We help medical institutions, pharmaceutical market representatives, and medical equipment manufacturers avoid risks and operate within the legal framework.
to the lead lawyer
The medical law sector is actively developing, as it is necessary to meet the growing need for medical services and rehabilitation not only for civilians, but also for injured military personnel. New medical and rehabilitation centers are emerging, and the law firm “DE-JURE” for its part helps medical institutions, representatives of the pharmaceutical market, manufacturers of medical equipment and doctors to develop, operate in the legal field and avoid risks, and patients to defend their rights and receive quality medical services.
To ensure that the work of a medical institution complies with all the norms of Ukrainian legislation and that inspections by state bodies do not bring unpleasant surprises, we recommend establishing constant cooperation with a medical lawyer. His help will be relevant even at the stage of opening a medical institution: it is the lawyer who will analyze the requirements for the building (including inclusivity, the ability to place X-rays and other equipment, lighting, the location of parking spaces and many other nuances), the features of obtaining a license for the planned direction of work, and draw up a plan for further work on training personnel and preparing documentation.
In the future, the help of a lawyer in the field of medicine may be needed for timely and prompt information about changes in medical law, licensing, reform and quick resolution of current issues (for example, patient complaints), representing the client’s interests in court. We help develop strategies, conduct negotiations, prepare internal documentation and a contractual framework, and also accompany the client at each stage of the organization’s activities. However, the law firm “DE-JURE” also provides one-time consultations.
As in most types of legal practice, in the field of medical law and pharmaceuticals, the starting set of documents will depend on the client’s request. For example, if a client wants to open a dental office, he must provide a document on the creation of a legal entity, the presence of premises (owned or rented) that meet legislative requirements, data on equipment and personnel, including certificates. A medical law lawyer ensures the process of obtaining a license for medical activities, for the use of narcotic drugs and the trade in medicines, and also suggests making the necessary changes.
The most frequent issues related to medicine and pharmacy are patenting or legalization of medical devices, obtaining licenses for medical practice and permits for the sale of medicines. The process of legalization of medical devices, for example, consists of the following stages:
These and other services provided by the law firm “DE-JURE” are aimed at ensuring the legality of clients’ activities in the medical sector, so that they can focus on helping patients.
Medical law is a dynamic industry that requires constant monitoring of changes and updates in licensing. There are many new regulatory and legal acts, reports that need to be implemented. For example, it is not enough to simply buy and install an X-ray machine – you also need to contact the State Nuclear Regulatory Inspectorate of Ukraine. For this, legal assistance is needed, the result of which is the legal activity of the client and the absence of questions from regulatory authorities.
In the TOP-50 ranking of leading law firms in Ukraine, “DE-JURE” is recognized as one of the leaders in the field of medical law (4th place in 2024). So no matter what problem our client faces, we will offer assistance with legal advice. In particular, “DE-JURE” specialists deal with the following issues:
We advise clients both on a regular basis, supporting the current activities of the enterprise and responding to new challenges, and on a one-time basis on a specific issue. Thus, we help in developing a strategy, conducting negotiations, licensing individual types of activities, preparing internal documentation, and also ensure compliance with all quality standards and requirements of regulatory bodies before accreditation.
In order for a medical institution to operate, a large number of contracts are required: returning to our example with X-rays, we note that not only a contract for the maintenance of the device itself is required, but also radiological control for all employees who interact with it, and consumables. And this is just one aspect of many. A medical law lawyer knows best what contracts and permits need to be drawn up and with whom to coordinate them so that the medical institution operates within the legal framework.
The legislation in the field of advertising of medical and pharmaceutical products contains many complex nuances and features, which our lawyers are well versed in. We analyze advertising campaigns and individual materials and help businesses operate effectively and in accordance with the law.
The task of a legal audit is to identify and eliminate possible legal risks that may negatively affect the medical business. The result is a written conclusion with recommendations for the further effective operation of the enterprise and the contracts that need to be concluded.
Another important specialization of “DE-JURE” lawyers is the patenting of medicinal products, which requires not only knowledge in the field of medical law, but also an understanding of intellectual property and patent law. We help navigate the complex patenting process: from preparing an application to representing the client’s interests in patent offices.
A license to practice medicine is issued by the Ministry of Health of Ukraine, and the candidate must meet the legislative requirements and provide the necessary documents. On this difficult path, a medical practice lawyer from the “DE-JURE” company comes to the rescue. He will draw up the necessary list of documents and take care of a positive result.
In addition, “DE-JURE” helps doctors from other countries to work legally in Ukraine, ensuring compliance with all necessary norms and procedures.
The assistance of a medical law lawyer will increase the company’s chances of successful participation in the tender and minimize the risk of disqualification. After analyzing the terms of the tender, the lawyer will draw up a package of documents in such a way as to emphasize the advantages of the enterprise (certificates, contracts, licenses, etc.).
The “DE-JURE” team of lawyers is ready to represent the client in court in the event of disputes in medical law. Thanks to our extensive experience in courts of various instances, we effectively defend the interests of our clients and ensure that their rights are respected.
We understand the complexity and unpredictability of medical legislation, so we make every effort to protect the interests of our clients.
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