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↵ ↵ ↵ Recently, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Drug Online Sales (hereinafter referred to as the Measures), covering drug network sales management, platform management, supervision and inspection, legal liability and other contents, which came into effect on
December 1 this year.
It is worth noting that for the first time, the new regulations make detailed provisions on online sales of
prescription drugs.
December 1 this year.
It is worth noting that for the first time, the new regulations make detailed provisions on online sales of
prescription drugs.
The interviewed experts believe that the promulgation of the Measures puts forward higher requirements for all parties in the industrial chain, plugs online loopholes such as "first prescription and then medicine", and effectively guarantees the safety
of drug use while improving the accessibility of drugs and supporting the development of emerging formats.
of drug use while improving the accessibility of drugs and supporting the development of emerging formats.
From explicit prohibition to orderly release
The "online sale of prescription drugs" has opened the floodgates and has been explored and brewed
for many years.
for many years.
The Measures for the Supervision and Administration of Online Drug Business (Draft for Solicitation of Comments), published in November 2017, make it clear that prescription drugs may not be sold through the Internet and prescription drug information
must not be displayed through the Internet.
The Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments) issued in February 2018 reiterated
this.
must not be displayed through the Internet.
The Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments) issued in February 2018 reiterated
this.
The turning point came in 2019
.
The new version of the Drug Administration Law, which came into effect in December of that year, proposed that prescription drugs other than vaccines, blood products, narcotic drugs and other drugs could be sold online, laying the legal framework
for the loosening of the "online sale of prescription drugs".
In November 2020, the State Drug Administration issued a new version of the Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments), which mentions that under the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, online sales of prescription drugs are allowed, and prescription transfer reviews are carried out in accordance with relevant requirements, and prescriptions that have been used are electronically marked
.
.
The new version of the Drug Administration Law, which came into effect in December of that year, proposed that prescription drugs other than vaccines, blood products, narcotic drugs and other drugs could be sold online, laying the legal framework
for the loosening of the "online sale of prescription drugs".
In November 2020, the State Drug Administration issued a new version of the Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments), which mentions that under the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, online sales of prescription drugs are allowed, and prescription transfer reviews are carried out in accordance with relevant requirements, and prescriptions that have been used are electronically marked
.
On this basis, the "Measures" stipulate the drugs prohibited from being sold online, including vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, and other drugs that are specially managed by the state, and introduce regulatory rules
for the whole process of information disclosure, prescription sources, pharmaceutical services, drug transportation and other operations.
for the whole process of information disclosure, prescription sources, pharmaceutical services, drug transportation and other operations.
Data show that the size of China's prescription drug market is about 1 trillion yuan, accounting for more than
85% of the market for the terminal consumption of drugs.
Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" of prescription drugs sold online is so prudent stems from the difficulty of ensuring drug safety and delineating the attribution of responsibility, etc
.
"The introduction of the new regulations further clarifies the obligations, legal responsibilities and penalties of pharmaceutical companies and platforms, and provides standards and paths for the development of the industry.
"
85% of the market for the terminal consumption of drugs.
Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" of prescription drugs sold online is so prudent stems from the difficulty of ensuring drug safety and delineating the attribution of responsibility, etc
.
"The introduction of the new regulations further clarifies the obligations, legal responsibilities and penalties of pharmaceutical companies and platforms, and provides standards and paths for the development of the industry.
"
"'Online prescription drugs' are no longer holding the pipa and half covering their faces
.
" Song Hualin, dean of the Law School of Nankai University and director of the Medical and Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps to promote the development of the pharmaceutical industry and build a higher level of open economy
.
.
" Song Hualin, dean of the Law School of Nankai University and director of the Medical and Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps to promote the development of the pharmaceutical industry and build a higher level of open economy
.
Plug the "first medicine behind" loophole
All along, the drug purchase process of each platform has been "before the drug is the rear": after the consumer selects the drug, places the order and pays, the page jumps to the Internet hospital built or cooperated by the platform, conducts online consultation and prescription or reviews the prescription, and the merchant ships
after the review is passed.
Industry insiders point out that this model has actually evolved into "the patient 'self-diagnosis' and the doctor 'on the drug'"
.
after the review is passed.
Industry insiders point out that this model has actually evolved into "the patient 'self-diagnosis' and the doctor 'on the drug'"
.
In accordance with the principle of online and offline consistency, in order to guide online drug purchase to return to "prescription before medicine", the Measures start with drug online retail enterprises and require that information such as prescription drug packaging, labels and other information must not be directly displayed on the main page and home page of prescription drug sales; Before passing the prescription review, information such as instructions must not be displayed, and services related to the purchase of prescription drugs must not be provided
.
In other words, patients cannot choose their own medications based on the information on the page, and must consult and prescribe to obtain more complete information
.
.
In other words, patients cannot choose their own medications based on the information on the page, and must consult and prescribe to obtain more complete information
.
The authenticity and reliability of prescription sources is an important prerequisite for ensuring the safety of
medications.
In this regard, article 9 of the Measures stipulates that the real-name system for online sales of prescription drugs shall be implemented, and drug online retail enterprises shall sign an agreement with the electronic prescription provider, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid the reuse of
prescriptions.
Where a third-party platform undertakes electronic prescriptions, it shall verify the circumstances of the provision of electronic prescriptions and sign an agreement
.
Song Hualin said that through traceability management, the rights and responsibilities
of all parties can be clearly defined.
medications.
In this regard, article 9 of the Measures stipulates that the real-name system for online sales of prescription drugs shall be implemented, and drug online retail enterprises shall sign an agreement with the electronic prescription provider, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid the reuse of
prescriptions.
Where a third-party platform undertakes electronic prescriptions, it shall verify the circumstances of the provision of electronic prescriptions and sign an agreement
.
Song Hualin said that through traceability management, the rights and responsibilities
of all parties can be clearly defined.
In order to achieve traceability of the whole process, the Measures also emphasize that drug online retail enterprises selling prescription drugs should keep records of prescriptions and online pharmacy services for a retention period of not less than 5 years and not less than 1 year
after the expiration of the validity period of the drug.
after the expiration of the validity period of the drug.
In view of the particularity of prescription drugs, the Measures require drug online retail enterprises to perform sufficient risk notification obligations and highlight risk warning information
such as "prescription drugs must be purchased and used under the guidance of pharmacists with prescriptions" under the drug display page.
Before the sale of prescription drugs, consumers shall be fully informed of relevant risk warning information, and consumers shall confirm their knowledge
.
such as "prescription drugs must be purchased and used under the guidance of pharmacists with prescriptions" under the drug display page.
Before the sale of prescription drugs, consumers shall be fully informed of relevant risk warning information, and consumers shall confirm their knowledge
.
The platform should be a good "gatekeeper"
The State Food and Drug Administration pointed out in the policy interpretation that the third-party platform, as the "platform manager", plays a unique role in the drug network sales activities and is a key part
of the healthy development of drug network sales standards.
of the healthy development of drug network sales standards.
In order to consolidate the main responsibility of the platform, the Measures require it to establish a drug quality and safety management agency, equipped with pharmaceutical technicians to undertake drug quality and safety management, and establish and implement management systems
such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reports, and complaint and report handling.
such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reports, and complaint and report handling.
In addition, the Measures also require the platform to sign an agreement with the drug network sales enterprise to clarify the drug quality and safety responsibilities of both parties, stipulate that the platform shall perform the obligations of auditing, inspection and monitoring, and stopping services and reporting when serious illegal acts are found, and strengthen the platform's cooperation obligations
in drug recalls, emergency handling of emergencies, and supervision and inspection.
in drug recalls, emergency handling of emergencies, and supervision and inspection.
"Third-party platforms must be good 'gatekeepers.
'
" Song Hualin said that platform enterprises should examine themselves according to the "Measures", check and fill in the gaps, and improve internal management processes and norms
as soon as possible.
"In the short term, it will increase the compliance cost of the platform, but in the long run, only by moving from disorder to order, can the industry win more room for
development.
"
'
" Song Hualin said that platform enterprises should examine themselves according to the "Measures", check and fill in the gaps, and improve internal management processes and norms
as soon as possible.
"In the short term, it will increase the compliance cost of the platform, but in the long run, only by moving from disorder to order, can the industry win more room for
development.
"
The virtual and cross-regional characteristics of drug network sales have brought new challenges to supervision, and one of the highlights of the new regulations is the "network management network"
.
Require the provincial drug supervision and administration department to establish a drug network sales monitoring platform to achieve data docking with the national platform; Encourage third-party platforms and drug regulatory departments to establish automated information reporting mechanisms
in the form of open data interfaces.
.
Require the provincial drug supervision and administration department to establish a drug network sales monitoring platform to achieve data docking with the national platform; Encourage third-party platforms and drug regulatory departments to establish automated information reporting mechanisms
in the form of open data interfaces.
Song Hualin believes that the security of drug network sales is a complex systematic project, how to construct the online pharmacy service system, how to balance the information display clause and the protection of consumers' right to know, how to solve the data security and privacy protection problems brought about by the real-name system of prescription drugs and the preservation of relevant records, all of the above will affect the effectiveness of the implementation of the new regulations, and it is urgent to introduce supporting measures to define
them more clearly in the future.
them more clearly in the future.
Recently, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Drug Online Sales (hereinafter referred to as the Measures), covering drug network sales management, platform management, supervision and inspection, legal liability and other contents, which came into effect on
December 1 this year.
It is worth noting that for the first time, the new regulations make detailed provisions on online sales of
prescription drugs.
December 1 this year.
It is worth noting that for the first time, the new regulations make detailed provisions on online sales of
prescription drugs.
The interviewed experts believe that the promulgation of the Measures puts forward higher requirements for all parties in the industrial chain, plugs online loopholes such as "first prescription and then medicine", and effectively guarantees the safety
of drug use while improving the accessibility of drugs and supporting the development of emerging formats.
of drug use while improving the accessibility of drugs and supporting the development of emerging formats.
From explicit prohibition to orderly release
The "online sale of prescription drugs" has opened the floodgates and has been explored and brewed
for many years.
for many years.
The Measures for the Supervision and Administration of Online Drug Business (Draft for Solicitation of Comments), published in November 2017, make it clear that prescription drugs may not be sold through the Internet and prescription drug information
must not be displayed through the Internet.
The Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments) issued in February 2018 reiterated
this.
must not be displayed through the Internet.
The Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments) issued in February 2018 reiterated
this.
The turning point came in 2019
.
The new version of the Drug Administration Law, which came into effect in December of that year, proposed that prescription drugs other than vaccines, blood products, narcotic drugs and other drugs could be sold online, laying the legal framework
for the loosening of the "online sale of prescription drugs".
In November 2020, the State Drug Administration issued a new version of the Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments), which mentions that under the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, online sales of prescription drugs are allowed, and prescription transfer reviews are carried out in accordance with relevant requirements, and prescriptions that have been used are electronically marked
.
.
The new version of the Drug Administration Law, which came into effect in December of that year, proposed that prescription drugs other than vaccines, blood products, narcotic drugs and other drugs could be sold online, laying the legal framework
for the loosening of the "online sale of prescription drugs".
In November 2020, the State Drug Administration issued a new version of the Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments), which mentions that under the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, online sales of prescription drugs are allowed, and prescription transfer reviews are carried out in accordance with relevant requirements, and prescriptions that have been used are electronically marked
.
On this basis, the "Measures" stipulate the drugs prohibited from being sold online, including vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, and other drugs that are specially managed by the state, and introduce regulatory rules
for the whole process of information disclosure, prescription sources, pharmaceutical services, drug transportation and other operations.
for the whole process of information disclosure, prescription sources, pharmaceutical services, drug transportation and other operations.
Data show that the size of China's prescription drug market is about 1 trillion yuan, accounting for more than
85% of the market for the terminal consumption of drugs.
Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" of prescription drugs sold online is so prudent stems from the difficulty of ensuring drug safety and delineating the attribution of responsibility, etc
.
"The introduction of the new regulations further clarifies the obligations, legal responsibilities and penalties of pharmaceutical companies and platforms, and provides standards and paths for the development of the industry.
"
85% of the market for the terminal consumption of drugs.
Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" of prescription drugs sold online is so prudent stems from the difficulty of ensuring drug safety and delineating the attribution of responsibility, etc
.
"The introduction of the new regulations further clarifies the obligations, legal responsibilities and penalties of pharmaceutical companies and platforms, and provides standards and paths for the development of the industry.
"
"'Online prescription drugs' are no longer holding the pipa and half covering their faces
.
" Song Hualin, dean of the Law School of Nankai University and director of the Medical and Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps to promote the development of the pharmaceutical industry and build a higher level of open economy
.
.
" Song Hualin, dean of the Law School of Nankai University and director of the Medical and Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps to promote the development of the pharmaceutical industry and build a higher level of open economy
.
Plug the "first medicine behind" loophole
All along, the drug purchase process of each platform has been "before the drug is the rear": after the consumer selects the drug, places the order and pays, the page jumps to the Internet hospital built or cooperated by the platform, conducts online consultation and prescription or reviews the prescription, and the merchant ships
after the review is passed.
Industry insiders point out that this model has actually evolved into "the patient 'self-diagnosis' and the doctor 'on the drug'"
.
after the review is passed.
Industry insiders point out that this model has actually evolved into "the patient 'self-diagnosis' and the doctor 'on the drug'"
.
In accordance with the principle of online and offline consistency, in order to guide online drug purchase to return to "prescription before medicine", the Measures start with drug online retail enterprises and require that information such as prescription drug packaging, labels and other information must not be directly displayed on the main page and home page of prescription drug sales; Before passing the prescription review, information such as instructions must not be displayed, and services related to the purchase of prescription drugs must not be provided
.
In other words, patients cannot choose their own medications based on the information on the page, and must consult and prescribe to obtain more complete information
.
.
In other words, patients cannot choose their own medications based on the information on the page, and must consult and prescribe to obtain more complete information
.
The authenticity and reliability of prescription sources is an important prerequisite for ensuring the safety of
medications.
In this regard, article 9 of the Measures stipulates that the real-name system for online sales of prescription drugs shall be implemented, and drug online retail enterprises shall sign an agreement with the electronic prescription provider, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid the reuse of
prescriptions.
Where a third-party platform undertakes electronic prescriptions, it shall verify the circumstances of the provision of electronic prescriptions and sign an agreement
.
Song Hualin said that through traceability management, the rights and responsibilities
of all parties can be clearly defined.
medications.
In this regard, article 9 of the Measures stipulates that the real-name system for online sales of prescription drugs shall be implemented, and drug online retail enterprises shall sign an agreement with the electronic prescription provider, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid the reuse of
prescriptions.
Where a third-party platform undertakes electronic prescriptions, it shall verify the circumstances of the provision of electronic prescriptions and sign an agreement
.
Song Hualin said that through traceability management, the rights and responsibilities
of all parties can be clearly defined.
In order to achieve traceability of the whole process, the Measures also emphasize that drug online retail enterprises selling prescription drugs should keep records of prescriptions and online pharmacy services for a retention period of not less than 5 years and not less than 1 year
after the expiration of the validity period of the drug.
after the expiration of the validity period of the drug.
In view of the particularity of prescription drugs, the Measures require drug online retail enterprises to perform sufficient risk notification obligations and highlight risk warning information
such as "prescription drugs must be purchased and used under the guidance of pharmacists with prescriptions" under the drug display page.
Before the sale of prescription drugs, consumers shall be fully informed of relevant risk warning information, and consumers shall confirm their knowledge
.
such as "prescription drugs must be purchased and used under the guidance of pharmacists with prescriptions" under the drug display page.
Before the sale of prescription drugs, consumers shall be fully informed of relevant risk warning information, and consumers shall confirm their knowledge
.
The platform should be a good "gatekeeper"
The State Food and Drug Administration pointed out in the policy interpretation that the third-party platform, as the "platform manager", plays a unique role in the drug network sales activities and is a key part
of the healthy development of drug network sales standards.
of the healthy development of drug network sales standards.
In order to consolidate the main responsibility of the platform, the Measures require it to establish a drug quality and safety management agency, equipped with pharmaceutical technicians to undertake drug quality and safety management, and establish and implement management systems
such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reports, and complaint and report handling.
such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reports, and complaint and report handling.
In addition, the Measures also require the platform to sign an agreement with the drug network sales enterprise to clarify the drug quality and safety responsibilities of both parties, stipulate that the platform shall perform the obligations of auditing, inspection and monitoring, and stopping services and reporting when serious illegal acts are found, and strengthen the platform's cooperation obligations
in drug recalls, emergency handling of emergencies, and supervision and inspection.
in drug recalls, emergency handling of emergencies, and supervision and inspection.
"Third-party platforms must be good 'gatekeepers.
'
" Song Hualin said that platform enterprises should examine themselves according to the "Measures", check and fill in the gaps, and improve internal management processes and norms
as soon as possible.
"In the short term, it will increase the compliance cost of the platform, but in the long run, only by moving from disorder to order, can the industry win more room for
development.
"
'
" Song Hualin said that platform enterprises should examine themselves according to the "Measures", check and fill in the gaps, and improve internal management processes and norms
as soon as possible.
"In the short term, it will increase the compliance cost of the platform, but in the long run, only by moving from disorder to order, can the industry win more room for
development.
"
The virtual and cross-regional characteristics of drug network sales have brought new challenges to supervision, and one of the highlights of the new regulations is the "network management network"
.
Require the provincial drug supervision and administration department to establish a drug network sales monitoring platform to achieve data docking with the national platform; Encourage third-party platforms and drug regulatory departments to establish automated information reporting mechanisms
in the form of open data interfaces.
.
Require the provincial drug supervision and administration department to establish a drug network sales monitoring platform to achieve data docking with the national platform; Encourage third-party platforms and drug regulatory departments to establish automated information reporting mechanisms
in the form of open data interfaces.
Song Hualin believes that the security of drug network sales is a complex systematic project, how to construct the online pharmacy service system, how to balance the information display clause and the protection of consumers' right to know, how to solve the data security and privacy protection problems brought about by the real-name system of prescription drugs and the preservation of relevant records, all of the above will affect the effectiveness of the implementation of the new regulations, and it is urgent to introduce supporting measures to define
them more clearly in the future.
them more clearly in the future.
Recently, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Drug Online Sales (hereinafter referred to as the Measures), covering drug network sales management, platform management, supervision and inspection, legal liability and other contents, which came into effect on
December 1 this year.
It is worth noting that for the first time, the new regulations make detailed provisions on online sales of
prescription drugs.
December 1 this year.
It is worth noting that for the first time, the new regulations make detailed provisions on online sales of
prescription drugs.
The interviewed experts believe that the promulgation of the Measures puts forward higher requirements for all parties in the industrial chain, plugs online loopholes such as "first prescription and then medicine", and effectively guarantees the safety
of drug use while improving the accessibility of drugs and supporting the development of emerging formats.
of drug use while improving the accessibility of drugs and supporting the development of emerging formats.
From explicit prohibition to orderly release
From explicit prohibition to orderly release The "online sale of prescription drugs" has opened the floodgates and has been explored and brewed
for many years.
for many years.
The Measures for the Supervision and Administration of Online Drug Business (Draft for Solicitation of Comments), published in November 2017, make it clear that prescription drugs may not be sold through the Internet and prescription drug information
must not be displayed through the Internet.
The Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments) issued in February 2018 reiterated
this.
must not be displayed through the Internet.
The Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments) issued in February 2018 reiterated
this.
The turning point came in 2019
.
The new version of the Drug Administration Law, which came into effect in December of that year, proposed that prescription drugs other than vaccines, blood products, narcotic drugs and other drugs could be sold online, laying the legal framework
for the loosening of the "online sale of prescription drugs".
In November 2020, the State Drug Administration issued a new version of the Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments), which mentions that under the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, online sales of prescription drugs are allowed, and prescription transfer reviews are carried out in accordance with relevant requirements, and prescriptions that have been used are electronically marked
.
.
The new version of the Drug Administration Law, which came into effect in December of that year, proposed that prescription drugs other than vaccines, blood products, narcotic drugs and other drugs could be sold online, laying the legal framework
for the loosening of the "online sale of prescription drugs".
In November 2020, the State Drug Administration issued a new version of the Measures for the Supervision and Administration of Online Sales of Drugs (Draft for Solicitation of Comments), which mentions that under the premise of ensuring the authenticity and reliability of the source of electronic prescriptions, online sales of prescription drugs are allowed, and prescription transfer reviews are carried out in accordance with relevant requirements, and prescriptions that have been used are electronically marked
.
On this basis, the "Measures" stipulate the drugs prohibited from being sold online, including vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, and other drugs that are specially managed by the state, and introduce regulatory rules
for the whole process of information disclosure, prescription sources, pharmaceutical services, drug transportation and other operations.
for the whole process of information disclosure, prescription sources, pharmaceutical services, drug transportation and other operations.
Data show that the size of China's prescription drug market is about 1 trillion yuan, accounting for more than
85% of the market for the terminal consumption of drugs.
Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" of prescription drugs sold online is so prudent stems from the difficulty of ensuring drug safety and delineating the attribution of responsibility, etc
.
"The introduction of the new regulations further clarifies the obligations, legal responsibilities and penalties of pharmaceutical companies and platforms, and provides standards and paths for the development of the industry.
"
Medicine and medicine85% of the market for the terminal consumption of drugs.
Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" of prescription drugs sold online is so prudent stems from the difficulty of ensuring drug safety and delineating the attribution of responsibility, etc
.
"The introduction of the new regulations further clarifies the obligations, legal responsibilities and penalties of pharmaceutical companies and platforms, and provides standards and paths for the development of the industry.
"
"'Online prescription drugs' are no longer holding the pipa and half covering their faces
.
" Song Hualin, dean of the Law School of Nankai University and director of the Medical and Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps to promote the development of the pharmaceutical industry and build a higher level of open economy
.
.
" Song Hualin, dean of the Law School of Nankai University and director of the Medical and Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps to promote the development of the pharmaceutical industry and build a higher level of open economy
.
Plug the "first medicine behind" loophole
Plug the "first medicine behind" loophole All along, the drug purchase process of each platform has been "before the drug is the rear": after the consumer selects the drug, places the order and pays, the page jumps to the Internet hospital built or cooperated by the platform, conducts online consultation and prescription or reviews the prescription, and the merchant ships
after the review is passed.
Industry insiders point out that this model has actually evolved into "the patient 'self-diagnosis' and the doctor 'on the drug'"
.
Hospital Hospitalafter the review is passed.
Industry insiders point out that this model has actually evolved into "the patient 'self-diagnosis' and the doctor 'on the drug'"
.
In accordance with the principle of online and offline consistency, in order to guide online drug purchase to return to "prescription before medicine", the Measures start with drug online retail enterprises and require that information such as prescription drug packaging, labels and other information must not be directly displayed on the main page and home page of prescription drug sales; Before passing the prescription review, information such as instructions must not be displayed, and services related to the purchase of prescription drugs must not be provided
.
In other words, patients cannot choose their own medications based on the information on the page, and must consult and prescribe to obtain more complete information
.
Enterprise enterprise.
In other words, patients cannot choose their own medications based on the information on the page, and must consult and prescribe to obtain more complete information
.
The authenticity and reliability of prescription sources is an important prerequisite for ensuring the safety of
medications.
In this regard, article 9 of the Measures stipulates that the real-name system for online sales of prescription drugs shall be implemented, and drug online retail enterprises shall sign an agreement with the electronic prescription provider, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid the reuse of
prescriptions.
Where a third-party platform undertakes electronic prescriptions, it shall verify the circumstances of the provision of electronic prescriptions and sign an agreement
.
Song Hualin said that through traceability management, the rights and responsibilities
of all parties can be clearly defined.
medications.
In this regard, article 9 of the Measures stipulates that the real-name system for online sales of prescription drugs shall be implemented, and drug online retail enterprises shall sign an agreement with the electronic prescription provider, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid the reuse of
prescriptions.
Where a third-party platform undertakes electronic prescriptions, it shall verify the circumstances of the provision of electronic prescriptions and sign an agreement
.
Song Hualin said that through traceability management, the rights and responsibilities
of all parties can be clearly defined.
In order to achieve traceability of the whole process, the Measures also emphasize that drug online retail enterprises selling prescription drugs should keep records of prescriptions and online pharmacy services for a retention period of not less than 5 years and not less than 1 year
after the expiration of the validity period of the drug.
after the expiration of the validity period of the drug.
In view of the particularity of prescription drugs, the Measures require drug online retail enterprises to perform sufficient risk notification obligations and highlight risk warning information
such as "prescription drugs must be purchased and used under the guidance of pharmacists with prescriptions" under the drug display page.
Before the sale of prescription drugs, consumers shall be fully informed of relevant risk warning information, and consumers shall confirm their knowledge
.
such as "prescription drugs must be purchased and used under the guidance of pharmacists with prescriptions" under the drug display page.
Before the sale of prescription drugs, consumers shall be fully informed of relevant risk warning information, and consumers shall confirm their knowledge
.
The platform should be a good "gatekeeper"
The platform should be a good "gatekeeper" The State Food and Drug Administration pointed out in the policy interpretation that the third-party platform, as the "platform manager", plays a unique role in the drug network sales activities and is a key part
of the healthy development of drug network sales standards.
of the healthy development of drug network sales standards.
In order to consolidate the main responsibility of the platform, the Measures require it to establish a drug quality and safety management agency, equipped with pharmaceutical technicians to undertake drug quality and safety management, and establish and implement management systems
such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reports, and complaint and report handling.
Adverse reactionsAdverse reactionssuch as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reports, and complaint and report handling.
In addition, the Measures also require the platform to sign an agreement with the drug network sales enterprise to clarify the drug quality and safety responsibilities of both parties, stipulate that the platform shall perform the obligations of auditing, inspection and monitoring, and stopping services and reporting when serious illegal acts are found, and strengthen the platform's cooperation obligations
in drug recalls, emergency handling of emergencies, and supervision and inspection.
in drug recalls, emergency handling of emergencies, and supervision and inspection.
"Third-party platforms must be good 'gatekeepers.
'
" Song Hualin said that platform enterprises should examine themselves according to the "Measures", check and fill in the gaps, and improve internal management processes and norms
as soon as possible.
"In the short term, it will increase the compliance cost of the platform, but in the long run, only by moving from disorder to order, can the industry win more room for
development.
"
'
" Song Hualin said that platform enterprises should examine themselves according to the "Measures", check and fill in the gaps, and improve internal management processes and norms
as soon as possible.
"In the short term, it will increase the compliance cost of the platform, but in the long run, only by moving from disorder to order, can the industry win more room for
development.
"
The virtual and cross-regional characteristics of drug network sales have brought new challenges to supervision, and one of the highlights of the new regulations is the "network management network"
.
Require the provincial drug supervision and administration department to establish a drug network sales monitoring platform to achieve data docking with the national platform; Encourage third-party platforms and drug regulatory departments to establish automated information reporting mechanisms
in the form of open data interfaces.
Medicines and medicines.
Require the provincial drug supervision and administration department to establish a drug network sales monitoring platform to achieve data docking with the national platform; Encourage third-party platforms and drug regulatory departments to establish automated information reporting mechanisms
in the form of open data interfaces.
Song Hualin believes that the security of drug network sales is a complex systematic project, how to construct the online pharmacy service system, how to balance the information display clause and the protection of consumers' right to know, how to solve the data security and privacy protection problems brought about by the real-name system of prescription drugs and the preservation of relevant records, all of the above will affect the effectiveness of the implementation of the new regulations, and it is urgent to introduce supporting measures to define
them more clearly in the future.
them more clearly in the future.
