How can "online sales prescription medicine" open the gate?

[Original title] Ensure that the source of the prescription is true and reliable, highlights the risk warning information, and it must not be sold before the prescription review ...

How can "online sales prescription medicine" open the gate?

Recently, the State Administration of Market Supervision issued the "Measures for the Supervision and Administration of Drug Network Sales" (hereinafter referred to as the "Measures"), covering the management of drug network sales management, platform management, supervision and inspection, legal responsibility, etc. It will be implemented from December 1 this year. It is worth noting that the new regulations make detailed provisions on the sales of prescription drug network for the first time.

Interviewed experts believe that the introduction of the "Measures" has put forward higher requirements on all parties on the industrial chain, blocking online vulnerabilities such as "first medicine", while improving the availability of medicines and supporting the development of emerging formats. Safe medicine safety.

From the Ming Dynasty to the orderly letting go

The "Internet Sales Prescription Pharmaceuticals" opened, and after many years of exploration and brewing.

The "Measures for the Supervision and Administration of Online Drug Management (Draft for Comment)" announced in November 2017 clearly stated that it is not allowed to use the online sales prescription medicine, and to display prescription information information through the Internet. The "Measures for the Supervision and Administration of Drug Network Sales (Draft for Opinions)" released in February 2018 reiterated.

The turning point appeared in 2019. The new version of the drug management law implemented in December of that year proposed that prescription drugs other than drugs such as vaccines, blood products, anesthesia drugs can be sold on the Internet, and laid a legal framework for the "online sales prescription drug" loosening. In November 2020, the State Drug Administration released the new version of the "Measures for the Supervision and Management of Drug Network Sales (Draft for Opinions)", which mentioned that under the premise of ensuring the authenticity and reliability of the electronic prescription, the network sales prescription drugs were allowed to be allowed to follow, and according to the Relevant requirements are reviewed by prescription agent, and electronic marking the prescriptions used in use.

On this basis, this "Measures" stipulates that drugs banned online, including vaccines, blood products, anesthesia drugs, psychotropic drugs, and medical toxic drugs, and are specially managed by countries. Pharmaceutical services, pharmaceutical transportation and other operations have launched regulatory rules.

Data show that the size of the prescription drug market in my country is around 1 trillion yuan, accounting for more than 85%of the pharmaceutical terminal consumer market. Shi Lichen, an expert in pharmaceutical strategic planning, told reporters that the reason why the road of "loosening" for online sales prescription medicines is so cautious from the difficulty of ensuring the safety of medication and delineation of responsibility. The platform's obligations, legal responsibilities and punishment methods provide standards and paths for industry development. "

"'Net sales prescription medicine' no longer hugs the pipa." Song Hualin, Dean of Nankai University Law School and Director of the Medical Health Law Research Center, told reporters that this not only meets the demand for online drug purchase, but also helps promote the development of the pharmaceutical industry , Construct a higher level of open economy.

Block the loopholes of "first medicine and then"

For a long time, the purchase process of various platforms is mostly "first medicine and then": after consumers choose drugs and pay for payment, the page jumps to the platform self -built or cooperative Internet hospitals on the platform to conduct online consultation or review prescription prescriptions After reviewing, the merchant shipped. Industry insiders pointed out that this model has actually evolved into "patients' self -diagnosis' and doctors'" medicines' diseases'. "

In accordance with the principle of online and offline consistency, in order to guide online purchase of drugs to return to the "first medicine", the "Measures" starts with the pharmaceutical network retail enterprise, and requires information on the homepage of prescription drug sales and the homepage. Before the prescription review, no information such as the manual shall be displayed, and the relevant services of the prescription medicine purchase shall not be provided. In other words, patients cannot choose medicines according to the page information, and they must obtain more complete information after consultation.

The true and reliable source of the prescription source is an important prerequisite for ensuring the safety of medication. In this regard, Article 9 of the Measures stipulates that the online sales prescription medicine implements a real -name system. The pharmaceutical network retail enterprise shall sign an agreement with the electronic prescription provision of the unit, and strictly conduct the prescription review and deployment in accordance with relevant regulations. Repeated use of prescriptions. If a third -party platform undertakes electronic prescriptions, the situation of the unit provided by the electronics prescription shall verify 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 the full process traceable, the Measures also emphasized that the drug network retail enterprises of the sales prescription medicine should save records, online pharmacy services and other records. The preservation period is not less than 5 years, and no less than one year after the expiration of the drug is valid.

In view of the particularity of prescription drugs, the "Measures" requires pharmaceutical network retail enterprises to fulfill their full risk notification obligations, and highlights the risk warning information such as "prescription drugs must purchase and use under the guidance of pharmacists under the guidance of pharmacists" under the drug display page. Before the preparation of prescription drugs, it shall fully inform consumers to fully inform the relevant risk warning information and confirm the knowledge by consumers.

The platform should be good

The State Drug Administration pointed out in the policy interpretation that third -party platforms as "platform managers" play a unique role in pharmaceutical network sales activities, which is a key part of the healthy development of pharmaceutical network sales.

In order to compact the main responsibility of the platform, the "Measures" requires it to establish a drug quality and safety management institution, equipped with pharmacy and technical personnel to undertake drug quality and safety management, establish and implement drug quality and safety, drug information display, prescription review, prescription drug real -name purchase, pharmaceutical distribution, pharmaceutical distribution , Sales record of transaction records, adverse reactions reports, complaint report handling and other management systems. In addition, the "Measures" also requires the platform to sign an agreement with the drug network sales enterprise to clarify the responsibility of drug quality and safety of both parties. It stipulates that the platform shall fulfill the obligations such as review, inspection and monitoring, and discovering serious violations of services and reports. Emergency disposal of emergencies and coordination obligations in supervision and inspection.

"Third -party platforms must be a good 'watchman'." Song Huarin said that platform companies should self -examine, check the lack of missing and make up for the "Measures", and improve the internal management process and specifications as soon as possible. "In the short term, the compliance cost of the platform will be increased, but in the long run, only from disorder to orderly, the industry can win greater development space."

The virtuality and cross -geographical characteristics of drug network sales have brought new challenges to supervision. One of the highlights of the new regulations lies in the "network management network". It is required that the provincial pharmaceutical supervision and management department establishes the sales monitoring platform to achieve data docking with the national platform; encourages third -party platforms and drug supervision and management departments to establish an automated information reporting mechanism in forms such as open data interfaces.

Song Hualin believes that the safety of drug network sales is a complex systematic engineering. How to build an online pharmaceutical service system, how to balance the right to know the right of information and protect consumers, the real -name system and preservation related records of the prescription drug How to solve the problem of privacy protection will affect the effectiveness of the new rules. In the future, it is urgent to launch supporting measures for clearer definition.

Source 丨 Workers' Daily (copyright belongs to the original author, if there is any infringement, please contact and delete)

- END -