For the first time, the supreme law has included clinical data fraud into criminal punishment

Source: cctv.com.cn May 2, 2017 (reporter Cheli Henan Taiwan reporter Wang Hongwei) according to the report of the voice of China News vertical and horizontal, the research and development of a new drug clinical trial is the most important link If the clinical trial data of a new drug is falsified, it will not only directly affect the safety and effectiveness of the drug, but also endanger the life safety of the public But in recent years, clinical data fraud in the pharmaceutical industry has been repeatedly prohibited Recently, the Supreme People's Court adopted the interpretation on several issues of applicable laws in criminal cases of drug and medical device registration application data fraud, which included the clinical data fraud drug approval into criminal punishment for the first time, with the highest death penalty Can the toughest punishment cure the stubborn disease of counterfeiting? In the office of Xu Hong, director of the administrative examination and approval Office of Anhui food and drug administration, the frequent phone calls interrupted the reporters' interviews from time to time, two of which were related to "clinical data fraud into punishment" In Xu Hong's opinion, the falsification of clinical data is related to the qualification of drug production license, which is different from the general digital falsification "These laws and regulations are clearer, and the most severe punishment is imposed on the falsification One of the "four strictest" punishments will definitely promote the further purification of the drug research and development environment " "Clinical data" is relatively unfamiliar to most people Mr Zhang, a staff member of Luohe food and Drug Administration in Henan Province, introduced that: simply speaking, a drug enterprise applies for a new drug, after passing the inspection, it must do human body efficacy experiment in the hospital before issuing the certificate "In order to get the approval number of the drug quickly, some enterprises involved in a lot of clinical trials Long, it has a treatment cycle and hundreds of cases If it fails to meet the expectation, it will cooperate with the clinical trial organization to change the data, or change the invalid data into effective data " It takes a long time for pharmaceutical enterprises to develop a new drug, and a large amount of money needs to be invested in the early stage Clinical data has become the "life and death" of new drugs, and the lowest cost and highest efficiency way is to pull clinical trial institutions into the water "Even if we are counterfeiters, I will give you the data, thousands of people or even tens of thousands of people, you can't confirm whether it is counterfeiting or not," said an insider from a clinical trial organization There are also some true and some false For example, I only made 500 personal data, but I purposely wrote it as 5000, and 10% of it is true Even if you check the people in the 500, you just get the real data, and it is true " Sun Hualong is the head of the data management and statistical analysis department of a medical research company in Beijing He has provided solutions for drug clinical trials and research for many well-known pharmaceutical companies In his opinion, due to the lax supervision in the past, many pharmaceutical companies can obtain drug approval documents even if they make large-scale data fraud, which gradually leads to a vicious circle "Some applicant pharmaceutical companies, when we went to bid, wanted to spend the least money to ensure that you have a positive result In fact, to ensure the quality of clinical data, it needs enough time and funds to complete this thing, such as If the price is not enough to support the clinical trial at all, there is a risk in itself if the applicant clearly knows that it is required to do so " In view of the difficulties existing in the supervision of clinical data at present, sun Hualong believes that the clinical trial itself is a complex process, and data falsification is likely to occur in almost any link The diversity of the sources of falsification makes it difficult for the supervision "In the clinical trial, falsification can come from many sources, such as the researcher is the doctor, the PRC is the clinical research coordinator, and it can be temporary The bed supervisor or the applicant pharmaceutical company may even be a member of the ethics committee Sometimes, for example, the laboratory data has been modified, the system time has been modified, and even the inspection records are suspected of fraud " As early as July 2015, the State Food and Drug Administration issued a notice that the clinical trial data in the application for drug registration was not true or even falsified At that time, active withdrawal and disapproval of drug registration applications accounted for 46.3% of the total number of 1622 pending drug registration applications According to song Ruilin, executive chairman of China pharmaceutical innovation promotion association, the deep-seated reason for clinical data's non-standard, untrue and even fake is mainly the system level problem "The formulation and supervision of drug laws in China for a long time are more focused on generic drugs However, when classifying drugs, clinical trials are needed for the management of drugs that are listed in foreign countries and not listed in China As you can imagine, the drugs that have been put on the market will prove their effectiveness Pharmaceutical companies can copy the clinical data of foreign drugs, that is, short cut and cheating " Now the State Food and drug administration has changed the classification of drugs "New drugs" use global concepts and improved new drugs, which are difficult to be fake in clinical practice without copying objects For the drugs that have been listed in foreign countries and have not been listed in China, the so-called "new drugs" in the past have also been classified as "generic drugs" Generic drugs do not need to do the original clinical trials, just do bioequivalence and efficacy consistency, there is no room for counterfeiting "We need to let the system do what it has to do, not let it do what it has to do repeatedly, because repeated things are often easy to fake," Song said Therefore, we need to do bioequivalence and treatment consistency, which is back to the essence of things Because in this process, due to the comparison, it is difficult to make a fake, which is easy to be found I believe that in the future, there will be a significant reduction in the problems of non-standard, untrue and even fake clinical data in China " China's "Drug Administration Law" and "Drug Administration Law Implementation Regulations" have clear provisions on the punishment of clinical data fraud, but only limited to administrative punishment, the punishment object is mainly institutions Song Ruilin pointed out that this time, the Supreme People's court increased the punishment on individuals and made clear the direct subject of responsibility, which is conducive to fundamentally solving the clinical data fraud caused by the irresponsibility or abuse of power of the executives.