The “impossible” informed consent for medical treatment of children whose parents are minors problems and proposals de lege ferenda
*The article is a translated version of the original, published in magazine “Contemporary Law”, issue 3, 2016.
Momchil Mavrov, PhD
Maria Sharkova, attorney-at-law
Associate Professor Ekaterina Uchikova M.D
The active participation of the patient in the medical treatment process is a relatively new concept that appears at the end of the past century, when the notion that the patient is an object of medical care and is therefore deprived of choice and role in the process of providing medical help[1] is gradually abandoned. The idea has gradually evolved, and the legislation of almost all countries today provides for an informed consent from the patient before conducting treatment. In some countries, such as the United States and the UK, the concept of ‘patient-centered care’[2] is being developed as one of the dimensions of the quality of medical care.[3]
In our [Bulgarian] legislation, special attention is paid to the informed consent, which we (the authors) consider to be one of the most important manifestations of the subjective right to health information. Despite the relatively detailed regulation that covers a number of hypotheses of informed consent, there is a gap in the Health Act concerning cases, involving children whose parents are minors. In this analysis we will explain why we call this consent “impossible” by discussing possible de lege ferenda proposals.
- Introduction.
Informed consent to treatment is provided personally by any adult [4], except when the person is placed under guardianship when he or she is in a state of inability to express informed consent[5] or when his or her physical or psychological condition prevents him / her from expressing consent[6], (е.g, the adult patient is in a coma, is under the influence of an anesthetic/drug, etc.).
Other persons may express informed consent instead of the patient only in the cases provided by the law: the parent instead of his/her minor child[7]; the guardian instead of the person under full guardianship[8]; the person who is entrusted with the care of a child legally separated from the family, following a positive opinion of the Social Assistance Directorate[9]; Social Assistance Directorate in cases where the child is placed outside the family by administrative order [10]; the persons determined by the order of art. 162, para. 3 of the Health Act in place of a patient with a mental disorder and an established inability to express informed consent [11].
The legal framework is not clear in cases when the parents of the patients have not reached the age of majority. This legal gap causes serious problems for several reasons. The first is related to the requirement to provide medical care only after informed consent [12] is given.[13] Тhose who provide medical care without informed consent from the patient will hold administrative liability.[14] Administrative liability also arises in case of non-observance of this requirement, laid down in the general rules for financing the medical assistance from the National Health Insurance Fund (NHIF) and in the conditions of the individual contracts with the medical institutions performing medical care. According to Art. 190 of the National Framework Contract for 2015[15] .. “the conduct of activities on using clinical pathway shall be reflected in the medical hospital documentation as well as in the following documents: (…) point 3 “Patient’s informed consent statement regarding the procedures carried out during the course of the medical-diagnostic process – prepared by Hospital care provider “ and point 4 “Patient information and consent statement regarding the source of payment for the diagnosis and treatment of their illness.”
In cases where the parents of a newborn (or say of a child up to the age of 3-4) are minors and not married, the phisicians of the child are in a state of impasse and in conflict with the acting legislation and the moral-ethical aspects of the profession. From the legislator’s point of view, informed consent given by such parents is irrelevant to the law, as they are incapacitated or limited in capacity. This problem creates obstructions for providing medical assistance to the most vulnerable group in society – children, and the lack of a legal framework causes serious problems in the practice of doctors, medical specialists and the administration of medical institutions.
- Merits of the problem
Minors can not express informed consent for their own treatment as they are incapacitated.[16] Instead, the consent is expressed by a parent;
Individuals between the age of 14 and 18 consent jointly with a parent, or respectively – with a guardian – if such is assigned (for example, the child has no parents);
The law states that the person who expresses informed consent must be informed about the state of health and the treatment of the patient.[17]
However, there are cases in which minors become parents and their children need medical assistance. Things are especially serious when these children need surgery, blood transfusions, various diagnostic and healing procedures, participation in clinical trials, etc.
The law stipulates that the individuals under the age of 14 are not capable of percieving medical information nor they are in capacity to consent for their own treatment under the Health Act. Therefore, the question arises whether in certain circumstances these parents could provide informed consent for the treatment of their own child. Minors between 14 and 18 could express their will in regard to their treatment, but only together with a parent or a guardian. The law, however, does not answer the question whether they can express their consent to the treatment of their children, or whether it is required that this will be expressed jointly with the minor’s parent. In addition, with regard to minors above 14, the law allows for exemptions from the requirement to express joint informed consent in the case of: health consultations, prophylactic examinations and research.[18] Does it mean that minors who have become parents could express independent consent for these medical activities to be performed on their children as well? Does it mean that they could not agree to more serious medical interventions such as invasive procedures[19], surgical operations, general anesthesia, and the like in regard to their children?
The Family Code only provides a solution to the problem in cases where a person put under full guardianship becomes a parent. Art. 153, para. 1 and 2 of the Family Code provides for children whose parent(s) are under full legal guardianship that a guardian or a trustee is appointed. Any person who knows that a child needs a guardianship is obliged to immediately notify the Social Assistance Directorate”.[20]
This specific problem is not regulated in the legislation and it remains currently unsolved. The birth of children from minors is not an exotic but rather a common occurrence in Bulgaria. The phenomenon “Children Born by Children” requires a careful analysis of the possible solutions under the current legislation. The need to create a regulation that guarantees the best interest of children in medical care makes it necessary to discuss possible changes in the legal framework in order to overcome the existing gap.
- Analysis of possible solutions:
Presently, there are two possible hypothesis that can be applied in those cases.
The first hypothesis is that the parent becomes emancipated by the birth of the child and therefore can provide informed consent about the child’s medical treatment. The argument is derived from the text of Article 87, para. 2 and 4 of the Health Act where the term “parent” is used but it is not clear whether it is an “adult parent”. The conclusion is that, although the person is a minor, he/she has become a parent with the birth of his/her child, therefore he/she can express informed consent about the treatment of his or her child. Such a conclusion, however, contradicts the rules on legal capacity regulated in Art. 3 of the Persons and Family Act, according to which minors and persons under guardianship can not carry out legal acts. Although they have become parents, this does not emancipate them. Particularly, they are not capable of providing informed consent for the treatment of their children, as our law lacks such regulation beyond what is foreseen in Art. 6, para. 4 of the Family Code. However, this thesis is practically applied by most of the children’s wards in the medical institutions in the country.
At the same time, however, the Health Act stipulates that only the parent / guardian expresses informed consent about the treatment of his or her minor child (not grandmother, grandfather or other kind), and the same applies to joint consent of minors between 14-18 years of age. Nevertheless, provided that there is no adult and capable parent to express such consent, is it actually impossible for the informed consent to be provided for these patients?
The second hypothesis is that any adult is entitled to provide informed consent for the treatment of their grandchildren whose parents are minors. An argument in favor of this is the norm of Art. 3 of the Persons and Family Act, which stipulates that legal actions can be carried by the parent of the incapacitated people on their behalf and therefore the right to consent for the treatment of the minor cascades to the grandparents. Тhe legal framework does not allow exceptions for minors under 14, even in the cases of consent to perform medical activities that do not pose a particular risk or danger to the patient such as providing health consultations, performing preventive examinations and studies, but an exception is expressly made for minors between 14 and 18 minors in Art. 87, para. 3 of the Health Act.
Thus, even the minor parents between 14 and 18 who are not emancipated in the meaning of the Family Code, should be able to express consent to the treatment of their child, together with a parent.[21] Emancipated minors, i.e. those who have been married by the permission of the District Judge shall be able to act and express consent in accordance with Art. 87, para. 1 of the Health Act, both for themselves and for their children. However, this legal norm only provides a solution for the cases of legally married minor parents (between 14 and 18 years of age).
This possible solution is difficult in practice because most often the minor parents and the grandparents live separately and the latter are not present in the medical facilities. Unlike other legal actions (eg concluding transactions of a property nature), the expression of informed consent concerns the health of the child. In this regard, any waiting or delay in medical intervention may lead to complications and to the provision of untimely and sometimes poor medical assistance in view of the technological, technical and personnel capacities of the medical establishment for diagnosis and treatment of the respective illness.
In the case of a condition that directly threatens the life of the young patient and the abovementioned persons can not provide informed consent in due time, the Health Act allows to carry out medical activities for the benefit of the child’s health[22]. However, in real life there are conditions that do not immediately threaten the life of the child, but can definitely lead to a variety of complications or are associated with significant discomfort or suffering (eg, performing operations, putting splint under anesthesia, undertaking cytostatic treatment). In this case the rule for emergency care could not be applied and treatment can not be undertaken without the consent of the patient or in these cases – by the grandparents.
The situation gets further complicated when minor parents between 14 and 16, who have to express their will instead of their children, have a different opinion about the suggested treatment. Art. 124 of the Family Code provides the opportunity to contact the Social Assistance Directorate for assistance or to contact the district court. However, such procedures take time, and as explained, this can lead to serious complications, unnecessary extend the patient’s suffering, cause ineffective, inadequate medical care, and even lead to irreversible consequences for the health of the child. Furthermore, this causes conflicts that are least desirable in a hospital setting and in a situation where the most appropriate decision should be made in regard to the sick child.
Due to the above-mentioned insufficiency of the law, the systematic interpretation of normative acts does not provide adequate solutions to overcome the problem of “impossible informed consent” of minor parents (under 14 and between 14 and 18). It is necessary to create a working regulation that would ensure the timely provision of informed consent for the treatment of children in the listed cases. New regulatory framework is also extremely necessary in order to fulfill the commitments of our country to ensure the highest possible achievable standards of health and to guarantee the right to access to healthcare for each child under the Convention on the Rights of the Child.[23]
- Proposals de lege ferenda
One of the possible solutions to the problems discussed so far is stipulating a special procedure under the Health Act for the appointment of a special representative by administrative order (by a court or by another body with child protection functions) in the case of the birth of a child by minor parents, as this fact itself leads to the risk of not obtaining an informed consent for medical care in any time after his / her birth. Such special procedures, specifically regulated in the Health Act, could solve other problems related to informed consent, for example in cases of disagreement between parents; or when they make decisions againts the child’s interest (denial of blood transfusion, refusal of treatment with certain medicines, premature termination of treatment and other hypotheses, which our current health system often faces).
A special representative of the child may be the head of the medical establishment, the head of the ward / clinic or another physician from the medical establishment.
We will not discuss in detail the procedural aspects of these solution as we believe that these should be the subject of public debate in the context of the health and child justice reform. We will only point out that the purpose of such a proposal is to ensure the speed of decision making in order to guarantee timely, qualitative and affordable treatment, according to the Health Act and the abovementioned norms of the Convention on the Rights of the Child
Another possible solution is stipulating an opportunity for health emancipation of minors. This emancipation would only cover their ability to make certain decisions related to their own health and that of their children. Such possibilities exist in some European countries and in the US, under the term “mature minor”.[24]
The shortcomings of this proposal is that decisions relevant to medical care are characterized by varying degrees of complexity, parents are often stressed, their maturity is different, and all this can not always guarantee the most appropriate solution, i.e. decision in the best interest of the child. In our opinion, if this opportunity for health emancipation of the parents is implemented, an additional agreement or opinion of the Social Assistance Directorate should also be envisaged as a guarantee of the best choice of a decision in the interest of the child and as long as this agreement/opinion can be ensured in a timely manner .
Practice has proven that the fastest and most accurate decisions regarding children’s physical and mental health, and development are taken by the respective professionals. This group of experts mainly includes pediatricians and GPs who are best able to assess the medical risk and possible outcomes of treatment, or the lack of treatment, at any given time but it also extends to other pedagogical and psychological specialists who are directly involved in the development and upbringing of children. Therefore, we should consider very carefully the quality of the figure of the representative and his / her rights in relation to the child. The interests of the child, particularly with regard to his or her health in early childhood when he/she is physically and emotionally most vulnerable, should not be linked to the personal views and wishes of his or her closest people – the minor parents. In situations related to children’s health, we should rather seek objective opinions. Such could be best provided by medical doctors, specialists, alone or as an expert group, depending on the condition of the patient, his/her physiological development, and the type of the disease.
One of the recommendations set out in General Comment No. 15 of the Convention on the Rights of the Child is a review of the national legal and political framework and amendment of the legislation of the signatories of the Convention. The general commentary on the health of adolescent children also draws attention to the special procedures that guarantee their rights. According to Article 4 of the Convention “States Parties shall undertake all appropriate legislative, administrative, and other measures for the implementation of the rights recognized in the present Convention.”. In the context of the right to health and development of adolescents, it is necessary for States Parties to ensure the adoption and application of specific provisions under national law, including the establishment of a minimum age for consenting to sexual activities, marriage and an opportunity for medical treatment without the consent of the parents. These minimum ages should be the same for boys and girls (Article 2 of the Convention) and accurately reflect the recognition of persons under the age of 18 as subjects of rights in accordance with their abilities, age and maturity (Articles 5 and 12 -17). Additionally, adolescents need to have easy access to mechanisms for personally filing complaints, as well as judicial and appropriate out-of-court redress mechanisms that guarantee a fair trial, with special regard to the right to privacy (Article 16 ).
Last but not least, we recommend that healthcare establishments provide and regulate the work of a hospital mediator (hospital ombudsman) to assist in case of problems such as those described in this report. Children’s unfolding abilities have implications on making autonomous decisions about certain health issues, and often this can lead to serious conflicts and problems between them and their parents. The more vulnerable groups of children usually have fewer opportunities to exercise autonomy in decision-making related to their health and medical manipulation. It is therefore essential to have supportive policies for children, and that parents and health workers have adequate, rights-based guidelines on consent and confidentiality.[25] This explanation from the General Comment No. 4 of the Convention on the Rights of the Child is a further argument in favor of establishing mechanisms for supporting young parents in rendering their children medical assistance, namely – establishing normative or internal procedures in the medical establishments themselves in order to ensure access to medical assistance for vulnerable groups of children in the cases described in this analysis. However, for these procedures to be mandatory, they need to be covered by the Health Act or the relevant medical standards.
Another measure that managers of healthcare establishments could implement is to provide conditions and opportunities for alternative dispute resolution within the healthcare establishments. The timely resolution of conflicts arising in a hospital environment affects the quality of the medical care provided. Mediation saves time and resources that are otherwise used to deepen and complicate conflicts; could prevent unwanted events during treatment and recovery of patients that are results of untimely addressed conflicts. The support of such policies is recommended by the prestigious American Accreditation Organization, the Joint Commission, in a number of their reports, recommendations and protocols.[26]
Today, society has a tremendous need to address all these issues and to take adequate legislative measures to ensure that every child has access to healthcare and allow medical professionals to provide the necessary treatment and care to our children.
[1]Saltman, Richard “Healthcare policy and Global Governance”, Palgrave Macmillian, January, 2015., стр. 11
[2]http://www.ipfcc.org/, в режим на достъп от 01.07.2016г.
[3]http://www.who.int/management/quality/assurance/QualityCare_B.Def.pdf, в режим на достъп от 01.07.2016г.
[4] Чл. 87, ал. 1 от Закона за здравето.
[5] Чл. 162 от Закона за здравето.
[6]Арг. от чл. 89, ал. 2, т. 1 от Закона за здравето.
[7] Чл. 87, ал. 4 от Закона за здравето.
[8] Чл. 87, ал. 4 от Закона за здравето.
[9] Чл. 87, ал. 5 от Закона за здравето.
[10] Чл. 87, ал. 6 от Закона за здравето.
[11] Чл. 87, ал. 7 от Закона за здравето.
[12] Чл. 87, ал. 1 от Закона за здравето.
[13] Чл. 89, ал. 1 от Закона за здравето.
[14] Чл. 220, ал. 2 от Закона за здравето.
[15]Към 2016г. в сила на основание чл. 54, ал. 8 от Закона за здравното осигуряване.
[16] Чл. 3 и чл. 5 от Закона за лицата и семейството.
[17] Чл. 88 от Закона за здравето
[18] Чл. 87, ал. 3 от Закона за здравето.
[19] Инвазивна процедура: това е всяка процедура, чието извършване изисква някакво проникване, навлизане в тялото на пациента;
[20] Чл. 153, ал. 3 от Семейния кодекс.
[21] Чл. 4 от Закона за лицата и семейството.
[22] Чл. 89, ал. 2, т. 2 от Закона за здравето.
[23] Чл. 24 от Конвенцията за правата на детето (КПД).
[24] http://pediatrics.aappublications.org/content/131/4/786, в режим на достъп от 02.04.2016г.
[25] Общ коментар 4 към Конвенция за правата на детето.
[26]http://www.jointcommission.org/assets/1/18/wp_leadership_standards.pdf, в режим на достъп от 02.03.2016г.