Cellular level 

Brazil’s cell and gene therapy industry. 

Brazil’s biotechnology sector, particularly in cell and gene therapies, is poised for significant advancement. As a major player in South America, Brazil’s efforts to enhance the accessibility and affordability of these therapies hold global implications.  

The reduced cost of cell and gene therapies in Brazil could significantly enhance their accessibility, attracting international patients and investors. “Fiocruz [controlled by the ministry of health] estimates that it will have to invest between BRL 5 billion and BRL 15 billion in these treatments,” reported a doctor in pharmaceutical sciences. “It clearly exposes the budgetary challenges that developing countries are likely to face.” 

Brazil’s cell and gene therapy industry holds a substantial “scale for growth,” identified a health and regulation adviser to Anvisa, but faces several scalability challenges. Key obstacles include limited infrastructure, a shortage of skilled professionals and high initial investment costs. Brazil currently has seven gene therapies approved by Anvisa, with two more expected soon. However, this lags behind “the 30 plus gene therapies approved in the US, with more than 500 in pipeline,” continued the health adviser.  

To capitalise on its potential, Brazil must overcome “the main challenges for the ‘democratisation’ of these treatments which will come in the form of regulation and technology,” suggested the pharmaceutical sciences doctor. Government support, strategic partnerships and investment in education and infrastructure are crucial for overcoming these challenges and achieving scalability. 

“The main challenges for the ‘democratisation’ of these treatments will come in the form of regulation and technology.”

Doctor in pharmaceutical sciences, University of Brasília, Brazil

Brazil’s cell and gene therapy industry may encounter significant regulatory challenges in the short to medium term. “The use of gene therapies in Brazil has been discussed by legislators and regulators since the early 2010s,” confirmed the doctor. “To obtain a regulatory certificate, these types of medical products need to undergo at least three steps which should: ensure its safety, guarantee safety and prove efficiency.” 

Obtaining regulatory certificates involves multiple steps to ensure safety, efficacy and compliance. “Each regulatory step adds additional cost to the production of immunobiological products.” A health and regulation adviser to Anvisa elaborated, “Moreover, the production of these medicines requires specialised materials, equipment, facilities and, also, high-skilled expensive labour.” Collaborative efforts between the industry and regulators can help mitigate these challenges and foster a thriving biotech sector. 

Can the success of Brazil’s cell and gene therapies indeed be replicated in other Latin American countries? The pharmaceutical sciences doctor is doubtful, but in regions such as Mexico, Argentina and Colombia, given their robust medical infrastructure, skilled workforce and growing biotech sectors, they are well-positioned. The doctor even conceded, Colombia is doing well,” having made progress through collaboration between its local health regulator INVIMA and Universidad de Antioquia in Medellín.  

Argentina has significant potential due to its reputable medical and scientific industry and strong pharmaceutical sector. “Argentina was the first country in Latin America to work jointly with North American hospitals and medical centres,” informed a pharmaceutical professional executive.

Despite having a good starting point and potential for growth, Argentina’s “challenges and restrictions are not minor, as is also the case with other national industries,” explained the executive. Challenges such as financing and investment costs hinder its development, with “very few teams researching gene therapies,” commented a pharmaceutical executive. 

 “[Argentina’s] challenges and restrictions are not minor, as is also the case with other national industries.”

Pharmaceutical professional executive, Argentina

High investment costs for laboratories and associated therapies, coupled with current funding restrictions, make it difficult to achieve the same level of impact as larger international centres. Although “few in number and resources, they have achieved very important advances in cases” such as treating muscular atrophy and blindness.  

Regulation in the biotech sector is crucial, given the medical, ethical and economic issues involved. “A ‘bad’ regulatory system can have serious consequences.” The pharmaceutical executive warned, “A lot of time and money can be wasted by copying and pasting a foreign standard without considering the socio-economic and cultural context.”

It is essential to consider local cultural factors when legislating, with Brazil and Argentina, the more advanced biotech regulation, serving as models for others. “Early interaction with the industry is critical.” The executive expanded, “If this does not happen, standards often end up being challenged or prosecuted, and the loss is for the whole.” Less advanced nations will need time and strategic efforts to achieve successful and relevant regulatory results. 

Brazil’s advancements in cell and gene therapies offer a promising avenue for increased accessibility, innovation and collaboration within the global biotech sector. With strategic efforts, Brazil and its neighbours can make advanced therapies more affordable and accessible, ultimately improving healthcare outcomes worldwide. 

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