Pharmaceutical Regulation

Regulation of the pharmaceutical market

We understand how fast legislative changes are taking place and what new challenges every pharmaceutical and healthcare business faces. The narrow specialization and vast experience of working in Ukraine's market allow us to quickly navigate the legislative environment, respond promptly to the needs of each client and adjust to new circumstances, including martial law.

The unique expertise of our team and exceptional achievements in regulatory affairs have been repeatedly acknowledged by authoritative global ratings and research. Every year, partners of the LA Law Firm (Legal Alliance) receive international recognition as Lawyer of the Year in life sciences in Ukraine, and the firm is repeatedly recognized as a preeminent law firm in medicine, pharmaceuticals and healthcare.

SERVICES

We advise to pharmaceutical market operators on a wide range of regulatory issues, including:

• Medicine procurement. Legal regulation of public procurement of medicines and healthcare products for budget funds within the framework of centralized procurement and at regional tenders, as well as their further supply.

• Price regulation. Government price regulation of medicinal products and medical devices.

• Bringing new medicines and medical devices to market. All necessary licensing procedures, certification, marking, etc.

• Import and export. Export and import operations with medicines and medical devices, support of unique supplies for the Ukrainian market.

RECENT PROJECTS

• Legal support for the international technical assistance project to promote transparency of Ukraine's pharmaceutical system.

• Participation in drafting of legislative acts on development and introduction of the reimbursement system for insulin in Ukraine.

• Legal support for import and delivery of the world’s most expensive medicine for the needs of Ukrainian patients and its subsequent acceptance as a charitable donation in the form of humanitarian aid. Nine shipments have been supported by Legal Alliance.

• Advising the major operator in medicine procurement on the proper development and implementation of anti-corruption policies and procedures.

• Expert support for health reform in a Central Asian country. Assess the implementation of the public health policy to evaluate progress, gaps, and bottlenecks and develop accurate recommendations. Cooperation with the government.

• Comprehensive advice on compliance with the requirements of Ukraine's pharmaceutical regulation on products of a top global pharma company. Development and adjustment of company policies to the conditions of Ukraine.

• Representing a group of pharmaceutical companies in the investigation of counterfeit medicines. Development of procedures and methodological guidelines on combating counterfeiting in Ukraine for pharmaceutical companies and law enforcement agencies.

• Legal support of issues related to clinical trials of medicines in Ukraine. In particular, drafting agreements on clinical trials, advice on legal regulation of clinical trials in Ukraine, legal support for the process of changing the composition of researchers and clinical sites.

• Legal advice and development of a scheme to boost the availability of an innovative medicine for patients to treat orphan diseases. Legal analysis of the scheme of expanding patients' access to innovative medicine through consideration of tax risks, perils in the economic competition sector and general risks.

• Legal analysis and development of a legal model on the organization of contract manufacturing with a third party licensed to produce medicines in Ukraine, and participation in drafting a business scheme considering the risks in competition and taxation. According to the analysis, manufacturing, quality and distribution agreements have been drawn up.

• Advising pharmaceutical companies on the risk of marketing authorization revocation and reduction of business in Ukraine.

• Advising on development strategy for an international pharmaceutical company in Ukraine.

• Advising a number of foreign pharmaceutical companies on bringing a new medicine to the Ukrainian market.