Recently, the author learned from the official website of the National Development and Reform Commission that the 2018 version of the "Negative Market Access List" was officially released, and both prescription drugs and special medical foods were listed on the list, which was classified as "prohibited access", which was developed by the National Development and Reform Commission and Commerce. After the official introduction of the new regulations, the pharmacy pharmacy, online pharmacies and other pharmaceutical and special medical food enterprises will be reshuffled. How do these production and management companies break through? Is it a change or a transformation? Is it restricted for Internet hospitals to sell prescription drugs? Discuss and read the extraneous sounds behind the policy documents. . . . . .
The online sales section of the pharmaceutical and food industry was "partially banned"
In the official website of the National Development and Reform Commission, the author saw from the "Negative List of Market Access (2018 Edition)" that in the "prohibition of access", "prohibition of illegal Internet-related business activities" clearly stipulates: "Special medical use formulas" Certain full-nutrition formula foods may not be traded online; pharmaceutical production and business enterprises may not directly sell prescription drugs to the public by means of mailing or internet transactions in violation of regulations."
This signal was interpreted by the industry as: Special medical food entered the "all-network ban". At the same time, some insiders believe that “the whole network ban†may be temporary, because in the “Description of measures forbidden accessâ€, special medical food and prescription drugs are added with the special symbol “★â€, the information is The official interpretation is “the establishment of a prohibition based on the lack of effective level to allow temporary retentionâ€.
When combing relevant information, the author found that Xu Shanchang, director of the National Development and Reform Commission's Department of Physical Reform, had publicly stated to the media reporters at the press conference that the market entities should not enter the ban, and the administrative agencies would not approve them. Such a powerful "two nos" voice has a permanent ban on the whole network. Moreover, in response to a question from Xinhua News Agency reporters on the "Principles of Principles", Director Xu Shanchang elaborated on the principle of the rule of law as the first point. He also emphasized that the individual establishments are strictly based on the effectiveness level and are strictly prudent on these matters. The assessment is indeed a management measure that is temporarily included in the list, and these measures are marked in the form of a ★ and the legislative process is required to be improved as soon as possible."
Opportunities in the Slit: Online pharmacies and Internet hospitals face new challenges!
The author saw in the "Permitted Access Class" item in the 2018 version of "Negative Access List": "Licenses in the Internet Market Access Prohibition Catalogue" clearly stipulates that: Internet information transmission and information services, and in the "Description of Licensed Access Measures", it is clearly required: "The Internet information services such as drugs and medical devices shall be subject to the examination and approval of the relevant competent authorities in accordance with laws, administrative regulations and relevant state regulations. Before applying for a business license or fulfilling the formalities for filing, it shall be examined and approved by the relevant competent department according to law. The website that intends to provide Internet drug information services shall, in accordance with the principle of territorial supervision and management, apply to the provinces, autonomous regions, and municipalities directly under the Central Government (food) where the website is hosted. The supervisory authority submits an application and obtains the qualification to provide Internet drug information services after approval."
To put it simply, it is necessary to engage in Internet and information services for medicines and medical devices, and obtain the permission of the relevant competent authorities to obtain the qualification of Internet drug information services. However, even if the license is approved, there is Internet drug information service qualification and Internet drug transaction service qualification, or it is not possible to directly sell prescription drugs to the public by mail, Internet transaction, etc., because "pharmaceutical production and operation enterprises must not violate the regulations by mail, Internet transactions, etc. The way to sell prescription drugs directly to the public is a prohibited entry category for the Negative List of Market Access (2018 Edition).
The relevant person in charge of Shandong Ruyi New Extraordinary Pharmacy told the author that according to the new regulations of “Negative Listâ€, the National Development and Reform Commission should focus on “violation of regulations†and “direct salesâ€. Currently, there are qualified pharmaceutical companies that have opened online pharmacies. In fact, it is a registration reservation system that is performed by a professional pharmacist to verify the condition of the patient and then let the patient or the patient's family upload the prescription before selling. With the rise of Internet hospitals, it is also recognized that patients prescribe electronic prescriptions through Internet hospitals or Internet clinics.
Speaking of Internet hospitals, the author believes that after the implementation of the new regulations, Internet hospitals should only charge for medical treatment and prescription fees, while the income from prescription medical expenses will be limited. This is the lifeline of limited performance of Internet hospitals.
In response to this point of view, the relevant person in charge of the Miao Ruyi National Medical Center believes that with the improvement and maturity of the medical separation policy, the medical and pharmaceutical drugs are gradually separated. Therefore, from this perspective, the Internet hospital cannot be regarded as a pharmaceutical business enterprise in a strict sense. He said that their future development direction will also work toward Internet hospitals, so he said that the new regulations issued by the National Development and Reform Commission and the Ministry of Commerce will have a serious impact on Internet hospitals. He is still optimistic. What do you think about this? (text / often talented)
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