[사회]Deregulation of’Dodoli Pyo’… damage is ultimately to patients

[앵커]

YTN, which is reporting in-depth reports of the suspicion and controversy surrounding stem cell treatment, yesterday reported the case of an elderly man in his 70s who died after an unauthorized stem cell treatment.

Even though stem cell treatments that have not been tested for safety and effectiveness have been carried out in such a way, the government is still trying to ease regulations.

This is reporter Seung-Hwan Kim from the Planning and Exploration Team.

[기자]

Unauthorized stem cell treatment in the blind spot of law.

The hospital’s art of crossing the line between legal and illegal attracts desperate patients.

[이 모 씨 / 무허가 줄기세포 치료 환자 가족 : 보약 형태로. 나머지 질환들도 다 완치가 되고 도움을 준다. ‘호밍 효과’로 인해서 안 좋은 데가 있으면 따로 찾아갈 거니까….]

It is patients who end up suffering damage from expensive stem cell treatments that have not been proven to be safe and how effective they are.

[이 모 씨 / 무허가 줄기세포 치료 환자 가족 : 처음에는 환청이 들리신다고 했고, 온몸에 두드러기 나고, 살결 다 벗겨지고 환각 증상까지 보이셨고. 점점 부작용들이 심해지니까 그리고 마지막 투여받고 나서 (돌아가셨어요.)]

There is no place to rely on the damage.

As the government loses its hands on the management of stem cell therapy, it is only busy to shift responsibility.

[이 모 씨 / 무허가 줄기세포 치료 환자 가족 : 식약처로 전화하든 보건복지부에 전화하든 줄기세포에 관한 법령은 자기들이 관할하는 게 아니다 그러면서 다른 부서에 연결하고….]

The management responsibility for stem cell treatment is divided into the Ministry of Health and Welfare and the Ministry of Food and Drug Safety.

If cells have been cultured, they are classified as therapeutics and are managed by the Ministry of Food and Drug Safety from approval review to post-marketing management.

[보건복지부 관계자 : 치료 목적은 병원 지정받고 지정된 병원 하에서만 저희 관리 체계 안에서만 가능합니다.]

However, advanced bio fields such as stem cells have been neglected because the classification system for the stability of raw materials is ambiguous.

[보건복지부 관계자 : (줄기세포 치료는) 국가가 제대로 개입을 못한 상태거든요. 그리고 제도와 법이 명확하지 않으니깐 공무원들도 움직이기 어려운 거죠.]

That’s why the’Advanced Regeneration Bio Method’ was created.

It means that the state will actively intervene and manage high-tech medical fields such as stem cell therapy, and the existing conditional licensing system, which allowed obtaining approval without going through phase 3 clinical trials, was maintained under the name of’expedited processing’. There are also concerns that the room for opinions to be reflected is greater than before.

[임현우 / 가톨릭중앙의료원 임상연구지원센터 교수 : 근본적으로 효과가 있는 약을 사람들한테 주겠다는 개념이 흐트러지면 안 되는 거예요. 그 개념에서 모든 것이 추진돼야 하는 거죠.]

From the Roh Moo-hyun administration to the Lee Myung-bak and Park Geun-hye administrations, successive governments have been criticized for fostering the stem cell field from an overly industrial perspective.

It is pointed out that related policies should be promoted in a direction that will ultimately benefit the public’s health by solidifying the foundation, but the government seems to have not changed much.

[이명박 / 당시 대통령 (2011년 9월) : 이런 (줄기세포) 분야가 좀 진취적이어야 합니다. 너무 보수적이어서도 안되고….]

[정세균 / 국무총리 (지난달 3일) : 첨단재생의료는 (난치병 환자들에게) 새로운 희망이 될 수도 있을 것입니다. 그렇지만 국내에서는 여전히 규정에 막혀서 환자들이 해외 원정치료를 선택하고 (있습니다.)]

Simplifying unnecessary processes and lowering the threshold of permits and approvals are quite different.

The United States and Europe, which are medically advanced countries, are striving to streamline the licensing process while still adhering to the licensing principle of’reasonable medical evidence’.

This is YTN Kim Seung-hwan.

[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]