Market Access Shake-Up: Medicine, Generics, Medical Devices

Mexico's healthcare system faces regulatory barriers and difficulties in accessing drugs, delaying access to essential treatments. Under these circumstances, experts highlight the need for public-private collaboration to improve equity and accessibility in the sector, helping to improve the Mexican healthcare system.

Access to medicines, both innovative and generic, is hindered by a regulatory system that has long approval times, says Jorge Luis Caridad, General Manager, Johnson & Johnson Innovative Medicine. While other Latin American countries approve scientific protocols in 45 to 60 days, in Mexico the process can take months, which puts the country at a disadvantage compared to other emerging economies.

“At best, approving drugs in Mexico takes between 12 and 18 months, which is too long. This delay has a significant impact on the system's ability to respond quickly to patients' needs, especially in an environment of rapid technological and scientific evolution,” says Caridad.

This regulatory inefficiency not only slows down access to treatments, but also affects Mexico's competitiveness in the global arena. “On average, it takes three and a half years for drugs to reach Mexican patients,” says Larry Rubin, Executive Director, Mexican Association of Pharmaceutical Research Industries (AMIIF). To improve access, Mexico needs a streamlined regulatory process, which would also increase investment in clinical research from US$200 million to US$4 billion a year, positioning the country as a hub for medical innovation in Latin America, says Rubin.

Policy Changes and Their Impact on the Industry

In recent years, government policies, particularly in the area of drug procurement, have generated uncertainty in the sector. These changes have altered the access landscape and forced companies to restructure their medium and long-term strategies. Rubén Ortiz, Executive Director Access and Corporate Affairs LACAM, Eli Lilly and Company, explains that the main barrier to access to medicines is underinvestment.?

“This lack of investment has exacerbated inequalities in health care, mainly affecting rural areas. To address this challenge, it is crucial to properly manage resources and focus on metrics that benefit the country as a whole,” says Ortiz.

While the need is pressing, opportunities also abound. The considerable boom of nearshoring in Mexico presents a unique opportunity to improve access to medicines and medical devices. “This is the opportunity for Mexico to consolidate advances and address barriers within the sector,” says Marcos Pascual, Commercial Director, ANAFARMEX.??

As they work to expand access, companies should also align their strategies with sustainability needs, an issue critical to the long-term success of the industry, says Pascual.

Equity of Access and Public-Private Collaboration

One of the most pressing issues is the disparity in access to medical resources among different regions of the country. Rural and marginalized populations are often the most affected by barriers to access to medicines and health technologies. “Access to medicines is an essential part of the right to health, which is a human right,” says Alejandro Luna, Partner, OLIVARES.?

Healthcare barriers may vary according to social, economic, or political factors, so a multidimensional approach is needed to overcome them, says Luna

To address these barriers, collaboration between the public and private sector is crucial. “Private initiative efforts can be aligned with public efforts to eliminate these access barriers,” says Eduardo Valencia, Founder, Parque Pharma. In addition, biotechnology and co-working models could help to optimize resources, he adds.

To address the needs of its population, Mexico must continue to strengthen its healthcare offer, says Ortiz. This goal cannot be achieved by the public sector alone, but requires the participation of private companies. Together, they have the power to change people's lives.