Transplantation of Human Tissues Act, No. 48 of 1987

An Act to provide for the removal and transplantation of human tissues and organs in Sri Lanka. Enacted in 1987, this Act establishes the legal framework for organ donation (both post-mortem and living), defines brain death (irreversible cessation of all brain functions), creates a multi-layered consent framework, prohibits the commercialisation of human tissues, and establishes the Technical Advisory Council on Human Tissue Transplantation to advise the Minister. The Act has remained unamended for 37 years.

Source

Full text available at LankaLaw (PDF). 23 sections in a single continuous body (no formal Parts). No amendments have been enacted.

Act Structure

The Act has 23 sections with no formal Part divisions. Sections are organised into 6 functional groups:

Group	Sections	Topic	Summary
Donation upon Death	2-6	Post-mortem consent and removal	Donor's written or oral request before death (S.2); next-of-kin consent hierarchy (S.3); prescribed officer authority (S.3); coroner/magistrate permission for medico-legal cases (S.4-5); eye/ear tissue special provisions (S.6)
Living Donation	7-8	Living donor consent and safeguards	Non-regenerative tissue: age 21+, sound mind, free consent, independent Medical Consultant certification, DG Health Services written authority (S.7); regenerative tissue: restricted to family members only (S.8)
Authority to Remove	9-12	Institutional authority	Government hospitals and prescribed institutions (S.9); post-mortem examination tissue removal (S.10); prisoner tissue removal with Superintendent authority (S.11); unclaimed bodies — 7-day waiting period (S.12)
Safeguards	13-18	Brain death, conflict of interest, penalties, prohibitions	Tissue removal only from deceased persons (S.13); two-doctor death certification (S.14); brain death definition (S.15); conflict of interest — certifying doctor cannot transplant, cornea exemption (S.16); commercialisation prohibition with Ministerial loophole (S.17); identity confidentiality (S.18)
Advisory Council	20-21	Composition, powers, procedure	Technical Advisory Council established (S.20); sole duty: advise Minister (S.21)
Administration	19, 22-23	Regulations, savings, definitions	Minister's regulation-making power (S.19); savings clause (S.22); interpretation and definitions (S.23)

Section Detail

Section	Topic	Summary
1	Short title	Citation as the Transplantation of Human Tissues Act, No. 48 of 1987
2	Donation by person before death	Any person may give written or oral direction (in presence of 2+ witnesses) for tissue removal after death
3	Removal with next-of-kin consent	If no direction under S.2, prescribed officer may authorise removal with consent of next-of-kin in priority order: spouse, adult children, parents, siblings
4	Restrictions on post-mortem removal	No removal during post-mortem ordered by coroner/magistrate unless coroner/magistrate consents
5	Coroner/magistrate may authorise	Coroner or magistrate may direct tissue removal during post-mortem examination
6	Eye and ear tissue	Special provisions for removal of eyes and ears; may be authorised by person in charge of hospital
7	Living donation — non-regenerative	Five cumulative conditions: (a) age 21+, (b) DG Health Services written authority, (c) independent Medical Consultant certifies fitness, (d) free consent without inducement, (e) sound mind
8	Living donation — regenerative	Regenerative tissue may be removed from a living person only for transplantation to a member of the donor's family
9	Government hospitals and prescribed institutions	Tissue removal may be carried out at government hospitals and institutions prescribed by the Minister
10	Post-mortem tissue removal	Tissue may be removed during post-mortem examination conducted under the Code of Criminal Procedure Act
11	Prisoner tissue removal	Tissue may be removed from a deceased prisoner with written authority of the Superintendent of Prisons
12	Unclaimed bodies	Body unclaimed for 7 days after death — prescribed officer may authorise tissue removal
13	Tissue only from deceased	No tissue removal from a living person except as provided in S.7-8; penalty for contravention
14	Two-doctor death certification	Death must be certified by at least 2 registered medical practitioners before tissue removal
15	Brain death definition	Death includes irreversible cessation of all functions of the brain; determined by: (a) accepted medical standards, (b) opinion of 2+ medical practitioners, (c) diagnostic tests recognised by medical profession
16	Conflict of interest	Doctor certifying death cannot participate in transplantation; exception: cornea removal may be authorised by the certifying doctor
17	Prohibition on commercialisation	No person shall sell or deal in human tissues; exception: with prior written approval of the Minister (S.17(2)); penalty: up to Rs. 10,000 fine or 2 years imprisonment
18	Confidentiality	Identity of donor and recipient must not be disclosed except as required by law; penalty for contravention
19	Regulations	Minister may make regulations for carrying out the purposes of the Act
20	Technical Advisory Council	Composition: 5 ex-officio + Minister-appointed consultants; 3-year terms; quorum 3; Council regulates own procedure
21	Council functions	Sole duty: advise Minister on administration and implementation of the Act
22	Savings	Act does not affect any other written law relating to post-mortem examinations or inquests
23	Interpretation	Defines: medical practitioner, dentist, medical consultant (by reference to Medical Ordinance), family member, human tissue, prescribed, next-of-kin

Statutory Bodies

1 Legally Active0 Obsolete

Advisory Council Composition Detail

The Technical Advisory Council consists of 5 ex-officio members and medical consultants appointed by the Minister. Quorum is 3 members. Appointed members serve 3-year terms.

Ex-officio members (5):

#	Role	Note
1	Director-General of Health Services	Chairman (S.20(1)(a))
2	Director-General of Teaching Hospitals	S.20(1)(b)
3	Deputy Director-General of Health Services (Laboratory Services)	Secretary (S.20(1)(c))
4	Judicial Medical Officer, Colombo	S.20(1)(d)
5	Medical Officer in similar capacity	Another medical officer holding a similar position (S.20(1)(e))

Appointed members:

Category	Appointed By	Term	Note
Medical consultants in surgery and general medicine	Minister	3 years	Number at Minister's discretion (S.20(2))

Term: 3 years for appointed members; ex-officio serve while holding their posts
Quorum: 3 members (S.20(8))
Procedure: Council regulates its own meeting procedure (S.20(9))
Sole function: Advise the Minister on administration and implementation of the Act (S.21)

The Act creates a multi-layered consent system for different donation scenarios:

Scenario	Consent/Authority Required	Key Conditions	Section
Donor's own direction (post-mortem)	Written direction, or oral direction in presence of 2+ witnesses	Direction given during donor's lifetime	S.2
Next-of-kin consent (post-mortem)	Prescribed officer + next-of-kin consent	Priority order: spouse → adult children → parents → siblings; no known objection by deceased	S.3
Living donation — non-regenerative	DG Health Services written authority + independent Medical Consultant certification + donor's free consent	Age 21+, sound mind, no inducement	S.7
Living donation — regenerative	Donor's consent	Transplantation only to a family member	S.8
Post-mortem examination	Coroner or magistrate	During inquest or post-mortem under Code of Criminal Procedure Act	S.5, S.10
Unclaimed bodies	Prescribed officer	Body unclaimed for 7 days after death	S.12
Prisoners (deceased)	Superintendent of Prisons	Written authority required	S.11

Brain Death Definition (Section 15)

Section 15 provides Sri Lanka's statutory definition of brain death:

Death includes the irreversible cessation of all functions of the brain, including the brain stem.

Brain death is determined by any of three methods:

Method	Description	Section
Accepted medical standards	Standards accepted by the medical profession	S.15(a)
Medical practitioner opinion	Opinion of two or more registered medical practitioners	S.15(b)
Diagnostic tests	Tests recognised by the medical profession for determining brain death	S.15(c)

Authorization Matrix

Scenario	Who Authorises Removal	Who Performs	Additional Requirements
Donor's own direction	Prescribed officer (S.3(1))	Registered medical practitioner or technician	Two-doctor death certification (S.14)
Next-of-kin consent	Prescribed officer with next-of-kin consent	Registered medical practitioner or technician	No known objection by deceased; two-doctor death certification
Living — non-regenerative	DG Health Services (written authority)	Registered medical practitioner	Independent Medical Consultant certifies fitness; age 21+, sound mind, free consent
Living — regenerative (family)	Donor's own consent	Registered medical practitioner	Transplantation only to family member
Post-mortem examination	Coroner or magistrate	Medical practitioner conducting post-mortem	Under Code of Criminal Procedure Act
Prisoner (deceased)	Superintendent of Prisons	Registered medical practitioner	Written authority from Superintendent
Unclaimed body	Prescribed officer	Registered medical practitioner	7-day waiting period after death
Eye/ear tissue	Person in charge of hospital	Registered medical practitioner	Special provision under S.6

Living Donation Safeguards (Section 7)

For non-regenerative tissue, all five conditions must be met:

#	Condition	Detail	Section
1	Age	Donor must be at least 21 years of age	S.7(a)
2	DG authority	Director-General of Health Services must give written authority	S.7(b)
3	Medical certification	Independent Medical Consultant must certify the donor is fit	S.7(c)
4	Free consent	Donor gives consent freely, without inducement or coercion	S.7(d)
5	Sound mind	Donor must be of sound mind	S.7(e)

Regenerative Tissue — Family Restriction (Section 8)

Living donation of regenerative tissue (e.g., blood, bone marrow) is permitted only for transplantation to a member of the donor's family. "Family member" is defined in S.23 (interpretation section).

Unclaimed Bodies (Section 12)

Where a body remains unclaimed for 7 days after death, a prescribed officer may authorise the removal of tissue for transplantation purposes. This provision applies at government hospitals and prescribed institutions.

Prohibition on Commercialisation (Section 17)

Ministerial Loophole

No person shall sell, deal in, or offer for sale any human tissue. However, Section 17(2) provides an exception: the Minister may give prior written approval for the sale of human tissue. This loophole has been criticised by reform advocates as undermining the spirit of the prohibition.

Aspect	Detail
General prohibition	No sale, dealing, or offering for sale of human tissues (S.17(1))
Exception	Prior written approval of the Minister (S.17(2))
Penalty	Fine up to Rs. 10,000 or imprisonment up to 2 years (S.17(3))

Confidentiality (Section 18)

The identity of both donors and recipients must not be disclosed except as required by law. Contravention is a criminal offence.

Aspect	Detail
Protection	Identity of donor and identity of recipient
Disclosure allowed	Only as required by law
Penalty	Criminal offence for unauthorised disclosure (S.18(2))

Conflict of Interest (Section 16)

The medical practitioner who certifies death cannot participate in the subsequent transplantation procedure.

Rule	Detail	Section
General rule	Certifying doctor excluded from transplantation	S.16(1)
Cornea exception	Certifying doctor may authorise cornea removal	S.16 proviso
Penalty	Criminal offence for contravention	S.16(2)

Penalties

Offence	Penalty	Section
Removing tissue from living person contrary to S.7-8	Criminal offence (penalty not specified in accessible text)	S.13
Certifying doctor participating in transplantation	Criminal offence (penalty not specified in accessible text)	S.16(2)
Sale or dealing in human tissues without Ministerial approval	Fine up to Rs. 10,000 or imprisonment up to 2 years	S.17(3)
Unauthorised disclosure of donor/recipient identity	Criminal offence (penalty not specified in accessible text)	S.18(2)

Cross-References

Medical Ordinance, No. 26 of 1927

Section 23 (interpretation) defines key terms by reference to the Medical Ordinance:

Medical practitioner: As defined in the Medical Ordinance
Dentist: As defined in the Medical Ordinance
Medical consultant: As defined in the Medical Ordinance

Prisons Ordinance

Section 11 provides for tissue removal from deceased prisoners with written authority of the Superintendent of Prisons, as defined under the Prisons Ordinance.

Code of Criminal Procedure Act

Section 10 permits tissue removal during post-mortem examinations conducted under the Code of Criminal Procedure Act. Sections 4-5 require coroner or magistrate consent for tissue removal when post-mortem has been ordered.

Amendment Timeline

1987

No amendments have been enacted since 1987 — the Act has remained unchanged for 37 years.

Entity Relationships & Governance

Governance Hierarchy (1952 Design)

Current Replacement Structure (Post-1989)

Data Confidence

Legislative Framework

high

Historical Details

medium

Current Operational Status

low

Definitions (Section 23)

Term	Definition
Medical practitioner	As defined in the Medical Ordinance (Chapter 105)
Dentist	As defined in the Medical Ordinance (Chapter 105)
Medical consultant	As defined in the Medical Ordinance (Chapter 105)
Family member	Defined in Section 23 — includes spouse, children, parents, siblings
Human tissue	Any tissue of a human body, including organs
Prescribed	Prescribed by regulations made under the Act
Next-of-kin	Priority order: spouse, adult children, parents, siblings (S.3)
Prescribed officer	An officer authorised by the Director-General of Health Services

Research Gaps

The following areas require further investigation:

Reform calls — age threshold: Persistent advocacy to lower the living donor age from 21 to 18, aligning with other jurisdictions
Penalty adequacy: Rs. 10,000 fines (set in 1987) are widely regarded as insufficient deterrent; no inflation adjustment in 37 years
Section 17 loophole: The Ministerial written approval exception to the commercialisation ban has been criticised as potentially enabling organ trafficking
Organ trafficking protections: The Act predates modern organ trafficking conventions and lacks specific anti-trafficking provisions
Advisory Council activity: Whether the Technical Advisory Council has been actively convened and what recommendations it has made is unknown
Current membership: Names and composition of the current Advisory Council are not publicly documented
Regulations made under S.19: Whether regulations have been gazetted and their content is not publicly compiled
Brain death protocols: Whether detailed clinical protocols implementing S.15 have been issued by the Ministry
Transplant statistics: Number of transplantations performed under this Act is not publicly tracked in accessible sources
International alignment: How this Act compares with WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation

Act Structure​

Section Detail​

Statutory Bodies​

Advisory Council Composition Detail​

Consent Framework​

Brain Death Definition (Section 15)​

Authorization Matrix​

Living Donation Safeguards (Section 7)​

Regenerative Tissue — Family Restriction (Section 8)​

Unclaimed Bodies (Section 12)​

Prohibition on Commercialisation (Section 17)​

Confidentiality (Section 18)​

Conflict of Interest (Section 16)​

Penalties​

Cross-References​

Medical Ordinance, No. 26 of 1927​

Prisons Ordinance​

Code of Criminal Procedure Act​

Amendment Timeline​

Entity Relationships & Governance​