China'S Breakthrough In Relaxing Hainan'S Medical And Health Market Access

On April 8, with the consent of the CPC Central Committee and the State Council, the national development and Reform Commission and the Ministry of Commerce held a special press conference to publicly release the opinions on some special measures to support the construction of Hainan free trade port and relax market access (hereinafter referred to as the opinions), and launched 22 innovative policies and measures in five major fields, including medical treatment and culture.

At the press conference, Xu Shanchang, director of the structural reform department of the national development and Reform Commission, pointed out to reporters of the 21st century economic report that this is another major policy dividend supporting the construction of Hainan free trade port, a breakthrough exploration of the market access policy mechanism of Hainan and even the whole country, and a new institutional arrangement.

This time, the opinion involves a total of 7 measures in the medical field, with the most content, among which online sales of prescription drugs have become one of the focuses of the industry. According to the opinion, we will support the development of Internet prescription drug sales, and will establish Hainan e-prescription Center (to provide third-party information services for prescription drug sales agencies) in the international medical tourism Pioneer Area of Le Cheng, Boao, Hainan. All prescription drugs listed in China are allowed to rely on the e-prescription center, except for the drugs specifically under special management specified in the National Drug Administration Law Internet sales will not be subject to separate approval. This means that the online sales of prescription drugs, which have been debated but have been brewing for many years, have finally opened up and will take the lead in Lecheng pilot area. Industry insiders believe that with the implementation of Lecheng pilot zone and the trial implementation of a set of effective supervision and operation experience, online prescription drugs may be launched nationwide in the future.

"The e-prescription platform is the result of the joint participation of all parties in the society. It is not a simple government function. We hope that the government can also learn from the opinions and wisdom of all parties to create a plastic, real platform that can make privacy information more secure and more convenient to use at the same time." On April 12, Gu Gang, director of the Bureau of international medical tourism in Boao Lecheng, said in an interview with 21st century economic reporter that this platform needs all-round participation.

Breakthrough exploration in medical field

It is understood that the national unified implementation of the "negative list of market access (2020 Edition)" has identified 123 prohibited or restricted market access items in 21 fields.

In order to support the construction of Hainan free trade port, a number of special measures to relax market access are put forward. Those who have access conditions in other areas of China can be admitted unconditionally in Hainan; those who are prohibited from access in other areas of China can be admitted with conditions or even without conditions in Hainan.

In fact, this is also the basis for Hainan to build an international tourism consumption center, an international medical tourism Pioneer Area of Boao Lecheng, and an international education innovation Island, etc., making medical and health, culture, education and other service industries as the key points of relaxing market access.

Li Dongyu, Deputy Secretary General of Hainan provincial government, also pointed out that Hainan will support Boao Le City from three aspects, namely, ensuring project construction, supporting policies and enterprise service.

For "Innovating the market access mode in the field of medicine and health", the opinions put forward seven measures, respectively: supporting the sales of prescription drugs on the Internet, supporting the innovative development of high-end medical equipment made in Hainan, increasing the support for drug market access, comprehensively relaxing the access restrictions of cro, supporting the development of high-end medical and aesthetic industry in Hainan, and optimizing the whole field of transplant science Access and development environment, the establishment of Hainan Medical and health industry development mixed reform fund.

Some people believe that this policy will open 10 billion, even 100 billion, trillion level industrial clusters for Hainan, which has great significance for promoting pharmaceutical innovation.

For the pharmaceutical industry, new drugs entering the hospital and opening the last kilometer are the key and driving force for pharmaceutical enterprises to innovate.

The "opinions" put forward that for pharmaceutical enterprises registered in Hainan, which have completed phase I - III clinical trials and obtained marketing license in China, medical institutions with corresponding conditions in Hainan are encouraged to use them directly according to the principle of "advancing with approval", and relevant departments shall not set additional market access requirements.

In fact, there has always been a saying that innovative drugs are "dying for life". The success rate of new drug research and development is less than 10%. The average cost of each new drug research and development is 1.5 billion to 2 billion US dollars, and the research and development time of each new drug needs more than 10 years.

In an interview with the 21st century economic report reporter, Ding lieming, chairman of Beida pharmaceutical, pointed out that an innovative drug needs to enter the hospital, which requires a lot of processes, and must go through provincial bidding. However, the bidding cycle of each province is different. If it is unfortunate to miss the bidding time window, it needs to wait longer.

With the support of this policy, innovative drugs in Hainan can quickly enter the terminal market and benefit more patients according to the principle of "follow the batch".

In this regard, Jiang Yi, deputy director of the Department of restructuring of the national development and Reform Commission, said at a press conference that encouraging the direct use of innovative drugs with marketing permission in Hainan is the last threshold for innovative drugs to enter the market, which not only ensures Hainan patients to use innovative drugs as soon as possible, but also further encourages excellent pharmaceutical enterprises to strengthen research and development.

For example, in July last year, zaiding medicine introduced repatinib, an innovative product for the treatment of gastrointestinal stromal tumors, in Lecheng pilot area. This is the first to realize three "first" products in the pilot area, the first one specially approved to be taken out of the pilot area for clinical use in urgent need; the first new drug to be used simultaneously by patients in China and the world; and the first landing of management project for patients on outlying islands.

After nine months of rapatinib landing in Hainan, more than 40 patients have submitted applications. After strict medical and ethical review, nearly 20 patients have been benefited. On March 31, this year, the State Food and Drug Administration approved the application of repatinib in China. At present, zaiding is stepping up the process of listing and landing, which also means that this new drug will soon move from Hainan to the whole country.

According to pan Lu, vice president of zaiding Pharmaceutical Co., Ltd., innovative pharmaceutical companies including zaiding Pharmaceutical Co., Ltd. can settle down in Lecheng. Its "first try" policy means that innovative products can be quickly launched in China, which can greatly accelerate the process of commercialization, so that more domestic doctors can contact with international advanced technology and accumulate clinical experience in advance before being approved, so that future products will be officially approved for listing After the market penetration will be very helpful.

The Opinions also pointed out that more support should be given to drug market access. In Xu Shanchang's view, "this measure has opened the last threshold for innovative drugs to enter the market, which not only guarantees Hainan patients to use innovative drugs as soon as possible, but also further encourages excellent pharmaceutical enterprises to strengthen research and development."

Will the nationwide ban on online prescription drugs be lifted soon?

The establishment of Hainan e-prescription center is the focus of the opinions, and also a major dividend measure to facilitate people's livelihood. Xu Shanchang pointed out that the measures to carry out Internet prescription drug sales are of breakthrough significance.

The opinions pointed out that it supported the development of Internet prescription drug sales. Except for the drugs under special management specified in the National Drug Administration Law, all prescription drugs can be sold on the Internet through the electronic prescription center without further approval.

According to the newly revised "Drug Administration Law", the scope of drug online prohibition was defined, but the online sales of prescription drugs were not directly prohibited. However, it is still unclear whether to open the online sales of prescription drugs. The introduction of the "opinions" above, in the view of the industry, releases the signal that the online sales of prescriptions will soon be implemented.

The establishment of Hainan e-prescription center in Boao Lecheng to provide third-party information services for prescription drug sales agencies to conduct Internet sales is an important breakthrough in the prescription drug circulation management system and the first independent construction and operation of the electronic prescription center in China, which means that Hainan has broken through the neck link of Internet sales of prescription drugs.

According to some data, the scale of China's prescription drug market is about 1 trillion yuan, and it is expected that 30% - 40% of the market share will turn online. Although there is a huge market demand, there has been no breakthrough before. What is the biggest difficulty in online sales of prescription drugs?

Gu Gang explained to the 21st century economic reporter that the biggest difficulty is the whole process supervision. "First, it is necessary to determine who will prescribe the prescription and who has the qualification to prescribe it; second, whether the patient and the prescription are completely matched; third, whether the safety of the prescription can be guaranteed in circulation; fourth, whether it can truly meet the needs of patients when taking it at the end. The core issue is the protection of data privacy. "

Gu Gang disclosed that Lecheng e-prescription platform is the result of the joint participation of all parties in the society, and it is also an embryonic form. It ensures security through traceability system and blockchain technology.

"Including the small program we cooperate with Tencent to ensure that each of our drugs is taken by patients themselves. The use of our licensed medicine and equipment is still very small. If it rises to the e-prescription platform, it will be a very large amount. In fact, it will be equivalent to a comeback. Therefore, it is necessary to consult and study multiple government departments and market entities, including the transportation and storage of the whole cold chain. " Gu Gang said that the follow-up work will be carried out in accordance with the established "14th five year plan".

Liu Zhefeng, deputy director of the Administration Bureau of Boao Lecheng International Medical Tourism pilot area, further analyzed to the 21st century economic reporter that Lecheng has its own advantages in ensuring drug safety. Lecheng can use licensed medical equipment, which is the result of the joint efforts of the health commission and the drug administration. The responsibilities of the two departments overlap but are strictly differentiated. Today, there has been seamless convergence in Lecheng. Lecheng has set up the first medical drug regulatory agency jointly established by the health department and the drug supervision department in China, and innovated and implemented the "health + drug" integrated supervision mode, which is more conducive to the follow-up Internet supervision of electronic prescription drugs.

"In the future, through the superposition of a series of policies of Lecheng, the functions of the drug administration and the health commission can be better connected; and the electronic tracking can be realized through the traceability management platform, so that the information after the prescription drug is issued and used can be effectively registered, so as to carry out pre -, in-process and post-processing supervision." Liu Zhefeng pointed out.

In Gu Gang's view, the e-prescription center is a platform, which does not necessarily need to sell drugs. It connects with internet hospitals, medical institutions, and various prescription drug sales platforms.

Gu Gang said that the next step for the e-prescription center is to graft in more Internet hospitals and public hospital resources, so that hospitals and doctors can prescribe prescriptions online. As a platform for supervision, traceability and demonstration, the e-prescription center can demonstrate what kind of doctors are qualified to issue electronic prescriptions, whether the drugs are genuine or not, and what the circulation of drugs depends on Whether the enterprises and drugs are really in the hands of the patients who apply.

It is also understood that the current service radiation in Hainan, that is, the electronic prescription is issued in Hainan. However, if the patient is issued in Beijing through an Internet hospital registered in Hainan, and the drugs are sent from Hainan, then the radiation scope is not only Hainan.

"Therefore, although it is the first trial in Hainan, we will promote the research on the specific implementation path and means. If the pilot project is completed, Hainan e-prescription center may be upgraded to a national one, or other regions will copy the Lecheng model, which requires top-level design at the national level in the future. " Liu Zhefeng pointed out.

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