Policy Making

LA Law Firm (Legal Alliance) lawyers participate in the preparation of draft normative documents along with laws of Ukraine, resolutions of the Cabinet of Ministers of Ukraine, orders of the Ministry of Health of Ukraine. This work is mainly performed within the technical support of the Government of Ukraine by international organizations.

Based on considerable experience in the preparation of normative documents, LA also provides legal consultations within the process of their approval by the relevant central government authorities. Our lawyers demonstrate a high level of proficiency, including in the areas of public procurements, health technology assessment (HTA), reimbursement, managed entry agreements (MEA) and medicine pricing.

Our lawyers have a strong history of cooperation with international organizations in the sphere of healthcare such as WHO, UNDP, USAID. They regularly contribute to the implementation of international projects and technical assistance projects in Ukraine and abroad as legal consultants or heads of legal groups, ensuring legal proficiency and competence.

SERVICES

Our regulatory lawyers ensure comprehensive solutions, in particular:

• Legal assessment of current normative documents
• Preparation of drafts of legal acts together with all supporting documents
• Legal support during the approval of legal acts by executive bodies
• Participation in the consultation process with stakeholders during public discussion of drafts
• Preparation of recommendations based on the results of the initiatives introduced by legal acts

REPRESENTATIVE PROJECTS

Projects recently implemented by LA Law Firm include:

• Participation in the development of the draft of the new Law of Ukraine "On Medicines" No. 2469-IX dated 28.07.2022. The draft law is based on the leading European practices regulating the circulation of medicines, in particular those provided by EU Directive 2001/83, EU Regulations 1394/2007, 536 /2014, 141/2000, 726/2004. Such sections of the draft law as the National Medicines Verification System, the National List of Essential Medicines, bioequivalence, and the use of the eCTD format were developed with the active engagement of Legal Alliance team.

• Legal support of the international technical assistance project to increase the transparency of the pharmaceutical system of Ukraine. The draft legal acts aimed at launching electronic prescriptions for medicines were developed in cooperation with the Ministry of Health of Ukraine and the National Health Service of Ukraine.

• Preparation of a package of documents for the purpose of introducing and functioning of the National List of Essential Medicines in accordance with the WHO Basic List. About 20 normative legal acts have been developed and approved.

• For the first time in the history of Ukraine, normative legal acts have been developed and approved regarding the implementation of the health technology assessment, which is an advanced global practice in the field of healthcare.

• Participation in the preparation of drafts of normative legal acts regarding the development and implementation of the insulin reimbursement system in Ukraine.

• Managing partner Dmytro Aleshko and counsel Oleksandr Bondar served as UNDP consultants in Ukraine for preparation of some legal acts regulating public procurement of medicines and medical devices with the involvement of international specialized organizations (UNDP, UNICEF and Crown Agents).

Also, Dmytro Aleshko, as an ex-vice president of the Association of Market Operators of Medical Devices (AMOMD), contributed to the preparation of amendments to the Laws of Ukraine, resolutions of the Cabinet of Ministers of Ukraine, orders of the Ministry of Health of Ukraine, which regulate the activities of market operators of medical devices.