<\/span>\n\n\t<\/div>\n<\/div>\nUkraine\u2019s competitiveness in the field of clinical trials was at the centre of the panel discussion \u201cClinical Trials in Ukraine: Potential and Development Pathways\u201d held during the National Forum \u201cHealthy Ukraine 2023\u201d, which took place on 5 June in Uzhhorod.<\/p>\n
The key conclusion of the discussion, reflecting the position of the Clinical Trials Subcommittee of the European Business Association, is that global competition for clinical trials is already underway and rapidly intensifying. To remain competitive in these conditions, Ukraine must act proactively rather than catch up with others.<\/p>\n
The global clinical trials landscape is changing under the influence of active competition and the targeted policies of individual regions. Asia, particularly China, is systematically increasing its share and may account for around 25% of the global market by 2030. This growth is driven by the speed of regulatory procedures, scalable infrastructure, digitalisation that significantly reduces timelines and costs, and the active role of the state.<\/p>\n
At the same time, the EU is moving from regulatory harmonisation towards a model of direct competition, embedding specific KPIs into its policies aimed both at increasing the number of clinical trials and accelerating their launch. One of the key indicators is becoming the period from submission to first patient enrolment.<\/p>\n
Clinical trials are no longer distributed among countries automatically. They are increasingly concentrated in jurisdictions where systems demonstrate the highest levels of speed and predictability. Some studies no longer reach less competitive markets, as countries undergo strict selection already at the planning stage, where sponsors assess the entire range of factors \u2014 from the speed of regulatory procedures to the system\u2019s ability to ensure stable, predictable launch and effective trial conduct.<\/p>\n
For Ukraine, this means that the risk of losing part of the clinical trials market is very real. The situation is further complicated by the fact that, after a sharp decline caused by the full-scale war, the number of clinical trials is only beginning to recover. Ukraine is simultaneously restoring its position while competing in much tougher global conditions, which requires fast, coordinated, proactive action and systemic solutions.<\/p>\n
At the same time, Ukraine has strong advantages that remain important for sponsors: experienced research centres, high-quality trial conduct, rapid patient recruitment, strong clinical expertise, and the ability to operate effectively under difficult conditions. These factors form an important competitive foundation, but today they are no longer sufficient without an effective regulatory policy and its consistent implementation.<\/p>\n
In this context, the key issue is not only the quality of regulation, but also how effectively it functions in practice.<\/p>\n
Increasing competitiveness requires focusing on the speed of the entire trial launch cycle \u2014 from submission to first patient enrolment \u2014 as well as ensuring predictability and coordination across the system as a single process. However, in the context of global competition, even this is no longer enough. Leading countries actively apply additional incentives to attract clinical trials, and Ukraine must follow this path as well.<\/p>\n
This includes, in particular, creating accelerated pathways for innovative medicines, introducing tax and customs simplifications for clinical trials, implementing priority review tracks, supporting research infrastructure, and considering mechanisms for early access or parallel procedures for innovation. Such measures help not only reduce barriers but also increase the country\u2019s attractiveness for global sponsors.<\/p>\n
In this context, European integration is also an important issue. Harmonisation with the EU Clinical Trials Regulation (EU CTR) is necessary but should remain adaptive. Without EU membership, Ukraine will not gain full access to the benefits of this system, while the literal replication of procedures and rules could already limit flexibility and reduce competitive advantages. Therefore, combining European standards with national solutions and instruments that ensure speed and efficiency is critical.<\/p>\n
Ultimately, competition today is no longer between regulatory frameworks, but between systems capable of ensuring fast, predictable, and barrier-free trial launch. At a time when Ukraine is only beginning to restore its role within the global clinical trials ecosystem, not only the direction of reforms matters, but also the speed of their implementation.<\/p>\n
The role of the state is decisive \u2014 its ability to shape the necessary solutions, implement them quickly, ensure consistent execution, and apply additional incentive mechanisms.<\/p>\n
At the same time, the entire clinical trials ecosystem in Ukraine is already prepared to launch and conduct new international studies \u2014 including research centres, patients, contract research organisations, and sponsors themselves. This readiness requires an equally high level of speed and determination from the state. Ultimately, this will determine whether Ukraine is chosen by global sponsors.<\/p>\n
The Association is grateful to the Ministry of Health of Ukraine for organising the forum and for maintaining an open dialogue between the government and clinical trials market participants, as well as to the State Expert Centre for the substantive and constructive discussion.<\/p>\n
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Ukraine\u2019s competitiveness in the field of clinical trials was at the centre of the panel discussion \u201cClinical Trials in Ukraine: Potential and Development Pathways\u201d held during the National Forum \u201cHealthy Ukraine 2023\u201d, which took place on 5 June in Uzhhorod. The key conclusion of the discussion, reflecting the position of the Clinical Trials Subcommittee of […]<\/p>\n","protected":false},"author":33544,"featured_media":749695,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n
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