Heriberto García Escorza: “Registration is not just an economic process”

VOICES · DRUG REGULATION · CHILE

Few people have seen Chile’s medicines system from as many sides as Heriberto García Escorza. A pharmaceutical chemist who worked in primary care and at the Ministry of Health, he took charge of the National Medicines Agency (ANAMED) in early 2020, weeks before COVID-19 reached the country. By August he was acting director of ANAMED’s parent body, the Institute of Public Health (ISP), a post he held until 2023 while the institute authorized COVID-19 vaccines. He led ANAMED until 2024 and now directs the pharmacy program at Universidad del Desarrollo.

He speaks as approvals speed up and coverage stands still. The government has promised to bring every type of cancer into the Explicit Health Guarantees (GES) progressively, starting in 2028. But the Ricarte Soto Law, which funds high-cost treatments, has not added a condition since 2019, and the 2027 budget bill cuts its fund by 14% even as overall health spending would grow by 4.7%. A bill to enlarge the fund passed the lower house in January and awaits the Senate. Meanwhile, seizures of illegal medicines have risen 130% in three years, according to ISP figures cited in the Senate, where a bill toughening penalties for illegal sales cleared the health committee on October 8th.

In this written interview, García Escorza argues that approval and coverage must be decided separately, proposes an FDA-style agency with its own health technology assessment body and says Chile’s rules on biosimilars are costing the public system money.

The interview

Since 2025 the ISP has had a formal procedure for biologics to rely on approvals by stringent regulatory authorities abroad. What has changed, and what should a national regulator always check for itself?

The ISP was using reliance before 2025. It applied it very well during the pandemic, in 2021 and 2022, to authorize COVID-19 vaccines, and later in other registrations. In 2023 it registered nirsevimab (Beyfortus), the monoclonal antibody against respiratory syncytial virus, in six months, and Chile became the first country in Latin America to use it.

The 2025 resolution sets rules for products already approved by two stringent regulatory authorities, but that is not enough. Reliance is not just about getting ahead in the queue or getting priority. It is about speeding up registration by not re-reviewing what another agency has already done. A national regulator should look only at what is specific to the country: distribution, the marketing authorization holder, and the validation and transfer of analytical methods and good manufacturing practice if the product comes from a different plant than the one the reference agency approved. One reference agency should be enough, not two, because a company may have chosen to launch in only one market. Still, it is progress. The procedure should be raised from an ISP resolution to a formal regulation and measured by how efficient the process really is, with targets for each reviewer. As long as it is only an ISP resolution, there is no way to file a complaint with the Ministry of Health if it is not met, as there would be with a decree. Above all, these processes cannot stay on paper: they have to be applied and really cut review times.

Figures from the Industrial Association of Pharmaceutical Laboratories (ASILFA), which represents Chilean drugmakers, put the average time to close a registration at 543 days, down from 695. What does a patient gain from a faster approval if there is no money to cover the drug?

We need to separate the two. Registration is a process that authorizes a product’s marketing and availability; it is not just an economic process. What Chile needs is an updated health technology assessment process that weighs pharmacoeconomics, treatment efficiency and timely access, so that the formularies of the GES and the Ricarte Soto Law stay current.

Not every registered product will be covered. What is already available may be more cost-effective. But patients need certainty that the treatments the system guarantees are the most appropriate and up to date. And even then, if access at health centers is poor, we will not achieve the goal. No one should pay out of pocket for a medicine that is already guaranteed.

A decree published in March brings 39 new categories of medical devices under mandatory health control, phased in during 2028 and 2029. How does an agency widen its remit like that without creating a backlog?

By applying reliance here too. The ISP became an affiliate member of the International Medical Device Regulators Forum in 2023, something we achieved. It should ask only for notification in low-risk categories and concentrate on higher-risk devices, require international certifications and keep up proper device vigilance. Registration must be faster and post-market surveillance stronger, and that takes staff the state has to fund. Registration is not the only tool, either: some devices should not be sold directly to the public, or only in outlets that meet storage and distribution rules.

The Ricarte Soto Law has not added a condition since 2019. Where is the bottleneck once a drug is approved: the company’s launch decision, public procurement or coverage?

There seem to have been budget problems for years, and several governments have been unable to add new medicines. The executive and Congress have to address it, starting with a health technology assessment agency that makes coverage decisions transparent.

My proposal is to separate ANAMED administratively from the ISP and make it the single regulator for medicines, medical devices, personal protective equipment, pesticides, food supplements and tobacco, along the lines of the FDA in the United States, with the assessment agency inside it. With efficiency targets, registration and coverage would both speed up, and a more efficient agency would receive more applications, and so a bigger budget.

“No one should pay out of pocket for a medicine that is already guaranteed.”

The government has promised to bring all cancers into the GES progressively from 2028. What would make that sustainable, and what role should biosimilars play?

Pharmaceutical companies should be encouraged to invest in researching, developing and registering medicines in Chile, and they have to want to bring biosimilars here. That means faster registration and coverage, and economic and tax incentives for multinationals to bring their offices back to Chile and use it as an export hub for Latin America and the Caribbean, since our regulator is one of the region’s reference authorities.

“One reference agency should be enough, not two, because a company may have chosen to launch in only one market.”

Doctors should be encouraged to prescribe more biosimilars, with the case made on efficacy and safety, not only cost; companies’ sales and marketing teams have a part to play. And the rules have to change. In Europe, regulators consider biosimilars interchangeable with each other and with the originator, so health systems can buy whichever has proved most cost-effective. Chilean rules provide for starting treatment with either the originator or a biosimilar, with no switching during treatment. That rules out real interchangeability and raises costs, because the state’s central drug-purchasing agency (CENABAST) has to buy both.

What drives the illegal market more: households that cannot afford formal prices, or organized crime?

Medicine prices in Chile are not higher than in other countries.^* What is high is households’ out-of-pocket spending, which is why I insist on better coverage.

We have to tackle demand. That means health education from school onward, which an independent ANAMED could lead, and a stronger role for pharmacies. Buying outside them is a real risk. The toxicity is chronic: the harm may not show up right away, because the products of a medicine’s degradation do damage over the long term. Heat and humidity speed up that degradation and reduce a medicine’s efficacy, and poor storage can generate potentially carcinogenic impurities, such as nitrosamines, in some medicines. That is what happens at street markets and with online sellers that are not pharmacies, which may also be selling counterfeits. That is why there must be tough penalties for those who sell medicines illegally.

*Editor’s note: A 2020 study of the six largest Latin American markets by Roberto Álvarez and Aldo González, published in CEPAL Review, the journal of the United Nations Economic Commission for Latin America and the Caribbean, places Chile mid-table overall and one of the two cheapest for unbranded generics. It used IMS Health (now IQVIA) pharmacy retail data for 2010–2015 and was funded by ProlMed, an association of Chile’s local medicine producers. IMS Health figures reported in the Chilean press in 2018 put Chile’s prices for originator brands among the region’s highest.

Sources: Ministry of Health (ANAMED appointment, 2020); Carey (ISP reliance procedure for biologics, 2025); BioBioChile (cancers in the GES); Ministry of Health (Ricarte Soto Law, 2019); Pauta (2027 budget); Chamber of Deputies; Senate (illegal medicines); Senate (health committee, October 8th); ASILFA via TXS Plus; Cuatrecasas (Exempt Decree 25/2026); CEPAL Review (Álvarez and González, 2020); Emol (2018).