In any case, in the pharmaceutical industry, history has turned again! But this time, fate marked the price in the choice.
Source | Medical Pulse Communication
Author | Ye Zhengsong
On October 10, the General Department of the State Medical Products Administration publicly released the "Announcement on the Implementation of Rewards for Internal Whistleblowers on the Quality and Safety of Drugs and Medical Devices (Draft for Comments)" (hereinafter referred to as the "Draft for Comments") to solicit opinions from the whole society.
Screenshot from the National Medical Products Administration
Once the draft for comments was released, it instantly became a hot spot and appeared on the hot search on the Internet.
The reason why it has aroused such heated discussions is that the core focus is to "encourage internal employees in the pharmaceutical industry to report", and if it is found to be true, a reward of up to 1 million yuan will be given.
In other words, with a huge reward of up to 1 million, employees are encouraged to report major violations of the law in their units.
Who will be the first "whistleblower" after the release of the Exposure Draft?
What constitutes a "material violation"?
The Consultation Paper clarifies that major violations refer to illegal acts that are suspected of committing a crime or being punished with administrative penalties such as being ordered to suspend production and business, ordered to close, revoke (revok) licenses, or fined or confiscated a relatively large amount in accordance with law. Where local regulations or local government rules have specific provisions on major violations, those provisions may be followed.
Relevant paragraphs of the original text of the draft for comments
According to the relevant provisions of the Drug Administration Law, there are at least 20 major violations. Among them, there are three points related to the pun of the pharmaceutical industry, such as:
Relevant personnel of pharmaceutical companies give or accept kickbacks or other improper benefits in the purchase and sale of drugs;
giving property or other improper benefits to the person in charge of the medical institution, drug procurement personnel, physicians, pharmacists and other relevant personnel who use their drugs;
Offering bribes to state employees in the development, production, or sale of drugs.
The above behaviors are described as "serious" in the Drug Administration Law, and they are all major violations.
According to the Consultation Paper, internal whistleblowers are required to provide clear information about the subject of the report, specific facts of the violation, or clues and key evidence of the violation. At the same time, the reported matter was not previously grasped by the drug regulatory department, and after the report, the drug regulatory department investigated and closed the case, and the reported party was administratively punished or investigated for criminal responsibility.
Relevant paragraphs of the original text of the draft for comments
If the internal whistleblower meets the above conditions at the same time, he or she can receive a reward for reporting, and the maximum reward amount is 1 million yuan. The reward shall be notified to the whistleblower within 15 working days after the case is investigated and concluded. After the whistleblower applies for the start of the reward procedure, he or she will receive the report within 30 working days, and if he fails to receive it within the time limit, he or she will be deemed to have voluntarily given up.
Why are internal whistleblowing encouraged?
Medicines and devices, used on patients, are closely related to life and health. From the maximum reward amount of 1 million this time, you can clearly perceive the law enforcement strength and determination of the drug regulatory department. In the future, if the pharmaceutical industry wants to take chances, it may suffer unbearable pain.
Whistleblowing is not unusual, but what is strange is: why should internal whistleblowing be encouraged this time?
The author personally thinks that the hidden attributes of illegal operations in the pharmaceutical industry are very strong and the technical barriers are very high, and it is difficult to identify the camouflage and break through the wall without the cooperation of internal personnel.
The 2018 Changchun Changsheng vaccine fraud case is a good example.
At that time, this vaccine fraud incident that caused anger at the top level, the official report after the investigation pointed out in extremely harsh terms: this problem vaccine case is a major case of vaccine manufacturers bending the law for profit, violating national drug standards and drug production quality management practices, fabricating false production inspection records, dereliction of duty and supervision by local governments and regulatory departments, and dereliction of duty by individual staff. It also reflects the institutional deficiencies in the production, circulation and use of vaccines.
The cause of this incident was the real-name report of an old employee in the internal production workshop of Changsheng Biotech. If it weren't for this, it would be difficult for the vaccine fraud incident that caused a sensation across the country to surface.
To treat sores you must scrape the bones, and you need fierce medicine for severe scabies.
With a reward of up to 1 million yuan, insiders of pharmaceutical companies are encouraged to "blow the whistle", which fully demonstrates the determination of the drug regulatory department to rectify the serious illness in the pharmaceutical industry.
Gandhi said that there are only seven things that destroy humanity: politics without principles; There is no worship of sacrifice; There is no science of humanity; There is no ethical business; There is no knowledge of right and wrong; Joy without conscience; Affluence without labor.
Among them, "business without morality" is the most hated by the common people. Because, this one is most closely related to everyone.
Who can guarantee that they will never become a patient?
To be honest, it is really helpless to encourage the internal personnel of pharmaceutical companies to "oppose water", because the concealment of drug production is too strong. In the production process, there is no one involved in the actual production operation to report, where, which, is the key point of falsifying records for inspection and acceptance approval, only relying on the external supervision and supervision of the regulatory department, it is difficult to find out the truth. The same is true for the circulation of drugs.
Although the "two-invoice system" has been implemented for many years, the methods of kickbacks and sales with gold have become more hidden. It can be said that it is not a last resort, and the drug regulatory department will not make such a "decision", hang a lot of money, and turn the relevant personnel within the pharmaceutical company into "undercover agents".
The bonus of 1 million cap may not be high for the middle and senior managers of pharmaceutical companies. However, for the front-line personnel in the production, quality inspection, and sales of pharmaceutical companies, this is already the salary equivalent for more than ten years, which is still extremely attractive.
Behind the frequent "reports" in the pharmaceutical industry
Changchun Changsheng Company, which was famous in China, finally collapsed and was destroyed in the face of a report from a front-line low-level employee. From this, it is conceivable what kind of effect the reward of 1 million will bring.
At present, the problems in the field of medicine have lasted for a long time, involved a wide range of issues, colluded interests deeply, and the masses have complained about a great deal of grievances, which is unprecedented. As a result, in the past two years, a significant feature has been derived from the industry, that is, reporting.
Subordinates report leaders, wives report husbands, conflicts within the unit, conflicts between family members, and conflicts between doctors and patients...... It is in this vigorous pharmaceutical anti-corruption campaign that has erupted.
These reports illustrate a lot of problems, on the one hand, it shows that the gray and even black problems in the pharmaceutical field have caused public outrage; On the other hand, it also shows that the medical field is not completely dark, and there are still many righteous people who dare to speak out.
For example, Dr. Zhu who reported Wuxi Hongqiao Hospital for insurance fraud.
Unfortunately, the risks are not proportional to the benefits. According to a person familiar with the matter, Dr. Zhu, who reported the hospital's insurance fraud, plans to leave Wuxi. However, the author is quite worried about his future path. Ask yourself, in the current environment, even if he leaves Wuxi, how many hospitals will be able to accept him?
Therefore, if you want the fortress to be broken from the inside, so that the insiders can "turn back" and have no worries, it is necessary to solve the problem that the risk is proportional to the return.
This is also the original element and starting motivation for the Food and Drug Administration to offer a reward of up to 1 million yuan to encourage pharmaceutical company insiders to report.
To tell the truth, every time the author sees the news that someone in the medical field is being investigated, no matter who it is, there is a faint pain in my heart-
One is heartache, these people have struggled all their lives, and the last vote is cleared, which is a pity;
The second is that I feel that these people are mixed up at this point, and their careers are prosperous, and after being investigated, many people will be implicated, and the involvement is too big and terrible.
Therefore, I would like to advise you: in the pharmaceutical industry, don't mess around with small actions. Behind every action, the price is indicated, and you are the payer, so you don't have to leave anything to chance. When you see the bargain, you must see what the price behind it is. Don't be stuck in front of you and lose sight of the risks in the distance.
In the midsummer of the year before last, the author visited Neixiang County Street in Henan Province and found that the dining hall and the men's prison in the county government were only separated by a wall. Whether it is God's retribution or the impermanence of fate, what needs to be vigilant is: those who have not reached this step, do not think that they will never reach this step.
Horses walk the day, like the field, must be in a limited range of elephant legs, do not horse feet, to a limited range of choices to play cards. Instead of relying on their own imagination, flying around randomly without following the rules.
Success is varied, and all roads lead to Rome. But it's never the arrival in Rome that matters, but the stories we leave behind along the way.
Whatever you do, you must be compliant, compliant, and compliant, and remember not to violate the law, let alone break the law!
In any case, in the pharmaceutical industry, history has turned again! But this time, fate marked the price in the choice.
Editor-in-charge|Atai Yiyi
Cover image source: Visual China