Brazilian Congress Debates Regulatory Data Protection for Pharmaceutical Products
“The fact that Brazil is considering debating this topic is encouraging news. While proponents of RDP argue that this measure is necessary to protect investments in innovation in the pharmaceutical industry, critics warn of the risks in terms of restriction on access to drugs and price increases.”
Brazilian Senate
In May 2024, the Brazilian Senate Committee on Science, Technology, Innovation, and Informatics hosted two public hearings to discuss implementing Regulatory Data Protection (RDP) for pharmaceutical products of human use. The call for hearings (REQ 27/2023) was presented by Senator Izalci Lucas (Liberal Party). While recognizing that regulatory changes would have significant implications for the local industry, the healthcare system, and consumers, Sen. Lucas expressed concern that a lack of measures could discourage investment in R&D.
Background and Context
RDP involves the protection of clinical and preclinical data necessary for the approval of a drug by regulatory agencies. Although the Brazilian IP Statute (Law No. 9,279/1996) provides protection for regulatory data on grounds of unfair competition, leading case law has established the need for Congress to properly address regulatory data exclusivity for drugs of human use.
RDP is a hot topic commonly addressed in negotiations of free trade agreements. Countries like the United States, Japan, and Canada, as well as the European Union, have specific legislation to address RDP. Brazil, however, has only regulated data protection for veterinary pharmaceutical products and agrochemicals, under Law No. 10.603/2002. Therefore, manufacturers of generic or brand-generic drugs face no obstacles in registering products that rely on the data belonging to the new drug marketing approval holder.
Senate Hearings and the Arguments Pro-RDP
In the Senate hearings, Interfarma (Association of Research-based Pharmaceutical Companies), represented by Mr. Renato Porto, advocated for protection, as RDP for pharma would guarantee a period of exclusivity for the test data submitted to regulatory authorities, preventing the use of this information by competitors for a certain period.
Interfarma’s arguments are based on Copenhagen Economics’ study on RDP (). The study took into consideration Brazilian health care system and RDP could bring benefits to the country. In contrast to patent protection, which aims to protect the inventor of specific biochemical assets of a particular drug, RDP ensures the protection of the dossier holders, usually a pharmaceutical company. While the patent offers 20 years of protection and is granted by the Brazilian Patent Office, RDP would be granted by the Anvisa (National Health Surveillance Agency).
The process of researching and developing drugs is complex, costly, and slow. It can last an average of 12 years, with six years for research and another six years for safety and efficacy testing. This is due to the need for detailed clinical research, usually conducted by the double-blind method, which, in addition to being time-consuming, requires a significant investment of $1.3 to $1.6 billion, representing 57% of the final cost of the drug.
Faced with Senator Hiran Gonçalves’ question about the production of generics in the country, Mr. Porto highlighted that the implementation of RDP for pharma could have a positive impact in this regard, as it would encourage the entry of innovative products into the Brazilian market, which in turn would accelerate the entry of generics.
Finally, Mr. Porto argued RDP for pharma would harmonize Brazilian legislation with international treaties, as well as with the regulations in place in other LATAM countries, since countries such as Chile, Colombia, Costa Rica, Peru, and Mexico already adopt similar protection.
Arguments Against RDP for Pharma
Critics of RDP raised several concerns, mainly focusing on public health care disruption. They argued that RDP could create unnecessary barriers to the entry of generic and branded-generic drugs into the market, delaying the population’s access to more affordable treatments. The arguments against regulation are largely based on studies by Dr. Julia Paranhos, coordinator of the Economic Innovation Group of UFRJ (Federal University of Rio de Janeiro), in which five possible scenarios resulting from the implementation of RDP for pharmaceutical products intended for human use were considered. In the first scenario, the current model was maintained, without the adoption of RDP. In the other four scenarios, different combinations of market and data exclusivity were considered. The conclusion was that any form of protection could represent a significant burden for public healthcare systems and consumers, especially to the low-income population.
Ms. Marcela Vieira, Regional Advocacy Advisor for Latin America at Doctors Without Borders, raised ethical and legal issues related to the topic. Ms. Vieira highlighted the issue of reproducing tests in humans, considered unethical, and emphasized that data protection for pharmaceutical products is not even provided for in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Mr. Thiago Vicente, President of PróGenéricos (Brazilian Association of Generic and Biosimilar Medicines Industries), also advocated against the implementation of RDP for pharma, arguing that this could hinder access to medicines and increase costs for the healthcare system.
Finally, economist Ricardo Lobato Torres affirmed there is no clear cause-and-effect between RDP and innovation. While there are benefits such as return on investment, he noted that the increased availability of medications and investment in innovation is not a certain benefit. Conversely, he highlighted that the costs to the healthcare system, expenses in acquiring medications, and delays in the release of incremental innovation in generic or similar medications are certain, recommending against the adoption of RDP for pharma.
Other Considerations
Some impartial stakeholders also made brief comments. For example, Ms. Jussanã Cristina de Abreu, Head of Quality Management and Intellectual Property at Anvisa, pointed out that a change in the RDP system would make the process to obtain marketing approval more complex and has the potential of increasing litigation, not to mention delaying the entry of generic drugs into the market.
Mr. Leandro Pedron, Director of Thematic Programs at the Secretariat of Strategic Policies and Programs of the Ministry of Science, Technology, and Innovation, identified several challenges that need to be addressed in the context of drug regulation. The first challenge is to balance the pursuit of innovation with access to medications, especially considering the interest of the Unified Health System (SUS) in incorporating new treatments. Another challenge is the need for international harmonization. It is important to remember that Brazil is a member of the World Trade Organization (WTO) and should seek international harmonization, respecting the commitments made in international agreements, such as the TRIPS Agreement. Finally, justice and social equity should be evaluated.
Final Thoughts
The fact that Brazil is considering debating this topic is encouraging news. While proponents of RDP argue that this measure is necessary to protect investments in innovation in the pharmaceutical industry, critics warn of the risks in terms of restriction on access to drugs and price increases.
During the first of the Senate hearings, Senator Izalci Lucas pointed out that there was a remarkable lack of supporters of RDP for pharma present, suggesting that additional hearings may be necessary to guarantee that all points of view are heard and considered by the Brazilian Congress.
Emanuella Kunz and Daniela Fernandes also contributed to this article.
Image Source: Deposit Photos
Author: Marcelo_Moryan
Image ID: 353181938
