Vaccine Event Fermentation: How to Break the Hidden "Iceberg" in the Pharmaceutical Industry?
Market Analysis of China Pharmaceutical Network: Vaccine safety is a matter of vital importance to human life. The Shandong Vaccine Incident in 2016 brought the entire vaccine industry to a freezing point. In order to severely punish illegal and criminal activities and regulate the development of the industry, the country has started to increase its punishment efforts, accelerate the improvement of regulatory systems, and implement the responsibilities of various links such as vaccine production, circulation, and vaccination. Vaccine companies are also responding to the national call, actively conducting self inspections and standardizing production according to requirements. However, two years have passed, and the trust and safety that have accumulated in the vaccine industry have collapsed again.
On July 15, the State Food and Drug Administration announced that the Rabies vaccine produced by Changchun Changsheng Bio-Technology Technology Co., Ltd. (hereinafter referred to as "Changsheng Bio-Technology") was found to have problems such as false production records, and had been ordered to stop production, withdraw the GMP certificate, and recall the Rabies vaccine that had not been used. On July 19, the Food and Drug Administration of Jilin Province determined that the "adsorbed acellular DPT combined vaccine" produced by Changsheng Bio-Technology did not meet the requirements in the "potency determination", and should be treated as inferior medicine. At present, relevant departments have imposed relevant penalties on the enterprises involved and launched a case investigation.
In response to the above two events, all sectors of society have given high attention. According to the latest news, the State Food and Drug Administration will organize flight inspections of all vaccine production enterprises, and will seriously investigate and punish any violations of laws and regulations. The vaccine industry will once again face a more stringent regulatory storm.
The vaccine incident deserves profound reflection from medical professionals
The two incidents continue to ferment, and some people cannot help but ask why the domestic vaccine industry has repeatedly encountered safety issues? In fact, drug safety is not only a problem for the vaccine industry, but also for the entire pharmaceutical industry. There are too many things worth reflecting on by medical professionals in these two events.
How can people's trust in domestically produced drugs be restored?
In recent years, drug safety issues have repeatedly occurred, which were originally meant to treat diseases and save people, but violated their essence. Drugs are different from ordinary commodities, as they belong to the economic sense of "trust goods", which means that consumers are in a state of information asymmetry regarding the quality of such goods and highly rely on trust, reputation, and word-of-mouth. If a fraudulent incident occurs, it will destroy the trust of countless people.
For example, in this vaccine incident, many parents exploded in their circle of friends and exposed their children's vaccination notebooks. A parent said, "Although the child has not received the vaccine involved, who can guarantee that the injected vaccine will be fine? When the toxic milk powder arrives, we can choose to purchase it on behalf of others, but when the 'toxic vaccine' arrives, what should we do? Lack of trust is really a big problem
To restore trust in domestic vaccines and drugs, some experts suggest that the country needs to integrate its regulatory system and increase the severity of punishment after major events. In Japan, if a company engages in fraud in the field of food and medicine, severe punishment will be imposed, and the involved companies may even lose their assets and never enter the industry. However, in China, the relevant regulatory efforts still need to be strengthened, and the relevant systems also need to be integrated and improved.
In addition, pharmaceutical companies also need to prioritize consumer interests. Industry insiders have once said, "To produce safe and effective drugs in the world, we need to make the world full of conscience medicine." To make conscience medicine and peace of mind medicine, based on practical work and driven by innovation, we can make more and more consumers trust domestic drugs.
How to solve the hidden "iceberg" problem in the pharmaceutical industry?
Drug safety is a major challenge in the pharmaceutical industry, but there are still many issues that restrict the healthy development of the industry. The industry issues exposed by this vaccine incident, such as "drug companies' persistent failure to reform", "regulatory deficiencies", and "accountability mechanisms", need to be addressed as soon as possible. Professor Liu, a pharmaceutical expert, believes that in order to achieve the effect of dealing with one education at a time, it is necessary to seize typical cases and handle them strictly in accordance with the law.
The lack of regulation and accountability mechanisms are institutional issues in the pharmaceutical industry. The industry points out that in order to improve the business environment of the pharmaceutical industry, what is important is not how many procedures pharmaceutical companies need, but how to make pharmaceutical companies more legitimate and unable to survive in the market. Because an enterprise that develops according to regulations and produces according to requirements will bring exemplary and positive effects to the entire society, while an illegal enterprise will disrupt the normal order of the industry and market, bringing serious harm.
The issues related to the outbreak of the vaccine incident are not only related to drug quality and safety, but also to the responsibilities of pharmaceutical companies, industry supervision, accountability and punishment mechanisms, which are precisely hidden issues in the pharmaceutical industry. I hope that after the vaccine incident, both the country and enterprises can completely solve these "iceberg" problems hidden under the seabed.
Objectively Viewing Vaccine Incidents, Do Not "Stop Eating Due to Choking"
Although the vaccine incident has left people disappointed, angry, and skeptical, the role of the vaccine still needs to be understood, and one should not "give up eating for choking". According to monitoring data from the National Drug Administration, since 2008, the National Drug Inspection Plan has sampled a total of 944 batches of vaccine products, with a qualification rate of 99.6%. This means that the vast majority of vaccines are very safe.
The author understands that adverse reactions caused by vaccines often occur within 24-48 hours after vaccination, mainly including local redness, swelling, fever, allergies, etc., which are generally mild. In severe cases such as allergies, the incidence is very low, and for most people, vaccines are safe.
"Hepatitis B, measles and whooping cough, which are prevented by the first class vaccine, and chicken pox, which are prevented by the second class vaccine, all pose a huge threat to children's health." Medical professionals said that vaccination is still an effective means to protect health, and vaccination should still be adhered to.
Although the vaccine incident has had a serious impact, we should also take an objective view. At present, relevant departments have launched investigations into the enterprises involved, and the vaccine industry will also be further regulated. Consumers cannot completely deny the entire vaccine industry due to this incident; Vaccine companies and more pharmaceutical companies should use this as a "warning bell", increase self inspection efforts, strictly follow national regulations for production, eliminate illegal and criminal activities, and promote the healthy development of the vaccine industry and the entire pharmaceutical industry.
(Source: China Pharmaceutical Network)