Stem cells are a type of cells with a special ability to transform into any type of cells with specialized functions. In other words, stem cells have the natural ability to generate various types of cells. These cells have a great role to play in regenerative medicines because they can be applied to people to rejuvenate and restore their diseased or damaged tissues. Such application of stem cells to treat an ailment or disease refers to stem cell therapy.
Stem cells are derived from 5-6 days embryos. Such embryonic stem cells are often taken from in-vitro fertilized embryos on a pure donation basis. Other sources are adult tissues like fat and bone marrow and amniotic fluid as well as umbilical cord blood. Somatic cells can too be converted into stem cells by introducing certain genes into those cells. Out of all these, embryonic cells have the least level of specialised differentiation.
This therapy had its origin in the late 1950s when six nuclear researchers who had been unintentionally exposed to radiation were saved by the first stem cell transplant of bone marrow grafts in 1958 thanks to the work of a French oncologist named Georges Mathé. Later in the 1960s, these cells were used to cure leukaemia. The industry of stem cell therapy has grown manifold over the years. The market for stem cell therapy, which was estimated to be worth $205.1 million in 2021, is expected to increase at a CAGR of 16.2% from 2022 to 2031 to reach $928.6 million which makes it imperative to be regulated.
REGULATIONS AROUND THE WORLD
The U.S.A.- The US government started strictly controlling the use of human embryos for research in the 1970s. The use of stem cells was often regarded as an immoral activity since embryonic stem cells, as they are also known, are derived from fertilised embryos. Since that time, medical advancements have introduced doctors to sources of stem cells other than human embryos. Today, stem cells can be extracted from a patient’s fat tissue, donated umbilical cords, and even other patients. Despite stem cells being obtained more morally, their use has not been permitted to increase in the United States.
Spain- With several rules and regulations that apply to various areas of the study, Spain has a comprehensive regulatory framework for stem cell research. Research on embryos is permitted for both therapeutic and scientific reasons under the Law on Biomedical Research. As stated in the following excerpt from the act’s preamble, the production of embryos especially for research is prohibited.
China- The regulatory framework in China was poor in terms of governing stem cell therapy and research in the country before 2003. In response to objections from abroad that Chinese officials were slack in their supervision and implementation of ethical rules for stem cell research, the government released its most recent stem cell research regulations in 2003. Advertisements of unproven cures through this therapy were rampant even after this. Between 2015 and 2019, China’s National Health Commission (NHC) and the National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), established several progressive initiatives to tighten the rules governing stem cell translational research.
REGULATIONS IN INDIA
The first attempt in the direction of regulation of this industry was taken in 2007 by the India Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) jointly. The guidelines issued were aimed to ban reproductive cloning and ensure that clinical trials were permitted only when carried out by certain ethical committees. The 2007 guidelines were revised and finalized in 2013. The prominent change was to remove the word “therapy” to show that stem cell therapy is “not a part of the standard care.” Consequently, the guidelines delivered that until the effectiveness of this therapy is proven, there can be no guidelines for stem cell therapy. Now as per the guidelines in 2017 for stem cell research haematopoietic stem cell transplantation that too under certain conditions is the only approved indication for stem cell therapy at this time. All stem cell therapies other than these are to be used only in the context of clinical trials after receiving all required regulatory clearances. Any additional use of stem cells outside of clinical trials will be viewed as unethical and is therefore not permitted. The Drug and Cosmetics Rules, 1945 were suggested to be amended on April 4, 2018, to include stem cell activities in the definition of “new drugs” and to control their use. But it exempted “minimally modified stem cells” from the definition of a “drug” and created an exemption from the reach of the laws. Before the rules come into play, “Stem cell-derived products” were included in the New Drugs and Clinical Rules, 2019 without any exceptions being provided for minimally modified stem cells. But the phrase “stem cell-derived products” has not been defined in the rules. The same goes for New Drugs, Medical Devices, And Cosmetics Draft Bill 2022. In December 2022 National Medical Commission declared that advertisement and promotion of stem cell therapy for autistic disorders will be considered professional misconduct. This brings some enforceability in such a regulatory framework where guidelines are not binding.
The guidelines issued by ICMR and DBT have no statutory enforceability. ICMR is a research organization of the government whose role is restricted to “formulation, coordination, and promotion of biomedical research.” The DBT, on the other hand, was established to promote biotechnology in India but has no authority to impose restrictions on medical facilities. Both of these organisations lack the regulating power over the clinics as a result private clinics are unregulated in India to a large extent.
Many stem cell therapy clinics advertise their unproven cure for certain diseases. Although this is in clear violation of the Drugs and Magical Remedies (The Objectionable Advertisements) Act of 1954 which prohibits the false advertisement of drugs and magical remedies, many organisations carry out such treatment under the disguise of the clinical study. Guidelines are not being enforced properly because of a lack of statutory backing. This creates a chance for such clinics to charge exorbitant prices and exploit customers.
Another issue is in the collection of stem cells for research work from the umbilical cord. Such collection will raise fewer ethical questions because it’s safer and doesn’t affect the embryo in any way but government hospitals are not being proactive in this approach. The cord is just discarded after the delivery.
Union legislation regulating and governing this soon-to-be billion-dollar industry is the need of the hour. The guidelines issued by research institutes need to be made enforceable by creating their statutory backing so that malpractices under the disguise of clinical trials by some clinics are stopped. Another point to be considered is the need to out define the terms like “stem cell-derived products” so that no loopholes are left once the regulation truly kicks in. A government-led approach in terms of the collection of stem cells at least for the initial phase would be the most viable option as the process will be ethical given that a democratic government at the end of the day is accountable to its people.
With gene editing tools like CRISPR being applied in the research field at a degree greater than ever before, research and work in stem cell therapy have increased manifold. Stem cell therapy and research have expanded the knowledge of diseases, and the testing of new drugs and regenerative medicines. Stem cell therapy is undeniably the next revolution in the medical industry. To ensure that the industry continues to grow and evolve, certain enforceable regulations need to be made, national legislation is the first step in the process.
Author(s) Name: Rahul Ranjan (National Law University Odisha)