Chile obliges the holder of a clinical trial’s provisional-use authorization — and, later, whoever holds the product’s sanitary registration — to keep supplying the trial treatment free of charge for as long as it retains therapeutic usefulness. The rule is Article 111 C of the Código Sanitario, inserted by Ley 20.850, and it is written in a way that binds an acquirer who was never involved in the trial.
That last clause is why Chile belongs on a deal checklist rather than only on a clinical operations checklist. A US sponsor can sell or out-license a Chilean-registered product and hand the buyer an open-ended, free-of-charge supply duty that appears nowhere in the trial budget, the product P&L, or most representations and warranties.
What Ley 20.850 actually did
Ley Núm. 20.850, “Crea un sistema de protección financiera para diagnósticos y tratamientos de alto costo y rinde homenaje póstumo a don Luis Ricarte Soto Gallegos,” was promulgated on 1 June 2015 by the Ministerio de Salud (BCN Ley Chile) and published in the Diario Oficial on 6 June 2015, a date recited in later ministerial decrees (Decreto 11 Exento, 30 April 2025).
The statute is best known for the high-cost treatment fund it created. But Article 34 of the same law added two new Titles to Book Four of the Código Sanitario: Title V on clinical trials of pharmaceutical products and elements of medical use (Arts. 111 A to 111 G), and Title VI on defective health-product liability (Arts. 111 H to 111 N). Chile’s trial authorization regime, its post-trial access duty, its strict-liability rule for trial injury and its ten-year limitation period all arrived in one act (Código Sanitario, DFL 725). Ley 20.850 restates the same right in Article 17: trial patients “tendrán derecho… a la continuidad gratuita de los tratamientos recibidos conforme al protocolo de estudio, aun cuando éste haya finalizado y mientras subsista su utilidad terapéutica” (Ley 20.850, Art. 17).
What Article 111 C requires
The operative text is short. Article 111 C, first paragraph:
“El paciente sujeto de ensayo clínico tendrá derecho a que, una vez terminado éste, el titular de la autorización especial para uso provisional con fines de investigación y, con posterioridad en su caso, el titular del registro sanitario del producto sanitario de que se trate, le otorgue sin costo para el paciente la continuidad del tratamiento por todo el tiempo que persista su utilidad terapéutica, conforme al protocolo de investigación respectivo.” (Código Sanitario Art. 111 C)
Four things follow. It is a patient right, not a sponsor best-effort. It is free to the patient, with no cost-sharing carve-out. It has no calendar end point: termination turns on loss of therapeutic usefulness, not commercial launch, not reimbursement listing, not a fixed number of years. And it is anchored to the study protocol, so the protocol’s definition of continued benefit stays load-bearing years after database lock. Brazil caps the equivalent duty at five years from commercial availability; Chile has a named obligor and no clock.
Breach is sanctioned under Article 111 G, which routes Title V infractions to Book Ten of the Código Sanitario and to Ley 20.120. Book Ten’s general penalty article allows fines from one-tenth of a UTM up to 1,000 UTM, doubled on recidivism, plus suspension of distribution and use of the products concerned (Código Sanitario, Art. 174).
Devices are expressly in scope
Most Latin American post-trial provisions are drafted around medicines and leave device sponsors to argue about scope. Chile does not. Article 111 A states that the special provisional-use authorization “se requerirá para todo producto farmacéutico o dispositivo médico,” and Title V is titled for “productos farmacéuticos y elementos de uso médico” (Código Sanitario Art. 111 A). Because Article 111 C attaches to the holder of that same authorization, the post-trial duty reaches device sponsors on the face of the text. The Ministerio de Salud may exempt, by supreme decree, device categories whose use “no conlleve un riesgo relevante para las personas” — that is an exemption from the authorization requirement, and a sponsor relying on it should confirm the specific decree rather than assume one exists for its class.
For an implantable or capital-equipment device, continuity “for as long as therapeutic usefulness persists” raises questions the statute does not answer: replacement units, consumables, explant and revision, software maintenance, end of product life. Those gaps close in the protocol and the informed consent, because Article 111 C points back to the protocol for its content.
The obligation follows the registration, not the sponsor
The second paragraph of Article 111 C is the one that changes deal economics:
“Esta obligación afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario.” (Código Sanitario Art. 111 C)
Read that literally. The duty binds the sanitary-registration holder even where that party never held the provisional-use authorization, and even where it acquired the registration afterwards. It travels with the asset by operation of law. An asset purchase that transfers only the Chilean registration — no trial contracts, no site agreements, no sponsor entity — still carries the tail. A licensing deal in which the licensee becomes the Chilean registration holder does the same.
Four diligence questions follow for anyone buying a product with Chilean clinical history. Was any Chilean trial run under an ISP provisional-use authorization for this product, per the public research register the ISP must keep under Article 111 A? How many participants remain on treatment, under what protocol definition of continued benefit? Who has supplied them since study close, under what import authorization? And is there seller indemnity for a duty Chilean law places on the registration holder directly — noting that allocation between the parties does not extinguish the duty toward the patient.
The exposure is unbounded in duration by design, which makes it hard to reserve for and easy to miss. We identified no published Chilean enforcement decision quantifying the tail, so today’s practical risk is less about fines than about inheriting an undisclosed supply commitment and finding it after closing.
Where the ISP fits
The Instituto de Salud Pública is the regulator on both ends of this obligation. It grants the provisional-use authorization under Article 111 A — valid for no more than one year, renewable for equal successive periods — accredits research centers under Article 111 D, and fiscalizes protocols, informed consents, good clinical practice and adverse-event reporting (Código Sanitario Arts. 111 A and 111 D). Article 111 D also makes any confidentiality obligation in a protocol or agreement unenforceable against the ISP. The authorization is a paid service: prestación 4111035 is listed at CLP $1,129,893 plus IVA (ISP). Article 99 separately lets the ISP provisionally authorize unregistered pharmaceutical products for trials and for urgent medicinal uses arising from shortage or inaccessibility (Código Sanitario Art. 99; ISP guidance).
What the ISP has not published is Article 111 C guidance. Its “Guía de consideraciones generales para estudios clínicos” (Res. Ex. N° 173, 29 January 2024 — BCN) and its first-edition “Guía de investigación clínica de dispositivos médicos en humanos. Buenas prácticas clínicas” (Res. Ex. N° 341, 7 April 2026, recorded as Res. Ex. 2.050 — BCN; ISP) were both reviewed for post-trial content. The device guide cites Article 111 A and covers post-participation care for adverse events and post-market clinical follow-up, but not Article 111 C or continued supply. Chile’s newest device GCP guidance is silent on the obligation its own statute imposes on device sponsors.
CENABAST and the exceptional-import backstop
CENABAST is Chile’s public procurement and supply agency, and Ley 20.850 gave it powers that matter when a supply chain breaks. Under Article 15, where a product covered by the high-cost system has its registration suspended, cancelled or lapsed, CENABAST may — with prior Ministry of Health authorization, and only where no alternative exists at the maximum industrial price — exceptionally import and distribute it “independientemente si cuentan o no con autorización o registro sanitarios.” The same article deems those circumstances public-health grounds under Chile’s industrial property law and closes with a liability rule: “Los titulares de los registros o autorizaciones sanitarias, los productores o los importadores serán responsables civilmente por la falta de continuidad de los tratamientos” (Ley 20.850, Art. 15). Article 31 adds the procurement side: contracting one product with more than one supplier where continuity requires it, direct contracting where CENABAST holds the registration itself, and requesting a provisional sanitary registration in shortage situations (Ley 20.850, Art. 31; CENABAST).
This is a state backstop for continuity of covered treatments, with civil liability pointed back at the registration holder. It is not a route to hand off an Article 111 C duty.
The Ricarte Soto Fund as the exit ramp, and its limits
Ley 20.850’s financial protection system is insured by FONASA for beneficiaries of every Chilean health system — FONASA, isapres, CAPREDENA and DIPRECA — regardless of socioeconomic status, and covers 100% of the cost of the medicines, medical devices or foods expressly guaranteed for each defined health problem (Superintendencia de Salud). ChileAtiende describes it as guaranteeing diagnosis and treatment for 27 high-cost conditions (ChileAtiende). Inclusion runs through a supreme decree under Article 5, subject to a cost threshold, favourable scientific evaluation, recommendation and an incorporation decision (Ley 20.850, Art. 5).
Getting a product into that decree is the cleanest way for Article 111 C exposure to become a state-funded treatment rather than a private supply obligation. It is also slow, competitive and outside the sponsor’s control — and nothing in Article 111 C ends the duty on listing. Treat it as practical mitigation, not a legal termination event.
What the statute leaves open
First, Title V repeatedly refers to a reglamento — adverse-event reporting under Article 111 B, center accreditation under Article 111 D, insurance under Article 111 F. We identified no ISP or MINSAL instrument in this review that operationalizes Article 111 C specifically. The obligation is statutory and self-executing on its face; the mechanics are not written down.
Second, entry into force. The first transitory article provides that “las normas de esta ley regirán a contar de la entrada en vigencia del decreto a que se refiere el artículo 5º” (Ley 20.850, disposiciones transitorias). The Article 34 amendments sit in the consolidated Código Sanitario text and the ISP has operated the Article 111 A authorization since, but how that clause interacts with the Title V insertions is a question for Chilean counsel, not for a CRO.
Third, “utilidad terapéutica” is undefined. Chile’s medical academy, writing on Title V and its draft reglamento in Revista Médica de Chile, argued that continuation should be decided case by case once final results including safety are known, by the patient and treating physician, and that “se necesita una definición de utilidad más objetiva y fácil de determinar” (Rev Med Chile). Until that definition exists, the protocol is the only instrument that sets the endpoint — an argument for drafting it at protocol design, not at study close.
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Frequently Asked Questions
Does Chile require post-trial access?
Yes. Article 111 C of the Código Sanitario gives clinical trial participants a right to continued treatment after the trial ends, free of charge, for as long as the treatment retains therapeutic usefulness. The duty falls first on the holder of the ISP special provisional-use authorization and then on the holder of the product’s sanitary registration. The same right is restated in Article 17 of Ley 20.850. This is a statutory patient right, not an ethics-committee expectation or a best-efforts commitment, and breach is sanctionable under Article 111 G through Book Ten of the Código Sanitario.
What is Ley 20.850 (Ley Ricarte Soto)?
Ley 20.850 is the Chilean statute that created a universal financial protection system for high-cost diagnoses and treatments, promulgated 1 June 2015 and published 6 June 2015. It is named in posthumous tribute to journalist Luis Ricarte Soto Gallegos. Beyond the fund, its Article 34 inserted Titles V and VI into Book Four of the Código Sanitario, creating Chile’s clinical trial authorization regime (Arts. 111 A to 111 G) and its defective health-product liability regime (Arts. 111 H to 111 N). Most sponsors know the fund and miss the clinical trial chapter.
What does Código Sanitario Art. 111 C require?
It requires that, once a clinical trial ends, the holder of the special provisional-use authorization — and afterwards, where applicable, the holder of the product’s sanitary registration — provide the participant with continuity of treatment “sin costo para el paciente,” for the whole time that its therapeutic usefulness persists, in accordance with the study protocol. A second paragraph extends the duty to a registration holder that never held the provisional authorization or that acquired the registration later. There is no calendar limit and no cost-sharing exception in the text.
Does Chile PTA apply to medical devices?
Yes, on the face of the statute. Article 111 A states that the special provisional-use authorization is required for “todo producto farmacéutico o dispositivo médico,” and Title V is titled for pharmaceutical products and elements of medical use. Because Article 111 C attaches to the holder of that authorization, device sponsors are captured. The Ministry of Health may exempt low-risk device categories from the authorization requirement by supreme decree, so confirm the applicable decree for your class rather than assuming an exemption applies.
Who pays for post-trial supply in Chile?
The obligated party pays. Article 111 C says the treatment is provided “sin costo para el paciente,” and names the provisional-use authorization holder and then the sanitary-registration holder as the parties who must provide it. There is no provision allowing the cost to be shifted to the patient, the treating institution, FONASA or an isapre. Sponsors may allocate the economics contractually between themselves, a licensee or an acquirer, but that allocation does not change who Chilean law holds responsible to the patient.
How long must sponsors provide post-trial access in Chile?
For as long as therapeutic usefulness persists — “por todo el tiempo que persista su utilidad terapéutica.” Chile sets no fixed term, no five-year cap, and no automatic termination at commercial launch or reimbursement listing. That makes it materially more open-ended than Brazil, where Lei 14.874/2024 permits interruption five years after commercial availability. Because “utilidad terapéutica” is undefined in the statute, the study protocol referenced by Article 111 C becomes the practical instrument that defines when the obligation ends.
What is the M&A diligence trap in Chile PTA?
The second paragraph of Article 111 C binds the sanitary-registration holder “aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario.” The supply duty travels with the registration by operation of law. A buyer acquiring only a Chilean marketing authorization — with no trial contracts, no sponsor entity, no site agreements — can inherit an open-ended, free-of-charge obligation to patients it has never seen, arising from a trial it never ran. Standard reps and warranties rarely surface it, and standard product P&Ls never price it.
What is ISP’s role in Chile PTA?
The Instituto de Salud Pública grants the Article 111 A special provisional-use authorization (maximum one year, renewable for equal successive periods), maintains the public register of authorized human research, accredits research centers under Article 111 D, and fiscalizes protocols, informed consents, GCP and adverse-event notification. Its listed fee for prestación 4111035 is CLP $1,129,893 plus IVA. The ISP’s public register is the practical starting point for confirming whether a Chilean-registered product has a trial history that could trigger an Article 111 C tail.
What is CENABAST and how does its exceptional-import route work?
CENABAST is Chile’s Central de Abastecimiento, the public health supply and procurement agency. Under Article 15 of Ley 20.850, where a covered product’s registration is suspended, cancelled or lapsed, CENABAST may — with prior Ministry of Health authorization and where no priced alternative exists — exceptionally import and distribute it regardless of whether it holds sanitary registration, to guarantee treatment continuity. Article 31 lets it contract with multiple suppliers and request a provisional sanitary registration in shortage situations. Article 15 also makes registration holders, producers and importers civilly liable for failures of treatment continuity.
Does the PTA obligation transfer with the marketing authorization?
Yes. That is the explicit effect of Article 111 C’s second paragraph, and it is the single most commercially consequential sentence in Chile’s post-trial regime. Acquirers and in-licensees should treat the Chilean registration as carrying a potential supply liability, diligence the ISP research register and the seller’s Chilean trial history, quantify the number of patients still on treatment, and negotiate indemnities knowing that the statutory duty to the patient sits with whoever holds the registration.
Sources
- Ley Núm. 20.850, Ministerio de Salud, promulgated 1 June 2015 — Arts. 5, 15, 17, 31, 34, disposiciones transitorias: https://www.bcn.cl/leychile/navegar?idNorma=1078148
- Código Sanitario (DFL 725), consolidated text — Arts. 99, 111 A, 111 B, 111 C, 111 D, 111 E, 111 F, 111 G, 111 H–111 N, 174: https://www.bcn.cl/leychile/navegar?idNorma=5595
- Decreto 11 Exento, M. de Salud, 30 April 2025 (recital confirming Ley 20.850 published 6 June 2015): https://www.bcn.cl/leychile/navegar?idNorma=1212845
- ISP prestación 4111035, provisional-use authorization for clinical study products: https://www.ispch.gob.cl/prestacion/4111035/
- ISP, autorización excepcional sin registro sanitario (Art. 99 / D.S. 3/2010 Art. 21, prestación 4111036, SAFIS): https://www.ispch.gob.cl/anamed/medicamentos/autorizacion-excepcional-sin-registro-sanitario/
- ISP, Estudios Clínicos: https://www.ispch.gob.cl/anamed/estudios-clinicos/
- Resolución Exenta N° 173, 29 January 2024, “Guía de consideraciones generales para estudios clínicos” (ISP): https://www.bcn.cl/leychile/navegar?idNorma=1201301
- Resolución Exenta N° 341, 7 April 2026 / Res. Ex. 2.050, “Guía de investigación clínica de dispositivos médicos en humanos. Buenas prácticas clínicas” (ISP): https://www.bcn.cl/leychile/navegar?idNorma=1223885 and https://www.ispch.gob.cl/wp-content/uploads/resoluciones/36444_2050-2026.pdf
- CENABAST, “Ley Ricarte Soto: con nuevas facultades, CENABAST asegura disponibilidad de medicamentos”: https://www.cenabast.cl/ley-ricarte-soto-con-nuevas-facultades-cenabast-asegura-disponibilidad-de-medicamentos/
- Superintendencia de Salud, Ley Ricarte Soto orientation page: https://www.superdesalud.gob.cl/tax-temas-de-orientacion/ley-ricarte-soto-6088/
- ChileAtiende, Ley Ricarte Soto: https://www.chileatiende.gob.cl/fichas/38873-ley-ricarte-soto
- Academia Chilena de Medicina, declaration on Title V of Ley 20.850 and its draft reglamento, Revista Médica de Chile: https://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872017000300013