There are a huge number of medical facilities in Ukraine that run international clinical trials, with the FDA noting that more than 250 drugs and devices were undergoing clinical research in Ukraine.
Patients have been placed in huge jeopardy by the war in Ukraine as medicines become harder to access and essential clinical trials are put on hold.
Attacks on hospitals have been in the news since the start of the war. While horrific, these attacks have also made it hard for patients to access emergency and essential medicines, putting people with chronic conditions at serious risk.
Manufacturing and supply of medicines and raw materials in the region have also been severely affected. The Ukrainian pharmaceutical market has become an important source for the development and distribution of medical supplies.1
However, the war led international insurance companies to create tough restrictions on cooperation with international suppliers. Fortunately, there is extensive local expertise and manufacturers in the region have been able to negotiate new terms to ensure the supply of raw materials to produce much-needed drugs.
Another challenge has been managing supply routes because airports and seaports have been closed. Instead, companies are using road transport and adjusting the routes regularly amid ongoing attacks.
Innovation has also been placed at risk by the war. There are a huge number of medical facilities in Ukraine that run international clinical trials, with the FDA noting that more than 250 drugs and devices were undergoing clinical research in Ukraine.2 It should also not be forgotten that Russia is an important country for clinical trials, and research there has been impacted.
There are steps that sponsors and contract research organizations can take to alleviate the crisis and, wherever possible, ensure patients keep participating. A first priority should be to conduct follow-up with patients and physicians involved in the trial, try to track where patients are located and, if possible, offer them the option to continue to participate in other parts of the world.
Clinical trial data should also be accessible via online channels, from when treatment starts to when it is completed, while working to ensure unblinding of participants is prevented. That does mean companies will need to implement processes to safeguard those data, including implementing data provenance, data privacy, traceability, and auditability. Further, it will be vital to provide emergency contact details to patients who have been displaced by the war so they can get the care they need.
There have been many lessons from previous wars, but the recent pandemic situation may serve as the best example of how to ensure continuity in terms of access to medicines and business generally. Technology and digital enablement came to the forefront during the pandemic as most interactions with health care providers, as well as clinical trial sites, moved to a remote setting.
During both the COVID-19 pandemic and now with the war in Ukraine, the life sciences industry has risen to the challenge. Companies are supporting Ukraine through financial donations and medical supplies.
Although many companies have decided to suspend operations in Russia and/or Belarus, patients everywhere remain a priority and companies have reiterated their commitment to ensuring access to life-saving products, in line with international humanitarian law.
As providers and consultants to the industry, we are committed to being part of the solution. For example, we can help our clients by building a broad network, or advisory alliance, to identify unmet needs and urgent priorities needed to support patients in impacted regions. Together as an industry we can and must do what is needed to make a difference for the people we serve.
About the Author
Thomas Dobmeyer, MD, is CEO of PharmaLex, with more than 20 years of experience in late-stage clinical development, medical affairs, and pharmacovigilance for a variety of therapeutic areas.
1. Ukraine Pharmaceutical and Healthcare Industry Report 2021, https://www.businesswire.com/news/home/20210720005504/en/Ukraine-Pharmaceutical-and-Healthcare-Industry-Report-2021-ResearchAndMarkets.com. Accessed June 2, 2022.
2. How Russia's invasion of Ukraine could affect 200+ clinical trials, https://www.advisory.com/daily-briefing/2022/02/25/russia-ukraine. Accessed June 2, 2022.