Industry call: Drug test data protection system as soon as possible to "brighten" the innovation background

Recently, the closely watched two national conferences successfully closedAccording to the People's Daily, delegates made 9,180 recommendations during this year's congress, an increase of 1,020 from last yearRecommendations covering the areas of science, education, culture and health, development planning and construction projects, social and public affairs accounted for more than half of the totalspecific to the medical and health sector, E drug managers noted that many people in the industry called for drug testing data protection system can be implemented as soon as possible, and gave relevant optimization recommendationsbecause drugs have unique properties, related to social stability and national security and healthThe safety and efficacy of pharmaceuticals have always been the focus of regulatory efforts in the pharmaceutical industryWhether from preclinical or clinical studies, considerable trial data is generated, and this series of trial data is a necessary condition for drugs to be registered and marketedIn the middle, it will cost pharmaceutical companies and research and development personnel a lot of human and material costs, with potential commercial valueand the data protection system is the protection of the experimental data obtained by the original research plant to demonstrate the safety and efficacy of the new drug, and it does not allow generic applications submitted on the basis of original research data to be approved for listing for a certain period of timeData protection and patent protection are separate and parallel protection systems, and data protection may be the only protection that can be obtained in the absence of patentsthe above, the object of experimental data protection emphasizes innovation, such as innovative drugs, innovative biological products, etcChina has become the world's second largest pharmaceutical market, as far as product structure is concerned, although China is still mainly generic drugs, but in recent years, under the guidance of the state to encourage innovation, China's pharmaceutical industry, the rapid rise of local innovation force, with foreign advanced markets in parallel with the opportunity to appearAccording to statistics, the number of applications for registration of innovative drugs in China reached 222 in 2018, compared with 86 in 2013, an increase of 158%Of the 51 new drugs approved by the State Drug Administration in 2019, 12 came from local companies, accounting for 23.5 percentAlthough there is still a significant gap with multinational drug companies, the figure is much higher than it was two years agobehind the rise of this local innovation force, it is also necessary to implement the data protection system of the relevant drug testas as soon as possible, in order to further strengthen the protection of intellectual property rights of innovative drugs, and inject a dose of "strong heart needle" into the whole pharmaceutical innovationthe head of the intellectual property department of an innovative pharmaceutical company in China, told E pharmaceutical managers that obtaining adequate market returns is the fundamental driving force for the continuous innovation of pharmaceutical enterprises, and that a sound experimental data protection system and intellectual property protection system is an important guarantee for enterprises to obtain market returns China's innovative drugs are difficult to obtain good economic returns in the existing patent period According to the general market earnings model of innovative drugs, sales need to go through 5 to 8 years of rapid growth in order to enter a stable earnings period in fact, it is not just the more innovative pharmaceutical companies that are calling for the implementation of the pilot data protection system E drug managers understand that the National People's Congress representative, Hengrui Group Chairman Sun Feng also proposed at this year's two sessions to establish a drug data protection system and expand the protection of objects, he said: "The current patent law on strengthening the protection of intellectual property rights in pharmaceuticals has been revised, as another important protection measure for new drug research and development enterprises - data protection is also urgently needed." This system has been in place for decades in the United States, Europe and Japan, allowing new drugs that cannot be protected by patents for special reasons to be protected in another form of protection, giving innovative drug companies the impetus to develop and promote the development of innovative drugs "
before joining WTO, China has no provisions on drug test data protection, after joining the WTO, because China needs to fulfill the obligations of the WTO, began to assume the obligation to protect the test data, and soon completed the TRIPS Agreement (Trade-Related Property Rights Agreement) related content of the domestic law transformation, which is mainly reflected in the Drug Administration Law Implementation Regulations Article 35 The first paragraph of the article provides for the object of protection and the duration of protection for six years, and the second provides for two exceptions to the disclosure of test data The contents of article 20 of the Measures for the Administration of Drug Registration are broadly similar to those of article 35, paragraph 2, of the Regulations on the Implementation of the Drug Administration Act, and also provide for a six-year data protection period 2017, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices (i.e., No 42 of the Two Offices) to promote drug innovation and the development of generic drugs, and to improve the data protection system for drug testing On October 23 of the same year, the CFDA issued the Drug Registration Management Measures (Amendment) which, for the first time, incorporated the concept of "data protection" in the previous version, and specified that the relevant authorities would protect the self-made and undisclosed test data and other data submitted by the applicant concerned The data protection period shall commence at the date of the approval of the drug for the market, and during the data protection period, the drug review authority will no longer approve other applicants' applications for the same variety of listing permits, except with the consent of the applicant who has obtained the listing license or the other applicant's own data The specific management of data protection will be developed separately April 25, 2018, the State Drug Administration publicly solicited comments on the Measures for the Implementation of Data Protection for Drug Trials (Provisional) (Draft for Comments), which can be seen as a further extension of the specific measures for the management of data protection in the 2017 Measures for the Administration of Drug Registration (Revised) but has not yet been implemented January 15, 2020, the latest edition of the Measures for the Administration of Drug Registration was approved by the State Administration of Market Supervision and Administration and will come into effect on July 1, 2020 Unfortunately, the content of data protection for drug testing is not mentioned in the new Version of the Measures during the two sessions, Hengrui Group Chairman Sun Feng, Beida PharmaceuticalS Chairman Ding Listing and other deputies called on China's drug test data protection system should be combined with national conditions, and gave their own recommendations in the draft of the Draft for the Implementation of Data Protection for Drug Trials (Temporary), the list of innovative drugs, innovative therapeutic biological products, rare disease treatment drugs, children's-specific drugs and patent challenges were listed in the draft for comments on the implementation of the Drug Test Data Protection (Provisional) draft This will make some of the drug types that require complex clinical trials and are not adequately protected by the huge investment in research and development For example, new modified drugs (i.e., Class 2 drugs) also need to be approved for market, and according to the Chemical Registration classification reform work programme, in addition to the new indications of known active ingredients, the rest of the improved new drugs need to have "obvious clinical advantages" to be approved, while new indications require more complete clinical trials the essence of drug test data protection is to give a certain amount of time to protect companies that conduct clinical trials at great time and economic costs from free-riding by other generic sacrovane companies using their data directly to declare From this concept, as long as a human clinical trial is conducted, it should be protected, as mentioned earlier, the new modified drug clearly requires human clinical trials In the absence of data protection for the new drug, generics of modified new drugs only need to be copied using their clinical trial data to declare imitations, which is clearly unfair to the first developer It is proposed to amend the Measures for the Implementation of Data Protection in Drug Trials (Temporary) to include protection for new modified drugs in the protection object, to give data protection to general lying-in-the-new drugs for three years, and to give the new indications section of the drug for four years Ding listed the proposal, from the point of view of encouraging the development of innovative drugs in China, to further extend the protection time of drug test data Drawing on the experience of Europe, an eight-year data exclusive period plus a 2-year market exclusivity period is available for all innovative drugs (chemical and bio-innovative drugs) and an additional one year can be extended if a new indication of significant clinical benefits is approved in the eight-year data monopoly period Or consider learning from the U.S experience to provide an independent data protection period for new clinical explorations such as new indications, and extend the data protection period of bio-innovative drugs to 12 years to bring our data protection system into line with international advanced experience original title: Industry call: Drug test data protection system as soon as possible to land "brighten" the innovation background color