This article is the first in our multi-part series centring around the topic of longevity from the perspective of Singapore law.
As a preliminary framework, the longevity industry consists of several distinct but intersecting segments and domains, including the following:
We believe that the relevance and significance of the longevity industry in Singapore cannot be overstated, and is underscored by several factors, of which the following are key:
Many companies in the longevity industry are developing prescription drugs and novel therapeutics (such as stem cell therapy) to stave off ageing. AgeTech, which refers to technological solutions to improve the quality of life of older people, has contributed to the development of less intrusive treatment options, in the form of external devices, for many age-related diseases or conditions. Companies in the longevity industry need to be aware of the regulatory framework surrounding the commercialisation of health products and services in Singapore, including but not limited to the Health Products Act 2007 (HPA).
Medicinal products are further regulated by the Health Sciences Authority (HSA) under various laws in Singapore including the Medicines Act 1975 (MA), the Medicines (Advertisement and Sale) Act 1955, the Sale of Drugs Act 1914, the Poisons Act 1938, the Tobacco (Control of Advertisements and Sale) Act 1993 and their subsidiary legislation.
Biotechnology companies have been attempting to develop longevity drugs, including senolytic drugs, which are a class of drugs that selectively clear senescent cells that accumulate in many tissues with aging and at sites of pathology in multiple chronic diseases. These are likely be considered as “therapeutic products” or “medicinal products” which are regulated by the HPA or MA respectively. Currently, clinical trials on therapeutic products are regulated under the Health Products (Clinical Trials) Regulations 2016 (HP(CT)R), while medicinal products are regulated under the Medicines (Clinical Trials) Regulations 2016 (M(CT)R).
It should also be noted that observational clinical trials for such therapeutic and medicinal products are excluded from the regulatory framework under the HP(CT)R and the M(CT)R, respectively. Companies that are seeking to employ clinical trials for their therapeutic products and/or medicinal products should be familiar with their duties under the relevant regulations, and also be mindful about whether their clinical trial would amount to an observational trial as defined in the (HP(CT)R) and the (M(CT)R).
Several longevity experts have proposed that human stem cells have the ability to regenerate damaged tissues and enhance cellular functions. They are therefore seen as promising candidates by biotechnology companies in the longevity industry for the development of CTGTPs to reverse the effects of aging. While CTGTPs were previously not regulated under the HPA, recent amendments to the HPA and the passing of the Health Product (Cell, Tissue and Gene Therapy Products) Regulations 2021 have seen CTGTPs fall under the scope of the HPA.
The licence required by a company for dealing in health products under the HPA will be based on the types of activities the company conducts with respect to such products:
In addition, the HSA may also impose additional advertising requirements on licence holders. The HSA has also issued various guidelines that set out the additional procedures for the registration of therapeutic products which are biological in nature.
AI has been playing an ever-increasingly important role in expediting decision-making in medical sciences by means of advanced machine learning (ML) algorithms. AI has revolutionised the drug discovery process and is being used to create the structure of new drugs based on the specific structure of the target disease-causing compound. ML techniques are also increasingly used in aging and longevity research to develop models for biological processes associated with aging including senescence, apoptosis, oxidative stress, telomere shortening and DNA damages. As with all new, cutting-edge technology, there are questions on how such technology will fit with our current legal structure, and whether there will need to be changes to the law to adapt to novel situations arising from ever-evolving technologies. We discuss below, some of the current legal considerations concerning AI in drug development and longevity research.
AI has allowed companies in the field of biotechnology to develop drugs as well as therapeutic medicine to counteract the effects of aging and age-related diseases. As companies focus on using AI to identify novel drug targets for untreated age-related diseases, there may be legal implications regarding such use of AI by companies.
From the outset, companies should protect their novel drug inventions created by their AI through the patent application process. The protection accorded by the patent would prevent anyone else from making, using, importing or selling the patented invention unless allowed by the applicant, for 20 years from the date of filing.
Companies should ensure that the novel drugs invented by their AI are kept confidential before patents are filed. Apart from protecting confidential information through data encryption, non-disclosure and confidentiality agreements should be prepared and entered into with the relevant parties to ensure that confidential information does not enter the public domain.
As health and biological data continue to grow, the use of AI in aging and longevity research will enable us to investigate the biological mechanism associated with the aging clock. Companies involved in this field should be aware that medical and health data will constitute personal data under the Personal Data Protection Act 2012 (PDPA) if such data (whether true or not) is capable, or would be capable with other information which the company has or is likely to have access, of identifying specific individuals. Such data, such as DNA profile and medical information, may be individually-identifiable and constitute personal data if it comprises human biological material or health information which may identify specific individuals with other information that an organisation (such as a research institution or a tissue bank) has or is likely to have access. Companies which deploy AI algorithms for ageing and longevity research must be aware of their obligations under the PDPA. They must manage and monitor the personal data collected, used or disclosed by their AI algorithms as well as eliminate all potential security issues with their AI solutions through regular review. A data breach management plan should also be put in place to identify and deal with data breaches from the use of AI algorithms.
In line with Singapore’s support for its growing longevity industry, Singapore’s current policies will aim to drive home the message that age is malleable and chronological age is increasingly becoming a poor measure of what it means to be old. The introduction of new legislation to combat ageism in the workplace can therefore be expected. Currently, there is limited legislation against ageism in the workplace, with guidelines and best practices providing some protection against hiring, promotion and dismissal based on age. However, in the Interim Report by the Tripartite Committee on Workplace Fairness published in February 2023, the Tripartite Committee on Workplace Fairness has recommended that new legislation be passed for:
The proposed laws under the new framework will coexist with the current framework for dealing with workplace discrimination under the Tripartite Guidelines on Fair Employment Practices. Employers should be more careful about how they recruit prospective employees when the proposed legislation comes into effect.
Longevity research and management have been receiving massive funding, particularly in the areas of age reversal research by biotechnology firms. As the longevity industry emerges, it will begin to take the form of several distinct segments such as biomedicine, geroscience, AgeTech and finance. As these individual segments intersect with each other, as well as with other domains like AI and government legislations and policies, we can expect new legislation and regulations to emerge to deal with the multidimensional nature of the industry.
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