A Defining Year for Chile’s ISP: Challenges Ahead

The Public Health Institute (ISP)—Chile’s public authority responsible for safeguarding public health through certification, supervision, and regulation in biomedical fields, environmental safety, and occupational health—has undergone a period of significant transformation. While it has rebounded from a crisis with strong leadership and renewed confidence, it now faces the tough challenge of delivering on its own bold modernization goals.

The crisis erupted in late 2023 when a decision regarding a bacterial outbreak triggered widespread outrage. It led to the unnecessary suspension of medical care, medications, and surgeries across public and private networks. This critical misstep cost the institute's director his job, sparking resistance from agency staff. The fallout shattered trust in both sectors, tarnishing the ISP’s 130-year legacy.

All expectations for restoring the agency’s standing hinged on the selection of a new director. In the final phase of the selection process, two candidates were former officials with strong political profiles and ties to President Gabriel Boric’s leftist coalition. Despite pressure from ruling parties to appoint someone from their ranks, the position ultimately went to Dr. Catterina Ferreccio, a specialist in epidemiology and public health. Dr. Ferreccio has over 40 years of experience in public health service and a distinguished academic career, serving as a professor of public health and director of the doctoral program in epidemiology at the University of Chile.

Dr. Ferreccio had already gained public recognition as a member of the COVID-19 Advisory Council, where she criticized the government's handling of the pandemic. She later participated in the National Pandemic Response Commission, eventually assuming its leadership when Dr. Ximena Aguilera was appointed Minister of Health. Their shared background at the University of Chile strengthened their professional relationship, and Minister Aguilera’s support was reportedly key to Ferreccio’s appointment.

New Leadership

The ISP’s new director brought a strong technical background, a career built on professional excellence, and a clear alignment with the Minister of Health. Her appointment marked a leadership shift focused on rebuilding trust and reassuring both public and private stakeholders.

Since taking office in May 2024, Dr. Ferreccio has honored this commitment by adopting an open-door policy, addressing the concerns of pharmaceutical industry associations and major international firms such as Sanitas, Sinovac, and Grünenthal.

Among her institutional priorities, she has emphasized accelerating institutional modernization, particularly through the incorporation of technology and process automation. Her goal is to develop an integrated module that streamlines interactions with external stakeholders and enhances the ISP’s health surveillance system. Additionally, she aims to establish a new laboratory for health surveillance and research, a long-standing institutional ambition. Construction could begin in early 2026, pending necessary approvals.

Beyond public announcements, significant progress is already underway. Quietly but steadily, a computerized system for product and service authorization and supervision is being implemented. This initiative is designed to integrate processes and enhance efficiency, reducing response times—an issue of particular concern to private sector stakeholders due to the lengthy approval processes required by the Chilean government. The problem has even led to a new word being coined ("permisología" or permitology) to describe bureaucratic delays affecting business activities across multiple sectors.

However, Dr. Ferreccio recognizes that technology and infrastructure alone will not resolve every challenge. She has acknowledged that the first priority is to integrate fragmented capabilities across the ISP’s various departments and laboratories. In announcing her plans in October 2024, she stated:

"We must maximize the use of our data and expertise to strengthen our competencies in the surveillance and analysis of pharmaceuticals, cosmetics, medical devices, infectious diseases, transplants, environmental health, and occupational health."

Strengthening knowledge management and research at the ISP is a central priority for the new director. She believes that, by contributing scientific expertise to policy discussions, the ISP can enhance its influence on public health policies and solidify its standing as a regional and international leader.

International Collaboration

The ISP is also prioritizing international cooperation, allowing it to adopt best practices and share critical information. This approach proved highly effective during the COVID-19 pandemic, significantly strengthening the country's response capacity.

In 2024, the ISP participated in the International Conference of Drug Regulatory Authorities, where it contributed to discussions on "deregulating" authorization processes among WHO-certified agencies. The goal of this initiative, known as "reliance," is to eliminate redundant approval processes for pharmaceutical products that have already been authorized in another country. This efficiency-driven strategy is gaining global traction and could foster innovation and competitiveness in the pharmaceutical industry.

Additionally, the ISP assumed the presidency of the Group of Regional Reference National Regulatory Authorities (ARNr) from the U.S. Food and Drug Administration (FDA). This Pan American Health Organization (PAHO)-led initiative seeks to promote regulatory convergence and reliance among countries with established regulatory agencies, while also advancing regional health self-sufficiency. Chile is one of only eight countries in the region to receive PAHO recognition as a reference entity following a rigorous evaluation process.

Photo credit: Freepik

As part of these efforts, the ISP will host the next ARNr Group meeting in Santiago in June 2025, marking a key moment for its international presence and regional leadership.

Dr. Ferreccio is a strong advocate of regulatory alliances and has publicly called for the creation of a supranational body akin to the European Medicines Agency (EMA), which was established through agreements among European Union member states. At a recent seminar, she stated: "This is a proven model of success, and we aim to promote a similar initiative across Latin America."

She has also shown keen interest in biosimilar medicines, which, unlike bioequivalent drugs, contain biologically derived active ingredients. Encouraging the development of biosimilars would increase market competition and expand access to treatments, but regulatory approvals remain complex and costly. Dr. Ferreccio believes international collaboration with other high-standard WHO-recognized regulatory agencies is key to overcoming these obstacles.

Combating Illegality

One of the tasks carried out by the ISP is to control the medications available in Chile throughout their lifecycle, from manufacture to use or sale, to ensure their quality and safety for people. However, this task is increasingly hindered by the rise of illegal drug trade, with medications being sold in unauthorized places like street markets, websites, and social media. This practice endangers people's health, as they could acquire counterfeit, expired, or deteriorated products due to poor storage and transportation conditions, which could have serious consequences or even cause death. This reality also harms the economy as a whole, both for private entities due to lower sales and for the Treasury due to loss of tax revenue and the allocation of resources to combat it.

Both the ISP and the police in Chile carry out seizures to curb this practice when detected, revealing that illegal drug sales are growing, driven by criminal gangs supplying the vendors.

Currently, Chilean legislation allows criminal prosecution of those who trade in psychotropics and narcotics, but not other types of drugs. Therefore, Congress is processing a bill that sanctions with prison terms of between 5 and 15 years those who sell drugs in unauthorized places, and also imposes the same penalties for a new crime of illegal drug distribution, applicable to the owner of a pharmacy supplying the illegal drug market. The bill also grants greater powers to the ISP, especially in terms of supervision.

Just as it has done with the project that toughens penalties for drug trafficking, the ISP has actively participated in the legislative debate on this initiative, contributing its knowledge and experience. In 2024, it also developed a communication campaign called "Stop Illegal Drug Sales," modest in scope but marking an important precedent on the importance assigned to this issue.

However, this problem continues to grow. For example, the public consumer protection agency in Chile reviewed what was happening with the online sale of cosmetic products by major pharmacy chains, supermarkets, and retail stores, detecting non-compliance with basic aspects, such as not being registered with the ISP.

Budgetary Challenge

Internally, one of the difficulties facing the ISP is a persistent budget deficit, which hinders its work. This situation has even led to mobilizations by its staff, who demand higher salaries, arguing that otherwise they cannot compete with the wages paid by the private sector, which ends up hiring the personnel trained at the institute but unable to pursue their professional careers there.

The situation for 2025 is highly complex, as in an unusual move, the government decided to make a budget adjustment in January 2025, cutting resources that had already been approved by the National Congress in November 2024, amounting to CLP 544 billion (US$ 576.160.000). This decision, agreed upon with legislators, aimed to contain the rise in public debt given the lower revenues forecasted for the current year, amid weak economic activity. As a result, the ISP saw its budget reduced by CLP 1.7 billion (US$1.768.000) out of a total of CLP 56 billion (US$58.240.000)

The complexity of this problem is greater because the ISP is a public entity that generates revenue from the services it provides to the private sector; for example, authorizations to import or store medicines, product registration, labeling changes, and clinical trials, among others. Therefore, it generates its income (estimated at around CLP 10 billion annually), which must be deposited into public coffers to contribute to financing public expenditure, and annually it is allocated operational resources that are determined centrally and authorized by Congress.

This is one of the most complex issues facing the ISP director. The scarcity of resources jeopardizes the incorporation of technology, process automation, infrastructure improvement, and staff training enhancement, all of which are the foundation of the modernization push that the organization aspires to make the hallmark of its management.

An additional difficulty is that the ISP is an entity of an eminently technical nature, so it does not usually interact with budgetary authorities, decision-makers, and legislators, who have the power to modify its situation in terms of the resources allocated to it.

Future Perspectives

The year 2025 presents an opportunity for the ISP to consolidate the steps it has taken under the leadership of its new director. Technological modernization, improved knowledge management and strengthened international relations are fundamental pillars for facing future challenges.

Achieving authorization for the new laboratory for health surveillance and research would be a milestone in the ISP's history. Additionally, it is crucial to continue optimizing processes and response times, benefiting all involved parties. The fight against illegal drug trade will remain a priority, pushing for more robust legislation to protect consumers.

The active participation of the ISP in the formulation of evidence-based health policies will allow the organization to remain a benchmark in the region and internationally. The director's vision of the need to push for collaboration between agencies with similar capacities and mandates as the ISP points to a strategy of peer integration to better fulfill the mission of protecting public health. This should, in turn, translate into increased activity and innovation in the pharmaceutical industry.

In summary, the ISP faces a challenging 2025 with the shadow of budgetary restrictions. The consolidation of its modernization and the strengthening of its leadership in the region are ambitious goals. With a focus on professional excellence, technology, and international collaboration, the ISP is well-positioned to continue protecting public health in Chile and beyond.

Marcela Gómez for Andes CA