Latin America embarks on digital submission journey to improve processes

The journey to digital regulatory submissions has not been an easy one for Latin American countries. To understand the reasons why the transition to digital has been difficult, it’s important to consider historical barriers and specific local challenges – from an economic, social, cultural, and organizational perspective.

Latin America is considered to be the “most unequal and divergent region in the world” as a result of technology and socio-cultural disparities between cities and rural communities, as well as between countries. Countries across the region struggle with poor infrastructure, inadequate Internet connectivity, and inequalities in terms of access to electricity, widespread unemployment and high levels of adult illiteracy.

These challenges mean that digital submissions have required more gradual adoption, support to maintain processes, as well as ways to address additional costs and commitments to ensure regulatory staff are adequately trained on digital systems and procedures.

Data sharing among health professionals has also been limited due to the restricted use of technology for communication, training, and decision-making.

Moreover, culture, education as well as the values in the  healthcare  process played an important role in the region. This impacted on the adoption of digital technologies and their development (for example, platforms).

To move forward, everybody needed to work together — at the local and regional level, and between governments, sometimes striving to overcome differences.

As other countries and regions that have made the transition have found, successful adoption meant pooling of files and expertise and alignment on regulatory requirements. Those at the forefront of the move to digital looked to expertise from countries with well-established vigilance practices, adopting some processes and procedures to simplify and speed up the transition. There was also a need to establish a department to focus on harmonization and simplification of the application process.

A successful transition to digital also required government departments and various industry bodies to take steps to become more efficient. To do that, they not only needed to invest in the information systems and innovation required for digital submissions, but also in education, training, scientific development and the promotion of a more progressive approach to all stakeholders. Investment needed to be made in public services to ensure they had the knowledge and resources to meet the challenge.

Training programs at the health authorities were needed to ensure reviewers knew how to use digital technologies, while also balancing the limited resources and financial constraints in this region and the health needs of various populations, especially in underserved areas.

With so many challenges and financial constraints to contend with, it’s understandable that many in the region were resistant to moving away from paper submissions.

However, there was also deep understanding of the advantages of digital submissions and how a more streamlined approach would benefit every country in the region through improved communications, simplifying management and access to medicines, better pharmacovigilance reporting and follow-up,  as well as faster and easier access to information.  With this in mind, the LATAM region decided to set aside their difficulties and embark on the digital journey.

The move to digital – embracing external support and expertise

For many years, LATAM countries have been very open to help from global organizations to improve skills and knowledge of digital systems and platforms.

Examples of programs aimed at helping countries transition to digital include:

• The World Health Organization (WHO) has published a guide to help developing countries to implement electronic health records (EHRs) including survey evaluations performed on e-health systems in developing countries, assessing their potential impact, and guiding future implementations and evaluations.
• The Fogarty International Center has trained informatics workers in the LATAM region on the Informatics Training for Global Health (ITGH) program, focusing on the health and informatics needs of countries.
• The Bill and Melinda Gates Foundation played a role in the development of digital in the region through the American Medical Informatics Association (AMIA)’s Global Partnership Program (GPP). This program was focused on general topics, such as expanding  local resource capacities and promoting collaboration.
• The Pan American Health Organization (PAHO), which works with countries across the Americas to improve the health and quality of life of their populations, has developed virtual courses, for example to highlight integrated health services networks.
• The Latin American and Caribbean Network for Strengthening Health Information Systems (RELACSIS), established in 2010, helps countries with best practices for improving data quality.
• Many volunteer groups have helped LATAM countries with technology development. For example, the Central American Health Informatics Network (RECAINSA) is a network of professionals from different areas across healthcare services, public health, research and other disciplines that came together in 2013 for the purpose of advancing good practices in digital health in Central America.
• Healthcare Information and Management Systems Society (HIMSS) of Health Level Seven Latin America (HL7 LATAM) has organized conferences in Costa Rica, Brazil, and Chile, and helps Latin American countries in the digital transformation of their health services.

Modernizing health agencies

In order to move to digital submissions, LATAM health agencies have had to implement the necessary platforms to manage administrative procedures and requirements remotely, using automation.

One country that has advanced its digital practices is Panama, which  created a website (https://www.panamadigital.gob.pa/) to centralize the information about processes involved in a digital submission. To streamline and harmonize processes, Panama’s regulatory authority is collaborating with several other organizations, including the national authority for transparency and access to information (ANTAI), the Ministry of Health of Panama,  government websites and a citizen care center.  This collaboration has led to the creation of a national platform centralizing the information. Applicants can now have access to the application approvals online; next step will be online submissions and health authority assessors will be able to carry out their reviews remotely.

Across the region, LATAM countries are working to simplify and modernize the requirements, administrative procedures, and the management of submissions. The aim is to reduce bureaucracy and increase competitiveness and accessibility. Recently, in Guatemala, the Congress of the Republic approved the Law for the Simplification of Requirements and Administrative Procedures (Ley para la Simplificación de Requisitos y Trámites Administrativos) which defines actions, stakeholders, and timelines.

Perhaps the greatest impetus for speeding up digital submissions has been the COVID-19 pandemic. During the pandemic, health authority offices were often closed, there was a ban on face-to-face meetings, and other in-person limitations were put in place to reduce the spread of the virus. The pandemic has also spurred the pharmaceutical sector and health authorities to reevaluate the use of tools to ensure that they are able to efficiently manage regulatory evaluation processes and operations so medicines get to patients in need. During the pandemic, countries across LATAM have been committed to working with all stakeholders and it is expected this willingness to collaborate will continue post-pandemic.

In addition, there is recognition that a robust and  better management of emergency situations will be required in future. That includes the use of digital-communication tools to speed up interaction and collaboration between all parties, and enable health authorities and companies to ensure the continuity of services.

Organizations, resources, training, and regulations for digitalization were quickly put in place, in particular, regulations governing teleworking. In El Salvador, for example, the effects of the pandemic forced the state to legislate on teleworking, and on March 20, 2020, the Legislative Assembly approved the Telework Regulation Law to protect employees working remotely.

While several countries had already implemented digital submission and evaluation (including Costa Rica, Dominican Republic, Ecuador, Honduras, El Salvador, Trinidad and Tobago, Argentina, Mexico, Colombia, and Chile), the pandemic accelerated the move to digital technologies. However, not every country is entirely digital as yet. For example, Nicaragua continues to use both digital and paper submissions, and will still request paper documents in some specific situations. Furthermore, a few countries are not yet ready to adopt digital submissions, including Aruba, Curacao, Jamaica, Panama, and Peru.

Nevertheless, the transition to digital is accelerating and the LATAM region will continue to move toward digital submissions, to adopting digital tools and platforms, and to training their reviewers in an effort to ease the regulatory burden.  The use of these agile regulatory approaches not only benefits the submission process, but also could potentially support innovative research. Digital will be crucial for the benefit of patients, society, and the pharmaceutical industry.

By Julie Chaumet Regulatory Affairs Specialist, Isabelle Sanvers Regulatory Affairs Officer and Milagros Ramos Regulatory Affairs Team Lead