新型重大傳染病之預防接種及藥害救濟法制改良芻議——從嚴重特殊傳染性肺炎為例

A preliminary exploration on regulation of vaccination and medication injury compensations program during a novel pandemic crisis–Using COVID-19 pneumonia as a special model

自古以來，傳染病即為人類社會健康的重大威脅之一。即使現今已有許多抗生素或藥物可供疫病的治療，仍無法完全消滅傳染病的存在。此外，隨著全球交通的拓展，新興傳染病一但出現，往往會快速散播，造成大量的傷亡。過去的SARS，新型流感，或2019年出現的嚴重特殊傳染性肺炎等都是因此造成全球性的大流行。因此，為了減少疫病造成的傷亡，有效的預防接種制度配合藥物治療，才能將疾病對社會的損害降低。
然而，不論是染病後的藥物治療，或預防疾病而施打的預防接種，都有可能因非預期性的副作用造成病患健康狀況受損；嚴重者可能會致死或是致殘。我國目前設有藥害救濟法及預防接種受害救濟基金徵收及審議辦法，針對正當使用藥物或接受預防接種下的受害者進行相關的救濟及補償。除了對正當使用藥物病患的權益保障外，更重要的是促進社會公共衛生的保障。主要原因為，要達到有效阻斷疾病傳遞的群體免疫門檻，必需有足夠的健康民眾願意施打預防接種；但對原本健康的民眾而言，因為公眾利益而施打疫苗，有可能因為副作用造成個人健康權的損害，此為行政法上的侵權行為，符合國家因公益需求的特別損害理論。因此，國家需要對接受預防接種的民眾提供適度的保障及損害補償，才能對民眾健康權的可能損害進行保障。
有鑒於此一觀念，我國及許多先進國家，如美日韓等，均因應各國的預防接種制度而有設計其補償措施；但因國情不同，補償金來源，疫苗種類，副作用的補償範圍與金額等均有所不同，但保障的疫苗範圍多以各國ACIP會議建議應常規施打的疫苗為主。然而，於嚴重特殊傳染性肺炎造成的公共衛生危機下，因快速造成大量病患死亡，故以傳統的藥物及疫苗臨床試驗審查時程而言，無法滿足目前緊急疫病控制的需求。因此，各國多以緊急授權使用(EUA)的方式，讓已有完成一定程度安全性及臨床效果驗證的藥物及疫苗，緊急提供民眾做為治療及預防接種使用，才能面對瞬息萬變的疫情。
然而，因現行的藥害救濟及預防接種制度多屬於保障核准使用的藥物與疫苗在臨床上的正當使用。對於緊急核准或進口的藥物及疫苗，是否仍可依尋上述管道尋求救濟，不無疑異。參著國外諸國的制度而言，美國在PREPA緊急事態法案下，緊急授權使用的藥物及疫苗均可由聯邦的經費進行保障與救濟；日本與韓國制度雖有不同，但是也經由修正國內的預防接種法或修正疫苗審議小組的建議等方式，將嚴重特殊傳染性肺炎疫苗的預防接種受害者納入原有的補償體系中。我國的預防接種損害補償制度，短期可以藉由比照日韓等方式，納入常規接種建議中；但以中長期而言，考量未來仍可能有新型態疫病或緊急事態需求，應比照美國制度，規畫成立緊急制度法案，將緊急狀況下所需的避難措施，如藥物，疫苗等，都可在緊急輸入或製造下，提供對民眾更完整的保護及補償措施，應為我國未來修法的方向。

Infectious diseases outbreaks were used to be the major threats to human lives. The innovation and development of antibiotics, though could reduce the mortality rates of some infectious disease, still failed to eradicate them. Besides, the convenience of global travel can facilitate the transmission of infectious diseases and lead to massive causalities. Previous pandemic associated with SARS, novel influenza, and current COVID-19 outbreaks were excellent examples. Therefore, in order to reduce the causalities from these transmittable diseases, effective vaccination program along with proper medical treatment are the best strategies to control the death tolls.
However, despite of the clinical benefits of medication and vaccines, we cannot neglect the potential adverse effects from their clinical use. Unexpected adverse events will, not only result in short-term health impacts, but also lead to permanent disabilities or even death occasionally. In Taiwan, we had Drug Injury Relief Act and Regulations Governing Collection and Review of Vaccine Injury Compensation Fund to compensate for the torts of the victims under proper medication or vaccines use. These Acts and Regulations, not only provide proper protections for the civilian health rights, but also promote the advances of the goodness of public health. The main reason is the so-called “herald immunity.” For each infectious diseases, it is vital for us to break the transmission chain before we can control the outbreak. The concept of “herald immunity” is the threshold of people with proper immunity to stop the transmission chain. The immunity can be resulted from natural infection or vaccination. In order to stop the pandemic, most of the healthy individuals should be vaccinated to maintain the herald immunity, which can provide additional protection to those who could not be vaccinated. However, since these immunization program may lead to some unwanted injuries to the healthy individuals, the government should provide adequate protection and compensation to maintain the civil rights of health.
Most of the developed countries, take Unites States, Japan, and Korea as examples, have their own vaccine injury compensation programs, though there are some differences in the funding source, covered vaccine types, range of adverse events, and the compensation amount for their loss. However, generally the ACIP-recommended vaccines are covered by the VICP program in each country. These vaccines were properly reviewed and approved by local FDA. However, during the COVID-19 era, the urgency of effective medication and vaccines shortened the essential time for clinical trials. Since the clinical trials were shortened and failed to provide adequate long-term safety data, the FDA in most countries elected to issue Emergent Usage Authorization (EUA) instead of a regular approval licensure since it can speed the rapid access of vaccines and medication before a complete review.
However, despite of the existence of current Drug Injury Compensation Act and vaccine injury compensation programs, it would be problematic if it could be applicable to medication or vaccines under EUA status. In Unites States, medication and vaccines under EUA status could not be compensated by regular VICP programs. Instead, PREP Act, which was funded by Federal government, could provide compensation of vaccine and medication associated adverse events under emergent situation as declared by the Department of Health and Human Service. Japan and Korea also declared Amendment to incorporate the COVID-19 Vaccines to their VICP (Vaccine Injury Compensation Program )structure after their ACIP(Advisory Committee on Immunization Practices) declared the essence of COVID-19 vaccines. In short-term, we should strengthen our VICP laws to incorporate EUA vaccines into our compensation system. In the long run, we should establish a PREPA-like system to accommodate for emergency situations like natural disaster, war, bio-hazard situation, or a novel pandemic like COVID-19 or SARS. It could provide a broader and more complete protection during an emergency situation.