By Dr Rhian Croke, Independent Children’s Rights Adviser and Observatory on the Human Rights of Children Affiliate and Rhian Thomas-Turner, Paediatric R&D Lead Children and Adult Research Unit, Children’s Hospital for Wales and PhD Candidate Hillary Rodham Clinton School of Law
Globally, children as a social group face unique challenges in accessing the benefits of high-quality paediatric research that supports the development of medicines. In this blog we focus on some of the challenges that children are facing in accessing paediatric research in the Welsh context[1] and consider how this may be in breach of international human rights law and domestic legislation.
In 2012, the Royal College of Paediatrics and Child Health (RCPCH) published its ‘Turning the Tide’ report on Child Health Research in the UK. In the report, it states that children:
‘need biomedical health services research that takes account of their changing physiology and addresses their problems directly, generating evidence to improve the quality of the treatments and the healthcare that they receive, and policies that affect their wellbeing.’[2]
However, in their 2018 ‘Turning the Tide’ report, they reported that funding for child health research (including paediatric research), has been decreasing year on year since 2012, and the UK paediatric workforce has limited time for paediatric research in their work plans.[3] Additionally, although legislation was passed in Europe in 2007, to try and stimulate medicines development for children, there are still large unmet needs in paediatric treatments.[4]
Under international human rights law, State parties have obligations to ensure that children are able to access the benefits of paediatric research and their access to essential medicines is respected, protected and fulfilled. The International Covenant on Economic, Social, and Cultural Rights (ICECSR), states that the right to health includes ‘access to health facilities, goods, and services’ without discrimination.[5] Although, the Covenant only requires the progressive realisation of the right to health in the context of limited resources, there is a core set of minimum obligations which are not subject to progressive realisation, including access to essential medicines.[6]
Under the United Nations Convention on the Rights of the Child (CRC), there are two key articles directly related to the right to the health, these are Article 6 (child’s right to life and to survive and develop to the maximum extent possible) and Article 24 (the child’s right to the highest attainable standard of health). However, given the interrelated nature of the articles, many rights of the CRC are relevant to achieving a child’s right to health, including access to essential medicines and research.[7]
Like the ICESCR General Comment on the Right to Health, the CRC’s General Comment No. 15 lays out the importance of the right to access health facilities, goods and services, in terms of what is commonly referred to as the AAAQ framework.[8] In brief, medicines, treatments and interventions, in this context must be made available and accessible without discrimination. They must be acceptable, which considers the design and development of medicines and how they align to the child patients’ needs and are good quality, based on the best available evidence/research, scientifically approved, quality assured and specific to children.[9] Without quality paediatric research, many ground-breaking medicines would never have been developed or if they are developed without appropriate paediatric research, can be ineffective, with unknown side effects.[10] High quality paediatric research supports access to ‘appropriate prevention, health promotion, curative rehabilitative and palliative services’ which are essential components if children are to realise their right to health.[11]
In Wales, children have faced continuous challenges to accessing the benefits of paediatric research. Furthermore, since 2015 there has been a loss of focus on clinical research for children across Wales, that has resulted from a change in the research infrastructure. These changes included the loss of the Children and Young People Research Network, previously funded by Welsh Government and the implementation of Activity Based Funding (ABF) model by the Government used to fund NHS for patients enrolled in trials: a model which fails the high complexity, low recruiting studies found in paediatrics.[12]
Over the last 2 years, a team from the Research Unit at the Children’s Hospital for Wales (CYARU), has utilised the international human rights treaties to challenge Welsh Government. Further detail of the children’s rights framework that CYRAU developed and utilised, can be found in an article written for the International Journal of Children’s Rights, June 2021.[13] In Wales, the CRC has been incorporated into domestic legislation via the Rights of Children and Young Person’s (Wales) Measure.[14] Although not direct incorporation, it does make it explicit that Welsh Government (WG) Ministers must have due regard to the rights of the child in all their functions. With the duty of due regard placed upon Ministers by the Measure rather than a duty to comply with the requirements of the CRC, CYARU challenged Welsh Government through political scrutiny by giving evidence at the National Children’s Rights Inquiry held by the Welsh Parliament’s Children, Young People and Education Committee (CYPE) in 2019.[15] During the evidence, CYARU highlighted the real-life impact of the disinvestment and failing funding models on children in Wales and requested Children’s Rights Impact Assessments (CRIAs) be published, to demonstrate that due regard has been paid during the decision-making process. However, CRIAs have still not been forthcoming on this issue.
CYARU highlighted the real-life impact of the funding models on children in Wales, and on those children living with cancer. As the Chair of the Committee commented:
It was a very powerful session that really did bring home to us the tangible and life changing difference putting children’s rights at the heart of decision making can make to children and their families.[16]
Cancer is the leading cause of mortality in children aged 0-9 years in Wales.[17] Children with cancer, who have exhausted all their traditional treatment options, can be offered the opportunity to participate in early phase clinical trials, trials which often help to prolong their lives. Until 2020, children treated in Wales would have to leave the country to participate. This has meant that children, in the most vulnerable and final stages of their lives are leaving their home, siblings and extended family for the opportunity to participate. In contrast, adults can access early phase studies at one of three sites in South Wales. The paediatric early phase infrastructure still relies upon charity funding to meet the costs, whilst the adult infrastructure is accessing statutory funding. This demonstrates evidence of inequity of funding and discrimination towards children as a social group.[18]
The COVID-19 pandemic has continued to highlight the lack of priority given by Welsh Government to paediatric research. In June 2020, CYARU wrote to the CYPE Committee emphasising a concern on the lack of CRIAs not being publicly shared on the impact of Covid-19 emergency legislation on children’s rights.[19] When the decision was made to reopen schools in Wales in June 2020, there was also inconclusive evidence on the role that children and schools played in rates of infection and transmission of the virus. This was agreed by the Welsh Government Technical Advisory Group on Education.[20] In July 2020, CYARU designed a research study to examine children and schools’ role in rates of infection, transmission and antibody prevalence of COVID-19. CYARU tried to secure funding from Welsh Government, who advised on applying for grant funding, so then approached a UK-based charity who advised that this research was the responsibility of Government.
Despite denying children the fulfilment of many of their rights due to the impact of school closures, the lack of systematic research and evidence continued into the pandemic. It also became increasingly evident; this was not just an issue for Wales; health professionals in the UK and across Europe also reported that paediatric research had not been prioritised as part of the pandemic research response.[21]
In April 2020 the first cases of a novel condition, PIMS-TS, were seen in the UK hospitals.[22] The condition, associated with COVID-19, causes multi-organ inflammatory syndrome in children and is considered to be a result of the immune system’s response to the virus. With a new condition such as this, research becomes an essential component of the treatment pathway in order to determine the best possible care. The same can be said for the vital vaccine research that is being undertaken in the adolescent population to understand the safety and efficacy in the population. The UK Chief Medical Officers have recently decided that adolescents aged 12-15 are to be offered one dose of the Pfizer vaccine, although questions on whether adolescents should be offered two doses remains to be answered.[23] The pandemic has demonstrated that clinical research is a vital component in answering these pertinent questions and a readily available infrastructure is needed to ensure that children are able to participate in these studies.
Another continuing issue is the lack of opportunity for children to express their views and perspectives on all these decisions. This is an important aspect of compliance with the CRC and the Rights of Children and Young Persons (Wales) Measure (Article 12 CRC, General Comment No.15).[24] In Wales, there are no mechanisms allowing children’s views to be heard in the production or the funding of paediatric research for conditions they are affected by.
Discussions on funding for the paediatric research infrastructure in Wales are still ongoing. Whilst some progress has been made, paediatric research in Wales is still in a poverty cycle. As yet, no Children’s Rights Impact Assessment has been published on the ‘needs based’ funding model that is replacing the ABF model. It is not yet clear whether this new funding model will help lift paediatric research out of this cycle…
It has become increasingly evident, that legal enforceability for children’s rights must be strengthened so that Welsh Government and public bodies, can be better held to account to comply with the CRC. We support the recommendations made in recently published research carried out for the Welsh Government on Advancing and Strengthening Equality and Human Rights in Wales 2021 (see recommendation 1 and 25).[25] There should be full and direct incorporation of the CRC, to provide legal enforceability against all public bodies in Wales and all children (including children with complex health conditions) must be offered a direct route to a legal remedy in a court of law for breaches of their human rights. Every child in Wales (and globally) deserves to be able to access the benefits of paediatric research.
[1] Wales is one of the devolved nations of the United Kingdom.
[2] RCPCH, Turning the Tide: harnessing the power of child health research (rcpch2012). Available at: https://www.rcpch.ac.uk/sites/default/files/Turning_the_Tide_Full_Report_2012.pd. Accessed 21 February 2021.
[3] RCPCH, Turning the Tide – Five years on (RCPCH 2018). Available at: https://www.rcpch.ac.uk/resources/turning-tide-five-years Accessed 15 January 2021.
[4] European Commission, State of Paediatric Medicines in the EU 10 years of the EU Paediatric Regulation, com (European Commission 2017). Available at: 2017_childrensmedicines_report_en.pdf (europa.eu). Accessed 7 February 2021.
[5] UN Committee on Economic, Social and Cultural Rights, General Comment No. 14 on the Right to the Highest Attainable Standard of Health, E/C.12/2000/4 para 43
[6] Ibid
[7] Croke, R., Thomas-Turner, R., Connor, P., & Edwards, M. (2021). Utilising the International Human Rights Framework to Access the Benefits of Paediatric Research in The covid Era: A Wales Case Study, The International Journal of Children's Rights, 29(2), 326-352. Available at:https://brill.com/view/journals/chil/29/2/article-p326_326.xml Accessed September 20 2021
[8] UN Committee on the Rights of the Child, General Comment No. 15 on the right of the child to the enjoyment of the highest attainable standard of health, CRC/C/15/2013.
[9] Ibid
[10] Joseph, P. D., Craig, J. C., Caldwell, P. H., “Clinical trials in children”, British Journal of Clinical Pharmacology 2015 (79(3)), 357–369. Doi:10.1111/bcp.12305.
[11] Ibid
[12] Croke, R., Thomas-Turner R., Connor, P., & Edwards, M. (2021). Utilising the International Human Rights Framework to Access the Benefits of Paediatric Research in The covid Era: A Wales Case Study, The International Journal of Children's Rights, 29(2), 326-352. Available at: https://brill.com/view/journals/chil/29/2/article-p326_326.xml Accessed September 20 2021
[13] Croke, R., Thomas-Turner, R., Connor, P., & Edwards, M. (2021). Utilising the International Human Rights Framework to Access the Benefits of Paediatric Research in The covid Era: A Wales Case Study, The International Journal of Children's Rights, 29(2), 326-352. Available online: https://brill.com/view/journals/chil/29/2/article-p326_326.xml accessed September 20 2021
[14] Rights of Children and Young Persons (Wales) Measure 2011, Available at: https://www.legislation.gov.uk/mwa/2011/2 Accessed 27 February 2021
[15] Welsh Parliament Children and Young People and Education Committee, National Inquiry Report into Children’s Rights (Senedd Children and Young People Education Committee August 26 2020). Available at: https://senedd.wales/laid%20documents/cr-ld13405-r/cr-ld13405-r-e.pdf. Accessed 15 January 2021.
[16] Chair of the Senedd Children and Young People and Education Committee, Twitter, 11/082020.
[17] RCPCH, State of Child Health 2020: Wales (RCPCH, 2020).
[18] Croke, R., Thomas-Turner, R., Connor, P., & Edwards, M. (2021). Utilising the International Human Rights Framework to Access the Benefits of PaediatricResearch in The covid Era: A Wales Case Study, The International Journal of Children's Rights, 29(2), 326-352. Available at: https://brill.com/view/journals/chil/29/2/article-p326_326.xml Accessed September 20 2021
[19] Ibid
[20] Welsh Government Technical Advisory Group Children and Education, a., Our latest understanding ofcovid-19 with respect to children and education, 3 June 2020. Available at: https://gov.wales/sites/default/files/publications/2020-06/our-latest-understanding-of-COVID-19-%20re Accessed 10 February 2021; Welsh Government Technical Advisory Group Children and Education, b., Our latest understanding of covid-19 with respect to children and education,7 July 2020. Available at: https://gov.wales/sites/default/files/publications/2020-07/technical-advisory-group-advice-from-children-and-education-subgroup_1.pdf. Accessed 3 December 2021.
[21] European Centre for Disease Prevention and Control., Covid-19 in children and the role of school settings in transmission – first update(ecdpc, 23 December 2020). Available at: https://www.ecdc.europa.eu/en/publications-data/children-and-school-settings-COVID-19-transmission Accessed 28 January 2021; Lewis, S J., Munro, P S., Davey, Smith G., “Closing schools is not evidence based and harms children,” BMJ 2021; 372: n521 23rd February 2021 http://dx.doi.org/10.1136/bmj.n521 Accessed 19 March 2021.
[22] RCPCH: https://www.rcpch.ac.uk/resources/pims-COVID-19-linked-syndrome-affecting-children-information-families. Accessed 19 February 2021.
[23] Participate - Oxford University | Com-CoV (comcovstudy.org.uk) Accessed 20 September 2021.
[24] UN Committee on the Rights of the Child, General Comment No. 15 on the right of the child to the enjoyment of the highest attainable standard of health, CRC/C/15/2013.
[25] Hoffman, S.; Nason, S.; Beacock, R.; Hicks, E. (with contribution by Croke, R.) (2021). Strengthening and advancing equality and human rights in Wales. Cardiff: Welsh Government, GSR report number 54/2021, Available at: https://gov.wales/strengthening-and-advancing-equality-and-human-rights- wales Accessed September 20 2021
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