The Parliament of Ukraine Passes Landmark Law on Parallel Import of Medicines

The Verkhovna Rada of Ukraine has turned a new page in the nation’s pharmaceutical history by passing the Law of Ukraine “On Amendments to Certain Laws of Ukraine (regarding parallel import of medicinal products).” This move promises to reshape the pharmaceutical market by introducing mechanisms to broaden access to medicines, intensify competition, and align with European standards. However, this change brings complex implications for innovative pharmaceutical companies and generics manufacturers, setting the stage for a nuanced, long-term debate.

Parallel import—a mechanism that allows the importation of medicines already approved in other jurisdictions—is often presented as a tool to improve accessibility and affordability. Proponents argue that such policies foster competition and lower costs, benefiting consumers and healthcare systems. Yet, the implications for innovative pharmaceutical companies are more layered and require a closer examination. These companies, which invest billions in research and development to create groundbreaking therapies, often depend on exclusive rights and pricing models to recoup their investments and fund future innovation. The challenge lies in finding a balance that supports affordability without undermining the incentives for innovation.

This law also brings Ukraine closer to European integration, with provisions designed to align with EU practices. However, the Cabinet of Ministers’ ability to expand the list of eligible countries for parallel imports has been deferred until Ukraine’s eventual EU accession, contingent upon fully implementing a medicines verification system, including 2D coding. This measured approach underscores the importance of ensuring the integrity and safety of imported medicines, a concern shared by all stakeholders.

From a regulatory perspective, including rigorous pharmacovigilance requirements for parallel imported products highlights the need for robust monitoring systems. These provisions ensure that medicines entering the Ukrainian market meet safety and efficacy standards comparable to those applied to locally registered products. For innovative pharmaceutical companies, these requirements may safeguard against the risks associated with unauthorized imports or counterfeits, reinforcing the importance of maintaining high standards across the industry.

Another key aspect of the legislation is its impact on public procurement. By allowing the State Enterprise Medical Procurement of Ukraine to procure medicines not registered locally but approved in trusted jurisdictions such as the EU, USA, Japan, or Canada, the law opens the door to life-saving treatments that might otherwise face lengthy regulatory hurdles. This creates opportunities for generics manufacturers to bring their products to market quickly, but it also poses competitive challenges for innovators who have invested heavily in securing local registrations.

The debate between generics and innovative companies has long been a cornerstone of pharmaceutical policy worldwide. Generic manufacturers advocate for policies prioritising accessibility, arguing that affordability is paramount in addressing public health needs. On the other hand, innovative companies emphasise the importance of protecting intellectual property and sustaining the financial ecosystems that make groundbreaking therapies possible. The introduction of parallel import in Ukraine adds a new dimension to this debate, requiring careful navigation by all stakeholders.

This legislative shift can be seen as a chessboard where each move alters the game's dynamics, whether by generics or innovators. Generics may seize immediate opportunities to advance affordability, but innovators strategically plan several moves, ensuring the foundation for transformative medical breakthroughs. The challenge for policymakers is akin to that of a grandmaster: crafting a strategy ensuring short-term gains do not sacrifice long-term victories in healthcare.

As Ukraine takes this significant step towards reforming its pharmaceutical market, the industry will feel ripple effects. The balance between innovation and accessibility remains a delicate one, and the outcome of this legislative shift will depend on the ability of stakeholders to adapt, collaborate, and prioritise both public health and long-term innovation. In this evolving environment, informed decision-making and strategic foresight are more critical than ever.

Authors: Mykola Lysenko, Yaroslav Ognevyuk