The 2020s thus far have been fraught with unforeseen circumstances with pharmaceutical companies working through everything from a global pandemic to wars and supply chain uncertainty.
When operating clinical trials, geopolitical instability can pose significant challenges, so companies in the space must be well equipped to deal with these complexities both before and during an unforeseen event.
In a panel session at Arena International’s Outsourcing in Clinical Trials DACH 2025 conference, speakers noted that flexibility is key to mitigating the impacts of geopolitical instability.
Assessing MFN’s impact on pharma
Traditionally, the US has been a key market for the pharma industry, with high list prices for drugs meaning that the region accounts for a strong proportion of many companies’ global sales.
However, the US pharma landscape is shifting, as President Donald Trump’s re-election has seen a wide range of policies introduced that impact everything from drug pricing to import tariffs.
One of the most notable policies to come out of the Trump administration this year was the Most Favored Nation (MFN) executive order. Introduced in May 2025, the bill was signed to slash drug prices in the US, which have traditionally been significantly higher than in countries across Europe and Asia.
While MFN’s introduction has caused a stir in the pharma industry, Amir Ahari, global head of clinical studies, neuroscience at Novartis, told Clinical Trials Arena that drug pricing pressure can be compensated by volume increase.
“Companies can likely achieve volume increases in specific disease and therapeutic areas, though it is yet to be seen if this will play out in all therapies,” he said.
Key opinion leaders previously interviewed by Clinical Trials Arena stated that drug pricing reductions triggered by MFN are unlikely to have a profound impact on pharma R&D.
Due to competition in the pharmaceutical market, Ahari noted that the way in which companies “provide drugs and make deals with specific administrations” will likely impact the gravity of drug pricing impacts, and subsequently, clinical trials.
Contracts as a fail-safe for risk mitigation
According to Ahari, geopolitical instability is also impacting the clinical trial contracting process. This is notable as they can serve as a first line of defence against changes caused by political shifts, war, or any other unprecedented scenario.
Amidst the dynamic modern geopolitical landscape, Ahari has observed a shift in the way that contracts are being drafted.
He said: “Companies are being more flexible with their contracts and building resilience into the contracting setup.
“In the context of war, we have always tried to include force majeure clauses into contracts. However, we’re now seeing more references to government restrictions, pandemics and cyberattacks.”
A key way to achieve flexibility and resilience, Ahari says, is through the addition of contingency clauses, which “cover the unexpected scenarios and allow parties to proceed accordingly” when an unexpected event occurs.
Mitigating risk amid geopolitical instability
Geopolitical instability has proven to be challenging for even the biggest companies in the pharma industry. Many are feeling its effects as monitors are less able to visit clinical trial sites, while sites battle with fatigue.
While geopolitical instability cannot be predicted, to best mitigate its associated risks, Ahari notes that clinical trial operators should be “flexible and diverse” in their approach. “It is good to assess if there are other countries or opportunities to start up and to shift a small portion of clinical side populations to be prepared,” he commented.
Ahari added: “Being globally connected is becoming increasingly important, which can be difficult for smaller companies. However, collaboration with contract research organisations (CROs) and knowledgeable partners can help us stay prepared for unexpected changes.”
He also touted the importance of stability in “workflow, financial flows and regular alignment between sites within their landscape”.
When looking to Europe, Ahari mentioned that the war involving Russia and Ukraine has impacted clinical sites and their compliance, meaning that companies will likely have to “step down” their operations there until the situation improves.
In a bid to reduce the impact of the war on operations, Ahari noted that companies should start an open dialogue with the impacted authorities and countries.
“If we cannot provide data for patients in a certain country because of a geopolitical situation, we could look to use data from patients in a neighbouring or reference country for submission,” he iterated.
“Flexibility is crucial to navigating geopolitical instability in clinical trials” was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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