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June 7, 2022
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“Uruguay has the longest terms for approval of innovative biotechnological products in the region”

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The head of the Roche laboratory for Uruguay, Nathalie Lecrerc, spoke with Café & Negocios about the laboratory’s projects, which in 2022 celebrates 75 years in the country. In this framework, she highlighted the government’s handling of the pandemic and asserted that the country is positioned as a leader in the region in the development of personalized and humanized health care.

On the other hand, he highlighted that one of the main challenges is in the implementation of approval mechanisms based on the evaluations of already registered products, a recommendation from the World Health Organization (WHO) that would allow the country to align with regional registries. of approval of innovative biotechnological products. Below is a fragment of the interview with Nathalie Leclerc.

You have been at the helm of Roche in Uruguay for a year, what are the axes of your management?

It is important to mention that my position covers three very different countries, such as Uruguay, Paraguay and Bolivia, which have different health systems and, therefore, different challenges. But regardless of geographical differences, at Roche we all work with a shared purpose: to do now what patients will need tomorrow. We know that the work we do can improve the lives of people in society and, at the same time, the treatments we develop are only meaningful when patients benefit from them. That is one of the axes of my management. We also want to help build ecosystems of personalized health care (this is the use of an individual’s genetic profile to guide decisions made in relation to the prevention, diagnosis and treatment of disease) because we recognize that it has the potential to transform health as we know it. To make personalized health care available to patients in our region, we need greater collaboration between the public sector, the private sector, and civil society, because no single entity or organization can solve current and future challenges. Together we can create the necessary conditions to promote innovative solutions, including a secure, interconnected digital infrastructure capable of handling large volumes of data, as well as legal and ethical frameworks that guarantee the availability of innovative products and technologies. In short, much of my work focuses on promoting significant changes in access to innovation, helping the implementation of personalized medicine and fostering collaboration between actors in the health system.

There are not many companies that are 75 years old in the country. How relevant is the Uruguayan market for Roche? And, at the same time, how established do you consider the brand to be in the country?

The company was founded on October 1, 1896 in Switzerland, at a time when the industrial revolution was changing the face of Europe. Fritz Hoffmann-La Roche was one of the first to recognize that the industrial manufacture of drugs would be a breakthrough in the fight against disease. In Uruguay, Roche has been a leader in the pharmaceutical market for 75 years. Today, we employ about 150 people, and we have three divisions: pharmaceutical, diagnostics and diabetes care. In addition, we are the logistics center and the regulatory affairs center for all of Latin America and, from here, we manage the Bolivian and Paraguayan markets. We are leaders and benchmarks in transformative treatments in areas of high need (such as cancer, ophthalmology, neurology, hematology, among others) and also in diagnosis. All this is reflected in a very close and rich exchange with specialists and also with reference patient organizations.

In the context of the pandemic, how do you analyze the Uruguayan health system?

Uruguay has highlighted the strengths of its health system in terms of universal coverage, equitable access and progress in health infrastructure. In addition, the country has demonstrated its commitment to investment in health and improving the results of the system and is positioned as a leader in the region in the development of personalized and humanized health care. The effective management of the pandemic has provided efficient examples that opened the door to an improved and integrated health system that can help manage other chronic health conditions that affect the Uruguayan population. We see this as an opportunity for the transformation of the health sector and for personalized care to become a widespread reality.

There are also other opportunities for improvement. For example, innovative biotechnological products in Uruguay have the longest approval terms in the entire region, approximately four and a half years when, in comparison, the countries of the region approve health registrations in approximately 12 months. To improve this situation, the WHO recommends the implementation of approval mechanisms based on the evaluations of products already registered in reference agencies. This work allows shorter times and facilitates the regulatory evaluation of complex products.

What is an innovative biotech product?

An innovative biotechnological product stands out for being made with living organisms through highly complex procedures, the result of research and development by the pharmaceutical industry, and for being the first or only one of its kind on the market.

More than 30 of its medicines are among the essential ones of the WHO. What is Roche’s research focus on today?

Roche is the world’s largest biotechnology company, with differentiated medicines in the areas of oncology, immunology, infectious diseases, ophthalmology and neurosciences. It is also the world leader in in vitro diagnostics and histological diagnosis of cancer. It is one of the 10 firms in all areas that invests the most in research and development. In 2021, for example, Roche invested more than $14 billion in innovation, the highest investment in the industry. Finding innovative solutions to unmet medical needs is at the heart of what we do. Some of the innovation areas in which Roche is deployed are hematology, oncology, degenerative neurological diseases, ophthalmology and rare diseases.

What drugs are the most requested by Uruguayans?

If we think about the most important health challenges in Uruguay, we see that non-communicable diseases represent almost 80% of the disease burden in our country. Cardiovascular diseases and cancer prevail in this group. Many of these conditions are preventable, and there is a very relevant area of ​​action to prevent people from getting sick and needing treatment. And, in many cases, a timely and accurate diagnosis allows treatments that even lead to a cure or a very noticeable increase in the quantity and quality of life. Cancer deaths account for 25% of all deaths in the country, occupying second place almost on a par with cardiovascular diseases, and breast cancer is the one with the highest incidence in women and prostate cancer in men. At Roche, as a world leader in the development of solutions for the diagnosis and treatment of cancer, we hope to contribute to continue progressing in the fight against this condition and others of great importance to society, families and individuals.

In December 2021, Roche was fined more than US$800,000 for an anti-competitive practice. The firm had among its plans to file administrative appeals, was it carried out?

Roche filed the corresponding administrative appeals in order for the commission’s decision to be reconsidered, so the proceedings will continue to be processed until a final resolution or judgment is issued on the matter.

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