25 March 2021
As part of a slew of measures to mitigate the effect of the COVID-19 pandemic in Singapore, the Health Sciences Authority (HSA) recently rolled out the Pandemic Special Access Route (PSAR) to facilitate early access to critical health products needed for the treatment and/or prevention of infectious diseases like COVID-19. Eligible health products may be granted interim authorisation for manufacture, import and supply in Singapore even before registration, while continuous evaluation of safety and efficacy is ongoing. We discuss the details of this new framework below.
From the early days of the pandemic, it has been a race against time to develop a vaccine. It has also been a challenge to ensure that our laws and regulations are regularly updated to keep pace with societal changes brought about by the pandemic.
In Singapore, legal reform driven by COVID-19 commenced with the introduction of the COVID-19 (Temporary Measures) Act 2020. The Act initially targeted segments of society that had suffered the most immediate impact from the pandemic and the resultant “circuit breaker”. Temporary relief was provided for businesses and individuals who suddenly found themselves unable to perform their contractual obligations. Specific regulations were progressively rolled out under this broad legislative framework, to help employees, tenants and proprietors, especially those in the hardest-hit sectors like tourism and aviation.
As the situation evolved, it became clear that our existing health product regulations also required changes to cope with the surge in demand for masks, ventilators, diagnostic tests and the like, all of which were crucially needed in our ongoing battle against the virus. Although it was sufficient to expedite the approval of some of these products via a temporary Provisional Authorisation process, a more permanent solution was necessary to deal with the consequences of COVID-19 in the long haul.
Overview of the PSAR
The PSAR was implemented on 1 December 2020 via amendments to the Health Products (Medical Devices) (Amendment) Regulations 2020 and the Health Products (Therapeutic Products) (Amendment) Regulations 2020 (the “Regulations”). The Regulations provide transparency and certainty in the approval process for health products, allowing companies authorised by the Singapore Government to import, manufacture and supply therapeutic products or medical devices for emergency use.
Under the PSAR, HSA commences the evaluation process for new health products right from the early stages of clinical studies, continually reviewing safety and efficacy data as and when available. Unlike the normal product registration framework, which requires all pre-clinical, clinical and manufacturing data to be submitted at the time of application, this expedited PSAR framework provides flexibility for research and approval to be conducted concurrently. Health products which demonstrate significant potential to address a public health emergency can thus be made available in Singapore within the shortest possible time.
With the PSAR, Singapore joins the ranks of countries such as Canada, United States, United Kingdom, Australia, China and Hong Kong which have all also rolled out their own emergency authorisation frameworks in response to the COVID-19 pandemic.
Qualifying for the PSAR
The requirements to qualify for the PSAR (as set out in the Regulations) are broadly the same for therapeutic products and medical devices.
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First, the Applicant must be an importer, manufacturer or supplier directed by the Singapore Government to supply the health product for or on the Government’s behalf.
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Second, the health product must satisfy the definition of an “emergency therapeutic product” or an “emergency medical device” pursuant to the Regulations.
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The health product must be needed to (a) prevent the spread or possible outbreak of an infectious disease, (b) treat an infectious disease or any medical condition associated with an infectious disease, or (c) treat any medical condition resulting from a civil defence emergency (the “Purposes”). The medical condition or infectious disease must be one that is potentially serious or life-threatening.
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HSA must be of the view that there is preliminary scientific evidence that the health product has the potential to achieve any of the Purposes, and (b) there is ongoing scientific evidence to demonstrate that the potential benefits outweigh the risks of using the health product.
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PSAR application procedure
The application process varies slightly depending on whether the Applicant is seeking authorisation for an emergency therapeutic product or an emergency medical device.
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For emergency therapeutic products, the Applicant must arrange for a pre-submission consultation with HSA before applying for the PSAR, to discuss the sequence and timelines for data submission. The Applicant may then submit all available data to kickstart the review process, along with a finalised data submission plan. Interim Authorisation will only be granted after the Applicant satisfies the minimum data requirement prescribed by HSA.
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For emergency medical devices, a pre-submission consultation is not necessary. The Applicant may simply apply for PSAR, and submit all documentation on hand to HSA via email. HSA will request additional documentation or clarification from the Applicant if necessary.
Outcome of the PSAR application
In the event that the PSAR application is successful, the Applicant will be issued Interim Authorisation for the import, manufacture or supply of the therapeutic product or medical device in Singapore for the duration of the emergency. Thus far, only the Pfizer-BioNTech and Moderna COVID-19 vaccines have obtained Interim Authorization for use in Singapore.
Continuing obligations for data review and registration
Even after being granted Interim Authorization, ongoing data must still be submitted to monitor the safety and efficacy for use of the health product in Singapore. For instance, HSA has directed Pfizer and BioNTech to conduct post-market monitoring to ascertain the effective period against COVID-19 and any other safety concerns. More data concerning use amongst certain subpopulations, such as pregnant women and children, should also be collected. This continuous data submission process allows HSA to take swift regulatory action should any safety concerns emerge. If necessary, HSA may cancel the Interim Authorisation.
Ongoing data submission is also required to support the eventual transition of Interim Authorisation to full product registration. Once sufficient data has been obtained to show that the health product is suitable for its intended purpose and the overall benefits of its use outweigh the risks, the Applicant will be required to file an application to register the health product.
Conclusion
More than a year after the first reports of COVID-19, the pandemic shows no sign of abating. Experts have commented that the coronavirus may be here to stay, and as much as we hope that they are proven wrong, it is only prudent to prepare for the long-haul – whether in relation to scientific innovation, technological transformation, or legal developments. The PSAR is a welcome development for health product manufacturers and suppliers, the healthcare industry and the public at large, by enabling expedited regulatory processes and removing unnecessary roadblocks in our fight against COVID-19.
Tze She Teo, Associate, Bird & Bird
