Participants in a webinar held by FAPESP pointed to disorganization of the research ecosystem, lack of government planning and underinvestment as obstacles to drug development in Brazil (photo: Fernando Zhiminaicela/Pixabay)
Published on 09/20/2021
By Maria Fernanda Ziegler | Agência FAPESP – The COVID-19 pandemic has highlighted the strategic importance of investing in innovation to promote the nation’s general welfare and development, and to create wealth and jobs. Brazil’s performance in this regard has been far from ideal, even though it has one of the world’s largest health consumption markets, according to participants in the online seminar “Challenges of Developing Pharmaceuticals and Biopharmaceuticals in Brazil”, held by FAPESP on September 1, 2021.
The event was the latest in the series of FAPESP COVID-19 Research Webinars, organized in partnership with the Global Research Council (GRC). It featured presentations by experts on the challenges, costs and uncertainties of drug development by Brazil’s complex research ecosystem, which includes universities, research centers, pharmaceutical companies, startups, clinical laboratories and hospitals.
“Brazil is one of the largest markets for the pharmaceutical industry. This gives us a very broad potential basis for drug development, but it’s not happening. Unfortunately, the number of drugs developed in Brazil, from fundamental research to commercialization, can be counted on the fingers of one hand. A great many difficulties explain this problem, and we need to broaden the debate if we’re going to find solutions to the bottleneck,” said Luiz Eugênio Mello, FAPESP’s Scientific Director, in his welcoming remarks.
The difficulties include insufficient research ecosystem integration, lack of government planning, and scant funding for companies, the speakers agreed. “In recent years there’s been enormous progress in such areas as big data, genomics, and the biological and biophysical methods that drive drug development. However, we’re not seeing the translation of promising initial research into clinical trials. The fact is that in Brazil we’ve done a lot of screening of potential molecules and targets, but little effective development of candidate drugs,” said Glaucius Oliva, principal investigator at the Center for Innovation in Biodiversity and Drug Discovery (CIBFar).
CIBFar is a Research, Innovation and Dissemination Center (RIDC) funded by FAPESP and hosted by the University of São Paulo’s São Carlos Institute of Physics (IFSC-USP).
A lengthy process of research, development and regulation is required for candidate compounds to reach the commercialization stage, Oliva noted, involving many stages from in vitro tests in cells to animal trials and several phases of clinical trials. In parallel, research is conducted to optimize the molecule that may eventually become a drug.
The entire process is costly and can take more than 12 years. Many candidates are abandoned en route. “Drug development combines identifying molecular targets – enzymes and receptors in an organism – and finding molecules that block the progress of specific diseases. A drug can be just a powerful molecule but has to reach the target. It has to be absorbable and soluble. It requires other characteristics besides potency and safety [non-toxicity]. All this determines the efficacy of a drug,” Oliva explained.
The research stage of drug development is distorted by imbalances of various kinds, he continued. “In Brazil, we typically measure the potency of a molecule in a Petri dish, but it should be borne in mind that this is only one of the parameters that must be considered in the process of drug discovery and development,” he said.
For Oliva, the main difficulties faced in basic research are a lack of qualified professionals and insufficient interaction among the different groups that make up the innovation ecosystem. “The number and variety of natural products available in Brazil give us a competitive advantage, but I’ve long yearned for the day when it becomes commonplace for professors and students to discover an important molecule, found a startup, stick to their guns while it matures, and set up a spinoff. We need much more interaction in order to innovate,” he said.
It’s the economy
Another important point made by the speakers was the need for state planning of innovation as a permanent economic policy. “If Brazil had such positive planning, we wouldn’t be in the situation we’re in now [with scant investment in science, technology and innovation, ST&I],” pondered Glauco Arbix, head of the Innovation and Competitiveness Observatory at the University of São Paulo’s Institute of Advanced Studies (IEA-USP) and Impact Coordinator at the Center for Artificial Intelligence (C4AI), an Engineering Research Center (ERC) established by FAPESP and IBM at the university’s Innovation Center (InovaUSP).
For Arbix, although 2020 was a particularly chaotic year, paradoxically it was possible to win public acceptance of the health sector’s strategic importance for Brazil. “Huge trade deficits evidence the problem of the low level of innovation in the healthcare industry, be it in pharmochemistry or equipment,” he said. “Just look at the deficits of the SUS [Brazil’s national health system] and how much the private sector pays by being obliged to import equipment and inputs. For every BRL 100 spent by the SUS, imports account for BRL 60. That means a very high social cost for the nation.”
Research based on data from the SUS shows that health-related imports (drugs, personal protective equipment, etc.) jumped from USD 5 billion in 2004, when the system was finally universalized, to USD 12 billion in 2019, and are set to continue rising in the years ahead as the population ages. Moreover, Arbix noted, the global health sector accounts for 24% of all the innovation achieved worldwide. “It’s more innovative than the defense sector, which has been the main driver of innovation for most of the world’s history,” he said.
The economic potential of investment in innovation in the health sector was also emphasized by Carlos Gadelha, Coordinator of the Center for Strategic Studies at Oswaldo Cruz Foundation (FIOCRUZ).
“Just as oil and steel were important production systems in the twentieth century, healthcare and a few other areas of the digital economy are key sectors in the twenty-first,” Gadelha said. “Their importance derives from the amount of jobs and wealth they help create, and their role as drivers of economic development and societal wellbeing.”
According to a survey conducted in 2020 by CMED, the Medicines Regulatory Board, the Brazilian market for medical drugs grew from BRL 65 billion to BRL 86 billion between 2015 and 2019, a period that included a severe economic recession. “A similar trend can be seen in the healthcare sector, which expanded in every year of the crisis and kept on creating jobs. Despite what many people believe, the health sector offers a big opportunity to emerge from a crisis,” Gadelha said.
The pandemic has shone a very strong spotlight on the extent to which health and the economy are interdependent, he added. “There’s no such thing as the world of the economy, science, technology and innovation on one hand, and the world of society and the environment on the other. Experience has now shown that if you lack scientific, technical and economic capacity, if you specialize in exporting ores, you risk becoming one big farm and failing to grow the economy enough for per capita income to rise continuously,” he said.
The growth of the health sector is linked to the development of information and connectivity. “The big techs are all in the health sector,” he said. “For example, we used to say vaccines were a segment of the pharmaceutical industry, but they couldn’t have advanced as they have now without genomics, artificial intelligence, big data, and other cutting-edge technologies. We couldn’t treat COVID-19 without information and connectivity, which are indispensable to ventilators and personal protective equipment, not to mention primary care, hospitals, diagnostic services, and so on.”
Gadelha also noted that the SUS is the largest universal health service in the world, that healthcare accounts for 9% of Brazil’s gross domestic product (GDP), and that it could reach 12% in a few more years. “It’s a productive system for the future and could be a gateway for Brazil to embark on the fourth technological revolution,” he said.
Systemic vision
Besides research centers, universities and the SUS itself, the ecosystem needs companies to adopt innovation as the path to development in the global market. “Many companies have created R&D [research and development] centers, and this is a cause for celebration, but although there’s been growth in recent years, even so, companies in the health sector don’t invest enough in innovation,” Arbix said.
The problem is particularly worrying in light of the growing importance of complex technology in the sector. “The pandemic has given us a glimpse of what clinical trials will be like in future. They will be increasingly global [rather than being conducted in single countries or by single institutions], and data will be collected by patients using wearables, with artificial intelligence playing a key role in their design. All this will assure far greater analytical capacity, permitting advances in precision medicine and analysis of larger swathes of the population,” said Luiz Rizzo, Head of Research at the Albert Einstein Jewish-Brazilian Institute of Education and Research (IIEP).
All speakers agreed that disorganized public policies are another major obstacle. Arbix highlighted the need for the state to participate more in planning and coordination of the sector, not least by defining funding priorities. “You can’t buy one product, develop the technology for another, fund a third, and prioritize education, intellectual property, public health regulation and industrial policy for other products. All that is just too enormous. You have to organize policies around the state’s purchasing power and indigenous procurement. Without a market, there can be no innovation,” Gadelha said.
Procurement, ST&I and funding are the main drivers and should go hand in hand, he added, alongside a consistent education policy and integration of the existing regulatory and educational frameworks.
The webinar “Challenges of Developing Pharmaceuticals and Biopharmaceuticals in Brazil” (in Portuguese) can be watched on Agência FAPESP’s YouTube channel.
Source: https://agencia.fapesp.br/36883
