MyFondia VirtualLawyer
August 16, 2016

3D printing – the technology revolutionising the pharmaceutical manufacturing industry

At the beginning of 2016, the world’s first U.S. Food and Drug Administration approved 3D-printed medicine Spritam will enter the US market. 3D printing of medicines has also been actively studied in Finland, for example, in Åbo Akademi University, for some time. The aim is to allow medicines to be printed on demand in pharmacy and hospital settings in the future, thus increasing the role of patients in the manufacturing process, as medications can be tailored to the specific needs of individual patients.

Although 3D printing of medicines has been studied for a long time, using 3D printing to manufacture ‘personalised’ medication is still a long-term goal. However, in time, this change will be revolutionary for pharmacies as well as pharmaceutical companies. A clear advantage would, of course, be the increased cost efficiency of manufacturing, which would surely lead to a drop in medicine prices. On the other hand, 3D printing would simplify the production of medicines to such an extent that copying them will also become easier.

Currently, it is beneficial for pharmaceutical companies if the initial investment costs required to begin manufacturing a medicinal product are so high that the process is not attractive to generics manufacturers, or if manufacturing the finished product is so complex that generics manufacturers simply cannot determine how the end product is achieved. This offers ‘protection’ to the product even after the patent protection has expired. When competing products do not enter the market after the patent protection has expired, the original product remains profitable. 3D printing will not facilitate the development or production of the active ingredient in the product or the manufacturing of liquid medicines, but it can be assumed to have an impact on both legal and illegal copying of tablets.

According to the Medicines Act, only medicinal product manufacturers that have acceptable production facilities and equipment and a licence from the Finnish Medicines Agency (Fimea) may manufacture medicinal products industrially. Fimea licenced pharmacies may only perform automated dose dispensing and contract manufacturing, i.e., manufacturing ingredient mixtures used in medicines and finished medications for other pharmacies. Hospital and medical centre pharmacies may also prepare medicinal products according to the operational needs of the hospital district, hospital or medical centre and in situations where the necessary medication for an individual patient cannot be obtained elsewhere. Thus, manufacturing tablets in a hospital pharmacy for use in the hospital district, hospital or medical centre should be possible under current law. However, since 3D printing of medicines is about much more than just automated dose dispensing, the Medicines Act would require some editing, so that printers could be used to produce medicines in pharmacies.

In addition, a 3D printer that is used to manufacture medicines is considered a medical device and is therefore subject to provisions on medical products and equipment. Consequently, a printer used to manufacture medicines must meet the requirements of the Council Directive concerning medical devices, which have been implemented in Finland through the Finnish Medical Device Act. A medical device must be suitable for its intended use and its intended functionality and productivity must be compatible with its intended use. In addition, the proper use of the device must not endanger the health and safety of the patient, user or others. The device must also have the CE mark. It is noteworthy that the manufacturer is responsible for the design, manufacturing, packaging, and labelling of the device regardless of whether these activities are carried out by the manufacturer itself or by another entity on its behalf.

Although 3D printing will surely facilitate and enhance the manufacturing of medicinal products, personalised medicine is still a long way away, especially in terms of the law. On the other hand, the effect on health care costs would probably be so large that the change would be quite welcome, particularly from the perspective of the Finnish economy.