Innovation is the cornerstone of the healthcare industry but with today’s ultra-fast proliferation of new technologies and therapies, governmental regulations are lagging behind and slowing down innovation. However, in certain countries, the COVID-19 pandemic opened the eyes of governments and regulatory agencies, which reinvented their processes and collaborated with academia and the private sector to accelerate processes and foster innovation.
“The pandemic taught us the importance of facilitating processes to have a rapid response and access to vaccines. Chile was able to vaccinate a large percentage of its population thanks to the collaborative work between the private sector, public sector and our universities. Chile approved Sinovac’s CoronaVac before WHO and became a point of reference in the region,” said Heriberto García Escorza, Director, Public Health Institute of Chile (ISPCH).
While CoronaVac studies were held in China, Turkey and Indonesia, Chile carried in-house clinical trials too, in collaboration with Sinovac and different universities that worked together with ISPCH to authorize the vaccine. Several countries in the region reached out to Chile to request its records, including Uruguay, Colombia, Ecuador and Mexico, aiming to leverage the work that ISPCH had already done to approve the CoronaVac vaccine.
“In May 2022, Sinovac began the construction of its first laboratory in Chile, aiming to start expanding in the Latin American region. The COVID-19 vaccine approval and the way it has been handled in Chile is a good example of positive public-private collaboration. The same happened with other industry players. We collaborated with them to provide our population with COVID-19 antigen tests through different alliances,” said García.
Global efforts have reduced the necessary time for innovations to reach patients. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), of which Mexico’s COFEPRIS is a member, aims to achieve greater global harmonization to ensure that safe, effective and high-quality medicines are developed and registered in the most efficient manner.
In this regard, Chile works closely with other regulatory agencies within the region to foster trust and reliance between them and accelerate approval processes. “Strong markets, such as the US and the EU’s can produce for their own population. However, we must collaborate with all Latin American players to benefit the entire region,” said García.
Completing the Telemedicine Patient Journey Through Regulation
While telemedicine and telehealth have been around for several years, the adoption of these technologies increased significantly during the pandemic. Lockdowns, social distancing and isolation have led patients to adapt to this practice at a faster speed. However, regulation in certain countries has not adapted that rapidly.
In Mexico, regulation lags behind and does not enable a complete patient journey through telemedicine. E-prescriptions are yet to be fully regulated and play an essential role in the practice of telehealth. An e-prescription connects the activity of the physician with the activity of a pharmacy, allowing the latter to provide a product.
Chile has already worked on making telemedicine a reality through regulation. “E-prescriptions were an important innovation, allowing the e-commerce of medicines. Chile is one of the few countries with complete regulation in this regard. Pharmacies must be authorized to sell online. In addition, Chile has a system managed by the Ministry of Health to have a complete telemedicine journey,” said García.