How to avoid legal risks for the export of anti-epidemic materials

Experts suggest that contract disputes should be under the jurisdiction of Chinese courts or arbitration institutions in China

□ Reporter Cai Yanhong

At present, the epidemic situation of New Coronary Pneumonia is spreading all over the world, and there are serious shortages of medical materials such as medical masks, protective clothing, and test kits in many countries. The Chinese government and enterprises are actively providing medical supplies to many countries, which is highly recognized by all walks of life. At the same time, the export of anti-epidemic materials did not meet the entry standards of the importing country and was cancelled or even returned, or some export enterprises were punished by the customs for violations of laws and regulations.

Recently, on the hot issue of how to avoid the risk of export of anti-epidemic materials, a reporter from Legal Daily interviewed professional lawyers in the fields of medicine, customs and international trade of King & Wood. The interviewed experts suggested that, as far as possible, it was agreed that contract disputes should be under the jurisdiction of a Chinese court or submitted to a Chinese arbitration institution for arbitration, and that Chinese law should be applied.

Increased export of anti-epidemic materials

Customs strictly investigate illegal activities

Customs statistics show that since late March, China ’s exports of prevention and control materials for epidemic outbreaks have increased significantly. From March 1st to April 4th, the value of inspection and release materials for prevention and control of export epidemics nationwide reached 10.2 billion yuan.

To deepen international epidemic prevention and control cooperation and strengthen the supervision of the export quality of medical materials, the Ministry of Commerce, the General Administration of Customs and the State Food and Drug Administration jointly issued the "Announcement on the Orderly Development of Export of Medical Materials" (hereinafter referred to as "Announcement") ), 5 types of products such as new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers, etc. that are required to be exported must obtain relevant qualifications from the national drug regulatory authority and meet the quality standards of the importing country (region).

Since the announcement, the Customs has seized 11.205 million medical materials produced by non-listed companies or without medical device product registration certificates in trade, mail, express mail, cross-border e-commerce and other channels, including 9.94 million masks and 155,000 protective suits. There are 1.085 million copies of new crown virus detection reagents and 24,000 infrared thermometers.

On April 9, the Hangzhou Customs Port Supervision Office reported that after risk analysis and on-site inspection, the customs seized more than 1,500 cases of goods declared as "plastic bottles" and "simulated flowers" at Hangzhou Xiaoshan Airport and Jinhua Freight Export Channel. It is actually an epidemic prevention material. These include 425,000 masks with CE certification marks on the outer packaging, nearly 38,000 bottles of disposable alcohol disinfectant, and nearly 32,000 bottles of disposable alcohol gel. At present, this batch of goods has been handed over to the customs anti-smuggling department.

On April 1, a Beijing biotechnology company faked 300 boxes of new crest virus detection reagents exported as "quick test paper cards" in an attempt to evade customs supervision and was seized by Beijing Customs. On April 2, Shanghai Customs seized the "Quick Diagnostic Test Paper" exported by a Hangzhou Biotechnology Co., Ltd., which was actually a new coronavirus test reagent, totaling 122,000 copies. On the same day, Ningbo Customs found that a batch of goods declared for export by a company in Yiyang, Hunan, contained 15 boxes of masks in it, totaling more than 40,000.

To ensure the orderly customs clearance of epidemic prevention and control materials, the General Administration of Customs has established a special working group to strengthen the organization and leadership of the export of medical materials. For new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers and other exported medical materials, strictly rely on the medical device product registration certificate approved by the drug supervision and management department; support enterprises to submit relevant certificates through electronic means; strengthen Customs protection of intellectual property rights, resolutely investigate and deal with infringement of anti-epidemic products; severely crack down on illegal acts such as export false reports, concealment, entrapment, false pretence, and unqualified impersonation.

It is understood that illegal acts punished by the customs will also serve as a reference basis for the customs to determine the credit status of the enterprise. If it constitutes a smuggling act or a smuggling crime, the customs will directly reduce the enterprise's credit rating to an untrustworthy enterprise, and implement strict management measures such as increasing the inspection ratio, increasing the frequency of audits and inspections, and collecting security deposits in full. At the same time, the General Administration of Customs will implement joint disciplinary measures against the enterprise with relevant state departments. Increase the exposure of the punished enterprises to violations of the law, publicize the punished enterprises on the official website of the General Administration of Customs and local credit websites, and expose relevant case information through the media.

Export of anti-epidemic medical devices

Need to obtain registration certificate

The "Legal Daily" reporter noted that the common anti-epidemic materials exported in large quantities in China at present, such as masks, protective clothing, medical gloves, goggles, and thermometers, are all medical devices supervised by the State Food and Drug Administration.

According to Lawyer Huang Jianwen, a partner of King & Wood Law Firm focused on the medical field, China manages medical devices in three categories according to the degree of risk, and implements record management measures for medical rubber gloves and other first-class medical device products with lower risk levels ; Strict management of registration licenses for medical masks, ventilators, and other high-risk second and third-class medical device products; for the production of medical devices marketed overseas, third-party certification of the medical device quality management system should be obtained or Domestic medical device registration permission or filing certificate for similar products.

"In the past export practice, the customs generally did not review the qualification certificates of medical devices. There are no export license requirements for masks, protective clothing, thermometers and other conventional anti-epidemic materials, and there are no other trade control conditions." Jin Du Lawyer Feng Xiaopeng, a partner of the customs and trade compliance business of the law firm, said that the "Announcement" puts forward new requirements for the export of medical materials under the epidemic. It is clear that from April 1, the export of new crown virus detection reagents, medical masks, Medical protective clothing, ventilators, infrared thermometers, etc. must provide a written or electronic statement, promising that the exported products have obtained the registration certificate of China's medical device products and meet the quality standards of the importing country (region). The customs shall check and release the medical device product registration certificate approved by the drug supervision and administration department.

In addition, due to the severe global epidemic situation recently, China's new coronavirus detection kits have been exported in large quantities. "Most of the new coronavirus detection reagents are classified into the customs tariff number of 30021500 and 3822090 due to the presence of biological components such as nucleic acids and antibodies. They are classified as special items and should be subject to sanitary quarantine approval. The consignor or agent of special items out of the country should obtain" "Export of Special Items for Health and Quarantine" and then declare to the local customs for export. "Feng Xiaopeng reminded that no matter whether it is a general trade channel, a personal mail channel, or a self-carrying method, special items such as export (outbound) detection kits are exported out of the country. The "Examination and Approval Form for Sanitary and Quarantine of Outward Special Items" shall be provided, and the contents and value of the declaration must be faithfully carried out, and no illegal articles may be carried.

"Legal Daily" reporter learned from the customs that for the purpose of epidemic prevention and control, special items such as vaccines, blood products, reagents and other items used for the prevention, treatment and diagnosis of new coronary pneumonia can be based on special approval documents issued by the provincial drug regulatory department. It is exempted from going through the examination and approval of entry-exit special items. Those who carry blood products or biological products for self-use only for the prevention or treatment of diseases do not need to go through the health and quarantine approval procedures, but should show the relevant certificates of the hospital to the customs, limited to a course of treatment determined by the prescription or instructions.

Import standards are tightening

Legal risks cannot be ignored

The quality and safety of medical products are directly related to human life and health rights. In the context of the increasingly severe global epidemic situation, countries have also imposed stricter controls on the import standards of anti-epidemic materials.

Huang Jianwen believes that for the quality of products after export, the laws of the European Union and the United States clearly stipulate that the producer is the main responsible body and is responsible for its products and all consequences caused by product failures. In addition, countries such as Europe and the United States attach importance to granting consumers extensive and highly operable claims, and through detailed and clear description of product responsibilities, they exert pressure on producers and sellers to protect the legitimate rights and interests of consumers.

"Foreign trade enterprises must not only see opportunities, but ignore risks and challenges. When signing a contract, they should strengthen the review of product quality standards, claims and other relevant provisions. If possible, it is recommended that Chinese companies stipulate the quality provisions in the contract. ' Product quality standards are subject to Chinese laws and regulations. "Huang Jianwen said.

In addition, affected by the epidemic, international cargo transactions may face the risk of delivery default due to insufficient capacity or increased import and export control by various countries. Faced with uncertain factors in price, delivery, dispute resolution, etc., Huang Jianwen and Feng Xiaopeng both suggested that foreign trade enterprises should pay attention to as few obligations as possible in transportation, customs clearance, etc. in the contract, such as selecting factory delivery, etc. At the same time, factors such as force majeure in the agreement should be considered as detailed and complete as possible.

"The export of anti-epidemic materials requires not only domestic registration, approval, quarantine, and customs declaration in accordance with law in the country, but also attention to the access standards of the importing country." Feng Xiaopeng said, such as the sale of medical masks in the United States, the FDA registration and the National Institute of Occupational Safety and Health NIOSH certification; medical masks exported to EU countries must be CE certified, and CE certification is divided into sterile and non-sterile categories, respectively, applying different certification procedures; in Japan, the marketing and circulation of medical devices must be controlled by an independent administrative legal person The PMDA review of a comprehensive medical device organization was approved by the Ministry of Health, Labour and Welfare.

During the interview, the two lawyers also specifically suggested that if the exporting enterprise has fulfilled its reasonable duty of care and is still concerned about disputes arising from changes in the policies of the importing country or other unforeseen circumstances, it should be agreed as far as possible that contract disputes should be settled by China The court has jurisdiction over or submitted to a Chinese arbitration institution for arbitration, and has chosen to apply Chinese law.