Health and Pharmaceutical Law

The matters we handle within the framework of the relevant provisions of the Turkish Code of Obligations and the Turkish Penal Code, together with the Regulation on Patient Rights and healthcare legislation:

• Patient rights and disputes arising from the patient–physician relationship
• Actions for pecuniary and non-pecuniary compensation due to medical malpractice
• The obligation of informed consent and legal review of consent forms
• Liability of private hospitals and medical centres
• Full remedy actions against the acts and operations of public hospitals
• Liability under contracts for work in aesthetic procedures
• Disputes arising from dental practice
• Criminal liability and disciplinary proceedings concerning healthcare professionals
• Organ and tissue transplantation and assisted reproductive treatments
• Health tourism contracts and relationships with foreign patients
• Protection of health data and patient confidentiality
• Pharmaceutical licensing, pricing and reimbursement processes
• Clinical trials and pharmacovigilance obligations
• Legislation on medical devices, cosmetic products and food supplements
• Conditions and limits of lawfulness of medical intervention
• Promotion and advertising rules for medicinal products and medical devices
• Product liability in medicinal products and medical devices
• Pharmacy and pharmaceutical warehouse operations and objections to Ministry of Health decisions

In health law, a dispute rarely arises solely from the outcome of a treatment. Insufficient information given to the patient, incomplete medical records, a delayed referral, a breakdown in communication within the medical team, the disclosure of health data to unauthorised persons or activities carried out outside the scope of an institution's licence may each give rise to a distinct form of legal liability.

We act on behalf of patients, physicians, dentists, healthcare professionals, private healthcare institutions, pharmacies and pharmaceutical and medical device companies in advisory work, administrative applications, investigations and litigation. Legal review is not a substitute for medical expert opinion; in matters requiring medical assessment, the opinion obtained from the relevant specialty, the patient records and the conditions of legal liability are considered together.

For healthcare institutions, we review consent forms, patient information texts, treatment refusal documents, referral procedures and record-keeping practices from a legal perspective. We also provide support in the establishment and transfer of private healthcare institutions, partnership structures, physician engagement models, licence applications, responses to inspection reports and remedies against administrative sanctions.

Health data constitutes a special category of personal data. Our advisory work covers health data inventories, privacy notices, access authorisations, remote healthcare services, patient portals, data transfers and breach response procedures, as well as the review of websites, social media content and promotional materials before publication in light of healthcare, advertising, patient rights and data protection rules.

In the pharmaceutical and medical device field, we prepare and review licence, manufacturing, supply, distribution, quality, clinical use, product liability and recall agreements. The legal aspects of information requests, inspections, product registrations and administrative sanctions before the Turkish Medicines and Medical Devices Agency are handled in coordination with the relevant technical teams, and clinical trial processes are addressed together with the appropriate specialists.

Among the disputes most frequently encountered in practice are allegations of medical malpractice. An unsuccessful treatment, the progression of an illness or a complication does not in itself establish fault. The assessment is made by reference to the medical standard at the time of the intervention, the patient's condition, the chosen method, the timing of the intervention, the follow-up process and the resources available to the institution. Conversely, a medically correct intervention may still give rise to liability where the patient was not adequately informed.

Informed consent is a recurring point of dispute. A standard form bearing the patient's signature does not in every case release the healthcare professional from liability; the nature, purpose, significant risks and alternatives of the intervention, and the consequences of refusing treatment, must be explained in a manner the patient can understand. Emergencies, lack of decision-making capacity and patients who are minors or under legal representation require separate assessment.

Whether the service was provided by a public hospital, a private hospital or an independently practising physician may change the competent court and the application procedure. Harm allegedly arising in the course of public healthcare services may call for an administrative application and a full remedy action, while consumer law provisions may apply to private healthcare services qualifying as consumer transactions. Bringing an action before the wrong court or omitting a required preliminary application may cause a serious loss of time.

Other frequently encountered matters include the organisational liability of healthcare institutions, parallel compensation, criminal, disciplinary and administrative proceedings against healthcare professionals arising from the same incident, the unauthorised disclosure or viewing of health data, sanctions arising from licence and inspection processes, and product liability claims concerning medicinal products and medical devices, where the defectiveness of the product, the instructions for use and the causal link with the harm are examined together.

The initial assessment does not seek only to answer whether an error occurred. First, the chronology of events is established, and the persons and institutions that provided the healthcare service, the application period, the competent court, the available evidence and the need for a medical expert review are determined.

Medical documents and contracts are then obtained. Admission records, examination notes, test and imaging results, consultation and referral records, consent documents, surgical and anaesthesia notes, nursing observation and medication records, discharge documents and insurance policies are reviewed, and incomplete or contradictory records are identified. Records should, as far as possible, be obtained in their original form, and digital images preserved in a technical format suitable for examination.

The intervention, the information given to the patient, the follow-up and the organisational processes are assessed separately, and an opinion is obtained from the relevant medical specialty where necessary. Fault, damage and the causal link are then evaluated from a legal perspective. On the patient's side, heads of damage such as pecuniary and non-pecuniary loss, loss of earning capacity, care needs, treatment expenses and loss of support are considered; on the side of the professional or institution, complication, causation, disclosure and record-keeping are addressed as distinct issues.

Depending on the nature of the matter, the appropriate course is determined among an administrative application, mediation, criminal proceedings or litigation. Where compensation, criminal, disciplinary and administrative proceedings run in parallel, the defence is planned with all of them in view, since a statement or internal report made in one process may be used as evidence in another.

The claim or defence is prepared in accordance with the actual evidentiary position of the file, and the proceedings are followed through each procedural stage. The client is regularly informed about the stages of the process, the possible risks and the legal remedies that may be pursued.