In this post, the authors analyse the various legal issues arising out of 3D printing in the pharmaceutical and healthcare industry.
In August 2015, the United States Food and Drug Administration (USFDA) approved a drug manufactured by Aprecia Pharmaceuticals called ‘Spritam’. It is the first 3D printed pill to have the approval by USFDA. This decision of the USFDA caused ripples in the field of intellectual property rights as well as medical laws, as it was an acceptance by the government of the legitimacy of 3D printing in the medical field.
So how does 3D printing work?
Regarded as a disruptive innovation by most, 3D printing or additive manufacturing has been gaining traction over the past few years. It refers to the processes involved to create a three-dimensional object with multiple layers of material(s) under computerised controls. This facilitates the designers/manufacturers to have a far greater degree of freedom as opposed to the cold-war era of mass produced goods. A plethora of materials ranging from polymers to metals can be used to manufacture 3D printed objects. In fact recently, stem cells have been used as ‘ink’ to create complex living tissues.[i]
Today, 3D printing technology has permeated into the hands of the end users themselves. 3D printers are available for commercial purchase along with the software used for designing the objects (CAD softwares for instance). The meteoric rise in the use of 3D printers across industries brings with itself complex legal conundrums which must be addressed at the earliest in order to ensure the least collateral damage to society.
In this blog we explore the applications of 3D printing in the field of medicine and the legal questions which arise because of them.
Printing of Living Tissues & Organs
Nearly 20,000 people die every year in India due to non-availability of organs. 3D bio-printers construct living tissue by placing layer-upon-layer of living cells. Skin tissues, heart tissues, blood vessels amongst other simple living tissues which can be utilised for transplantation and research have been printed successfully.[ii] It is realistic to believe that in the future, fully fledged organs can be manufactured with the help of 3D printing.
Printing of Prosthetics
3D printing facilitates manufacturing of objects free from geometrical constraints. The technology can manufacture prosthetics which can be customised to fit the bodily needs of specific individuals. This eliminates standardisation (which has the potential of not conforming with specific needs of the individual using it) in favour of customisability and precision which ensures that the prosthetics are the exact replacements of the original body parts in terms of dimensions and functionality.
Creation of anatomical models
As 3D printing can create models of impeccable accuracy, anatomy of individuals can be created with the help of 3D printing which would help surgeons and other medicine practitioners to assess surgical challenges with a greater degree of insight rather than simply relying on X-Ray, MRI and other such scans. Anatomical models provide the sort of representation which has the potential to assist surgeons in their pre-surgery preparations.
Manufacturing of drugs
3D printing technology can create drugs which can be administered with relative ease when compared to drugs manufactured with conservative technologies. One such drug is Spritam which was approved for usage by the USFDA.
The growth of 3D printing technology has outpaced the formulation of laws governing it in India at least. It is clear that the legal framework in India would find it challenging to incorporate the mainstream usage of 3D printing, especially in the field of medicine. Here are some of the challenges that the existing legal framework would face :-
3D printing & piracy — Section 14 of the Indian Copyright Act, 1957 has provisions to tackle infringement of copyright in fixed works. However, these laws might prove to be inadequate in the wake of the usage of 3D printers. 3D Printing technology is available for open source usage which implies that everyone is free to use it. However, perhaps the Information Technology (Intermediary Guidelines) Rules, 2011 would be useful to pin liability on websites such as Shapeways and Thingiverse, which presently host CAD files for free. According to Rule 3, such intermediaries need to carry out due diligence, and necessarily warn users not to upload any information which ‘infringes any patent or copyright’. Therefore, a more comprehensive legal analysis of the issues of copyright and patents in the context of regulating 3D printing is warranted.
Liability of the products — 3D Printers can create a vast array of objects ranging from drugs to weapons. In case of damages resulting in the misuse or faulty working of the 3D printers, it is going to be a challenge for the courts to ascertain liability. The potential parties involved in such cases are: the owner of the 3D printer, the manufacturer of the printer, the person who created the product. The issue of liability has not been laid out in the Indian laws.
That said, various solutions have been offered in this regard — whether it be in the form of bar coding of products printed by a particular printer, or having a check on the nature of materials available to the public for printing (for instance, radioactive materials should not be made available without the appropriate documentation and check of facilities).
It has been suggested by some that the CAD file itself should be regarded as patentable or copyrighted work as users who download it, download it for the end product the file represents, rather than the file itself. By considering the CAD file as the end product, it is far easier to pin liability and enforce the appropriate legal provisions, as it is not required to check each person who prints the final product. This has also been criticised on the ground of being an overly preventive approach to infringement.
Presently, intermediaries such as Thingiverse and Shapeways allow users to download CAD files for free. Instead of this, an account of who downloads what file would ease the burden of the law, as it would help estimate the infringers and thereby aid in the enforcement process.
Privacy — 3D printers incorporate personal data to manufacture products to fit the specific needs of individuals. The design is essentially a creation of CAD software by the healthcare provider who subsequently manufacture it. This is more common in the field of medicine and here complex legal questions start to emerge. If a 3D printed organ specific to the individual is created by a healthcare provider, the question of consent arises. However this data or 3D printed organ can also be used for purposes such as research, sharing with other healthcare provider as a type of cooperation, marketing, insurance premiums among others. Indian laws are not prepared to handle issues pertaining to the true ownership of such data or manufactured 3D product. Moreover, Indian laws are notorious for being a laws safeguarding privacy and the usage of 3D printers in the field of medicine may further going to emphasise this deficiency in Indian law.
3D printing as a technology is full of potential because of its ability to swiftly produce cost-effective and customised products. However, with the advent of this technology, there are several adverse effects that legislators need to be mindful of. The extant legislations which seek to protect intellectual property and the unlawful use of firearms, etc., would be rendered anachronistic in their current form as they may not be elastic enough to accommodate violations using 3D printed technology. A study by an analyst group, Granter, suggests that companies may lose nearly US$100 billion due to the alleged IP violations by 3D printing by 2018. At this juncture, it is pertinent to revamp legislations in order to usher in this technology, and use it to its optimum potential.
[i] New bio-ink for 3D printing with stem cells, available at http://www.thehindu.com/todays-paper/tp-national/New-bio-ink-for-3D-printing-with-stem-cells/article14400415.ece.
[ii] Scientists Create 3D printed brain-like tissue from stem cells, available at http://www.abc.net.au/news/science/2017-07-26/scientists-create-3d-printed-brain-like-tissue-from-stem-cells/8740794.