The Law of Ukraine “on Medical Products” as One of the Ways to Solve the Problems of the Industry

08/ 02/ 2018

Lidiya Sangarovskaya, senior associate at Legal Alliance Company Yurydychna Gazeta Nowadays the issues of legal regulation of the creation, production and conduct of conformity assessment, treatment and quality control of medical products are becoming increasingly relevant in our country. Most of the practical problems faced by manufacturers and distributors of medical products are associated with the disparity of legal norms, unsettledness of certain aspects of activity in the medical products market and ambiguity of law enforcement practice. Among the basic legal acts currently applied to medical products there are at least four laws of Ukraine, namely On General Safety of Non-Food Products, On State Market Surveillance and Control of Non-Food Products, On the Main Principles of State Supervision (Control) in the Economic Sphere , On Technical Regulations and Conformity Assessment , more than fifteen basic resolutions of the Cabinet of Ministers of Ukraine, including those that approved the main technical regulations: Technical Regulations on Medical Devices, Technical Regulations on Medical Devices for In Vitro Diagnostics, Technical Regulations for Active Medical Devices which Implant, and a number of orders of the Ministry of Economic Development and Trade of Ukraine and the Ministry of Health of Ukraine. It should be noted that the Law of Ukraine On Medical Products is not included. Attempts - 2013. In 2013, significant steps have already been taken towards the adoption of a single basic law of Ukraine in the sphere of the turnover of medical devices. Thus, on March 28th, 2013 the draft Law On Medical Products was registered in the Verkhovna Rada of Ukraine under number 2648 and submitted for consideration by the Parliament. The bill was initiated by Tetiana Bakhteeva, Peoples Deputy of Ukraine. According to our assessment, the draft law was thoroughly worked out (including the work done by working group with representatives of the Ministry of Health of Ukraine, the Ministry of Economic Development and Trade of Ukraine, the State Service of Ukraine on Drugs and Drug Control and professional public organizations) and constituted a good basis for general regulation of the industry. The basis of the bill was the adoption of three main Council Directives 93/42 / EEC On Medical Products, 90/385 / EEC On Active Medical Devices for Implantation, 98/79 / EEC On Medical Diagnostic Tools in vitro. If the draft law is adopted in 2013, it would allow to establish uniform norms and mechanisms for the legal regulation of the introduction of medical devices into circulation and operation, a clear classification of medical products, uniform standards for the application of the national conformity mark, the basic requirements for assessing the conformity of medical devices, basic requirements for clinical assessment of medical products for various purposes and active medical products that are implanted, evaluation of the characteristics of medical products for laboratory in vitro diagnostics, to regulate the introduction of the state register of medical devices, the procedure for the import, export, disposal and destruction of medical devices. As a result, the above would still significantly bring Ukraine closer to harmonizing the national legislation with the legislation of the European Union and would improve the implementation of state policy in the sphere of turnover of medical products. Unfortunately, the attempt of 2013 was just an attempt. Intentions - 2018. The issue of the need to develop and adopt a unified harmonized Law of Ukraine On Medical Products is still raised by market participants of medical devices and specialized associations. Legal Alliance Company fully supports such an initiative and provides legal support in the direction of reforming the regulatory and legal regulation of the industry. International experience as an example for us In Germany, a specialized legislative act in the sphere of the turnover of medical devices was adopted in 1956. During the application of the Law, only about 20 amendments were made to it, which indicates the quality and effectiveness of the introduced norms. Other examples of uniform basic and effective legislation on medical products may also be the relevant laws adopted in Poland, Germany, Bulgaria, Moldova, and England. The above international experience can and should be taken into account when drafting the relevant bill in Ukraine. Fortunately, in this area, we do not necessarily have to reinvent the wheel. It is enough to approach this problem with initiative and understanding.

Lidiya Sangarovskaya, senior associate at Legal Alliance Company

Yurydychna Gazeta

Nowadays the issues of legal regulation of the creation, production and conduct of conformity assessment, treatment and quality control of medical products are becoming increasingly relevant in our country.

Most of the practical problems faced by manufacturers and distributors of medical products are associated with the disparity of legal norms, unsettledness of certain aspects of activity in the medical products market and ambiguity of law enforcement practice.

Among the basic legal acts currently applied to medical products there are at least four laws of Ukraine, namely “On General Safety of Non-Food Products”, “On State Market Surveillance and Control of Non-Food Products”, “On the Main Principles of State Supervision (Control) in the Economic Sphere “,” On Technical Regulations and Conformity Assessment “, more than fifteen basic resolutions of the Cabinet of Ministers of Ukraine, including those that approved the main technical regulations: Technical Regulations on Medical Devices, Technical Regulations on Medical Devices for In Vitro Diagnostics, Technical Regulations for Active Medical Devices which Implant, and a number of orders of the Ministry of Economic Development and Trade of Ukraine and the Ministry of Health of Ukraine.

It should be noted that the Law of Ukraine “On Medical Products” is not included.

Attempts – 2013

In 2013, significant steps have already been taken towards the adoption of a single basic law of Ukraine in the sphere of the turnover of medical devices.

Thus, on March 28th, 2013 the draft Law “On Medical Products” was registered in the Verkhovna Rada of Ukraine under number 2648 and submitted for consideration by the Parliament. The bill was initiated by Tetiana Bakhteeva, People’s Deputy of Ukraine.

According to our assessment, the draft law was thoroughly worked out (including the work done by working group with representatives of the Ministry of Health of Ukraine, the Ministry of Economic Development and Trade of Ukraine, the State Service of Ukraine on Drugs and Drug Control and professional public organizations) and constituted a good basis for general regulation of the industry.

The basis of the bill was the adoption of three main Council Directives 93/42 / EEC “On Medical Products”, 90/385 / EEC “On Active Medical Devices for Implantation”, 98/79 / EEC “On Medical Diagnostic Tools in vitro”.

If the draft law is adopted in 2013, it would allow to establish uniform norms and mechanisms for the legal regulation of the introduction of medical devices into circulation and operation, a clear classification of medical products, uniform standards for the application of the national conformity mark, the basic requirements for assessing the conformity of medical devices, basic requirements for clinical assessment of medical products for various purposes and active medical products that are implanted, evaluation of the characteristics of medical products for laboratory in vitro diagnostics, to regulate the introduction of the state register of medical devices, the procedure for the import, export, disposal and destruction of medical devices.

As a result, the above would still significantly bring Ukraine closer to harmonizing the national legislation with the legislation of the European Union and would improve the implementation of state policy in the sphere of turnover of medical products.

Unfortunately, the attempt of 2013 was just an attempt.

Intentions – 2018

The issue of the need to develop and adopt a unified harmonized Law of Ukraine “On Medical Products” is still raised by market participants of medical devices and specialized associations.

Legal Alliance Company fully supports such an initiative and provides legal support in the direction of reforming the regulatory and legal regulation of the industry.

International experience as an example for us

In Germany, a specialized legislative act in the sphere of the turnover of medical devices was adopted in 1956. During the application of the Law, only about 20 amendments were made to it, which indicates the quality and effectiveness of the introduced norms.

Other examples of uniform basic and effective legislation on medical products may also be the relevant laws adopted in Poland, Germany, Bulgaria, Moldova, and England.

The above international experience can and should be taken into account when drafting the relevant bill in Ukraine.

Fortunately, in this area, we do not necessarily have to reinvent the wheel. It is enough to approach this problem with initiative and understanding.