In theory tissue engineering sounds like a great advancement for the healthcare industry, so what could possibly go wrong you may ask? Well like everything else in healthcare there is always some kind of risk that needs to be addressed. Tissue engineering will eventually dissolve the need for organ transplants and in the process save millions of people’s lives. Like I stated in my previous two posts, tissue engineering will eliminate the need to wait for a transplant because a new organ will be created in only a short amount of time with that individuals cells. But before we start to sign our lives away in the process let’s look at what could go wrong and the legal issues that occur.
With new innovation comes new laws and regulations that have to be put into play to insure that someone will be held liable if something tragic occurs. In this case, tissue engineering is still new so there has not been many clinical trials to ensure that this procedure is safe and effective. Since tissue engineering is not in full effect in the healthcare industry quite yet the legal issues first have to start out in the trail stage. In the journal “Liability Versus Innovation,” Keren-Paz, a student at Keele University School of Law in the United Kingdom discusses the legal process that has to be done to ensure that malpractice is not occurring in the clinical trial period. Keren-Paz states that their ultimate goal is to guarantee that both the “innovation is done responsibly” and that the “legal outcome is fair to the patients.” In order for clinicians to hold trials every patient much first be informed about the treatment they are receiving and the risks that could occur. With new innovation happening in healthcare the patient must know that the specific procedure is new and there are still uncertainties. By receiving an informed consent from the patient the clinician can now continue with the treatment. Next, even if the doctor informs the patient about all the risks and benefits of the treatment they can still be held liable for negligence if something goes wrong. Before a doctor can be labeled as negligent a court must first decide if the doctor was actually negligent or if they did everything correct and the procedure itself was negligent. Along with defining the negligent act the courts must also determine if the “unforeseeable risks to the patients are foreseeable benefits to the third party.” Lastly, Keren-Paz poses the question of whether these laws restrict the innovation of regenerative medicine.
Tissue engineering will one day save millions of people’s lives and the hope is one day people will not have to die waiting for a transplant. Since this innovation is still new it has to be tested and in the clinical trials meet the legal requirements above. Once that is done and the treatment is on the market, humans will then be able to live longer and healthier lives.