[전문] 바른의료연구소가 세계보건기구(WHO) 사무총장에게 보낸 서신

존경하는 세계보건기구 사무총장님께, 

최근 대한민국에서는 고어사가 독점 공급하던 소아용 인공혈관의 재고가 소진되면서 수술이 필요한 환자들이 수술을 받지 못하는 사태가 벌어졌습니다.

대한민국의 보건복지부 장관은 이번 사태를 다국적 의료회사의 독과점 횡포의 문제로 규정하고는 5월 WHO 총회에서 이 문제를 정식 아젠다로 제기하겠다고 발표했습니다.

하지만 고어사가 대한민국에 소아용 인공혈관 공급을 중단한 것은 독과점 횡포의 문제가 아니라는 것이 대한민국 의료 전문가들의 의견입니다. 고어사가 인공혈관 공급을 중단한 이유는 낮게 책정된 보험수가와 제조사에 부담을 주는 제조 및 품질관리(GMP)제도 때문입니다.

고어사가 공급을 중단하기 전인 2016년에 대한민국의 인공혈관 수가는 46만원이었습니다. 그런데 그 시기에 미국은 약 82만원, 중국은 147만원으로 인공혈관 수가가 책정되어 있었습니다. 결국 대한민국은 미국의 절반, 중국의 1/3에도 못 미치는 수가를 책정해 놓고 있었던 것입니다.

그런데 이 가격도 과하다고 판단한 대한민국 정부는 추가로 19%가량을 삭감하겠다고 고어사에 통보하였습니다. 또한 3년 주기로 실시하는 GMP 실사에서 기업의 영업 비밀을 포함한 방대한 자료를 요구하는 횡포도 부렸습니다. 이에 더 이상 견디지 못한 고어사는 2017년 2월 대한민국에 공급 중단을 선언하면서 철수했습니다.

고어사의 공급 중단 발표 직후 대한민국의 흉부외과학회 및 의사들은 수술 중단 사태가 발생할 우려가 높음을 정부에 경고하고 대책을 요구했었습니다. 하지만 약 2년 간 정부는 아무런 대응도 하지 않았습니다. 2년 동안 인공혈관 공급 재개를 위해 고어사와 접촉했었다고 발표했지만 고어사는 그런 일은 없었다고 밝혔습니다. 결국 대한민국 정부가 자신들의 잘못을 감추기 위해 거짓말을 한 것입니다.

결국 2년의 기간 동안 대한민국의 병원들이 확보하고 있던 인공혈관의 재고가 바닥나면서 수술 중단 사태가 현실화되자 그 때서야 대한민국 정부는 고어사와 접촉을 했습니다. 이 사태의 핵심은 독과점 기업의 횡포가 절대로 아니며, 오히려 대한민국 정부의 의료시장에 대한 과도한 규제와 횡포가 원인입니다.

대한민국 정부는 의료에 대해서 자유를 인정하지 않는 과도한 규제와 억압 정책을 펼치고 있습니다. 대한민국 정부의 이러한 규제로 인해서 반드시 필요한 치료나 약제 처방을 받지 못하는 환자들이 많이 있습니다.

또한, 아래의 그림에서도 볼 수 있듯이 극단적으로 낮은 의료 수가로 인해서 의료 행위에 대한 적절한 보상을 받지 못하는 의료기관들은 경영난에 힘들어하고 있습니다. 낮은 수가로 인해서 폐업하는 의료기관들이 늘어나고 있고, 이는 결국 국민들의 의료 서비스 이용 기회도 줄어들게 만들어 건강에 악영향을 미치고 있습니다.

이러한 문제는 전세계인의 건강을 책임지고 있는 WHO에서도 심각하게 경고해야 할 사안으로 생각됩니다. 따라서 다가오는 5월 총회에서는 대한민국 보건복지부 장관이 주장하는 ‘다국적 의료회사의 독과점 횡포’를 아젠다로 삼을 것이 아니라, 자국민의 건강에 심각한 악영향을 주는 ‘대한민국의 관료적 의료정책과 횡포’를 아젠다로 삼아 주실 것을 부탁드립니다. 
 
Dear Dr Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO)

I, on behalf of the Barun Medicine Institute, would like to appreciate your overall effort, as the Director-General of the WHO, to promote health, keep the world safe, and serve the vulnerable.

As you may or may not have been made aware, an unfortunate crisis is unfolding in South Korea. Pediatric vascular grafts, which are indispensable devices for correcting congenital cardiac abnormalities, are nearly depleted in our country, resulting in indefinite postponement of such procedures. In response, the S. Korean Minister of Health and Welfare, Park Neung-Hoo, announced recently that this crisis was solely attributable to the monopoly and tyranny of Gore-Tex, a multinational medical device company based in the U.S., which manufactures and distributes vascular grafts. The S. Korean Minister further stated he would call for this issue to be discussed as official agendum at WHO World Health Assembly to be held in May.

The S. Korean medical community, however, has a differing opinion on the root cause of this crisis. Gore-Tex withdrew its operation from S. Korea, only after S. Korea unilaterally lowered reimbursement rates for vascular grafts, and imposed on the manufacturer a burdensome regulatory policy for quality control known as Korean Good Manufacturing Practice (KGMP). KGMP applies to all high-risk medical devices, both foreign and domestic; what is unusual about KGMP, however, is its reimbursement policies.

Even before 2017, which was when Gore-Tex decided to pull out of S. Korea, its reimbursement rate for vascular graft was set far lower than in other countries. S. Korea was paying $420 for each, whereas People's Republic of China was paying $1,330 and the U.S. $745. That is, S. Korea was paying less than one third of the price China was paying and a little more than a half of what the U.S. paying the manufacturer.

Even more puzzling was that the S. Korean government was still not happy with such deeply discounted price. In 2016, the government informed Gore-Tex unilaterally that it would pay even less -- 19% less -- for vascular graft. Furthermore, using the inspection clause in KGMP, it demanded Gore-Tex submit all of its operational documents relevant to S. Korea, including confidential information. In February of 2017, Gore-Tex announced its withdrawal from S. Korean market and closed its operation permanently.

Immediately thereafter, cardiovascular surgeons and other doctors in S. Korea pleaded with their government to come up with an alternate plan for procuring vascular grafts, while warning of the dire consequences once the existing supplies run out. Unfortunately, the government had not taken any action on these requests over the last 2 years (and the existing supplies did run out).

The most egregious of all, however, happened just recently. The S. Korean government, through its press release, stated that its officials had been negotiating with Gore-Tex over the last 2 years. Gore-Tex denies this report. In other words, the S. Korean government attempted to cover up its ineptitude with an inept lie on its press release. Of course, it was the same ineptitude that has led to the present crisis clearly foreseen and forewarned by the surgeons and other doctors 2 years ago. The government did contact Gore-Tex but only recently -- only after the crisis has become clear and present.

As can be clearly seen, the monopoly and tyranny never resided with the multinational U.S. manufacturer. Instead, the monopoly and tyranny were (and have always been) the two defining attributes of the S. Korean government's regulation of its medical industry. With excessive and whimsical regulations, the S. Korean government has long oppressed the country's physicians, drug companies, and medical device companies, even at the point of harming patients as this current crisis amply demonstrates. In fact, there have been numerous such patients denied of needed procedures and medications; those patients were simply not as well publicized.

In this current environment, it is not just foreign companies who decide the risk is not worth the reward. As the table below shows, many S. Korean doctors are struggling to keep their clinics open, with an increasing number of them having to declare bankruptcy. This, of course, further limits access for patients, thereby demoting (rather than promoting) general health of the nation.

Ultimately, this is the grounds on which we stand and write this letter to you, Director-General of WHO, the regulatory body of its member nations. We would like to make you aware that such ill-conceived policies of excessive regulation and low reimbursement in S. Korea's medical industry have resulted in actual harm of its people. Again, its Minister of Health will attempt to discuss as an official agendum the monopoly and tyranny of multinational medical device manufacturers. Again, in the eyes of countless citizens of S. Korea, the monopoly and tyranny have always resided with the S. Korean government itself, with its excessive regulations of and low reimbursement for doctors, drug companies, and medical device companies. That shall be adopted as an official agendum to be discussed at WHO World Health Assembly in May, we respectfully request.

With best regards,
Director of the Barun Medicine Institute

*Barun Medicine Institute was founded in February 2017 in Seoul, South Korea by a group of young physicians, with the aim of in-depth analysis of the faulty health care plan or policy which endangers the public health, thereby providing the right direction for the better public health.