(Original title: Third Review of the Draft Amendment to the Drug Administration Law: Importing new drugs abroad that have not been approved is no longer punishable by false medicine)

On August 22nd, at the 12th session of the Standing Committee of the 13th National People's Congress, the draft amendment to the Drug Administration Law (hereinafter referred to as the Draft Amendment) was reconsidered, which redefined what constituted counterfeit drugs.

News found from the revised draft provisions on counterfeit drugs, the import of domestic unapproved foreign legal new drugs are no longer treated as counterfeit drugs;

Redefining fake drugs, removed as fake drugs

From last year's hit film "I am not a drug god" and its prototype Lu Yong case, to this year's liaocheng fake drug case, the purchase of new drugs for overseas anti-cancer drugs was identified as counterfeit drugs once caused widespread concern.

Kabotini in the case of the fake drugs in Liaocheng, Lu Yong case of The Grewe, these foreign listing and obtained a certain effect of the new drugs because the case did not go through the approval of China's drug supervision department, imports are in accordance with the false drug theory, of which the main legal basis is China's current "drug management law."

Articles 48 and 49 of the current Drug Administration Law clearly provide for counterfeit drugs, counterfeit drugs, inferior drugs and inferior drugs:

Counterfeit drugs: If the contents of a drug do not correspond to those prescribed by the national drug standard; According to the false drug theory: the drug supervision and administration department under the State Council prescribes the prohibition of use; in accordance with this Law must be approved without approval, or not produced, imported, or sold without inspection in accordance with this Law; if it deteriorates; if it is polluted; the use of raw materials produced without obtaining the approval number in accordance with this Law?

the indication of the indication or functional treatment is beyond the prescribed scope.

Bad Medicine: The content of the pharmaceutical ingredients does not meet the national drug standards.

According to the bad medicine sin: not marked or changed the expiration date; not indicating or changing the production batch number; exceeding the expiration date; direct contact with the pharmaceutical packaging materials and containers without approval; adding colorants, preservatives, flavors, flavorants and accessories without authorization; other non-compliance with the provisions of the drug standards. On August 21st, at a press conference held by the Standing Committee of the National People's Congress, Yan Tiewei, a spokesman for the Standing Committee of the National People's Congress, said that the current law defines the scope of counterfeit drugs in a broader way, ranging from the case of counterfeit drugs defined according to the quality of the drugs and the situation in which unapproved drugs are treated as inferior drugs.

Some cases have not had a good social effect, and the scope of counterfeit drugs needs to be redefined mainly in accordance with the efficacy of drugs. News noted that the revised draft submitted this time intends to redefine counterfeit drugs and inferior drugs.

Originally according to the false drug, according to the case of bad medicine or directly included in the scope of counterfeit drugs, inferior drugs, or listed separately.

The revised draft makes it clear that counterfeit drugs include drugs containing ingredients that do not conform to those prescribed by the National Drug Standards, drugs that are disguised as drugs with non-drugs or other drugs posing as such drugs, drugs that deteriorate, drugs indicated by indications or drugs with functional treatment that are outside the prescribed scope.

The inferior drugs include: drugs with ingredient content that do not meet the national drug standards, contaminated drugs, drugs that have not marked or changed the validity period, exceeded the expiration date, failed to indicate or change the batch number of the product, drugs that add preservatives and accessories without authorization, and other drugs that do not meet the requirements of the drug standards affect the quality of the drug. In the original case of "under the false drug theory" and "in accordance with the treatment of inferior drugs", the drug prohibition of the drug administration department under the State Council must be approved and produced and imported without approval, and the drug that must be tested and sold without inspection shall be used with the medicine produced with raw materials that must be approved and not approved,

The production of drugs produced using packaging materials and containers that have no unauthorized direct contact with drugs is expressly prohibited from producing, importing and marketing these drugs, and penalties are strictly imposed.

Experts: Legal risks remain over overseas purchases of new drugs

The revised draft not only proposes to import illegal drugs illegally outstanding overseas from overseas, but also proposes that the unauthorized import of a small number of drugs that have been legally listed abroad may be reduced if the circumstances are less serious;

An expert on the direction of pharmaceutical legislation told The News that incidents such as the Lu Yong case and the Chaocheng fake drug case are likely to have similar situations in the future, and that after the revision of the Drug Administration Law, regulators will have a more complete legal basis for dealing with such incidents.

The above-mentioned experts believe that the revised draft law for the purchase of new drugs overseas "opened a small mouth", but does not mean to liberalize, overseas purchase still exists legal risks.

Article 98 of the revised draft makes it clear that the production and import of drugs without the approval documents of the drug shall be prohibited, and the production of raw materials, packaging materials and containers that have not been reviewed and approved in accordance with the provisions shall be prohibited. Article 124 of the revised draft stipulates that failure to obtain proof of drug approval for the production, importation of drugs and the use of raw materials and pharmaceuticals that have not been reviewed and approved, etc., will face the confiscation of illegal production, import, sale of drugs and illegal proceeds, as well as raw materials, accessories, packaging materials and production equipment used in illegal production, and ordered to stop production and rectify the operation. , revoke or sell the certificate of approval of drugs, and impose a fine of 15 times or less than 30 times the value of the value of the drugs illegally produced, imported or sold; if the value of the goods is less than 100,000 yuan, it shall be calculated at 100,000 yuan; if the circumstances are serious, the drug production license, the drug business license or the medical institution preparation license shall be revoked, and the legal representative, The principal person in charge, the person in charge directly responsible and other responsible personnel shall confiscate the income obtained from the unit during the period of the illegal act, and shall be fined not more than 30 percent or less than three times the income obtained, and shall be prohibited from engaging in pharmaceutical production and business activities for life.

and may be detained by the public security organ for five days to 15 days or less.

It is worth noting that article 124 of the revised draft also makes it clear that the sale and use of certain medicines is, in certain circumstances, subject to responsibility. These include: the production and import of drugs without proof of drug approval, the use of raw materials and pharmaceuticals that have not been approved for review, etc., and the punishment in accordance with the provisions of the preceding paragraph if the sales or use units illegally use the above-mentioned drugs;

If the person in charge and other responsible persons directly responsible have a medical and health personnel's practising certificate, the practising certificate shall also be revoked. Extensions
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Another "Drug God" reality version: liver cancer patients buy life-saving drugs to be detained

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