The Draft Law on Amendments to the Criminal Code of Ukraine on Liability for Counterfeiting of Medical Products and Similar Crimes Threatening Health Care (hereinafter referred to as the Draft) has been registered.
The project was registered in the Verkhovna Rada of Ukraine on 14.12.2020 № 4491, the text and accompanying documents are posted at the link.
Today, the Project is being worked out by the Verkhovna Rada Committees, among which the Main Committee is the Law Enforcement Committee.
The explanatory note to the Draft states that its Adoption will close the gap in the legislation and prosecute for offenses related to counterfeiting and smuggling of medical products and similar crimes that threaten health care, as well as promote:
- ensuring further harmonization of the national regulatory framework in the field of circulation of medical products with international and European legislation;
- creating appropriate conditions for doing business in the pharmaceutical market of Ukraine, which will positively affect the processes of “de-shadowing” of the economy in this area;
- non-admission to the circulation of counterfeit medical products.
The project defines the concept of “counterfeit medical products” –
any: medicines, including medical immunobiological drugs and medicines intended for clinical trials (API, products “in bulk; finished medicines (medicines, drugs, medicines); homeopathic remedies;
tools used to detect pathogens, as well as control pathogens or parasites; medicines, cosmetics, and food additives);
veterinary drugs (including substances or combinations thereof);
excipients (excipients) intended for use in the manufacture of a medicinal product or veterinary medicinal product;
medical devices (including an aid (accessory) to a medical device, part or material, developed and intended for use in the production and operation of a medical device and which are important for its integrity, software, a reagent for laboratory research);
foods for special medical purposes, dietary supplements, if these products were intentionally counterfeited and/or labeled, resulting in a misconception about its identity, packaging, labeling, name, composition (indicating all ingredients, including excipients, and the strength of these ingredients), the source of medical devices, including information about the manufacturer, country of manufacture, country of origin or the country in which the holder of the marketing authorization for medical use of medical products, or the history of medical products, including data and documents on the used delivery routes.
The draft, in particular, provides for a new wording of Articles 305 and 321.1 of the Criminal Code of Ukraine, is proposed in Articles 305 and 3211 replace the term “falsified medicines” in all cases with the term “falsified medical products” in the appropriate cases; define the meaning of the term “counterfeit medical products”.
In case of adoption of the Draft, the Law shall enter into force on the day following the day of its publication.