Comparison, duration of drug data protection in different countries

The drug data protection system is to protect the intellectual property rights of the data and information submitted in the process of drug registration By granting the original manufacturer a certain period of market monopoly, it effectively protects the interests of the original manufacturer and encourages its enthusiasm for research and development Drug data protection system has a good positive incentive effect on innovative drug research and development Each country has formulated different drug data protection laws and regulations according to its own national conditions In the trips (trade related intellectual property rights agreement) signed when China joined the WTO in 2001, Article 39 (3) stipulates that when a member requests to submit undisclosed test data or other data as a condition for approving the listing of pharmaceutical or agricultural chemical products with new chemical composition, if the data is obtained through efforts and is original, the member shall protect the data According to, in case of improper commercial use In 2017 and 2018, China issued "relevant policies on encouraging innovation of pharmaceutical medical devices to protect the rights and interests of innovators (Draft for comments)" and "measures for the implementation of drug test data protection (Provisional) (Draft for comments)", respectively, with detailed provisions on drug data protection issues This paper compares and analyzes the duration of drug data protection in different countries, hoping to help you The United States is the first country to establish a drug data protection system The drug data protection in the United States came into being before the TRIPS Agreement, and has established a relatively perfect legal system, which is also the country with the most classification of data protection At present, the United States is the most developed country in the pharmaceutical industry Its developed pharmaceutical industry is closely related to the continuous improvement of the pharmaceutical industry policy in the long-term practice process, which is worth learning from and learning from China Drug data protection in EU has experienced several stages of development, but at present, data protection is implemented for drugs according to the situation in Table 2 In EU, drug registration applicants do not need to apply for special drug data protection After the approval of marketing license, qualified drugs naturally get data protection The rapid rise of Japan's drug data protection industry is inseparable from its drug protection system Japan drug protection system provides data protection for new drugs, rare diseases, etc within a certain time limit, as shown in Table 3 China drug data protection China's drug data protection legislation started from the regulations for the implementation of the drug administration law of the people's Republic of China issued in 2002, Article 35 of which stipulates that the State shall protect the test data and other data obtained by itself and not disclosed submitted by the manufacturer or seller who has obtained the license to produce or sell drugs with new chemical ingredients In China, the current protection period is not divided into different protection periods according to different types of drugs, but a unified protection period of 6 years However, in May 2017, the relevant policies (Draft for comments) on encouraging innovation of pharmaceutical medical devices to protect the rights and interests of innovators were released, as shown in Table 4 The protection period is divided according to different types of drugs However, in May 2018, measures for the implementation of drug test data protection (Provisional) (Draft for comments) were issued and some adjustments were made, as shown in Table 5 By comparing the two drafts published in different periods before and after Table 4 and table 5, we can find that the latest draft stipulates that the listed innovative therapeutic biological products can obtain data protection for up to 12 years, which is the same as that in the United States In terms of rare diseases and special drugs for children, they were also adjusted to 6 years, reducing the requirement of innovation However, the successful drugs are not explained in detail, and the protection time is not regulated It is estimated that the drug patent link system and other policies need to be improved before they are determined According to whether the clinical trials are carried out in China and whether they are listed in China at the same time, the data protection of new drugs or new biological products is classified in detail The regulation is conducive to accelerating the internationalization process of drug research and development in China and encouraging new drugs to be listed in China faster At the same time, from the process of data protection, the latest solicitation of opinions stipulates that the application for data protection needs to be submitted at the same time as the application for drug listing license, and then it goes through the subsequent processes of acceptance publicity, technical review and publicity authorization.