Accelerating the Importation of Imported Drugs | Billions Exported Medical Tourism Market or Change

In the past two years, the pharmaceuticals network reported that the underground drug purchasing chain for cancer drugs has attracted much attention. In addition to the large price difference, the huge demand for imported drugs and innovative drugs has made overseas medical tourism a serious number of cancer patients. One of many options.

According to statistics, in 2016, the number of outbound medical tourists in China exceeded 500,000 tourists, and the average price exceeded 50,000 yuan. The market capacity was nearly 30 billion yuan. In October 2017, the General Administration of Food and Drug Administration issued the “Regulations on the Adjustment of Imported Drug Registration. Decision on Related Matters (hereinafter abbreviated as "Decision") allows simultaneous R&D of imported drugs, optimization of registration procedures, and cancellation of requirements for overseas imports of certain imported drugs.

With the steady advancement of the construction of Hainan Boao Music City's international medical tourism pioneer area, the decentralization of the approval authority for imported medical devices is expected to achieve the simultaneous use of Chinese and foreign drugs.

'China's General Administration of Food and Drugs stipulates that foreign drug imports still require clinical trials. Although it is only required to start from phase III, due to queues, applications, trials, approvals and other links, the speed of imported drugs is still not up to market demand. On June 1st, a well-known economist and financial commentator Guo Fanli said in an interview with a reporter from the 21st Century Business Herald that the introduction of the above "Decision" has also accelerated the speed of examination of imported drugs.

Insiders pointed out that the price difference, the new drug lags behind, weak imitation technology, limited medical coverage is the root cause of emergence of underground cancer drug purchasing industry chain.

In this market, India's generic drugs account for more than half of the country due to its low price. The types are divided into Indian local generic drugs and foreign companies listing two kinds of original research drugs. The generic drugs are mostly oral, and the original drugs are mostly injections. , Indian generic drug lenalidomide (has multiple functions such as anti-tumor, immune regulation and anti-angiogenesis) 10 mg purchase price 300 yuan, 25 mg 700 yuan, the original version of ibutinib listed in India price is 17000 (yuan ) to 19,000 (yuan), while the domestic price is 48,600 yuan/bottle.

From the perspective of the way drugs enter the country, they are divided into direct mail and 'human flesh' consignments. Drugs that can be stored at room temperature will be transported by express delivery. Drugs that require constant temperature refrigerated storage will be put in the incubator and returned manually. When the quantity exceeds the mailing limit or human consignment capacity, Indian medicines are generally responsible for passing customs from Hong Kong and then brought into Shenzhen and sent to the whole country.

In addition, the progress of importing and exporting of imported medicines in China is also lagging behind. According to data from the CFDA, 433 new drugs were approved for listing in the United States from 2001 to 2016, and only 133 were listed in China, accounting for 30.7%. 29 companies listed in China in the past 10 years A typical new drug, the market is 5-7 years later than Europe and the United States.

'Underground cancer drug purchasing industry chain is precisely shows that the current medical environment can not meet people's needs, mainly foreign hard drugs, domestic supply and price problems.' medicine Industry researcher Jiang Ting told reporters in the 21st Century Business Herald that although the review of new drugs has entered the fast lane and the imported drugs have been approved for approval, all common drugs, including anticancer drugs, will have alkaloids with anticancer effects since May 1. The importation of drugs and imported Chinese medicines with actual import tariffs to zero has been introduced. However, due to the final results of the implementation of the policy, it will take time. In the short term, the underground cancer drug purchasing industry chain may continue to exist, but in the medium term, Medicine ', 'affordable' will be gradually implemented.

The price difference and the lagging effect of imported drugs on the market has created a huge demand for drugs that have not yet been met by critical patients such as cancer. Overseas medical tourism and super hospitals have become the first choice for these patients.

Regarding the sustained heat of overseas medical tourism, Jiang Ting told reporters that it was mainly because the local medical and tourism supplies could not satisfy people's timeliness of medical treatment, reasonable prices and medical service requirements.

For medical tourism destinations, such as Thailand and India, they have locally-accepted high-quality medical services and have heterogeneous tourism and cultural resources. They can use their excellent tourism resources to help medical tourism.

Guo Fanli admitted frankly that, in foreign countries, medical tourism has become common practice, and the value of global medical tourism is nearly 700 billion US dollars. 'The current medical tourism is subject to medical examinations and the beauty journey is more common. The hot medical tourism market is due to the lack of medical resources in our country and it is difficult for residents to The country enjoys an adequate medical experience and has to go abroad to obtain more and better medical resources. At the same time, due to the fact that some people have the idea of ​​foreign moons and blindly worship foreign medical treatments, they choose to enjoy foreign medical treatment while outbound tourism. Treatment in the country. '

In order to cater to the needs of the market, the concept of a super hospital has also emerged in the country. In 2013, the State Council promulgated the “Approval for the Establishment of Hainan Boao Music City International Medical Tourism Pioneer District”. On March 31 this year, the government and private The Boao Super Hospital opened with capital and 8 academicians of the Chinese Academy of Engineering are strong Join , and become the only hospital that currently enjoys substantial dividends on this policy; On April 8, the State Council issued the “Suspension of Implementation of the International Medical Tourism Pilot Area in Boao Music City, Hainan Province. <medical instruments Supervision and Management Regulations > Decision on Relevant Provisions, formally delegating the approval authority for imported medical devices to Hainan Province.

CITIC Securities strengthens team report and points out that with the completion of Hainan Boao Music City international tourism pioneer area, unlisted imports drug In the predecessor area will also speed up the listing, and gradually achieve the simultaneous use of Chinese and foreign medicines.

The recent rapid development of Hainan Boao Music City's international medical tourism pioneer area is only a microcosm of the policy level to promote accreditation of innovative drug review and approval.

On May 23, the State Food and Drug Administration and the National Health Supervision Committee jointly issued the “Notification on Optimizing the Registration and Approval of Drugs (No. 23 of 2018)”, which further optimized the priority evaluation and approval system and improved innovative drugs. In particular, the effectiveness of overseas innovative drug marketing approvals, the announcement pointed out that 'for the prevention and treatment of overseas listed diseases that are seriously life-threatening and have no effective treatment means and rare diseases, applicants for registration of imported drugs have submitted that if there are no ethnic differences, they can submit The clinical trial data obtained overseas are applied directly for registration of drug listing.'

"Overall, the approval of imported medicines in China continues to increase." Jiang Ting explained, 'For a simple example, at the end of April this year, the Nine Human Papilloma Virus vaccine was approved for listing. Only from the submission of applications to the listing approved In 8 days, the speed of approval was unprecedented in the history of drug approvals in China. In contrast, tetravalent vaccines took ten years from application to listing. From 10 to 8 days, the speed of approval of imported drugs can be described as qualitative. Leap.'

For Super hospital With regard to the future development trend of outbound medical tourism, Guo Fanli believes that after the implementation of new rules for multiple policy adjustments across the country, it means that the predecessor area of ​​Boao City and the country will implement the same policy, and the first-mover advantage will be reduced. 'At the same time, because it can be submitted The clinical trial data obtained from abroad directly apply for registration of pharmaceuticals. The speed of import of imported drugs will be faster. Some people who choose to exit the country may choose to remain in the country waiting for the listing of new drugs, resulting in changes in the composition of outbound medical tourism personnel and outbound medical tourism. The pattern will change. '