Fábio Cunha is General Counsel of DASA, Latin America’s leading medical diagnostics company. In this interview, he discusses DASA’s key role in testing the COVAXX’s UB-612 vaccine in Brazil, the challenges of heading the legal department of a world-leading medical diagnostics company and the main legal and regulatory impacts of the pandemic on the Brazilian healthcare sector.
Leaders League.What are the main challenges and advantages of heading the legal department of Latin America’s largest medical diagnostics company?
Fábio Cunha. The main advantage, as a company that wants to transform the sector, is delivering health to the Brazilian population in a more efficient, innovative and sustainable manner. We want to look after people’s health much more than their illnesses. We have the advantage of wanting to do something new, something different.
Our greatest challenge is transforming the health industry’s existing models which from the perspective of regulations, rules and laws have become outdated. As such, helping DASA to challenge these outdated and archaic models of our sector by seeking to enact transformation is one of our greatest challenges, as this could mean coming into conflict with existing rules and norms.
Our great challenge is leading this transformative effort with safety, quality, care for our patients and providing legal security but without impeding that our company fulfills its goal, this wave of transformations, which would have the greatest impact on Brazilian society.
In Brazil, DASA will oversee phase two and three trials of Covaxx’s UB-612 vaccine against Covid-19. What kind of legal challenges does such a project involve?
This project is an international partnership and represents a relatively complex operation, as DASA is overseeing it as a not-for-profit initiative. DASA will supply everything at cost value, will make an expressive donation and is also relying on a series of other partners and project donors. This is an initiative with the only goal of benefitting Brazilian society, however, it is a project which also involves international players with global technology, operating here in Brazil.
Hence, the challenge is to harmonize these elements and ensure the company implements all the necessary measures in the shortest possible timeframe so that the vaccine is equally ready in the shortest time possible.
This means complying with all quality and control regulations, respecting norms and legislation, but also ensuring the process does not take too long in order to positively impact society.
In legal and regulatory terms, which have been the main impacts of the pandemic on DASA’s operations? And on the Brazilian health sector?
The pandemic made it very clear that we were not prepared, as a health sector, to perform well in a crisis. We did not have enough tools with which to face this scenario. And what the pandemic indirectly brought on, which has been positive, is the development of these tools.
In light of this, in recent months, the activity of our legal department focused much more on seeking to change old and outdated rules at the National Health Surveillance Agency (ANVISA) and the Ministry of Health in order to replace them with swifter and more efficient solutions which will help overcome the pandemic.
A great example is the process for approving the importation of international medical equipment, which previously took approximately three months. Within the legal department, when we saw this figure, we quickly understood this period would be impracticable amidst a major pandemic and health crisis. So we proposed a new and faster process for the importation of medical equipment which was approved both by the National Congress as well as ANVISA. Today, in 72 hours we achieve what previously took us three months! Thus, an opportunity to improve our sector was seized and what we had attempted to change in the past but couldn’t, became much easier in light of the urgent demands triggered by the pandemic.
Another example is the now widespread use of telemedicine, which had been discussed for many years, and which had always faced great resistance. The entire sector began to use this technology due to the pandemic, regardless of the rules and even contrary to the rules at first, because there was a pressing social need for it. And what happened immediately afterwards? Legislation was approved allowing the use of telemedicine.
As such, we have had new developments in the Brazilian health sector in which legal departments playing a key role. Imagine if our legal department, along with sectoral associations, had said to Covaxx: “You will have to wait three months because that is Anvisa’s regulatory timeframe” or accepted that telemedicine could not be used due to its digital format. We did the opposite, for the good of society we petitioned for regulatory change, and this change happened.
In recent years, what has been the role of technology in DASA’s legal department?
With regards to workforce and case management legal technology, DASA has already implemented these tools. For example, we currently rely on artificial intelligence as well as electronic signatures, standardized digital contracts, budget control systems and more.
In my opinion, the next big thing in legal technology will be related to preventive and predictive algorithms. By evaluating a company’s caseload, for example, this technology will be able to analyze the data of a corporate legal department, predict future legal developments and indicate the best course of action.
What kind of initiatives can we expect from DASA and its legal department in the next 12 months?
As I mentioned, DASA does not simply want to be a diagnostics and healthcare company which only treats diseases, our aim is to go beyond. We want to look after people’s health, keep them healthy and avoid the overuse of medical resources as much as possible, allocating medical, hospital and laboratorial resources intelligently, thus effectively caring for the health of the Brazilian population.
DASA’s legal department will be a key internal tool in achieving this. We will have to create new regulatory, contractual, assistance and doctor-patient models as well as new ways of interacting with society itself – all of this will be rethought, rediscussed and reformulated in new rules, laws and models, both at the WHO and ANVISA.
We want to be the protagonists of this transformation as we are the largest medical diagnostics company in Latin America as well as the second-largest independent hospital network in Brazil – so we have this transformational capacity. We will direct all of our energy and assets in this direction. Not only to carry out exams and care for the sick in hospitals but to have much broader set of activities, as an integrated health ecosystem.