Bill 18.

Summary.

The bill establishes a framework for the use, administration, and trade of injectable body contouring and filler substances in facial and body medical aesthetic treatments in the Republic of Panama (República de Panamá). It covers preventive measures and comprehensive care for people affected by prohibited substances. It would apply to individuals and entities in the public and private sectors that produce, import, export, market, donate, use, or administer these substances. It defines nonabsorbable biopolymers and polymers, permitted and prohibited substances, procedures for removing prohibited substances, and iatrogenic allogenosis.

The Ministry of Health (Ministerio de Salud) would issue lists of permitted and prohibited substances no later than thirty days after the law takes effect. It would update them every ninety days and whenever necessary, taking traceability findings into account, among other matters, and publish them through its communication channels and website. Administering substances on the prohibited list for medical aesthetic purposes would be forbidden. Permitted substances could be administered only by qualified dermatology and plastic surgery specialists accredited by the Technical Health Council (Consejo Técnico de Salud), or by qualified general practitioners with aesthetic competencies and the required accreditation. Administration would be limited to public or private health establishments authorized by the Ministry of Health and holding the required current permits. Informed consent would have to specify aftercare, product components, possible complications, adverse effects, and risks.

Importation, exportation, and marketing would be limited to substances listed as permitted by the Ministry of Health and holding sanitary registration. Within no more than sixty days after the law takes effect, the ministry would implement an interoperable information register covering sanitary registration and permits for marketing and use. Participants in marketing would report information identifying the substances’ origin and each party to the transaction. The Ministry of Health and the Social Security Fund (Caja de Seguro Social) would conduct nationwide campaigns addressing risks, measures for affected people, offenses, penalties, reporting channels, and ways to consult lists of permitted substances and authorized professionals and institutions, including information on precautions concerning procedures performed abroad.

The State would provide mechanisms, health programs, and facilities for comprehensive medical and psychological care for people with iatrogenic allogenosis, ASIA syndrome, or other illnesses caused by prohibited substances. The Ministry of Health and the Social Security Fund would implement a plan covering diagnosis, treatment, rehabilitation, removal or management of substances, medicines, mental health treatment, and psychosocial support, regardless of where the substances were administered. A special commission would develop a medical treatment protocol and examine studies and treatment techniques. Its members would represent the Ministry of Health, the Social Security Fund, the Epidemiology Committee of the National Secretariat for Science, Technology and Innovation (Secretaría Nacional de Ciencia, Tecnología e Innovación), the University of Panama’s Faculty of Medicine (Facultad de Medicina de la Universidad de Panamá), and professional associations in dermatology, plastic surgery, and aesthetic medicine.

The Ministry of Health would receive complaints, process alleged offenses under the Law Governing General Administrative Procedure, and conduct inspections, surveillance, and oversight. It would coordinate with the competent authority on misleading advertising. Administrative fines would be ten thousand balboas (B/.1 O 000.00) for producing, advertising, sponsoring, or donating prohibited substances; fifteen thousand balboas (B/.15 000.00) for importing, exporting, or marketing them; and twenty thousand balboas (B/.20 000.00) for administering them. Civil, criminal, and professional disciplinary liability could also apply. An entity would be jointly liable when an individual acts on its behalf. Fine proceeds would go to the Ministry of Health for the purposes of the law. The Executive Branch would issue implementing regulations within no more than sixty days after promulgation, and the law would take effect the following day.

The bill concerns the Ministry of Health, the Social Security Fund, the Technical Health Council, the National Secretariat for Science, Technology and Innovation, and the University of Panama’s Faculty of Medicine. It could affect patients, health professionals and establishments, medical associations, and sectors involved in producing, importing, exporting, and marketing medical aesthetic products.