New standards for stem cells

Clinical research plays a crucial role in the approval of pharmaceuticals and the improvement of patients’ lives. In Costa Rica, clinical investigation is governed by the provisions of the Biomedical Research Act, Law No. 9234, and Regulations Nos. 39061-S.

Despite the existence of this legal framework, in May 2018 the Ministry of Health and the Executive Branch implemented Regulations Nos. 41183-S, called Regulations for the Clinical Investigation of Adult Stem Cells. Since the enactment of this legislation, Costa Rica has benefited from direct foreign investment in research and development, and the value this brings to access to the latest knowledge and technology.

On the matter at hand, the scientific community has agreed on various routes by which stem cells can be obtained: (i) embryonic stem cells, which are derived from an embryo, and thus are inadmissible both legally and ethically; (ii) cells obtained from the umbilical cord of a newborn child; and (iii) adult stem cells that may be obtained from bone marrow cells, and which can also be obtained from adipose tissue.

The new regulations show that clinical research of stem cells is a promising area within restorative or regenerative medicine, but that its development is still in an experimental period in many of its potential applications.

Therefore, the requirements for the investigation and the application of stem cell therapies are very different from those of traditional clinical investigation of pharmaceuticals and vaccines. This is because these regenerative therapies deal with living material that must be processed and stored in completely different ways, so different standards should apply.

Comprehensive framework

The new regulations create a comprehensive framework regarding the establishment of clinical investigations of adult stem cells. As a founding base, the regulations establish that clinical investigations using embryos or embryonic stem cells are forbidden.

In addition, they provide that clinical investigation of adult stem cells that have suffered more than minimal manipulation are subject to all existing regulations for pharmaceuticals, including compliance with preclinical studies, and clinical studies of phases I through IV.

In addition to the requirements to obtain authorisation for a clinical investigation according to the provisions of the Biomedical Research Act, Law No. 9234, and Regulations Nos. 39061-S, the new regulations establish that clinical investigation of adult stem cells should focus mainly on patients who have no other therapeutic options, justifying broadly the inclusion of people who do not meet this criterion.

There should be a rigorous assessment including the risks and potential benefits of the investigation, and a long-term follow-up of the adverse effects.

The new regulations establish the requirements for the extraction, import, and quality standards of the application of the product to patients. In addition, they regulate the standards of the investigation protocol which must indicate the specifications required for each of the preparations of adult stem cells, in order to confirm the quality of the preparation during the different phases of its elaboration before their use with human beings.

Finally, for the characterisation of each cell type, the protocol must consider the identity, dosage, power, purity, and security of the adult stem cells.

Although clinical investigation still creates uncertainty due to its possible effects and ethical nuances, a comprehensive legal framework encourages science and the development of new alternatives for patients.

Regenerative therapies offer new possibilities for the treatment of human diseases, but also present new challenges for the medical community and the legal system. Nevertheless, Costa Rica has encouraged for years the establishment and development of clinical investigations, regenerative therapies, and new alternatives for patients and foreign businesses seeking to take advantage of the benefits in the country.

María del Pilar López heads the IP and life sciences group at Zürcher Lawyers. She assists companies with strategic portfolio development and management, regulatory and compliance, counselling on the registration of rights, and enforcement policies, in industries such as pharmaceuticals, biotechnology, and medical devices. She can be contacted at: plopez@zurcherip.com

Esteban Monge is an attorney at Zürcher Lawyers. He has broad experience in IP. Monge provides advice on a variety of areas of IP law, including product development and testing, advertisements, regulatory and compliance, and enforcement strategies. He can be contacted at: emonge@zurcherip.com