Read the Conversation
EF: What are your key priorities, challenges, and opportunities in 2024?
ES: Internationally, the challenges we face include continuing to provide value to our partners. This means delivering products on time and in full, meeting their expectations. With numerous supply chain issues, timely delivery can occasionally become challenging. On the strategic side, we aim to become a key partner for our customers. Many companies, especially in the U.S., have extensive portfolios and cannot develop all the products they want to include. We step in to help where their resources fall short or when it is more efficient for them to license rather than make them in-house. We are also expanding our services to some innovative companies, building new relationships for the future. We are working towards becoming a B Corp company. We are moving towards digitalization to become more efficient, allowing our people to focus on strategic tasks.
EF: Could you elaborate on Medichem's evolution and its capabilities beyond manufacturing?
ES: We focus on development and innovation. Unlike innovators who handle basic research, we provide our customers with the products they need and comprehensive technical and regulatory support. Regulatory requirements are becoming increasingly stringent everywhere. We are proud that we can meet these high standards, showing authorities that our products comply with the required specifications in each country. A pharmaceutical product needs to be as reliable on day one as they are on day five hundred and beyond.
EF: Could you provide your perspective on the current trends in the European generics market? And where do you see the biggest opportunities for Medichem globally?
ES: The main challenges revolve around the prices of generic products spiralling. Pharmaceutical products need to be delivered on time and in full despite various supply chain issues. We strive to be a strategic partner to our customers. Especially in the U.S., where companies have broad portfolios but cannot develop every product themselves, we step in to fill those gaps. We also aim to serve some innovative companies beyond the generic space, building relationships there. Medichem is focusing heavily on sustainability. We are also moving towards digitalization so that our team can focus on strategic tasks.
Our opportunities lie in a market that grows due to an aging population that needs affordable medicines and new markets becoming more regulated. Regulatory requirements are becoming more balanced across countries, ensuring product quality. There are new opportunities in value-added medication where we can improve existing drugs to change their form for better use or combine them with other molecules. This aligns with sustainability goals because it avoids repeating clinical trials, as the molecules and their therapeutic action are well-understood by physicians. However, generics in Europe face challenges with price reviews due to rising costs. Some countries are introducing mechanisms to address this, but overall, there needs to be a balance between maintaining quality and affordability. Countries must decide if they want reliable, high-quality products for their patients, which might mean paying a fair price to avoid shortages and ensure continued production. For instance, the shortage of tamoxifen in Germany highlighted how low prices can lead to a lack of essential medicines. Small price increases for affordable products could prevent such shortages and ensure continuous supply.
EF: What are your ambitions and expectations for the Brazilian market, especially considering its significance in the generics industry?
ES: Brazil is a fascinating market, as large as Europe in terms of patient numbers, but it is highly regulated and protected. This makes it a bit challenging for European companies to enter. However, it is a dynamic market with great opportunities in certain categories. For instance, we recently underwent an ANVISA inspection for both APIs and finished products at our Maltese sites, highlighting our commitment to navigating and succeeding in this promising market.
Historically, Medichem has been more successful. With APIs, it is easier to supply an API for development and support the customer through the process. Licensing out a finished product is more complex due to extensive regulatory requirements, and commercial operations cannot start until the product obtains marketing authorization in Brazil. Brazil follows the US Pharmacopeia (USP) more than the European one, which sometimes requires using two different methods for the same analysis. We are exploring opportunities with partners interested in the Brazilian market and look forward to making it a significant market for Medichem.
EF: Could you explain the strategic decision behind the recent investment to expand your injectables portfolio?
ES: Medichem started as an API producer. To better serve our API customers, we decided to offer the production of finished products with the resources of a sister company called Combino Pharm. Combino Pharm originally focused on injectables, which were manufactured by third parties in Europe. We had an opportunity to acquire a sterile plant in Asturias that had been shut down. We decided to rebuild this facility to fully comply with European Annex 1 requirements. This rebuild involved redesigning the facility, process, and material flow. Our goal with this new facility is twofold: to bring some of our production in-house and to offer specific capabilities to our customers. We aim to provide smaller batch sizes and greater flexibility. This flexibility is particularly important for products requiring multi-packaging and multi-labeling for different countries. We have experience in this area with our oral products and aim to replicate this success.
EF: How does Medichem attract and retain top talent in a competitive market?
ES: Putting people first, which means carefully considering how every business decision impacts the team. It involves thinking about what each decision implies and whether it is achievable. For example, if there is a spike in demand, can your team handle it? Do you need to hire more people? Leaders at Medichem are responsible for their team's development, helping each member grow professionally. This includes involving them in different projects and ensuring continuous communication.
EF: Having been embedded in the Spanish market for over 50 years, what key milestones do you reflect on?
ES: The first major milestone for Medichem was becoming an FDA-approved API supplier. One of the first generics launched in the U.S. under the Watchman-Hatch Act a major brand used included an API made by Medichem. This achievement pushed the company to expand its focus beyond Spain and Europe to a global market. In the 1990s, this was a significant leap, even though it might seem obvious today.
Getting FDA approval was a confidence booster for our team, proving that our processes met the high standards of a leading health authority. Another significant milestone was starting to produce finished products and having our solid oral plant in Malta FDA-approved. Our goal is to get the injectable plant FDA-approved as well. Externally, key milestones include securing customers for specific projects and product launches. Success for our partners translates to success for us, as Medichem is a B2B company that thrives on building trust and delivering on promises.
EF: With your extensive career in the industry, is there any additional topic you would like to discuss, or do you have a final message for our readers?
ES: My final message, especially as the current president of Medicines for Europe, is that we rely on innovators to develop new, personalized therapies and conduct research for unmet clinical needs, balancing with the affordable medicines the generic and biosimilar industry provides. In Europe, seven of ten medicines dispensed are generics, essential for treating a wide range of conditions, including immunotherapy, oncology, hypertension, and diabetes, often for chronic diseases that improve people's lifespan.
EF: How do you see the balance between innovative medicines and generics across different markets like Europe, Africa, and the U.S.?
ES: This is a complex topic. For example, in the U.S., healthcare coverage varies greatly. In contrast, most European countries have social security or some form of universal healthcare, leading to a different level of discussion. In Europe, health authorities must consider a wide range of needs, like funding vaccines for the elderly, alongside managing other healthcare expenses. There are no simple solutions to these issues.
