The ‘boom’ of new anti-obesity medications is undeniable, brutal, and unprecedented. It’s curious because, although I just used three superlative and exaggerated adjectives, I’ve likely understated it. Ozempic and other GLP-1 agonists have no real precedents, and that’s breaking the rules of the game.
The Legal Loophole
The best example is that, since last year and taking advantage of a small legal clause, hundreds of US pharmacies have been manufacturing and marketing this type of medication without paying a dollar to the patent owners.
2023: The Year of Ozempic
The “Ozempic year”. 2023 was the moment when all these drugs became a mass phenomenon. Their boom was so big and unexpected that, despite pharmaceutical companies working on these types of medications for years, demand exceeded supply.
This “lack of availability” created a huge bottleneck. And a business opportunity.
The Evolution of Pharmacies
What is a pharmacy really? Traditionally, all pharmacies manufactured the medications they dispensed themselves. With the growth of the pharmaceutical industry during the 20th century (and the increased production complexity of medications), this changed radically. To the point that, in many cases, pharmacies have become retail stores without the ability to make anything.
The Legality of Pharmacy-Made Medications
This doesn’t mean they can’t do it. In many countries worldwide, legislation allows pharmacies to manufacture versions of patented medications under certain circumstances. One of these is scarcity, and another is customization. In Spain, this is usually known as “magistral formulas”.
But is it legal? The truth is, yes. For example, Article 61.1 of the Spanish Patent Law states that “the rights conferred by the patent do not extend to the preparation of medicines made in pharmacies extemporaneously and per unit in execution of a medical prescription, nor to the acts related to the medicines thus prepared”. In the US, something similar occurs.
A “Gigantic Health Experiment”
And it has generated a “gigantic” health experiment. Because when laboratories and large chains found the possibility of serving “magistral formulas” with a much higher margin (and availability), they didn’t hesitate to take advantage of it. Even though the legal clause wasn’t intended for this.
In other words, a regulatory mechanism that allows solving the problems of standardization of pharmacological presentations is being used as a way for mass production and commercialization of patented medicines.
And, as Angela Fitch, former president of the Obesity Medicine Association, points out in Axios, “we’ve never done this before in healthcare, right? To me, this is like a gigantic scientific experiment”.
The Future of Personalized Medicine
Magistral formulas in times of precision medicine. And that’s just from Novo Nordisk (the manufacturer of Ozempic). The rest of the “proprietary” pharmaceutical companies are also at it, and everything seems to indicate that a legal battle is coming that could change the way the pharmaceutical world works.
After all, large corporations are pushing for restrictions on legislation affecting magistral formulas: something that, “while satisfying an important medical need for certain patients”, has shown itself to be a ‘legal loophole’ flexible enough to allow the creation of an industry outside the normal circuit.
It would be paradoxical if, just as medicine is moving towards greater personalization, we lost the most customizable mechanism of traditional pharmacy.
The Broken Balance
A balance that has been broken. The problem is that these restrictions would have implications for the health of many people who need magistral formulas (or even our ability to respond to a lack of availability of important medications). That’s why this “delicate balance” was maintained and has been working for years. But once broken, no one is very clear about what will come next.
0 Comments