The new Human Biomedical Research Act: compliance and potential risks

LEGISWATCH SEPTEMBER 2015 1 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). THE NEW HUMAN BIOMEDICAL RESEARCH ACT: COMPLIANCE AND POTENTIAL RISKS On 18 August 2015, Parliament passed the Human Biomedical Research Act (“HBRA”). Whilst the HBRA has not yet come into effect, it provides a comprehensive legal framework for key areas of medical research and tissue banking. Healthcare institutions and organisations that conduct research (each, a research institution or “RI”), tissue banks and research professionals are each impacted, and owe legal duties under the HBRA. Organisations will now need to ensure that their processes and policies meet the specific standards imposed by the HBRA, and that programmatic efforts are established and implemented to maintain levels of compliance in both legal and operational terms. The key areas of compliance include research subject consent management, reporting protocols, filings and declarations of compliance with authorities. This Update looks at some of the key provisions of the HBRA and outlines what organisations and professionals need to do to comply with the new legislation. Overview of the HBRA The HBRA regulates the conduct of human biomedical research (including certain restricted types of research), tissue banks and tissue banking activities. It also prohibits certain types of human biomedical research, as well as the commercial trading of human tissue. Broad definition of “human biomedical research” The definition of “human biomedical research” under the HBRA is broad and there is a limited list of exclusions set out in the Second Schedule. Notable examples of exclusions are human psychological / psychiatric tests, IQ tests, measuring human intelligence, as well as clinical trials. Compliance with the HBRA Establishment of a program for compliance Institutional Review Board to oversee compliance Though the HBRA does not necessarily revolutionise or impose a radically new regime of governance on human biomedical research or tissue banking activities, it does mandate that organisations establish governance arrangements, implement specific key steps, and file declarations with the Ministry of Health so as to be able to continue to conduct human biomedical research. Each RI should ensure that there is an Institutional LEGISWATCH SEPTEMBER 2015 2 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). Review Board (or “IRB”), which will perform key functions of compliance efforts. Research subject consent management - Proper consent required for (a) research; and (b) removal or use of tissue Consent to be obtained for human biomedical research Patient autonomy is a key theme of the HBRA, with various safeguards implemented for vulnerable individuals such as nonprecocious minors, or mentally incapacitated individuals. No research permitted without proper consent Section 25 of the HBRA contains a broad prohibition against conducting human biomedical research if appropriate consent has not been obtained in accordance with the HBRA. Mandatory information to be provided to obtain consent Section 12 of the HBRA (information to be provided before taking appropriate consent) as compared to Section 12 when the HBRA was at Bill stage establishes more prescriptive standards around the content of information to be provided when obtaining consent and specifies the information which must be provided before appropriate consent can be obtained. Consent from adults who lack mental capacity and minors in general Distinct consent requirements for certain research subjects In particular, the HBRA contains specific provisions in relation to obtaining consent from adults who lack mental capacity and minors, with further distinctions drawn between minors who have sufficient understanding and intelligence to understand what is proposed in the biomedical research (precocious minors), and minors who do not or those who lack mental capacity. Specific criteria apply when determining whether research can be conducted in respect of such individuals, with reliance on parents, guardians or donees under a lasting power of attorney in some cases as safeguards. Guidelines to be issued for consent by third parties The provisions of the HBRA also indicate that future guidelines will be issued on the considerations that the deputy, donee or appropriate third party should take into account when deciding whether or not to give consent. LEGISWATCH SEPTEMBER 2015 3 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). Tissue removal from adults lacking mental capacity and certain minors Restrictions on tissue removal for certain research subjects Under Section 37(2)(a) of the HBRA, no tissue may be removed from an adult that lacks mental capacity unless the removal was primarily for a therapeutic or diagnostic purpose. An IRB may waive the requirement that there be primarily a diagnostic / therapeutic purpose if the IRB is satisfied that (i) the removal of tissue involves no more than minimal risk to the person and (ii) there are reasonable grounds that the proposed area of research “cannot be carried out” without the use of the tissue from the class of persons to which the tissue belongs. Subsections 37(2)(b) and (c) apply the same requirement of there being a “therapeutic or diagnostic purpose” (as in Subsection 37(2)(a)) to tissue removal from a non-precocious minor or a minor who lacks mental capacity. Waivers of consent Waiver of consent may be permissible Under the HBRA, the IRB will play a key part in guiding the RI and the researchers as to when waivers are granted to waive requirements of procuring consent under the Act. Reporting and declaration protocols and processes to manage liability Sections 23 and 24 of the HBRA require an RI to submit notifications and declarations of compliance for its human biomedical research. Declarations required before commencing new research The RI must file a “maiden” declaration before commencement of its “first” research conducted under control. While there are transitional provisions which help provide some breathing room for ongoing projects, it will be necessary to execute declarations before commencing new projects. The RI will also have annual duties to make declarations of compliance, and duties to ensure that the only research conducted is that which has been granted “in-force” approval by IRB. Compliance obligations for tissue banks A similar duty on tissue banks to submit a declaration of compliance applies under Section 35 (read with Section 36) of the HBRA. While there are transitional provisions which help provide some breathing room for “legacy” tissue, these do not apply to the obligations to make declarations of compliance. LEGISWATCH SEPTEMBER 2015 4 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). An inventory of tissue banking activities will be needed as such activity must be reported. The format of the report is to be prescribed. Duty to notify about changes in information There are also duties to notify the Director of Medical Services about any changes to the information. RIs must therefore ensure that they implement reporting and declaration protocols and processes to manage liability (including liability from the obligations discussed above) under the HBRA. Review of collection and handling procedures, as well as disclosures for donor information Sections 38 and 39 of the HBRA prescribe offences relating to compelling tissue donation and disclosure of information on tissue donors. Offence to coerce or deceive to procure consent Generally, Section 38 states that it is an offence to use coercion or intimidation, or deception or misrepresentation to procure consent or tissue removal from the person or another person who can consent on his / her behalf. Disclosure of identifiable information prohibited Section 39 prohibits disclosure of individually-identifiable information on any donor of human tissue which has come to that person’s knowledge except in limited circumstances, such as when ordered to do so by a court or where the information is publicly available etc. Contravention of Section 39 is an offence under the HBRA and RIs will need to ensure that their tissue and donor information collection or handling procedures do not fall foul of such offences. Be aware that the HBRA remains a source of personal and corporate liability risk The HBRA also contains procedural and enforcement powers, including provisions on powers to seize (and corresponding duties to label, mark or seal seized items), and additional penalties for interfering / tampering with investigations. Enhanced penalties and liabilities for offences There are enhanced penalties for corporations, liability for organisations for acts committed by employees, and personal liability of officers where the offence is committed by the corporation. LEGISWATCH SEPTEMBER 2015 5 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). Criminal penalties included There is an increase in criminal liabilities in the HBRA under Section 63 (Regulations) as compared to the legislation when it was at Bill stage. This section of the HBRA empowers the Minister to make regulations under the HBRA. These regulations can extend to, among other things, requirements for protection of the identity of individuals. The provisions also have room for the further elaboration of requirements or standards and the penalties which the Minister is empowered to provide for under the regulations have been enhanced to an imprisonment term of 2 years from an imprisonment term of 1 year. Under Section 15 (appointment and review of IRBs), RIs must appoint IRBs to both supervise and control research. Failure to notify the Director of appointments and/or revocations of IRBs is a criminal offence, and liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or both. This has been enhanced from the previous “6 months” in the Bill. Organisations must develop a guided fast-tracking approval process which conforms to emergency research waiver requirements The Fifth Schedule describes the circumstances in which waivers of requirements for appropriate consent by IRB can be obtained. Waivers for emergency research In particular, the Fifth Schedule now fleshes out the requirements for waivers for emergency research. These include requirements such as the subject is to be “informed as soon as is practicable” after he or she regains capacity, of his or her participation in the research and given an opportunity to withdraw from further participation in the research; or the need for a medical practitioner to certify that certain conditions are fulfilled before enrolment of the research subject. Compliance programs to protect / safeguard individually identifiable human biological material and health information Duty to protect identifiable material and information The HBRA imposes further duties in respect of the collection, use, disclosure, storage and handling of individually identifiable human biological material and health information, including placing restrictions on their re-purposing or use when originally collected for diagnostic or therapeutic purposes and where they were specifically collected for research purposes. LEGISWATCH SEPTEMBER 2015 6 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). Transitional Provisions Savings and transitional provisions in the HBRA allow (i) RIs to supervise and control the conduct of human biomedical research and (ii) persons to conduct human biomedical research, as if the HBRA had not been enacted, for a period of 12 months after the HBRA comes into effect or for such longer period as the Director may allow in any particular case. Most of the HBRA (except certain provisions e.g. those relating to prohibited human biomedical research, etc.) does not apply to legacy human biological material. Legacy human biological material generally refers to human biological material that has been removed or stored, and rendered non-identifiable before the HBRA comes into effect, or information derived from such material. Conclusion With the pace of medical research and innovation in today’s world, and the enormous potential for benefits to society and profit for organisations who pursue such research, the HBRA is a key step in ensuring and maintaining an ethical framework in the field of human biomedical research. Given the wide-ranging liabilities and offences contained in the HBRA, RIs and organisations carrying out research potentially falling within the definition of “human biomedical research” will need to take appropriate steps to address the potential risks and liabilities arising from the HBRA. If you would like information on this or any other area of law, you may wish to contact the partner at WongPartnership that you normally deal with or any of the following partners: Lam Chung Nian Head – Intellectual Property, Technology & Media, Telecommunications and Data Protection Practices DID: +65 6416 8271 Email: chungnian.lam @wongpartnership.com Click here to see Chung Nian’s CV. Jeffrey Lim Partner DID: +65 6416 8250 Email: jeffrey.lim @wongpartnership.com Click here to see Jeffrey’s CV. LEGISWATCH SEPTEMBER 2015 7 © WongPartnership LLP This update is intended for your general information only. It is not intended to be nor should it be regarded as legal advice. WongPartnership LLP (UEN: T08LL0003B) is a limited liability law partnership registered in Singapore under the Limited Liability Partnerships Act (Chapter 163A). 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