Latin America a Promising Market for Pharma

Q: What are your main priorities as Organon’s new strategic projects lead for emerging markets?

A: My role involves advising the Emerging Market's leadership team, specifically on projects aimed at seeking operational efficiencies to better serve diverse markets, countries, and clusters within these markets. This region encompasses Latin America, the Middle East, Africa, and the Asia-Pacific, including Japan. Despite the diverse nature of these regions, the common thread across emerging markets is the growth opportunities they present. While more developed markets like the European Union, the United States, and China have limited growth potential for portfolios like ours, the emerging markets segment offers dynamic growth opportunities.

Q: What are some of the challenges and considerations when operating in diverse geographical regions, particularly within emerging markets?

A: These regions are incredibly diverse and complex, presenting enormous and varied challenges. Latin America enjoys relative stability with a growing economy in 2024, providing opportunities for growth, particularly in healthcare investment. Conversely, regions like the Middle East are fraught with conflicts, which impacts business operations.

Managing a business in such diverse contexts requires tailored strategies for each country and cluster. There is no one-size-fits-all approach in emerging markets. We must instead adapt strategies to the unique realities of each region.

Q: What opportunities has Organon identified in Latin America?

A: Latin America is relatively more stable compared to other regions, and the economies of Mexico and Brazil are growing. Governments across the region also show a clear intent to improve access to medication. In Mexico, despite turbulence in procurement processes over the past six years, we see a willingness to enhance and rectify these procedures. Recent tenders reflect efforts to reconcile previously unacquired volumes, demonstrating a commitment to improving medication access domestically.

There is room for improvement, but there is also a palpable drive to do better. Significant regulatory changes have taken place under Commissioner Alejandro Svarch's tenure at COFEPRIS. Although there is still a backlog in approval processes, the approval rate surpasses the rate of submissions, gradually reducing this backlog. While there is ongoing work to further streamline regulatory procedures, we are optimistic about the trajectory and its positive implications for business in Mexico.

Q: What efforts is the industry undertaking to enhance collaboration with authorities? What have been the results of recent meetings with regulators?

A: There is a willingness to listen, discuss, and create more forums for these discussions. Despite differing objectives, the ultimate goal remains advancing healthcare accessibility through collaborative efforts among the private sector, government, and NGOs. We advocate for transparent, open, and sensible dialog regarding healthcare needs, positioning ourselves as strategic allies to governments in improving healthcare delivery. We remain impartial but optimistic about the potential for increased discussion and cooperation.

Q: What are the latest innovations Organon has brought to the market, and what other projects is the company working on?

A: We continue to work across various therapeutic areas, including cardiology, pain management, anti-inflammatory drugs, non-steroidal analgesics, dermatology, and respiratory health. We maintain and innovate within this portfolio to capitalize on the opportunities presented by the Mexican market for further growth. We also have a line of products for women's health, particularly for contraception. These products include the single-rod implant, which serves as a primary tool in fighting teen pregnancy, a significant issue in Mexico.

COFEPRIS recently approved a medical device designed to protect mothers during childbirth in cases of postpartum hemorrhage. This device is inserted into the vagina to swiftly control bleeding, effectively managing uterine atony, which accounts for 90% of postpartum hemorrhage cases. This innovative solution, which has been used in the United States for the past three years, demonstrates our commitment to bringing cutting-edge medical advancements to Mexico and abroad. While our portfolio of biosimilars is not yet accessible in Mexico, we plan to introduce some of these products into the Mexican market in the future.

Q: What are the implications of the underrepresentation of women in clinical trials, and how does Organon address this issue?

A: Historically, women have been underrepresented in most clinical studies. Typically, around 80% of study participants are men, with women being only about 20% or less. Some studies did not contain any female participants. Increasing female participation in clinical trials is crucial for understanding how innovation impacts women and how they can benefit from it. That is why Organon's clear focus on female health innovation is so significant. As a major player in this field, Organon aims to address past oversights and strive for gender inclusivity in medical research.

Q: What factors have allowed Mexico to reduce its teenage pregnancy and fertility rates?

A: The Mexican government has taken strategic decisions to address the issue. These include initiatives such as health centers that offer free contraceptives and provide teenagers with medical advice on suitable contraception methods. Since 2016, teen pregnancy rates have reduced, largely due to these proactive governmental efforts. While there is still much to be done, Mexico's approach serves as a model for the entire Latin American region. While companies provide contraceptive methods, the government's strategic decisions have been instrumental in reducing teenage pregnancy rates, making these methods accessible to adolescents, which yields results in the medium term.

Q: What initiatives is the company undertaking to enhance its manufacturing operations and expand its market reach?

A: Organon has six manufacturing plants around the world and one in Mexico. These plants follow a philosophy of continuous improvement, constantly seeking efficiencies to improve quality. Every minor issue that could potentially cause inconvenience is addressed promptly, with a plan of action and solution generated. Continuous improvement within our plants remains a priority. The plant in Mexico manufactures, packages, and exports products to various countries in Latin America and beyond, including Australia and Canada. Despite its proximity, the plant in Mexico does not supply the US market, so we are focusing on getting it certified by the US Food and Drug Administration (FDA). This certification will allow it to cater to the US market.

Q:What initiatives is the company undertaking to enhance its manufacturing operations and expand its market reach?

A: The company is implementing various initiatives to improve its manufacturing operations and broaden its market presence. These initiatives include focusing on continuous improvement within the plant, seeking efficiencies to reduce quality impacts, and addressing minor issues promptly.

Nearshoring is becoming a reality in Mexico, and we have invested in the country and have over 300 employees working in the manufacturing plant. We will leverage this plant to better supply our most important market: the United States. We are also transforming our plant into a business unit, allowing us to produce for other companies. The plant operates at 40% capacity so it has the potential to produce for numerous other companies. Discussions with potential partners are already underway, as we aim to diversify our production capabilities.

Q: How should the healthcare sector as a whole collaborate to improve access to pharmaceutical products, innovation, and healthcare treatments in Mexico?

A: The private sector, public sector, and non-governmental organizations should determine how they can collaborate to improve healthcare in Mexico, elevating standards and increasing access to pharmaceutical products, innovation, and treatments. Healthcare encompasses more than just medication; it includes institutions, hospitals, and pharmacies. While we may compete in certain areas, we must acknowledge opportunities for collaboration. By working together with non-governmental entities, the government, and the private sector, we can enhance healthcare for all in Mexico.

Organon, a spin-off of MSD, is a pharmaceutical company that focuses on psychiatry, reproductive medicine, contraception, and anesthesia, among other specialties.