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Healthcare in Iraq: Legal & Regulatory Guide

Establishing, investing in and operating a healthcare or life sciences business in Iraq, from licensing and registration to patient rights and disputes.

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About this guide

Legal and regulatory considerations for healthcare and life sciences in Iraq

This guide examines the legal and regulatory considerations involved in establishing, investing in and operating a healthcare or life sciences business in Iraq. It covers facility licensing, foreign ownership, healthcare professionals, pharmaceutical and medical-device registration, scientific bureaus and distribution, pricing and market access, advertising, and interactions with healthcare professionals.

It also addresses digital health, telemedicine and AI, clinical trials, controlled medicines, patient rights and medical records, health insurance, public procurement, product liability and malpractice disputes, including the differences between Federal Iraq and the Kurdistan Region.

This publication provides general information only and does not constitute legal advice.

Contents

What this guide covers

Healthcare Regulation & Market Entry

What is the principal legal and regulatory framework governing healthcare and life sciences activities in Iraq?
Which authorities regulate healthcare institutions, pharmaceuticals, medical devices and healthcare professionals, and how are their responsibilities divided?
What regulatory due diligence should be conducted before acquiring, investing in or contracting with an Iraqi healthcare business?
How may foreign healthcare and life sciences companies establish and operate in Iraq?
Are there restrictions on foreign ownership or foreign investment in hospitals, clinics, pharmacies and other healthcare businesses?
What is the regulatory position in the Kurdistan Region, and how does it differ from Federal Iraq?
What licences and approvals are required to establish a private hospital, clinic, medical centre or laboratory?
What approvals are required to expand, relocate, renovate or change the activities of an existing healthcare facility?
Are healthcare licences transferable following a share sale, asset sale or change of control?
What are the legal consequences of operating a healthcare facility without the required licences?

Healthcare Transactions and Commercial Arrangements

What legal and regulatory issues arise in healthcare mergers and acquisitions and private equity transactions?
What healthcare-specific warranties, indemnities and conditions precedent should be included in acquisition agreements?
How does Iraqi competition law apply to healthcare transactions and market concentration?
What competition risks arise from exclusivity, pricing, referrals and market-allocation arrangements in healthcare?
How may healthcare joint ventures with foreign investors be structured?
What provisions should be included in healthcare joint venture agreements?
How are hospital management agreements regulated, and which responsibilities must remain with the licensed hospital?
What legal issues arise when healthcare services or support functions are outsourced?
How are healthcare franchise and brand-licensing arrangements regulated?
What legal considerations apply to the closure, suspension, restructuring or insolvency of a healthcare facility?

Healthcare Professionals and Employment

How are doctors, dentists, pharmacists, nurses and other healthcare professionals licensed in Iraq?
What requirements apply to foreign healthcare professionals working in Iraq?
How should hospitals verify qualifications, professional registrations and clinical privileges?
What employment, immigration, social security and work-permit requirements apply to healthcare personnel?
What legal duties apply to visiting doctors, locum professionals and independent medical contractors?
How should healthcare employment contracts address confidentiality, patient records, intellectual property and professional liability?

Pharmaceuticals and Market Authorisation

How are pharmaceutical manufacturers and pharmaceutical products registered in Iraq?
What documents and technical information are required to register a pharmaceutical product?
How are variations, renewals and changes to registered pharmaceutical products handled?
What legal responsibilities apply to pharmaceutical marketing authorisation holders, importers and distributors?
How are scientific bureaus established and licensed, and what functions may they perform?
What is the difference between a scientific bureau, commercial agent, importer and pharmaceutical distributor?
How should pharmaceutical agency and distribution agreements be structured?
Who owns and controls the pharmaceutical registration file when the relationship with the Iraqi distributor ends?
What rules apply to local pharmaceutical manufacturing and technology-transfer arrangements?
What Good Manufacturing Practice and Good Distribution Practice requirements apply in Iraq?
What requirements govern pharmaceutical labelling, packaging and patient information?
How are pharmaceutical prices determined, approved or controlled?
How do pharmaceutical products obtain access to the public and private healthcare markets?
What rules apply to compassionate use, named-patient supply and off-label use of medicines?
How are dietary supplements, herbal products and medical nutrition products classified and regulated?
How are cosmetics, cosmeceuticals and personal-care products classified and regulated?

Medical Devices and Healthcare Technology

How are medical devices classified and registered in Iraq?
What responsibilities apply to manufacturers, authorised representatives, importers and distributors of medical devices?
What regulatory requirements apply to installation, calibration, maintenance and after-sales support for medical equipment?
How is software as a medical device regulated?
How are digital therapeutics and health applications regulated?
Is telemedicine permitted in Iraq, and what requirements apply to local and cross-border telemedicine services?
How is artificial intelligence used in diagnosis and treatment regulated?
Who may be liable where an AI system or digital healthcare product contributes to patient harm?

Advertising, Promotion and Industry Relationships

What rules apply to advertising hospitals, clinics and healthcare services?
What rules apply to advertising and promoting pharmaceuticals and medical devices?
May prescription medicines be advertised directly to the public?
What restrictions apply to interactions with doctors, pharmacists and other healthcare professionals?
How are gifts, samples, sponsorships, conferences, travel and hospitality regulated?
What legal risks arise from using social-media influencers to promote healthcare services or products?
What anti-bribery and conflict-of-interest risks arise in healthcare registration, procurement and distribution?

Public Procurement and Supply

How are government healthcare tenders regulated in Iraq?
What requirements apply to pharmaceutical and medical-device procurement through KIMADIA and other public entities?
What bid bonds, performance guarantees and qualification documents are commonly required?
What legal remedies are available where a bidder is disqualified or a healthcare tender is improperly awarded?
How are sanctions, export controls and healthcare trade-compliance requirements applied?
What import, customs and border-control requirements apply to pharmaceuticals and medical devices?
What rules apply to the supply chain, cold chain, transportation and storage of medicines?
How should temperature excursions, damaged products and supply interruptions be managed?
How are counterfeit medicines, parallel imports and product diversion addressed?
What tax, customs and investment incentives may be available to healthcare and pharmaceutical projects?

Product Safety and Post-Market Compliance

Who may be liable for defective pharmaceuticals and medical devices?
What product-liability claims may be brought against manufacturers, importers, distributors, pharmacies and healthcare institutions?
What obligations apply to pharmaceutical and medical-device product recalls?
How should adverse events, product complaints and safety signals be reported?
What pharmacovigilance obligations apply to manufacturers, scientific bureaus, importers and distributors?
What post-market surveillance obligations apply to medical devices?
How should expired, damaged, recalled or unregistered healthcare products be destroyed?

Clinical Trials, Research and Biotechnology

What approvals are required to conduct a clinical trial in Iraq?
What provisions should be included in a clinical trial agreement?
What responsibilities apply to the sponsor, investigator and participating healthcare institution?
How are research ethics committees established, and what matters must they review?
How are informed consent and the participation of vulnerable persons regulated in clinical research?
How are serious adverse events and protocol deviations reported?
How do Good Clinical Practice and international research standards apply in Iraq?
How are investigational medicinal products imported, stored and accounted for?
How are biological samples and clinical trial data transferred outside Iraq?
How are biotechnology products, biologics and biosimilars registered and regulated?
What legal requirements apply to genetic testing and genomic data?
Who owns clinical trial results, research data, inventions and other intellectual property created during a study?

Vaccines, Controlled Medicines and Special Products

How are vaccines registered, imported, distributed and monitored?
What special cold-chain and traceability requirements apply to vaccines?
How are narcotic drugs, psychotropic substances and other controlled medicines regulated?
What prescribing, dispensing, storage and recordkeeping obligations apply to controlled medicines?
What should hospitals and pharmacies do where controlled medicines are lost, stolen or unaccounted for?
How are emergency medicines, donated medicines and medical samples regulated?

Pharmacies and Distribution Channels

What requirements apply to establishing and licensing a pharmacy?
May a company own or operate multiple pharmacies as a pharmacy chain?
What duties apply to the responsible pharmacist and other pharmacy personnel?
How is the online sale and home delivery of medicines regulated?
May an electronic pharmacy sell prescription or controlled medicines?
What responsibilities apply to online platforms connecting patients with pharmacies?

Patient Rights, Data and Cybersecurity

What rights do patients have when receiving healthcare services in Iraq?
What constitutes valid informed consent to medical treatment?
Who may provide consent for children, unconscious patients and persons lacking legal capacity?
What rules apply when a patient refuses medical treatment?
Who owns medical records, and what rights do patients have to access or obtain copies of them?
How long should healthcare institutions retain medical records?
What confidentiality obligations apply to doctors, hospitals, insurers and service providers?
How are electronic medical records and digital prescriptions regulated?
What cybersecurity duties apply to hospitals and healthcare technology providers?
How should healthcare institutions respond to ransomware, data breaches and loss of medical information?
What rules apply to the cross-border transfer of patient and clinical data?
When may health information be considered anonymised or de-identified?
What safeguards should apply where cloud-service providers process patient information?
May patient information, photographs or medical images be used for marketing, teaching or research?

Specialised Healthcare Services

What licensing and professional requirements apply to cosmetic clinics and aesthetic medicine?
What rules apply to fertility clinics and IVF services?
How are embryos, gametes and other reproductive materials stored, transferred and disposed of?
How are mental-health facilities regulated, and what rights do mental-health patients have?
Under what circumstances may a patient be admitted or treated involuntarily?
What requirements apply to emergency departments and ambulance services?
What rules apply to home healthcare, nursing homes and long-term care facilities?
How are dental clinics and dental laboratories regulated?
What requirements apply to medical laboratories, diagnostic centres and blood banks?
How are organ transplantation, human tissues and biological materials regulated?
What licensing requirements apply to radiology, nuclear medicine and radiation-producing medical equipment?

Healthcare Facilities, Environment and ESG

What land, construction and regulatory approvals are required to develop a hospital or healthcare facility?
What should investors examine before acquiring or leasing real estate for a healthcare project?
What Civil Defence, fire-safety, accessibility and occupancy requirements apply?
How are medical, pharmaceutical, infectious and hazardous wastes regulated?
What environmental liabilities may arise from operating a hospital, laboratory or pharmaceutical facility?
How do environmental, social and governance requirements apply to healthcare and life sciences businesses?
What business-continuity and emergency-preparedness obligations apply to healthcare institutions?

Healthcare Insurance and Payment

How is the Iraqi health-insurance system regulated under Health Insurance Law No. 22 of 2020?
How may private healthcare providers participate in the health-insurance system?
What provisions should be included in agreements between healthcare providers and insurers?
How should reimbursement claims, pre-authorisation, rejected claims and overpayments be handled?
What fraud and abuse risks arise in healthcare billing and insurance claims?
What professional-indemnity and medical-malpractice insurance should healthcare providers maintain?

Complaints, Liability and Dispute Resolution

How should hospitals receive, investigate and respond to patient complaints?
When must a medical incident be reported to the Ministry of Health or another authority?
How should hospitals conduct internal investigations while preserving evidence and confidentiality?
What civil, criminal and disciplinary liabilities may arise from medical malpractice?
What evidence is commonly required in healthcare litigation?
How are medical experts and expert committees appointed and used in Iraqi proceedings?
What limitation periods may apply to healthcare and product-liability claims?
Can healthcare, pharmaceutical and hospital-management disputes be submitted to arbitration?
Which disputes remain subject to the exclusive jurisdiction of Iraqi regulatory, disciplinary or criminal authorities?
How are foreign judgments and arbitral awards involving healthcare businesses recognised and enforced in Iraq?

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Healthcare in Iraq: Legal & Regulatory Guide

Legal and regulatory considerations for healthcare and life sciences in Iraq

What this guide covers

Healthcare Regulation & Market Entry

What is the principal legal and regulatory framework governing healthcare and life sciences activities in Iraq?

Which authorities regulate healthcare institutions, pharmaceuticals, medical devices and healthcare professionals, and how are their responsibilities divided?

What regulatory due diligence should be conducted before acquiring, investing in or contracting with an Iraqi healthcare business?

How may foreign healthcare and life sciences companies establish and operate in Iraq?

Are there restrictions on foreign ownership or foreign investment in hospitals, clinics, pharmacies and other healthcare businesses?

What is the regulatory position in the Kurdistan Region, and how does it differ from Federal Iraq?

What licences and approvals are required to establish a private hospital, clinic, medical centre or laboratory?

What approvals are required to expand, relocate, renovate or change the activities of an existing healthcare facility?

Are healthcare licences transferable following a share sale, asset sale or change of control?

What are the legal consequences of operating a healthcare facility without the required licences?

Healthcare Transactions and Commercial Arrangements

What legal and regulatory issues arise in healthcare mergers and acquisitions and private equity transactions?

What healthcare-specific warranties, indemnities and conditions precedent should be included in acquisition agreements?

How does Iraqi competition law apply to healthcare transactions and market concentration?

What competition risks arise from exclusivity, pricing, referrals and market-allocation arrangements in healthcare?

How may healthcare joint ventures with foreign investors be structured?

What provisions should be included in healthcare joint venture agreements?

How are hospital management agreements regulated, and which responsibilities must remain with the licensed hospital?

What legal issues arise when healthcare services or support functions are outsourced?

How are healthcare franchise and brand-licensing arrangements regulated?

What legal considerations apply to the closure, suspension, restructuring or insolvency of a healthcare facility?

Healthcare Professionals and Employment

How are doctors, dentists, pharmacists, nurses and other healthcare professionals licensed in Iraq?

What requirements apply to foreign healthcare professionals working in Iraq?

How should hospitals verify qualifications, professional registrations and clinical privileges?

What employment, immigration, social security and work-permit requirements apply to healthcare personnel?

What legal duties apply to visiting doctors, locum professionals and independent medical contractors?

How should healthcare employment contracts address confidentiality, patient records, intellectual property and professional liability?

Pharmaceuticals and Market Authorisation

How are pharmaceutical manufacturers and pharmaceutical products registered in Iraq?

What documents and technical information are required to register a pharmaceutical product?

How are variations, renewals and changes to registered pharmaceutical products handled?

What legal responsibilities apply to pharmaceutical marketing authorisation holders, importers and distributors?

How are scientific bureaus established and licensed, and what functions may they perform?

What is the difference between a scientific bureau, commercial agent, importer and pharmaceutical distributor?

How should pharmaceutical agency and distribution agreements be structured?

Who owns and controls the pharmaceutical registration file when the relationship with the Iraqi distributor ends?

What rules apply to local pharmaceutical manufacturing and technology-transfer arrangements?

What Good Manufacturing Practice and Good Distribution Practice requirements apply in Iraq?

What requirements govern pharmaceutical labelling, packaging and patient information?

How are pharmaceutical prices determined, approved or controlled?

How do pharmaceutical products obtain access to the public and private healthcare markets?

What rules apply to compassionate use, named-patient supply and off-label use of medicines?

How are dietary supplements, herbal products and medical nutrition products classified and regulated?

How are cosmetics, cosmeceuticals and personal-care products classified and regulated?

Medical Devices and Healthcare Technology

How are medical devices classified and registered in Iraq?

What responsibilities apply to manufacturers, authorised representatives, importers and distributors of medical devices?

What regulatory requirements apply to installation, calibration, maintenance and after-sales support for medical equipment?

How is software as a medical device regulated?

How are digital therapeutics and health applications regulated?

Is telemedicine permitted in Iraq, and what requirements apply to local and cross-border telemedicine services?

How is artificial intelligence used in diagnosis and treatment regulated?

Who may be liable where an AI system or digital healthcare product contributes to patient harm?

Advertising, Promotion and Industry Relationships

What rules apply to advertising hospitals, clinics and healthcare services?

What rules apply to advertising and promoting pharmaceuticals and medical devices?

May prescription medicines be advertised directly to the public?

What restrictions apply to interactions with doctors, pharmacists and other healthcare professionals?

How are gifts, samples, sponsorships, conferences, travel and hospitality regulated?

What legal risks arise from using social-media influencers to promote healthcare services or products?

What anti-bribery and conflict-of-interest risks arise in healthcare registration, procurement and distribution?

Public Procurement and Supply

How are government healthcare tenders regulated in Iraq?

What requirements apply to pharmaceutical and medical-device procurement through KIMADIA and other public entities?

What bid bonds, performance guarantees and qualification documents are commonly required?

What legal remedies are available where a bidder is disqualified or a healthcare tender is improperly awarded?

How are sanctions, export controls and healthcare trade-compliance requirements applied?

What import, customs and border-control requirements apply to pharmaceuticals and medical devices?

What rules apply to the supply chain, cold chain, transportation and storage of medicines?

How should temperature excursions, damaged products and supply interruptions be managed?

How are counterfeit medicines, parallel imports and product diversion addressed?

What tax, customs and investment incentives may be available to healthcare and pharmaceutical projects?

Product Safety and Post-Market Compliance

Who may be liable for defective pharmaceuticals and medical devices?

What product-liability claims may be brought against manufacturers, importers, distributors, pharmacies and healthcare institutions?