The process is the product. It's a slogan, currently popular in the biopharmaceutical industry, that sounds like it could have been coined by Marshall McLuhan on one of his off days. But there's a lot going on beneath the bland surface: For starters, the sentence is a rallying cry for brand-name-drug makers in their latest battle against generic manufacturers; an oblique reference to the nearly infinite complexity inherent in current biotechnology; and a snapshot of the confused state of pharmaceutical regulation across the globe. That's good stuff, so let's try to unpack it. (Thanks to the IP-Health mailing list for tipping us off to the controversy.)
One reason why generics are cheaper than the drugs they copy is that generics makers do not need to go through all the time and expense of proving that their drugs are safe and effective. Once they've demonstrated physiochemical "equivalence" to the original drug they're home-free. But in the new age of biopharmaceuticals -- complex proteins derived from living organisms, cultured from cells in a laboratory -- proving equivalence is much tougher. These new biopharmaceuticals, which include drugs such as interferon, human growth factor and erythropoietin (better known to fans of the Tour de France as EPO), are constructed from molecules containing thousands of atoms, manufactured in processes that involve hundreds of steps. They are hard to copy, exactly.
In the last couple of years, some of the big names in biopharmaceuticals have begun to go off-patent, and many more will follow in the next decade. This is opening the door for biogenerics, or "biosimilars," as they sometimes are called, and you can already find such drugs in China and India. Consumers in the United States and European Union could potentially save vast amounts on medical care if biogenerics were widely available. But neither the U.S. nor the E.U. yet has a comprehensive regulatory structure for biogenerics in place.
Reason No. 1 for this is that the brand-name manufacturers are fighting tooth and nail to slow the entry of biogenerics. And this time around, they've got some potent ammunition on their side. When it comes to proving equivalence, biogenerics have a tougher row to hoe than your old-school "small molecule" generic drug. Postmodern fans of complexity theory will love this: According to current scientific thinking, using "current analytical methods" it is impossible to fully "characterize" the physiochemical properties of the new proteins being cooked up by Big Pharma. Not only are these proteins constructed out of thousands of atoms, but specifying the exact dimensions of their warped and intricately folded-in-upon-itself structures defies description. In other words, while it might be feasible to say what a new drug does, after extensively testing it in clinical trials, it's not possible to say exactly what it is. And if you can't describe the exact structure and essential nature of the original, then, naturally, you can't say that something else is an exact copy of it.
So when brand-name-drug makers say "the process is the product," they are arguing that only those chemical entities that are made in exactly the same way as the original can claim to be equivalent to the original. Anything made differently is a different critter ... and, down the line, might cause different results when used to treat patients.
In a perfect world, the brand-name manufacturers would prefer for the European Union and the United States to simply forbid biogenerics from being substituted for brand-name drugs. But they seem to be aware that they will lose that battle, especially in the European Union, where many of the E.U. member states are strongly interested in achieving public health cost savings via biogenerics. So instead, the brand-name manufacturers are fighting a defensive battle over labeling. They'd like generic manufacturers to be required to use individual brand names, or barring that, want all biogenerics to be explicitly tied, via their names, to their original manufacturer.
Their reasons are ostensibly based on safety grounds. As it stands now, when a doctor prescribes a drug, he or she can simply use the generic chemical name of the preferred medicine and leave it up to the patient or health plan administrator to decide whether to go brand name or generic. But say something goes wrong. The patient experiences some unexpected side effect, or, worst of all, dies. In the doctor's subsequent report to health authorities, only the generic name of the treatment is prescribed, and no one will know what drug was actually used, claim the brand-name manufacturers. This will make it impossible to trace the true causes of the adverse health event.
Generic makers and health activists say that the safety claims are a smoke screen, that the real aim of the labeling plan is to protect market share. And it is true, safety is a common excuse used by the drug industry in its war against generics. But it's also true that the inherent complexity of the new drugs on the market raises new questions of public safety.
Which brings us back to the troubling fundamental observation that the complete physiochemical characteristics of the new proteins being cooked up in laboratories across the globe defy definitive "characterization." That implies a disturbing fuzziness about the state of our knowledge concerning the leading edge of biotechnological innovation. It suggests that we are now swimming in seas of complexity that are deeper than we can fathom. And we've actually barely even dipped our toes in the water.