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Can "drug god" exist after the newly revised Drug Administration Law is implemented?

Can "drug god" exist after the newly revised Drug Administration Law is implemented?

  • 分类:最新消息
  • 作者:华讯知识产权
  • 来源:
  • 发布时间:2019-09-26 10:06
  • 访问量:1

【概要描述】OnAugust26,the12thMeetingofthe13thNPCStandingCommitteevotedthroughthenewlyrevisedtheDrugAdministrationLaw,whichwillbeimplementedonDecember1,2019.ThisrevisionisthefirstcomprehensiverevisionoftheDrugAdm

Can "drug god" exist after the newly revised Drug Administration Law is implemented?

【概要描述】OnAugust26,the12thMeetingofthe13thNPCStandingCommitteevotedthroughthenewlyrevisedtheDrugAdministrationLaw,whichwillbeimplementedonDecember1,2019.ThisrevisionisthefirstcomprehensiverevisionoftheDrugAdm

  • 分类:最新消息
  • 作者:华讯知识产权
  • 来源:
  • 发布时间:2019-09-26 10:06
  • 访问量:1
详情

On August 26, the 12th Meeting of the 13th NPC Standing Committee voted through the newly revised the Drug Administration Law, which will be implemented on December 1, 2019. This revision is the first comprehensive revision of the Drug Administration Law after a lapse of 18 years. Issues of prominent social contradictions have been adjusted, such as imported drugs, innovative drugs and online drug sales, mainly from the following aspects: First, to make provision for drugs saled online.It requires third-party online drug sales platforms to file to the drug regulatory department, to examine the qualifications of drug license holders and drug business enterprises applying for entry into the platforms, and to manage the drug business activities on the platforms. Second, the market authorizer system has been established. The regulation is that, drug market authorizer is responsible for the safety, effectiveness and quality controllability of the whole process of drug development, production, operation and use according to law, and separates the production license from the market authorization. Third, the punishment has been strengthened, and it will be increased considerably in many articles involving punishment. For example, those who produce and sell substandard drugs will be confiscated of their illegal income and fined at least tenfold and less than twenty-fold the value of the goods, while the predecessor fined at least double and less than triple. Fourth, unlicensed imported drugs are no longer treated as "counterfeit drugs", and the scope of counterfeit drugs is defined in a new way. It is stipulated that the punishment for importing without approval a small number of drugs legally marketed abroad can be mitigated or exempted.

南京华讯知识产权顾问有限公司

In 2018, the film "Dying To Survive" adapted from a true story triggered widespread discussions on the issues such as "counterfeit drugs", "purchasing agents" importing drugs without national approval, etc. The hero prototype of "Dying To Survive" is Yong Lu, who developed leukemia in 2002. But he can't afford the domestic drugs.Later, Lu Yong learned online that there was a drug with the same efficacy in India. The price is very cheap, but no relevant documents for export to China were achieved, so the drug can only be bought secretly by some channels from India. Since then, Yong Lu not only took the drug himself, but also helped other patients to purchase this drug. In early 2015, Yong Lu was arrested on suspicion of selling counterfeit drugs. During this period, many patients that once obtained the drug from Yong Lu joined together to protest and plead with the judiciary for exemption Yong Lu from criminal punishment, and finally the Procuratorate made a non-prosecution decision.

Drugs imported without approval shall be treated as counterfeit drugs in the past, and corresponding perpetrators shall be punished according to relevant regulations. Jie Yuan, director of the administrative law department of Legislative Affairs Committee of the NPC Standing Committee, said at a news conference that the scope of counterfeit drugs had been revised this time, and that the unauthorized imported drugs had not been listed as counterfeit drugs, which responded to the concerns of the public. Article 98 of the new Drug Administration Law stipulates that "production (including preparation, the same below), sale and use of counterfeit drugs are prohibited. It would be considered as a counterfeit drug, in any of the following cases: ingredients contained in drugs do not conform to those prescribed in the national drug standards; drugs faked by non-drugs or other drugs; deteriorated drugs; instructed indications or functions are beyond the prescribed scope." Compared with its predecessor, the new Drug Administration Law removed the item "drugs that must be approved of production or import in accordance with this Law yet are produced or imported without approval, or drugs that must be inspected before on sale in accordance with this Law yet are sold without inspection". In addition, Article 124 updates that " the punishment for importing without approval a small number of drugs legally marketed abroad can be mitigated or exempted according to the law, if in lighter criminal circumstances".

Drug is a kind of commodity about life and health. Drugs imported without approval are not treated as counterfeit drugs, which meets the urgent needs of the public. Drug gods like Yong Lu will no longer be punished for their warm heart. It means that self-use drugs can be purchased abroad. However, if drugs are purchased on behalf of other people for profit and/or in large quantities, then the purchasers are very likely to commit illegal business crime or smuggling crime.

南京华讯知识产权顾问有限公司

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