Does Chile’s post-trial access duty transfer to an M&A buyer?

Yes. The second paragraph of Código Sanitario Article 111 C binds the sanitary-registration holder even when that party never held the provisional-use authorization and even when it acquired the registration afterwards. The free continued-supply duty travels with the Chilean registration by operation of law.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the M&A diligence cut. For the full Art. 111 C analysis, device scope, and ISP role, use Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C. For the 1 December 2026 DPA refresh under Ley 21.719, use Chile Ley 21.719 PTA DPA refresh.

Short answer

Article 111 C, first paragraph, gives the trial patient a right to free continuity of treatment after the study ends, for as long as therapeutic usefulness persists, from (1) the holder of the special provisional-use authorization and, later, (2) the holder of the sanitary registration. The second paragraph is the deal clause:

“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.”

Read that literally. 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. Standard reps and warranties rarely surface it, and standard product P&Ls never price it.

Diligence questions before you buy or in-license

1. Was any Chilean trial run under an ISP provisional-use authorization for this product, per the public research register ISP must keep under Article 111 A?
2. How many participants remain on treatment, under what protocol definition of continued benefit?
3. Who has supplied them since study close, under what import authorization?
4. Do the indemnities in the purchase agreement acknowledge that the statutory duty to the patient sits with whoever holds the registration — not only with the seller’s representations?

Breach of Title V is sanctioned under Article 111 G, which routes 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 and open-ended duration

Devices are expressly in scope through Article 111 A’s “elementos de uso médico,” so the Art. 111 C duty is not a drug-only problem. Duration has no calendar end point: termination turns on loss of therapeutic usefulness under the study protocol, not commercial launch and not a fixed number of years. Brazil’s Lei 14.874/2024 Art. 33 VI permits interruption five years after commercial availability; Chile has a named obligor and no clock.

Keep the Art. 111 C supply analysis separate from the data-protection contract. Ley 21.719 enters into force on 1 December 2026 and changes how Chilean PTA DPAs should be drafted — that is a companion workstream, not a substitute for the supply diligence above.

bioaccess® operates regulatory, importadora and PTA architecture for Latin American post-trial programs. For Chile PTA diligence on a live asset or in-license, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Related pillar

Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C

Sources

• Ley Núm. 20.850, Ministerio de Salud, promulgated 1 June 2015 — https://www.bcn.cl/leychile/navegar?idNorma=1078148
• Código Sanitario (DFL 725), Article 111 C — https://www.bcn.cl/leychile/navegar?idNorma=5595
• Chile PTA pillar: https://bioaccessla.com/blog/chile-post-trial-access-ley-20850
• Chile Ley 21.719 DPA refresh: https://bioaccessla.com/blog/chile-ley-21719-pta-dpa-refresh