Drug Administration issued a document to regulate online prescription drugs

The Drug Administration announced the latest documents.

Prescriptions must be "pre-positioned" to ensure medication safety

On November 9, the Hainan Provincial Drug Administration issued the "Interim Regulations on the Supervision and Administration of Drug Online Sales in Hainan Province (Draft for Solicitation of Comments)" (hereinafter referred to as the "Regulations") to support Internet prescription drug sales and to ensure the safety of drug use by the public

The "Regulations" require that when engaging in online drug sales and providing drug online transaction services, information and data should be authentic, complete, and traceable, and personal information should be kept confidential in accordance with relevant regulations

For vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, pharmaceutical precursor chemicals, and other drugs subject to special management by the state, it is strictly forbidden to sell them through the Internet

It is worth noting that if pharmaceutical retail companies sell prescription drugs online, they are prohibited from providing prescription drug purchase operations through self-built websites or third-party platforms before obtaining the prescription

This means that prescription drugs sold online by pharmacies must "prescribe first and sell drugs behind".

Electronic prescription, AI robot operation is prohibited

Online prescription drugs in pharmacies must involve electronic prescriptions

The "Regulations" stated that when pharmaceutical retail companies sell prescription drugs online, they should ensure that the source of electronic prescriptions is authentic and reliable, conduct prescription deployment reviews in strict accordance with relevant requirements, and mark the use of electronic prescriptions that have been used

For electronic prescriptions issued by Internet hospitals, the sales scope of the prescriptions shall meet the requirements of Internet diagnosis and treatment

At present, the country's attitude towards electronic prescriptions is very cautious

It can be seen that online sales of prescription drugs emphasize the importance of "sales by prescription", but the use of AI technology is strictly prohibited for "prescription" on the Internet platform and must be handled by offline physicians

It should be mentioned that online pharmacies selling prescription drugs can only show the general name, product name, dosage form, specification, and holder information of prescription drugs to the public.

The requirement also states that when pharmacies sell prescription drugs on online platforms, they must be consistent with offline pharmacies, and advertising information is prohibited

In addition, for prescription drugs that are marketed in China, except for drugs that are specifically regulated by the national drug management laws and regulations, pharmaceutical retail companies can rely on Hainan Electronic Prescription Center for sales, and third-party platforms can rely on the Electronic Prescription Center to provide transaction services

It is understood that in order to ensure that the "safety of online prescription drugs" is controllable, the National Development and Reform Commission and the Ministry of Commerce issued a document on April 8 requesting the establishment of a pilot program for Hainan's electronic prescription center

Online drug distribution must ensure "quality" and "full traceability"

Not only "prescription drugs sold online", the "Regulations" also require the service capabilities of online pharmacies and third-party Internet platforms

Regarding the provision of pharmacists, the "Regulations" point out that when pharmaceutical retail companies sell drugs online, they should establish an online pharmacy service system, allocate legally qualified pharmacists or other pharmacists appropriate to their business scale, and conduct prescription review and deployment.
, Guide the rational use of medicines and other work
.

In terms of the safety of drug distribution, drug network sellers shall be responsible for the quality and safety of drug distribution
.
The “Regulations” stated that the appropriate means of transportation and temperature control methods should be selected according to the quantity of drugs to be delivered, the transportation distance, and the temperature and humidity requirements during transportation.
The drugs to be delivered should be placed in an independent space and clearly marked to ensure that the transportation process meets the requirements.
The whole process of distribution activities can be traced to ensure the quality of medicines during the distribution process
.

In the case of entrusted delivery, the drug network seller shall supervise the entrusted enterprise to ensure the quality of the drug during the delivery process
.

In order to maintain compliance with drug online sales, the "Regulations" require third-party platforms to establish drug quality management agencies and be responsible for the following tasks:

1.
Equipped with pharmaceutical technicians to undertake drug quality management work;

2.
Establish and implement a system to ensure drug quality and safety;

3.
Establish and implement transaction record keeping, complaint management and dispute resolution, and adverse drug reaction information collection systems;

4.
Establish and implement a distribution quality management system;

5.
Establish and implement a prescription review and monitoring system, a drug information display inspection and monitoring system, a prescription drug real-name purchase system, etc.
;

6.
Ensure the truthfulness, completeness and safety of materials, information and data
.

The "Regulations" also talked about the supervision and management of drug online sellers and third-party platforms in compliance with laws, regulations and rules and other relevant regulations and the principle of "online and offline consistency" by drug regulatory authorities at all levels
.
If drug online sellers or third-party platforms constitute a crime, they shall be investigated for criminal responsibility in accordance with the law
.

The development of online drug sales can promote coordinated regional development

In August this year, a "Measures for the Supervision and Administration of Drug Online Sales (Draft for Review)" (hereinafter referred to as the "Measures") circulated on the Internet and sparked heated discussions
.
By comparison, it is found that the content of the "Measures" and the above-mentioned "Regulations" have a lot in common
.

In response to the "Measures", Song Hualin, director of the Medical and Health Law Research Center of Nankai University, wrote in the Legal Daily News that compared with physical pharmacies, there are more drug information and drug varieties on the Internet, with a wider coverage, and the purchase of drugs can be free from time and space restrictions.
For patients, this is a more convenient, fast, time-saving and labor-saving way to purchase drugs
.
At the same time, online drug sales can also change the trend of excessive concentration of traditional drug circulation resource elements in central cities, promote the coordinated development of large, medium and small cities and small towns, and improve the efficiency of social public services
.

Internet drug sales may have a certain impact on the drug retail industry in the short term, but effective cooperation between Internet platforms, drug online retailers, and drug retail formats can objectively promote the transformation and upgrading of the drug retail format, and promote the line Integration of online and offline development
.

Song Hualin also emphasized that the legislation and supervision of drug online sales should be based on “sparse” and not a “one size fits all” restriction.
It is recommended that strict legal liability penalties be established to deal with non-compliant or even illegal online drug sales.
Severe punishments are imposed on behaviors to promote the evolution of regulatory concepts and the innovation of regulatory methods
.