Medical network May 16 - May 11, state drug safety administration issued "about to encourage pharmaceutical medical equipment innovation drugs in whole life cycle of medical equipment management policy" (draft), faces the society for public opinion. 

 

The "draft" clearly put forward to regulate the behavior of medical representative academic promotion, and the promotion and for the record registration of a medical representative how to do, put forward the specific implementation measures. 

 

From "countries do hair [2017] no. 13" file is put forward, the agency must strengthen the management of medical representative, build system of medical representative register put on record, the record information in a timely manner. Medical representatives can only engage in activities such as academic promotion, technical consultation and so on, and may not bear the sales task of pharmaceutical products, and their breach of trust in the personal credit record. 

 

By the end of December 2017, the general administration of the pharmaceutical administration will complete the management measures for the registration and filing of medical representatives by the end of December 2017. 

 

To "draft" designated specific implementation path, just three months, and then a file, a file to a medical representative and its traditional sales mode of "revolution", apparently come faster than expected. And the new code of conduct for medical representatives is becoming clear. 

 

The consultation paper suggested that medical representatives can do something: 

 

"The medical representative is responsible for the academic promotion of new drugs, introduces the knowledge of new drugs to clinicians, and listens to the clinical use of new drugs." 

 

The solicitation made clear the "three bans" for medical representatives: 

 

"Ban pharmaceutical representatives responsible for drug sales, private contact with doctors, medical representatives to ban anyone to a medical representative of medical institutions, pharmaceutical production management enterprise to provide the individual doctor prescribe medicines." 

 

Among them, "banning medical representatives from private contact with doctors" is a relatively new idea. 

 

Since the end of CCTV exposure after receiving kickbacks, across the country have launched a "block" a medical representative action, mainly reflected in the forbidden area is engaged in the medicine representative to diagnosis and treatment of drugs, medical apparatus and instruments sales promotions. The "nine forbids" also has "prohibit doctor to take part in medical enterprise or medical representative to arrange, organize, pay the recreational activity of recreational place that pays expenses". 

 

It is not yet clear what the "private" category of "the solicitation" of "forbidden medical representatives" is in contact with doctors. Will it exceed the existing rules? The definition will determine the size of the grey room for medical representatives. 

 

The consultation paper also puts forward specific measures for the management of the medical representatives' filing: 

 

"A medical representative in medical institutions of academic promotion activities shall be heard in public, and in the medical institutions designated department for the record. Authorisation holder (pharmaceutical production enterprise) should be a medical representative list the site specified in the food and drug regulator for the record, to the public." 

 

"Draft" put forward at the same time, "recordation open, drug business activities in the name of the medicine representative, by the relevant departments of relevant business and medical representative according to the illegal drug investigation." 

 

These are all new proposals. 

 

Not for the record to sell medicine medical representatives will be effected according to the illegal drugs is investigated, and illegal drugs already violated the rules of the pharmaceutical administration law, also included in the "criminal law", can be investigated for penalties. 

 

"Criminal law" regulation, the crime of illegal business if the circumstances are serious, shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention, and concurrently or independently be sentenced to a fine one times more than five times the illegal income; If the circumstances are especially serious, they shall be sentenced to fixed-term imprisonment of not less than five years and shall also be sentenced to a fine of less than five times of the illegal earnings and shall be fined or confiscated. 

 

Once the content of the consultation is approved, medical representatives are selling drugs illegally, or face jail time. It would be a direct and intimidating "straitjacket" for medical representatives and pharmaceutical companies. 

 

This is another big step in the regulation of drug regulation. Drug violation behavior "the execution phase" is the national important regulatory reform is moving forward, and the drug safety administrative penalty and criminal liability of projects cohesion, the national two sessions this year when projects when doing report has highlighted it. 

 

In addition, the "draft" on medical representatives of academic promotion and filing management although only to the relevant provisions of the drug, but today is just the tomorrow of medical apparatus and instruments of the drug, medical apparatus and instruments sales representatives shall, in accordance with the provisions of also will face the same day and night. 

 

, including drugs and medical devices, pharmaceutical representatives behavior standardization is imminent, and the earlier companies are prepared to deal with measures, to avoid a crisis, or even win the new development opportunity. 

 

"The consultation paper also suggested that" medical representatives should be seriously investigated for misleading doctors using drugs and concealing drugs." 

 

This has also raised higher requirements for the expertise of medical representatives, and the professional training of medical representatives has become more important. 

 

In the future, the "medicine industry access or training" system that has long existed in many countries will also take root in our country.