Jamie Goodman is a guest blogger and is an associate at Gilbert’s LLP in Toronto, where he works alongside Law in the Making co-founder Paul Banwatt.
Lee Cronin, a renowned professor of chemistry and nanoscience, recently gave a TED talk discussing the progress that is being made towards the 3D-printing of pharmaceuticals. While still in its infancy, the process envisioned by Cronin entails utilizing a universal set of chemical inks with the support of a chemical-biological “network” (or rather, a digital archive or drug molecules). Once realized at an affordable level, this process has tremendous potential to improve the accessibility of medicine and to drastically change the way that drugs are manufactured and sold.
Most notably, as Cronin explains, “if we can manufacture it after we discovered it, we could deploy it anywhere…we can print drugs at the point of need.” The transaction costs associated with manufacturing drugs on a large scale, and the transportation costs often associated with drug delivery, could be all but eliminated with this model. The optimistic result could be that remote communities and developing countries would no longer need to rely on foreign drug companies for the delivery of medicines, as they could instead be equipped with the tools required to print whichever pharmaceuticals they need on site.
Granted, with the cost of ordinary printer ink being more expensive than champagne, it is likely that the “universal set of chemical inks” Cronin refers to would not be cheap. On the other hand, though, these chemical inks would at least be (likely) available at their cost price, and not at the mark-up that they are sold at when purchased directly from a traditional drug manufacturer.
The legal implications of this still-hypothetical process are elaborate. For example, in the same way that more conventional 3D-printed designs run the risk of infringing a copyright, the drug molecule database referred to by Cronin carries with it the risk of enabling drug patent infringement (which, as we all know, is the most expensive type of infringement aside from ripping off an iPhone). Today, a brand drug manufacturer with a patented molecule/drug formulation probably does not need to worry about its patent being infringed by anyone except for a competing generic manufacturer (given the high costs of drug production), and in such an event the infringement will almost always be caught (and eventually resolved) through a country’s legal system. With the capability of a bio-chemical 3D printer and an archive of available drug designs, meanwhile, a patented drug could potentially be infringed by anyone.
There are significant regulatory implications as well. Normally, government agencies hold large-scale drug manufacturers to rigorous standards that require demonstrating the safety and efficacy of any drug that they hope to market. Yet, how can the safety standards of a drug be adequately regulated if the drug can be manufactured in someone’s kitchen? Consequently, there are valid concerns about the potential for 3D-printing to facilitate counterfeit pharmaceuticals and pill-form narcotics, which are already global problems.
Despite the legal and safety concerns, the outlook for this process is still bright. With any advancement in technology, adjustments in how we implement that technology will be required. Access to medicine is an ongoing challenge around the world, and while the technology behind 3D-printed drugs may not be an all-encompassing solution, it is certainly a promising step.