Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.

BACKGROUND: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward. METHODS: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session. RESULTS: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process. CONCLUSIONS: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

Recent Australian Legislative Developments in the Regulation of Assisted Reproductive Technology.

This section considers the recent resurgence of regulatory interest in the field of assisted reproductive technology (ART) practices focusing on the new legislative framework in the Australian Capital Territory (ACT). It provides an overview of the Australian regulatory framework in this field and considers how the new legislation in the ACT sits alongside this framework. A detailed overview of the key provisions of the ACT legislation is provided, before considering whether the legislation goes far enough in addressing some of the more controversial issues in the field of ART.

Congress Must Update FDA Regulations for Medical AI.

This JAMA Forum discusses pending legislation in the US House and Senate and the history of the "firm-based approach" the US Food and Drug Administration (FDA) could use when regulating artificial intelligence (AI) medical devices to augment patient care.

Challenging Pennsylvania's Firearm Preemption Law as a Public Health Danger: The Case of Philadelphia.

Firearm violence has soared in American cities, but most states statutorily preempt municipal firearm regulation. This article describes a unique collaboration in Philadelphia among elected officials, public health researchers, and attorneys that has led to litigation based on original quantitative analyses and grounded in innovative constitutional theories and statutory interpretation.

Deciphering Discord: How Conflicting Information and Political Ideology Shape Public Attitude Toward PFAS Regulation.

Per- and polyfluorinated substances (PFAS) contamination is an emerging environmental and health risk facing the world. This study examines the impact of conflicting information on Americans' attitude toward PFAS regulation and intention to engage in mitigation behaviors through a one-way, between-subjects experiment. Participants were 1,062 U.S. adults recruited from CloudResearch. Results showed that compared to participants exposed to consistent information, those exposed to conflicting information displayed less favorable attitude toward existing regulation, which led to lower intention to support related policies and to engage in mitigation behaviors. Political ideology moderated these relationships, with stronger experimental effects among conservatives. These findings underscore the importance of conveying consistent risk messages, especially when multiple stakeholders are involved.

Untested Stem Cell Treatments: An Analysis of Australia's Current Regulatory Regime.

Stem cell therapies have emerged as a miracle cure that could treat diseases and conditions. The past decade has seen the rapid growth of private clinics in some nations, including Australia, offering stem cell treatments largely untested and unsupported by clinical trials. These putative treatments have caused adverse events, some of which were serious and even fatal. The unscrupulous businesses exploit vulnerable and desperate patients who falsely believe these unproven therapies are their only salvation to cure different illnesses and conditions. This article emphasises the importance of strict oversight to ensure that only safe stem cell products reach patients, given the largely vulnerable patient base and the magnitude of risks involved. It examines the effectiveness of Australia's regulatory environment governing stem cell therapies to restrict the advertisement of dangerous and unproven stem cell therapies and the enforceability of these measures.

The Anatomy Act 1977 (NSW) Dissected: Review and Reform.

This column discusses the Anatomy Act 1977 (NSW) and its regulatory environment. The column begins with examining the history of anatomy regulation in the United Kingdom and Australia. It then goes on to analyse the history of the current anatomy regulation in New South Wales, pointing out areas for reform.

Research on emerging infectious diseases: pros and cons of centralised government controls.

As the world grapples with the constant threat of new pathogens, the role of government oversight in research and response efforts has become a topic of considerable debate in the academic community. In the recently released "SOP [standard operating procedure] for Nipah virus research in Kerala for studies involving human participants / human samples" by the Government of Kerala, the SOP, apart from administrative permission, requires the proposal to be cleared by the Institutional Research Committee at a Government Medical College, and the inclusion of an investigator from a government institution [1]. In these challenging times, it is crucial to weigh the pros and cons of stringent administrative controls to ensure an effective and ethical approach to tackling emerging infectious diseases.

Road To Deceased Donor Transplantation in Egypt.

In Egypt, there is presently a growing need to have a deceased donor transplant program. Egypt conducted its first kidney transplant from a living donor in 1976 and a first partial liver transplant in 2001. Since 2009, the Egyptian Health Authorities Combat Transplant Tourism in concordance with ethics codes and the Declaration of Istanbul Custodian Group has been in place. The Egyptian Transplantation Law of 2011 mentions that organs could be procured from deceased donors based on a will and on family consent. This law has had many critics, including religious authorities who have stressed that organs cannot be taken from a person with brain death because, in their view, life ends with death of all organs. Many intensivists disagree over the definition of death. In addition, the media has communicated contradicting and sometimes misleading health care information. Mummification is rooted in pharos practice and linked to religious beliefs. The ancient Egyptians believed that, by burying the deceased with their organs, they may rejoin with them in the afterlife. Since 2019, the transplant community in Egypt has started collaborations with international transplant organizations and campaigns with doctors and celebrities to donate their organs after death, which have stressed that a deceased donor program could help against end-stage organ mortality. In November 2022, after communications with politicians, President Abdelfattah El Sisi directed the government to establish a regional center for organ transplantation, which aimed to be the biggest in the Middle East and North Africa region. The new center will be part of a new medical city that would replace Nasser Medical Institution in Cairo, Egypt. The Ministry of Health issued an official form to be signed by a person before his death, accepting use of organs, to give hope and support to other patients in need.

Organ Donation in Syria.

The first living donor kidney transplant in Syria was performed 44 years ago; by the end of 2022, 6265 renal transplants had been performed in Syria. Kidney, bone marrow, cornea, and stem cells are the only organs or tissues that can be transplanted in Syria. Although 3 heart transplants from deceased donors were performed in the late 1980s, cardiac transplant activities have since discontinued. In 2003, national Syrian legislation was enacted authorizing the use of organs from living unrelated and deceased donors. This important law was preceded by another big stride: the acceptance by the higher Islamic religious authorities in Syria in 2001 of the principle of procurement of organs from deceased donors, provided that consent is given by a first- or second-degree relative. After the law was enacted, kidney transplant rates increased from 7 per million population in 2002 to 17 per million population in 2007. Kidney transplants performed abroad for Syrian patients declined from 25% in 2002 to <2% in 2007. Rates plateaued through 2010, before the political crisis started in 2011. Forty-four years after the first successful kidney transplant in Syria, patients needing an organ transplant rely on living donors only. Moreover, 20 years after the law authorizing use of organs from deceased donors, a program is still not in place in Syria. The war, limited resources, and lack of public awareness about the importance of organ donation and transplant appear to be factors inhibiting initiation of a deceased donor program in Syria. A concerted and ongoing education campaign is needed to increase awareness of organ donation, change negative public attitudes, and gain societal acceptance. Every effort must be made to initiate a deceased donor program to lessen the burden on living donors and to enable national self-sufficiency in organs for transplant.

Regulatory Intensity on Private Forestland and its Relationship with State Characteristics in the United States.

Though the federal government impacts private forest management across the United States through legislation such as the Clean Water Act, state-level regulations applied to private forest landowners vary remarkably. Despite this diversity of policies, little is known about how variations in regulatory intensity (defined here as number of forestry regulations) correlate with state-level political and socioeconomic characteristics. In this study, we use a quantitative approach to explore the intensity of regulation on forest practices impacting private landowners across all 50 states. We quantified intensity by tabulating the number of regulated forest practices, then used a quasi-Poisson regression to estimate the relationship between regulatory intensity and state-level characteristics, including forestland ownership types, the economic importance of the forest industry, and measures of state environmentalism. Results indicated a positive association between regulatory intensity and the percent of private corporate land, environmental voting records of elected officials, and direct democracy. Foresters and landowners may learn from these relationships, consider how to influence different policies, and build or achieve greater levels of public trust. This study starts to help us explain why state-level forestry policies differ, not just how they differ.

State Regulation of Ensuring the Quality Medical Care During Martial Law in Ukraine: Lessons for the International Community.

Background: Nowadays, the quality of medical care and health care measures is considered the main target function of the health care system and at the same time the determining criterion for its activities. Objective: The article examines state regulation of medical care quality post- COVID and during martial law, identifying improvement areas. It emphasizes state roles in healthcare standardization, continuous feedback monitoring, and studying patient satisfaction. Interrelationships among Ukraine's state regulation mechanisms are determined, highlighting the need to enhance tools such as criteria and quality indicators for medical care assurance. Methods: The authors of this article utilize various scientific methods, including analysis, synthesis, induction, and deduction, as well as historical and legal, formal legal, and comparative legal methods to examine the state regulation of ensuring the quality of medical care during martial law in Ukraine. Results: The article considered the interrelationships of mechanisms and instruments of state regulation of quality assurance of medical care in Ukraine. Conclusions: The state should enhance medical care quality regulation, drawing on international experiences from the EU and the USA and adapting best practices to national circumstances. The resilience of the healthcare system depends on effective quality assurance, ensuring preparedness, stability, and ongoing improvement prospects.

Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue-Based Products.

This Viewpoint discusses the death of a patient caused by unregulated biological products and efforts to encourage federal government oversight of such products.

A prescription model for vapes: the way we 'do' medicines policy in Australia.

On 2 May 2023, the Australian Federal Government announced a suite of reforms aimed at ensuring the effectiveness of the prescription model of regulation of vaping (or e-cigarette) products in Australia. These reforms are intended to protect Australians, particularly young people, from the harms of vaping and nicotine dependence. The ensuing public debate on the issue has often created the impression that the options under consideration are to either retain 'recently introduced' prescription regulation or to 'revert to' a retail supply approach. However, the sale of nicotine vapes by retailers such as tobacconists and convenience stores has never been lawful in Australia. The reforms do not seek to change the way nicotine vaping products are regulated, but rather to ensure that the existing prescription model can be effectively enforced and can function as originally intended. This paper describes the historical context and rationale for strengthening prescription regulation of vapes in this country.