Trust, Reliance Among Fellow Agencies Enhances Innovation Access

Q: Chile’s public health sector is internationally recognized for its standards of excellence. What has been the role of the Public Health Institute (ISPCH) in achieving this reputation?

A: The ISPCH has excellence and quality at its core. During the COVID-19 pandemic, we had to come up with a smart strategy to protect our population. As a regulatory agency, we now focus on studying the effectiveness of the COVID-19 vaccines, the different variants of the virus that are emerging and how these factors change the way we tackle the pandemic.

Public healthcare is constantly besieged by new challenges. The arrival of monkeypox is another element on our radar. Our goal is to study if the virus is behaving as it has in the rest of the world. After COVID-19, Chile is taking further precautions to avoid another crisis. We are trying to break the stigma surrounding monkeypox to avoid discrimination of the groups that have suffered from it. We are also raising awareness of the vulnerability the monkeypox virus.

Q: In 2021, Chile led Latin America’s ranking of innovation in COVID-19. How did the country achieve this recognition?

A: We were recognized for our management of COVID-19 and for the provision of essential health services. Chile ensured the continued provision of quality services even during the highest peaks of contagion. The ISPCH has not stopped providing laboratory tests and continues its efforts to provide access to innovation. It also surveys the internet for misinformation and the black market for drugs. Overall, the institute has enhanced its control of sanitary issues in Chile to avoid long-term impacts.

The ISPCH was quick to approve COVID-19 vaccines, which allowed our government to access the doses on time. The Institute, as a regulatory entity, was allowed to act autonomously during this period following a normative that answered the needs of the situation. During the pandemic, the Ministry of Health allowed us to advise the government directly.

We allied with many universities to generate a hub for clinical research. In 2021, Chile broke its record for clinical trials and we hope to maintain this progress. Chile and the ISPCH successfully integrated efforts to avoid duplication. Open communication among all actors allowed everyone to contribute to the fight against the pandemic in innovative, multichannel and integral ways.

Q: Chile has a highly digitized health system, with significant infrastructure and software investments. When did this transition begin and what are the goals?

A: The Ministry of Health began working on a digitalization process for years before the pandemic, starting with telemedicine. Chile’s geography is unique; it is a long and narrow country with many cultural differences and health access challenges. Chile’s rural zones are hard to access but telemedicine allows us to reach patients in those areas, providing them the knowledge and technology that Chile has in other parts of the country.

Another priority for us was to regulate the appropriate channels to sell medicines online. For example, some individuals are offering medicines through social media channels, which are not authorized to sell drugs online. Physical pharmacies with an e-commerce platform are the only channels authorized to do so. We also had to regulate delivery services from companies such as Rappi and Cornershop to allow them to participate in the distribution of medicines. These companies undergo the same authentication process as digital prescriptions. For us, it was important to have clear regulations for e-commerce because many companies think it is simple and overlook many fundamental requirements. Through these regulations, we are able to have more control over online purchases. Our job is to protect the population from sanitary risks whether they come from the digital or the physical world.

Q: How is ISPCH working to improve regulatory measures in the region?

A: Chile’s work in this regard is similar to the work of other regulatory agencies in the region. We have worked to foment trust among our counterparts. Chile’s regulations take into consideration the decisions of certain regulatory agencies to accelerate approval processes. For this to occur, developers have to present us with the same evidence they gave other regulatory agencies. Alongside the National Institute for Drug and Food Surveillance (INVIMA) and the National Sanitary Surveillance Agency (ANVISA), ISPCH agreed to foment trust regarding each other’s decisions and improve access to innovation.

It is essential to promote regulatory trust and reliance as well as promote regulatory convergence. Every country has its own ways to look at regulation, considering commercial and sanitary aspects. Thus, focusing too much on convergence rarely gets us anywhere because of our many differences. However, our many similarities’ can help us inspire trust and recognize that other regional agencies have the same capacity that we do to regulate innovative products, which would bring enormous benefits in regard to access, control and cost-efficiency.  

Q: How does your regulatory framework enhance pharmaceutical innovation?

A: To encourage access to innovation, Chile’s universities have become research hubs. Before this decision, research mainly focused on meeting the commercial needs of the pharmaceutical laboratories, which is important but not the only priority. When universities join this process, they can scale up their projects.

Chile, for example, participated in the Sinovac COVID-19 vaccine trial. In real terms, Brazil and Chile made the largest contribution to support the approval of this vaccine, allowing its use in the West, as approval processes in Eastern countries differ from ours.

Public Health Institute of Chile (ISPCH) is an autonomous public service that promotes and protects healthcare by strengthening sanitary control through monitoring, research and technology transfer activities, among others.