Raw material shortages and geopolitical instability have shaped the current supply chain landscape in the pharmaceutical sector. The inclusion of medicines on the radar of possible tariff measures, the exclusion of generics and the lack of clarity on the effective application of tariffs make up a complex scenario that the sector predicts will have an effect on costs, access, supply planning and international competitiveness of the European industry. Countries like Spain continue to import a relevant part of their inputs from places like the United States, among others, according to a study by the consulting firm Llorente y Cuenca on the impact of the Trump Administration’s tariffs on the pharmaceutical industry, prepared in October 2025. These tariffs have not affected the sector equally, since in the case of generics they have been exempt from tariffs since September of last year. This relative tranquility contrasts with the industry’s sense of being a kind of geopolitical currency to trade with. For this reason, the pharma business advocates providing itself with greater productive and logistical sovereignty.
“Protectionism could lead to an extremely dangerous situation for our country”
José Antonio Navarro Member of the Spanish Association of Vaccinology
“We find ourselves in a situation that could become very compromising,” explained the member of the Spanish Association of Vaccinology, José Antonio Navarro, during a parliamentary session on pharmaceutical strategic autonomy held in the Congress of Deputies. Trump’s pact with the European Union (EU) of 15% tariffs on vaccines manufactured on Community soil has meant that, according to the expert, up to 16 manufacturing companies have joined the American magnate’s plans to manufacture medicines on American soil. The sum of investments would be greater than 420,000 million euros. “This protectionism could lead to an extremely dangerous situation for our country and for the relocation of manufacturers,” Navarro warned. On the other hand, the sector is beginning to worry not so much about the immediate effect, but about the underlying message. We must also not forget that President Trump announced 100% rates on brand or patented pharmaceutical products that are not manufactured in the United States.
In such a context, “the trade in medicines can become an instrument of pressure,” highlights the general secretary of the Spanish Association of Generic Medicines (Aeseg), Elena Casaus. This, he asserts, represents a clear wake-up call about the need to strengthen European industrial autonomy and reduce strategic dependencies. From the Federation of Pharmaceutical Distributors (Fedifar) they assure that “it is early” to know the impact that measures such as tariffs will have on the pharma business, but that in any case, “we do not see direct impact for full-range distributors who, with very few exceptions, acquire and sell medicines in Spain.” However, in the medium term “we do see a risk of instability” in the EU supply of certain medicines, “which would affect their activity.” For this reason, Brussels has revived the regulatory framework to reinforce the availability and security of the supply of essential medicines, as well as the availability and accessibility of medicines of common interest.
“In such a context, the medicine trade can become an instrument of pressure”
Elena Casaus Aeseg General Secretariat
And the creation of new manufacturing capacities for active ingredients and the expansion of EU capacities do not currently sufficiently attract private investment, also taking into account that in other parts of the world the costs are lower, as recently recognized by the European Parliament. In fact, the Spanish employers’ association Farmaindustria has already spoken out as “sincerely concerned” regarding the pact reached between the EU and the United States regarding 15% tariffs on European pharmaceutical products and, above all, because the lack of specificity about how and when the agreement will be applied generates many doubts regarding investment in R&D. Farmaindustria warned that any tariff increase could “make access to medicines more expensive, put global supply chains at risk and hinder strategic investments” such as those estimated at 100 billion euros for the next four years. These tariffs could raise production costs in Europe by 30 billion euros, according to the employers’ association, without the sector being able to pass the costs on to final price increases.
“In the last 20 years, Europe has lost its leadership in the launch of new drugs compared to the United States and China, where more and more companies invest, and it has also lost 25% of its investment in R&D,” highlights Farmaindustria. The insurance company Crédito y Caución also warns: pharmaceutical production will plummet in 2026 to 1.6%, falling eight percentage points after closing 2025 with an increase of 9.1%. And this will be seen especially in the case of Europe, where the credit insurer foresees a sharp slowdown in production, which will fall to 3.7%. In this context, Farmaindustria has conveyed to the administrations a series of proposals so that Spain in particular becomes a production hub. Among these measures are having a predictable regulatory framework; reinforce the innovation ecosystem; review fiscal pressures; and increase deductions for investments in R&D and incentives for the production of strategic medicines. All in line with the European Parliament’s text, which calls for creating strategic projects in the EU and prioritizing financial aid for these projects in the current budget and in the next financial framework.
The European Parliament itself calls for the urgency of the European Commission establishing and updating a list of medicines originating in third countries for which there is no adequate substitute in Europe to identify and supervise the dependencies. “There has been progress, but dependence on Asia is still relevant, especially in certain active ingredients,” says Elena Casaus (Aeseg). “Manufacturing active ingredients and medicines in Europe is possible, but it requires adequate incentives: competitive energy, regulatory stability and prices that allow for the recovery of investments.” In this sense, Spain has an industrial base in active ingredients and generic medicines, “but to consolidate it, coherent policies that are sustained over time are needed.” In the opinion of the president of the Cofares Foundation, Eduardo Pastor, who also participated in the parliamentary session on pharmaceutical autonomy in the Congress of Deputies, said autonomy “must become a priority of Spanish and European policy”, while promoting the defense of public-private collaboration to “guarantee the essential role of full-range pharma distribution”.
“We have forgotten that hope is not a strategy. What is our real strategy?”
Kasper Ernest Executive Director of the European Health Products Distribution Association
To better anticipate and manage shortages, MEPs call for the creation of an EU coordination mechanism for state stocks and contingency stocks of critical medicines. They also want the European Commission to be able to decide, as a last resort, the redistribution of medicines from a state reserve to other countries, in cases where a shortage or interruption of supply has been detected. The proposal also seeks to improve access to certain medicines of common interest that face market failures. More than 50% of the drug shortage is due to manufacturing problems, including a lack of active ingredients. Despite pointing the way, the sector believes that the framework is not ambitious enough to reverse the trend of loss of competitiveness compared to other regions.
“We have forgotten that hope is not a strategy. What is our real strategy?”, asked the executive director of the European Association for the Distribution of Health Products (GIRP), Kasper Ernest, in the Congress of Deputies. In the opinion of this Danish expert, a more stable breadth of vision and greater coordination are needed “because we are 27 independent States and we have to start working together so that our infrastructures are ready from the beginning of the logistics process to the end. It is not about moving a little box with a medicine; it is that we move 75,000 million pharmaceutical packages a year throughout the EU.”
CONTINGENCY PLANS IN THE PHARMA SUPPLY CHAIN
According to a study by the Spanish association of manufacturers and distributors Aecoc on the pharmaceutical industry in 2025, 83% of companies in the sector have implemented contingency plans within their supply chain to strengthen relationships with suppliers and customers, improve data exchange, increase the visibility of the supply chain and ensure its resilience. In the case of generic medicines, these contingency plans are based on diversifying suppliers, increasing the visibility of supply chains, reinforcing reasonable safety stocks and improving the productive flexibility of logistics plants, as described by Aeseg. Protocols that, after the pandemic, have become structural, explains its general secretary. “It is no longer just about responding to a specific crisis, but about anticipating: analyzing risks, identifying bottlenecks and having logistical agreements prepared to react quickly.”
“In addition to increasing inventory, it is vital to guarantee its technological control and traceability”
Eduardo Pastor President of the Cofares Foundation
In the case of distributors, they usually collaborate with laboratories and pharmacies to react quickly to possible disruptions in the supply of medicines. Its contingency plans also contemplate reinforced security stocks and making itself available to state and European authorities to take advantage of public plans regarding strategic reserves, Fedifar sources describe. The Cofares Foundation also advocates having a strategic reserve to cover the daily demand for essential medicines and to absorb an increase in demand in a crisis situation. “In addition to increasing inventory, it is vital to organize effective management of it, as well as guarantee its technological control and traceability to guarantee safety in its transportation,” explains its president, Eduardo Pastor.
On the other hand, at the time, the industry requested that there be aid for the relocation of production in Spain, or at least, in Europe. At this point, Elena Casaus (Aeseg) admits that “there has been progress”, especially at the European level, while at the state level, dialogue with administrations exists, “but we are still in a phase in which intentions must be transformed into concrete instruments: aid adapted to the sector, realistic industrial programs and coordination between health and industrial policy. That is one of the challenges of 2026”, she identifies. Regarding European regulations, now is the negotiation phase of the European Parliament with the member countries so that the Critical Medicines Regulation is closed during the second half of 2026, under the Cypriot Presidency of the Council. “Until then, it is essential not to make national decisions that go in the opposite direction. The industry needs coherence and predictability,” warns Casaus.
date: 2026-02-11 04:12:00
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