Newsletter 41st Congress Day 2


Bureaucracy and legal uncertainty are bad for health

The delay, bureaucracy, and legal uncertainty faced by investors in the processing of patent applications in the health area within the scope of the BPTO and Anvisa (National Health and Surveillance Agency) set the tone for the debate on “Patents as a mechanism for public health protection”, with presentations by lawyer Marina Roversi Zago; Julia Davet Pazos, from ABPI; Ana Carolina Cagnoni, from Interfarma and ABPI directors Rodrigo Ouro Preto and Ricardo Boclin as moderator and debater, respectively.

In the presentation addressing Anvisa’s performance, Marina Zago demonstrated with practical examples how the lack of updating of the institution’s rules could go against the interests of investors and consumers. One of the examples referred to a smartwatch for medical use, which cannot be marketed due to a regulatory gap on the use of software in medical devices. In another case, electronic cigarettes were vetoed due to a prohibitive rule from Anvisa from more than ten years ago, which did not prevent the product from reaching the consumer illegally.

In the overview concerning laboratories, Ana Carolina Cagnoni explained that it takes more than ten years to launch a new drug, from its development to reach the consumer. The risk of delay in granting a patent by the BPTO, which has already exceeded a decade of waiting, is high: if the product is out of date, all the investment will go down the drain. “Security and predictability are essential for the investor’s decision making”, explained the representative of Interfarma. “The uncertainty as to whether the patent is being analyzed within a compatible period interferes with the investor’s decision on the destination of his investment”.

In her presentation, Julia Davet Pazos spoke of the importance of innovation and the patent system. “Health is not just not having a disease, and it is not just medicine, but physical, mental and social well-being”. She showed the elements of disruptive innovation listed by the European Union: citizen-centered healthcare; radical change from previous models; new skills and professional roles; new values ​​for professionals in the field, patients, citizens, and the community; and cultural changes in healthcare provision. “Innovations of this type can generate markets and demands that people could not even imagine”, she pointed out.