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What are the differences between Japanese drug market access management and China? | the first scene

 Last Update: 2022-10-03
 Source: Internet
 Author: User

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Compared with China's complex and changeable drug pricing system and medical insurance policies, Japan's drug sales, circulation and reimbursement links are very convenient

Compere:

Business Development Division, Business Development Management Department, EPS International Corporation

Director Ms.

: EPS Holdings Co.

Report Finishing: Dong Lei on-site simultaneous interpretation: Teacher Aoyama, Teacher Su

The lecture series on clinical research in Japanese medicines, jointly organized by the Pharmaceutical Research Agency, EPS International Co.

In his report, Mr.

In Japan, the role of wholesalers is to stabilize the supply of medicines, and their importance is self-evident

Let's look at the cash flow

Whose profits are affected by price cuts?

In order to stabilize product supply, Japan's drug pricing is officially priced and free pricing

Free pricing can give pharmaceutical companies, wholesalers and hospital pharmacies a certain profit

In Japan, drug prices change

Mr.

Even if hospital pharmacies are asked to reduce prices by the government, their profits remain the same, because their purchase prices will be reduced

Wholesalers are exposed to greater risk

Mr.

"Wholesalers play a very important role
in the stable supply of medicines in Japan.
" Mr.
Goto said
.
In China, after the two-invoice reform of the drug process, the existence and role of Chinese drug wholesalers have gradually declined
.

The following flowchart illustrates in more detail the impact of the government's price reductions on all aspects of circulation:

(1) Japan publishes newly adjusted drug price regulations
every year.
(2) Free pricing
is adopted between pharmaceutical companies and drug wholesalers.
(3) The size of the decision on drug procurement is: medical institutions> drug wholesalers > pharmaceutical enterprises
.
(4) As a result of price reductions, drug wholesalers need to cut profits, resulting in deficits and the possibility
of insufficient income.
(5) Pharmaceutical enterprises make weak adjustments to the prices of wholesalers, and the result is that the price adjustments made by the wholesalers of drugs to stabilize the supply, resulting in a reduction in
the profits of the wholesalers.

"Since medical institutions have the greatest right to speak, pharmaceutical companies and wholesalers need to communicate more with medical institutions to minimize unnecessary friction and contradictions
in drug sales and circulation.
" Mr.
Goto said
.

In addition to the risk of price cuts, wholesalers also need to be aware of the risks of
inventory.

In the wholesaler inventory storage link, regardless of whether the hospital finally purchases or not, the manufacturer has obtained sales revenue and profits
.
Therefore, in order to ensure sales, wholesalers should strive to contact and communicate
with hospitals.
The wholesaler's sales volume is based on the amount of prescriptions from the hospital
.
However, the actual situation is often that wholesalers buy more than prescriptions, resulting in increased inventory, and even a large amount of waste of drugs, which makes the burden of wholesalers increase
sharply.
Therefore, wholesalers need to do market research and planning in a timely manner, increase communication with hospitals and pharmaceutical companies, and achieve a tailored purchase and a balance between
income and expenditure.

The role of medical representatives

Pharmaceutical companies need to provide all the correct information
about the drug.
The Medical Representative (MR) needs to work hard to provide the correct information on the use of the drug (see figure below).

For medical representatives, "the biggest challenge encountered at present is that some new technology products such as regenerative medical products, new anti-cancer drugs and vaccines face many safety risks, and doctors need to obtain a lot of knowledge and information to prescribe
.
" Mr.
Goto said
.

After the doctor has prescribed the prescription, he needs to inform the hospital pharmacy to make the purchase
.
In addition to supplying medicines, wholesalers also need to confirm that the medical representatives of the pharmaceutical companies have done their homework and clearly explained all the information about the drugs to the
doctors.
Usually, Japanese medical representatives visit doctors and carry out drug introduction activities in the database; If there is no explanation, it is necessary to visit the doctor in time to detail the efficacy and safety information
of the drug.
If it is found in the database that the medical representative has not completed this work, the wholesaler has the right not to deliver the goods
.

"Introducing new drugs to doctors is a lesson
that medical representatives must complete.
" Mr.
Goto stressed
.
When the doctor has comprehensive drug information, the wholesaler can deliver it
.

How do Japanese medical representatives introduce new drugs to doctors? Specifically, there are direct visit interviews and remote interviews
.
Visits to hospitals are restricted due to the COVID-19 pandemic, making it difficult for doctors and medical representatives to meet; At the same time, doctors are not interested in remote interviews, affinity is low, and appointments and connections are cumbersome, so the success rate of remote interviews is low and cannot replace offline visits
.

Mr.
Goto said that in order to improve the success rate of remote interviews, we must try to integrate artificial intelligence into practical work
.
Make an appointment with a clinician online through iPAD and use PPT to clearly and clearly introduce new product information, which can also do more with less (see the flow chart below).

The visits of medical representatives are based on academic discussions, which are central to the content of their work
.
The academic information they pass on determines whether doctors can keep up to date with the latest information about
the product.
Pharmaceutical companies in Japan have set up call centers to assist medical staff, patients, and wholesalers (the professional backgrounds of center operators are: pharmacists, nurses, nutritionists, and medical representatives
).
Specific services for call centers include:

(1) The Drug Counseling Office will respond once

(2) The Drug Counseling Office will respond twice

(3) Literature Search Center

(4) Medical Representative Support Center (Consultation Desk for Medical Representatives)

(5) Night and Holiday Reception Center (available 24/365)

(6) Patient Education Contact Center

(7) Subject recruitment (trial advertising) contact center

(8) Emergency call center (specific implementation of independent recycling, special events, etc.
)

According to statistics, in Japan, pharmacists in pharmacies account for more than
80% of the consultations.

Through the call center business, professionally trained and qualified personnel can assist in the writing of IF, FAQ (FAQs and answers), product information summary, instructions and usage notes
.
After submitting the first draft for several revisions, the final draft is
finally submitted.
In addition to paper versions, pharmaceutical companies and wholesalers also make electronic formats and put them online and submit them to doctors for their reference
.

How to collect drug safety information

Japan attaches great importance to the collection
of drug safety information.
After the drug is on the market, the problem of the safety of the exposed drug will gradually increase
.

In terms of regulations, GVP (Good Pharmacovigilance Practices, Good Pharmacovigilance Quality Management Practice), GPSP (Good Post-marketing Surveillance Practice, Post-marketing Regulatory Quality Management Practice) and GQP (Good Quality Practice, Good Quality Practice (Good Quality Practice (Good Quality Management Practice).

。

At the same time, Japanese drug manufacturers and sellers have also deployed several key responsible persons, including the head of production and sales, the person in charge of quality control, the person in charge of safety management, and the head of PMS (Post Market Surveillance, post-marketing clinical research) and other management leaders (pictured).

The person in charge of production and sales is the supervisor of the specific implementation of drug production, sales and other aspects, and the person in charge of safety management is responsible for the planning and establishment of the overall safety plan, and also writes, executes, evaluates, and modifies the risk management plan (RMP), safety discussion matters, safety monitoring plan, and how to minimize
drug risks.
The Head of PMS Management is responsible for the execution and investigation of clinical trials, and he works
closely with the Head of Safety Management.
People in both positions use RMP as a benchmark to provide each other with investigations, clinical trial results and reports, and records of implementation, and comprehensively collect drug safety information
.

After the pharmaceutical company sells the drug, it will continue to cooperate with the hospital to collect the drug safety questionnaire
.
Mr.
Goto will practice GVP, GPSP
.

For example, as shown in the figure above, under the supervision of GPSP and GVP regulations, pharmaceutical companies need to write RMPs, and carry out a series of investigation plans and PMS monitoring and safety management in the application, approval, sales and review to ensure that the whereabouts of drugs can be traced back to the source and the safety of patients' medications is guaranteed
.

However, before carrying out post-marketing clinical research, hospitals and pharmaceutical companies should carry out relevant preparatory work, mainly including the following steps: First, the sponsor and the main investigator of the PMS must agree to the clinical plan; Second, prepare the application materials; Third, make an application; Fourth, sign the contract
.
All this work is complete before research and investigation can begin
.

In the process of collecting drug safety information in Japan, there are also various challenges
.

For example, some doctors are not very cooperative with the investigation of drug use, mainly because the pharmaceutical company will pay hospital-related expenses for these investigations (e.
g.
, 35,000 to 45,000 yen per case), but the individual doctors do not have any income, so their motivation is not high; After obtaining the prescription, the medical representative fails to actively invite the doctor to assist in the post-marketing investigation, because they are afraid of increasing the burden on the doctor, offending the doctor and thus affecting the doctor's prescription; In addition, it is not easy for medical representatives to meet with doctors, and even if they meet, they cannot communicate in depth, and the report of adverse events is understated; In addition, the personnel of the medical representative has changed, the previous term has not been handed over a good job, and the new medical representative is not able to understand the contents of the survey smoothly, which will lead to the stagnation of the recovery investigation
.

Q&A

Q: What is the difference between a medical representative and a medical commissioner?

A: The main responsibility of a medical representative is to provide accurate academic information related to the safety, efficacy and quality of a new drug and is not allowed to sell the product
.
The main responsibility of the medical specialist is also to provide product information for new drugs, but has the right to sell products
.
There is a division of labor between the two, with the medical representative mainly providing academic information and the medical commissioner mainly responsible for selling drugs
.
In terms of familiarity with the product, the medical representative is much higher than the medical commissioner, so the medical representative usually provides detailed information
directly to the doctor.

Q: There are four major drug wholesalers in Japan, would you please give us a brief introduction?

A: There are about 106,500 medical institutions
in Japan.
Of these, 100,000 are private clinics large and small, and 6,500 are university hospitals or specialized hospitals
.
The four major drug wholesalers in Japan cover 100,000 clinics, but these four major drug wholesalers have allocated 100,000 clinics and will not compete
with each other.
And 6,500 hospitals bid to decide which wholesaler to purchase
.
The government will also directly designate wholesalers to the hospital for docking procurement
.
All in all, the market layout of the four major wholesalers is very clear, without interfering with each other, and the market order is good
.

Q: How is medication guidance for patients in Japan carried out?

A: In Japan, patients are guided by pharmacists in in-hospital pharmacies or out-of-hospital pharmacies, who provide patients with a lot of medication information
.
Another channel is a call center set up by pharmaceutical companies that invites people with a medical professional background to answer consultation calls and guide patients on medication
.
For example, when some more complex medication situations such as insulin that require self-injection arise, patients can call the call center
of the relevant pharmaceutical company.

Q: In the production and sales process, can the personnel in the four important positions (quality control leader, production and sales leader, safety management person, and post-marketing clinical research leader) be part-time?

A: You can't work part-time, each position must be a different person
.

Q: After training qualified people in the call center, what types of documents can they specifically assist in writing?

A: They can help write IFs, FAQs and answers, product information summaries, and instruction manuals, which are basically written
in Japanese.
If you need English, you can ask someone to interpret it
.

Q: In China, drugs are sold from pharmaceutical factories to first-level wholesalers to issue an invoice, and wholesalers sell to hospitals to issue another invoice
.
What about invoicing in Japan? Is it possible to allow multiple layers of wholesalers?

A: There is only one middleman link in Japan, and more wholesalers are not allowed
.
The Japanese government strictly regulates the entry of drug wholesalers into hospitals
.

Q: Are the call centers in the doctor contact platform you described earlier uniform in Japan? Does each hospital have its own system?

A: Each hospital's contact platform is not uniform, and each hospital has its own system
.
In addition, some systems are also developed by enterprises, and different enterprise systems are different, and their characteristics are different
.

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