Montana has signed a "right to try" law that lets people with severe conditions access experimental gene therapies not yet approved by the FDA. The push comes from stories like Kris DeVault's: his son Brody, born in March 2023, showed early developmental delays. A genetic diagnosis arrived only when the child was two and a half, when options were already limited. The law does not regulate the future: it normalizes an existing practice and puts it into a legal frame.
Why should an Italian business care? Gene therapies are the next massive pharma market, and Europe is watching. Someone will try to import the model. We know how American laws end up when transplanted without their context.
Look at the numbers. A gene therapy can cost hundreds of thousands of euros. If access is set by law, costs do not disappear: they are socialized. Insurers and public systems will decide who gets what. Without solid data, that decision becomes political, not clinical. And when politics decides in a hurry, it decides badly.
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The European problem is real. The European Medicines Agency takes years to assess therapies that could save lives. Trials are slow because data stays in silos, registries do not talk to each other, and studies are centralized. We do not need lower standards. We need faster research through secure digital infrastructure: informed consent, real-world evidence, remote monitoring, interoperability. Italy already saw the cost of emergency approvals during the Covid pandemic: urgency must not mean opacity.
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Montana has just over one million people. Such a law does not build a system: it sets a precedent. And American precedents eventually cross the Atlantic.
Our position is clear
We at Meteora Web build tools that measure results. We come from accounting, ERP, retail. We can read balance sheets, and we know that "right to try" is the wrong answer to a right question. Why should patients wait years for a therapy that could change their life? The answer is not to sell out safety. It is to build smarter trial systems, shared data, decentralized studies, AI to stratify patients. But every AI output must be checked by someone who knows. Healthcare is not an e-commerce: you don't run A/B tests on patients. We built proprietary platforms for social media and billing: the hard part is adoption, not code.
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What to do, concretely. If you're a developer, treat health-tech as a serious sector. If you're an entrepreneur, study the digital health grants: the money exists, and if you don't take it, big corporations will. If you're a PMI, do not wait for the law to change: build interoperable systems, durable systems that collect data. Think about the long term, not just the next funding round. If you're a patient or a family member, always ask who funded the study and what the known side effects are. The right to hope does not include the right to be deceived.
Technology is not an emotional shortcut. It is a tool for accountability. Let's build it properly.
