Pharmaceutical Innovation’s Ultimate Goal: Patients

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Behind pharmaceutical innovation are long efforts and large investments. However, the main goal of innovation is only achieved when it reaches the patient, a path that is still fraught with challenges in Mexico.

In the last few years, access to basic sanitation, clean water, immunization and access to pharmaceuticals have been critical drivers of health improvement, said Cristobal Thompson, Executive Director of the Mexican Association of Pharmaceutical Research Industries (AMIIF). Global economists point out that in the last 100 years at least a third of economic growth and development has been driven by access to innovative therapies worldwide. In short, being healthy increases quality of life and wellbeing, explained Thompson. 

The speed at which innovations arrive to the market and the industry pipeline play an active role in patients' quality of life. “We are moving from mitigating the impact of diseases through symptom management to novel treatments that create real transformative change for patients, their families and their environment,” said Cynthia Ramírez, Communications Director of AMIIF. “What was once untreatable is now becoming treatable.” The value of innovation, however, only becomes meaningful when it reaches the patients who need it. Achieving this is no easy task, says Ramírez, as everyone in the healthcare ecosystem, from patients to service providers, doctors, researchers, pharmaceutical companies and healthcare institutions, needs to accelerate access pathways to pharmaceutical innovation so that patients have access to new treatments.

Access must be provided on time, which has not yet been achieved in Mexico as regulatory processes are slow. “Until a year ago we had a big bottleneck in COFEPRIS’ New Molecules Committee, which was not operating,” Thompson said. “Albeit with the arrival of Alejandro Svarch to lead the commission, the processes have accelerated for new therapies.” Despite this progress, Thompson mentioned that the bottleneck now lies in the issuing of registrations because there are still 22 pending registrations to bring the medicines into the country to treat those who need them.

A solution to process delays, while vital for innovation, is just one of many potholes that are holding the industry back, says Angeles Martínez, Senior Principal and Head of Consulting for North Latin America at IQVIA. Mexico, unlike other countries like Brazil, the US or Japan, still has many areas of improvement to make innovation accessible. While in Mexico it takes over four years to make a treatment available, in other regions of the world it can take less than two. “All the changes that have taken place in the health system have also generated some uncertainty and delays in processes that used to work properly.” IQVIA, which has provided health information technology and conducted clinical research since 1982, found in a recent study that countries that allocate a higher percentage of government spending to health services have much healthier populations.

Working in partnership rather than individually in the healthcare ecosystem is another step towards bringing innovation to patients. Florencia Davel, VP and General Manager for Latin America of Bristol Myers Squibb, explained that scientific advances over the last century have addressed the diseases challenging the sector, such as HIV, which has seen a 60 percent decrease in deaths compared to 2004. More recently, she noted, the COVID-19 vaccine that has lowered the risk of hospitalization is a sign of “early accessible innovation.”

The pandemic is an unprecedented event where collaboration between different stakeholders of the healthcare ecosystem has taken place at a global scale, added Country Medical Director of Sanofi Genzyme Antonio Loaeza. “This has given us the opportunity to bring new technologies and biologic platforms like those using messenger RNA (mRNA), which are gaining strength in areas such as oncology and immunology.” In Mexico, Sanofi recently launched a product for moderate to severe atopic dermatitis “that otherwise would not have had a specific treatment,” Loaeza said.

According to Davel, who also chairs the Latin American Federation of the Pharmaceutical Industry (FIFARMA), pharma’s global investment in 2020 was approximately US$188 billion, while this year the figure is estimated to exceed US$200 billion. "The efforts we have made to digitize the approval of registrations is fundamental to get this innovation to patients earlier and to bring more clinical research to the region's markets,” she states.