Release date: 2015-11-06

What kind of "legal hurdles" need to be taken?

There are many legal issues associated with 3D printing. For example, is the bone made by 3D printing technology applicable to the requirements of the three types of medical device products to be controlled in the Medical Device Supervision Regulations? Is the product manufactured by 3D printing technology a "product" in the sense of "Product Quality Law"? Is it illegal to use a printer to directly manufacture a three-dimensional product created by another person without authorization? Does the 3D printing world touch the legal edge of intellectual property protection? Who should be responsible for the medical damage caused by 3D printed products in medical institutions?

It is said that 3D printing technology is an emerging technology for the benefit of mankind. The state should introduce policies and regulations for 3D printing as soon as possible to ensure its healthy development. However, Xu Qingsong, director of the Law School of the Second Military Medical University, believes that the legal problems caused by 3D printing technology can be adjusted in China.

It is understood that the current medical institutions use 3D printed bones, although the medical staff in the medical institutions use 3D printing equipment to manufacture, but because the medical institutions themselves do not have the production qualification of medical device products, the medical practice of 3D printing technology in practice The organization is customized by entrusting qualified medical device manufacturers. For example, the artificial bone of 3D printing printed by Shanghai Jiuyuan Rehabilitation Surgery was completed by entrusting Shanghai Bilcom Biomedical Technology Co., Ltd., which fully complies with the Regulations on the Supervision and Administration of Medical Devices for the third category (ie implanted into the human body, used for Supporting the maintenance of life; medical devices that are potentially dangerous to the human body, medical devices that must be strictly controlled for their safety and effectiveness), the classification management of medical devices, and the research project was approved by the former State Food and Drug Administration. It can be seen that although the products manufactured by 3D printing technology are different from the products mass-produced in the factory in the traditional sense, they are still defined as the “products” stipulated in the “Product Quality Law”. “The products referred to in this Law refer to the processing and production. Products for sale."

Xu Qingsong believes that the existing laws can also be completely solved in terms of intellectual property protection related to 3D printing technology. The "Copyright Law" stipulates: "The works referred to in this Law include works of literature, art and natural sciences, social sciences, engineering and other works created in the following forms... engineering drawings, product design drawings, maps, schematics, etc. And model works.” It can be seen that protected by copyright law includes not only traditional graphic works, but also “model works” with three-dimensional angles. Therefore, the use of 3D printers for commercial purposes to directly "manufacture" three-dimensional products created by others constitutes infringement without authorization.

As for the legal responsibility of medical institutions for using 3D printed products for damage caused by patients, Xu Qingsong believes that Article 59 of the Tort Liability Law clearly states: "Due to defects in medicines, disinfectants, medical devices, or input failure If the blood causes damage to the patient, the patient may request compensation from the producer or the blood supply institution, or may request compensation from the medical institution. If the patient requests compensation from the medical institution, the medical institution shall have the right to the responsible producer or The blood supply agency recovers."

Law enforcement and control mechanisms must be innovative"

At present, the application of 3D printing technology in the medical field has just started, and the development momentum and prospects cannot be underestimated. Xu Qingsong suggested that relevant departments should urgently clarify and clarify the following issues in law enforcement in order to achieve innovation in management mechanisms.

One is the restraint and regulation of 3D printer manufacturers. At present, 3D printers used by domestic medical institutions are mainly imported from abroad, but the future does not rule out the emergence of domestic 3D printer manufacturers. It is recommended that relevant national departments include 3D printer manufacturers in the special industry for management and restraint, and strictly regulate and supervise the types, procedures and uses of printing equipment, as well as production, sales, purchase, use and maintenance; 3D printing technology The more sensitive and specialized materials and auxiliary materials involved are also strictly managed.

The second is the constraints and controls on the use of 3D printer users and technology. The National Health and Family Planning Commission shall make provisions as soon as possible which medical institutions are eligible to purchase 3D printing equipment, which medical institutions and personnel are qualified to carry out and use 3D printing technology, and apply 3D printing technology to clinical practice. At the same time, the establishment and establishment, holding and use of data models and design drawings for 3D printing products should be established, and their channels of communication should be strictly regulated.

The third is the constraint and regulation of 3D printer manufacturing products. For the different types of products manufactured by medical institutions using 3D printers, they are subject to the Regulations on the Supervision and Administration of Medical Devices. For the 3D products that are generally managed to ensure their safety and effectiveness, the first category is applicable; for the safety and effectiveness of the 3D products, the second category is applicable; for the implanted human body, the third type must be strictly controlled. class. The specific classification catalogue is formulated, adjusted and announced by the State Food and Drug Administration according to the medical device classification rules and approved by the National Health and Family Planning Commission. The daily supervision is the responsibility of the food and drug supervision department.

Source: China Securities Journal

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