{"id":32380,"date":"2021-03-30T19:20:15","date_gmt":"2021-03-30T17:20:15","guid":{"rendered":"https:\/\/cysae.com\/3d-printing-regulation-standards-and-responsibilities\/"},"modified":"2021-03-30T19:20:15","modified_gmt":"2021-03-30T17:20:15","slug":"3d-printing-regulation-standards-and-responsibilities","status":"publish","type":"post","link":"http:\/\/cysae.com\/en\/3d-printing-regulation-standards-and-responsibilities\/","title":{"rendered":"3D Printing: Regulation, Standards and Responsibilities"},"content":{"rendered":"

It is becoming increasingly common to see objects that have been manufactured using new processes thanks to innovative technologies. In this sense, we highlight three-dimensional printing<\/strong>. This type of printing is revolutionizing the industry in very diverse sectors, especially due to cost <\/strong>savings <\/strong>and in the manufacturing <\/strong>time <\/strong>of multiple products<\/strong>. <\/p>\n

Through 3D printing<\/strong>, a user can manufacture their own products starting from digital <\/strong>plans <\/strong>(or based on the scanning of the product) provided by third parties or created by themselves.<\/p>\n

Basic objects can be manufactured, such as pens and textiles, as well as more sophisticated objects, such as prosthetics, buildings or aircraft parts.<\/p>\n

What legal problems does 3D printing pose?<\/strong><\/h2>\n

Just as the Internet phenomenon brought with it an increase in violations of third-party rights <\/a>through the illegal downloading of audiovisual content (known as \u201cpiracy<\/strong>\u201d), three-dimensional printing may entail a potential violation of rights, especially intellectual and industrial property rights.<\/p>\n

Along with this infringement of rights, we also find a problem regarding the control<\/strong> and authorization <\/strong>regime for the manufacturing <\/strong>of such objects. For example, the production <\/strong>of medicines <\/strong>or the manufacturing <\/strong>of illegal <\/strong>products <\/strong>(drugs<\/strong>, narcotics<\/strong>, weapons<\/strong>).<\/p>\n

control <\/p>\n

The problems arise from two <\/strong>different perspectives:<\/p>\n

    \n
  1. From the perspective of the printed <\/strong>object<\/strong><\/li>\n
  2. From the source <\/strong>used <\/strong>to carry out the printing. That is, whether the object has been scanned <\/strong>or if it has been manufactured <\/strong>based on digital <\/strong>plans<\/strong>. In addition, it considers how <\/strong>the source <\/strong>was obtained <\/strong>(granted, created, or misappropriated). <\/li>\n<\/ol>\n

    Virtually all situations that may arise in the field of 3D printing have a response in current legislation. Below, we will detail some of the legal protections in place regarding printed objects. <\/p>\n

    Copyright or Intellectual Property<\/u><\/strong><\/h3>\n

    In traditional <\/strong>piracy<\/strong>, cultural and audiovisual content is shared. In 3D <\/strong>printing<\/strong>, piracy <\/strong>will be considered from the point of view of the files used to carry out the printing<\/strong> (digital plans or scans). These infringements of rights are regulated by the Intellectual Property Law<\/strong><\/a> (LPI<\/strong>). <\/p>\n

    When one person provides another access to a work, including the elements needed to create it, this may be considered an act of reproduction (Art. 18 LPI). <\/strong>This applies regardless of whether that person ultimately carries out the act of illicit exploitation. In addition, one must also consider distribution <\/strong>rights (Art. 19 LPI<\/strong>) and transformation rights<\/strong> (Art. 21 LPI). <\/p>\n

    Furthermore, Art. 138 LPI provides for civil actions against infringements of intellectual property rights<\/strong>. In this way, the rights holder may pursue the following actions:<\/p>\n

      \n
    1. Cease the illicit activity<\/li>\n
    2. Remove illicit objects from the market<\/li>\n
    3. Compensate the rights holder for damages and losses<\/li>\n<\/ol>\n

      Article 270 of the Criminal Code <\/strong>also provides for the crime against Intellectual Property<\/strong>, reserved for cases in which there is<\/strong> profit <\/strong>motive <\/strong>on <\/strong>the part<\/strong> of <\/strong>the offender<\/strong>. Specifically, when the offender reproduces, distributes, publicly communicates, or transforms a literary, artistic, or scientific work for economic gain without the proper authorization of the holder.<\/strong> <\/p>\n

      Industrial Property Rights<\/u><\/strong><\/h3>\n

      The doctrine on Industrial <\/strong>Property <\/strong>Rights excludes the classification of the offense when the user’s<\/strong> scope <\/strong>of action <\/strong>or the purposes for which the object has been produced are strictly private and non-commercial<\/strong>. However, when there is a commercial purpose<\/strong>, the offense is classified according to the provisions of Article 274 of the Penal Code.<\/strong> <\/p>\n

      In the field of medicine<\/u><\/strong><\/h3>\n

      3D printing is increasingly widespread in the field of medicine. The production of artificial tissues compatible with the human body, medications, or prosthetics has driven the use of these technologies in the medical field. <\/p>\n

      Along with this rise, a number of uncertainties and risks have emerged, particularly regarding the damages <\/strong>caused <\/strong>and the associated liability<\/strong>. For this reason, both at the EU level and at the national level, strict regulations have been enacted, such as the Law on Guarantees and Rational Use of Medicines and Medical Devices<\/strong><\/a>.<\/strong> Penalties for illegally manufacturing or even altering medications carry criminal consequences, as established in Articles 361 and 362 of the Penal Code.<\/strong> <\/p>\n

      At the European level, regulations such as Directive 2001\/83\/EC <\/a>and Regulation EC\/726\/2004<\/strong><\/a>, on medicines, and Directive 93\/42\/EEC<\/strong><\/a> with respect to medical products, may apply.<\/p>\n

      Threats to public health and safety<\/u><\/strong><\/h3>\n

      The ease <\/strong>of 3D <\/strong>printing <\/strong>has led to an increase <\/strong>in the possibility <\/strong>of manufacturing <\/strong>illegal <\/strong>objects <\/strong>or products<\/strong>. Among these illegal <\/strong>products<\/strong>, the most concerning at present are narcotics and firearms.<\/strong> <\/p>\n