The Legislation of Mexico and Stem Cells

Within Mexican laws, there are enough elements to make the use of stem cells viable, chiefly as explained in the previous article titled “Regenerative Medicine and Stem Cells in Mexico: Advances, Initiatives, and Legal Landscape“

During the First Inter-American Congress for the accreditation of clinical laboratories, blood banks, and hematopoietic progenitor cells, Dr. Angel Guerra Márquez gave a keynote presentation on the subject.

The Legislation of Mexico and Stem Cells

Mexican Legislation

Emphatically, Mexico has made significant legal advancements in regenerative medicine. Additionally, this ensures that the development of therapies is implemented with logical and appropriate regulations for the progress of regenerative medicine. Firstly, we present the laws that have seen advances in this regard:

1. Constitution of the United Mexican States
2. General Health Law
3. Regulation of the General Health Law
4. Official Mexican Standards (NOM)

We will now mention various articles to move from abstract to practical aspects. This allows readers to verify and see the legal benefits of Regenerative Medicine.

Constitution of the United Mexican States

Article 4th

• Every person has the right to health protection.
• The law will define the bases and modalities for access to health services.

General Health Law

Article 3rd

• In terms of this law, it concerns general health.
• The health control of the disposition of organs, tissues, their components, and cells.

Title Fourteenth: Donation, Transplants, and Loss of Life

I. Common Provisions

Article 313

• The Ministry of Health is responsible for the health control and surveillance of the disposition and transplants of organs, tissues, and cells of humans. Through the decentralized body called the Federal Commission for Protection against Sanitary Risks.
• It establishes and directs health policies regarding the donation, procurement, and transplantation of organs, tissues, and cells. With support from the National Transplant Center and the National Blood Transfusion Center.

Article 316

• Establishments conducting acts of blood disposition, blood components, and hematopoietic progenitor cells must have a Transfusion Medicine Committee, subject to the provisions issued by the Ministry of Health.

Article 316

• Healthcare establishments using progenitor or stem cells for tissue regeneration must have the Internal Transplant Committee referred to in Article 316 of this Law.

II. Donation

Article 321 Bis

• The Ministry of Health will ensure that every obstetric care establishment systematically requests the voluntary and altruistic donation of placental blood from every pregnant woman. This is to obtain stem cells for therapeutic or research purposes.

Article 327

• The commerce of organs, tissues, and cells is prohibited. Their donation for transplants will be guided by principles of altruism, non-profit, and confidentiality, making their procurement and use strictly free of charge.

III. Transplantation

Article 330

• Transplants of organs, tissues, and cells in living humans can take place when research results are satisfactory, representing an acceptable risk to the health and life of the donor and the recipient, and provided there are therapeutic justifications.

Article 338

• The registration of transplants of progenitor or stem cells will be handled by the National Blood Transfusion Center.

Article 340

• The health control of blood disposition will be exercised by the Ministry of Health through the Federal Commission for Protection against Sanitary Risks.

Article 341

• The disposition of blood, blood components, and hematopoietic progenitor cells for therapeutic purposes will be managed by blood banks and transfusion services established and operated by applicable provisions. Blood will be considered tissue.

Article 341 Bis

• The Ministry of Health and state governments, in their respective areas of competence, must promote the donation of hematopoietic progenitor cells to assist in the treatment or cure of patients who require them. The Ministry of Health will establish the bases and modalities to which the National Health System will adhere in this regard.

Article 341 bis

• The Ministry of Health will issue regulations governing both the infrastructure that blood banks carrying out acts of disposition and distribution of hematopoietic progenitor cells should have, as well as the procurement, processing, and distribution of these cells.

Regulations

• Regulation of the General Health Law regarding Health Control of Organs, Tissues, and Corpses of Humans.
• Regulation of the General Health Law regarding Transplants.

Official Mexican Standards (NOM)

• NOM253-SSA2-2012, for the disposition of human blood and its components for therapeutic purposes.
• Draft-NOM-____SSA1-2015 for the disposition of stem and progenitor cells for therapeutic and research purposes (17 references to laws, regulations, and NOMs).

Conclusion:

In conclusion, Mexican laws regarding regenerative medicine and stem cells reflect a significant commitment to health protection and scientific advancement. Likewise, these regulations provide a logical and appropriate framework for the development of innovative therapies, promoting altruistic donation, and prohibiting the trade of organs, tissues, and cells. Certainly, the legal structure establishes clear guidelines for research, transplantation, and disposition of progenitor cells, ensuring an ethical and therapeutic approach in the application of these technologies. Additionally, the importance of specialized committees and collaboration between institutions is emphasized to guarantee proper and ethical management of practices. Practices related to regenerative medicine in Mexico.

The Legislation of Mexico and Stem Cells

finally, if you want to know more about regenerative medicine. I invite you to read our article “What is Regenerative Medicine?”