Private Medical Institutions (Registration) Act, No. 21 of 2006
An Act to provide for the registration and regulation of private medical institutions in Sri Lanka and to establish the Private Health Services Regulatory Council (PHSRC). Enacted in 2006, this Act repeals the Nursing Homes (Regulations) Act, No. 16 of 1949 (Chapter 220) and creates the modern regulatory framework for private healthcare.
Full text available at LawNet (HTML). The PHSRC website PDF (phsrc.lk) is a scanned image and not machine-readable. No amendments exist.
Act Structure
The Act has 22 sections organised into six functional groups:
| Section | Topic | Summary |
|---|---|---|
| 1 | Short title and date of operation | Citation and commencement provisions |
| 2 | Registration requirement | No person shall operate a private medical institution unless registered; offence for non-compliance |
| 3(1-3) | Application for registration | Application to Provincial Director in prescribed form with fee; forwarded to Council with recommendations; 50% fee remitted to Council |
| 4 | Effect of registering / closure | Council may direct unregistered institutions to cease operations |
| 5 | Registration of existing institutions | Three-month compliance window for institutions operating before commencement |
| 6(1-2) | PHSRC establishment | 28-member Council: 12 ex-officio + 16 appointed by Minister; quorum 7; 3-year terms |
| 7 | Body corporate | Council is a body corporate with perpetual succession, may sue and be sued |
| 8 | Seal of the Council | Custody with Secretary; dual authorisation for use (Chairman + Secretary) |
| 9 | Objects of the Council | Develop standards, norms, and evaluation methods for private medical institutions |
| 10 | Duties and functions | Quality assurance programmes, staffing standards, data collection, grading systems |
| 11 | Delegation | Council may delegate duties to members or committees |
| 12 | Fund of the Council | Revenue from fees, grants, and other sources; expenditure as authorised |
| 13 | Accreditation | Minister may approve accreditation schemes on Council recommendation; 9-month advance notice |
| 14 | Power to enter and inspect | Authorised officers may enter without prior notice, at any time by day or night |
| 15 | Offences | Violations of Act provisions or registration conditions |
| 16 | Penalties | Fine up to Rs. 50,000; imprisonment up to 6 months for continuing offences |
| 17 | Offences by body of persons | Executive officer liability unless due diligence proven |
| 18 | Regulations | Minister may prescribe operational details by regulation |
| 19 | Rules | Council may make rules on infrastructure, staffing, and disposal standards |
| 20 | Interpretation | Definitions of key terms |
| 21 | Repeals | Repeals Nursing Homes (Regulations) Act (Chapter 220); 3-month transition |
| 22 | Sinhala text prevails | Language precedence clause |
Statutory Bodies
PHSRC — Composition Detail
The Council consists of 28 members: 12 ex-officio and 16 appointed by the Minister. Quorum is 7 members. Terms are 3 years with eligibility for reappointment.
Ex-officio members (12):
| # | Role | Note |
|---|---|---|
| 1 | Director-General of Health Services | Chairman (S.6(2)(a)) |
| 2 | Director, Private Health Sector Development | Secretary (S.6(2)(b)) |
| 3-11 | Provincial Directors of Health Services (9) | One per province (S.6(2)(c)) |
| 12 | Registrar, Sri Lanka Medical Council | S.6(2)(d) |
Appointed by Minister (16):
| # | Category | Count | Note |
|---|---|---|---|
| 1 | Sri Lanka Medical Association representative | 1 | S.6(2)(e) |
| 2 | Independent Medical Practitioners' Association representative | 1 | S.6(2)(f) |
| 3 | Sri Lanka Nursing Council representative | 1 | S.6(2)(g) |
| 4 | Pharmaceutical Society of Sri Lanka representative | 1 | S.6(2)(h) |
| 5 | Sri Lanka Dental Association representative | 1 | S.6(2)(i) |
| 6 | College of Medical Laboratory Technologists representative | 1 | S.6(2)(j) |
| 7 | Private hospital representatives (nominated by recognised association) | 4 | S.6(2)(k) |
| 8 | Specialist in hospital administration | 1 | S.6(2)(l) |
| 9 | Specialist in health economics | 1 | S.6(2)(m) |
| 10 | Specialist in medical laboratory technology | 1 | S.6(2)(n) |
| 11 | Attorney-at-Law | 1 | S.6(2)(o) |
- Term: 3 years; eligible for reappointment
- Quorum: 7 members
- Body corporate: Perpetual succession, own seal, may sue and be sued (S.7)
- Seal custody: Secretary; use requires authorisation by both Chairman and Secretary (S.8)
Registration Process
Registration is administered through Provincial Directors, who act as intermediaries between applicants and the PHSRC.
| Step | Details |
|---|---|
| Application | To the Provincial Director of Health Services in prescribed form with prescribed fee (S.3(1)) |
| Provincial review | Provincial Director forwards application to Council with recommendations (S.3(2)) |
| Fee remittance | Provincial Director remits 50% of registration fee to Council (S.3(3)) |
| Council decision | Council approves or rejects registration |
| Non-compliance | Council may direct unregistered institutions to cease operations (S.4) |
Transitional Provisions
Institutions operating before the Act's commencement had a 3-month window to apply for registration (S.5). The repealed Nursing Homes (Regulations) Act's registrations carried over during this transition period (S.21).
Objects and Functions (Sections 9-10)
Objects (S.9)
The Council's primary objects are to:
- Develop standards, norms, and methods for evaluating the performance of private medical institutions
- Promote quality in private healthcare delivery
Duties and Functions (S.10)
| Function | Description |
|---|---|
| Quality assurance | Implement quality assurance and quality improvement programmes (S.10(a)) |
| Staffing standards | Develop standards for staffing levels and qualifications (S.10(b)) |
| Data collection | Collect and maintain data on private medical institutions (S.10(c)) |
| Grading | Grade registered institutions based on standards (S.10(d)) |
Accreditation Framework (Section 13)
The Minister may, on the recommendation of the Council, approve accreditation schemes for private medical institutions. Key features:
- 9-month advance notice: Institutions must be given at least 9 months' notice before an accreditation scheme takes effect
- Voluntary to mandatory: The scheme allows a transition from voluntary to mandatory accreditation
- Implementation status: Unknown — no publicly available evidence of accreditation schemes being gazetted
Whether any accreditation schemes have been approved under Section 13 is unknown. This is a significant gap given the Act's emphasis on quality standards.
Inspection Powers (Section 14)
Section 14 grants broad inspection powers:
- Scope: Any authorised officer may enter and inspect any private medical institution
- Notice: No prior notice required
- Timing: At any time by day or night
- Patient privacy: The Act does not explicitly restrict access to patient medical records (contrast with Nursing Homes Act S.6(3) which prohibited inspection of patient records)
Unlike the repealed Nursing Homes (Regulations) Act of 1949, which explicitly protected patient medical records from inspection (S.6(3)), this Act does not contain an equivalent patient privacy safeguard. This is notable given the broad inspection powers in Section 14.
Penalties (Section 16)
| Offence | Penalty |
|---|---|
| Operating unregistered institution | Fine up to Rs. 50,000 |
| Continuing offence | Imprisonment up to 6 months |
| Corporate liability (S.17) | Executive officers deemed guilty unless due diligence proven |
The Rs. 50,000 fine represents a significant increase from the repealed Nursing Homes Act (Rs. 50), but may still be inadequate as a deterrent for large private hospital operators given modern revenue scales.
Cross-References
Nursing Homes (Regulations) Act, No. 16 of 1949 — Repealed
Section 21 fully repeals the Nursing Homes (Regulations) Act (Chapter 220). The 1949 Act's Nursing Homes Advisory Board (7 members) is replaced by the PHSRC (28 members). A 3-month transition period was provided for existing registered institutions.
Medical Ordinance, No. 26 of 1927
The SLMC Registrar serves as an ex-officio member of the PHSRC (S.6(2)(d)), providing a direct link between medical practitioner regulation and private institution regulation.
Ayurveda Act & Homoeopathy Act — Exclusions
Section 20 (Interpretation) defines "private medical institution" to exclude institutions operating exclusively under the Ayurveda Act (No. 31 of 1961) or the Homoeopathy Act (No. 7 of 1970). These traditional medicine institutions have their own regulatory frameworks.
Amendment Timeline
No amendments have been enacted since 2006.
Entity Relationships & Governance
Governance Hierarchy (1952 Design)
Current Replacement Structure (Post-1989)
Data Confidence
Definitions (Section 20)
| Term | Definition |
|---|---|
| Private Medical Institution | Any premises used for the diagnosis, treatment, or care of persons, operated by a person other than the Government; excludes Ayurveda and Homoeopathy institutions |
| Accreditation | A process of evaluation by which an institution is recognised as meeting prescribed standards |
| Council | The Private Health Services Regulatory Council established under Section 6 |
| Provincial Director | Provincial Director of Health Services |
| Authorised officer | Any person authorised by the Council for purposes of inspection |
Research Gaps
The following areas require further investigation:
- Accreditation implementation: Whether any accreditation schemes have been gazetted under Section 13
- Registration statistics: Number of institutions currently registered; how many were transitioned from the 1949 Act
- Fee schedule: Current registration fees (both initial and renewal) — not publicly documented
- PHSRC meeting records: No publicly available minutes or annual reports
- Grading system: Whether the institutional grading system under S.10(d) has been implemented
- Complaint mechanisms: How patient complaints about private institutions are handled
- Rules made under S.19: Whether the Council has exercised its rule-making power on infrastructure and staffing standards
- Patient privacy: Whether any administrative guidelines address the gap in patient record protection during inspections (S.14)
- Fee adequacy: Whether the Rs. 50,000 penalty ceiling (S.16) is sufficient as a deterrent for large private hospitals