In 2019, another
unprecedented incident caused new fears and anxieties among consumers: the Ministry
of Food and Drug Safety (MFDS) revoked the license of Invossa-K Inj.
(hereinafter “Invossa”), the world’s first therapeutic drug for degenerative
osteoarthritis developed by Kolon Life Science Inc. (hereinafter “Kolon”), after
its belated acknowledgement of Kolon’s false data reporting. Nowadays, we
consumers cannot even be sure of the reliability and safety of medicines due to
Kolon’s deceptions and the MFDS’s incompetence.
Therefore, 11 member
organizations of the Korean National Council of Consumer Organizations (KNCCO),
due to their deep concern regarding the Invossa crisis, are urging emergency
measures which are necessary for the safety of patients.
First, the government must use its best efforts
to confirm a list of the patients treated with Invossa.
According to a press release from the MFDS,
3,707 local patients were administered with Invossa in 437 hospitals, among whom
1,040 subjects have registered via
the 245 medical institutes as of May 27, 2019. However, the number of the
victims should be accurately confirmed for the purpose of investigations in
relation to the criminal charges against Kolon and a civil class lawsuit of the
patients. The hottest issues in this incident will be the specific amount of
damages and proving causation; thus, it is important to find and to register the
remaining 2,667 subjects in the system. The problem is that it is highly likely
that the unregistered patients do not know they have been injected Invossa, or else
they not know how and where they should report the damage. Hence, we can’t just
keep waiting for the patients to appear by themselves. The medical institutes involved
may also be avoiding active cooperation to find the subjects, since they may
feel guilty for recommending and administering this expensive drug (KRW 5 to 7
million) not covered by the National Health Insurance to patients. Our demand
is that the government of South Korea, instead of the health authorities,
should enforce the demand for a list and information on all the patients
treated with Invossa.
Second, a fair investigation and severe
punishment against those in charge are the things most required for further
improvement of the system.
The MFDS has promised that such an incident will
never happen again due to the development of an advanced approval system with
the appropriate solutions including patient safety measures. It is the MFDS’s
duty to prevent such incidents threatening public health and safety. But the things
we need to do first and foremost, which will lead to an actual enhancement of
the system, are as follows: to accurately determine the instances of illegality;
to identify who will take responsibility; and to impose a severe punishment to
those in charge for their incompetence and violation of due diligence. Kolon
falsely submitted data while the MFDS approved the drug based only on the
documents filed by Kolon, without any other review or monitoring processes; thus,
Kolon’s willful fraud and the MFDS’s gross negligence must have an equal share
of the blame. They will learn from what they have done by a thorough
investigation and disciplinary actions alone, which must be undertaken before developing
further remedies if the government wants to inform the public of accurate
facts, ease the consumers’ anxiety and restore public confidence.
Although there is nothing more important than people’s
health, lives and safety, the media have focused on pointless issues such as the
“World’s First Therapeutic Drug”, “Research Funds over KRW 10 Billion” and
“Stock Prices” pertaining to the Invossa incident. What we have to remember is
that thousands of civilians have suffered physically and mentally due to
Kolon’s shameless misconduct and the MFDS’s ineptitude. Hence, we demand justice
for the peoples – we demand that the government addresses our needs with a thorough
investigation and disciplinary actions, as well as by developing an enhanced
management/supervision system for the approval of foods and drugs.