May 17, 2020

Why Pharma Companies Should Invest in Brazil's Medical Market (and How)

pharma
Brazil
Latin America
medical devices
Admin
4 min
A skyline view of Sao Paulo, Brazil.
Brazil, a signature country of South America, just surpassed 200 million residents. It is the main economy in Latin America and one of the most importan...

Brazil, a signature country of South America, just surpassed 200 million residents. It is the main economy in Latin America and one of the most important at world level, regionally considered industrialized in spite of the variety of income, from very low in rural and peripheral areas to very high in the most populous cities.

Brazil’s health system is universal and available to all citizens for free and financed by the state, with an extensive use of other non-vital health products related, like cosmetics and alternative medicine and aesthetic surgery. 

Private medicine is well developed for the people with higher income mostly wanting a better and faster service. Research also demands an important investment by the government and universities, particularly related to tropical diseases. For citizens, health care comes in third place as priority after home ownership and quality education.

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The health care market spends annually almost $138 billion USD, with 54 percent of that amount in the private sector. Local private laboratories have the highest profit in the area and are aware of the high bureaucracy involved to get the approval of any new product to market.

The government agency ANVISA (National Agency for Sanitary Control) was created in 1999 and is dedicated to the control of all matters related to health regulation as well as market regulation in health care. Being mostly independent in management and budget, the organization is closely related to the directives of the Brazilian Health Ministry.

ANVISA embraces many issues related to health care, such as approval of the commercialization and control of:

  • New pharmaceutical products and recommendation for its use in state-sponsored lists for patients
  • Regulation of health care products importing
  • Laboratory testing
  • Cosmetics
  • Food and supplements
  • Bioequivalence of new drugs in comparison to those already approved and used in the health system
  • Health providers
  • Tissue, blood and organ use for transplantation
  • Sanitary control at airports, ports and borders

As any of us can imagine, having a product approved for commercialization can mean a fast exponential growth for any pharmaceutical company. To introduce any new product it is necessary to register it and get the approval of ANVISA.

Currently, the organization manages too many health care issues other than this so the process for foreign companies of any size is time and money consuming without the proper knowledge of the process, language and idiosyncrasy of the Brazilian public sector.

According to the Brazilian Research and Development Institute of Pharmaceuticals, the approval of a given product can take in average more than 15 months, even if previously approved in other countries by agencies like FDA3. Companies trying to introduce a new product can have a real headache learning the right way to register, losing time and money in the process.

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Counseling companies for medium- to large-sized investors in pharmaceuticals and related health care products are a great way to facilitate the insertion of a new product through the knowledge of regulatory affairs and a step by step guide in this process with ANVISA, saving money, time and risks (and nerves) when entering a competitive market like this.

Counseling companies over every point including market and distribution studies, authorization to carry out a preliminary analysis, audit and identification of required certifications, determination of fees for necessary registration or notifications, monitoring and securing a business environment and the procedures for registration, that include filing and following up with relevant agencies.

One of the firms advocated to assisting new game players include Mandala International and their Brazilian branch, which in a recent interview the chairman Stephan Fontanel commented that “most of our companies that come seek our services are companies that tried to register a product in Brazil by themselves and realized it is far from being a peaceful walk at the park.”

Currently, important facts that attract foreign pharmaceutical companies to invest in this extensive market in spite of the ANVISA bureaucracy and regulations include:

  • Improving living standard of the population
  • The population is growing older, with the related needs of medical treatment
  • Progressive organization and better regulation of the health care industry, which benefits foreign companies
  • Higher investment in technology and communications

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Jun 15, 2021

 NHS trials test that predicts sepsis 3 days in advance 

sepsis
MachineLearning
clinicaltrial
blooddisorder
2 min
Queen Alexandra Hospital is trialling a new sepsis test by Presymptom Health that uses machine learning to detect the onset of the disease

A new test that can predict sepsis before the patient develops symptoms is being trialled at a National Health Service (NHS) hospital in the south of England. 

Clinicians at Portsmouth’s Queen Alexandra Hospital are leading medical trials of the blood test, which they hope will help them save thousands of lives a year. 

The test is being developed by government spin-out company Presymptom Health, but the research began over 10 years ago at the Defence Science and Technology Laboratory (Dstl). This included a study of 4,385 patients and more than 70,000 samples, the largest study of its kind at the time. 

From the samples taken, a clinical biobank and database were generated and then mined using machine learning to identify biomarker signatures that could predict the onset of sepsis. The researchers found they were able to provide an early warning of sepsis up to three days ahead of illness with an accuracy of up to 90%.

Unlike most other tests, Presymptom Health identifies the patient’s response to the disease as opposed to detecting the pathogen. This is an important differentiator, as sepsis occurs as a result of the patient's immune system’s overreaction to an infection or injury, which can then cause life-threatening organ dysfunction. 

Worldwide, an estimated 49 million people a year contract sepsis, while in the UK almost two million patients admitted to hospital each year are thought to be at risk of developing the condition. If Presymptom's test is effective, it could save billions of pounds globally and improve clinical outcomes for millions of sepsis patients.

The initial trials at Queen Alexandra Hospital will last 12 months, with two other sites planned to go live this summer. Up to 600 patients admitted to hospital with respiratory tract infections will be given the option to participate in the trial. The data collected will be independently assessed and used to refine and validate the test, which could be available for broader NHS use within two years. 

If successful, this test could also identify sepsis arising from other infections before symptoms appear, which could potentially include future waves of COVID-19 and other pandemics.

Dr Roman Lukaszewski, the lead Dstl scientist behind the innovation, said: “It is incredible to see this test, which we had originally begun to develop to help service personnel survive injury and infection on the front line, is now being used for the wider UK population, including those fighting COVID-19.”

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