Development and management of online pharmacies in China

Qualification of online pharmacies in China

In China, only chain pharmacies can apply for establishing an online pharmacy. ² In order to do so, first of all, it should obtain the “Qualification Certificate for Drug Information Services over the Internet,” then obtain the “Qualification Certificate for Drug Transaction Service over the Internet.” The code of the qualified certification should be posted on a noticeable place on the homepage of the online pharmacies website. Any chain pharmacy that applies for establishing an online pharmacy must also fulfill the following conditions:

It should have a sound network, measures supporting safe transactions and a complete administrative system.

Information distribution and transaction restriction of online pharmacies in China

The drug information provided by online pharmacies should be scientific evidence based, accurate, and in compliance with laws and regulations of drugs and medical devices. ³ The information for narcotic drugs, psychotropic substances, medical toxic drugs, radioactive pharmaceuticals, addiction treatment pharmaceuticals, and medical institution preparations cannot be distributed by online pharmacies. Drug advertisements distributed by online pharmacies should be approved by the Provincial Food and Drug Administration, and the approval number of the advertisement certification should be posted on a noticeable place on the online pharmacies website. In China, online pharmacies only can sell the non-prescription drugs, and should not sell drugs to the other pharmaceutical enterprises or medical institutions.

Criminal activities and legal liabilities of online pharmacies in China

If any online pharmacy provides unapproved, unauthorized, or false drug information over the internet and causes negative impacts to patients, the violator will receive a disciplinary warning from the State Food and Drug Administration or Provincial Food and Drug Administration and be instructed to rectify the violation within a certain time limit. If the circumstances are serious, the violator will be fined not less than RMB 10,000 yuan but not more than RMB 30,000 yuan. ³ If a crime is constituted, criminal liabilities shall be investigated in accordance with article 222 of the “Criminal Law of the PRC.” Also, the violator may be sentenced to fixed-term imprisonment of not more than 2 years or criminal detention, and may also be fined. ⁴

If any online pharmacy does not post the code of the “Qualification Certificate for Drug Information Services over the Internet” on a noticeable place on the homepage of the website, the violator will receive a disciplinary warning from the State Food and Drug Administration or Provincial Food and Drug Administration and be instructed to rectify the violation within a time limit. If the violation is not rectified within the time limit, the violator will be fined not less than RMB 5000 but not more than RMB 10,000. ³

If any online pharmacy does not post the code of “Qualification Certificate for Drug Transaction Service over the Internet” on a noticeable place on the homepage of its website, or provides internet drug transaction services without approval, the violator shall receive a disciplinary warning from the Food and Drug Administration and will be instructed to rectify it within a certain time limit. If the circumstances are serious, the qualifications of the internet drug transaction service will be annulled and the “Qualification Certificate for Drug Transaction Service over the Internet” will be revoked. ³

If any online pharmacy sells prescription drugs, or sells any drug to other pharmaceutical enterprises or medical institutions over the internet, the violator shall be punished by the State Food and Drug Administration, the violator’s qualifications of internet drug transaction service shall be annulled, and the “Qualification Certificate for Drug Transaction Service over the Internet” shall be revoked. ³ If any online pharmacy sells drugs to other pharmaceutical enterprises or medical institutions over the internet, pursuant to article 73 of the “Drug Administration Law of PRC,” the drugs illegally sold and the illegal gains will be confiscated, and the violator will also be fined not less than two times but not more than five times the value of the drugs. ⁵ If a crime is constituted, criminal liabilities shall be investigated in accordance with article 225 of the “Criminal Law of the PRC.” If the circumstances are serious, the violator shall be sentenced to fixed-term imprisonment of not more than 5 years or criminal detention, and concurrently or separately be sentenced a fine of not less than one time but not more than five times the value of the illegal gains. If the circumstances are particularly serious, the violator shall be sentenced to fixed-term imprisonment not less than 5 years and concurrently be sentenced to a fine of not less than one time but not more than five times the value of the illegal gains or confiscation of the property. ⁴

Forecast and advice on perfecting legal supervision on information issuance

“Provisions for Health Care Information Service Administration over the Internet” outlines that only medical institutions, health prevention and care services institutions, or other social organizations institutions, which obtain “Health Care Information Service Approval Document over the Internet,” can offer the service of providing health care information. ⁶ Therefore, as drugs retailers, no online pharmacies in China have the qualifications to offer health care information, release the medical advertisements, or engage in online diagnosis and treatment activities. However, many qualified online pharmacies release medical information or medical advertisements, and carry out health information, self-diagnosis tools, education on diseases, guidance on medical institutions and pharmacies, and physician and pharmacist consultations. China needs to standardize the information provision laws. First, the specific scope shall be clear on medicines information issue. Information should be strictly limited within the scope of the non-prescription drugs insert that has been approved by the State Food and Drug Administration. Second, the advertisements should also be strictly limited to non-prescription drugs and the content of the advertisement should also be based on non-prescription drugs insert approved by the State Food and Drug Administration.

Forecast and advice on legal supervision on consultation specialization

“Provisional Regulations of Drug Transaction Service Approval over the Internet” requires online pharmacies to have licensed pharmacists to offer online consultation, and have the facilities, equipment, and related control systems to preserve the contents of the consultation. “Good Supply Practice” requires that drug retailers clearly display the license certification of the pharmacists at the physical business location. During business hours, licensed pharmacists or pharmacists should wear insignia that indicates their name and professional qualifications. ⁷ Most online pharmacies in China offer online consultation by licensed pharmacists. As the consultations are offered by phone or internet, it is difficult for customers and supervisors to verify if the consultation services are actually offered by a licensed pharmacist or not. China needs to regulate the online consultation of licensed pharmacists through several methods. First, purchase guidance for non-prescription drugs can only be offered by licensed pharmacists of online pharmacies. Second, if video telephone consultation or online video consultation is used records of these consultations should be kept by management and verified. Third, the information of pharmacists of online pharmacies should be posted clearly on the homepage of website, with details such as the name, professional qualification, license of the pharmacists, and a telephone number by which the pharmacists can be contacted at anytime.

Forecast and advice on legal supervision on operating activities

“Provisional Regulations of Drug Transaction Service Approval over the Internet” requires online pharmacies only can sell non-prescription drugs, and also they cannot sell drugs to other pharmaceutical enterprises or medical institutions. Most online pharmacies in China sell western medicine, traditional Chinese medicines, prepared slices of Chinese crude drugs, health food, cosmetics and toiletries, medical devices, sexual products, fertility products, and sundries. Online pharmacies have no specific limitations for merchandise compared to traditional brick-and-mortar retail pharmacies, and the merchandise range can expand infinitely. China needs to set out laws to standardize its merchandise. For example, any online pharmacies which sell drugs, health food, food, cosmetics and toiletries, and medical devices should have the appropriate licenses for the range of merchandise (i.e., “Drug Trade License,” “Health Food Sanitary License,” “Food Sanitary License,” “Cosmetics Sanitary License,” and “Medical Sanitary Equipment,” respectively).

“Notice of Strengthening Drug Retailers Supervision” requires drug retailers to set up a non-drug product sales area to separate drugs and non-drug product sales, and set up an obvious sign in the non-drug product areas. The drug area cannot sell non-drug items. Signage of the non-drug products counter should be shown clearly, and the category label of non-drug products should be placed accurately and tangibly. Sales staff should also introduce the drugs indication, property, usage, contraindications, and precautions clearly, and should not exaggerate the efficacy of drugs or recommend any non-drug products to customers in place of actual drugs. ⁸ In China, the design of most pharmacies websites is different, and the navigation of drug and non-drug products of most online pharmacies does not provide clearly enough differentiation between the two. China should enhance the design of online pharmacies websites with laws. Online pharmacies could divide drug and non-drug products into two groups on the navigation menu on their homepage. Drug items should be divided into Class A and Class B OTC drugs and non-drug products could include health foods, foods, cosmetics and toiletries, etc.

“Measures for Supervision and Administration of Drug Distribution” requires drug retailers to stop selling prescription drugs and Class A OTC drugs when the pharmaceutical technicians are not present. ⁹ Online pharmacies in China are open for 24 h, but most licensed pharmacists cannot be online 24 h, and Class A OTC drugs can be ordered easily when licensed pharmacists are not present. Therefore, China should require licensed pharmacists to be online for 24 h by turns to guide consumers to select appropriate OTC drugs, particularly Class A OTC drugs.

Forecast and advice on legal supervision on transportation

“Measures for Prescription Administration” requires that prescriptions be used within 24 h, and should not be prolonged for more than 3 days except by clear indication of a physician on special situation. ¹⁰ China is a geographically expansive country, but online pharmacies can deliver drugs by express parcels or allow self pick-up within 24 h in the cities where online pharmacies are located. However, in the other cities where online pharmacies do not have any physical pharmacies, they can only deliver the drugs by postal parcels, EMS, or express parcels, and delivery time varies depending on the region in most cases, not less than 2 days currently. Although online pharmacies can ensure delivery of the drug within the valid period of the prescription, they cannot ensure that consumers will receive the drugs within the valid period of the prescription. China should standardize the transportation with laws. First, online pharmacies can provide the self pick-up service in cities where online pharmacies or its chain pharmacies are located, and self pick-up locations can only be distribution centers of online pharmacies, or its brick-and-mortar chain pharmacies. Second, governments can encourage cooperation between online pharmacies, or even between online pharmacies and the other brick-and-mortar chain pharmacies. Online pharmacies can provide OTC drugs information, and brick-and-mortar chain pharmacies can deliver OTC drugs within 24 h to the city where the customers are located, and be responsible for the quality of the OTC drugs.

Forecast and advice on legal supervision on after-sales services

“Measures for Reporting and Monitoring Administration of Adverse Drug Reaction” requires drug retailers to appoint special persons responsible for reporting and monitoring on adverse drug reactions. Any adverse drug reaction shall be recorded in detail through the “Adverse Drug Reaction/Incident Report Form,” investigated, analyzed, evaluated, and with the drug disposed. The adverse drug reaction shall be reported to the local provincial monitoring center of adverse drug reactions each quarter. Any new or serious adverse drug reactions should be reported within 15 days. In cases of death, these require immediate reporting. ¹¹ “Measures for Drug Recall Administration” requires drug retailers to stop selling drugs immediately which have safety problems, notify drug manufacturers or distributors and report finding to the Drug Administration Agency. ¹² In China, the after-sale services of most online pharmacies only involve reimbursement or refunds, and do not involve responsibility of adverse drug reactions and drug recalls. China needs to standardize after-sale services of online pharmacies with laws. First, online pharmacies shall make a promise to ensure the quality of drugs sold over the internet and be responsible for the drugs safety. Second, online pharmacies shall have special persons with responsibility for monitoring and dealing with complaints of any adverse drug reaction, and shall offer channels such as the internet or telephone for consumers to complain. Third, online pharmacies should notify consumers via internet or telephone to stop taking unsafe drugs, and also should report to the Drug Administration Agency immediately.