Introduction
As the world advances in developing therapies through adaptive clinical trial designs and artificial intelligence, Mexico persists in national plans that prioritize rhetoric over action. The recent IQVIA Biotech report, “Beyond the Benchmark: How Innovative Trial Designs are Transforming Clinical Research,” presents an uncomfortable example of what Mexico could be if it genuinely embraced science and evidence.
Global Pharmaceutical Industry’s Response to Global Volatility
The pharmaceutical industry responds to global volatility with methodological innovation: decentralized clinical trials, external controls, and real-time data use. Meanwhile, the FDA (Food and Drug Administration) and the EU have launched initiatives like Project Optimus and ACT EU, shortening approval timelines and promoting diverse population inclusion.
Mexico’s National Development Plan: A Lack of Progress
The newly presented National Development Plan 2025-2030 (PND) promises to “modernize” healthcare with electronic files and telemedicine. However, it fails to acknowledge that Mexico’s regulation remains trapped in a slow, bureaucratic model. The plan promises to support clinical research but blocks key reforms, such as granting COFEPRIS (Federal Commission for Protection against Health Risks) autonomy to facilitate access to innovative medicines.
Five Strategic Axes and Regulatory Barriers
The PND outlines five strategic axes: prevention, continuous care, strengthening IMSS-Bienestar, supply of medical supplies, and digitalization. Yet, none address breaking regulatory barriers. While a clinical trial can be approved in weeks in the US, Mexico experiences delays up to 288 days. This slowness discourages health investment, innovation, and development.
The Gap Between Two Realities
The disparity becomes even more evident when we see that in 2023, 56% of newly approved therapies globally came from biotech startups. In Mexico, we still struggle with essential medicine shortages in rural clinics. The promise of “24/7” medical attention is made without explaining how to prevent staff burnout or financially sustain this promise.
Regulation: An Ally or Obstacle to Progress
While the FDA launches the Center for Clinical Trial Innovation and the EU simplifies multinational trial processes, Mexico continues discussing “modernization” without detailing how to integrate clinical histories, eliminate corruption in bidding, or build trust in the system.
Telemedicine and AI: A Revelation
A revealing statistic: 78% of decentralized trials accelerate patient recruitment through telemedicine. In Mexico, the Médicas y Médicos del Bienestar program boasts competitive salaries but overlooks training in emerging technologies and lacks solutions for areas without connectivity.
Investment in Innovation: A Marginalized Priority
Bristol Myers Squibb invests over 13 billion dollars in R&D amid global financial uncertainty. Meanwhile, Mexico allocates 85% of its meager health budget to salaries and maintenance, with almost nonexistent investment in innovation.
Lessons Unlearned Post-Pandemic
While many countries capitalized on pandemic experience to strengthen surveillance and response systems, Mexico did not. Today, we face measles and fatal tetanus outbreaks. We’ve learned little.
The Role of Artificial Intelligence in Healthcare
The IQVIA report highlights how AI is transforming protocol design, data analysis, and clinical care. The FDA approves therapies based on algorithms. In Mexico, we lack legal frameworks regulating telemedicine or guiding ethical AI use in healthcare.
The Paradox of Universal Coverage
There’s an irony: discussions on “free universal coverage” lack definitions on funding disruptive technologies like portable sensors for diabetes management. In a country with one of the highest childhood obesity rates, such technologies aren’t even considered in the plan.
The Need for Dialogue and Collaboration
What’s missing, besides resources, is dialogue. Real, open, cross-sectoral conversation. The global report emphasizes integrating all stakeholders – patients, researchers, regulators – in policy design. In Mexico, the conversation remains vertical.
Case Study: Lack of Strategic Education in Vaccination Campaign
An emblematic example: the lifelong vaccination campaign, a pillar of the new plan, didn’t consider strategies to combat misinformation. Consequently, 40% of Mexicans now distrust infant vaccines according to ENSANUT. How can we prevent without trust?
Conclusion: A Paradigm Shift
We need a paradigm shift, moving from PowerPoint presentations to actionable strategies prioritizing measurable results, effective partnerships, and constant dialogue.
- Measurement of Reduction in Childhood Obesity? Specify how obesity reduction will be measured.
- Digital Tools for Rural Doctors? Define the digital tools rural doctors will have.
- Funding for Chronic Disease Research? Identify partnerships financing research on chronic diseases.
“Strategic collaboration is the key to accelerating processes,” as Murray Aitken, Director of IQVIA, stated. Let’s hope the federal government takes notice to improve Mexicans’ health, currently second only to security in concern.
*The author (www.ectorjaime.mx) is a general surgery specialist, certified in public health, with doctorates in health sciences and public administration. He is a legislator and advocate for Mexico’s public health, a reelected PAN group member in the LXVI Legislature.
