Progress or Paralysis? Pharma Pushes Back on Sheinbaum’s Healthcare Reforms

Pharmaceutical innovators are sounding the alarm on Mexico’s healthcare reforms, despite the government’s bold claims. At industry group AMIIF’s 75th anniversary, Health Secretary David Kershenobich hailed the Sheinbaum administration’s investments and regulatory shake‑up as game-changing. But pharma leaders argue that real-world access remains elusive, with one industry veteran warning it can still take “up to seven years” for new treatments to reach Mexican patients.

Promises and Progress: Tackling a Broken System

Speaking at the AMIIF event, Kershenobich presented the reforms as major progress, but the industry remains unconvinced. The administration, he said, is laying the foundation for a more efficient and innovation-driven healthcare system, backed by strong regulatory frameworks and forward-looking policies.

A major milestone came earlier this month when the government announced it had resolved Mexico’s chronic medicine shortages. With an investment of MXN 284 billion, officials claimed that 96 percent of the medicines required for public health have now been procured.

In a separate move aimed at attracting international investment, Sheinbaum issued a decree designed to boost foreign biopharma manufacturing in Mexico. Thanks to its low production costs and proximity to the US, Mexico is already a major global manufacturing hub, but it continues to fall short in providing access to cutting-edge therapies.

Obstacles to Innovation

Despite being Latin America’s second-largest pharmaceutical market and ranking among the top 15 globally, Mexico suffers from chronic underinvestment. Only 5.5 percent of GDP is allocated to healthcare – well below OECD averages. Meanwhile, the country’s regulatory agency, the Federal Commission for Protection against Health Risks (COFEPRIS), is frequently criticised for slow approvals and excessive bureaucracy, which hamper innovation and delay access to new treatments.

Former AMIIF Executive Director Larry Rubin underscored the problem, warning that it can take “up to seven years for a medical innovation to reach patients” in Mexico. AMIIF itself has echoed these concerns, pointing to persistent delays and the limited availability of new therapies through the public health system, even as Mexico positions itself as a regional manufacturing hub.

Further regional data from FIFARMA shows that only 44 percent of medicines approved internationally between 2014 and 2024 are authorised in Latin America, and just 33 percent are accessible via public healthcare systems. In Mexico, average wait times for innovative treatments hover around 5.6 years—an indicator of deep structural inefficiencies.

Kershenobich acknowledged these challenges, while emphasising the vital role of innovative pharmaceutical companies in improving population health. “The pharmaceutical industry has great potential to develop in this country,” he said, underscoring the ministry’s intention to support the sector.

Toward a More Agile Regulatory Environment

In response to mounting pressure, COFEPRIS has begun taking concrete steps to improve efficiency and transparency. According to Kershenobich, the agency is working to reduce bureaucratic bottlenecks, accelerate approvals, and align more closely with international standards.

“COFEPRIS is becoming a more agile regulatory agency – an essential component for the growth of the pharmaceutical industry,” he said. “Innovation requires solid regulatory frameworks, visionary public policies, and protection of intellectual property.”

One key reform has been the implementation of tacit affirmative approvals, which allow certain applications to move forward without delays once deadlines pass. Additionally, COFEPRIS has invested in institutional digitalisation and created specialised committees to handle complex drug evaluations—moves intended to cut red tape and improve turnaround times.

Notably, a 2021 presidential decree shortened COFEPRIS’s timeframe for processing foreign medicine applications to 45 working days, a significant improvement over previous timelines that could stretch to 180–240 calendar days. These steps mark progress, but industry leaders stress that consistent implementation and cross-agency coordination are still lacking.

Government-Industry Collaboration

Kershenobich also emphasised the need for deeper collaboration between government and industry, especially in expanding clinical research and improving patient access. “This collaboration is essential to position Mexico as an attractive country for pharmaceutical production and clinical trials,” he noted. “It benefits the industry while giving Mexican patients earlier access to cutting-edge therapies.”

He called for “intelligent coordination” and “mutual recognition of our complementary strengths,” expressing hope for a partnership that could create a more equitable and innovative health system for all Mexicans.

Industry Pushback: “Seven Years to Reach Patients”

Despite the optimistic tone of the health secretary, industry leaders were more cautious. Former AMIFF Executive Director Larry Rubin warned that institutional hurdles are still holding the country back from becoming a regional leader in clinical research and innovation.

“In Mexico, it can take up to seven years for a medical innovation to reach patients,” Rubin said, highlighting delays and the lack of coordination between government agencies as key issues. While acknowledging the country’s potential, he called for urgent reforms to unlock faster, more predictable regulatory processes.