Gov't will specify scope of expense report details disclosed

By pharmaceutical companies under the K-Sunshine Act by April

Report to be submitted by June... will be disclosed on the HIRA webpage in December

MOHW “Collected industry opinions at the recent meeting with doctors, pharmacists, pharmaceutical companies, and medical device companies"

Has not decided whether to disclose names of doctors and hospitals…"Is struggling between the public’s right to know and infringement of private interest”

The Ministry of Health and Welfare recently met with physician and pharmacist organizations and the pharmaceutical, biotech, and medical device industries to collect opinions on setting the ‘scope of disclosure of expense reports’ that are prepared to report the expenses legally paid by pharmaceutical and biotech companies and medical devices to doctors and pharmacists.

 

At the meeting, doctors' and pharmacists' organizations and the pharmaceutical, biotech, and medical device industries expressed their opinions that disclosing too much detailed information, such as the names of doctors and pharmacists and medical institutions, could lead to privacy violations or leakage of trade secrets.

 

After reviewing the submitted opinions and consulting with legal experts, the MOHW plans to hold another meeting with medical and pharmaceutical organizations and the pharmaceutical, biotech, and medical device industries next month to deliver the final scope of information that will be disclosed in the expense reports.

 

An MOHW official explained so regarding the government’s expense report disclosure system at a meeting with the press corp.

 

The expense report on economic interests is a system that creates and stores information on items legally provided by pharmaceutical companies, medical devices, distributors, etc.

 

to doctors and pharmacists to improve transparency and self-regulation of drug and medical device transactions.

 

The system was introduced to Korea in 2018 and is known as the 'K-Sunshine Act' after a similar law in the United States.

 

The scope of disclosed information in expense reports in the pharmaceutical, bio, and medical device sectors is a hot topic in the healthcare industry.

 

This is because the disclosed information can directly or indirectly affect the activities between doctors and pharmacists and companies depending on whether the names of doctors and pharmacists, names of medical institutions and pharmacies, and license numbers are included.

 

The MOHW is pondering over disclosing the list of doctors and pharmacists.

 

The MOHW explained that it is seeking advice from legal experts including law firms, as there is potential for legal disputes due to the clash of private and public interests as individual and corporate information is disclosed.

 

Under the current law, 7 categories of economic benefits are allowed to be provided to healthcare providers: sample products, support for academic conferences, support for clinical trials, product presentations, discounts under pharmacy payment terms, post-marketing surveys of medical devices, and use for performance verification before purchase.

 

The MOHW held a meeting with providers including the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Medical Devices Industry Association, as well as the pharmaceutical, biotechnology, and medical device industries, to finalize the scope of the disclosed information on expense report on legitimate economic interests.

 

At the meeting, the providers requested a conservative scope of disclosure, citing concerns about privacy violations and trade secret leaks.

 

The ministry plans to deliver and finalize the scope of information disclosure, including whether to disclose the list of doctors, at a meeting in April after internal review and external legal advice.

 

A MOHW official said, "For example, for conferences, only the amount supported and the name of the conference is disclosed in the expense report.

 

For product briefings, the amount supported and the list of attending doctors are disclosed.

 

"For medical devices, the list of doctors in charge without the amount supported is disclosed to obtain MFDS approval.” The official added, "We plan to disclose the amount of money spent to check the performance of medical devices.

 

However, whether to disclose of the list of doctors will be finalized after internal discussions.

 

If the pharmaceutical, biotech, and medical device industries submit their 2023 expense reports by June, the information will be disclosed on the HIRA’s website by the end of December.” “The Ministry of Health and Welfare will actively promote the disclosure of information about the expense reports by preparing pamphlets for conferences and other events to spread awareness.” Meanwhile, on December 29 last year, the MOHW first disclosed the results of a survey on expense reports on economic interest (expenses) legally provided to doctors and pharmacists in 2022 by pharmaceutical companies, and medical device distributors.

 

At the time, a total of 11,889 pharmaceutical and medical device companies submitted data, of which 3,274 companies provided economic benefits.

 

The amount of benefits provided amounted to KRW 808.7 billion in monetary value, and to 20.47 million items in terms of products.