Hundred-time Meishi Guibao: lose the pawn car or negative injustice?

On the 20th, the Ministry of Science and Technology imposed administrative penalties on Shishi Shiguibao (China) Investment Co., Ltd. (referred to below as Shi Guibao) and Ai Enkang Clinical Medical Research (Beijing) (referred to below as Ai Enkang).
't know the rules for the Ministry of Science and Technology's national penalty numbers, but the Nos. 1 and 2 are likely to be the first and final in 2020, after all, heading into 2021.
briefly, Mr. Shi commissioned Mr. Ai to apply for international cooperation in category Chinese genetic resources, and Mr. Aincon's clerk forged official seals and legal signatures and submitted false information to regulators.
the penalties for the 1st and 2nd are different subjects of the same event.
01, genetic resources on human genetic resources news, more frequent recently, but the most affected events are China Biotechnology Development Center Deputy Director was monitored and investigated.
the speciality of the deputy director's post may involve human genetic material management, based on the fact that most of these surveys are related to the main job, so there are similar rumors.
, for example, to say that there may be genetic material, of course, the end result has not yet come out, we do not make the presumpt of guilt here.
just analyze what might be affected if it were such an event.
common sense, genetic material is "human blood, genes, anyone's body long."
although the interim approach to the management of genetic resources was introduced in the country on 10 June 1998, there is still a difference between the prior stage and the present.
few companies involved in human genetic material in recent years, such as in 2018, when six domestic companies were administratively punished by the Ministry of Science and Technology for illegally exporting human genetic resources.
project involving Huada Gene, Huashan Hospital affiliated with Fudan University and Oxford University.
they collaborated on a study of severe depression in Chinese women and successfully found several gene spots, but the problem came when Huada Genetics sent some genetic information abroad via the Internet.
netizens think that only China has such management departments, but it really is not.
June 10, 2019, China's Regulations on the Administration of Human Genetic Resources of the People's Republic of China were promulgated, which is Decree No. 717.
Then the U.S., on June 11, 2019, local time, also discussed the issue, and the two senators jointly proposed to the White House Departments of Health and Human Services that the use of U.S. genetic resources be strictly controlled, especially to prevent Chinese companies from gaining access to U.S. human resources.
this point, personally believe that the description of the two administrative penalty decisions, Shi Guibao and Ai Enkang, is actually flawed.
the room? In both decisions, the legal basis is "in accordance with the Interim Measures for the Administration of Human Genetic Resources," the Administrative Licensing Law of the People's Republic of China and the Administrative Punishment Law of the People's Republic of China."
The Interim Measures for the Management of Human Genetic Resources were in 1998, and the most recent regulation should be State Council Order 717.
I did not confirm this 717 order and interim approach, is there a "new rules out, old rules back" logic.
but personally feel that Order 717 should be the primary regulation.
, of course, this is debatable.
another regulation that has not yet been formally implemented is the Biosecurity Law of the People's Republic of China.
Presidential Decree No. 56 will not enter into force until 2021.
02, hold the booty called Qu? In this incident, in fact, there are many people feel that Shi Guibao is wronged, "after all, the fraud is that Enkang salesman ah!" "But many things are judged on the basis of the "biggest beneficiary".
yes, Shi Guibao just wants Ahn Kang to help coordinate the qualifications.
But the problem is that the matter must be clearly documented by itself, and according to the Code of Quality Management of Drug Clinical Trials, "Article 33 The contractor-commissioned contract research organization shall meet the following requirements: the bidder may entrust part or all of the work and tasks of its clinical trials to the contract research organization, but the candidate is still the ultimate responsible person for the quality and reliability of clinical trial data and shall supervise the work undertaken by the contract research organization."
" Shi Guibao as the bid party is ultimately responsible for the quality of data, if this fraud has not been discovered, then the biggest profit is the bid party.
if you sacrifice a person to get this benefit, then the use of chess in the "lost car" strategy is undoubtedly the most economical and fast.
is precisely to prevent this strategy, the bid party as the ultimate responsible party.
whether it is to buy services or raw materials, spend money party must do audit, and even to do background checks, to see in front of this patting chest packing tickets have no historical stains.
so Shi Guibao is difficult to be alone, can only regret not to do management responsibilities.
03, mourning for the aftereers? That's it? Is there any lessons for other pharmaceutical companies or regulators? Too much, I look at the possible process from a practitioner's point of view.
a farewell statement: the following is not a referring to Seguibao and Enkang, but a generalization of the common event flow.
: Can you do this? Party B pick-up: No problem.
: How long will it take to make it? Other companies have given a package ticket, once the overdue people will take the initiative to give us the wrong work costs.
B party pick-up officer: this matter can not be written too strict, after all, we still have to run the mouth of the organ, the time-sensitive is not very good to say.
: I just look at XX brother's face to talk to you, not even.
B pick-up officer: LINE, then.
contract states that if we can't figure it out by x-month x, we're willing to pay xx million for lost work.
Party A: That's bright! Do! But wait for Party B to take the order back after an internal meeting, found that this matter during the contract period is not easy to do.
the contract pushed? Which line, how can the meat in the mouth be let go? So brother a few one to discuss, anyway, this thing seems not easy to check the authenticity, and did not like CDE as publicity.
so many cross-border approvals, with official seals, signatures, and even letters of certification from foreign agencies.
who has the energy to go one by one on the phone to check? So, let's make one, dry! The result did not expect to be found to be false.
if not found, this may even become a third-party service agency energy, Lu Zino proof.
to starve and die timid, as has always been the case.
Shi Guibao may be wronged, but the relationship is certain.
at least there is a contract to prove that there is a third-party company's fault here, in the pharmaceutical enterprises, there are many are not at all to reflect the third-party fault.
such as you are a research and development organization, very small kind, and set up a new company, intended to register a new drug, only to find that people have no relevant experience.
dig tall people? No money; touch a stone across the river? There's no time.
you open a search engine and find an industry coaching company.
you may be embarrassed at first, " I'd like to ask a few experts to coach us on the process.
" results after the other side asked a few words, directly and you said, "I have a complete set of information documents, just can be used for you."
" so you use the tutoring company's information template, made to file, the expert said, "Your stable data is not compliant ah, you have to supplement the data to do again."
done first, report it in a year or two.
you this is your own factor caused by the delay, service charge is not refundable ha.
"You panicked, the shelves are up, how can you press the pause button ah.
the expert said, "The method is not without, but not compliant."
you want to listen, I can say to you, but something happened and I have nothing to do with it.
" so you declare it in other unusual ways.
didn't find out, everything was great; "We're just reviewing the format and integrity of documents and records, we're not identifying and regulating data authenticity, we're not official, we're just an industry service provider,"
said.
" the latter can check, it is difficult to say.
the case of Shi Guibao can be completely optimized to eliminate the process.
04, publicity plus review system one by one publicity at the same time, if you can, even the signature, seal and other physical maps are also exposed.
In addition, it may be necessary to add a review, that is, each clinical institution has its own account number linked to the Ministry of Science and Technology, the Ministry of Science and Technology received the application, clinical institutions need to review the account management confirmation.
this greatly improves the probability of fake dew, which in disguise increases the cost of counterfeiting.
our medicine mouth, the accident should be directly from the prevention of correction to consider, can not be like other industries, "discover together, check together" as a benchmark.
instead of focusing on "discovery and investigation", we should focus on "institutionally reducing the probability of occurrence".
is the meaning of prevention and correction in the quality system, cut the risk from the root, otherwise, this may not be the last fraud.
don't let drug companies suffer injustice because of their partners.
: Ministry of Science and Technology Government Service Platform, State Council website, "Drug Clinical Trial Quality Management Code"