Since 2016, Stem cell treatments are legal in Costa Rica. The Regulation to authorize regenerative therapy using adult stem cells was approved on 2016. Bylaw number 39986-S replaced a bill that failed in 2014.

The Regulation came to identify the different types of regenerative stem cells therapies that are legal in Costa Rica and the process of obtaining the specific permits to operate such therapies.

The law categorizes in 3 the therapies:

Category 1

Progenitor cell transplants obtained from peripheral blood or haematopoietic cell transplants obtained from umbilical cord blood do not require authorization from the Health Authority, when indicated for the treatment of acute myeloid or lymphoid leukemia, chronic lymphocytic or myeloid leukemia, Hodgkin lymphoma or non-Hodgkin lymphoma , as more frequent causes or in a lesser case for severe aplasic anemia, paroxysmal nocturnal hemoglobinuria, immune system diseases, some hemoglobinopathies and hereditary metabolic diseases, as well as in multiple myeloma and in certain solid tumors.

Category 2

Therapies whose stem cells are exposed to more than minimal manipulation[1] will need authorization from the Health Controller. Anyone interested in obtaining authorization to implement therapies, whose adult stem cells are exposed to more than minimal manipulation, for regenerative purposes, must submit to the corresponding Health Authority, a request that includes:

  1. Evidence that the therapy has completed preclinical studies, which, same as drugs, demonstrate that it is effective and safe for use in clinical practice. If this requirement is not fulfilled, the procedure must be carried out under a research protocol, as provided in Law No. 9234 of April 22, 2014 "Regulatory Law of Biomedical Research" and Bylaw No. 39061-S of May 8, 2015 "Regulation of the Biomedical Research Regulatory Law".
  2. The complete characterization of the cell types that will be transplanted and their characteristics, cellular processing and their production.
  3. The description of how the cells will be administered, including adjuvant drugs, agents and surgical procedures.
  4. A clinical monitoring plan and data records to ensure the effectiveness and adverse effects of cell therapy.
  5. Original and copy of the title or certificate stating the training on stem cell therapies of the personnel who will perform the procedure.

Category 3

Those therapies with adult stem cells will be authorized by the Health Controller for exclusive autologous use, for regenerative purposes and where their cells are exposed to minimal manipulation[2].

Anyone interested in obtaining authorization to implement therapies with adult stem cells for exclusive autologous use, for regenerative purposes where their cells are exposed to minimal manipulation, must submit a request to the Health Authority that includes:

  1. Scientifically reasoned justification that this procedure has a reasonable chance of success, including any preclinical or clinical evidence of proof of concept, of its efficiency and safety. If this requirement is not fulfilled, the procedure must be carried out under a research protocol, as provided in Law No. 9234 of April 22, 2014 "Regulatory Law of Biomedical Research" and Executive Decree No. 39061-S of May 8, 2015 "Regulation of the Biomedical Research Regulatory Law".
  2. Clinical justification of the reason why this proposal for stem cell treatment should be implemented, compared to existing treatments.
  3. The complete characterization of the cell types that will be transplanted and their characteristics, the process and their production.
  4. The description of how the cells will be administered, including adjuvant drugs, agents and surgical procedures.
  5. A clinical monitoring plan and data records to ensure the effectiveness and adverse effects of cell therapy.
  6. Original and copy of the title or certificate stating the training in stem cell therapies of the personnel who will perform the procedure.

Costa Rica plays an important role in Stem cell investigations and therefore our regulatory laws intend to promote and allow our country to become a medical hub of stem cells treatments in the world.