Medical Law

Medical and pharmaceutical activities in Ukraine are subject to strict state regulation, licensing and continuous supervision. Errors in internal documentation of a healthcare institution or an individual practitioner’s office, improper maintenance of medical records, breaches of licensing requirements or defects in service agreements may lead to licence cancellation, significant fines by the Ministry of Health, State Service of Ukraine on Medicines and Drugs Control or State Labour Service, as well as prolonged litigation capable of disrupting business operations.

KAVCHUK & PARTNERS Law Office provides comprehensive legal support for private healthcare institutions (medical centres) and individual medical practices, including dental and cosmetology centres providing medical services, diagnostic centres, laboratories and pharmacies.

We provide both support for specific tasks, such as licensing, consultations and litigation, and full turnkey ongoing legal support, replacing or strengthening your institution’s internal legal department or in-house lawyer.

Stages and components of our service

Our approach covers the full legal cycle — from launching a medical startup to day-to-day operational legal support for a clinic.

1. Medical consulting, licensing and compliance

• Obtaining medical and pharmaceutical licences: we support the launch of new medical and pharmaceutical institutions. We analyse statutory requirements applicable to a particular medical practice, including requirements for premises, equipment and qualifications of medical personnel, provide legal advice and support at the initial stage, prepare documents for the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control, and support inspections of the material and technical facilities.
• Audit of medical documentation: we verify that internal instructions, medical-record forms (including Form No. 025/o), logs and internal orders are available and compliant with applicable standards.
• Medical compliance implementation: we develop reliable patient informed-consent forms for diagnostics and treatment, in addition to mandatory Ministry of Health forms where applicable, internal rules of the healthcare institution or individual practice, visitor conduct rules, and strict regulations for the protection of personal and medical data and medical confidentiality.

2. Ongoing legal services for healthcare institutions (Outsourcing)

To ensure lasting legal security for your business, we offer ongoing legal support that includes day-to-day assistance:

• Day-to-day operational support: prompt advice to management, HR departments and medical directors on legal issues arising during the clinic’s operations.
• Turnkey contract work: drafting, review and support for agreements with suppliers of medical equipment, consumables and pharmaceutical products; legal structuring of agreements for the provision of medical services to consumers (B2C) and contracts with corporate clients or insurance companies (B2B).
• Employment relations with personnel: drafting specialised employment contracts for medical staff, job descriptions, policies on material liability for damage to expensive equipment, and non-disclosure agreements (NDAs) protecting trade secrets.
• Monitoring and adapting to legislative changes: continuous analysis of updates to Ministry of Health orders, treatment standards and licensing requirements, followed by prompt implementation of changes in your institution’s operations to avoid liability and penalties.

3. Support during inspections and protection against supervisory authorities

• Preparing for inspections: we develop staff instructions and behavioural scripts, provide training and prepare the clinic’s documentation for inspectors’ visits.
• Legal support during inspections: our lawyers are directly present during scheduled and unscheduled inspections by the Ministry of Health of Ukraine, State Service of Ukraine on Medicines and Drugs Control, State Service of Ukraine on Food Safety and Consumer Protection, and State Labour Service, monitoring the legality of inspectors’ actions and recording violations on their part.

Court protection for medical businesses

Medical disputes in Ukrainian courts involve numerous technical issues and often require comprehensive forensic medical examinations. We provide professional protection for healthcare institutions, minimising financial and reputational risks:

• 📜 Protection against abusive patient claims: we defend clinics against unfounded claims and lawsuits by patients seeking to pressure the institution or recover money for alleged poor-quality treatment or diagnostic deficiencies.
• 🔍 Challenges to decisions of public authorities: we seek judicial cancellation of unlawful decisions by the Ministry of Health or the State Service of Ukraine on Medicines and Drugs Control suspending or cancelling licences, as well as penalty decisions issued by supervisory authorities.
• 🤝 Conflict resolution through mediation: we conduct negotiations and prepare legally secure settlement agreements at the pre-trial stage, protecting the clinic from unnecessary publicity and litigation costs.

What do you receive as a result?

• A complete legal department for the cost of one lawyer: continuous support for your healthcare institution by a team of specialists in medical law.
• Licensing stability: confidence in the legality of your medical practice and legal protection of the licence against unexpected cancellation by supervisory authorities.
• Reduced litigation risk: strong contracts and patient informed-consent forms designed to prevent unfounded pressure on the clinic.
• Protection of brand and reputation: resolution of legal crises and conflicts at an early stage before they develop into public scandals or court disputes.