Interpretation of Relevant Policies on Encouraging Pharmaceutical and Medical Device Innovation and Protecting Innovators' Rights and Interests (Draft)

In order to further deepen the reform of the review and approval system, promote the structural adjustment and technological innovation of the pharmaceutical and medical device industry, improve the competitiveness of the industry, and meet the clinical needs of the public, the State Food and Drug Administration, in consultation with relevant departments of the State Council, organized the drafting of the ''About Encouraging Pharmaceutical and Medical Device Innovation Relevant Policies for Protecting the Rights and Interests of Innovators (Draft for Solicitation of Comments) ", a total of Four articles.

In the interpretation (above), we have already discussed two of them. Now we might as well look at the remaining two.

"3. improve the drug test data protection system. The applicant may submit an application for trial data protection at the same time when submitting a drug marketing application. For innovative drugs approved for listing, a 6-year data protection period will be given. It is not only an innovative drug, but also a rare disease drug and a special drug for children, and is given a 10-year data protection period. Rare disease drugs and special drugs for children that belong to improved new drugs are given a 3-year data protection period. It is an innovative therapeutic biological product and is given a 10-year data protection period. Challenge patent success and overseas listed but domestic first imitation listed drugs to give 1.5 years of data protection period. The European Medicines Agency, the United States and Japan within 1 year after the approval of the listing of new drugs in China to apply for listing and data protection, to give the corresponding category of data protection period; more than 1 year to China to apply for listing, according to the excess time deduction of data protection period time; less than 1.5 years after deduction, to give 1.5 years of data protection period. The data protection period is calculated from the date of approval of the drug. During the data protection period, the review agency will no longer approve the listing application of the same variety of other applicants, except for the data obtained by the applicant himself.

4. the establishment of a list of listed drugs. Drugs approved for marketing in China shall be included in the Catalogue of Drugs for Marketing in China, indicating the attributes of innovative drugs, improved new drugs and generic drugs that have passed the evaluation of quality and efficacy consistency; Indicate the active ingredients, dosage forms, specifications, marketing license holders and other information of the listed drugs, as well as the exclusive rights information such as patents, monitoring period and trial data protection."

Looking at the policies issued by CFAD in recent years, especially since 2015, its orientation has been very clear, and the four major policies issued in succession on May 11 and 12 this year have confirmed this orientation.

Although China's pharmaceutical industry has developed vigorously in recent years, there has always been a drawback, that is, 40 or 50 good projects of imitation drugs in the market scale are often declared, but in contrast, there are very few innovative drug projects. Facing the current situation of the expiration of the blockbuster patent and the urgent product line, the demand of enterprises to find new drugs and good projects is becoming more and more urgent. However, the new drug research and development cycle is long and the risk is high, and the return in China is far less than that of developed countries such as the United States. How to realize the investment model in China has been exploring the successful model, and there is no replicable case. Due to the pressure of medical insurance costs, the clinical requirements for new drugs are becoming more and more stringent, and they need to be more effective or safer than existing drugs, which will greatly increase the probability of failure. In order to ensure the return on investment, it is inevitable to speed up the internationalization process of new drugs in China.

Therefore, the third point of the policy came into being, which focuses on data protection. As the name implies, data protection means keeping the data confidential, making it impossible for the outside world to obtain the applicant's experimental data, so enterprises that want to imitate the drug can only find their own experimental methods, this process is bound to increase their finished products, the low-cost advantage of generic drugs no longer exists, and the result will lead generic drug enterprises to improve their technical level, and then turn from imitation to their own innovation.

On the other hand, data protection will be a right to market. After the new drug is on the market, when the generic drug is difficult to market, it will monopolize the market, and the length of data protection time determines the time of monopolizing the market to a certain extent, and the economic benefits it brings can be imagined.

Data protection is also the protection of intellectual property rights. For example, when the protection period of a drug patent is not extended after the drug is marketed, but the protection period is less than 3 or 6 years, then data protection increases the validity of the patent in disguise. In addition, the drug has passed its validity period, because it has obtained new indications due to new clinical data. At this time, data protection also increases its patent validity period in disguise.

The list of listed drugs is the standardized management of the drug market. On the one hand, fake drugs can not survive, to protect the rights and interests of the people, on the other hand, it can also be regarded as a list of enterprises free of charge. But this is bound to be a long and arduous task.

In any case, the state to encourage innovation is also very obvious. Looking forward to the future, made in China will turn into created in China!

News source:http://www.sda.gov.cn/WS01/CL0778/172606.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.