NTA Audits in the Health Sector

Following press articles and television coverage regarding the National Transparency Authority's audit work in the Health Sector, the following clarification is provided:

NTA's audits are carried out using modern audit methodologies. These methodologies are based on national and european rules, international standards, best practices and the applicable regulatory framework. This approach contributes to the standardisation of audit procedures, the strengthening of findings' documentation and the consistent handling of cases under audit.

The process of assessing complaints has also been given particular attention. Complaints are handled in a methodical and considered way, and not in an arbitrary or isolated manner. They are assessed using specific criteria and methodologies to evaluate their seriousness, validity, audit priority, and potential for further investigation. This approach aims to ensure the rational allocation of audit resources and the more effective handling of cases of particular interest to the audit.

Former Health and Welfare Services Inspectors (SEYYP) reported directly to the Minister of Health and were administratively classified at General Directorate level. In contrast, the NTA's founding law safeguards its operational independence, as well as its administrative and financial autonomy. The Authority is not subject to control or supervision by government bodies, state agencies or other administrative authorities. However, it is subject to parliamentary oversight and submits its Annual Report to the Greek Parliament.

Consequently, the NTA's institutional framework offers robust safeguards for neutrality and independence when conducting audits, investigating complaints and drafting audit reports. The transfer of responsibilities and personnel of the SEYYP to the NTA, along with the establishment of a single independent audit institution, is in line with international best practices aimed at enhancing transparency.

The Head of the Authority is appointed through a statutory procedure involving specific criteria and defined stages, which reinforces the guarantees of the Authority's institutional independence.

The recruitment of inspectors is carried out in accordance with rigorous selection procedures. These procedures involve the thorough evaluation of candidates' qualifications and are divided into clearly defined stages of examination and evaluation, including both written and oral components. This ensures that the audit mechanism is staffed based on objective, meritocratic criteria.

Digitising administrative and audit procedures was a key step in the process of modernisation. It should be noted that the former SEYYP did not have an electronic register or any electronic system for recording and monitoring the assignment and progress of cases to ensure transparency and accountability in the assessment and handling of complaints and cases until the NTA was established.

The transition to an electronic register has replaced the former manual procedures for document management and circulation. This shift has led to notable enhancements in traceability, transparency, security and efficiency in case management.

The combination of these elements establishes a new model for audit operations. This model encompasses an independent institution with well-established recruitment procedures, modern audit methodologies, complaint assessment based on specific criteria, digital tools, an electronic register, and organised record management.

The National Transparency Authority has also assisted the Ministry of Health in carrying out systemic audits of its supervised bodies (pharmaceutical warehouses, pharmacies, hospitals, and mental health facilities), as well as investigating complaints submitted to the Ministry and forwarded to the Authority.

Furthermore, the NTA's audit work includes investigations, systemic and ad hoc audits, and sworn administrative enquiries (E.D.E.). Inspectors also participate in Joint Audit Teams alongside staff from other services. Preliminary investigations are also carried out following orders from prosecutorial authorities.

From the establishment of the NΤΑ until June 2026, the following were issued:

• More than 2,500 reports on special public health protection audits, and more than 1,500 reports concerning regular audit work in the field of Health. Furthermore, sworn administrative inquiries (E.D.E.) and over 40 preliminary enquiries were conducted in accordance with orders from the Public Prosecutor's office
• A total of 1,400 investigations were completed, resulting in the submission of relevant recommendations, reports or information. In addition, requests were made from Ministers and Heads of organisations regarding the operation of the bodies they oversee
• In particular, 287 audits were carried out in private healthcare facilities, as part of the total number of regular audits. These audits focused on the operational management of the facilities.

The following table shows the number of regular audits carried out each year:

YEAR / TOTAL

2020 / 11

2021 / 145

2022 / 247

2023 / 234

2024 / 342

2025 / 374

2026 / 223

TOTAL / 1,576

The audit reports included recommendations for improvements and proposals for establishing or amending the legal and regulatory framework where appropriate.

It is important to note that an audit report is not the result of a simple, formal or automated process. Instead, it is the result of a complex and thorough audit process conducted in accordance with applicable auditing rules, principles and tools.

Each case is assessed on its own merits, taking into account the specific factual and administrative circumstances involved. Consequently, the audit approach cannot be uniform and rigid. The adjustments and tailoring of this process are dependent on a number of factors, including the subject matter, the complexity, the nature of the findings and the specific characteristics of each audit.

The initial phase of the process involves the collection, processing and evaluation of the necessary information, as well as cross-checking available data, examining the facts and documenting the audit findings. It is essential to note that a judgement can only be made after the audit investigation has been completed and all the findings have been evaluated.

Therefore, an audit report is not merely a record of certain findings. It is a documented presentation of the outcome of a specific audit process. This process is designed and carried out based on the data and specific circumstances of the case. In order to ensure comprehensiveness, objectivity and thorough documentation, a methodical approach and sufficient time are required. It is also necessary to seek the views of individuals against whom allegations have been made regarding findings that concern them. It is essential to refrain from making any premature conclusions regarding these findings until the audit has been fully completed.

The scope of audits and complaints investigations (indicative list) includes the following areas:

• Medical and nursing care
• Rules of medical and nursing ethics
• Complementary and alternative medicine
• Legal operation of healthcare providers
• Equipment and facilities
• Shortages of medicines and the supply and distribution of medicines
• Compliance with procedures for storing and disposing of out-of-date medicines
• Supply of medicines by private pharmacies, their online stores and websites selling medicines and pharmaceutical products
• Prescription of medicines and diagnostic tests, and execution of prescriptions
• Compliance with public health protection measures against COVD-19 by healthcare facilities and providers, including hospitals, private clinics, diagnostic laboratories, etc.
• Legality of the operation of alternative therapy centres (naturopathic centres)
• Operation of non-profit civil companies (equipment, facilities, staff numbers, patient safety, services provided)
• Operation of psychiatric clinics (care conditions for psychiatric patients, equipment, facilities and services provided)
• Compliance with current legislation and operation of beauty centres
• Compliance with current legislation (health regulations) and operation of thermal springs (equipment and facilities)
• Enforcement of current legislation (health regulations) and operation of bottling plants (equipment, facilities)
• Operation of Center for the Treatment of Addicted Individuals (KETHEA) and Organization Against Drugs (OKANA)
• Compliance with public health protection measures against COVD-19 by healthcare facilities (hospitals, private clinics, doctors' offices, diagnostic laboratories)
• Operation, quality and adequacy of facilities, equipment and services provided by welfare organizations
• Hygiene and safety of Building and their surroundings, as well as safety measures for those in care
• Adoption and foster care procedures
• Administrative and financial operations of organisations and services
• Conducting regular and ad hoc management and financial audits
• Attribution of financial deficits

Case-by-case findings:

• Non-medical staff performing medical procedure (hair transplants, acupuncture and homeopathy)
• Facilities being operated without the presence and supervision of the designated scientific officer (a medical procedure performed by a clinic employee under a doctor's instructions via video call)
• Provision of medical services by a specialty not included in the operating license
• Employees providing services outside the professional rights associated with their qualifications
• Administration of vaccinations at a medical practice by a pediatrician using an expired vaccine
• Performance of cosmetic procedures by individuals lacking the necessary formal qualifications
• Provision of nursing services by individuals who did not meet the formal requirements for practicing that profession
• Inadequate nursing staff at a private clinic
• Advertising by a private clinic for a department not included in its operating license and more generally, operation outside the legal framework
• Performance of surgical procedures by a doctor in private clinics to remove tissue for dispatch to a tissue bank abroad for the development of innovative medicines, without complying with the relevant legal provisions
• Operation of private umbilical cord blood banks without an operating license. In one case, tanks containing cryopreserved tissues from a facility were transported within the premises of a private school
• Operation of a chronic haemodialysis unit without the Head Nurse being present and employing individuals without a professional licence in nursing assistant roles.

The audit reports included proposals and recommendations for improvement where appropriate, as well as proposals for establishing or amending the legal and regulatory framework. In 26 cases, the reports were forwarded to the relevant disciplinary bodies for examination of potential disciplinary liability, and/or to the Athens Court of Appeal Prosecutor's Office for criminal assessment.

Representative cases are attached below.

HEALTH AND WELFARE SECTOR

Audit of a private health clinic in Attica following a complaint concerning medical procedures (hair transplantation) performed by non-specialized staff

Findings:

• The dermatology clinic is to be operated in the absence of a dermatologist
• The designated scientific officer (a dermatologist - venereologist) was employed by the company on a part-time basis
• The hair transplantation procedures were carried out by a qualified anaesthetist and our dedicated nursing staff
• Services were provided by a nurse who does not hold a professional licence

Forwarding of the Audit Report:

• To the Athens Medical Association for the investigation of disciplinary liabilities
• To the Public Prosecutor of the Court of Appeal

Implementation: The Athens Medical Association (ISA) revoked the operating licence of the dermatology clinic for a period of one month and has imposed a fine of €14,600. In addition, the Association opened a disciplinary file with the intention of instigating disciplinary proceedings. The case has now been referred to the Athens Public Prosecutor's Office for the Court of First Instance for a preliminary investigation, which is being conducted by Hellenic Police officers. Furthermore, as part of the implementation of recommendations concerning hair transplantation procedures, the Ministry of Health requested an opinion from the Central Board of Health (KESY), which was subsequently issued.

Audit of a company providing mental health treatment and rehabilitation services

Findings:

• In accordance with the company's articles of association, the organisation provided services to individuals with intellectual disabilities, as well as to those suffering from substance use disorders (excluding medical treatment)
• According to the company's website, its services include the treatment of eating disorders, addictions, mental health conditions, infertility, Alzheimer's disease, diabetes, and menopause. One of the methods listed was "IV Drip Methods"
• Further online research has revealed that the company is promoted on third-party websites as a rehabilitation and addiction treatment centre
• The services are provided by authorised bodies that are subject to supervision and operate under specific conditions, in accordance with the applicable legal framework
• Signs were displayed at the entrance of the regulated organisation. They stated that the company's legal representative was a Mental Health Counsellor, a profession not regulated by law
• The sole partner did not hold a degree in psychology, nor did the company employ a qualified psychologist as its scientific officer

Forwarding of the Audit Report:

• To the Ministry of Health in order to establish a legal framework governing the practice of the profession of 'Mental Health Counsellor'
• To the Public Prosecutor of the Court of Appeal

Implementation: The Athens Court of Appeal Prosecutor’s Office forwarded the case to the Athens Magistrates' Court Prosecutor's Office for a preliminary investigation. The Ministry of Health has informed NTA that it has drafted a bill to regulate the matters raised in the recommendations of the Audit Report.

Audit of 146 private pharmacies nationwide

The audit was conducted in response to a relevant request and following an assessment of data provided by the Ministry of Health. It concerned the management of medicines that must be prescribed electronically, as well as medicines included in the decision of the President of the National Organisation for Medicines (EOF), ref. no. 96618/ 05.08.2024, concerning the "Temporary ban on parallel exports and intra-EU distribution of pharmaceutical products".

During the initial audit phase, the physical inventory of specific medications was meticulously recorded and subsequently verified against the records maintained in the Electronic System for Monitoring the Distribution of Medicines (HSPADIF), the Ministry of Health's digital platform for overseeing medicine stocks and distribution.

Findings:

• It was found that the actual stock levels for the majority of medicines did not match the stock recorded in HSPADIF for the following reasons:
  • sale of medicines using handwritten prescriptions has taken place, even though the platform has only recorded the execution of electronic prescriptions
  • sale of heparins to Chronic Haemodialysis Units (CHUs) was documented with the relevant tax document
  • sale of medicines to ships in individual cases was carried out.

Forwarding of the Audit Report:

• to the Ministry of Health to address and regulate the above issues, with a view to enabling the calculation of pharmaceutical stock at all points in the supply chain to be as accurate as possible in almost real time. This would support the Ministry of Health's monitoring of stock and the distribution of selected medicines through the operation of the Electronic System for Monitoring the Distribution of Medicines (HISPADIF). The system aims to prevent and address shortages of medicines and help citizens locate and obtain them
• The Panhellenic Pharmaceutical Association for investigating possible disciplinary issues and, where appropriate, referring them to the relevant local Pharmaceutical Association for further examination.

Implementation: The Ministry of Health has informed the NTA that procedures have been initiated to establish the necessary regulatory acts and, where appropriate, issue interpretative circulars.

Audit of eight private umbilical cord blood banks was conducted to ensure they were operating legally

Implementation: Following a recommendation in the Audit Report, the Ministry of Health decided to halt the operations of two banks and impose a two-year restriction on their ability to apply for an operating licence. Following the forwarding of the Audit Report concerning an Umbilical Cord Blood Bank to the Ministry of Education regarding the transfer of stem cells to a private school, disciplinary penalties were imposed, and a preliminary investigation is being carried out by the relevant Prosecutor's Office.

Audit of a private pharmacy

In response to a relevant recommendation by the NTA as part of an audit of a private pharmacy, the National Organization for Medicines prepared a draft amendment to Ministerial Decision No. DY8d/GP/oik.1348/04. This amendment aims to regulate the legal procedure for returning expired or soon-to-expire medical devices from pharmacies to suppliers, in accordance with the principles and guidelines of Good Distribution Practice for medical devices.

Investigation of a complaint concerning acupuncture performed by a non-doctor

Following a relevant recommendation by the NTA, the Ministry of Health has informed the Authority that the relevant department of the Central Health Council (KESY.) has been notified of the complaint. The Ministry emphasised the necessity of establishing clear terms and conditions for the practice of acupuncture. The absence of such rules gives rise to serious public health concerns.

Forwarding reports to medical associations for the purpose of examining disciplinary liability

Athens Medical Association: 13

Piraeus Medical Association: 1

Thessaloniki Medical Association: 1

Magnesia Medical Association: 1

Forwarding reports to the Public Prosecutor's Office: 26

NTA THESSALONIKI REGIONAL OFFICE

Audit of the legality of the operation of two alternative therapy centres (naturopathy centres)

The NTA carried out an audit of the legality of the operation of two alternative therapy centres (naturopathy centres), one in Thessaloniki and one in Athens. In both centres, an alternative "therapist" was found to be operating without holding a medical degree. The individual under investigation maintained websites and was active on social media.

The audit revealed that the individual under investigation:

1.            has been found to make unsubstantiated claims regarding a range of diseases and medical conditions, as well as to use equipment in the practice of medicine without the necessary qualifications

2.            promoted colloidal silver products as dietary supplements without the relevant authorisation from the National Organisation for Medicines

3.            in the centres where she operated, she used bio-resonance devices, but it was unclear whether non-doctors are legally permitted to possess such devices

4.            she offered dietary supplements through the aforementioned private centres, despite the fact that such products can only be sold through pharmacies.

It should be noted that there is no regulatory framework governing the operation of alternative medicine centres in Greece. These centres operate without professional certification or an operating licence.

The NTA's report was forwarded to:

• The National Organisation for Medicines (EOF) to impose a fine of €40,000 and conduct an audit into the circulation of colloidal silver products in the Greek market. This decision has been taken because these products pose a risk to public health
• The Ministry of Health to introduce legislation without delay in order to govern all alternative medicine activities by establishing terms and conditions
• The Central Health Council (KESY) to clarify the remit and operating procedures for bio-resonance devices
• The Ministry of Finance in order to stop issuing Activity Codes (KAD) for “Alternative Therapy Services” and related codes
• The Public Prosecutor's Office to arrange a criminal assessment

Implementation: The National Organisation for Medicines (EOF) imposed a fine of €10,000 on six dietary supplement companies. The Public Prosecutor's Office is conducting a preliminary investigation.

Audit of an illegal private cosmetic clinic

In response to a complaint regarding the operation of an illegal cosmetic surgery clinic, a joint team consisting of inspectors from the NTA Thessaloniki Regional Office and officers from the Northern Greece Economic Crime Division carried out an Audit in the Thessaloniki area.

The investigation revealed that the individual in question, who claimed to be a doctor, had converted her/his home into an illegal clinic, providing cosmetic and dermatological services, and was attracting clients through a social media profile.

The following items were found on the premises:

• packages of the prescription medicines Dysport and Botox (with authenticity seals). These contain botulinum toxin type A as their active ingredient. This is a toxic substance that is improperly used to eliminate facial wrinkles
• counterfeit (fake) packaging for the product Dysport
• vials of unknown origin, which are in illegal circulation in Greece. It is suspected that these contain botulinum toxin type A
• vials of an injectable growth hormone, which are being traded illegally in Greece
• packages of hyaluronic acid
• medical supplies such as syringes, needles, cotton, gloves and examination bed sheets etc. were also found. These items are fully consistent with the use of the premises as a medical practice.

The investigation found the following:

1) unlawful practise of medicine

2) Illegal distribution of medicines and pharmaceutical products falling under jurisdiction of the National Organisation for Medicines (EOF)

3) administration of medicines not approved for their intended use

4) distribution of counterfeit medicines

The Audit Report was forwarded to:

• the National Organisation for Medicines (EOF), as the competent authority, pursuant to Article 19(2) of Legislative Decree 96/1973 (A' 173), to impose the prescribed administrative fines. These fines are being imposed due to the individual under investigation practising the medical profession and supplying pharmaceutical products illegally, thereby endangering public health
• the Macedonia Operational Directorate of the Financial and Economic Crime Unit (SDOE), as the person under investigation was carrying out illegal and undeclared professional activities
• the Athens Public Prosecutor's Office for Appeals and the Thessaloniki Public Prosecutor's Office for First Instance for criminal assessment
• the Thessaloniki Medical Association for its prompt response and its information
• to the Public Prosecutor's Office for criminal assessment of the matters referred to in the Audit Report.

Implementation: Following the identification of incriminating evidence during its own investigation, in conjunction with the findings of the NTA audit, the Financial and Economic Crime Unit (SDOE) forwarded the case to the Public Prosecutor's Office.

NTA LARISSA REGIONAL OFFICE

Audit regarding the legality of the prescription and dispensing of medicines and vaccines by a private pediatrician and a pharmacy owner in Ioannina.

Findings: Vaccine prescriptions are to be directed to the pharmacy under inspection. During the on-site inspection of the pediatrician's practice, a quantity of 45 non-prescribed vaccines was found to have been stored on the premises. These were found to originate from the pharmacy under investigation.

The Audit Report was forwarded for disciplinary review to the Athens Public Prosecutor's Office.

Implementation: The National Organization for the Provision of Health Services (EOPYY) has requested the pharmacist to provide an explanation. Criminal proceedings have been initiated and the individuals involved have been referred to the court.