3D printing: the new falsification scam? -

3D printing technology is now an essential factor in the health sector production process. For several years now, customized medical devices have been manufactured by 3D technology and a recent breakthrough has been made in the pharmaceutical sector. In 2015, the FDA (the agency responsible for the control and safety of medicines in the United States) gave its approval for the first 3D medicine, an anti-epileptic treatment, to be manufactured.

3D printing is a simple system which creates a device by spreading layers of a product, one by one. It is used today to create plastic, metal and minerals. The system can also be applied to medicines. A layer of a molecule is spread, then a “binder” such as glucose is added, a second layer of the molecule is spread, followed by the binder and so on. US company Aprecia Pharmaceutical manufactures the anti-epileptic treatment in question and has stated that 3D printing technology also creates a porous formula which dissolves faster than normal pills. 3D printing could also provide highly precise doses, according to patients’ individual needs.

Could we really print our medicines in our own homes?

Health department experts in Dubai seem to think so: for Alvaro Goyanes, spokesperson for British company FabRx: “We aim to bring this technology to patients’ homes, hospitals and clinics. Patients will be able to “print” their doses of medication themselves. If applied correctly, the method will be less costly and more time-efficient for patients. Currently, hospitals do not produce medicines, but this could change: health centers could start to manufacture medicines.”

A more plausible hypothesis could be that hospitals and pharmacies would be equipped with 3D printers to produce medicines themselves, according to their patients’ precise needs. 3D printing-on-demand means that each patient could receive a dose which is adapted to his or her needs, and several different molecules could be combined in one single pill. This would be particularly beneficial for patients who must take many pills in one day. This possibility may be within reach: the University of Michigan has invented a process which allows for precise doses of medicines to be printed on various surfaces, for example, on a patch.

3D printing and security issues

Although 3D printing may be a highly positive revolution for the health sector, the technique is also a serious challenge for authorities as its capacity to reproduce causes numerous problems over and above adhering to intellectual property rights.

The Swiss Freight Forwarding and Logistics Association revealed that in 2015, traffickers managed to conceal a container theft with 3D printing. A seemingly intact medicine container had in fact been forced open and most of the shipment had been stolen. The container’s security seals had been replaced by falsified 3D versions. This type of falsification is even more dangerous than the norm because patient security depends on theft being rapidly detected and suspect batches being immediately removed from the supply chain.

3d Prining

The Association reported that: “The advantages of this technology have already been discovered by organized crime.”
Another very real problem is how to ensure that “printed” medicines are safe. There is currently no answer to this question as the solution would require a global overhaul of tracking rules and medicine production chain security procedures. Printers are much more vulnerable to cybersecurity attacks. Hackers could, for example, make changes to a medicine’s formula or dose in the hospital or pharmacy where they are printed.

We are only one step away from falsified pills being created on these machines and 3D printers could soon be used to make illicit medical devices such as prostheses and heart valves.

What are 3D printers used for in the health sector?

• Since 2012, 3D printing is used to recreate jaws, teeth and orthopedic prostheses.
• Human skin can also be made on 3D printers.
• In 2015, a 3D-printed vertebra was implanted in a patient in a Beijing teaching hospital.
• In 2017, mice were born from artificial ovaries created by a US team.

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