La Autoridad de Ciencias de la Salud tendrá más poderes y personal bajo la nueva ley propuesta

Singapore's Health Sciences Authority (HSA) is set to gain expanded regulatory and investigative powers under newly proposed legislation, marking a major shift in the country's healthcare governance structure. The Health Sciences Authority (Amendment) and Other Matters Bill was introduced in Parliament on August 4, aiming to consolidate and transfer key healthcare responsibilities from the Ministry of Health (MOH) to the HSA. If enacted, the bill will significantly expand the authority's role in overseeing medical research, biotechnology, and healthcare services while enhancing its capacity to enforce regulations and protect public health. The proposed changes involve transferring the administration and enforcement of several key acts, from the Biological Agents and Toxins Act to the Human Biomedical Research Act, away from the MOH’s director-general and into the hands of the HSA’s chief executive. These transfers would grant the HSA greater autonomy in regulating human biomedical research and managing the use, possession, and importation of biological agents. Additionally, the bill outlines the transfer of powers related to the Infectious Diseases Act, MediShield Life Scheme Act, and Termination of Pregnancy Act, further broadening the scope of the HSA’s regulatory duties. Alongside these legislative shifts, the bill proposes the relocation of multiple MOH departments, including those responsible for regulatory compliance, regulatory transformation, and surveillance and enforcement, to the HSA. This move aims to centralize oversight of healthcare service licensing, ensuring that entities such as acute and community hospitals, blood banks, medical transport services, dialysis centers, and nursing homes adhere to strict safety and quality standards. The HSA will also be tasked with promoting regulatory transformation to address emerging challenges in the healthcare sector, such as securing the cybersecurity of connected medical devices. A notable aspect of the proposal involves the investigation and enforcement of violations. For instance, the HSA would assume responsibility for auditing and addressing lapses in practices, as demonstrated by past actions taken against cord blood banking company Cordlife, which faced a temporary suspension due to issues in storing cord blood units. The bill ensures that the transfer of staff from MOH to HSA does not result in job losses or changes to employment conditions, maintaining continuity in workforce stability and rights. The HSA currently oversees health product regulation, including medicines, cosmetics, medical devices, and tobacco, as well as managing the national blood bank, transfusion medicine, and forensic medicine expertise. With the proposed amendments, the authority will also take over support functions previously handled by the secretariat of healthcare professional boards. Since 2020, this secretariat has assisted around 11 professional bodies, including the Singapore Medical Council and Singapore Dental Council, providing administrative and legal support. While the HSA will assume these support roles, the actual regulation of healthcare professionals will remain under the purview of the respective autonomous boards. The bill was introduced by Minister of State for Health Rahayu Mahzam on behalf of Minister for Health and Coordinating Minister for Social Policies Ong Ye Kung. In addition to amending the HSA Act, the legislation seeks to revise the Human Biomedical Research Act and the Healthcare Services Act. One key provision allows the HSA’s chief executive to appoint auxiliary authorized officers, who can conduct inspections during normal business hours. However, these officers lack the authority to search premises or seize items such as equipment or blood samples. The bill is anticipated to undergo debate during the next parliamentary session, with discussions likely focusing on the implications of increased regulatory power and the potential impact on healthcare operations and compliance. As the legislative process unfolds, the HSA stands poised to play an even more pivotal role in shaping Singapore’s healthcare landscape.