Abstract
Numerous and diverse participants are involved in the development of novel therapies: patients, physicians, scientists, sponsors, governing bodies, lawmakers, institutional review boards, and bioethics proponents. While the welfare of the patient must always and unquestionably be at the forefront of any intervention along with informed consent, their wishes, their requests, and their expectations should also be considered at every step. The availability of stem cell research in various countries with dissimilar regulatory agencies has opened the door for thought-provoking questions about their validity from an ethical, legal, and moral perspective, which will be addressed in this chapter, framed within the doctor-patient relationship
In 2010, the Ministry of Health of Costa Rica disallowed stem cell therapy, citing concerns about the experimental nature of these procedures. This abrupt decision left several patients unable to continue receiving treatment at the San José hospital – most notably, a young pilot suffering from spinal cord injury after a 2008 airplane accident that rendered him paraplegic with no perspective of ever regaining mobility, according to two independent physicians. Having experienced encouraging progress in muscle recovery and bowel and sexual function following stem cell therapy, [1] he promptly filed a legal remedy for protecting his constitutional rights to the Supreme Court of Costa Rica, along with other patients in a similar predicament. In their appeal, they argued that patients had “a right to exhaust all technically feasible procedures to recover [their] health and quality of life”, citing Article XI of the 1948 American Declaration of the Rights and Duties of Man (the right to the preservation of health and well-being) [2]. This right should not, they contended, be limited by a political authority. Additionally, they invoked the American Convention on Human Rights, namely Articles 5 (the right to physical integrity) and 2 (whereby States Parties undertake to adopt (…) legislative or other measures to grant the rights or freedoms enshrined in The Convention). Lastly, none of the plaintiffs declared having experienced any adverse effects from their therapy at the time of the appeal; they had, in fact, perceived improvements in their health condition.
The Supreme Court ruled that medical treatments had to be permitted by law before their implementation, as had been argued by the defendant (the Ministry of Health). While the judges acknowledged the principle of patient autonomy, the doctor/patient relationship, human dignity, and the right to health, selecting a treatment should rely on the law. However, the Court also recognized that no adverse events had been noted throughout these treatment cycles with stem cells and that they had no factual or legal arguments to halt the treatments that had already begun. The plaintiffs were therefore permitted to continue their therapy.
Six years later, presidential decree n°39,986-S authorized regenerative therapies with adult stem cells in Costa Rica, based on national scientific recommendations, under the human right to health access principles, and citing decades of past research on the safety of hematopoietic stem cells transplants [3]. Therein are outlined the requirements to be submitted by those seeking stem cell therapy administration: safety profile, scientific rationale, cellular characterization, administration, and requirements for the qualifications of health professionals and facilities. While the decree makes a distinction between minimally manipulated and more than minimally manipulated cells, both are permitted with different avenues for authorization.
This Costa Rican case is pivotal because the Supreme Court ruling marks the first legal precedent in a Latin American country that allows patients who are already being treated with stem cells to continue their treatment – a first step, perhaps, to implement international legislation on stem cells. Following the law to the letter in that instance proved to be rather impractical, falling almost into irrationality as it limited the right of access to health for patients who required treatment as a last resort, and going against international law, which stipulated that Costa Rica must have taken the necessary legislative, economic and political measures to facilitate access to the said right to health. The subsequent presidential decree is also a landmark case since it authorizes using a non-minimally manipulated therapeutical product currently not permitted in other jurisdictions, notably in the USA according to the Federal Drugs Administration (FDA) guidance. The compassionate use of or access to drugs and new therapies remains limited on the grounds of minimizing harm to terminally ill patients [4]. How much evidence is necessary to release a given drug or a given experimental therapy? Are Phase I studies sufficient? Can effectiveness be shown at this stage? Answers remain unclear
