Tony Yeo                                                      Benjamin Gaw
Director, Drew & Napier LLC                      Director, Drew & Napier LLC
T: (65) 6531 2512                                        T: (65) 6531 2393
E: tony.yeo@drewnapier.com                    E: benjamin.gaw@drewnapier.com

Background

The Singapore Government has continually placed strong emphasis on developing the healthcare and biomedical sectors in Singapore, and has invested significant resources in research and development, including in the area of biomedical sciences. As the biomedical sciences continue to advance on the back of strong research and development efforts, the need for the healthcare and biomedical regulatory landscape to similarly keep pace with advances cannot be overemphasized.

This article sets out some of the key recent developments in Singapore’s healthcare and biomedical regulatory landscape, namely in the areas of therapeutic treatment and research, and provides a brief update on the Bioethics Advisory Committee’s (“BAC”) issuance of the Ethics Guidelines for Human Biomedical Research (“Ethics Guidelines”) and the introduction of the Human Biomedical Research Bill (“HBR Bill”) in Singapore Parliament.

Some Recent Developments

Ethics Guidelines for Human Biomedical Research The Ethics Guidelines were published on 23 June 2015 by the BAC.

The BAC has expressed that the Ethics Guidelines contain the BAC’s current views on the standards expected of researchers and research institutions in Singapore, with regard to human biomedical research.

Prior to the issuance of the Ethics Guidelines, the BAC had published several reports dealing with specific aspects of human biomedical research, such as the following:

• Ethical, Legal and Social Issues in Human Stem Cell Research

• Genetic Testing and Genetic Research

• Personal Information in Biomedical Research

• Donation of Human Eggs for Research

In preparing the Ethics Guidelines, the BAC has not only reviewed its past reports and consolidated its earlier recommendations as expressed in those reports, but the BAC has also sought to incorporate its recommendations on recent emerging issues such as whole genome sequencing and the management of incidental findings.

The Ethics Guidelines were published following a thorough process of deliberation by the BAC on a range of ethical issues concerning human biomedical research, including consideration of feedback received during the BAC’s public consultation on the draft Ethics Guidelines in June 2012.

Human Biomedical Research Bill

On 13 July 2015, the HBR Bill was introduced in Parliament.

This follows the public consultation held by the Ministry of Health (“MOH”) in late 2014/early 2015 on a draft version of the HBR Bill.

Types of human biomedical research covered under the HBR Bill

Human biomedical research is broadly defined under the HBR Bill, and it includes:

• certain types of research involving subjecting an individual to any intervention on the body of the individual, the use of any individually-identifiable human biological material, or the use of any individuallyidentifiable health information;

• any research involving human gametes or human embryos;

• any research involving the introduction of human-animal combination embryo into an animal or a human; and

• any research involving the introduction of human stem cells or human neural cells into an animal at any stage of development.

Clinical trials which are conducted in accordance with the Health Products Act (Cap. 122D) or the Medicines Act (Cap. 176) will continue to be regulated by the Health Sciences Authority (“HSA”), and do not come under the regulatory purview of the HBR Bill.

The HBR Bill also specifies certain types of human biomedical research as being “prohibited” or “restricted”. For instance, human biomedical research involving the implantation of any human-animal combination embryo into the uterus of an animal or a human is prohibited. Restricted human biomedical research includes any human biomedical research involving human eggs or human embryos. Additional requirements apply in respect of such restricted human biomedical research.

Scope of the HBR Bill

Some of the aspects covered under the HBR Bill include:

• consent-taking requirements in respect of individuals participating in human biomedical research (e.g. the types of information that must be provided to an individual before seeking that individual’s consent with regard to participation in human biomedical research, as well as for cases involving the removal, donation or use of human tissue);

• the role of Institutional Review Boards (“IRBs”) in the conduct of human biomedical research;

• the types of persons who may conduct human biomedical research (e.g. human biomedical research must be conducted under the supervision and control of a research institution which has a place of business in Singapore and which has at least two individuals ordinarily resident in Singapore who are responsible on behalf of the research institution for the supervision and control of the research);

• restrictions on the disclosure of individually-identifiable information of any research subject;

• issues relating to human tissues and tissue banks; and

• MOH’s powers to order the cessation of activities relating to human biomedical research or tissue banks.

Codes of practice and codes of ethics

The HBR Bill also provides for the issuance of codes of practices and codes of ethics by the MOH’s Director of Medical Services.

Such codes of practices may provide guidelines in respect of matters such as consent-taking, safety and research practices, and the protection of the identity of individuals visà- vis individually-identifiable human biological material and health information.

Codes of ethics may be issued with respect to the ethical conduct of human biomedical research or tissue banking activities.

It will be interesting to see if, and the extent to which, these codes issued by the MOH’s Director of Medical Services (in particular, any codes of ethics) adopt and incorporate the BAC’s recommendations and views as expressed in the Ethics Guidelines.

National Telemedicine Guidelines for Singapore

Another notable development in the Singapore healthcare regulatory landscape is the issuance of the National Telemedicine Guidelines for Singapore (“NTG”) by the MOH on 30 January 2015.

Telemedicine, or telehealth, is the systematic provision of healthcare services over physically separate environments via Information and Communications Technology (“ICT”).

It comprises, broadly, four dimensions:

(a) Tele-collaboration, which refers to the interaction between facility-based or mobile and remote healthcare professionals (“HCPs”) for clinical purposes;

(b) Tele-treatment, which refers to the interaction between a patient or caregiver at one end and a HCP on the other end, where such interaction creates or presupposes the existence of a professional-patient relationship;

(c) Tele-monitoring, which refers to the interaction between a HCP or healthcare organisation at one end and a patient or caregiver collecting health data on the other end as part of an organised arrangement, where such interaction does not create or presuppose the existence of a professional-patient relationship; but, instead, such interaction may give rise to the healthcare organisation owing a duty of care to the patient; and

(d) Tele-support, which refers to the use of online services for non-clinical purposes, such as educational and administrative purposes, to support a patient and his/her caregiver (e.g. through the use of treatment prompts in chronic disease management).

Whilst face-to-face interactions between a HCP and a patient remain the gold standard for healthcare service delivery, this traditional mode of healthcare service delivery has its limitations. With the increased sophistication in ICT, telemedicine offers a strong value proposition in, potentially, being able to assist healthcare providers to overcome some of the challenges faced by the healthcare sector.

The NTG is structured so as to provide guidance under four broad domains which are considered to have an important role in the delivery of high-quality healthcare: (i) clinical standards and outcomes; (ii) human resources; (iii) organisational; and (iv) technology and equipment.

At its inception, the NTG is intended to provide only a broad and generic framework for the delivery of healthcare services by telemedicine. Individual specialties are encouraged to adopt a customised approach in applying these guidelines to meet the specific requirements of their respective fields.

The issuance of the NTG signals the acceptance of the increasing use of, and reliance on, ICT in the management and delivery of healthcare in the Singapore context. In this regard, the NTG expressly acknowledges that continuity and business sustainability are important considerations in the offer of telemedicine services, so as not to compromise the interests of patients.

Conclusion – Developing the Regulatory Framework in Tandem with Industry Practice

The healthcare and biomedical sectors continue to be heavily regulated under an array of legislation as well as guidelines and reports issued by various agencies such as the MOH, the HSA, the BAC, the National Medical Ethics Committee and the Singapore Medical Council.

As the use of technology becomes more pervasive in the contexts of healthcare delivery and biomedical research, there is a need for regulators to continue to assess if the existing regulatory framework remains relevant in light of practical developments. The challenge remains that any regulatory intervention must strike an appropriate balance between the interests of patients and stakeholder concerns that over-regulation may curb innovation in the biomedical field.

In this regard, the issuance of the BAC’s Ethics Guidelines and the NTG are important steps in the implementation of a more formal and transparent framework to guide developments and the industry practice in the area of human biomedical research and the use of ICT in the delivery of healthcare services.

1 Singapore’s Deputy Prime Minister recently indicated, at an industry event, that the Government remains committed to investing in R&D as part of its strategy for economic competitiveness and sustainable growth and biomedical sciences will continue to be a significant part of Singapore’s R&D efforts. (Source: http://www.mha.gov.sg/Newsroom/speeches/other-speeches/Pages/Gala-Dinner-for-the-30th-Anniversary-of-the-Institute-of-Molecular-and-Cell-Biology-(IMCB)-.aspx.)

2 A copy of these guidelines can be accessed at: http://www.bioethics-singapore.org/images/uploadfile/reportOnly.pdf.

3 More information on the MOH’s public consultation on the draft HBR Bill can be accessed at the MOH’s website (https://www.moh.gov.sg).

4 A copy of these guidelines can be accessed at: https://elis.moh.gov.sg/elis/publishInfo.do?task=download&pkId=200

5 Definition of “telemedicine” as provided in the Telemedicine Guidelines.