Regulations on the crime of manufacturing and trading of counterfeit medicines for treatment or prevention of diseases in Vietnam

Regulations on the crime of manufacturing and trading of counterfeit medicines for treatment or prevention of diseases in Vietnam (Internet image)

1. What are counterfeit goods?

According to Clause 7, Article 3 of Decree 98/2020/ND-CP, counterfeit goods include:

- Goods whose uses are not consistent with their nature or names; the goods which are useless or whose uses are other than the announced or registered ones;

- Goods of which one of quality indicators or basic specifications or the amount of primary substances contributing to their uses only reaches 70%, or less, compared to the minimum levels prescribed in technical regulations or quality standards registered, or announced, or specified in their labels or packages;

- Counterfeit drugs defined in Clause 33 Article 2 of the Law on Pharmacy 2016 and counterfeit herbal ingredients defined in Clause 34 Article 2 of the Law on Pharmacy 2016;

- Veterinary drug or pesticide that does not contain any active ingredients; does not contain all of registered active ingredients; contains active ingredients other than those specified on its label or package;

Contains at least an active ingredient whose content only reaches 70%, or less, compared to the minimum level prescribed in relevant technical regulations or quality standards registered or announced;

- The good whose label or package containing information forging name or address of manufacturer, importer or distributor, forging registration number, declaration number or barcode of the good, forging package of good of another entity, or forging the origin of good or place of manufacturing, packaging or assembling;

- Counterfeit stamps, labels and packages of goods.

2. Regulations on the crime of manufacturing and trading of counterfeit medicines for treatment or prevention of diseases in Vietnam

The crime of manufacturing and trading of counterfeit medicines for treatment or prevention of diseases in Vietnam according to Article 194 of the Criminal Code 2015 (amended 2017) is as follows:

(1) Any person who manufactures or deals in counterfeit medicines for treatment or prevention of diseases shall face a penalty of 02 - 07 years' imprisonment.

(2) This offence committed in any of the following circumstances carries a penalty of 05 – 12 years' imprisonment:

- The offence is committed by an organized group;

- The offence is committed in a professional manner;

- Dangerous recidivism.

- The offence involves the abuse of the offender's position or power;

- The offence is committed in the name of an agency or organization;

- Goods are traded across the border;

- The value of counterfeit goods, according to the value of genuine goods with the same quantity, specifications or features, is assessed at from VND 150,000,000 to under VND 500,000,000;

- The illegal profit earned is from VND 100,000,000 to under VND 500,000,000;

- The offence causes 31% - 60% WPI for another person;

- The property damage caused by the offence is assessed at from VND 100,000,000 to under VND 500,000,000.

(3) This offence committed in any of the following circumstances carries a penalty of 12 - 20 years' imprisonment:

- The value of counterfeit goods, according to the value of genuine goods with the same quantity, specifications or features, is assessed at ≥ VND 500,000,000;

- The illegal profit earned is from VND 500,000,000 to under VND 2,000,000,000;

- The offence results in the death of a person;

- The offence causes ≥ 61% WPI for another person;

- The offence causes a total WPI of 61% - 121% for more than one person;

- The property damage caused by the offence is assessed at from VND 500,000,000 to under VND 1,500,000,000.

(4) This offence committed in any of the following circumstances shall carry a penalty of 20 years' imprisonment, life imprisonment or death:

- The illegal profit earned is ≥ VND 2,000,000,000;

- The offence results in the death of ≥ 02 people;

- The offence results in bodily harm to ≥ 02 people who suffer from a total physical disability of ≥ 122%;

- The offence results in property damage assessed at ≥ VND 1,500,000,000.

(5) The offender might also be liable to a fine of from VND 20,000,000 to VND 100,000,000 , be prohibited from holding certain positions or doing certain works for 01 - 05 years or have all or part of his/her property confiscated.

(6) Punishments incurred by a corporate legal entity that commits any of the offences specified in this Section:

- A corporate legal entity that commits this offence in any of the circumstances specified in (1) shall be liable to a fine of from VND 1,000,000,000 to VND 4,000,000,000;

- A corporate legal entity that commits this offence in any of the circumstances specified in Points a, b, c, e, g, h, I, k Clause 2 of Article 194 of the Criminal Code 2015 shall be liable to fine of from VND 4,000,000,000 to VND 9,000,000,000;

- A corporate legal entity that commits this offence in any of the circumstances specified in (3) shall be liable to fine of from VND 9,000,000,000 to VND 15,000,000,000;

- A corporate legal entity that commits this offence in the circumstance specified in (4) shall be liable to a fine of from VND 15,000,000,000 to VND 20,000,000,000 or has its operation suspended for 01 - 03 years;

- A corporate legal entity that commits this offence in the circumstance specified in Article 79 of the Criminal Code 2015 shall be permanently shut down;

- The violating corporate legal entity might also be liable to a fine of from VND 100,000,000 to VND 300,000,000, be banned from operating in certain fields or raising capital for 01 - 03 years.

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