A recent "Administrative Penalty Decision" released by the Market Supervision Administration of Jing'an District, Shanghai has attracted attention. Due to illegal advertising of prescription drugs through Yilapao at a hotel venue, BeiGene (Shanghai) Biotechnology Co., Ltd. has been fined 400000 yuan. Lawyers have stated that in hotel conferences, Yilapao advertising is very common, and this behavior can have an impact on ordinary patients and consumers without professional medical and pharmaceutical knowledge. It cannot guarantee the scientific, correct, reasonable, and safe use of medication, and there are compliance risks.
During the hotel conference, prescription drug advertisements were posted through Yilapao
The company involved, BeiGene (Shanghai) Biotechnology Co., Ltd., is a subsidiary indirectly owned by BeiGene with a 100% stake. It is mainly responsible for the marketing of BeiGene's anti-cancer prescription drug Pamipali Capsules (trade name: Baihuize).
In August 2022, BeiGene (Shanghai) Biotechnology Co., Ltd. held the "Baihuize City Fair" on the third floor of the Marriott Hotel branch in Puxi, Shanghai. During this period, BeiGene (Shanghai) Biotechnology Co., Ltd. promoted the drug Pamipali capsules in public places through promotional flyers, easy pull ups, and other forms, claiming that "Baihuize (Pamipali) is the only PARP inhibitor approved for the treatment of 3LgBRCAm platinum sensitive and platinum resistant recurrent ovarian cancer; CGCS guidelines recommend Pamipali as the preferred drug for the treatment of recurrent ovarian cancer; the monthly treatment cost for medical insurance patients is only 1929 yuan.".
The Market Supervision Administration of Jing'an District, Shanghai believes that the product in question is a prescription drug and can only be advertised in medical and pharmaceutical professional journals jointly designated by the health administrative department and the drug regulatory department of the State Council.
Considering that the illegal behavior of the parties involved has lasted for less than 3 months; The increase in sales of goods before and after advertising is within 30%; Not causing social impact; Due to discretionary factors such as first-time violations and active cooperation in investigating and punishing illegal activities, the Jing'an District Market Supervision Administration of Shanghai has imposed a lenient punishment on BeiGene (Shanghai) Biotechnology Co., Ltd., with a fine of 400000 yuan.
Lawyer: Compliance regulation in the pharmaceutical industry will become increasingly strict
According to the relevant provisions of the "Classification Management Measures for Prescription Drugs and Non prescription Drugs" (Trial), prescription drugs must be formulated, purchased, and used with a prescription from a practicing physician or assistant practicing physician. Only through the examination and diagnosis of the physician, purchasing medication based on the prescription issued by the physician, and using medication reasonably according to the physician's guidance, can patients ensure the prevention of diseases and protection of health. Misuse not only fails to treat the disease, but may also cause illness and even endanger life safety. Therefore, prescription drugs are only allowed to be advertised in professional medical newspapers and magazines, and their target audience must be professionals with medical knowledge.
Wang Meng, a senior lawyer in the pharmaceutical industry and partner of Guohao Law Firm (Nanjing), stated in an interview with the New Beijing News that as a prescription drug, Pamipali capsules are promoted in public places in the form of easy to pull tab and promotional leaflets, with an unspecified target audience for advertising. The above advertising behavior will have an impact on ordinary patients and consumers without professional medical and pharmaceutical knowledge, and cannot guarantee the scientific, correct, reasonable, and safe use of medication, which poses compliance risks.
Similar situations are not uncommon at meetings held by some pharmaceutical companies in hotels. "The compliance supervision of the pharmaceutical industry will become increasingly strict in the future," said Wang Meng.
New Beijing News reporter Zhang Xiulan