Possible Legal issues that could arise from Banking of cord blood
Cord blood is the blood that is derived from the umbilical cord or the placenta tissue of a newborn baby, it is derived by inserting a needle into the vein of the umbilical cord and connecting the needle to a blood bag. Only about 75ml of blood can be collected from an umbilical cord at a time. There are several uses of cord blood in regenerative medicine, and one of them is that it could be used in the treatment of hematopoietic and other genetic disorders because it contains a high amount of stem cells.
The banking of cord blood has become increasing because of its importance, and we have over 600,000 cord blood banks globally now. The purpose of the Cord Blood determines the method of banking it, as there are two methods of banking Cord Blood, which are: Private cord blood banking and Public cord blood banking.
Public cord blood banking is a case whereby the cord blood is collected and stored for persons unrelated to do the donor, while the Private cord blood banking is a case where the family of the donor orders the storage of the cord blood, and also pays the cost of the storage. The private cord blood banking is mostly ventured into by the people because of the possibility of needing cord blood that may arise, either by a family member of the donor or by the donor himself. The idea behind Private cord blood banking has caused lots of controversies, since in reality most donors of cord blood barely use it, and research has shown that only 1 out of 200,000 donors will end up using his cord blood. In essence, Cord Blood banking is a very sensitive process because ethical and legal cases can be easily made in respect of it. For this reason, several Laws have been implemented in several states in the United States to regulate Cord blood banking, and the following are some Laws regulating Cord Blood bank that have been made in some states in the United States.
• Umbilical Cord Blood Banking Program Act: This act was implemented in Mississippi in 2014 it provides that the umbilical cord blood banking awareness program should be organized by health care service providers, and it also provides that educational materials that people on the importance of cord blood donation should be produced.
• Bill 102: This was passed in Ohio in 2009, this bill provides that the health department of the state should produce materials to educate people about cord blood banking and that pregnant women should be informed about the option of donating cord blood before the end of their third trimester.
• The Umbilical Cord Education, and Donation Act: This act was implemented in Pennsylvania in 2008, and the law provides that, the health care providers should inform pregnant women about the option of cord blood banking before the end of the second trimester.
Despite the several laws that regulate cord blood banking and donation in different states in the United States, it has not erased the possible legal issue that could arise from it and will be considering the possible legal issues that could arise from cord blood banking below.
• Consent: Since the cord blood is extremely useful for both clinical and research purposes, the consent of its collection will be a little difficult to justify. In addition to this, there are lots of issues that relate to consents that still have to be unanimously agreed upon. For instance, questions relating to when consent could be obtained and from whom consent should be obtained is yet to be given a unanimous view, the position we have today is the policy for consent required for cord blood collection is different from banks to banks, which is not potent to solve potential legal issues that might arise in the future. Another important issue that is tied to who gives consent, is the fact that naturally the cord blood is formed because of the birth of the child and should be drawn from the child, which makes the child a legitimate owner of such tissue. But, in some cases, the cord blood could be derived from the mother other than from the child. This will mean that the mother will become the legitimate owner of the cord blood whose consent will be required when needed. This is one of the questions that could arise because it is difficult to determine who should legally give consent whenever consent is needed.
• Issues relating to property right: This is another emergent issue that concerns cord blood banking, because cord blood is considered as a type of tissue, and property right questions and issues can ensue at the instance of the donor of the cord blood. Although this was not usually the case because initially the common law never recognized cord blood banking as an important aspect with which property law right could be asserted unless it has been preserved through some work and skills. But this position has changed over time, as the law has started to recognize property law issues that could arise from tissue economy, including cord blood banking, even where it is not dependent on any work or skills. Therefore, tortuous and contractual issues like negligence, possession, bailment, right of use, and breach of agreement, could arise from the banking and use of cord blood. Other issues like the gift of cord blood are also a right that is exercisable by the donor of the tissue, which implies that an individual can give the out his cord blood without having to collect money for it since ‘gift’ is a recognized property transaction. For this reason, a donor or parent of the donor has the right to withdraw cord blood that is already banked on their term, and they may decide to gift the cord blood to a public cord blood bank or to an individual.
• The principle of the respect for human dignity and integrity: This is also an important legal issue that may arise from the cord blood banking, because of the principle that prevents the commercialization of human tissue which is pointed out by the European Union Group on Ethics on the 21st July 1988 in its opinion number 11. And according to the opinion, cord blood is a type of human tissue, and the commercialization of it would be unlawful. However, in a case where consent is validly granted by the donor, this legal provision can be lawfully circumvented. Furthermore, the purpose of the donation must be lawful and where the purpose of the donation is not lawful, the donation will still be regarded as unlawful.
• The principle of proportionality must be respected: Principle of proportionality, in this case, means there must be a balance between the means, and the goal, so that more cord blood would not be banked without any purpose or possibility of granting this blood to those that need it. The major justification for cord blood banking is the fact that it can provide treatment for several health conditions such as; hematopoietic and other genetic conditions. Therefore, the major focus of these banks should be to obtain cord blood that is sufficient to help treat as many people that are suffering from these medical conditions, the purpose of cord blood banking should not be for mere aesthetic value i.e. purposes that are not medical in nature, and it should not be used for medical researches that are unethical.
• The Obligation of Non- Maleficence or the Obligation to do no harm: Cord that is banked or stored must not be used for medical research that is unethical, the right of the vulnerable people must be protected, the privacy, as well as the confidentiality of donor, must also be protected. Information relating to a donor of cord blood cannot be maliciously published and it cannot be breached as well. These details are very confidential and must not be publicly stated without the approval of a concerned donor.
The possible legal issues that may arise from Cord blood banking have been discussed above, and the following recommendations are made in view of these legal issues.
• The central accrediting agencies must adopt similar standards for the accreditation, and the inspection of cord blood banks and the compliance with the uniform standards must also be monitored by the agencies.
• A uniform regulation governing compliance must be adopted by policymakers and government agencies.
• Policymakers must also make policies on the list of things that cord blood should be Legally used for, and illegal use of cord blood should be totally condemned.