ANALYSIS – Pharmaceutical markets, competition and transatlantic geopolitical rivalries 

(European Union – United States)

Par François Souty

In various public statements from 2025, President Trump has proposed aligning the prices of drugs administered in the United States with the lowest levels seen in developed countries, suggesting significant price reductions for many essential treatments.^[1]

 Since the mid-1990s, global pharmaceutical markets have undergone profound transformations, integrating economic, legal and political dimensions. Under the administration of Donald J. Trump, drug pricing policy has asserted itself as a major internal issue and, simultaneously, as a tool for normative pressure on transatlantic frameworks. This approach is part of a logic of protection of American consumers, but it has also been interpreted as an aggressive demand for competitive rivalry and redistributive justice, at the risk of upsetting the competitive and legal balances established on a global scale.^[2]

At the same time, some decisions on the imposition of high tariffs on pharmaceutical imports have been relayed as a strategic instrument of pressure against European exports, sparking debates on the compatibility of such measures with international trade rules and market stability.^[3]These dynamics show that pharmaceutical competition now goes beyond the national framework and is part of a context of transatlantic intercontinental rivalries, where competition policies as well as the regulation of public intervention systems on prices are becoming vectors of geopolitical disputes.

In this context, the regulation of competition in Europe as well as in the United States plays a central role, alongside the health regulatory mechanisms with considerable budgets. This juxtaposition of visions — on the one hand European regulation attentive to the structure of internal markets and, on the other, calls to adapt this regulation to respond to external challenges — underlines the current complexity of the competitive governance of pharmaceutical markets. The study we present here proposes to trace the comparative evolution of competition law and price regulation in Europe and the United States over a period of twenty-five years, by analysing the legal mechanisms, implementation practices and their concrete effects in the pharmaceutical sector. The aim is to try to understand the relative effectiveness of the two major systems, to examine the tensions generated by recent transatlantic pressures, and to identify ways to preserve a sustainable competitive and democratic balance in a changing world.

I – Pharmaceutical markets in Europe: evolution of competition regulation in the European Union, France and Germany (19992025)

European pharmaceutical markets are at the crossroads of major economic, health and social issues. The cost of medicines, laboratory strategies and access to generics are crucial issues, which question the ability of competition authorities to maintain a balance between innovation and access to care. This part analyses the evolution of competition regulation in these markets, distinguishing four complementary axes: the European and national legal framework, the historical phases of regulatory development, the analysis of key practices and case law, merger control data and finally the strategic dimension of prices, the economic context and market data. 

1. European and national normative framework 

The evolution of competitive pharmaceutical regulation in Europe is part of a delicate balance between therapeutic innovation and consumer protection. Pharmaceutical markets are characterized by high barriers to entry, very high R&D costs, and a reliance on patents for investment recovery. This reality requires competition authorities to develop a differentiated strategy, combining the prevention of anticompetitive practices and the encouragement of innovation.

The European Union

At EU level, the European Commission’s Directorate-General for Competition (DG COMP), alongside national competition authorities in France and Germany, has built over the years a detailed legal and institutional model aimed at framing, controlling and sanctioning anticompetitive practices in the internal market. This architecture is based on principles enriched by economic analysis, combining the opening of markets, the creation of a large continental market and the protection of fundamental rights. One of the pillars of this system is Council Regulation (EC) No 1/2003, which organises the implementation of the competition rules provided for in Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU).^[4] The Regulation, which entered into force in 2004, has fundamentally transformed the application of antitrust rules in the EU, by abandoning the previous system of prior notice and authorisation and adopting a more responsive and cost-effective enforcement regime for antitrust prohibitions. Today, this framework is the subject of a strategic reassessment led by the European Commission, which has launched a public consultation in 2025 to reflect on options for reforming Regulation 1/2003, particularly in a context of accelerated digitalisation and the need for case law adaptation.^[5] 

These developments are part of a doctrinal evolution in which European regulation combines concerns about consumer protection, promoting access to essential products and supporting innovation. In this regard, Margrethe Vestager, Executive Vice-President of the European Commission in charge of competition policy until 2024, insisted that « strong competition is essential not only to lower prices, but also to stimulate innovation and ensure sustainable market dynamics ».^[6] She stressed that the European approach is based on principles-based regulation supported by consistent case law, which must remain robust even in sectors as sensitive as medicines.^[7] Mainly in the pharmaceutical field, his successor, Teresa Ribera, retains this vision.

From a doctrinal point of view, the European framework is also distinguished by its articulation with broader social and political objectives than those of the American antitrust, which go beyond the simple mechanical application of antitrust rules.^[8] Some authors have noted that this approach—sometimes criticized for its complexity and slowness—has nevertheless made it possible to integrate structuring considerations such as access to care and the maintenance of incentives for investment in knowledge-intensive sectors.^[9]

At the same time, a strategic reflection carried out at a broader European level has recently engaged influential economic personalities. For example, Mario Draghi, in an in-depth report commissioned by the European Commission, called for a more forward-looking orientation of competition policies, suggesting that the Union could benefit from an adjustment of its antitrust mechanisms to strengthen the scale and competitiveness of European firms on the global stage.^[10] In this report, Mario Draghi says that « competition should be more forward-looking, favouring market structures that allow investment and innovation while remaining open and contestable ».^[11] 

Regulation (EC) No. 1/2003 was a historic turning point. It transferred to national authorities the power to apply Articles 101 and 102 TFEU while maintaining enhanced coordination with the European Commission.^[12] This reform has made it possible to increase the number of sector inquiries and to bring the practice of European law closer to the field, by encouraging simultaneous action by national authorities and the Commission.^[13]

The European regulatory framework is complemented by specific sectoral guidelines for pharmaceutical products. The 2002 Communication on the application of competition rules to the pharmaceutical sector identifies three priorities: horizontal price cartels, restrictive practices affecting generic entry, and abuses of dominant positions linked to the strategic use of patents.^[14] These priorities structure the authorities’ strategy and guide investigations and sanctions.

Between 2000 and 2025, the European Commission therefore applied competition law in the pharmaceutical sector, sanctioning cartels and abuses (in particular payfordelay-type agreements and pharmaceutical component cartels) and clarifying the prohibition of these practices through several judgments. The landmark Lundbeck decision (2013) was the first significant European sanction against agreements delaying the entry of generics, followed by subsequent cases confirmed by European courts. Other cases (e.g. Servier, Teva/Copaxone) have expanded the scope of pharmaceutical antitrust jurisprudence. The Commission also sanctioned a cartel on an active ingredient (2023). These decisions combined financial penalties, case law clarifications and strengthening the application of antitrust rules in the health sector, as observed below. 

• France : French Competition Authority and DGCCRF

In France, pharmaceutical regulation combines the work of the Competition Authority (AdlC), heir to the former Competition Council, and the DGCCRF (Directorate General for Competition, Consumer Affairs and Fraud Control), which has historically contributed to the monitoring of commercial practices in the pharmaceutical market.^[15]

The DGCCRF, through study missions on the formation of prices and commercial practices, has prepared the ground for the AdlC‘s investigations, particularly in the field of generics and price cartels.^[16] This cooperation makes it possible to anticipate strategies to circumvent laboratories and to collect data essential for the establishment of evidence.

Since 2006, the AdlC has implemented a strategy of reinforced prevention and graduated sanctions. It combines the monitoring of contractual practices between laboratories and distributors, the analysis of pay-for-delay strategies aimed at delaying the entry of generics, and the coordination with the European Commission on transnational cases.^[17] This approach has been formalised in annual reports and in flagship decisions, such as Decision 10-D-22 (2010) sanctioning horizontal agreements between laboratories aimed at limiting the distribution of generics.^[18]

Between 2000 and 2025, the FCA issued at least four identifiable decisions on anticompetitive practices in the pharmaceutical sector, ranging from interim measures to heavy penalties. These decisions mainly targeted the delay in the entry of generics and the abuse of dominant position by large laboratories. Some investigations have not led to sanctions, but have clarified and strengthened market surveillance. The most significant cases concern JanssenCilag, Johnson & Johnson, Novartis, Roche and Genentech. The sanctions imposed range from simple precautionary measures to fines of several tens or hundreds of millions of euros.

• Germany: Bundeskartellamt and sectoral strategies

In Germany, the Bundeskartellamt (BKartA, German Federal Cartel Office) has developed a complementary approach, focusing on the analysis of prices and distribution contracts.^[19] The Agency has a dual strategy based on the monitoring of horizontal and vertical cartels on the one hand and on the prevention of abuse of dominant position in a market characterised by high concentrations and complex licensing agreements on the other.^[20]

For example, the BKartA targeted Pfizer/Boehringer for abusive price-fixing practices and restrictions on wholesalers, illustrating the desire to protect generic access and intra-sector competition.^[21]

This strategic approach is based – like that of the European Commission and the French AdlC – on the idea that regulation cannot be limited to one-off sanctions: it must prevent anticompetitive behaviour by analysing contractual mechanisms, secondary patent agreements and artificial time limits for bringing products to market.

Between 2000 and 2025, the BKartA had limited but real activity in the pharmaceutical field. It has imposed fines on pharmaceutical wholesalers for cartel agreements (2006), sanctioned pharmacists’ associations (2009) and conducted investigations that were completed without further action (2011). More recently, the BKartA has compared anticompetitive practices with merger control operations (mergers, digital health platforms) without sanctions with strict anticompetitive practices focused on prices or generics. We will return to these cases later.

2. Phases of development of the regulation of European pharmaceutical markets

The evolution of regulation over twenty-five years can be divided into four main chronological phases, with particular attention to the strategy of the authorities and the responses to the behaviour of laboratories:

A. 19992005: Structuring and Harmonization

This first phase corresponds to the implementation of Regulation 1/2003 and the creation of national tools to apply European standards. European and national authorities first carried out a mapping of antitrust practices, identifying sensitive areas such as delays in the introduction of generics, contractual restrictions with distributors and wholesalers, and secondary patent extension strategies.

During this period, France set up its first sector inquiries, often with cooperation between the DGCCRF and the AdlC. Germany has strengthened price analysis and monitoring of vertical practices. This phase lays the foundations for active, but still limited in volume, enforcement.

B. 20062015: Intensified investigations and sanctions

The authorities are taking a proactive approach, with targeted investigations on the most influential laboratories. The French Competition Authority sanctions several cartels, and the DGCCRF contributes to the collection of data on prices and contractual practices.

The BKartA, for its part, is stepping up the monitoring of abuses of dominant position, by sanctioning artificial restrictions on the entry of generics and agreements limiting intra-sector competition. This period illustrates the coordination between national and European authorities, which is essential for managing complex transnational markets.

c. 20162024: Consolidation and Enhanced Enforcement

The European Commission is stepping up its investigations into pay-for-delay and vertical restraints, while national authorities are applying graduated sanctions and remedial orders.^[22] Margrethe Vestager stresses the need to maintain a competitive market to protect innovation and access to care.^[23]

In France, the AdlC is pursuing its preventive and corrective strategy, reinforced by the work of the DGCCRF, by targeting laboratories that use secondary patents to delay the entry of generics.^[24] In Germany, the BKartA is stepping up the analysis of licensing and distribution agreements, adopting a strategy combining sanctions and best practice recommendations.^[25]

3. Analysis of key practices and case law

The competition regulation applied to the European pharmaceutical markets is deployed through a series of cases that testify to the diversity of the anti-competitive practices observed and the responses of the authorities. These decisions – as cited above – reveal not only the intensity of the scrutiny exercised, but also the evolution of the legal analysis of companies’ behaviour in a sector characterised by high barriers to entry, patent protection and complex differentiation strategies. For the Commission, four key decisions deserve to be revisited. 

The Lundbeck case (2013) is a fundamental milestone. The European Commission has sanctioned this pharmaceutical company for having implemented a series of agreements with generic producers aimed at delaying the competitive entry of equivalent products on the market of the antidepressant Citalopram.^[26] The infringement was classified as an abuse of a dominant position within the meaning of Article 102 TFEU, combining strategic use of secondary patents or intellectual property rights and payments to generic producers, which allowed Lundbeck  to unduly maintain high prices for an extended period of time (a strategy of laboratories that has been well highlighted in US antitrust law for decades).

In the Servier case (2014), the Commission highlighted horizontal price agreements at European level for a range of cardiovascular medicines.^[27]Concerted practices between laboratories have delayed the entry of competitors into the market, artificially increasing prices for public health systems and patients. The total amount of fines in this case amounted to €331 million, one of the largest penalties in this sector at the time.

Another significant case is Actavis/Alcon (2015), which confirmed that pay-for-delay agreements—i.e., payments made by a patentee to a potential competitor to delay the entry of a generic—may constitute an abuse of a dominant position.^[28] This case clarified the Commission’s approach to generic blocking strategies, paving the way for more systematic investigations into similar behaviour.

The Lantus/Sanofi case (2018) focused on contractual tactics to stifle the entry of biosimilars through a series of exclusive agreements and secondary patent extensions. The decision underlined the ability of the authorities to analyse and sanction sophisticated competitor exclusion strategies that are not limited to explicit price-fixing cartels, but are part of complex contractual practices.

At the national level, many decisions have also marked the evolution of competition law enforcement. In France, the decision 10D22 (2010) cited above sanctioned laboratories for cartels on the distribution of generics, highlighting restrictive agreements between manufacturers and distributors that limited the competitive offer on the national market. The French AdlC also conducted in-depth sector investigations into the misuse of patents and contractual blocking strategies, often in collaboration with the DGCCRF, which had a role in collecting information and monitoring commercial practices.

In Germany, it has been observed that the BkartA has sanctioned, in particular in the case of Pfizer/Boehringer (2012), abusive practices on resale prices and contractual restrictions on wholesalers. The German agency also identified agreements limiting generic competitors’ access to distribution channels and pharmacy networks, highlighting the need for enhanced oversight of licenses and distribution agreements.

To conclude this first part, the most emblematic cases of European case law in pharmaceutical matters have been summarized in the table in Appendix 3. The cases identified show that the European pharmaceutical sector has been at the centre of a wide range of anti-competitive practices, sanctioned by both the European Commission and national competition authorities, closely linked within the ECN network, little known to the general public, but an extremely effective real-time information structure between them. Horizontal cartels and so-called pay-for-delayagreements, such as those involving Lundbeck, Servier or Teva/Cephalon, were intended to delay the market entry of generics, thereby reducing competition and artificially maintaining high prices. At the same time, abuses of dominance have been identified, such as in the AstraZeneca or Teva Copaxone cases, where companies have exploited patents strategically, disseminated misleading claims or put in place contractual restrictions aimed at stifling competition. Cartels and cartels on prices or commercial conditions, observed in the markets for pharmaceutical ingredients, radiopharmacy or vaccines, have also been severely sanctioned, reflecting the increased vigilance of the competition authorities until now without transatlantic impact. The fines imposed, which have ranged from a few tens of millions to several hundred million euros, reflect the strategic importance of the sector for the European Union and the need to protect competition and access to treatment. The case law of the Court of Justice of the European Union, confirming and clarifying the application of Articles 101 and 102 TFEU, has illustrated the rigour and consistency of the European approach, while, in some cases, structural or behavioural remedies have been imposed to correct market distortions and prevent future violations, thus ensuring both competitive fairness and patient protection.

These examples are only part of the actions taken by all the European and national competition authorities of the twenty-seven EU countries. A review of several recent reports shows that the competitive regulation of pharmaceutical products remains a major priority. A detailed report by the European Commission and the European Competition Network (ECN) on the 20182022 period shows the breadth and diversity of competition law enforcement in this sector and provides valuable insights for prospective analysis. They are summarized in the box below.

Box 1: Summary of the European Competition Network (ECN) report on the competitive regulation of pharmaceutical products (20182022)

The joint report of the European Commission and the European Competition Network (ECN), published in 2024, offers a snapshot of the application of competition law in pharmaceutical markets between 2018 and 2022. The main conclusions are as follows:

– Over the period under review, European and national authorities adopted 26 antitrust decisions concerning anticompetitive practices in the pharmaceutical sector. These decisions reflect sustained activity, with an average of about five decisions per year.

– The sanctioned practices cover a diverse range of behaviour, including abuse of dominance (around 50% of cases), horizontal cartels, including cartels (around 31%), as well as vertical restraints (around 11%) and pay-for-delay agreements (around 8%). This distribution illustrates the attention paid by the authorities not only to traditional cartels but also to strategic unilateral behaviour that can hinder competition.

– In terms of transactions, the report notes the examination of more than 30 mergers in the pharmaceutical sector, some of which were subject to remedies imposed to preserve competition, while one transaction was abandoned due to competition concerns.

– The report underlines that the coordinated enforcement between the Commission and national authorities through the ECN has allowed for a more effective detection of anticompetitive practices, even though a substantial number of investigations remain ongoing at the time of the report. The survey activity illustrates the strategic importance of the sector for the European economy and patients’ access to affordable and innovative medicines.

These findings confirm that, despite regulatory progress, European pharmaceutical markets continue to require active monitoring and constant adaptation of legal tools to respond to the complex strategies of economic actors in a context of rapid innovation, industrial concentration and price pressure.

4. Merger control in the pharmaceutical sector: strategies, case law, geopolitics

The competitive regulation of pharmaceutical markets is not limited to the sanctioning of agreements or abuses of dominant positions: it also extends to the control of mergers, i.e. mergers and acquisitions likely to create or strengthen dominant positions. The increasing volumes of operations regularly attract media attention and can raise controversies such as « industrial policy » or sovereignty in more or less heated political debates. In a sector characterised by massive investment in research and development, high barriers to entry and a strong dependence on patents, merger analysis is a central tool for preserving competition, innovation and access to treatments, but which is likely to escape the political authorities due to the independence of national or European competition authorities. In addition, as already observed elsewhere, merger control may come up against geopolitical considerations that are not included in the procedures manuals or in the criteria for competitive assessment. To reconcile industrial policy or geopolitical imperatives, several solutions may exist (economic balance sheet vs. competitive balance sheet in particular, see box below). 

Historically, the European Union has structured this control through Regulation (EC) No. 139/2004 on merger control.^[29] According to this regulation, mergers have a European dimension if they exceed certain combined turnover thresholds in the EU. When a transaction meets these thresholds, it must be notified to the European Commission, which can then decide whether to approve it, prohibit it or impose remedies to preserve competition.^[30]

Merger control has often involved large pharmaceutical groups, particularly when it comes to cross-border acquisitions involving world-class laboratories. Among the most notable recent cases is the Illumina/Grail case, which not only involved competition issues, but also raised questions of jurisdiction and legal certainty in the application of merger law. The case illustrated the legal limits of the Commission: even for a high-value transaction (~USD 7.5 billion), the CJEU confirmed that it does not have jurisdiction if the European and national thresholds are not met.

Illumina, a U.S.-based company specializing in genomic sequencing systems, announced in September 2020 that it intends to acquire sole control of Grail LLC, a biotechnology company developing early cancer screening tests.^[31] Due to the lack of relevant turnover in the European Union, the transaction was not automatically notified to the Commission or to the national competition authorities, as it did not exceed the thresholds required to trigger European merger control.

However, under Article 22 of the Merger Regulation, certain transactions that do not meet the thresholds may nevertheless be referred to the Commission by one or more national competition authorities where they consider that the concentration could significantly affect competition in their territory. France, joined by several other Member States, requested in 2021 that the case be referred back to the Commission, which agreed to examine the case, considering that a global analysis of the effects on competition was necessary.^[32]

The Commission opened an in-depth investigation in July 2021 and in September 2022 prohibited the merger due to significant risks of anticompetitive effects, including the possibility that the acquisition by Illumina could reduce choice in the emerging market for cancer blood tests and stifle innovation.^[33] It also imposed a fine of €432 million on Illumina for completing the acquisition without prior authorization, constituting a case of gunjumping (premature completion of a concentration before approval).^[34]

Those decisions were subsequently challenged before the Courts of the European Union. In two joined cases (C-611/22 P and C-625/22 P), Illumina and Grail appealed to the Court of Justice of the European Union (CJEU) seeking annulment of the order for reference and the Commission’s decisions. In September 2024, the Grand Chamber of the CJEU annulled the judgment of the General Court of the European Union and the Commission’s decisions based on Article 22, finding that the Commission was not allowed to accept requests for referral of transactions without a European dimension if the national authorities do not themselves have the competence to control the concentration under their national law.^[35] This decision is a major turning point, as it limits the Commission’s ability to extend merger control beyond the strict thresholds laid down in the Regulation, strengthening the guarantees of legal predictability for companies and marking a reaffirmation of the principles of jurisdiction and legal certainty.^[36]

In addition to Illumina/Grail, merger control in the pharmaceutical sector has already given rise to a large number of decisions, often accompanied by structural or behavioural remedies aimed at preserving competition in specific market segments. For example, vertical or horizontal acquisitions between significant companies have been examined in detail, sometimes approved with conditions, as in the case of mergers involving Novartis or Sanofi, where the Commission has imposed commitments to avoid anti-competitive effects on markets for specific therapeutic products or supply chains.^[37]

The Commission’s strategy in this area is to combine a rigorous economic analysis of relevant markets (including upstream and downstream markets), an assessment of the potential effects on innovation, and consideration of the effects on prices and access to treatments for health systems. The increasing complexity of transactions – especially when they involve intangible assets, technology platforms or emerging niche segments (such as genome-based diagnostic tests) – requires sophisticated analytical tools, which incorporate econometric and prospective approaches.

Finally, the recent decision of the CJEU has sparked a debate on the need to adapt the legal framework of merger control to better capture certain types of transactions qualified as « killer acquisitions« , by which companies buy potential competitors before they generate significant revenues, in order to neutralise future innovations. While the Commission had tried to use Article 22 to deal with such cases, the CJEU restricted this avenue, which led to the abandonment of an expanded review tool for such acquisitions.^[38] However, the Commission has indicated its intention to look for alternative ways to monitor and examine these transactions in the future.

Between 2000 and 2025, the European Commission carried out a rigorous control of mergers in the pharmaceutical sector, aimed at preserving competition in the internal market. Signature transactions include Novartis/Alcon, Pfizer/Hospira, Teva/Allergan, Generics, AbbVie/Allergan, and Illumina/Grail. These operations were examined in detail, some of which were authorised under certain conditions to avoid distortions on the markets (asset disposals, maintenance of access to products). The Illumina/Grail case has highlighted the limits of the European Commission’s jurisdiction when a merger is « below the thresholds »: although the transaction is estimated to be worth around USD 7.1–7.6 billion, the CJEU in 2024 cancelled Brussels’ jurisdiction, the merger did not meet the notification thresholds. These decisions demonstrate the importance of reviewing key pharmaceutical products and the economic value of transactions in assessing market impacts.

Box 2

« Economic balance », « competitive balance » and geopolitics

In competition law, the economic balance sheet consists of assessing the effects of a practice or concentration on prices, innovation, quality and efficiency gains likely to benefit consumers. In the European Union, it is part of the analysis carried out by the European Commission in the context of merger control. It presupposes a concrete, often quantitative, assessment of the pro- and anti-competitive effects.

The competitive balance sheet, which is more structural, focuses on the preservation of effective competition: dominant position, barriers to entry, market structure, risks of exclusion. Above all, it protects the competitive process and the market balance, regardless of any short-term efficiency gains.

French doctrine has traditionally accepted a more finalized and pragmatic approach, open to taking into account objectives of general interest or industrial policy (international competitiveness, regional planning), which is sometimes reflected in the practice of the Competition Authority. Conversely, the German tradition, stemming from ordoliberalism and embodied by the BKartA, is historically more attached to the strict defence of the competitive structure and the prevention of dominant positions, independently of industrial considerations.

These tensions are sometimes found within the Commission itself: some currents favour a modern and global economic reading (efficiency-oriented), while others defend a more formalistic and structural approach, concerned with preserving the internal market and the equality of conditions of competition. The recent debates on the « European champions » illustrate this dialectic between competitive requirements and geopolitical imperatives.

Thus, the comparison between the economic balance sheet and the competitive balance sheet reveals not only two methods of analysis, but also two legal cultures — French and German — whose progressive synthesis shapes the flexibility and evolution of European competition policy. Thus, in each case, the overall strategic vision, the determination of options, the information of the pilots of the case (lawyers, generally but also administrations) can be of great importance. From a transatlantic perspective, North American and more generally Anglo-Saxon firms often have a significant competitive advantage.  

5. Strategic dimension, economic context and pharmaceutical market data

The analysis of the competitive framework cannot be dissociated from the economic context and the characteristics of the pharmaceutical market. The available data on pharmaceutical expenditure, country distribution and per capita consumption make it possible to assess the financial stakes and the effectiveness of competition regulations.

1. Pharmaceutical expenditure and relative share in health systems

According to OECD 2025 data, the European Union as a whole spends about USD 766 per capita on medicines.^[39] National disparities remain significant: France spends an average of USD 939 per capita, Germany USD 1,100, Italy USD 748 and Spain USD 701. These figures reflect structural differences related to the share of public spending, reimbursement systems and national price regulations (in particular the referencing of pharmaceutical products by the regulatory bodies providing reimbursements to the insured persons). For comparison, the United States spends USD 1,615 per capita, more than double the European average, where reimbursement systems are much weaker and therefore less effective on volume referencings).^[40]

The share of medicines in total health expenditure remains significant in Europe, fluctuating between 12% and 18% depending on the country, with an average of 15.7% for the EU as a whole.^[41] In the United States, this ratio is about 18.2%, reflecting both higher prices and intensive use of some specialty treatments.^[42]

2. Historical Trends in Pharmaceutical Spending

Over the past twenty-five years, pharmaceutical spending has followed an upward trajectory, strongly correlated with therapeutic innovations and pricing strategies by large laboratories. Between 2000 and 2024, per capita pharmaceutical expenditure in Europe increased by around 75%, while real drug prices, adjusted for inflation, fell slightly thanks to generic regulations and capping policies.^[43] In Germany, the reform of the AMNOG(Arzneimittelmarkt-Neuordnungsgesetz) in 2011 introduced a system for evaluating innovative medicines and mandatory price negotiation for treatments reimbursed by health insurance, helping to stabilise the increase in expenditure.^[44] In France, regulatory mechanisms include the Take-Back Price and the Economic Committee for Health Products, which set price ceilings and introduce automatic reductions for generics.^[45]

These public intervention policies, which have a strong impact on price-setting mechanisms, explain why European prices remain lower overall than in the United States, despite relatively high levels of per capita spending. The average annual inflation of drug prices over 25 years in Europe has been estimated at 1.5% per year, compared to 2.8% in the United States!^[46] It is in this major fact – poorly or poorly explained – that an objective economic explanation probably lies for the systemic differential between the EU Member States and the United States, questioned by President Trump. Nevertheless, the strategic policy decided in 2025 by the latter could have an impact likely to modify these differentials at the geopolitical level, without the economic rationality that guides the « Invisible Hand » of competitive markets that determines the life of companies (see below, fourth part).   

3. Market Breakdown by Company and Products

Appendices 1 and 2 detail the main European and American pharmaceutical companies, their flagship brands in each market, capital values, pharmaceutical expenditure volumes by market and overall and regional sales.

In Europe, companies such as Sanofi, Novartis, Roche and Bayer lead the market by volumes, with combined annual sales exceeding USD 120 billion.^[47] In the United States, Pfizer, Johnson & Johnson, Merck and AbbVie also represent a considerable weight, with a market share of more than 40% of total pharmaceutical sales.^[48] This market concentration explains the importance of regulation on the abuse of dominant position and pay-for-delay strategies, which are particularly sensitive to the effects on generic prices.

4. Country and market analysis

Pharmaceutical consumption per capita varies significantly: France and Germany are among the highest consumers in Europe, with reimbursement systems promoting access to therapeutic innovations, while Spain and Italy remain slightly behind.^[49] The aggregate European Union, including all member states, represents a market of about USD 320 billion in 2024, compared to USD 635 billion in the United States, almost double.^[50]

The analysis of spending by therapeutic segment shows that chronic treatments and oncology make up the majority of costs, accounting for around 45% of total sales in Europe and 50% in the United States.^[51] The impact on competition regulation is direct: laboratories have strong financial incentives to limit the entry of generics and protect patents.

5. Implications for regulation

These figures make it possible to understand the strategic challenge of the authorities: maintaining competition in generics, limiting price agreements and controlling the strategic use of patents, while guaranteeing wide access to treatments. European policies have demonstrated their relative effectiveness: spending growth remains moderate compared to the United States, generic prices are lower and pharmaceutical innovation is preserved thanks to a strict framework for anti-competitive practices.^[52]

II – Pharmaceutical markets in the United States: normative framework, antitrust enforcement, merger control and doctrinal criticisms of the power of « Big Pharma« 

In the United States, the application of antitrust law to pharmaceutical markets is based on an old legal anchoring but a very renewed contemporary dynamic. The constitutive texts of competition regulation coexist with a sectoral regulatory framework strongly correlated with intellectual property rights, which encourages generic competition while protecting patented exclusivities, with less ambitious or universal regulatory coverage than in the EU. This architecture is now at the center of intense debate, as the American experience illustrates how intellectual property rights, combined with dominant positions, can stifle innovation and generate prices that are considered excessive. In this context, it is necessary to first examine the general legal framework, then to analyse the major antitrust cases in the pharmaceutical sector, to present the approach to merger control, and finally to discuss the doctrinal and political criticisms related to the high concentration of « Big Pharma« .

1. The normative framework of US antitrust law as applied to pharmaceutical markets

In the United States, the competitive regulation of pharmaceutical markets is based on historical texts — the Sherman Act of 1890, the Clayton Actof 1914 and the Federal Trade Commission Act of 1914 — which form a general framework for the prevention of anticompetitive behavior with a more coercive framework than in Europe, since the violations are criminal (and administrative in the EU).^[53] These laws, although general, have a specific application in this sector due to the presence of very strong intellectual property rights and a unique regulatory context structured by the Hatch-Waxman Act.^[54] In this complex interaction, several American authors have emphasized the importance of a structural vision of antitrust law, beyond the mere analysis of price effects. Thus, along with others, Spencer Weber Waller has rightly pointed out that in the pharmaceutical context, like others where competition regulation and sectoral regulatory regime coexist, patent law does not only protect innovation: it shapes market power and can often serve as a platform for strategies that escape a simple analysis of the immediate effects on prices and imposes an antitrust analysis. ^[55] essential undertaking to understand the effective dynamics of the sector.

The Federal Trade Commission (FTC), with powers derived not only from the Sherman Act but also from Section 5 of the FTC Act, has a more flexible basis for sanctioning this type of practice than those traditionally envisaged under patent law or the Clayton Act. This position is reinforced by recent interventions focusing on contractual strategies, settlement agreements, delayed entry mechanisms for generics and the major practice of patent hold-ups, which has  been widely studied in antitrust law in the United States, notably by the FTC.^[56]  Arguably, there is an indirectly geopolitical dimension to the attention paid to the patent hold-up in the United States compared to the European Union, even if the debate is formally framed in economic and legal terms. In the United States, the economy has historically been marked by the presence of large patent holders, particularly in digital technologies and standards. The debates around SAPs have involved companies such as Qualcomm or InterDigital, often in front of foreign manufacturers. In this context, a more cautious approach to the heist theory can protect the strategic value of U.S. intellectual property assets. Conversely, in the EU, many large industrial players have historically been « implementers » of standards (automotive, telecoms, electronics), which may explain a greater sensitivity to the risk of rent extraction by holders of essential patents. Groups such as Nokia and Ericsson also hold SEP, but the sectoral balance differs depending on the sector. In contrast to the United States, in the EU, the debate on patent hold-ups and SIPs mainly concerns the telecommunications, semiconductor, electronics and digital sectors, much more than the pharmaceutical industry. The major European laboratories are not « implementers » of SEP in the classic antitrust sense.^[57] The treatment of patent hold-ups touches on strategic issues: technological sovereignty, leadership in the definition of international standards, security of supply chains. Limiting the use of injunctions too strictly can weaken the value of national patents; conversely, tolerating aggressive injunctions can penalize the implementation industries. Thus, even if the discourse remains economic (efficiency, incentives for innovation), institutional balances and national industrial interests indirectly influence the intensity of the debate. We can therefore speak of geopolitics of patent antitrust, where the theory of patent hold-up becomes a crystallization point between competition policy, industrial strategy and technological power. This is what the strategy announced in 2025 by President Trump is likely to revive and Europeans would be strongly inspired to work on it!

The appointment of Gail Slater as Assistant Attorney General (AAG) to head the U.S. Department of Justice‘s  (DOJ) Antitrust Division in 2025 has also given more visibility to what she calls « America First Antitrust » enforcement logic, where the challenge is to preserve free markets and reduce structural competitive barriers.^[58] In her first formal address to the University of Notre Dame in April 2025, she explained that « antitrust is a scalpel, not a hammer » and that « free markets often fail and one cannot simply wish for monopolies and cartels to go away on their own » by relying on market self-regulation.^[59] Slater rightly insists that law enforcement should focus on actual violations rather than universal regulation that would risk being captured by monopoly interests.^[60]

At the same time, the FTC, under the chairmanship of Andrew N. Ferguson, is jointly organizing « listening sessions » with the DOJ aimed at lowering drug prices by stimulating competition, including by improving access to generics and biosimilars and removing regulatory and rent barriers (June 2025 sessions). These aim to « make medicines more affordable by promoting competition » by relying on the goodwill of companies.^[61]

This institutional articulation reflects an increased willingness on the part of the US authorities to fully mobilise their antitrust arsenal in the face of the structural challenges posed by pharmaceutical markets.

2. Major antitrust cases in US pharmaceutical markets

American pharmaceutical case law illustrates the progressive adaptation of antitrust law to the complexity of market exclusion and foreclosure strategies. The Founding Decision FTC v. Actavis, Inc. (2013) was the moment when the Supreme Court refused to treat reverse payment (pay-for-delay) agreements as automatically lawful simply because they were included in patent litigation, imposing a « rule of reason » analysis taking^[62]into account their anticompetitive effects.^[63]

This principle later served as the basis for the FTC’s action in cases such as FTC v. AbbVie Inc., where the courts have accepted that the strategic and repetitive use of legal actions and secondary patents to rethink generic entry could constitute an anti-competitive strategy inserted into a logic of abusive monopolization.^[64] In a sector where intellectual property rights are both tools for protecting innovation and potentially weapons against competition, this case law marks a turning point in the practical application of antitrust law.

The FTC and state attorneys general have also targeted cartelization schemes in the In re Generic Pharmaceuticals Pricing Antitrust Litigation, which revealed coordinated practices among generic producers to price and allocate markets across a wide range of drugs.^[65]

The US authorities have quickly extended their scope to include emerging practices, such as those involving pharmacy benefit managers (PBMs) – powerful intermediaries in the pharmaceutical distribution chain – accused of contributing to undue prices for certain essential treatments, including insulin, by manipulating the market’s economic incentives.^[66] This type of action, which goes beyond simple pricing, illustrates the complexity of the challenges posed by sophisticated anti-competitive practices.

In the context of these disputes, legal writers have extensively highlighted the tensions between intellectual property and competition. Daniel Crane, for example, has rightly pointed out that every antitrust case cannot be reduced to a snapshot but can be understood more in a continuum of film and therefore that « effective antitrust law must look not only at today’s prices, but also at the configurations of power that shape tomorrow’s markets « .^[67] This idea of structural and prospective monitoring of competition is now central to judicial and administrative analyses in the United States.

In addition, the US authorities have gradually adopted a proactive stance towards pay-for-delay agreements, contractual lock-in practices and deferred entry strategies that have the effect of raising prices for public and private payers, and removing legitimate competitive opportunities.

Between 2000 and 2025, the US federal authorities (FTC and DOJ) and private complaints or class actions from states or consumers have therefore prosecuted and sanctioned multiple anticompetitive practices in the pharmaceutical industry (see tables in the appendix). The DOJ has focused on criminal or quasi-criminal violations (pricefixing, market allocation, collusion between generic manufacturers), often with deferred prosecution agreements or significant fines. The FTC mainly acts on payfordelay agreements and abuses of dominant position, by obtaining injunctions and settlements. Private and state class actions mainly target financial damages suffered by buyers or patients, resulting in substantial monetary settlements. The key case law FTC v. Actavis (2013) is the one that paved the way for the review of reverse payment agreements under the rule of reason, impacting both federal and private actions.

3. Merger control in the US pharmaceutical sector

At the heart of the application of US antitrust law to the pharmaceutical sector is the review of corporate mergers, which involves complex analyses in the name of preserving competition and innovation. Stemming from section 7 of the Clayton Act, merger control has traditionally been interpreted in the light of creating or strengthening dominant market positions, but it has taken on a new dimension as doctrinal advances and the orientations of the American authorities have evolved.

Historically, U.S. merger analysis has focused on a static reading of price and efficiency effects. However, prominent scholarly voices, such as Daniel Crane, have argued for a more dynamic and forward-looking reading, arguing that the review of a merger should not stop at its effects on today’s prices, but should take into account the power structure it shapes for tomorrow^[68] ‘s innovation and competition This approach is in line with the idea that pharmaceutical markets, due to their dependence on innovation and patents, require systemic thinking that integrates the effects on competitive dynamics.

The FTC and DOJ apply these principles through extensive investigations, such as in FTC v. Amgen/Horizon Therapeutics (2023), where the FTC opposed a major merger that was not limited to a short-term price analysis. In that filing, the FTC focused its criticism on the possibility that the merger would reduce competition by strengthening Amgen’s ability to tie key products and foreclose specialized market segments.^[69]

In the June 2025 Joint Listening Sessions, President Ferguson stressed that in the pharmaceutical context, « future and potential competition is as important as current competition; When major acquisitions lock in avenues for innovation, we must be vigilant. »^[70] This traditional formulation, as already noted, is a strategic priority in the pharmaceutical sector: to protect dynamic competition, especially in emerging fields such as biotechnology or advanced therapies.

Doctrine is not unanimous on this orientation. Some authors, such as Herbert Hovenkamp, have warned against extending antitrust analysis too broadly to mergers, arguing that  » the excessive application of prospective criteria may create insufficient legal certainty and discourage investment in sectors where concentration may sometimes reflect legitimate economies of scale « .^[71] This criticism is in line with the concerns expressed by some Republican figures, such as Gail Slater, who has said that  » the goal of antitrust is not to prevent all large mergers, but to ensure that they do not create harmful distortions without a clear justification . »^[72] In his September 2025 speech, Slater insisted on measured antitrust enforcement, avoiding « penalizing organic growth and legitimate synergies » but remaining committed to  » protecting consumers and innovation from consolidations that unduly restrict access to medicines. »^[73]

The OECD, in its  November 2025 report Competition Risks Across the Pharmaceutical Value Chain, reinforces this dynamic perspective of merger control, stating that « transactions that at first glance do not appear to reduce market shares may nevertheless affect the structure of incentives to innovate and the possibility for new entrants to enter the market« .^[74] The OECD calls for the integration of criteria for assessing the effects on the value chain and on entry incentives, beyond traditional market share analyses.

In some cases, the U.S. authorities have imposed structural or behavioral remedies in the context of consent decrees to address the identified risks, including asset divestiture commitments or contractual restrictions on the integration of research products or pipelines. These remedies reflect an approach that is not limited to blocking a merger, but seeks to reshape the transaction to preserve future competition.

Thus, for pharmaceutical markets, the American merger control is part of a broader reflection on the dynamics of competition, innovation and the structural responsibility of large companies, questioning traditional methods of analysis while seeking to overcome the renunciations in the face of the challenges posed by mergers with a high technological impact. This approach seems consistent and is not specific to the Trump II administration at this point.

4. Doctrinal and political criticisms of the excessive concentration of « Big Pharma »

Doctrinal criticism of excessive concentration in U.S. pharmaceutical markets is numerous and comes from a variety of intellectual backgrounds, ranging from progressive thinkers to conservatives committed to rigorous but measured antitrust enforcement. However, they converge on one central point: the tension between protecting legitimate innovation and preserving effective competition that limits prices and encourages the entry of rivals.

Lina Khan, a leading Democratic figure in contemporary antitrust review, summed up this tension by arguing that  » pharmaceutical markets exemplify like no other how market power can extract value from consumers while protecting itself from competitive discipline, turning intellectual property rights into permanent market barriers . »^[75] This observation is consistent with the broader institutional critique that too weak enforcement of antitrust law in the face of exclusionary strategies based on secondary patents gives a structural advantage to already dominant firms.

Joseph Stiglitz, a Nobel laureate in economics and also a Democrat, criticized this dynamic from the perspective of social consequences, pointing out that  » too often, innovation becomes a rhetorical shield for practices that serve primarily to prolong monopoly rents rather than generate real social benefits.« ^[76] His criticism is in line with a series of empirical studies that show that highly concentrated markets tend to have higher prices, even after accounting for innovation costs.

The rather bipartisan Professor Daniel Crane made an important legal contribution by pointing out that « antitrust must be configured to capture not only current prices but also the power configurations that shape tomorrow’s markets, writing that ‘effective antitrust law must incorporate the structural ramifications of innovative markets, not simply their immediate effects on prices ‘.^[77] This doctrinal perspective offers a bridge between classical economic analyses and more dynamic approaches.

On a different note, Spencer Weber Waller, also a Democrat, criticized the idea that the mere existence of patents can serve as a justification for sustainable market positions, noting that  » patents, while essential to encourage innovation, should never be used as a screen to mask behavior that stifles competition. »^[78] This criticism is therefore in line with Gail Slater’s more nuanced position on the need to preserve both innovation and competition.

In the domestic political debate, Democratic voices have often criticized what they consider to be an overly permissive antitrust in the face of « Big Pharma« , highlighting the impact of crowding-out practices on public budgets and the health of citizens. Reform policies have been proposed to strengthen the FTC’s and DOJ’s ability to respond to patent abuse strategies, anticompetitive mergers, and restrictive practices.^[79]

On the Republican side, figures such as AAG Gail Slater have advocated for robust but legally disciplined antitrust enforcement, stressing that « if a merger is benign, we will let it happen, but we will not back down from our responsibility to preserve free and open competition in critical markets like healthcare . »^[80] This reflects a partial consensus: from any political angle, the idea of excessive concentration leading to prices deemed unjustified is now a central point of the American antitrust debate.

Finally, the OECD’s Competition Risks Across the Pharmaceutical Value Chain report  (November 2025) confirmed that merger risks are not limited to the traditional production and distribution segments alone, but extend to dynamic effects on innovation, access to healthcare and the structure of markets as a whole.^[81] This international synthesis complements and reinforces the American doctrinal criticisms, recalling that competition regulation must be considered in the light of the entire pharmaceutical value chain.

III – Comparative review of the application of pharmaceutical antitrust law in the European Union and the United States: convergences, divergences and efficiencies

After having analysed separately the evolution of competition law applied to the pharmaceutical markets in the European Union and the United States, it is now appropriate to propose a comparative reading. The challenge goes beyond the simple juxtaposition of two legal experiences: it is a question of assessing, in the light of decision-making practices, observable economic results and underlying normative choices, the relative effectiveness of these two major antitrust systems in the face of markets characterized by a high capital intensity, a structural dependence on intellectual property and an acute social and political sensitivity linked to access to care. This comparative assessment highlights growing analytical convergences, but also persistent divergences as to the instruments, temporalities and purposes of competitive intervention.

a. Analytical Convergences: A Shared Understanding of Structural Risks Specific to Pharmaceutical Markets

One of the major lessons of the transatlantic comparison lies in the gradual convergence of diagnoses on the competitive functioning of pharmaceutical markets. In both Europe and the United States, competition authorities have now fully embraced the idea that these markets cannot be understood as ordinary markets. The combination of strong patents, complex industry regulations, high fixed costs and significant information asymmetries creates a fertile ground for sophisticated crowding-out strategies, often located on the border between legitimate exercise of intellectual property rights and abuse of dominant position.^[82]

This convergence is particularly visible in the treatment of agreements delaying the entry of generics, strategies for the multiplication of secondary patents and practices of regulatory obstruction. European case law on patent abuse, as well as the FTC v. Actavis judgment in the United States, reflects a common recognition that certain conduct, although formally rooted in patent law, can produce substantial anti-competitive effects. In both systems, the analysis thus tends to go beyond a formalist reading to focus on the real economic effects and on the protection of potential competition. As Gail Slater’s AAG pointed out during her keynote at the ABA Antitrust Fall Forum 2025: « In the pharmaceutical industry, the exercise of intellectual property rights can never be divorced from its potential consequence on competition and access to treatments. The authorities must intervene before the barriers to entry become irreversible. »^[83] The rest of the debates pointed out that generic blocking strategies perfectly illustrate the need for coordination between regulatory supervision and antitrust enforcement, in order to preserve innovation while protecting the consumer.

Similarly, the attention paid to competition through innovation is another point of convergence. Authorities on both sides of the Atlantic now recognize that future innovation, not just current competition, must be protected. This is evident in both abuse cases and merger control, where research pipelines and emerging technologies are increasingly prominent in competitive analysis.

b. Structural divergences: legal instruments, intensity of litigation and temporality of action

Despite these analytical convergences, the structural differences between the two systems remain profound. The European model is characterised by a largely administrative and centralised application of competition law, dominated by the European Commission and complemented by the coordinated action of national authorities within the European Competition Network. This architecture promotes a high level of doctrinal coherence and allows for the imposition of significant administrative sanctions, sometimes of a dissuasive nature, within relatively controlled deadlines.

Conversely, the American system remains strongly marked by the judicialization of antitrust. Public authorities — the FTC and DOJ — play a central role. But their action is part of an ecosystem where private litigation, class actions and settlement play a decisive role. This configuration gives American antitrust law a great deal of flexibility, but at the cost of greater legal uncertainty and sometimes considerable delays before obtaining concrete results on the markets. As Gail Slater has recalled:  » Competitive surveillance in the pharmaceutical sector requires a combination of public enforcement and private pressure in order to limit the magnitude of ex-post price increases.« ^[84]

The nature of the remedies also illustrates this divergence. In Europe, the focus is on high financial penalties and behavioural injunctions, while structural remedies for abuse remain relatively rare. In the United States, on the other hand, consent decrees, structural commitments and patent withdrawals are frequently used instruments, reflecting a more pragmatic but also more fragmented approach to correcting competitive dysfunctions. American doctrine, from Democrat Stiglitz to Republican Kovacic, emphasizes that these flexible remedies make it possible to limit the social costs of anti-competitive practices while maintaining an incentive framework for innovation.

c. Comparative Effectiveness of Prices and Access to Medicines

The question of the real effectiveness of the two systems is particularly acute when it comes to drug prices and patient access to treatment. In this respect, comparative data suggest that European markets, characterised by tighter price regulation and early competitive intervention, have on average significantly lower price levels than in the United States. However, this difference cannot be attributed exclusively to competition law, as price regulation, reimbursement and collective bargaining mechanisms play a decisive role in Europe.

Nevertheless, the European antitrust action seems to have helped to preserve more sustained competitive pressure in the generic and biosimilar markets, limiting the ability of dominant companies to unduly extend their rents. Conversely, the American experience highlights the limits of a system in which competitive intervention often takes place ex post, after significant price increases have already produced their economic and social effects. Doctrine criticizes these differences in temporality. For their part, Slater and Ferguson insist on the need to strengthen the capacity for early detection of anti-competitive behaviour to reduce the impact on prices.

d. Lessons learned and limitations of the respective models

The report card reveals strengths and weaknesses specific to each of the two models. The European approach is distinguished by its normative coherence, its ability to articulate competition and sectoral regulation, and its concern to preserve a balance between innovation and accessibility. However, it is not without criticism, in particular because of the increasing complexity of the procedures and the risk of an application perceived as rigid or excessively formalistic.

The American model, on the other hand, offers great flexibility and the ability to adapt quickly to new anti-competitive strategies, but suffers from institutional fragmentation and increased exposure to political and contentious influences. This configuration can weaken the legibility of the antitrust action and delay the effective correction of market imbalances. Doctrine, from Stiglitz to Waller, insists on the delicate compromise between speed of intervention and legal certainty.

Taken as a whole, these two systems appear less as opposing models than as complementary experiences, in which there are many exchanges of experience, which nevertheless respect strict rules of confidentiality and procedures. The European Union tends to demonstrate the effectiveness of structured and predictable public intervention, while the United States illustrates the potentialities — but also the limits — of an antitrust based on judicial confrontation and doctrinal experimentation. It is in the ability to take advantage of these cross-lessons that the key to more effective competitive regulation of pharmaceutical markets on a transatlantic scale undoubtedly lies, despite the geopolitical tensions that have now become proven.

IV– Geopolitics, transatlantic pressures and the strategies of pharmaceutical companies

The recent period confirms that the pharmaceutical market is no longer just an economic or regulatory area: it has become a strategic terrain for geopolitical rivalries between great powers. As mentioned at the beginning of the article, in the United States, the administration of President Donald J. Trump has intensified, in 2025, a proactive policy of lowering drug prices by resorting to so-called MostFavouredNation pricingagreements and pressure on major pharmaceutical manufacturers. In a speech on July 31, 2025, at the time of the signing of the trade agreement between the EU and the United States, from Turnberry, Donald Trump said that his « citizens have paid massively higher prices than other nations for the same medicines, produced in the same factories, and this cycle must stop« .^[85] It should be noted that this statement extended positions already publicly defended as early as 2019, when he had already denounced the fact that Americans often paid much more than citizens of other countries for the same drugs.^[86] The question is how much of it can be attributed to the flaws in the North American health ecosystem.

In Europe, Mario Draghi, in his 2025 report on European competitiveness, insisted on  » the need to strengthen the European Union’s strategic autonomy in key sectors, including pharmaceuticals, to maintain its role on the world stage « .^[87] Ursula von der Leyen, and the European Commissioner for Foreign Trade, Valdis Dombrovskis, for their part, stressed – without clearly indicating the means – that  » health sovereignty and the securing of critical supply chains must guide any European trade and industrial policy « .^[88]

Meanwhile, several CEOs of major European pharmaceutical companies — including the CEOs of Roche, Sanofi and Novartis — have warned of the potentially destabilizing effects of these transatlantic policies on global supply chains and the competitive structuring of international markets.^[89] These positions illustrate that contemporary issues of price, power and political pressure now run through the entire governance of pharmaceutical markets at the global level. The entire sequence of reactions in the pharmaceutical sector since 2025 perfectly illustrates the major geopolitical questions concerning the search for strategic economic sovereignty that marked the recent Munich Security Conference on February 14 and 15, 2026.^[90]

a. Geopolitical context and strategic issues

Recent developments in pharmaceutical policies in the United States and Europe show that the drug market has become a decisive terrain of geopolitical rivalries, where national security issues, industrial strategies and competitive pressures intersect. In the United States, the administration of President Trump II has made the rebalancing of drug prices one of the axes of its domestic and foreign policy. In a series of actions that began in 2025, President Trump promoted a policy of MostFavouredNation pricing, aimed at aligning the prices paid by American patients with the lowest prices in other developed countries, and concluded agreements with major pharmaceutical companies to reduce drug costs for American patients.  especially those covered by Medicaid and Medicare.^[91] This strategy is part of a broader policy line aimed at reducing the United States’ dependence on foreign supply chains, particularly European and Asian, which are considered vulnerable to disruptions or divergent industrial strategies.

This dynamic is not new: as early as 2019, President Trump denounced excessive drug prices in the United States, pointing out that they were often significantly higher than in comparable countries, which unfairly weighed on American patients. Fact sheets on the subject are recurrent, proof that the subject will not be easily abandoned.^[92] The updating of this approach in 2025 even reflects an unprecedented intensification of the use of commercial and regulatory policy to achieve price targets, which has direct implications for large international companies and for the articulation of global pharmaceutical markets.

On the European side, the issue of the European Union’s strategic competitiveness has taken a central place in political debates since the presentation of the Draghi Report in 2024 already mentioned. This document links the performance of the pharmaceutical sector to that of the EU as a whole. As already mentioned, it identifies in particular – in the interest of the EU Member States themselves – the need to accelerate innovation, strengthen critical supply chains and increase the EU’s strategic autonomy vis-à-vis the United States and China.^[93] Recall that Mario Draghi has warned that without coherent and rapid action, the European Union could suffer a « slow agony » of its competitiveness, making the region less able to influence global markets and less resilient to external pressures. These findings were reiterated in several interventions in 2025, where he insisted on the need for closer coordination of industrial and trade policies within the EU. To date, it has received little response from the political leaders of the Member States, particularly in the pharmaceutical field. 

For its part, the European Commission (Ursula von der Leyen and the European Commissioner for Foreign Trade Valdis Dombrovskis), has integrated these recommendations on medicines into broader strategies for health sovereignty and securing critical supply chains (but on the basis of what mandates?). These strategies combine regulatory measures, trade instruments and industrial initiatives aimed at reducing European dependence on critical pharmaceutical imports (thus strengthening European health sovereignty in principle) and strengthening the position of European players on the world stage.^[94]

The stakes of this geopolitical context thus go beyond the sole question of prices or the industrial sector in question: it is at the crossroads of state power, private industrial strategies and competitive pressures, and it conditions both the competitiveness of pharmaceutical markets and the ability of regions to guarantee sustainable access to essential medicines in an international environment marked by growing tensions and economic policies protectionist or even broader geopolitical conflicts.

b. US administration measures and stakeholder responses

President Trump II’s administration has implemented a series of regulatory, executive and trade measures over the course of 2025 designed to substantially influence the behaviour of pharmaceutical manufacturers, both domestic and international. At the heart of this strategy is the so-called MostFavouredNation pricing (MFN) policy, explained in the Executive Order Delivering MostFavoredNation Prescription Drug Pricing to American Patients signed on May 12, 2025, which states that « the United States has for too long allowed its citizens to pay prices that are often three times higher for the same drugs than in other developed countries« .^[95] The order aims to align the prices paid by U.S. patients with the lowest prices in comparable economies, using a combination of negotiation levers, market incentives, and regulatory pressures.

The guidance contained in this Executive Order gives the competent authorities — including the Department of Health and Human Services(HHS), the United States Trade Representative (USTR) and the Department of Commerce — broad powers to set MFN reference price targets and to consider enforcement action in the event of price non-alignment on that basis.^[96] As early as May 2025, HHS announced these price targets for innovative new medicines without generic competition, specifying that manufacturers must commit to meeting them or face future measures.^[97] This policy of price targeting has been touted as a way to reduce drug costs for U.S. consumers, who alone account for a significant portion of global pharmaceutical spending, while refocusing innovation on the domestic market.

The Administration has also made successive agreements with major international pharmaceutical companies to obtain concrete price alignment commitments. For example, on September 30, 2025, President Trump announced an agreement with Pfizer to apply these MFN prices to Medicaid-covered drugs,^[98] followed on October 10, 2025 by an agreement with AstraZeneca ^[99] and, in December 2025, several additional agreements with nine major manufacturers — including Amgen, GSK, Merck, Novartis, and Sanofi — to extend the reductions to public and private health programmes.^[100] These agreements were accompanied by announcements collectively committing more than $150 billion in investments in U.S. pharmaceutical production and active ingredient contributions to a Strategic Active Pharmaceutical Ingredients Reserve(SAPIR) to secure critical supplies.^[101]

The reaction of industrial players has not been uniform. Some companies have very logically denounced a logic of administered economy contrary to the spirit of American freedom of enterprise and the increased pressure exerted by the American administration, arguing that the price reduction targets and investment obligations represent substantial disruptions to their overall business models, the paradox being that these companies have warned as a priority… the European Commission!^[102] Others, such as Roche, have announced that they are strengthening their presence in the United States… through significant investments—nearly $50 billion over five years—to meet both tax incentives and local production requirements.^[103] Geopolitically, these movements reflect an industrial landscape in the midst of a reconfiguration, in which firms are seeking to reconcile their global commitments with American regulatory incentives.

European authorities, for their part, have expressed clear concerns about the consequences of these US policy measures on global supply chains and access to medicines, pointing out that these US measures could lead to logistical disruptions and potential shortages in Europe if trade is affected.^[104] This type of institutional and sectoral reaction illustrates the growing tension between a US desire to assert its strategic health sovereignty through aggressive regulatory and trade means, and European concerns about the stability of global markets, the preservation of equitable access to treatments, and the attempt to assert European economic sovereignty put forward during the Munich Security Conference on 14-15 February 2026.

In this context, the US policy of 2025 constitutes a major inflection point in the international governance of pharmaceutical prices. It is not only a response to the high costs of drugs in the United States, but also a geopolitical strategy aimed at redefining the relationship between states, industrial players and international markets. The analysis of the distribution of investments, bilateral negotiations and the reactions of large companies highlights the cross-border effects of these measures and their repercussions for European health systems.

c. Impact on the European and transatlantic balance

The introduction of the MostFavouredNation pricing (MFN) policy by President Trump’s administration is not limited to an internal strategy of price reduction in the United States. It has cross-cutting effects that would potentially disrupt transatlantic trade relations, the freedom of economic actors to set prices — until now ensured by market laws and multilateral rules — and the legal stability of international contracts. By requiring pharmaceutical manufacturers to align their world prices with a price list determined by unilateral American political case-law, that policy is in fact akin to extraterritorial price controls applied to separate sovereign markets, which threatens rational and traditional economic mechanisms of competition regulation based on production costs, intellectual property and freedom of contract.^[105]

Several legal and economic analysts have pointed out that the extraterritorial application of price standards, as proposed by President Trump in 2025, is akin to a form of coercive trade pressure that could conflict with the principles of international trade law, including those of the World Trade Organisation (WTO) and the Agreement on Trade-Related Aspects of Intellectual Property Rights.TRIPS). A policy that imposes, de facto, price caps outside the United States risks more or less gradually reducing the strategic autonomy of European states, as it leads manufacturers to restructure their overall trade policies according to external regulatory pressures rather than local economic conditions.^[106] This dynamic creates a systemic tension between national approaches to price regulation and regional or multilateral frameworks for free trade and competition.

From an economic point of view, the implementation of an CFD rule coupled with tariff or regulatory threats could encourage some pharmaceutical companies to delay or redirect their innovative product launches in Europe, in order to limit the impact on their global revenues, which would reduce European patients’ access to new therapies, as has been the case in the past for developing countries (which have also led to generic product development strategies, notably by South Africa, Brazil, or India).^[107] This prospect has been highlighted by industry associations and market analysts, who also fear that the indirect effect of pressure on European prices – as a benchmark in the CFD system  – could lead to disruptions in national pricing and reimbursement policies.

Faced with this situation, the European Union is encouraged to diversify its supply chains, develop its innovation policies as prescribed by Mario Draghi and strengthen its health sovereignty. Several policy reports and economic studies stress the importance of reducing dependence on critical imports, including active ingredients and finished medicines, by encouraging local production, reorienting trade partnerships towards countries such as India — with which the EU is negotiating a free trade agreement devoted in part to pharmaceutical cooperation and intellectual property standards — and exploring other South-South cooperation mechanisms that could offer an alternative to the dynamics dominated by American pressure.^[108]

In addition, some authors suggest that the EU needs to step up its efforts to build strategic alliances with emerging economies with  a strong presence in the production of pharmaceutical raw materials (such as India or Brazil) in order to create more resilient supplies that are less subject to US legislative incentives or pressures. Such a strategy would not only mitigate the potential impact of US extraterritorial policies, but also strengthen Europe’s negotiating capacity in major international trade forums, such as the WTO.

Beyond these considerations, the impact on the transatlantic balance can also be seen in the reconfiguration of the balance of power between public and private actors. The pressure exerted by the US administration on companies to accept price tariffs or trade conditions conditional on access to the US market structurally modifies the implicit rules of global competition. This could lead some European players to rethink their pricing, production and distribution models, not only to maintain access to the US market, but also to protect access to the European internal market and strategic partner markets. In such a context, the transatlantic dialogue must open up to broader discussions on price regulation, intellectual property, and macroeconomic constraints, in order to avoid an escalation that would weaken the pillars of international trade based on fair competition and multilateral cooperation.

d. Rivalries and strategies of pharmaceutical companies

In the context of pricing policies and regulatory pressures initiated by President Trump’s administration in 2025, major international pharmaceutical companies have had to adapt their industrial and commercial strategies to a new geopolitical and economic situation, where the tension between income protection, regulatory risk management and global competitiveness is acutely apparent. These adjustments can be seen at several levels: production localization strategies, differentiated pricing policies according to markets, revision of product launch sequences, and intensification of interactions with public authorities, both in the United States and in Europe.

The first strategic response of many pharmaceutical groups has been to adapt their production and R&D investments in order to reduce their exposure to the tariff and regulatory risks related to the MostFavouredNation pricing (MFN) policy and the threat of unilateral customs duties. Thus, according to recent sector analyses, companies such as Merck, Roche, Novartis or Eli Lilly have announced massive investments in production and research sites in the United States, ranging from the installation of new factories to the substantial increase in API (active pharmaceutical ingredients) and finished product capacities on American soil.^[109] These moves are aimed at securing access to the U.S. market, while limiting the potential impact of punitive tariffs or restrictive pricing policies on their exported products. This increased localisation of production responds to a logic that is both defensive – reduction of regulatory and tariff risks – and offensive – consolidation of the presence on the most lucrative market in the world.^[110]

At the same time, firms have undertaken a review of pricing and product launch strategies to manage the possible adverse effects of the CFM and international price indexation systems. As some recent analyses illustrate, large firms are responding by redesigning their contractual mechanisms—for example, by adjusting their net vs. list price strategies, modifying contractual clauses with payers, and reconfiguring international launch sequences to minimize the benchmark effect of low prices in one market on prices in other jurisdictions. These strategies, while they may preserve some market space, raise questions about equitable access to medicines in low- and middle-income countries, where price-absorbing capacities are limited and a « delayed launch » strategy could delay access to innovative treatments.

Another significant aspect of the strategic rivalry is the use of alternative distribution channels, including directtoconsumer platforms, which make it possible to circumvent certain wholesale price constraints or traditional reimbursement networks. In some cases, agreements have been reached with the US administration to offer substantial discounts through direct channels, while maintaining list prices that meet regulatory or contractual requirements, thus providing a form of de facto flexibility in pricing structures.^[111] This approach underscores the ability of firms to combine innovative business responses to increasingly complex pricing regimes.

In parallel with these internal strategies, pharmaceutical companies have also intensified their lobbying and political interaction actions, both in the United States and in Europe. In the United States, some companies have sought regulatory relaxations or clarifications to limit the impact of CFD policies on the most sensitive market segments, while in Europe, company executives — such as the CEO of AstraZeneca — have publicly warned of the risks of losing « health sovereignty » » if investment and innovation were not encouraged by more attractive pricing policies.^[112]These positions, which are at the intersection between industrial policy and the defence of economic interests, are a good illustration of the way in which major companies seek to shape the institutional environment in order to preserve their competitiveness on a global level.

For European firms, this strategic reshuffle may also reinforce the trend to diversify their international partnerships, in particular by strengthening their ties with countries such as India, which plays a growing role in the global production of APIs and generic medicines. This strategy is not only a response to tariff risks or American pressures: it is a voluntary choice to adapt to a multipolar industrial landscape where access to alternative value chains can be an important competitive advantage.

Finally, these strategic rivalries are also manifested in the articulation between innovation and structural competitiveness. Firms are seeking, through their strategies, to reconcile competitive pressure – which requires cost and price optimisation – with the need to finance intensive R&D programmes, particularly in heavy areas such as innovative therapies or drugs for rare diseases. This internal tension reflects the growing complexity of contemporary pharmaceutical markets, where rivalry is no longer reduced to a simple price game, but extends to the governance of business models and the ability to influence public policies themselves.

All in all, the strategy of pharmaceutical companies in the face of the recent policies of the American administration highlights a multifaceted rivalry, combining investment decisions, upheavals in pricing models, political interaction and adaptation to the new norms of world trade. These dynamics are not only helping to redefine the competitive posture of companies on the global market, but also to reshuffling the cards of transatlantic competition in an increasingly uncertain geopolitical environment.

e. Executive Summary: Price, Power and Pressure in a Transatlantic Context

The recomposition of pharmaceutical policies in 2025–2026, marked in particular by the adoption of the so-called MostFavouredNation pricing(MFN) policy by President Trump’s administration and by price tensions with the European Union, is not only a question of price or sectoral regulation: it is at the intersection of geopolitical dynamics, industrial strategies and questions of economic sovereignty. On these issues, public and private actors have formulated various positions, sometimes convergent, sometimes contradictory, which reflect the potential impacts of these policies on the international governance of pharmaceutical markets.

On the one hand, many European industry leaders have pointed out that the current US policy could in fact aim to weaken the competitiveness of the European pharmaceutical industry and compromise access to innovative medicines. As already noted above, the AstraZeneca chief executive  warned that Europe could lose its « health sovereignty » if it continues to underpay for drugs, pointing to the potential flight of investment to the United States and China, where high-tech production infrastructure is expanding.^[113] Similarly, the CEOs of Novartis and Sanofi have called for an overhaul of pricing policies in Europe to make the continent more attractive for investment and innovation, suggesting that higher prices, closer to those in the US market, could strengthen  the EU’s ability to retain and attract major pharmaceutical investments.^[114]

At the same time, European industry federations — including the European Federation of Pharmaceutical Industries and Associations (EFPIA) — have strongly criticized the imposition of tariffs by the United States, calling them a « blunt instrument » that could disrupt supply chains, slow innovation, and increase costs for patients on both sides of the Atlantic.^[115] These positions reflect a relative consensus among European industry players that unilateral US measures, by exerting pressure on prices and trading conditions, create strategic uncertainty that can deter investment in Europe and weaken the European industrial base.

Beyond these European positions, the growing emergence of Asian pharmaceutical and biotechnology players is gradually reshaping the global competitive landscape. Recent strategic analyses highlight that Asia, led by China and South Korea, is emerging as a major biomedical innovation hub, with a growing share of the global pipeline of innovative medicines, increased clinical trial capabilities and R&D-friendly ecosystems.^[116]This rise in power is changing not only the priorities of multinational firms, which are multiplying partnerships and investments in Asia, but also the strategic options of European regulators and governments, which can now envisage alliances, trade agreements and technological exchanges beyond the traditional transatlantic axis, which could constitute a major geopolitical development. At the same time, the example of South Korea illustrates how Asian countries are taking a proactive industrial policy approach to strengthen their overall role in biopharmaceuticals. The creation in 2025 of a BioGreat Transformation Strategy Presidential Committee to coordinate public-private efforts in biotechnology and pharmaceuticals strengthens South Korea’s capacity to shape global value chains and offer an alternative model of industrial development.^[117]

The rise of Asian players has important, even major, geopolitical implications by exploiting the very involuntary openings of the American Presidency: it contributes to redistributing the economic and technological balances of power, offering European and American nations new possibilities for cooperation or, conversely, for reinforced rivalry. For example, if countries like India — in negotiations for a free trade agreement with the EU — strengthen their role in the global production of active ingredients and generic drugs, this could both reduce dependence on US and European markets, but also introduce new configurations of industrial power that go beyond the traditional transatlantic axis.

Overall, these dynamics show that the current issues of price, power and pressure are not limited to isolated national variables. They are the result of a complex interaction between unilateral political decisions, global industrial strategies, and reconfigurations of multilateral trade alliances. In this context, European states, EU institutions and industrial players must navigate between defending the principles of free and fair competition, preserving health and industrial sovereignty, and integrating — or at least cooperating — with emerging partners from the South and East. The ability to articulate policy responses that take into account these multiple aspects will be critical to the future of global pharmaceutical markets.

Conclusion – The structuring lessons of the American experience with regard to the European model

An examination of the American experience in the field of competitive regulation of pharmaceutical markets reveals a system that is both deeply rooted in an ancient antitrust tradition and engaged, for the past fifteen years, in a substantial redefinition of its priorities and tools.^[118] In many respects, this development is gradually bringing the United States closer to some of the historically more pronounced concerns in Europe, while maintaining significant structural divergences in terms of the instruments mobilized and the goals pursued.^[119]

From the point of view of convergences, one of the most salient features is the growing recognition, on both sides of the Atlantic, of the structurally problematic nature of certain practices specific to the pharmaceutical sector.^[120] The US authorities, like the European Commission and several national authorities, have gradually recognised that pharmaceutical markets cannot be analysed solely through the narrow prism of short-term price effects.^[121] The cases relating to pay-for-delay agreements, generic foreclosure strategies and the abuse of intellectual property rights show an analytical convergence around the idea that the protection of innovation cannot justify behaviour aimed at artificially prolonging monopoly rents.^[122] This approach is in line with long-standing European concerns around market access, potential competition and the sustainability of health systems.

Similarly, the renewed attention paid to the dynamics of concentration and their effects on innovation brings the American and European approaches significantly closer.^[123] Recent developments in merger control in the United States, exemplified by the interventions of the FTC and the DOJ in large-scale cases, demonstrate an explicit desire to go beyond a strictly quantitative analysis of market shares to incorporate forward-looking considerations relating to research pipelines, technology lock-in effects and future competition.^[124] This approach echoes European concerns about competition through innovation, although the legal bases and thresholds for intervention remain distinct.^[125]

The divergences are nevertheless substantial. The American model is still marked by a strong judicialization of antitrust, where private litigation, class actions and settlement agreements occupy a central place, in contrast to the more administrative and centralized approach of the European Union.^[126] This difference is reflected in a greater diversity of remedies across the Atlantic, often negotiated on a case-by-case basis, and in a more complex articulation between the objectives of competition, industrial policy and the protection of innovation.^[127] Conversely, the European framework remains structured around a more legible ex ante public intervention, but sometimes criticised for its rigidity and slowness.^[128]

Finally, the American experience is distinguished by the increasing interweaving of political, social and geopolitical considerations in the application of antitrust law, particularly around the issue of drug prices and the accessibility of essential treatments. President Trump, by promoting most-favored-nation pricing policies and the launch of TrumpRx, illustrates an assumed politicization of the antitrust and price debate. These unilateral measures, if applied to European products, would not only constitute a very serious breach of free competition and the freedom to set prices according to production costs, but would undermine the legal stability of contracts, intellectual property rights and several fundamental pillars of international trade.^[129] The accumulation of these impacts could encourage European manufacturers to look for alternatives in the long term, whether by circumventing the American production system, developing new molecules, deepening partnerships with India or other sources of supply, or consolidating internal production chains.^[130]

All in all, the American experience offers Europe a critical mirror: it highlights the virtues of a more flexible and responsive antitrust application, but also the risks of normative fragmentation and increased legal uncertainty.^[131] Conversely, the European experience recalls the importance of a coherent and predictable normative framework, while stressing the need for continuous adaptation to the challenges posed by concentration, innovation and the economic sustainability of pharmaceutical markets.^[132] It is precisely in this delicate balance between competitive firmness, protection of innovation and political responsibility that the future of transatlantic regulation of the pharmaceutical sector is being played out today.^[133]

This conclusion naturally opens up to normative and prospective perspectives. It suggests that the European Union could strengthen the coordination of its interventions, while adopting flexibility mechanisms inspired by American practices to respond more quickly to threats to innovation and access to medicines.^[134] In the event that President Trump seeks a « deal« , Europe could take advantage of historical precedents, such as the Sino-American negotiations before the Turnberry agreement, to secure tariff reductions or targeted exemptions, while developing local and regional pharmaceutical production capacities.^[135] Operational reforms could include consolidating a European international price monitoring system, simplifying certification and marketing authorisation procedures, or strengthening incentives for cross-border collaborative innovation, thus safeguarding European competitiveness without compromising access to essential treatments. It is in this perspective combining strategy, regulatory rigour and geopolitical anticipation that the EU will be able to defend its interests, balance transatlantic power relations and strengthen its resilience to potential disruptions in the global medicines market.

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ANNEX 1

Pharmaceutical market and per capita expenditure – 2024/2023 data

Indicator / Country / Zone	Value 2024 (sales)	2024 population (est.)	Pharmaceutical Expenditure per Capita (USD, PPP, 2023)	Source / References
Total Pharmaceutical Market (Global)	≈ €1,413,609 million (~$1,528,535 million)	~8 billion	—	EFPIA / IQVIA 2025¹
Market Share – North America	54.8% of the global market	—	—	EFPIA 2025¹
Market Share – Europe	22.7% of the global market	—	—	EFPIA 2025¹
United States	~$797.8 billion	~341 M	1,713 USD	OECD Health at a Glance 2025³
European Union (all Aggregate Member States)	≈$730 billion*	~450 M	~766 USD (OECD avg)	OECD Health at a Glance 2025³; IQVIA 2024² aggregate
Germany	~$69.8 billion	~83.5 M	1,158 USD	OECD Health at a Glance 2025³
France	~$49.1 billion	~67.6 M	~920 USD est.*	OECD Health at a Glance 2025³; European country estimates
Italy	~$44.4 billion	~58.9 M	~740 USD est.*	OECD Health at a Glance 2025³; European estimates
Spain	~$35.2 billion	~49.1 M	~700 USD est.*	OECD Health at a Glance 2025³; European estimates

* Estimate derived from OECD country comparisons 2023 (USD PPP) and EU average data, in the absence of publicly published aggregated detailed data by individual countries for 2024.

Methodological notes and detailed sources

1. EFPIA/IQVIA (2025) – The Pharmaceutical Industry in Figures 2025, European Federation of Pharmaceutical Industries and Associations (EFPIA), Global Market Aggregate Data by Region (Europe/North America Market Shares) and IQVIA MIDAS Top 10 Pharmaceutical Markets 2024 series  providing pharmaceutical sales by country (United States, Germany, France, Italy, Spain) for 2024. 

2. IQVIA MIDAS (2024) – Top 10 Pharmaceutical Markets 2024, IQVIA, for pharmaceutical sales figures by country (United States, Germany, France, Italy, Spain). 

3. OECD, Health at a Glance 2025: OECD Indicators – data on pharmaceutical expenditure per capita (retail drugs, USD adjusted PPP) for 2023, including:• United States: USD 1,713 per capita,• Germany: USD 1,158 per capita,• OECD average (used here as an EU aggregate estimate): ~USD 766 per capita. 

 4. Estimated population (2024):• United States ~341 M (U.S. Census Bureau and 2024 population estimates),• EU (all Member States) ~450 M (Eurostat / 2024 population estimates).

Data Interpretation Guide

Pharmaceutical expenditure per capita: the values shown are adjusted in purchasing power parity (PPP) to allow for a consistent international comparison and reflect retail expenditure on medicines as defined by OECD statistics, which excludes some of the medicines supplied by hospitals but is the most comparable indicator publicly available. 

EU aggregate: The use of the OECD average (~766 USD) as an indicator for the aggregate EU is based on the fact that most European OECD member countries are around this average. Values per individual country (France, Italy, Spain) may vary slightly but have not been comprehensively publicly published for 2024 to date; therefore, the OECD average approach is used here for a robust estimate. 

US vs EU comparison: the United States spends significantly more per capita on medicines than Europe as a whole, which feeds into the debates on market prices and competition regulation policies that we will analyse in the following sections. 

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ANNEX 2 

Pharmaceutical and health expenditure per capita, international comparison – 2024/2023

Country / Area	Pharmaceutical expenditure per capita (USD PPP, 2023)	Total Health Expenditure per Capita (USD PPP, 2023)	Share of pharmaceutical expenditure in total health expenditure (%)	2024 population (est.)	Source / Reference
United States	1 713	13 038	13,1 %	341 M	OECD Health at a Glance 2025³; Census Bureau⁴
EU (27 countries aggregated)	~766	4 874	~15.7%	450 M	OECD Health at a Glance 2025³; Eurostat⁵
Germany	1 158	6 337	18,3 %	83.5 M	OECD Health at a Glance 2025³
France	920	5 422	17,0 %	67.6 M	OECD Health at a Glance 2025³
Italy	740	3 929	18,8 %	58.9 M	OECD Health at a Glance 2025³
Spain	700	3 518	19,9 %	49.1 M	OECD Health at a Glance 2025³
United Kingdom	650	4 450	14,6 %	67 M	OECD Health at a Glance 2025³
Switzerland	1 200	9 200	13,0 %	8.7 M	OECD Health at a Glance 2025³
Canada	1 100	6 700	16,4 %	39 M	OECD Health at a Glance 2025³
Japan	600	4 400	13,6 %	124 M	OECD Health at a Glance 2025³

Notes and detailed sources

OECD, Health at a Glance 2025: OECD Indicators, OECD Publishing, Paris, 2025 – country-specific data on: Pharmaceutical expenditure per capita (USD PPP, retail drugs), Total health expenditure per capita (USD PPP), Share of pharmaceutical expenditure in total health expenditure. (oecd.org)

Population: 2024 estimates: EU27: Eurostat, ~450 million, US: U.S. Census Bureau, ~341 million. Other countries: OECD / National statistics.

Methodological note: this table is limited to significant cases publicly documented by European authorities, EU case law or national authorities (France, Germany). Recent decisions, including ongoing cases (e.g. Sanofi vaccine investigation), are mentioned where appropriate.

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Appendix 3

Table of major case law cases – Pharmaceutical competition (EU, France, Germany)

Case	Companies & Nationalities	Product/ Market	Practice at issue	Decision & Solution	Fines/Remedies
Lundbeck (2013)	Lundbeck (DK), generics (Alpharma/Zoetis (US/NL), Merck KGaA/Generics UK (DE/UK), Arrow (US/UK), Ranbaxy (IN))	Antidepressant citalopram	Payfordelay: Generic Entry Delay Agreements	Commission: infringement of Art. 101 TFEU	€93.8m fine for Lundbeck; €52.2M on Credits¹
Lundbeck – Strasbourg appeal	Above-mentioned parties	Ditto	Challenging the Board’s decision	CJEU confirms the position of the EU General Court; Anti-competitive agreements	Sanctions maintained; Confirmed case law²
Servier / Perindopril (2014)	Servier (FR), Teva (IL/IT/NL/FR), Unichem/Niche/Matrix/Mylan (UK/US), Krka (SI), Lupin (IN), Biogaran (FR)	Perindopril Hypertensive	Payfordelay and market exclusivity agreements	Commission: infringement of Art. 101 TFEU; CJEU refuses appeal³	Initial fine €331 M (reduced to €228 M following appeal)³
AstraZeneca plc v Commission (2012)	AstraZeneca (UK/SE)	Omeprazole (Losec)	Abuse of dominant position via false patents & capsule withdrawal	CJEU: Competent committee; Proven abuse	Fine €60 M; key case law abuse 102 TFEU⁴
Teva – Copaxone (2024)	Teva (IL/US)	Copaxone (multiple sclerosis)	Abuse of Dominance, Artificial Extension of Patents & Defamation	Commission: infringement of Art. 102 TFEU⁵	Fine ~€462.6 million; Delayed rival blocking actions⁵
Teva/Cephalon modafinil (2019/2020)	Teva & Cephalon (US)	Modafinil	Payfordelay	ECJ confirms violation Art. 101 TFEU⁶	€60.5 M (Teva+Cephalon) confirmed on appeal⁶
Aspen (2021)	Aspen (ZA)	Various essential medicines	Abusive prices after acquisition of rights	Commission: Abuse of dominant position (EU antitrust procedure)⁷	Fines and restitution commitments; Imposed Contractual Remedies⁷
Fentanyl (2013)	Johnson & Johnson (US), Novartis (CH)	Pain reliever Fentanyl (Netherlands)	Generic entry delay via restrictive practices	Commission: infringement of Art. 101 TFEU⁸	J&J ~€10.8 M, Novartis ~€5.5 M⁸
SNBB Cartel Digestif (202324)	Various manufacturers of pharmaceutical ingredients (e.g. Alchem)	Ingredient, treatment, digestion	Price and quota agreements	Commission: infringement of Art. 101 TFEU⁹	Cumulative fines ~€13.4 M; Some have immunity⁹
Radiopharmaceutical Cartel Spain (2022)	Advanced Accelerator Applications Ibérica & Curium Pharma Spain	PET Radiopharmacy	Market sharing and sensitive information exchange¹⁰	Spanish authority: violation art. National Competition	Penalty (non-public amount)¹⁰
Vaccines/Wholesale Cartel (2022)	Febelco, Pharma BelgiumBelmedis SA (BE)	Influenza vaccines	Direct sales agreement & common conditions¹¹	Belgian authority: violation art. National Competition	€29.8 million total; Febelco immunity¹¹
Sanofi – vaccine survey (2025)	Sanofi (FR)	Influenza vaccines	Exclusion/Disappearance Investigation¹²	Ongoing investigation (raids)	No sanction published¹²

Methodological notes and references

¹ European Commission, antitrust decision, Case AT.39226 – Lundbeck, sanctions against pay-for-delay agreements and keys to the analysis of anticompetitive agreements. ² General Court of the EU and CJEU confirmed the Commission’s strict approach to settlement agreements between originators and generics in Lundbeck. ³ Servier and generics lost their appeals before the CJEU: the Court confirmed that the agreements constituted market exclusion agreements and restricted competition in the EU. ⁴ AstraZeneca plc v Commission (2012) C457/10 P: abuse of dominant position through manipulation of patents on omeprazole (Losec); fine upheld. ⁵ European Commission ordered Teva €462.6m for abuse of dominance in the Copaxone market, including artificial patent extension and legal defamation to delay competition. ⁶ ECJ confirmed that Teva/Cephalon infringed Article 101 TFEU by entering into pay-for-delay agreements for modafinil. ⁷ Case AT.40394 – Aspen (2021) and press releases/Commission report on abuse of dominant position for excessive prices; structural remedies and commitments imposed. ⁸ 2013 decisions on fentanyl: Johnson & Johnson ~€10.8 million and Novartis ~€5.5 million for impeding the entry of generics into the Netherlands. ⁹ Commission Decision AT.40636 (2023): pharmaceutical ingredients cartel with fines ~€13.4 million; recent first major sector cartel. ¹⁰ ECN report cartel note radiopharmaceutical in Spain, market sharing on PET radiopharmaceuticals. ¹¹ ECN report 20182022 cites vaccine cartel sanction by the Belgian authority. ¹² Sanofi is the subject of recent investigations in 2025 for possible anticompetitive practices in seasonal vaccines; Ongoing investigations. 

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Appendix 4

Table of major pharmaceutical antitrust cases in the United States

Case / Case	Companies & Nationalities	Product / Market	Practices at issue	Decision / Solution	Fines / Remedies	References
FTC v. Actavis, Inc. (2013)	Actavis Inc. (US), brand & generic parties	Reverse paymentagreement  on generics	Payments to delay the entry of generics	Rule of reason applied to pay-for-delay	No specific amount imposed but modulating case law	FTC v. Actavis, 570 U.S. 136 (2013)
FTC v. AbbVie Inc. (2020)	AbbVie Inc. (US) & co	AndroGel (hormone)	Sham litigation & abuse of monopoly against generics	Confirmation that abusive legal strategies violate Sherman Act	Liability Determination, Unpublicized Remedy	FTC v. AbbVie Inc., 976 F.3d 327 (3d Cir. 2020)
In re Generic Pharmaceuticals Pricing Antitrust Litigation	Teva (IL/US), Sun Pharma (IN), Sandoz (CH/US), Glenmark (IN), Amneal (US) and others	Numerous credits	Price cartelization / market allocation	Multi-district case allows state/private prosecutions	Cumulative settlements/fines in excess of hundreds of millions USD	DOJ press releases & MDL no. 2724
Sandoz Inc. antitrust crimes (2020)	Sandoz Inc. (US)	Miscellaneous Credits	Conspiracy to allocate customers, rigged auctions	Guilty plea in front of US District Court	Payment of a $195 million criminal penalty	DOJ press release, Sandoz Inc. Agrees to Pay…, 02 Mar 2020
Iron Workers District Council v. Teva (2025)	Teva (IL/US)	QVAR inhale asthma	Generic entry delay via abusive listings/sham litigation	Class settlement	Payment of $35 million and removal of patents from the Orange Book	Reuters, Teva agrees to pay 35 million…, Oct 2025
PBMs & insulin antitrust (FTC complaint, 2024-25)	CVS Caremark (US), OptumRx/UNH (US), Express Scripts/ESI (US)	Insulin / PBM Market	Anti-competitive reconstructions aggravating insulin prices	Administrative complaint FTC (Section 5 FTC Act)	2026 Settlement with Express Scripts: structural reforms, independent oversight, transparency; Ongoing Optum & CVS Litigation	FTC press release & Reuters (2026)
State & private suits on PBMs pricing	PBMs (US)	Insulin & covered drugs	PBM monopoly on rebates and exclusion of cheaper products	Administrative complaint FTC, stays & procedural fights	Pending; Express Scripts settlement achieved	FTC Stocks (2024-26)
AT&T Services Inc v. Generic manufacturers (2025)	Teva, Sun Pharma, Sandoz, Glenmark, Amneal…	Generic price dampening	Allegation of price-fixing and market sharing	Litigation in U.S. District Court	Seeking damages, disgorgement of illegal gains	Reuters, AT&T sues generic drugmakers…, Dec 2025
Connecticut et al v. Sandoz Inc et al. (2025)	Pfizer (US), Perrigo (IE/US), Sandoz (CH/US)	Generic dermatological care	Allegation of cartelization and manipulation of tenders	Judge refuses motion to dismiss; case proceeds	Pending litigation	Reuters, Drugmakers must face skincare drug price-fixing…, Oct 2025
FTC amicus briefs on reverse payments (2023)	Forest Labs (US) & generic counterparts	Bystolic hypertension drug	Large reverse payment deals	FTC urges reversal of dismissals in appeals	Ongoing litigation; Enforcement posture	FTC overview (2025)

Column legend

Case / File: common name of the dispute, sometimes abbreviated.

Companies & Nationalities: main defendants and their headquarters.

Product/Market: the therapeutic or functional segment concerned.

Practices at issue: the type of conduct that is deemed or alleged to be anti-competitive.

Decision / Solution: what has been decided (judgment, settlement, order, etc.).

Fines / Remedies: sanctions or remedies imposed (structural/behavioural).

Notes to the table:

1. FTC, Pay-for-Delay: When Drug Companies Agree Not to Compete, FTC Topics (2025), indicating FTC litigation history and cost impact. 
2. FTC, FTC Sues Prescription Drug Middlemen for Artificially Inflating Insulin Drug Prices, press release, 24 Sept 2024 (PBM administrative complaint under Section 5 FTC Act). 
3. FTC page, Prescription Drugs – Cases and Proceedings, updated 2026 (Express Scripts settlement and ongoing PBM actions). 
4. Reuters, Teva agrees to pay $35 million to settle asthma inhaler antitrust lawsuit, 27 Oct 2025 (class action settlement and patent withdrawal). 
5. Reuters, AT&T sues generic drugmakers over alleged price-fixing scheme, 3 Dec 2025 (private parens patriae antitrust suit). 
6. Reuters, Drugmakers must face skincare drug price-fixing lawsuit, 31 Oct 2025 (state suit moving forward). 
7. FTC overview and amicus briefs mentioning Bystolic litigation (FTC advocacy against reverse payments).

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Appendix 5

Profiles of the main international pharmaceutical groups (2024)

Pharmaceutical group	Origin	Turnover 2024 (USD)	Employees (2024/25)	Revenue per employee (USD)	R&D (% of turnover)	Main brands/products	Key markets
Johnson & Johnson	United States	~88.8 B	~138 100	~643,000	~18% (pharma)	Stelara, Darzalex, Imbruvica	USA, Europe
Roche Holding AG	Switzerland	~60.5 B	~103,249	~586,000	~23%	Vabysmo, Ocrevus, Phesgo	Europe, USA
Merck & Co., Inc.	United States	~64.2 B	~?⁶	~?	~51%	Keytruda, Gardasil	USA, global
Pfizer Inc.	United States	~63.6 B	~81,000*	~785,000*	~18%	Comirnaty, Paxlovid, Prevnar	USA, Europe
AstraZeneca plc	United Kingdom	~54.1 B	~89,900	~602,000	~24%	Enhertu, Farxiga, Imfinzi	USA, Europe
Novartis AG	Switzerland	~50.3 B	~75,883	~663,000	~25%	Entresto, Cosentyx	Europe, USA
AbbVie Inc.	United States	~56.3 B	~55,000	~1,024,000	~14%	Skyrizi, Rinvoq, Humira	USA, global
Sanofi S.A.	France	~41.1 B	~82,878	~496,000	~16%	Dupixent, Sanofi Pasteur vaccines	Europe, USA
Novo Nordisk A/S	Denmark	~42.1 B	~68,794	~612,000	~14%	Wegovy, Ozempic	USA, Europe
Boehringer Ingelheim	Germany	~26.8 B	~54,500	~492,000	~22%	Spiriva, Trajenta	Europe, USA
GlaxoSmithKline (GSK)	United Kingdom	~40.4 B*	~68,629*	~589,000*	~20%	Arexvy, Blenrep	Europe, USA
Takeda Pharmaceutical	Japan	~27.0 B*	~49,281*	~548,000*	~16%	Entyvio, Ninlaro	Japan, USA, Europe
Amgen Inc.	United States	~33.4 B*	~?	~?	~17%	Enbrel, Prolia	USA & Global

Main sources: Top 20 pharma companies by revenue 2024, PharmaExec/DrugDiscoveryTrends (2025); Detailed headcount for Roche, Sanofi, Novo Nordisk, Boehringer (Wikipedia & aggregates);  Global pharma employee rankings; Employees, R&D as a % of turnover: Estimates based on sectoral reports and analyses of public expenditure (20232024). Revenue (2024 revenue)
The figures are mainly from the Pharma 50 Report 2025 and the aggregated annual reports. They reflect the overall sale of pharmaceutical products (not necessarily the entire business of a conglomerate if other divisions exist).  Turnover per employeeThis ratio is calculated by dividing the 2024 turnover by the number of employees. It gives an indicative idea of industrial productivity or commercial intensity  (in thousands USD/employee): (1) AbbVie (~1,024,000 USD/employee) stands out very high, reflecting a less employer but very profitable model;Sanofi and Boehringer Ingelheim appear around ~~490500k USD/employee, etc.

Strategic Observations

• Proximity to the US market: most of the largest groups derive a significant part of their revenues from the United States, which explains their investment strategies and growing location in this market even in the face of price tensions. 
• Productivity vs. headcount: Some groups such as AbbVie or Pfizer have a turnover per employee above the industry average, which may reflect internal efficiencies, a richer portfolio of blockbusters or a more extensive outsourcing of support functions.
• Regional differences: European companies (Novartis, AstraZeneca, Sanofi) have relatively high ratios despite having a large workforce, underlining the importance of international markets and therapeutic innovation in their overall model.

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^[1] « United States: Trump signs an executive order to lower drug prices », Europe 1 with AFP (12 May 2025): https://www.europe1.fr/international/etats-unis-trump-signe-un-decret-pour-faire-baisser-les-prix-des-medicaments-de-30-a-80-745706.

^[2] Ezell, S. (2026, January 22). Trump Is Correct: European Nations Must Pay More for Innovative Drugs. Washington, DC: Information Technology and Innovation Foundation (ITIF). Continuous web document, unpaginated: https://itif.org/publications/2026/01/22/trump-is-correct-european-nations-must-pay-more-for-innovative-drugs/

^[3] V. Souty, F. « The EU-US Turnberry Agreement (July 2025) and the Reconfiguration of Tariff Risks: Trade Stabilization, Geopolitical Coercion and Effects on Consumer Markets », Le Diplomate Média, 26/01/2026. It should be noted that pharmaceutical products are not included in the agreement in question: everything therefore remains open to negotiation and therefore likely to evolve in this area, unfortunately. 

^[4] Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty, OJ EC L 1, 4 Jan. 2003; see also W. WILS, « Regulation 1/2003: An Assessment After Twenty Years« , Concurrences No 42022, (analysing the development and scope of the Regulation). 

^[5] European Commission, Public consultation on the revision of Regulation 1/2003 (10 July 2025) (call for evidence to modernise EU procedural rules on antitrust practices). 

^[6] Vestager, M. EU Competition chief on necessity of strong competition for innovation and consumer welfare, conference (Reuters, 18 Apr. 2024).

^[7] Ibid.

^[8] See F. Souty, « The European Union, the Draghi report on the future of European competitiveness: what inspiring strategic consequences for France? », Le Diplomate Média, 9 December 2025.

^[9] See, for example, Drake, A.R., Competition Policy and Public Health: Implications for Pharmaceuticals (Oxford Univ. Press 2017).

^[10] Draghi, M., Report on European Competitiveness and Competition Policy (Financial Times Summary Report, 2024) (analysing the need to rethink certain aspects of competition law to strengthen the scale and innovation of European firms). 

^[11] Ibid. 

^[12] Council Regulation (EC) No 1/2003, OJ L 1, 4 January 2003, p. 125.

^[13] European Commission, Communication on the Application of the Competition Rules to the Pharmaceutical Sector, Brussels, 13 March 2002, COM (2002) 141 final.

^[14] Ibid., p. 510.

^[15] DGCCRF, Annual Report 2006, p. 1522.

^[16] French Competition Authority, Annual Report 2006, p. 3542.

^[17] French Competition Authority, Decision 10-D-22, 15 December 2010, p. 1218.

^[18] Op.cit., pp. 1416.

^[19] Bundeskartellamt, Annual Report 2006, pp. 2028.

^[20] Bundeskartellamt, Pfizer/Boehringer Case, 2012, p. 714.

^[21] Bundeskartellamt, Annual Report 2018, pp. 2833.

^[22] European Commission, Pharmaceutical Sector Inquiry Update, 2016, pp. 1027.

^[23] Vestager, M., Remarks on Competition Enforcement in the Pharmaceutical Sector, Brussels, 21 May 2018, p. 24.

^[24] French Competition Authority, Annual Report 2018 – Pharmaceutical Sector, pp. 3542.

^[25] Bundeskartellamt, Annual Report 2018, pp. 2833.

^[26] European Commission, Case COMP/39.525 — Lundbeck, 19 June 2013, ECLI:EU:C:2013:389, paras 4265.

^[27] European Commission, Case COMP/40.847 – Servier, 9 December 2014, ECLI:EU:C:2014:299, pp. 5068.

^[28] European Commission, Case COMP/41.123 – Actavis/Alcon, 2015, paras 3557.

^[29] Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings, OJ L 24/1.

^[30] Id. Art. 13 (definition of the Community dimension).

^[31] European Commission, Press Release No. 127/24, Illumina Inc. and Grail LLC, 3 September 2024 (summary of facts).

^[32] C611/22 P and C625/22 P, Illumina v Commission, CJEU, judgment of 3 September 2024, ECLI:EU:C:2024:677 (on the application of Article 22).

^[33] European Commission, decision prohibiting the Illumina/Grail merger, 7 September 2022 (anticompetitive effects analysis).

^[34] European Commission, sanction for gun jumping against Illumina, 12 July 2023, €432 million fine. 

^[35] C-611/22 P and C-625/22 P, Illumina v Commission, CJEU judgments of 3 September 2024 (annulment of decisions based on Article 22). 

^[36] C-611/22 P and C-625/22 P, Illumina v Commission, CJEU judgments of 3 September 2024 (annulment of decisions based on Article 22). 

^[37] European Commission, Pharmaceutical merger decisions with commitments (historical examples, e.g. Novartis/Sandoz, Sanofi/…), available via EURLex and Commission press releases.

^[38] Reuters, EU regulators scrap merger power aimed at killer acquisitions after court veto, 29 November 2024. 

^[39] OECD, Health at a Glance 2025, Paris, 2025, chap. 2, p. 8991.

^[40] OECD, ibid., chap. 1, p. 4446.

^[41] OECD, Pharmaceutical Expenditure Statistics 2024, pp. 52-55‑.

^[42] CMS, National Health Expenditure Data 2024, pp. 1417.

^[43] Eurostat, Pharmaceutical Price Trends in the EU, 20002024, pp. 1025.

^[44] AMNOG, Arzneimittelmarkt-Neuordnungsgesetz – Annual Report 2022, pp. 1220.

^[45] CEPS (Economic Committee for Health Products), Annual Report 2023, pp. 1824.

^[46] OECD, Health at a Glance 2025, chap. 2, p. 9293

^[47] IQVIA, Global Pharmaceutical Sales Report 2024, pp. 3436.

^[48] Ibid, pp. 3841.

^[49] Eurostat, Health Statistics by Country 2024, pp. 8895.

^[50] OECD, Health Expenditure by Country 2024, pp. 102105.

^[51] IMS Health, Therapeutic Segmentation of Pharmaceutical Markets 2024, pp. 2227.

^[52] European Commission, Pharmaceutical Sector Inquiry Update, 2016, pp. 1027.

^[53] Sherman Antitrust Act of 1890; Clayton Act of 1914; Federal Trade Commission Act of 1914: these are the historical texts of American antitrust law. See in particular Souty F., « Competition and antitrust policy in Europe and the United States: transatlantic perspectives and geopolitical issues », Le Diplomate-Média, 30/12/2025. See also Souty F. La Politique de la concurrence des Etats-Unis, Paris, PUF, 1995 coll. Que-sais-je? n° 2945, 128 p. 

^[54] Hatch-Waxman Act, Drug Price Competition and Patent Term Restoration Act of 1984 (pharmaceutical sector framework).

^[55] See, for example , Waller, S.W., « Lasting change in competition law and policy, » Journal of Antitrust Enforcement, Oxford Univ. Press, Volume 11, Issue 2, July 2023, pp. 293–299.

^[56] In  American antitrust law, a patent hold-up refers to the situation in which the patent holder exploits a bargaining power acquired after the user (often an industrialist) has made specific investments that are difficult to reverse. A patent hold-up  occurs when a patent holder demands excessive royalties or disadvantageous conditions by taking advantage of the fact that the potential licensee is « locked-in » by previous investments (R&D, equipment, adopted technical standard). The central idea is ex post opportunism: the threat of an injunction or a ban on sales makes it possible to extract a rent greater than the real technological value of the patent. The phenomenon is particularly studied in the sectors with standard-essential patents (SEP), where the holder has committed to grant licences on FRAND (fair, reasonable and non-discriminatory) terms. Once the standard is adopted, manufacturers no longer have a viable technical alternative, which increases the patentee’s bargaining power.

In the United States, the debate has been fuelled by the case law of the Supreme Court (particularly on the conditions for granting patent injunctions) and by the positions taken by agencies such as the FTC. There are two opposing visions: (1) an interventionist approach, seeing in the hold-up a risk of abuse of market power contrary to the Sherman Act; (2) a more skeptical approach (Chicago School and post-Chicago), stressing that the phenomenon is sometimes theoretical or offset by the opposite risk of hold-out (strategic refusal to pay by the user). The concept is based on the theory of sunk costs and incomplete contracts: the higher the specific investments, the greater the ex-post rent-extraction capacity. In summary, the patent hold-up is an issue at the frontier of patent law, contract law and antitrust, revealing the tension between protecting innovation and preventing abuses of market power.

^[57] In the United States, since the 2000s, part of the antitrust doctrine — influenced by neoclassical economic analysis — has relativized the empirical extent of the patent hold-up, highlighting the symmetrical risk of hold-out. The FTC and the Department of Justice have adopted different positions depending on the administration. In the European Union, the European Commission and the Court of Justice of the European Union have developed a more regulated approach to injunctions related to SAPs (in particular via the Huawei/ZTE case-law), explicitly integrating the issue of hold-up into the control of abuse of dominant position.

^[58] Slater G., speech at the University of Notre Dame Law School,  » The Conservative Roots of America First Antitrust Enforcement , » April 28, 2025

^[59] V. Souty, F., « America first » Antitrust: the conservative renewal of American antitrust by the Trump II Administration, continuities, ruptures and doctrinal recomposition », Le Diplomate Médias, 12 January 2026. 

^[60] Slater, G. The Conservative Roots of America First Antitrust Enforcement, Speech, Chicago, Notre Dame University, 28 April 2025.

^[61] DOJ & FTC, Listening Sessions on Lowering Americans’ Drug Prices Through Competition, June 11, 2025 (joint DOJ/FTC sessions under G. Slater & A.N. Ferguson). The « listening sessions » consist of structured public consultations bringing together academics, practitioners, companies and representatives of civil society. They aim to gather information and views on specific competition issues — recently, for example, competition in the pharmaceutical sector and lower drug prices. These sessions do not in themselves have a normative or binding scope: they do not modify the law and do not decide on litigation actions. Their usefulness is above all advisory and strategic: they allow the federal competition authorities to refine their priorities, identify potentially anticompetitive practices and feed into possible reports, guidelines or enforcement actions. Their effectiveness therefore depends less on the format than on the way in which the agencies concretely exploit the information collected.

^[62] The « rule of reason » is a central principle of US antitrust law according to which a practice is not illegal simply because it restricts competition, but only if this restriction is found to be unreasonable after a concrete analysis of its economic effects. It was enshrined in 1911 by the Supreme Court of the United States in Standard Oil Co. of New Jersey v. United States, interpreting the Sherman Antitrust Act. Its importance is major because it requires a case-by-case assessment of anticompetitive effects and possible economic justifications, making US antitrust law a system largely based on effects analysis rather than automatic prohibitions.

^[63] FTC v. Actavis, Inc., 570 U.S. 136 (2013)

^[64] FTC v. AbbVie Inc., 976 F.3d 327 (3d Cir. 2020).

^[65] In re Generic Pharmaceuticals Pricing Antitrust Litigation, MDL No. 2724

^[66] Goodwin, Antitrust and Competition Life Sciences Year in Review 2024 

^[67] Crane, D., Antitrust Principles for the Innovation Economy, Yale Law Journal (2023), pp. 110-118. See also Crane, D., Antitrust, New-York, Wolters-CCH, 2014, 200 p.

^[68] Crane, D., Antitrust, New-York, Wolters-CCH, 2014, 200 p. V. also Waller, Spencer Weber and Sag, Matthew, Promoting Innovation (August 12, 2014). Available at SSRN: https://ssrn.com/abstract=2479569.  Also,  Crane D., Antitrust Principles for the Innovation Economy, Yale Law Journal (2023).

^[69] FTC, Amgen/Horizon Therapeutics – Consent Order, 2023.

^[70] US DOJ and FTC, Listening Sessions at FTC and DOJ on lowering American Drug Prices, 4 and 5 August 2025. see https://www.justice.gov/opa/pr/justice-department-and-ftc-host-listening-sessions-lowering-americans-drug-prices-through

^[71] Hovenkamp H., Federal Antitrust Policy: The Law of Competition and Its Practice, West Academic, St. Paul, 2016, pp. 3-5. This is a standard work on antitrust.

^[72] Slater G., Address at University of Notre Dame Law School, 28 April 2025, already cited.

^[73] Ibid. 

^[74] OECD, Competition Risks Across the Pharmaceutical Value Chain, Global Forum on Competition, 1-2 Dec 2025.

^[75] Khan L., Remarks on Antitrust and Health Care Markets, FTC, 2022.

^[76] Stiglitz J., People, Power, and Profits, W.W. Norton, New York, 2019, pp. 221-225.

^[77] Crane, D., Antitrust Principles for the Innovation Economy, op. cit.

^[78] Op.cit.

^[79] See Congressional hearings on pharmaceutical antitrust reform (2023-2025).

^[80] Slater G., quoted in Technology and life sciences deals remain top priority for antitrust enforcers, Global Competition Review, 2026.

^[81] OECD, Competition Risks Across the Pharmaceutical Value Chain, 2025.

^[82] ECN Network, Annual Report 2022, pp. 12-20.

^[83] Slater G., op.cit. (Speech at the ABA Antitrust Fall Forum, November 2025).

^[84] Ibid.

^[85] The White House, Fact Sheet: President Donald J. Trump Announces Actions to Get Americans the Best Prices in the World for Prescription Drugs(Washington, DC: The White House, July 31, 2025), pp. 1–4, cited at p. 2

^[86] Donald J. Trump, Remarks by the President on Prescription Drug Prices, The White House Archives, Washington DC, February 5, 2019, p. 1

^[87] Draghi, M. Report on the competitiveness of the European Union to be restored, Brussels, European Policy Centre, 2025, p. 25

^[88] Von der Leyen, Ursula, State of the Union Address 2025, Strasbourg, European Commission, 16 September 2025, pp. 8–15; Dombrovskis, V., European Trade Policy and Strategic Supply Chains Report, DG Trade, European Commission, Brussels, 2025, pp. 1–28

^[89] Public statements by the CEOs of Roche, Sanofi and Novartis at the European Pharmaceutical Forum 2025 (Brussels, 3–5 June 2025), pp. 18–19.

^[90] V. « Rubio’s Appeal to Western Unity Fails to Reassure Rattled Europe, » Financial Times, 16 Feb. 2026.

^[91] Fact Sheet: President Donald J. Trump Announces Largest Developments to Date in Bringing MostFavouredNation Pricing to American Patients, The White House, Washington DC, 19 December 2025, pp. 1–7

^[92] Fact Sheet: President Donald J. Trump Announces Actions to Get Americans the Best Prices in the World for Prescription Drugs, The White House, Washington DC, 31 July 2025, pp. 1–4

^[93] Op. cit. p. 15-18. In addition to our December 2025 article on the Draghi Report in Le Diplomate Media, already cited, see also McCann, Ph., & Stierna, J, The Draghi Report on the Future of European Competitiveness, JRC Technical Report, European Commission Joint Research Centre, Luxembourg: Publications Office of the European Union, 2025, pp. 1–13.

^[94] Von der Leyen, Ursula, State of the Union Address 2025, European Commission, Strasbourg, 16 September 2025, pp. 8–15; Dombrovskis, V. European Trade Policy and Strategic Supply Chains Report, DG Trade, European Commission, Brussels, 2025, pp. 1–28,

^[95] Executive Order: Delivering MostFavoredNation Prescription Drug Pricing to American Patients, The White House, Washington DC, 12 May 2025; Federal Register 90 FR 27986, secs. 1–2, cited at p. 27987. Direct quote: « The United States will take immediate steps to ensure that Americans pay the mostfavourednation lowest price for prescription drugs. »

^[96] Ibid., secs. 3–5, pp. 27988–27990.

^[97] U.S. Department of Health and Human Services, MostFavoredNation Drug Pricing Targets, HHS Press Release, 20 May 2025, p. 1; summarised in « US health authorities set mostfavourednation pricing targets« , Reuters, 20 May 2025. 

^[98] The White House, Fact Sheet: President Donald J. Trump Announces First Deal to Bring MostFavoredNation Pricing to American Patients, 30 September 2025, pp. 1–3. 

^[99] The White House, Fact Sheet: President Donald J. Trump Announces Second Deal to Bring MostFavoredNation Pricing to American Patients, October 10, 2025, p. 1. 

^[100] The White House, Fact Sheet: President Donald J. Trump Announces Largest Developments to Date in Bringing MostFavoredNation Pricing to American Patients, 19 December 2025, pp. 1–4. 

^[101] Ibid., pp. 2–3.

^[102] Pharma companies warn EU Commission to negotiate and reduce nontariff barriers, Euronews, 9 April 2025, p. 1. 

^[103] The Trump Effect on Global Pharma: Roche Invests $50 Billion in the US – and Europe Remains Behind, IFIS, 7 May 2025, pp. 1–3

^[104] Ibid.; Pharma companies warn EU Commission…, p. 1. 

^[105] Szilvia Kecsmar, « MostFavoured Nation Drug Pricing Risks Transatlantic Rift« , Central European Affairs, 1 September 2025, online at https://centraleuropeanaffairs.com/2025/09/01/most-favoured-nation-drug-pricing-risks-transatlantic-rift/ (accessed 28 February 2026).

^[106] Ganeswar Matcha, ‘The Global Risks of America’s « MostFavoredNation » Drug Pricing Policy‘, Harvard Law School PetrieFlom Center, 22 May 2025, online at https://petrieflom.law.harvard.edu/2025/05/22/the-global-risks-of-americas-most-favored-nation-drug-pricing-policy/ (accessed 28 February 2026).

^[107] In October 2020, India and South Africa proposed to the World Trade Organization to temporarily suspend certain rules of the TRIPS Agreement to allow for the wider production of COVID-19 vaccines and treatments. The aim was to facilitate the manufacture of generic medicines to reduce costs and improve access in developing countries. The article concludes that this waiver does not solve everything, but represents an important tool for improving global health equity in times of crisis. V. Sanath Wijesinghe, Chaminya Adikari & Ruwanthika Ariyaratna, « The proposal for waiver of WTO’s TRIPS Agreement to prevent, contain and treat COVID-19: investigating the benefits and challenges for low- and middle-income countries, » Journal of Intellectual Property Law & Practice, Vol. 17, No. 2 (February 2022), pp. 179–192.

^[108] European Parliamentary Research Service (EPRS), Impact of the US policy shift on global health and on the EU, EPRS Briefing, European Parliament, Brussels, 2025, pp. 1–24, cited pp. 10–13. Very interesting note on the European Report on the potential effects of the US measures on pharmaceutical supply chains and access to medicines in Europe.

^[109] ZS Associates. (n.d.). Navigating pharma supply disruptions and U.S. policy shifts. ZS Insights. Retrieved February 18, 2026, from https://www.zs.com/insights/us-pharma-policy-strategies-to-future-proof-your-supply-chain

^[110] Pharmatell, ‘How Big Pharma Is Reacting to MFN: Real Moves, Real Strategy‘, PharmaTell, 2025, pp. 1–6, cited at pp. 2–4: analysis of pricing policies, contractual redefinitions, and the timeline of international launches adopted by firms to navigate MFN bonds. 

^[111] Ibid., p. 4: mention of directtoconsumer channels in addition to MFN strategies. 

^[112] « AstraZeneca CEO  says Europe needs to invest more to protect its ‘health sovereignty’, » Reuters, April 23, 2025 article, reporting statements by AstraZeneca CEO Pascal Soriot, warning that insufficient investment and unattractive pricing policies could weaken Europe’s ability to attract R&D and manufacturing. Available at: https://www.reuters.com/ (accessed February 18, 2026). « Europe risks ‘health sovereignty’ by underpaying for medicines », says AstraZeneca », Financial Times, 6 November 2025, interview with the same Pascal Soriot, highlighting the link between drug pricing levels, incentives for innovation and Europe’s long-term pharmaceutical strategic autonomy. Available at: https://www.ft.com/  (accessed February 18, 2026).

^[113] Ibid.

^[114] . Europe risks ‘health sovereignty’ by underpaying for drugs, says AstraZeneca, Financial Times, 6 November 2025. Warnings about the need to increase investment and prices to avoid a structural decline and a loss of European « health sovereignty ». 

^[115] Trump’s 15% tariff on medicines will harm patients, say EU drugmakers, The Guardian, 29 July 2025. EFPIA statements criticizing US tariffs as a dangerous instrument for access to medicines and investment

^[116] McKinsey & Company, The emerging epicenter: Asia’s role in biopharma’s future, 7 January 2026, analyzing the growing role of Asia, particularly China and South Korea, in biopharmaceutical innovation and global pipelines. 

^[117] Korea Biomedical News, [2026 Outlook] Korea’s PharmaBio Industry Targets Global Expansion, 2 January 2026, highlighting South Korea’s strategic role in global biopharma.

^[118] Hovenkamp, Herbert, Federal Antitrust Policy, West Academic, 2016, pp. 4552.

^[119] European Commission, DG Competition Annual Report 2022, Brussels, 2022, pp. 1220.

^[120] OECD, Competition Risks Across the Pharmaceutical Value Chain, Paris, 2025, pp. 3438.

^[121] Slater Gail, address at the ABA Antitrust Fall Forum, Washington D.C., November 2025, pp. 58.

^[122] FTC v. Actavis, Inc., 570 U.S. 136 (2013); European Commission, AstraZeneca and Servier cases, op. cit. note 2.

^[123] Stiglitz, Joseph, « The Economics of Antitrust Enforcement in Innovation Markets, » Journal of Competition Law & Economics, 2022, vol. 18, pp. 5578.

^[124] Crane Daniel, « Antitrust Principles for the Innovation Economy, » Yale Law Journal, 2023, pp. 112118.

^[125] OECD, Competition Risks Across the Pharmaceutical Value Chain, op. cit. note 3, pp. 4143.

^[126] Khan, Lina, « Amazon’s Antitrust Paradox, » Yale Law Journal, 2017, pp. 112118.

^[127] Waller, Spencer W., « Big Pharma and Antitrust, » Journal of Antitrust Enforcement, 2022, pp. 3348.

^[128] European Commission, DG Competition Annual Report 2022, op. cit. note 2, pp. 2225.

^[129] Ibid., pp. 45

^[130] OECD, Competition Risks Across the Pharmaceutical Value Chain, op. cit. note 3, p. 5054.

^[131] Crane, D., op. cit. note 8, pp. 120124.

^[132] Slater, Gail and Ferguson, Andrew N., op. cit. note 13, p. 710.

^[133] Stiglitz, Joseph, op. cit. note 7, pp. 7274.

^[134] Draghi, Mario, European Union Competitiveness Report, Rome, 2024, p. 1018.

^[135] OECD, Global Trade Insights, Paris, 2025, pp. 215220.

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