Responsibility protection of stakeholders in MCM product distribution under public health emergency

The pandemic and all hazards prevention reauthorization act of 2013 (pahpra act), [1] strengthened the emergency use authority of approved and unapproved MCM productsDue to the related liability protection, it usually depends on the proper authorization of the MCM products usedTherefore, the authority stipulated in pahpra act is very important to protect the torts liability protection of public health stakeholdersPandemics and all hazards prevention and promoting innovation act (pahpaia act), once again clarify the relevant authority[2] The implementation of drug emergency use authority and related liability protection are indispensable conditionsIn the specific practice and development of EUA, responsibility protection plays an indispensable role in promoting the protection of disaster preparedness, emergency response and related personnel[3] < br / > under 42 USC 233 and 28 USC 2679, the Secretary of health and human services or his designee shall, as the case may be, provide public health services to all persons or employees of the public health service, In order to protect the injury caused by the negligence of the relevant personnel, including death, or the relevant personnel working in the office or the scope of work, and performing medical, surgical, dental or related functions (including carrying out clinical research or investigation work); and if the relevant employees are assigned to foreign countries or specified national or political departments or their non-profit organizations, Accordingly, remedies for such damage or damage to the United States as described in 28 U.S.C2679 (b) may be excluded[4,5] < br / > in 2011, the Centers for Disease Control and Prevention (CDC) determined that 15 competencies were used as national standards for public health preparedness planningSince then, these capacity criteria have become an important framework for state, local, tribal and regional disaster preparedness programmes to plan, implement and assess their capacity to prepare, respond to and recover from public health emergencies[6] In 2017, upgrade these capabilities, focusing on language simplification, aligning content with new national standards, evolving scientific research results, and current public health priorities and strategiesThese capabilities also support themes such as fighting influenza pandemics, environmental health, high-risk and tribal populations< br / > ▲ Table 1The 15 capabilities determined by CDC to respond to public health emergencies [6] < br / > MCM product distribution is a core public health preparation capability[6] In case of emergency, the way of large-scale distribution is indispensable for the institutions and personnel who undertake the distribution operationTo effectively address these concerns, as an important part of training for personnel responsible for distributing MCM products or assisting related activities, such as providing support for point of distribution (POD), can help to strengthen the preparedness of response personnel, so as to enhance the community's preparedness for emerging infectious disease emergency or chemical release agent emergency< br / > although the legal consideration is different from the type of personnel mobilized to support the relevant process, the two recurring problems cause the anxiety of institutions and individuals involved in large-scale distributionThese legal issues are related to the authority to issue specific MCM products and the collateral liability of those who issue MCM products< br / > emergency use of MCM products < br / > in addition to the traditional drug review and approval channels, there are several new legal channels, which are conducive to the emergency use of MCM productsThese approaches include the authorization for emergency use (EUA) and, in specific cases, the use of FDA approved MCM products, as well as the FDA approval of new drugs, simplified new drug applications, and medical devices, which are different from those under normal circumstances< br / > MCM product development is facing challenges < br / > in the 1980s, the main emerging infectious disease faced by human is AIDSHowever, since the 1990s, there have been many emerging infectious diseases, recurrent infectious diseases and pandemic eventsThe novel coronavirus pneumonia epidemic situation before(90s: [11])has been threatened by emerging infectious diseases since the last century, and the new infectious diseases have been emerging before the outbreak of the new crown pneumoniaSince the understanding of the pathogens is still going on, MCM products are developing in emergency situations, which are different from the normal development of drugs, and the production and post marketing links are also differentThere is often more uncertaintyHow to ensure that MCM products can be put into use effectively involves many links, such as research and development, evaluation, manufacturing, distribution, distribution, management and use< br / > ▲ Table 2Under the public health emergency, the evaluation of related MCM products under research is different from that under normal circumstances [12] < br / > the consideration of tort liability < br / > before the issue is launched, the legal concepts of liability and tort are introduced firstLiability, in law, refers to the responsibilities and obligations that should be performed according to the law or the principle of justice, including all kinds of absolute, accidental, or possible responsibilities and obligations that can be implemented through litigation in the future; also refers to the actual or possible state of responsibilityThe common meaning of torts in law refers to the illegal acts or damages that violate the rights stipulated by law rather than the contract and lead to litigationIn common law, the infringement is the private interests pursued by the infringed Tort law is the general principle of liability which can be applied to all kinds of cases [13] < br / > after the Hurricane Katrina disaster in 2005, at the end of 2005, Congress passed the public readiness and emergency preparedness Act (prep act), which provided responsibility protection for a series of activities related to MCM product development and delivery and helped MCM product innovation [14] The prep act, which came into force on December 30, 2015, amended the Public Health Service Act (PHS act), adding section 319-f-3, which mainly describes the exemption of liability, and section 319-f-4, which describes the relevant compensation scheme Added statutory content, 42 U.S.C 247d-6d and 247d-6e [15,16] < br / > in addition to addressing the responsibility concerns of MCM manufacturers and distribution agencies, Congress sought to pass legislation to ease concerns about possible legal risks in the distribution, prescribing and management of MCM products [17] Once the relevant liability protection is triggered, it can cover "all participants involved in MCM products" according to the liability protection stipulated in prep act [18] In particular, the prep Act gives the Minister of health and human services the authority to declare that he / she is authorized to be exempt from tort liability for all claims for damages related to specific health problems caused by the management or use of specific MCM products Except in rare cases where death or serious personal injury is caused by "intentional misconduct", immunity is granted, excluding all lawsuits for infringement compensation for losses suffered by MCM product recipients according to federal or state laws [15] < br / > different from other types of decrees involved in the terms of reference of the Minister of health and human services, such as public health emergency statement or statement supporting emergency authorization, prep act statement, which provides specific liability protection for priority MCM products [19] In accordance with the prep act, in order to issue the prep act statement, the Minister of health must determine whether a disease, illness, or threat to public health constitutes a public health emergency, or a specific risk in the future Depending on the severity of the threat, the Minister of Health issued a prep act statement, which may recommend one or more MCM products, specifying the type of medical problems involved in the recommended MCM products, the period of validity of legal protection, the number of people who accept the products, and the restrictions on all geographical areas for distribution management or use (see the table below) The statement could further refine the restrictions on distribution methods, as well as other categories of authorized persons who are qualified to prescribe, manage or distribute MCM products, such as those who are not authorized by the applicable state laws in accordance with the state laws of the relevant state [15] The prep act can be made before public health emergencies, and it can provide exemption for activities before and after public health emergencies < br / > entry of prep statement < br / > the pandemic and all hazards preparedness reauthorization act, pahpra, pub L 113-5, which came into force on March 13, 2013 [1], among other things, The pahpra act complements sections 564a and 564b of the federal food, drug, and Cosmetic Act (FD & C act) to provide new authorization for emergency use of approved products and reserves of related products for emergency use in emergency situations The pahpra act accordingly amends the definitions of "covered pharmaceutical responses" and "qualified products for pandemic and epidemic use" in section 319f-3 (prep Act provisions) of the public health services act (PHS act), so that the prep act statement covers products authorized to be supplied under the relevant FD & C act [3] The pahpra act also expands the definition of qualified pandemic and epidemic products that may be covered in the prep act statement, including products or technologies designed to enhance the use of drugs, biological products, devices for pandemic or epidemic use, or products or technologies for adverse events of related products < br / > ▲ Table 3 The content and legal basis of the declaration of pahpra Act [23] < br / > the liability protection provided by prep act is applicable to the "covered persons" involved in the "covered countermeasures" The prep Act states that all terms are specifically defined to define their scope of protection "Covered countermeasures" include products that have been approved; products that are covered by clinical trials of new drugs (ind applications) or clinical trials of devices (ides); products that have been authorized for emergency use (EUA), or products that have been approved by FDA and approved by pandemics and all hazards prevention reauthorization act of 2013, Pahpra act) is an emergency drug approved for use under the emergency use authority [3] For the management and use of MCM products covered, "covered persons" may include both state authorized medical practitioners who prescribe or distribute them, and other groups designated by the prep act statement itself [1] 4 novel coronavirus pneumonia act, [20] , which is currently in force, is [20] , which takes the bill of PREP act as the example of the new crown pneumonia in January 31, 2020 In January 31, 2020, according to the PHS act 319th, the United States Code of laws forty-second 247d, Alex Minister Azar Azar, was introduced into the public health emergency in January The U.S medical and health community is required to respond to the outbreak of the new coronavirus [22] < br / > in the prep act statement issued on February 4, Minister Azar said that when considering MCM products to be covered, we must consider whether we need to encourage design, development, clinical testing or research, manufacturing, labeling, distribution, formula, packaging, marketing, promotion, sales, procurement