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EF: What is Interfarma’s agenda for 2023?
EC: Our focus has been on three key strategic areas: access, intellectual property, institutional relations, and communications.
Regarding access, we are advocating for funding and collaborating with the government to highlight specific requirements such as increased resources or better management.
Pharmaceutical companies have shifted from primary care development products to specialized and personalized medicines.
We are developing new drugs that address significant challenges for all stakeholders in this field. Consequently, our association is also seeking to determine new reimbursement models, as we need to adapt the system to receive these new medicines and provide the right access to patients.
Moreover, we have been working to generate new investment models analyzing the practices of other developing nations that we can customize to suit Brazil’s context.
The final component is the synchronization of digital transformation with real-world evidence. Real-world evidence can aid in the improvement of access and intellectual property solutions. In Brazil, we have discovered that robust real-world evidence generated in Europe, the United States, or Japan does not translate to our context. As a result, we are collaborating with various associations to establish new clinical trial centers that are more cost-effective.
EF: What is the role of research and clinical trials in Brazil’s healthcare system?
At this moment, we are in the 19th position for research worldwide. However, Brazil has the potential to grow and be in the top 10 countries for clinical trials.
This year, one of our missions is the approval of a low protein "therapeutic area" that can improve the market and open the potential to generate more than two billion per year in investments for clinical research that will impact more than 50,000 physicians and 60,000 patients. This mission will be aligned with our access and IP strategy because we can improve the affordability of new medicines. We will train physicians in new technologies and generate data to reinforce the importance of intellectual property in the country.
Our efforts focus mainly on three therapeutic domains, oncology, rare diseases, and vaccines, which are of significant interest to the government and our organization. These fields attract substantial investment from pharmaceutical companies and offer immense potential for advancement within the country.
A comprehensive overhaul of our systems is imperative, encompassing funding allocation, management protocols, and resource utilization. Thankfully, our government has taken a positive step forward by establishing a dedicated oncology directory within the Ministry of Health. We are in discussions with the Ministry and share a common vision in our endeavors to develop oncology trials. The same level of commitment applies to our efforts in rare disease and vaccine research.
Even though Brazil was a frontrunner in the Covid immunization plan, the adoption of vaccines has been decreasing lately. To address this alarming trend, our association approached the Ministry of Health and committed to devising effective solutions to improve the situation and offering to share all the diagnostic tools available.
To tackle the issue, we need a robust campaign and solid communication strategy to overcome fake news and raise awareness of the importance of immunization in society.
Another challenge is Brazil’s muti-leveled structure in Federal, state, and municipality operations. Our initiatives seek to eliminate gaps in the system, especially in the municipalities, and address regulatory issues and how the government has been buying, distributing, and managing vaccines.
EF: How can Brazil attract more innovation and new investments?
EC: To become an appealing investment location, investors must feel secure. Achieving this forms part of our collaboration with the Brazilian authorities as we work together to comprehend and convey this mindset.
Understanding the government’s strategy is crucial since the Ministry of Health intends to generate local production in the health sector, which will cover 70 % of the total needs. This plan is challenging since not all local manufacturers are prepared for this demand. To guarantee a positive outcome for this ambitious goal, we have to understand how to transfer patent-protected products and set our production priorities.
South Korea, for example, started its strong project 20 years ago and became an independent global player. Brazil must learn from this success story and adapt it to our reality while creating a solid step-by-step plan. From Interfarma's perspective, the API (Active Pharmaceutical Ingredients) industry should be the starting point. Brazil might not be able to compete with the structure of Asian countries, but it can become a regional hub.
It is imperative to establish a comprehensive and resilient regulatory and legal framework that will facilitate the transfer of patent-protected technologies to the Brazilian healthcare scene and flourish investment in new projects. This applies especially to Industrial Property, for even with the prominence of the generic industry, the production of reference products remains crucial, as they will serve as generics in the future and stabilize the industry.
EF: To what extent has Brazil progressed in establishing a digital healthcare ecosystem?
CN: Brazil has made progress in developing a digital healthcare ecosystem. The Ministry of Health has initiated several digitalization projects, including digital consultations, which have become more important during the pandemic. However, there is still room to improve the environment between physicians and patients, including resource allocation and communication infrastructure.
The private sector has advanced significantly in digitalization, while the public lacks the required resources. This reality has to be considered and addressed properly before moving on with the authorities’ plans for autonomy.
We now need to use technology in our favour and apply better resources for the total restructuring of our country. In the adoption, we need clear frameworks to guarantee that all stakeholders keep the digitalization process ongoing.
EF: How do you envision the progress of pharmaceutical innovation in Brazil in the next ten years?
EC: Brazil needs a clear state policy. Health priorities should remain independent of which political party is in power.
The pharmaceutical companies in Brazil, both local and multinational, have been working to meet the needs of the country and the world. However, a pragmatic approach is necessary to ensure progress is made and to avoid the same problems being perpetuated for the next 30 years. To achieve this, the country needs to have a comprehensive list of current and long-term priorities that includes everything from generic products to the development of new medicines.
Interfarma has been working in specific therapeutic areas to provide solutions that address issues such as better management, resource allocation, and a different approach to treatments. Fortunately, Brazil has many good examples that can be applied to similar scenarios, such as the internationally recognized AIDS, hepatitis, and transplant programs.
Lastly, Brazil has to resolve its decentralized healthcare system. Fragmented into three levels of authority, the responsibility for medical care lies with the state and municipal, while high-complexity diseases are the responsibility of the state and federal levels. Additionally, there is a lack of coordination between the public and private sectors when it comes to personalized medicine, and more needs to be done to accelerate learning in this area.
One of the initiatives being undertaken by Interfarma is the development of a better data center. While Brazil has a lot of data, it is still not being used effectively to improve patient outcomes and increase efficiency. Brazil’s important reference centres, such as leading Hospitals for oncology treatment, provide more services than renowned cancer centres in the USA. If we smartly collect information through the SUS, we can obtain valuable data for cancer treatment and even learn to apply the methodology to other therapeutic areas.
