Starting in 2018, the domestic pharmaceutical companies, including medical equipment makers, will have to submit economic benefit expenditure reports concerning their clinical trial contracts signed with universities and university-industry cooperation corps.
That is, drugmakers should make public all the economic benefits they provide to universities through clinical trial contracts, the Ministry of Health and Welfare said.
The ministry plans to distribute a draft of the “guideline for making expenditure report” at the end of this month.
It recently held a meeting of an advisory committee to collect opinions about the guideline. The guideline includes details about how to report details concerning the financial support related to clinical trials.
“The report should focus not on who are formal contract parties but on who will benefit from testing contracts,” a ministry official said. “Even though they make clinical trials contracts with universities or university-industry foundation, you should report it if medical professionals are among the performers of trials.”
In particular, even though the operators of clinical trials aren’t professors at the school of medicine but those at biotechnology departments, the latter should be subject to reporting if they are working in medical institutions, according to the draft guideline.
On the other hand, researcher-led clinical trials that provide rights to researchers, and clinical trials that drugmakers conduct because of legal obligations will be exempt from such reporting.
“Client-initiated clinical trials approved by the ministry are excluded from obligatory reporting because they are done by a law, and submit the similar reports to other related organizations such as the Ministry of Food and Drug Safety (MFDS)식품의약품안전처,” it said.
Also, clinical trials conducted at foreign headquarters will also be exempt from reporting.
“According to the pharmaceutical law, the subjects to submit the report are drug suppliers. Accordingly, foreign headquarters don’t have obligations to hand in the report,” it said.
“Even though the headquarters are main contractors, if the domestic suppliers pay all or part of the costs for clinical trials, they have to submit the report,” the guideline says.
The ministry will finalize the guideline by the end of September.
Beginning next year, medical suppliers, including drugmakers, will have to write and keep an expenditure report if they provide economic profits to healthcare experts, according to the pharmaceutical law revised last December.
The system called the “K(orean)-Sunshine Act” after the Sunshine-Act in the U.S. is designed to improve transparency in selling medical products and equipment and enhance the market’s self-purifying ability in managing and keeping economic profits.
Accordingly, when drugmakers provide samples, support costs to take part in academic conferences, provide food in presenting their products, and support research costs after clinical trials and selling, they have to write a report about “who,” “when,” “to whom,” “how much,” and “what kind of products they provide” while keeping related documents such as receipts or contracts for five years.