Ministry of Health (MOH) is set to update the Private Hospitals and Medical Clinics Act (PHMCA) that governs all healthcare services in Singapore, which is said to ensure continued relevance in regulation of healthcare services and facilities
At the 2016 Scientific Conference of Centre of Regulatory Excellence (CoRE) on Tuesday morning (25 Oct), Minister of State for Health Lam Pin Min said that MOH is reviewing the PHMCA to keep pace with the rapid advances in medicine and health technology, new and changing modalities of services, and profile and needs of our population.
Dr Lam pointed that the health products regulatory landscape is rapidly evolving even as cutting-edge health products and services are being offered as new healthcare solutions. Three recent examples of major developments that were given:
- The promising therapies in precision medicine,
- More personalised healthcare through wearable technology, and
- New clinical applications in 3D-printing.
“These non-conventional health products and services are very different from the ‘traditional’ pharmaceutical medicines, and will challenge the way we develop our policies and regulate new products and services,” Dr Lam said.
Dr Lam noted that the healthcare regulatory system should be able to fulfil the dual roles of ‘Protector’ and ‘Enabler’. As Protector, each regulatory system needs to be robust and have the necessary safeguards in place so that patients and consumers can have access to services and products that are safe, of good quality and efficacious. While as an Enabler, regulatory systems need to be flexible enough to support a vibrant ecosystem for biomedical R & D and service and technology innovations that can provide Singapore’s population with potentially better healthcare.
Dr Lam said, “In Singapore, the regulation of health products is overseen by the Health Sciences Authority (HSA). Recently, HSA gazetted new subsidiary legislation to regulate therapeutic products – conventionally regarded as pharmaceuticals – and clinical trials under the Health Products Act.”
He added, “The new regulations, which will take effect from 1 November this year, implements an activity-based licensing regime for the registration, manufacture, import and wholesale of therapeutic products in Singapore.”…“A risk-based regulatory framework for clinical trials has also been introduced in the new Regulations. These changes aim to ensure that the controls remain relevant and adequate for different operational and business models while safeguarding public health and safety.”…“To keep up-to-date with new developments, HSA also stays tuned in by working with stakeholders in its regulatory framework. This iterative process will continue, even as we strive to ensure our regulatory environment keeps pace with rapid developments in the healthcare sector,” he stated.
Dr Lam also explained that currently, the Private Hospitals and Medical Clinics Act (PHMCA) under MOH is the key piece of legislation for all healthcare services in Singapore utilised by public and private patients. The PHMCA was enacted in 1980 and last amended in 1999.
“MOH is, therefore, reviewing the PHMCA to keep pace with the rapid advances in medicine and health technology, new and changing modalities of services, and profile and needs of our population.”
“What would be more appropriate is to tier the PHMCA’s regulatory requirements according to the type and nature of service. MOH will also take the opportunity to strengthen governance systems and improve regulatory clarity. By doing so, providers will be more aware as to their responsibilities, and hence be more accountable to patients,” Dr Lam said.
He also said in the coming months, MOH will consult widely on where and how the Act should be revised.
“Starting next month, we will hold focus group discussions with representatives from both large and small healthcare players, such as clinics, hospitals, clinical labs, nursing homes and many others. Subsequently, we will reach out to patient groups and members of the public.”