Stem cells in Costa Rica: a boost for medical research

Regenerative medicine allows the application of experimental therapies using adult stem cells to treat various diseases that so far have been incurable. This branch of medicine has been promoted by the knowledge that stem cells have the ability to become cells of different tissue that the body uses for self-repair. Scientific research has shown that these cells have the potential to regenerate organs and other body tissue.

In 2014, Costa Rica enacted the Biomedical Research Statute, No. 9234, after a drawn-out period of uncertainty for the medical community that had left the country deprived of the gains from foreign and local investment and the subsequent benefits for patients that comes from medical research. Today, the country is benefiting from a rising market of companies and individuals seeking to move their clinical trials to Costa Rica as a result of the business-oriented provisions contained within the statute, as well as the support of local authorities.

One of the flaws of the statute was its omission of the application of regenerative therapies using adult stem cells. The Costa Rican Secretary of Health had considered that under the provisions of the statute these regenerative therapies were illegal.

However, aware of the current developments in science and the benefits of regenerative therapies, the Costa Rican President and the Secretary of Health secured a decisive political victory at the end of 2016 by implementing Regulation No. 39986 on the Authorization for Regenerative Therapy Using Adult Stem Cells. This resulted in a dramatic shift in public health policies coming from a nation that banned in-vitro fertilisation for more than a decade and declared that clinical trials were against the Constitution for several years.

Formal requirements

Under the new section 2, the regulation provides that “no official authorisation is required for transplants of progenitor cells obtained from peripheral blood or transplants of haematopoietic cells obtained from umbilical cord blood when they are indicated for treatment of acute myeloid or lymphoid leukaemia, chronic lymphoblastic or myeloid leukaemia, Hodgkin or non-Hodgkin lymphoma as the more frequent causes or to a lesser degree for severe aplastic anaemia, nocturnal paroxysmal haemoglobinuria, immune system diseases, some haemoglobinopathies, hereditary metabolic diseases, as well as multiple myeloma and some solid tumours”.

Moreover, therapies are subject to authorisation where the stem cells are exposed to more than minimal manipulation. The regulation follows the standards of science in section 1 providing that minimal manipulation entails processing that does not alter the relevant biological cell characteristics and includes nonproliferation conditions.

On the other hand, more than minimal manipulation involves processing that alters the relevant biological cell characteristics, such as when adult stem cells are subject to expansion during the cell cultivation and storage steps and in the nutrition, simulation, or intervention processes.

In both scenarios, any party interested in obtaining authorisation to implement therapies for regenerative purposes must submit an application in writing to the local Health Controller attaching formal requirements that include:

(i) Evidence that the therapy has completed preclinical studies that, as in the case of medications, demonstrate that they are effective and safe for use in clinical practice;

(ii) The complete characterisation of the cell types that will be transplanted and their characteristics, cellular processing and production;

(iii) The description of the cells and how they will be administered, including assistive drugs, agents, and surgical procedures;

(iv) A clinical follow-up plan and data records to ensure that the cellular therapy is effective and has no adverse effects; and

(v) Credentials substantiating training in stem cell therapy for the staff who will carry out the procedure.

If requirement (i) is not met, the procedure must be performed using a research protocol as set forth in the statute mentioned previously.

Before the new regulation was implemented, the criterion of the Secretary of Health was that all types of regenerative therapies were subject to the investigational protocol, leaving the country unattractive for patients and practitioners enthusiastic to apply therapies that are effective and safe for use in clinical practice.

Clinical research and regenerative therapies are an essential part of the approval of new drugs and human health findings. A comprehensive legal framework encourages the science and technology sector to invest in the country. It is of utmost importance to encourage sponsors and all parties managing the investigation and application of therapies to comply with all applicable rules and standards, without disregarding the importance of the protection of a patient’s rights.

María del Pilar López is a partner at Zürcher Lawyers. She handles all aspects of IP practice, assisting companies with strategic portfolio development and management, counselling on the registration of rights, enforcement policies, advertisement and promotion of innovations. López has established a life sciences and data privacy practice in order to comply with clients’ demands in these areas. She can be contacted at: plopez@zurcherip.com

Esteban Monge is an attorney at Zürcher Lawyers. He provides advice on a variety of areas of IP law, including counselling on aspects such as product development and testing, advertisement, regulatory compliance and enforcement strategies. He can be contacted at: emonge@zurcherip.com