In the era of rule of law, drug supervisors may attack hard

Source: the remarkable Fourth Plenary Session of the 18th CPC Central Committee on October 24, 2014 officially ended on October 23, marking the coming of an era of rule of law How will this affect the pharmaceutical industry? The power of industry rule of law will show that we first look for relevant contents from the communique of the Fourth Plenary Session: it is not difficult to find out, which is proposed in the communique“ We will promote multi-level and multi field legal governance, adhere to systematic, legal, comprehensive and source based governance, deepen the legal governance of grass-roots organizations, departments and industries, support self-discipline and self-management of all kinds of social subjects, and give full play to the positive role of social norms such as citizen conventions, township rules and regulations, industry rules and regulations, and group charters in social governance The "multi-level and multi field" proposed here undoubtedly includes all fields such as medicine, medical treatment and general health, all of which need to be governed by law Not only that, legal governance should be combined with "system governance, comprehensive governance and source governance", but also "industry governance according to law", which has formed a huge legal power 2014 is the year of policies and regulations for the medical device industry in China, which coincides with the theme of rule of law proposed at the Fourth Plenary Session of the CPC Central Committee It can be said that the regulations on the supervision and administration of medical devices promulgated on June 1 this year has been a subversive change Knowing the changes of laws and regulations is only the basis, more importantly, the deep cognition and application of laws and regulations The regulation has been revised since 2006, and opinions were solicited in 2007 and 2010 respectively After the General Administration of food and drug finalized the draft and sent it to the Legislative Affairs Office of the State Council, the Office collected five rounds of opinions from nine departments, and reduced the original more than 100 articles to more than 80 extremely refined articles In the old regulations, there were some shortcomings, such as the imperfect classification management system, the low classification and high classification, the lack of specific corporate responsibility, the emphasis on product approval and the light process supervision, the repeated supervision of departments, and the lack of supervision in the use process However, the new regulations reflected: the whole process supervision, involving all aspects of production, research and development, registration, recall, evaluation and use; Risk management - risk and safety, is a new concept that has not been existed before Social co Governance - corporate responsibility, government supervision, industry self-discipline, public participation, department coordination, public opinion supervision, and legal protection, originally drug supervision alone, now is social co governance; strict responsibility - refine punishment, adjust punishment range, increase punishment types, and increase punishment intensity for serious violations These four points fully reflect the concept of "rule of law" On September 27, 2013, Sanmen County food and Drug Administration found that 1056 boxes of "permanent root canal filling equipment" sold by a medical device Co., Ltd in Taizhou City contained prednisolone acetate, which was inconsistent with the product registration certificate According to relevant regulations, an administrative penalty of confiscating 39 boxes of surplus products, illegal income of more than 220000 yuan and fine of more than 800000 yuan shall be imposed The company refused to accept the decision of administrative penalty and filed an administrative reconsideration with Taizhou food and drug administration On January 17, 2014, Taizhou food and drug administration made a decision on administrative reconsideration to maintain the original punishment On February 7, 2014, the company filed a lawsuit in three courts In addition, it is found that the company operates 1095 boxes of the above products, with an average sales price of 217.78 yuan per box Based on the average sales price, the sales income is 229975.68 yuan, and the value of goods involved is 238469.10 yuan According to the old version of the regulations and in violation of the provisions of these regulations, those who operate medical devices without product registration certificate, qualification certificate, expiration, invalidation or elimination The drug regulatory department of the people's government at or above the county level shall order it to stop trading, confiscate the illegally traded products and illegal income, and impose a fine of more than two times but less than five times the illegal income if the illegal income is more than 5000 yuan; if there is no illegal income or the illegal income is less than 5000 yuan, impose a fine of more than 5000 yuan but less than 20000 yuan; if the circumstances are serious, The original license issuing department shall revoke the license of medical device business enterprise; if a crime is constituted, criminal responsibility shall be investigated according to law Therefore, according to the old version of the regulation, the punishment results are: confiscate 39 boxes of the remaining products; confiscate 229975.68 yuan of illegal income; fine 804914.88 yuan; According to the new version: in case of any of the following circumstances, the food and Drug Administration of the people's government at or above the county level shall confiscate the illegal income, the medical devices illegally produced and operated, the tools, equipment, raw materials and other articles used for the illegal production and operation; if the value of the medical devices illegally produced and operated is less than 10000 yuan, a fine of more than 50000 yuan but less than 100000 yuan shall be imposed; the value of the goods shall be confiscated If the amount is more than 10000 yuan, a fine of more than 10 times but less than 20 times of the value of the goods shall be imposed; if the case is serious, the application for medical device license submitted by the relevant responsible person and enterprise shall not be accepted within 5 years Therefore, according to the new version, the punishment result is: confiscate 39 boxes of remaining products; confiscate the illegal income of 229975.68 yuan; confiscate the tools, equipment, raw materials and other articles used for illegal production and operation; 2384691 yuan < fine < 4769382 yuan; it can be seen that the strength of the fine is nearly 4 times to 6 times of the original strength, which cannot be said to be strong enough Is the SFDA ruthless? It is undeniable that there are still many illegal and even illegal behaviors in the pharmaceutical industry, but have they all been dealt with legally? This is undoubtedly very difficult to achieve Taking the illegal advertisement of medicine as an example, the drug regulatory department investigates and punishes a large number of illegal advertisements every year and submits them to the industrial and commercial department for handling, but they still exist every year However, it can be seen from the new government's independence of the food and drug regulatory system from the health system and upgrading it to the ministerial level that strict governance of the food and drug field has become the meaning of the highest decision makers And how to govern is undoubtedly "according to law" Back in the new year of medical device laws and regulations, the supervision and management regulations of the industry "parent law" took such 8 years to revise, and the Legislative Affairs Office of the State Council made major changes, which can be said to be a very perfect regulation The purpose of the regulation is to strengthen the supervision of the industry and make sure that there are laws to abide by Such important laws and regulations are not made out to see, but the top-down regulatory demand In the future, Whoever violates the rules again, although it is only the same serious injury as a few months ago, may receive a fine several times more than the original In addition to the "Regulations on enterprise credit information publicity" issued by the State Council, enterprises "are illegal and restricted everywhere" It can be said that the era of rule of law in the industry has come quietly Medical device field as a relatively backward field of regulation has been so, does the pharmaceutical industry still need to say? In this way, it is inevitable for the drug administration to be "ruthless" in accordance with the law!