Ethico-Legal Issues in Health Sector: HPCs and Australia's Laws

This report provides a comprehensive analysis of the ethico-legal issues surrounding Haemopoietic Progenitor Cells (HPCs) in the Australian healthcare system. It explores the use of HPCs in treating various medical conditions, including the ethical dilemmas associated with donor consent, particularly in pediatric cases. The report examines the Australian legal system's role in regulating HPC treatments, including the jurisdiction of the Supreme Court, Family Court, and regulatory bodies like the Australian Health Practitioner Regulation Agency (AHPRA) and the Therapeutic Goods Administration (TGA). It also delves into fundamental concepts of health law and ethics, such as informed consent, patient privacy, and the principles of duty of care. The report highlights ethical concerns related to unproven HPC treatments offered by private clinics, potential health risks to both patients and donors, and the erosion of public trust due to unregulated practices. It concludes with precautionary suggestions for patients, emphasizing the importance of verifying the credibility of HPC treatments and scrutinizing advertising claims, while also mentioning the role of organizations like the National Stem Cell Foundation of Australia in providing guidance. The report underscores the need for stringent regulation and evidence-based practices to ensure patient safety and maintain ethical standards in the field of HPC therapy.

Running Head: ETHICO-LEGAL ISSUES IN HEALTH SECTOR
Ethico-legal Issues in Health Sector
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1ETHICO-LEGAL ISSUES IN HEALTH SECTOR
Ethicolegal issue in health service delivery in Australia:
Clinician ought to know about the specific physical and mental dangers of
haematopoietic-undifferentiated cells donated in the paediatric setting, and the fluctuating
laws among states and domains (Polischchuk et al. 2016).
Allogeneic donor blood and bone marrow transplantation can treat a number of
harmful and non-dangerous infections. For youngsters with aplastic weakness, extreme joined
immunodeficiency, leukaemia, sickle-cell sickness and thalassaemia, it might give a
probability of fix and long-term survival (Terakura et al. 2016). In spite of the fact that
related with beneficiary mortality (5-12% transplant-related mortality at one year) and
coldness, propels in tissue composing, sympathetic care , quiet determination, and the
counteractive action and treatment of join versus-host disease have drastically enhanced
results, with up to 80% of beneficiaries ending up long term survival of bone marrow
transplant (Gaziev et al. 2016).
ETHICAL ISSUES WITH HPCs:
From the donor’s bone marrow or peripheral blood or from the umbilical cord, HPCs
cells are collected. After this collection, there is a slight chance of psychological and social
risks in both peripheral blood and bone marrow donation. These risks must be cautiously
considered as donation is non-therapeutic, giving no health advantage to the benefactor
(Mousavinejad, Andrews and Shoraki 2016).
A general anaesthesia, which is quite relatively safe, is required during bone marrow
harvest. This is related with the post-operative morbidity, which includes nerve, bone and
tissue damage, pain, sickness and many other risks related with transfusion (Volarevic et al.
2018).

2ETHICO-LEGAL ISSUES IN HEALTH SECTOR
The harvest of peripheral blood stem cell, an alternative way in the older child donors,
also has some risks, which included venous injury and anxiety when inserted with large
gauge catheters. The HPCs tools are used for apheresis, thrombocytopenia and has an adverse
effect with the use of sedative (Oliveira et al. 2016).
Most of the donors being children, a serious question emerges regarding the
agreement and permission of the donor because the donation is a non-therapeutic process and
this process occur within a family. Therefore, the moral issue is that while guardians are
expected to settle on choices that are in their child’s best interest and not decided by other’s
interest, which may not be inconceivable with the context of other sibling's donation
(Iwanowicz-Palus et al. 2016).
Key features of the Australian Legal System pertinent to Health Service Delivery
The following are the roles of the Australian court system (Vajdic et al. 2016).:
 In each state or territory, the Supreme Court has the jurisdiction, that is,
‘Parents patriae’ for the minors, to act on behalf of the juvenile delinquent
who cannot defend for themselves, in a situation where a minor may need
HPC treatment.
 The minors undergoing HPC treatment have been provided with welfare and
government provisions for the treatment or any other kind of procedures. The
Family Court provides this provision.
 The Australian Health Practitioner Regulation Agency and the Therapeutic Goods
Administration, along with the Australian Medical Association has supreme
power in their hand compared to the patient’s guardian or parents to ensure the
decisions relating the treatment of the patients concerning with his or her life.

3ETHICO-LEGAL ISSUES IN HEALTH SECTOR
As observed by Ghosh et al. (2016), if the donor child is unaware of the fact that he or
she is being used as the bone marrow transplantation, the parents patriae jurisdiction of that
state or territory can come forward and help that child from doing further health experiment
on him or her.
Alternatively, as observed by Shparberg and Vickers (2018), even during the medical
procedure, what kind of methods and decisions are being taken for the child donor can be
regulated by the family court with the help of any welfare provisions.
On the other hand, as examined by Trounson and DeWitt (2016), during the harvest of
peripheral blood cells, which is a life risking procedure, the court has the supreme power
either to stop the procedure or to ensure the donor child’s safety irrespective of the decision
made by the parents.
Fundamental Concepts and Principles of Health Law and Ethics (van Walraven et al.
2018):
 Following are the principles of the health law and ethics which must be practiced prr
to the conductance of HPC treatment, as per the code of ethics outlined by the
Australian Medical Association.
 Health practitioners must obtain informed consent and permission from the
patient as well as the family prior to the conductance of HPC treatment.
 The concerned patient and the family be provided with precautionary care and
skills in health care services, as per standardised treatment principles of patient
centred and family centred approaches to treatment.
 Patient’s identity and information should be kept in privacy and confidential.
 Involvement of all levels of communities, government, and businesses could
be of great use in the well-being of health care and in promoting HPC health

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services across the country, as observed in the collaborative services provided
by the Department of Health’s Bone Marrow Transplant Program,
International Searches Program and the Haemopoeitic Progenitor Cell
Program.
 To justify any kind of mischievous act or harms in public health service and
care, overall benefit must be adequate as per the guidelines of compensation
covered by the legal provisions of Duty of Care.
 To maintain the social contract, pubic trust should be protected by the
interventions as observed in the regulatory impositions on healthcare
advertisements claiming HPC therapy which will be discussed in the
succeeding sections.
 People should be supported and benefited who contribute to the health care
service. For example: the Department of Health of the Government of
Australia finances the expenditures incurred by the patient family in the
situation of a donor or HPC samples procured internationally.
HPCs: Situation in Australia
The Department of Health of the Australian Government recognises the Haemopoietic
Progenitor Cell Therapy (HPC) as a treatment breakthrough with potentially beneficial
implications and positive health outcomes of for the treatment of patients who are suffering
from various immunological and haematological conditions. In addition to this program,
additional organizations such as the Australian Bone Marrow Donor Registry (ABMDR) is
finance by the Commonwealth for the maintenance of registration of bone marrow donors
residing in the nation (McLean, Stewart and Kerridge 2015). The ABMDR also aids in the
coordination of international along with national searches through surveillance of
international registries in order to obtain donors for the treatment of patients in need of stem

5ETHICO-LEGAL ISSUES IN HEALTH SECTOR
cells from cord blood and bone marrow. The additional organization notable in the HPC
situation in Australia is the National Cord Blood Collection Network (NCBCN) which is
responsible for banking and collection of such blood. Further, in a situation of obtaining a
donors from nations beyond Australia, the International Searches Program (ISP) and the
Bone Marrow Transplant Program (BMTP) are responsible for searching such donors along
with the provision of financial aids to the patients for covering the expenditures incurred in
obtaining blood units internationally (Lindsay et al. 2016). Citizens residing in Australia can
enrol their names as potential bone marrow donors, by calling the Australian Red Cross
Blood Service. For successful enrolment, the individual must be a resident of Australia,
within the age of 18 to 45 years old and in possession of a sound physiological and
psychological health. However, at present, a number of private healthcare clinics have
emerge claiming to provide HPC therapy, which has raised clinical and ethical issues and will
be discussed in the succeeding sections (Nornal et al. 2017).
Problems and Ethical Issues
As observed by Then, Kerridge and Marks (2018), despite clinically beneficially and
life saving capabilities of stem cells as harbingers of replenishment and rejuvenation in
critically ill patients suffering from a complex debilitating conditions, researchers and clinical
practitioners are still undertaking extensive testing and clinical trials in order to evaluate and
approve the safety efficacy of such treatments. In such a situation of unproven and
inconclusive evidence based research, some private clinics and healthcare organizations in
Australia are emerging with claims of providing HPC therapeutic procedures which have still
not been proven. Further as postulated by Liso et al. (2017), undertaking such treatments
which have not yet been approved as per evidence based guidelines raises major ethical
issues on the physiological health of the patients availing such therapies, by increasing the
susceptibility of tumours, bleeding, infections at unacceptable and unprecedented levels

6ETHICO-LEGAL ISSUES IN HEALTH SECTOR
resulting in death. Unethical conductance of HPC treatment which has not been researched
can also result in serious detrimental health conditions in the donors such as weakness
associated with anaesthesia, soreness at site of bone marrow donation resulting in hindered
walking, muscle aches, bone pains, fatigue, headache, vomiting as well as nausea. Further,
as examined by Lysaght et al. (2018), illegal conductance of such inconclusive and invalid
treatments raises several legal questions on the credibility of existing evidence based research
resulting in erosion of the nation’s trust in the field of evidence based healthcare. Further, as
examined by the Centre for Stem Cell System at the University of Melbourne, clinicians and
health professionals have still been unsuccessfully in establishing a guaranteed adaptation of
the patient’s physiology in response to a foreign bone marrow or HPCs. At present, despite
the promising research and success attached to a limited number of trials, there still lies no
information on the methods used by private clinics in the processing of cells once they have
been extracted hence raising several ethical and health related concerns (Smith et al. 2017).
Law Enforcement
As researched by von Tigerstrom et al. (2017), treatments and biological samples
involving stem cells donations, HPCs and bone marrow transplantations are regulated by the
Australian Health Practitioner Regulation Agency (AHPRA) and the Therapeutic Goods
Administration (TGA). Such regulations are exempted for tissue samples obtained from a
patient and to be used on the same patient by a registered clinician or the same hospital in
which the concerned patient is residing. Taking insights from Gharaibeh, Anderson and
Deasy (2016), it can implied that as a result of further regulation, private clinics or health
organizations claiming to practice such treatments have been depleted of the right to advertise
such services directly to customers followed by a notice period of observation from the
month of July this year. Such regulations have been implicated in response to the recent cases
of medical malpractices affecting patients undertaken HPC therapeutic procedures. Further,

7ETHICO-LEGAL ISSUES IN HEALTH SECTOR
the AHPRA, in collaboration with the Medical Council of New South Wales oversees and
observed medical procedures and practices undertaken at healthcare organizations and private
clinics. However, as observed by Dominici et al. (2015), despite such regulations, legal
loopholes still exist where such ‘overseeing’ yields no regulatory or legal frameworks which
may prevent doctors or clinics in their experimentation or innovation with practices and
procedures deemed to yet unproven, inconclusive and erroneously researched.
Conclusion: Precautionary Suggestions
Stem cells and HPC treatments have been implicated as an emerging potential
treatment for life debilitating conditions. Despite the beneficial implications, HPC therapeutic
procedures have raised several ethical dilemmas followed by the possibility of detrimental
health consequences considering the present rampant availability of such treatments by
clinics which have not yet been proven or evidenced. However, in accordance to the National
Stem Cell Foundation of Australia, citizens can undertake several precautionary measures for
the protection of the health of themselves and their family members. One of the primary
precautions as researched by Munsie et al. (2017), which patients must lookout for is the
credibility of the HPC treatment being offered by the concerned private clinic or healthcare
organization. A stem cell treatment may be deemed to be effective and safe if its conception
can be traced to a registered clinical trial without which, there is no assurance regarding the
safety or efficiency of the same. Further, as postulated by Weber et al. (2015), it is suggested
that consumers observe the nature of HPC related advertisements disseminated by the
concerned private clinic. Advertisements utilising mass media as a means for communicating
healthcare services are overfilled with persuasive language without any scientific evidence to
justify these claims. Hence, taking insights from Nivison-Smith et al. (2016), it is advisable
for consumers to avoid such deceptions and interact personally with the concerned clinician
behind the basis for such claims. Additionally, consumers must be cautious from clinicians

8ETHICO-LEGAL ISSUES IN HEALTH SECTOR
who offer the same HPC treatment as an intervention for a variety of disease conditions using
only patient testimonials and no evidence based research as a justification. Hence, while HPC
treatment may prove to be ray of hope in the treatment of several harmful and disruptive
health conditions, consumers must prevent themselves from being deceived by being alert. In
conclusion, it must be remembered that different health conditions bring forth an array of
varied challenges for which, merely a novel treatment involving HPCs will not be a cure and
hence, must be evidenced thoroughly prior to administration.

9ETHICO-LEGAL ISSUES IN HEALTH SECTOR
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