U.S. pharmaceutical company Eli Lilly will launch the diabetes and obesity treatment 'Mounjaro' (known as Zepbound in the U.S.) in Korea in mid-August. Mounjaro reduced average weight by 20.2% at 72 weeks in a phase 3 trial involving obese adults without diabetes. Given that its competitor Wegovy had already achieved a 15% weight loss in just 68 weeks, the domestic launch has garnered significant attention.
However, domestic daily newspapers, economic news outlets, and broadcasters failed to report it in a timely manner. Eli Lilly's Korea division distributed a press release announcing the domestic launch of Mounjaro only to medical publications on the 23rd of last month. This situation mirrored that of Denmark's Novo Nordisk when it launched Wegovy in October of last year.
On the 8th, patient groups, as well as pharmaceutical companies and the medical community, protested that in an era when conversational artificial intelligence (AI) can search and provide information on all medications in the world, it is illogical for drug information to be disclosed only in a limited manner. While the concern is due to potential misuse of drugs, it is difficult to understand as the largest pharmaceutical market in the world, the U.S., freely allows professional drug information in advertisements and places no restrictions on pharmaceutical companies' promotional media.
◇Regulation of the AI era established 34 years ago under the Pharmacists Act
The basis for pharmaceutical companies restricting the provision of drug information is the Pharmacists Act. Article 68, Section 6 of the Pharmacists Act stipulates that professional medications, excluding vaccines, can only be advertised in medical journals or information provided to professionals. Exposing such information to the general public poses a significant risk of drug misuse.
The introduction of Article 68 to regulate drug advertising was established in 1991. At that time, exposing the names of active ingredients or product names in general media was considered advertising and was restricted. While exceptions might be made for public health information when ingredient names are unavoidable, this must be coordinated in advance with the Ministry of Food and Drug Safety or the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA).
Because of this provision, pharmaceutical companies have limited the distribution of press releases containing information about the launch of professional medications or insurance coverage and have excluded daily newspapers and broadcasting companies from press materials and media briefings. The situation remains the same, even after 34 years since the regulation was established.
In April, the Korean division of Johnson & Johnson (J&J), known as Janssen Korea, held a press briefing to introduce the combination therapy of the non-small cell lung cancer treatment 'Rybrevant' (active ingredient amivantamab), announcing the news only to medical publications. At this event, domestic hematology-oncology professors explained the combination treatment.
The drug used in conjunction with Johnson & Johnson's Rybrevant is Yuhan Corporation's new drug, Lecarz (lazertinib), which was the first domestic anticancer drug to enter the U.S. market. Thus, it garnered considerable interest from domestic patients and investors. While expert explanations were needed on how this combination therapy was received in actual medical settings, there were restrictions on the dissemination of such information to the public.
Although there are no statements in the Pharmacists Act or the Ministry of Food and Drug Safety advertising guidelines that consider the distribution of press materials to daily newspapers as advertising or explicitly prohibit it, both domestic and international pharmaceutical companies cite strict legal systems as their reason. They have no choice but to minimize the risk of being excluded from the eyes of regulatory authorities or facing issues raised by competitors.
The pharmaceutical industry claims that unless the Ministry of Food and Drug Safety provides clearer guidelines or the government and National Assembly take action, it is difficult for them to voice their concerns. However, the Ministry explained that whether the level of information provided constitutes advertising or informational disclosure is a matter for each corporation to review on a case-by-case basis, effectively leaving them unregulated.
Jeong Ji-yeon, Secretary General of the Consumer Alliance, stated, "Even for professional medications, system improvements are necessary to ensure that objective facts such as approvals and insurance coverage can be communicated widely through the media," adding that "the lower the accessibility to information, the narrower the patients' choices may become."
◇Need for legal system improvements in line with changes in the media environment
The largest pharmaceutical market in the world, the U.S., is different from ours. It legally allows advertising for professional medications aimed at the general public. Advertising that compares competitive drugs and their efficacy is also possible. The intent is to enable patients to more easily access drug information and actively communicate with healthcare providers during the medication selection process.
A domestic pharmaceutical industry official remarked, "It is contradictory that access to information in medical publications is not restricted just to licensed professionals like doctors and pharmacists, while such information is widely available on internet portal sites," adding that "it is an outdated regulation that does not fit reality, yet no one is addressing it."
An official from a global pharmaceutical company stated, "When the media environment changes, the legal system must also be improved to match reality." For instance, in the past, daily newspaper reporters were not allowed to use the names of drug ingredients in articles, but this has effectively become obsolete as the media environment has changed, with most outlets now using both product and ingredient names in articles.
The industry calls for more rational and clear guidelines that reflect the opinions of patients, who are stakeholders in healthcare, and pharmaceutical companies. An official from the Korean division of a global pharmaceutical company stated, "Pharmaceutical companies are in a subordinate position, needing to undergo evaluations and examinations by regulatory authorities, so how can they voice their opinions?" but also emphasized that "for the sake of communication with patients, it is necessary to revise the law."
There were also opinions suggesting the need to selectively allow advertising based on disease categories. Professor Kim Yang-hyun of the Department of Family Medicine at Korea University Anam Hospital stated, "I agree that highly关注medications like anti-obesity drugs may have some advertising effects that make them appear like general medications when aired on broadcasts or in daily newspapers," but emphasized that "basic information such as launches and approvals must still be provided."
Professor Kim noted, "While the U.S. broadly advertises professional medications in the media, South Korea has stringent regulations to the extent that information is limited even to healthcare professionals regarding psychoactive drugs," suggesting that "it might be a good idea to allow related legislation gradually by disease category."
Lee Eun-joo, a professor at the Gynecologic Cancer Center of ChungAng University Hospital, stated, "As the amount of unverified or distorted information online is increasing, it is becoming increasingly important to accurately inform and convey information about professional medications and the latest treatments."