The recent geopolitical situation in the Middle East could affect clinical processes and daily healthcare practice because rising oil prices and disruptions to maritime transport may impede the arrival of medical supplies, technology (including healthcare software), and raw materials used to manufacture drugs.

Although the trade blockade threats announced by the US President Donald Trump appear to have eased, the possibility remains. Given this scenario, Jesús Sanz Villorejo , secretary and member of the board of directors of Spanish Society of Health Managers, told El Médico Interactivo, part of Medscape’s Professional network, that Spanish hospitals do not have a single, uniform number of days of stock for materials because much of what is sold under US brand names is not manufactured entirely in the US: it may be assembled in Europe, have active ingredients from Asia, and be finally released in the EU.

He added that stocks also depend on the logistics model — centralized by the Madrid Health Service, the Catalan Institute of Health or the Andalusian Health Service — as well as on clinical criticality, expiration dates and frequency of supply.

Since the pandemic, surveillance of supplies and retention of stock in times of tension has been strengthened, Sanz continued. Measures include interventions to prevent parallel exports when there is a risk for shortage. In general, for reagents and disposables, stock is measured in weeks rather than months. For medicines, because of cost and expiration, the system also tends toward weeks of stock, supported by regulatory surveillance and contingency measures.

Technology

Regarding technology, it is necessary to distinguish between the manufacturer and technological dependence. For MRI and CT imaging, the major suppliers in Europe are usually Siemens Healthineers (Germany), Philips (Netherlands), GE Healthcare (US) and Canon Medical (Japan), among others. However, even when the final equipment is European or Japanese, there are cross-cutting dependencies of the US origin in advanced electronic components such as semiconductors, graphics processing units/central processing units, and field-programmable gate arrays; in cybersecurity and core software — operating systems, libraries, and development tools — and in certain value chains that rely on cloud services and updates.

In this context, the executive points out that direct dependence — meaning dependence on equipment manufactured in the US — varies by hospital and by installed base; indirect dependence — on software, chips, critical components, and licenses — is high across the sector, even among European manufacturers.

With respect to surgical robotics, the Intuitive da Vinci in the US integrates hardware, software, consumables, and services as part of its value proposition. Intuitive reported in December of last year that there is a combined installed base of more than 470 systems in Italy, Spain, and Portugal. “That is why dependence here is especially intense because the usage model relies on proprietary instruments and maintenance, updates, and life cycles are tightly linked to the manufacturer.”

Pharmaceuticals

Hospitals cannot absorb a 30%-50% price increase for US brand drugs without compromising solvency, unless that is offset with financing and management measures. In hospital pharmacy, a very significant portion of expenditure is concentrated in biologics, onco-hematology, immunotherapy, and orphan and high-impact drugs. A 30%-50% increase in a meaningful subset would strain pharmaceutical spending, risk-sharing agreements and force the rescheduling of investments or activities unless budgets are increased.

To address this potential problem, hospitals should replace drugs with biosimilars or generics where a clinically equivalent alternative exists; renegotiate spending ceilings, discounts, price-volume agreements, and confidential deals; prioritize clinical indications to ensure the highest-value uses; and review therapeutic positioning through pharmacy committees.

Alternatives

For US equipment or drugs that can be substituted, Sanz noted that procurement competitions can be won with European and Japanese alternatives. It is not “plug and play,” however, integration with picture archiving and communication system/radiology information system/electronic health record, training, construction work, maintenance, and multi-year contracts are needed.

Looking at clinical information systems (healthcare software), US vendors have a notable presence in Spain in certain areas; Cerner emerged as a market leader in Spain in 2023 market analyses.

Sanz’s alternatives focus on European platforms, regional in-house developments and mixed ecosystems, but substitution usually takes multiple years because of complexity, data migration, and organizational change.

For surgical robotics (da Vinci) there can be partial, but not immediate substitution. European-deployed alternative platforms include Medtronic, which is expanding capabilities and communications and seeking CE marking/market expansion, and Versius, which is used in Europe and expanding regulatory approvals. There is also evidence of implementation and activity in Spain, with public procurement documentation, and other platforms reviewed in the scientific literature — a post-Da Vinci landscape.

Substitution

It should be noted that Da Vinci benefits from considerable inertia because of its installed base, accumulated experience, instruments, and training programs. In Spain and the Iberian Peninsula, the installed base is high. Replacement is usually gradual — driven by new purchases and renewals — rather than a sudden switch.

For US brand drugs, when generics or biosimilars exist (many biologics now have biosimilars), substitution is feasible and guided by pharmacy committees and protocols. The situation is more complicated for medicines without therapeutically equivalent alternatives.

Sanz recalls that established mechanisms exist: the Spanish national medicines and medical devices regulator, the European Medicines Agency (EMA), and Health Emergency Preparedness and Response are already active. “If commercial tensions escalate, it would be reasonable to intensify coordination and identify critical products.”

Clinical Trials

There is concern in Europe about a declining share of commercial clinical trials over the past decade. The EMA reports progress in implementing Clinical Trials Information System as a driver of efficiency, but competitiveness also depends on local execution. Spain competes well in trials because of clinical capacity and experience, but if logistical friction or costs increase, there is a risk of losing marginal attractiveness for some studies, especially those that rely on highly centralized supply chains.

Sanz declared having no conflict of interest.

This story was translated from El Médico Interactivo.