As presidential candidates debate health reform, the expression “Medicare for All” (“M4A”) is on repeat, yet few appear to understand precisely what Medicare is or what M4A would mean. Even more striking is that Americans are vigorously debating health reform when the ACA – President Obama’s signature legislation and a health reform effort on a scale not seen in decades – turns 10 on March 23. The ACA pioneered universal coverage, but it also ratcheted up health care complexity by building new scaffolding around an old foundation. This fragmented landscape has been exacerbated by a crazy quilt of implementation crafted in the wake of four trips to the U.S. Supreme Court in less than nine years. Even so, measured by the ACA's central goal of universal coverage, studies show successes such as decreased uninsurance rates, improved access to care, reduced health disparities, decreased financial strain, and economic benefits for both states and health care providers – especially in states participating in Medicaid expansion. These findings make the health reform clamor even more notable: why does a broad cry for health reform exist? and what does the public want? This symposium asked whether M4A is the solution. To find an answer, this paper surveys current health reform bills and analyzes the constitutional queries they may face. Part I suggests lessons to be learned from the ACA’s enactment and implementation, contextualized by historic weak spots in American health policy. Part II surveys the structure and approach of each of the major federal health reform bills proposed in 2019, placing them on a spectrum of disruption relative to the current health care landscape and comparing a handful of key state reform efforts. This analysis exposes that most of the legislative energy is directed toward filling the gaps of the ACA by facilitating a new public insurance product, a “public option, and reveals that only one bill actually calls for one comprehensive, single-payer, government-provided public insurance program. The paper then exposes the distance between law and policy (and politics) by evaluating the constitutional implications of these major proposals. Finally, the paper considers whether existing proposals capture the health reform gestalt, which reflects broad desire for administrative simplification, fairness, and lower costs.
코로나19 바이러스의 출현에 따라 전 세계의 제약회사는 치료제와 의약품을 개발하기 위해 전력을 다하고 있다. 의약품의 신속한 개발을 위해서는 제약회사와 규제기관의 협동이 필요하다. 개발 초기 단계부터 제약회사와 규제기관이 함께 계획을 수립하고 이를 진행하기 위한 법적 근거가 필요한데 본 논문에서는 국내 신속심사제도 근거 법령 및 외국의 신속심사제도에 대해...
식품의약품안전처(이하 ‘식약처’라 한다)는 2014년에 “임상시험 및 대상자보호프로그램(Human Research Protection Program, 이하 ‘HRPP’라 한다) 가이드라인”을 배포한 이후, 2017년부터는 식약 처가 정한 기준에 따라 HRPP를 운영하는 기관에게 연구자임상시험, 교육, 자체점검과 관련하여 인 센티브를 주고 있다. 그러나...
