The Challenge of Unregulated Regenerative Medicine – A Latin American Perspective
by
M. Ignacia Cádiz, MsCFernando Figueroa, MDUniversidad de los Andes
Santiago, Chile
Over the past decades, traditional medicine has been negotiating the unique challenges brought forward by the advent of advanced medical therapies and regenerative medicine. To this end, the regulatory boards of the world's major powers, mainly the FDA (US) and the EMA (EU), have developed extensive guidelines that set the standards by which scientists, clinicians, patients, and the biomedical industry move from research to clinical application under high quality standards. The dilemma is to properly balance the needs of all actors involved.
In Central and South America, the challenge remains partly non addressed. Of more than 20 countries that make up the region, two thirds do not have specific regulations for regenerative medicine or only mention biological treatments in their health rulings, alluding to organ transplants or blood donation. This situation leaves cellular medicine and therapy centers in most of the developing countries in our region with few alternatives: to establish their own criteria in the development of a ATMPs, to follow international standards that ensure the quality of their product or… to become part of the problem!
In this context, although there are laboratories that develop therapies following a strict scientific method, currently a great majority of centers (or “clinics”) offer therapies without adequate facilities, or quality controls required to ensure good manufacturing practices (GMP) that minimize patient risk. Some of these clinics tend to profit from a so-called “regulatory paradise” that nurtures medical or cell tourism.
In an effort to assess these risks, we have made a search of Centers that offer such therapies, mainly in countries without specific regulation on ATMPs such as Dominican Republic, Venezuela, Honduras, Bolivia, Peru, Ecuador, Guatemala, El Salvador, and Paraguay, among others in the region. Often their websites are no more than social network profiles, including direct to consumer advertising of up to 200 different services at the mercy of the criteria applied by the provider. Frequently the label for "stem cell therapy" is widely exploited, given the mix of public interest, misunderstandings, and lack of knowledge on this subject.
However, we must also highlight countries such as Brazil, Colombia, or Argentina, providing a reference for standardization in our region. These countries have developed specific regulations for advanced therapies, that stem from a wider understanding -within their Health Agencies- of the similarities and differences of legal requirements for traditional pharmaceutical medications, as opposed to this new type of biological products.
Indeed, this has fueled innovative and complex clinical trials, such as the recent one (2022) authorized by the National Health Surveillance Agency (ANVISA) of Brazil, for the first CAR-T gene therapy in the region. In contrast, other countries in the region promote the influx of multinational biotech and other life science companies, exhibit a legislation that addresses stem cells only for research purposes, thus hindering the progression of preclinical research into translational or clinical Trials.
On the other hand, countries such as Chile have a patchwork legislation, with no specific reference to ATMPs. Furthermore, recent laws regulating clinical trials (Laws 20.120 & 20.850) introduce peculiar requirements, such as a non-fault compensation for events occurred up to 10 years after the Trial, or life-long free provision of treatments to study subjects. This type of solution for ATMPs is what we have previously described as “Magic Realism”[1]. Earlier this year, the Chilean Institute of Public Health (ISP), has issued a first and promising Technical Guide for Biological therapies2, based on the recommendations of the World Health Organization (WHO). Of course, this proposal must navigate a complex legal scenario prior to enforcement. Thus, there is still a long way to go not only in Chile, but also in the whole center and south of our continent, to bridge the gap between technical guides or proposals and legal rulings covering the full range of topics from quality control to clinical trials and marketing approvals. Along these lines, we should aim to count on a worthy cadre of scientists and technicians, trained under common legislative minimums imposed by leading institutions such as FDA (CFR21), EMA (regulation 1394/2007) and WHO (Pharmacopoeias). Such agencies have longstanding experience, in regular and accelerated approval pathways, eventually applicable as main tools aiming towards the achievement of a world-class development in biomedical innovation in our Region.
Both lay public and experts from the field experience the need to strike the right balance for the protection of research subjects and their options to access safe therapies, while fostering the development of an innovative biomedical industry able to strive during the uncertainties. Hopefully, our legal rulings should become a part of the solution.
Current situation legislation by country in Central and South America
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