health outcomes comparable to children in Australia.
ii. Impact on public health
a) “Rarity” does not reflect the true burden of disease
When CLAN was first invited to help children living with CAH in Vietnam (2004), doctors estimated there were around 150 children alive nationally with CAH. Collaborative efforts focused on improving quality of life, and prevalence increased as rapidly as mortality plummeted. A burgeoning CAH community prompted questions around incidence, and the Vietnamese government implemented a pilot NBS program for CAH, further reducing mortality, raising awareness and improving health outcomes (Pillar 2,3). In 2016 there are over 1000 children on CAH registers coordinated by APPES members at the major children’s hospitals in Vietnam (Pillar 2)22
APPES members have worked to establish CAH communities in Indonesia (KAHAKI), the Philippines (CAHSAPI) and Pakistan (CLIP), driving improvements in child survival and quality of life.
b) Health literacy
Translation of educational resources on CAH, Diabetes, OI and CH into local languages by APPES members has been a key success factor (Pillar 2,3). These resources are utilised by health professionals and families; increase community awareness; promote empowerment of community champions; and reduce the burden on strained outpatient and inpatient systems. Incorporation of these resources into a mobile phone app that can be used by health professionals and families is currently being trialed by CLAN and APPES in Pakistan, with support from Pfizer Australia.
iii. Impact on human rights
a) Empowering young people living with NCDs
CLAN has developed child-friendly resources for NCD communities, outlining specific articles in UNCRC as they relate to the needs identified by families in CLAN’s five pillars (Pillar 2). To date, flyers on Diabetes (English, French, Spanish)23 and Childhood Cancer (English)24 have been finalized, with flyers on Rheumatic Heart Disease, Asthma, CAH, OI / disability and NCDs (prevention and management more generally) under development.
b) NCD Child
Rights-based advocacy efforts by CLAN to integrate children and adolescents within the global NCD discourse (Pillar 2) resulted in CLAN chairing the NCD Alliance Child Focused Working Group in January 2011 and later founding NCD Child (www.ncdchild.org) immediately following the UN High Level Meeting (UNHLM) on NCDs in September 2011.
Inclusion of children and a focus on a life-course approach to NCDs in the UNHLM Declaration was an important outcome in terms of remedying policy incoherence and uniting facilitating future action by civil society and government alike. A partnership with UNICEF around the development of a chapter on NCDs for their Facts For Life publication will support awareness amongst communities about the rights of children who are living with and at risk of NCDs.
a) Embracing the sustainability and scalability of community development
Because of the chronic nature of NCDs, many of the families and young people CLAN works with have been partnering with us for over a decade (Pillar 4). The strength of community history, ownership and commitment means CLAN and APPES are able to implement activities in a very cost effective fashion.
The success of collaborative efforts between CLAN and APPES to address endocrine conditions in Vietnam prompted health professionals to successfully replicate CLAN’s Five Pillars model to other NCDs (including Nephrotic Syndrome, Autism and Duchenne Muscular Dystrophy). CLAN’s Strategic Framework for Action has allowed the scaling of action beyond the Asia Pacific region, with new CAH Communities recently established in Nigeria and Algeria using CLAN’s model. Led by GPED (the Global Pediatric Endocrinology and Diabetes organisation of which APPES is a member) the Algerian CAH community launch has already facilitated early success in clarifying barriers around local access to medicines25. CLAN’s Five Pillars have also been used in Kenya (Rheumatic Heart Disease - RHD)26, with the Kenyan national NCD policy including RHD for the first time just one year after the establishment of the Nairobi RHD Club.
b) Innovating to improve access to medicines
CLAN’s 5th Pillar is focused on financial independence, and challenges thinking as to how to consider innovative solutions to medically-induced bankruptcy and poverty. A successful trial of a micro-finance and enterprise development projects over three years in Indonesia for the CAH community demonstrated the capacity for multisectoral action to improve access to medicines and health outcomes simply by increasing income generation of poor families27.
Utilization of CLAN’s Strategic Framework for Action by APPES members has facilitated a number of significant improvements in access to essential medicines, diagnostics, technologies and healthcare for some of the most vulnerable children and adolescents in the Asia Pacific region over the last decade.
CLAN and APPES welcome the opportunity to address the HLP in person to share further information about our experiences redressing inequities associated with childhood NCDs in LMICs. We believe change is possible when we all work together.
Bibliography and References
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