Collaboration, Digitization Crucial for Oncology Innovation

The outcomes for people diagnosed with cancer have transformed drastically over the past 50 years. Innovation within oncology has led to breakthroughs in the detection, understanding and treatment of cancer. While there have been notable advances, there are still numerous challenges slowing down research and stopping treatments and medicines from reaching patients, ranging from regulatory bureaucracy to fragmented healthcare systems and economic hurdles, agreed industry experts.

“Regulatory agencies play an essential role. These organizations review the safety, quality and efficacy of treatments. Although there is a long way to go in Mexico, there have been advances. Recently, COFEPRIS entered the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH),” said Isabela Rivas, Medical Value Lead Lung Cancer, Roche.

ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of therapeutics and develop guidelines. The international council’s mission is to achieve greater global harmonization to ensure that safe, effective and high-quality medicines are developed and registered in the most efficient manner. “[COFEPRIS joining ICH] enables easier approval processes for therapeutics in Mexico. Based on globally recognized regulatory agencies, such as the US’s FDA and the EU’s EMA, ICH members can harmonize and streamline processes. It is all about reliance, trust in other institutions,” said Rivas.

Innovation and the right ecosystem to innovate are important to the development of specialized treatments for complex diseases, such as cancer. In 1970, of those diagnosed with cancer in the US, about half would have been alive five years later. For those diagnosed in 2009, the figure was closer to 70 percent, according to McKinsey. Oncology therapeutics amounted to US$143 billion in global branded pharmaceutical sales in 2019 and analysts’ figures indicate that global oncology therapeutics sales will hit US$250 billion by 2024.

In Mexico, it takes over 2,000 days for an innovative therapy to be fully accessible to the public and private health system, according to IQVIA. “COFEPRIS is a pillar. It regulates between 10-12 percent of Mexico’s GDP. We must seek to create a favorable ecosystem, focusing on regulatory improvement. Digitization of processes plays an important role in their acceleration,” said Fernando Cruz, Director General of Public Affairs and Communications, Novartis.

Agreements and collaborations that strengthen COFEPRIS also benefit Mexican companies, said Teófilo Tijerina, CEO, Hera Diagnostics: “Sometimes, healthcare professionals show a lack of trust when a product is manufactured in Mexico. In the medical devices segment, we have found inconsistencies in regulation, which add costs and time and limit the industry. COFEPRIS should be more pragmatic and consistent between the consumer and medical sectors.”

Pharmaceutical giants and multinational companies have great opportunities to support the local development of regulation and create synergies, leveraging their global experience and best practices, said Cristian Von Schulz Hausmann, Managing Director and GM, Merck. While innovation progresses rapidly, regulations tend to lag behind, especially in highly specialized areas, such as cancer, he added: “Today, innovation progresses twice as fast as regulations. Digitization is a key step, but working together and creating synergies is the right path for improvement.”

While regulations may delay access to these treatments, a considerable part of the population does not have access due to the fragmentation of the health systems. Limited infrastructure and economy, among other factors, also play a role, said Camila de Pamphilis, Chief Data and Patient Experience, Mamotest.

Cancer treatments, according to Rivas, must involve:

- Prevention in cancer is paramount. If not, timely diagnosis is key.

- Access: patients must receive innovative medicine or clinical studies through healthcare institutions. This is where Mexico falls behind. However, through more studies in Mexico, more innovations would enter the country.

- Adherence: once patients have access to the treatment, they must adhere to it.

Mexico faces several overall healthcare system problems, which impact oncology treatments, said Cruz. The country has one bed per 1,000 inhabitants, according to the OECD, which has an average of three beds. OECD member South Korea, for example, has 12.7 beds per 1,000 inhabitants. Regarding healthcare professionals, Mexico has 2.5 physicians per 1,000 inhabitants, while the OECD’s average is 3.5. 

Prevention and disease awareness must also improve in Mexico, said Cruz, as access to medicines and the public purchase model represent additional hurdles. In addition, collaboration between players within the health industry and other sectors plays a pivotal role in the arrival and availability of innovative therapies, he concluded.