3D Printing Pharmaceuticals: The Changing Legal Landscape
3D printing, perhaps more than any other invention since the internet,has the potential to completely change the face of business. It could change how things are made and how they are bought. 3D printing has already shaken the medical profession to its core by opening up the potential for 3D printing prosthetics and even human tissue. A few months back, the Food and Drug Administration (FDA) approved the first 3D printed drug—Spritam.
The drug is created by layering incredibly thin sheets of powdered medication using an aqueous fluid—resulting in a pill that dissolves extremely easily. Beyond how easily it dissolves, however, the drug is currently no more efficient than a drug produced by normal mean. The creator of the process, AppreciaPharmaceudicals, speculates that someday the process could allow for drugs customized to the person who takes them.
As 3D printing becomes more available to the public—3D printers are already available for less than $400—the implications of printing drugs become even greater. Instead of giving prescriptions, doctors might simply 3D print your medication at their hospitals 3D printer. They may even give you algorithms to allow you to print your pharmaceuticals in the comfort of your own home.
The Usual Suspects: Common Legal Issues with 3D Printing
This raises some clear legal issues, such as regulating the 3D printing of drugs and protecting the intellectual property of pharmaceutical companies.
Beyond restricting the sale of materials necessary to print drugs, it becomes awfully hard to regulate the quality of a drug when the patient is printing it at home with purchased materials—or even if it’s being printed at hospitals across the country. The FDA will need to regulate not only when somebody print a drug, but also how they and be printed, on what kind of 3D printers, and more. If private citizens are allowed to 3D print pharmaceuticals, there will obviously also need to be regulations that prevent 3D printers from printing drugs just any old time. The potential headaches for the FDA are countless.
3D printing also has manufacturers fearing for their intellectual property rights. Many have likened the availability of 3D printers to the digitization of music and fear the potential of a Napster for physical products. One leaked design could undercut an entire physical product line by allowing anybody with the internet and a 3D printer to download the design and print the product for the cost of the materials. This sort of infringement of intellectual property, much like music pirating today, would be extremely hard to trace and cut easily reach a scale that could put a manufacturer out of business.
There is not really a system in place to handle infringing designs posted online. The safe harbor policies outlined in the Digital Millennium Copyright Act (DMCA) provides a well-known and important (albeit often criticized for its misuse) tool for quickly and cheaply having material which infringes copyright taken off of a website. The DMCA has already been used to try and take down a 3D printing design at least once already—a design allowing the user to print a physical version of an optical illusion known as the Penrose Triangle. It has also been discussed in a take down request from HBO over a 3D printing design of a phone charger based on the “Iron Throne” from their television show “Game of Thrones.”
Unfortunately, copyright is not really a good fit for 3D printing designs. Copyright provides no or very little protection to useful articles. The CAD files for a 3D printing design would likely fall under this umbrella in most cases. This means that the designs may be limited to weak copyright protection or patent protection—losing the protection of the DMCA take down. There is no similar system in place to deal with take downs of designs that might infringe a patent. This would leave a pharmaceutical company with little recourse if an infringing design of a drug they spent years developing hit the web then spread like wildfire.
Intellectual property and regulation are legal issues which flow fairly logically from the sort of technological leap 3D printing represents. However, an issue that a layperson might not expect is the potential issues that 3D printing could create for product liability.
Whose Product is It Anyway?
Products liability is an area of law dealing with a party trying to recover for damages caused by a defective product. Such a claim can generally be brought by a purchaser of the product, somebody who uses the product, or a bystander injured by the product.
A product is considered defective in three situations: where the product is unsafe by design, where the manufacture of the product is defective, or where the product does not have sufficient warnings about its use.
These types of suits can be brought against the defective product’s designer, distributor, or manufacturer. However, once 3D printing becomes readily available, who exactly is going to be the manufacturer?
Considering the risk inherent in creating pharmaceuticals, very small mistakes in design could have drastic consequences, this is an issue that is going to leave those injured by 3D printed pharmaceuticals scratching their head. It may well be that whoever 3D prints medication is the manufacturer. If this is the case we may never see hospitals 3D printing their own medication, despite potential saved costs and convenience, out of fear of the liability they may open themselves up to.
Law Catching Up to Science
3D printing will change the world—full stop. As 3D printing becomes cheaper and more accessible, 3D printers have the potential to become as much a fixture in the home as a refrigerator. As this happens, the technology around how 3D printers work will also likely see drastic strides.
Law has historically lagged behind technology; decades after its invention we still haven’t found perfect solutions for matching law to a world where the internet exists. 3D printing will test our courts once again. The potential for advancement in medical science through inventions such as Spritam is tremendous, but so too are the legal challenges that such advancements bring with them.