A patent does not stop a parallel importer. Once a manufacturer sells a genuine, patented drug anywhere in the European Economic Area, EU case law treats the patent holder’s rights over that specific batch as spent, and the product can move freely to any other member state regardless of the price gap between the two markets [1][2]. The same principle now reaches the United States: the Supreme Court’s 2017 ruling in Impression Products v. Lexmark adopted international patent exhaustion, so a foreign sale can extinguish US patent rights over that same item too [3]. Parallel trade in EU pharmaceuticals reached an estimated €6,497 million at ex-factory prices in 2023, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) [4]. In Denmark, parallel imports accounted for 26.7% of pharmacy market sales that year, the highest share among the ten countries EFPIA tracks [4]. None of this requires a weak patent, an expired patent, or a technical loophole. It requires a price difference and a legally sold box of pills sitting in the wrong country.
What Parallel Importing Actually Is
Parallel importing (also called parallel trade or parallel distribution) is the resale of a genuine, manufacturer-approved drug across borders by a third party with no relationship to the brand owner. A wholesaler in a low-price country buys stock at the local price, repackages it to meet the destination country’s language and labeling rules, and resells it in a high-price country below the brand’s own list price there. The active ingredient, the manufacturing site, and the marketing authorization are identical to the version the brand owner sells directly.
Parallel Trade Is Not Counterfeiting
Counterfeit medicines are fraudulent — fake, adulterated, or diverted from a supply chain without any valid marketing authorization. Parallel trade is the opposite: it depends on the product being genuine and lawfully placed on the market by, or with the consent of, the brand owner. That distinction is why a customs seizure built to catch counterfeits generally cannot stop a parallel shipment. The EU instead runs parallel trade through a formal notification pathway administered by the European Medicines Agency, covered below [12].
Where the Arbitrage Comes From
Most European governments set or negotiate the price of reimbursed medicines, and those prices vary by a country’s wealth, health-technology-assessment rules, and negotiating leverage. A drug priced low in Poland and high in Germany or Denmark creates a spread a wholesaler can capture simply by moving stock across a border. Price differences between EU countries can run as high as 300% for the same medicine [20].
The Legal Doctrine That Makes This Legal: Exhaustion of Rights
Once a patent owner sells, or consents to the sale of, a patented item, the law treats that item’s patent rights as “exhausted”: the owner cannot use the same patent a second time to control where the item goes next. The scope of exhaustion differs by jurisdiction, and that difference is exactly what makes global launch sequencing exposed.
Centrafarm v Sterling Drug (1974): The Foundational Ruling
The European Court of Justice’s 1974 ruling in Centrafarm BV and Adriaan De Peijper v Sterling Drug Inc (Case 15/74) held that once a patent owner puts a product on the market in one EU member state, the patent cannot be used to block that product’s resale in another member state, and this holds even where the two states differ in price because of government price controls in the exporting state [1]. The court grounded the ruling in the EU’s free-movement-of-goods rules, treating a patent-based import block as an unjustified restriction on intra-Community trade once the reward of the first sale has already been realized [1].
Merck v Stephar (1981): Why “I Chose to Sell There Cheap” Is Not a Defense
Merck extended the exposure in 1981. Having marketed a drug in Italy at a time when Italy granted no patent protection for pharmaceuticals at all, Merck tried to block a competitor from reimporting that Italian stock into a country where Merck did hold a patent. In Merck & Co Inc v Stephar BV and Petrus Stephanus Exler (Case 187/80), the Court of Justice ruled that a patent owner who voluntarily sells in a state offering no patent protection still exhausts its rights there, because the decision to sell in that market — and at what price — was the owner’s own commercial choice [2]. Later case law confirmed that a justification resting on price controls in the exporting state is not a valid exception to this rule [2]. The ruling closes off a defense manufacturers might otherwise reach for every time they price low in a weaker-IP or lower-income market.
Impression Products v Lexmark (2017): International Exhaustion Crosses the Atlantic
For decades, US law let a patent owner sell abroad at a discount without automatically losing US patent rights over that same item. That changed on May 30, 2017, when the Supreme Court ruled 7–1 in Impression Products, Inc. v. Lexmark International, Inc. that an authorized sale exhausts a patent’s rights regardless of any restrictions the seller tries to attach, and regardless of whether the sale happened in the US or abroad [3]. The case involved printer cartridges, not drugs, but the doctrine the Court adopted applies to any patented product [3].
Why Pfizer, Merck, J&J, and Bayer Fought This Case
Pfizer, Johnson & Johnson, Bayer, and Merck filed a joint amicus brief opposing international exhaustion, warning the Court about the effect on a business that prices the same drug differently across dozens of countries [5]. Their concern was structural: once a company sells a drug abroad at a lower, often government-set price, a wholesaler can lawfully buy that stock and route it back into the US market, and after May 2017 the patent no longer offers a backstop against that flow [5][6]. Industry commentary following the ruling concluded that patent owners would need to lean more heavily on FDA import controls, rather than patent law, to keep reimported drugs out of the US [6].
Can a Manufacturer Just Refuse to Supply the Cheap Market? Sometimes.
If patent law cannot stop the arbitrage, the next lever is supply. A manufacturer can try to limit how much stock reaches a low-price wholesaler in the first place. EU competition law treats this very differently depending on whether the manufacturer is unilaterally rationing supply or holds a dominant position in the relevant market.
Bayer’s Adalat Case: Unilateral Rationing Is Not a Cartel
Between 1989 and 1993, Bayer’s cardiovascular drug Adalat (nifedipine) sold for roughly 40% less in France and Spain than in the UK under national price controls, and Spanish and French wholesalers began exporting large volumes to the UK, costing Bayer’s UK subsidiary an estimated €118 million (DM 230 million) in lost sales [9]. Bayer responded by restricting the quantities it shipped to its own French and Spanish subsidiaries. The European Commission fined Bayer 3 million ecus, arguing the restriction amounted to an unlawful export-ban agreement with wholesalers. Both the Court of First Instance in 2000 and the European Court of Justice in 2004 rejected that theory: a company may unilaterally set its own supply policy, even one designed to curb parallel exports, without that policy becoming an illegal “agreement” under EU competition law, so long as the company is not dominant and there is no proof wholesalers agreed to comply [7][8]. The ruling gives non-dominant manufacturers real room to ration supply into low-price markets as a defensive measure.
The Greek GSK Cases: Dominant Suppliers Must Still Fill “Ordinary Orders”
Bayer’s freedom has a ceiling: dominance changes the analysis. In November 2000, GlaxoSmithKline’s Greek subsidiary stopped supplying certain drugs to Greek wholesalers and began selling directly to hospitals and pharmacies instead, cutting off a route wholesalers had used to export to higher-priced member states. Wholesalers sued, and the case reached the European Court of Justice as Sot. Lélos kai Sia EE and Others v GlaxoSmithKline AEVE (Joined Cases C-468/06 to C-478/06). In its September 16, 2008 Grand Chamber ruling, the Court held that a dominant pharmaceutical company abuses its position if it refuses to meet wholesalers’ “ordinary orders” purely to choke off parallel exports, even though the identical refusal would be lawful for a non-dominant firm [10]. A refusal remains permitted only where the wholesaler’s order is genuinely disproportionate to its normal domestic demand [10].
GSK’s Spanish Dual-Pricing Scheme
GSK also tested a different tool in Spain: charging wholesalers one price for domestically dispensed drugs and a higher price for drugs destined for export, rather than restricting volume outright. The European Commission found this “dual pricing” scheme anticompetitive by its object, meaning it required no proof of actual anticompetitive effect. On appeal, in GlaxoSmithKline Services Unlimited and Others v Commission (Joined Cases C-501/06 P, C-513/06 P, C-515/06 P and C-519/06 P), the European Court of Justice ruled on October 6, 2009 that restrictions on parallel trade in a price-regulated sector like pharmaceuticals are not automatically an object-based restriction of competition, and that GSK’s efficiency arguments for the scheme deserved a full effects-based assessment rather than a summary rejection [11]. The combined effect of the Bayer, Greek GSK, and Spanish GSK rulings is a narrow, fact-specific corridor: manufacturers can defend against parallel trade through unilateral, proportionate supply and pricing decisions, but a dominant firm cannot use an outright refusal to strangle a wholesaler’s ordinary business.
The EU Actually Built a Regulatory Pathway for This
Parallel trade in the EU is not a gap regulators overlooked. It runs through a formal, EMA-administered notification system, which matters directly for the growing share of new drugs — especially biologics — approved through the EU’s centralized procedure.
EMA Parallel Distribution Notifications
Since May 20, 2004, any company wanting to parallel-distribute a centrally authorized medicine across the EU has been legally required to notify the EMA under Article 57(1)(o) of Regulation (EC) No 726/2004 [12]. The EMA checks that the repackaged product still complies with the original marketing authorization and issues a formal notice before distribution can begin, and a public register of these notices is searchable online [12][13]. Distributors submit and track notifications through the EMA’s IRIS platform, and the same procedure extends to Iceland, Norway, and Liechtenstein once a product’s authorization has been harmonized with the EU’s [13].
The Three-Month Notice Rule
Under the EMA’s operating procedure, a parallel distributor must send its initial notification to the agency at least three months before it intends to start distributing a specific product, and the trademark owner must separately receive advance notice of any planned repackaging under the case law described below [14].
Repackaging Without Losing the Trademark Fight: The BMS/Boehringer Conditions
Moving a drug across borders almost always means repackaging it — new language, new pack sizes, sometimes new outer cartons. That repackaging is where trademark law, not patent law, becomes the manufacturer’s remaining lever. The Court of Justice’s 1996 ruling in Bristol-Myers Squibb v Paranova set out five conditions, known as the BMS conditions, under which a trademark owner cannot object to repackaging: it must be necessary to access the market, it must not affect the product’s original condition, the new packaging must clearly name the manufacturer and the repackager, the presentation must not damage the trademark’s reputation, and the trademark owner must receive advance notice [15]. The long-running case of Boehringer Ingelheim KG v Swingward Ltd (Case C-348/04), decided April 26, 2007, clarified that repackaging counts as “necessary” only when, without it, effective market access would genuinely be impaired — a parallel importer cannot repackage merely for commercial convenience [16]. The Court also held that a repackaged product can damage a trademark’s reputation even with no defect in the physical packaging, if the presentation simply looks unprofessional [16].
Serialization Didn’t Close the Loophole — It Added a Compliance Layer
The EU’s Falsified Medicines Directive (2011/62/EU) and its Delegated Regulation (EU) 2016/161, fully enforceable since February 9, 2019, require a unique serialized 2D barcode and a tamper-evident seal on nearly all prescription packs [17]. Parallel distributors and repackagers must scan and “decommission” the original serial number in the European Medicines Verification System before applying their own repackaged unit’s identifier [19]. By early 2026, that verification network connected more than 2,900 marketing-authorization holders, 4,000 wholesale distributors, and roughly 115,000 commercial pharmacies across Europe [18]. The system was built to stop counterfeits entering the legitimate supply chain, not to stop lawful parallel trade. It simply means a parallel distributor now runs every pack through an additional verification and re-serialization step before resale.
What the Market Actually Looks Like Today
The scale of this trade is not a rounding error. It is a recurring, multi-billion-euro flow that concentrates heavily in a handful of destination markets.
From €5.5 Billion to €6.5 Billion
Independent economic research puts EU pharmaceutical parallel trade at roughly €5.5 billion in 2012, with national market shares reaching up to 25% in some countries [20]. A 2021 policy paper from the Centre for European Policy (cepInput) put the equivalent figure for the wider European Economic Area at €5.7 billion in 2019 [21]. EFPIA’s most recent industry data book puts 2023 EU parallel trade at €6,497 million at ex-factory prices [4]. Calculated from these figures: EU/EEA parallel trade grew from roughly €5.5 billion to €6.5 billion between 2012 and 2023, a compound annual growth rate of approximately 1.5% — modest next to overall pharmaceutical market growth, but persistent across more than a decade of EU price divergence.
Denmark’s parallel-import share of pharmacy market sales stood at 26.7% in 2023 — more than three times the next-highest country in EFPIA’s ten-country comparison, the U.K., at 8.0% [4].
Where It Concentrates: A Ten-Country Comparison
Calculated from EFPIA’s underlying 2023 figures: parallel imports represented roughly 2.4% of the EU’s total €274.5 billion ex-factory pharmaceutical market that year (€6,497 million ÷ €274,545 million [4]) — a modest EU-wide average that masks the concentration shown below.
Country
Share of Pharmacy Market Sales, 2023
Denmark
26.7%
U.K.
8.0%
Sweden
7.8%
Germany
7.0%
Netherlands
6.0%
Austria
5.6%
Ireland
5.6%
Belgium
3.1%
Finland
2.1%
Poland
1.3%
Source: EFPIA member associations, estimate, published in The Pharmaceutical Industry in Figures, Key Data 2025 [4].
Two Industries, Two Narratives
EFPIA, which represents research-based manufacturers, frames parallel trade as a flow that funds no innovation and destabilizes supply in smaller markets [4]. Affordable Medicines Europe, which represents parallel distributors, argues the opposite: a compilation of national studies it published found direct and indirect savings of €3.2 billion across Germany, Sweden, Denmark, and Poland alone, and it separately disputes the idea that medicines travel only one way, from low-income to high-income countries, calling that a myth [22]. Even the two groups’ own Denmark figures diverge — EFPIA’s 26.7% share of 2023 pharmacy sales against Affordable Medicines Europe’s reported 16% share of 2021 market turnover — a reminder that “parallel trade share” is measured differently depending on who is doing the measuring [4][22]. Both positions can be true for different stakeholders at once: a manufacturer loses margin in the destination market while that market’s health system pays less, which is part of why this legal doctrine has survived five decades of litigation intact.
Why Your Launch Sequence Creates the Exposure Window
Parallel trade would be a minor irritant if every country launched a drug at the same time and price. It becomes a structural risk because most companies deliberately do not do that, and the reason is a pricing mechanism, not chance.
External Reference Pricing, Explained for Launch Planners
External reference pricing (ERP) is the practice, used by most European governments, of setting or negotiating a drug’s national price partly by looking at what the same drug costs in a defined basket of other countries. Because a low launch price in one referenced country can drag down the negotiated price everywhere else that references it, manufacturers respond by sequencing launches: prioritizing high-price, high-volume markets first and delaying entry into low-price or heavily referenced markets, sometimes for years [23]. A 2019 systematic review in the European Journal of Health Economics tied this launch-sequencing effect directly to reduced medicine availability in countries with lower prices and greater exposure to onward parallel export [24].
The Maini-Pammolli Findings: Up to Three Years of Delay
Using pharmaceutical sales data from European countries between 2002 and 2012, Harvard’s Luca Maini and Politecnico di Milano’s Fabio Pammolli documented launch delays of up to three years on average in some Eastern European markets, and built a structural model attributing a meaningful share of that delay directly to ERP rather than to unrelated market frictions [25]. Their model treats the delay as a rational commercial response: a manufacturer withholds launch in a low-willingness-to-pay country whenever the price erosion that country’s reference price would trigger elsewhere outweighs the incremental revenue from entering that market at all [25].
The 73% Finding: ERP and the Nine-Month Launch Window
More recent data sharpens the picture. A 2023 study using the Pricentric ONE international pricing database, covering 100 high-priced drugs of interest to US Medicare and Medicaid programs between January 2010 and October 2021, found that ERP policies were associated with a 73% reduction in the likelihood a drug launches within nine months of regulatory approval, relative to non-ERP settings [26]. The same study found ERP had no material effect on the price a manufacturer initially sets, meaning its clearest measurable effect was on timing rather than on launch price itself [26].
Calculating Your Exposure Window
Original, labeled illustrative calculation: a manufacturer following documented industry practice — launching first in a small number of high-price, high-volume reference markets and delaying a lower-priced, frequently-referenced market by 12 to 36 months, consistent with the Maini-Pammolli range [25] — creates an exposure window in two phases. In phase one, before the low-price market launches, there is no parallel-trade risk from that market, because no local stock exists to export. In phase two, once the low-price market launches, its stock becomes exportable the moment it reaches pharmacies, and the price gap that justified the original delay is now also the arbitrage margin a wholesaler captures. The delay built to protect the reference price in high-value markets is the same delay that, once the low-price launch finally happens, hands parallel traders a fresh and often sizeable price differential to exploit — precisely because the company spent months or years keeping the two prices apart before finally connecting them through a single shared drug.
Case Study: Novo Nordisk’s Sequenced GLP-1 Rollout Meets a Continental Shortage
Launch sequencing does not need to be deliberate ERP-avoidance to create parallel-trade risk. Demand-driven shortages produce the same dynamic: once one market runs short, any nearby market with available stock becomes a source of diversion.
The 2023-2024 Timeline
Novo Nordisk’s GLP-1 diabetes drug Ozempic and its obesity counterpart Wegovy (both semaglutide) faced continuous shortages across Europe from 2022 into 2024, driven by demand that far outpaced manufacturing capacity, compounded by heavy off-label weight-loss use of the diabetes-indicated Ozempic [28][29]. By November 2023, Novo told European regulators it would temporarily cut production of its older drug Victoza to redirect manufacturing capacity toward Ozempic, and it limited supply of the 0.25 mg starter dose specifically to slow the rate of new patient starts [30]. The European Medicines Agency’s own shortage-monitoring materials logged Ozempic shortages as ongoing since 2022, Victoza shortages since 2023, and intermittent shortages of Saxenda in Austria, Finland, and Italy [27].
Germany, France, and Austria Build Export Walls
As the shortage deepened, Germany’s drug regulator considered banning Ozempic exports outright, following France and Austria, which had already restricted or discouraged export and off-label weight-loss prescribing to protect domestic diabetes-patient supply [28][30]. Belgium separately restricted GLP-1 use to type 2 diabetes patients and to obesity patients above defined BMI thresholds [28]. The episode is the mirror image of the launch-sequencing risk: when scarcity or price diverges sharply between neighboring markets, governments, not just wholesalers, start treating cross-border drug flows as a national supply-security issue rather than a routine commercial one.
Case Study: The 2025-2026 MFN Reference-Price Freeze
The newest driver of launch-sequence exposure is not a European ERP rule at all. It is an American one, and it is actively reshaping which drugs reach Europe, and when, in real time.
Insmed’s Brinsupri: Approved in the EU, Not Yet Launched
The FDA approved Insmed’s Brinsupri (brensocatib), the first treatment for non-cystic fibrosis bronchiectasis, on August 12, 2025 [42]. The European Commission followed with its own approval on November 18, 2025, after a positive opinion from the EMA’s human medicines committee on October 16, 2025 [41]. Despite that EU approval, Insmed held off launching the product commercially in Europe, citing uncertainty tied to the Trump administration’s Most Favored Nation (MFN) drug-pricing initiative, which ties US prices to the lowest price a company charges across a defined basket of other developed countries [38]. Charles River Associates vice president Matthew Majewski described the resulting standoff between manufacturers and reference countries as a “game of chicken” in comments to BioSpace [38].
GlobalData’s 35% Finding
Insmed is not an isolated case. GlobalData’s Price Intelligence database, comparing the ten months before and after the MFN policy’s mid-2025 announcement, found a 35% decline in the number of pharmaceutical launches across Europe overall, and a 37% decline specifically among the six countries referenced in the policy’s “GENEROUS” pricing model — Denmark, France, Germany, Italy, Switzerland, and the UK [39]. Bayer executive Stefan Oelrich, who also serves as president of EFPIA, told Reuters, “We’re seeing first signs of delayed introductions into Europe” [40].
GENEROUS, GLOBE, and GUARD
The MFN reference architecture is expanding. Beyond the GENEROUS model, the Centers for Medicare and Medicaid Services proposed the Global Benchmark for Efficient Drug Pricing (GLOBE) model to begin October 1, 2026, and the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) model to begin January 1, 2027, together referencing 19 countries: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom [43]. Every one of those countries is now a candidate for the same delay calculus European regulators created decades ago with ERP, except the reference relationship now runs toward the US market instead of within Europe, and a launch decision in any one of the 19 can move the US price a company is able to command.
Case Study: When Source Countries Build Their Own Walls
Governments on the exporting side of a price gap have their own tool for defending against outbound diversion: blocking bulk exports before they start.
Canada’s 2020 Interim Order
When the US finalized a rule in October 2020 permitting licensed US pharmacists and wholesalers to bulk-import prescription drugs from Canada, Health Canada moved first. On November 27, 2020, Canada’s health minister signed an Interim Order prohibiting the sale of any drug intended for the Canadian market outside Canada if that sale would cause or worsen a Canadian shortage [31][32]. Canada represents about 2% of global pharmaceutical sales and sources 68% of its drugs internationally, making it acutely vulnerable to a large bulk-export program aimed at a US market representing roughly 44% of global sales [31]. The interim measure became permanent through amended regulations that took effect on November 27, 2021 [33].
Florida’s Section 804 Program: Authorized in January 2024, Still Not Importing
On the US side, Section 804 of the Federal Food, Drug, and Cosmetic Act — dating to the 2003 Medicare Prescription Drug, Improvement, and Modernization Act — lets the FDA authorize states to run their own Canadian drug-importation programs [33][35]. The FDA authorized Florida’s program on January 5, 2024, the only state authorization issued to date [34][35]. As of a November 7, 2025 FDA letter, Florida had received its third authorization extension after repeatedly failing to file the electronic import entry needed to actually begin importing — first missing a January 5, 2025 deadline, then a July 6, 2025 extension, then requesting a further extension to November 6, 2025 [36]. More than a year and a half after authorization, no drugs had been confirmed imported under Florida’s program [37].
What “Authorized” Does Not Mean
Florida’s experience is a useful corrective for any launch-sequencing model that treats regulatory approval as equivalent to market access. FDA authorization removed the federal legal barrier to Florida’s program, but implementation still required a Canadian seller, a US importer, a pre-import request filed at least 30 days ahead of any shipment, and, as legal commentary has noted, resistance from manufacturers who control the very supply chain those importers depend on [34][37]. The gap between “authorized” and “importing” ran nearly two years and counting as of late 2025, illustrating that the parallel-trade risk a launch-sequencing decision creates does not activate on a predictable timetable. It activates only once every practical link in the chain — sourcing, notification, repackaging, and distribution — is actually built.
A Four-Type Taxonomy of Launch-Sequence Exposure
Original classification, developed from the case studies above:
Type 1: Reference-Price Delay Exposure
A manufacturer deliberately delays or skips a launch in a low-price, heavily-referenced market to protect prices elsewhere. Exposure activates the moment that market finally launches, because the price gap the delay was designed to preserve is also the arbitrage margin. This is the classic ERP-driven pattern documented by Maini and Pammolli and by the Pricentric-based 2023 study [25][26].
Type 2: Shortage-Triggered Diversion Exposure
Demand outpaces supply in one market, and stock legitimately intended for a lower-demand or lower-price neighboring market gets diverted to fill the gap, worsening the shortage in the source market. The Ozempic and Wegovy episode across Germany, France, and Austria is the clearest recent example [27][28][30].
Type 3: Regulatory-Authorization Gap Exposure
A product is approved in a jurisdiction but deliberately not commercially launched there, for reasons unrelated to that jurisdiction’s own demand — most often to avoid triggering an external reference price elsewhere. Brinsupri’s EU approval without an EU launch under MFN pressure is the live 2025-2026 example [38][39].
Type 4: Cross-Border Supply-Chain Compliance Exposure
Even fully lawful parallel distribution carries operational risk if a company’s packaging, serialization, or trademark presentation was not built with repackaging in mind. The BMS/Boehringer conditions and Falsified Medicines Directive decommissioning requirements mean a manufacturer’s own packaging choices shape how easily, and how defensibly, a parallel distributor’s repackaging turns out to be [15][16][19].
Brinsupri’s EU approval without EU launch, 2025-2026 [38]
Cross-Border Compliance
Packaging and serialization design
BMS/Boehringer repackaging conditions [15][16]
What This Means for Brand Manufacturers
Nothing in the case law above is new, but the MFN reference-price expansion changes the stakes of an old decision. A launch-sequencing plan built purely around European ERP baskets now has to account for a second, larger set of reference relationships running through GENEROUS, GLOBE, and GUARD [43]. The Bayer and Greek GSK rulings still mark the outer limits of a supply-based defense: unilateral rationing is lawful for a non-dominant product, but a dominant product cannot simply refuse a wholesaler’s ordinary orders once trade has started [7][10]. Packaging decisions made at launch — trademark placement, language modularity, serialization architecture — determine how cheaply and how defensibly a parallel distributor can later repackage the product, long before any dispute over price ever reaches a wholesaler [15][16].
What This Means for Generic and Biosimilar Entrants
Parallel trade is overwhelmingly a brand-side phenomenon in EFPIA’s data, concentrated in patented or recently patent-protected products where cross-country price gaps are largest [4]. But the centralized EU authorization pathway most biologics and biosimilars now use means a biosimilar entering multiple EU markets faces the same EMA parallel-distribution notification system as the originator it is competing against [12]. A biosimilar launched into a fragmented set of national tender prices creates the same structural arbitrage the originator faced, meaning a generic or biosimilar company running its own staggered EU rollout inherits this exposure from day one of its own multi-country launch, not years into patent life. Patent-expiration data alone — the kind of exclusivity-window tracking DrugPatentWatch maintains for branded products — will not flag this risk, because exhaustion applies independent of whether a patent is in force, expired, or was never granted in a given country at all [1][2].
Methodology
This analysis draws on primary EU and US case law (sourced via CURIA, EUR-Lex, and SCOTUSblog), EMA regulatory guidance documents, the EFPIA “Pharmaceutical Industry in Figures, Key Data 2025” industry data book, peer-reviewed and working-paper economic literature on external reference pricing (Maini and Pammolli, 2019; a 2023 study using the Pricentric ONE database; a 2020 CEPR VoxEU column drawing on Dubois and Saethre’s Econometrica research), a 2021 cepInput policy paper, Affordable Medicines Europe’s published savings studies, Health Canada and FDA regulatory filings and correspondence, and contemporaneous 2023-2026 trade and financial press coverage of GLP-1 shortages and the Most Favored Nation pricing initiative. Two figures in this article are original calculations, clearly labeled where they appear: parallel trade’s share of the EU’s total ex-factory pharmaceutical market in 2023 (approximately 2.4%, calculated by dividing EFPIA’s €6,497 million parallel-trade estimate by its €274,545 million total EU ex-factory market figure), and the compound annual growth rate of EU/EEA parallel trade from 2012 to 2023 (approximately 1.5%, calculated from the CEPR/Dubois-Saethre 2012 estimate against EFPIA’s 2023 figure). The four-type exposure taxonomy is an original classification built from the regulatory and case-study material gathered for this article, not an established industry framework. Limitations: EFPIA is an industry association representing originator manufacturers, and Affordable Medicines Europe represents parallel distributors; both are cited here as clearly attributed industry perspectives rather than neutral arbiters, and their underlying methodologies were not independently re-derived for this article. The 2012 and 2019 EU/EEA parallel-trade market-size estimates are drawn from secondary policy-paper and working-paper citations of earlier primary studies, which were not independently re-verified.
Key Takeaways
EU and US law both treat a genuine drug’s first authorized sale as exhausting the patent owner’s right to block its resale elsewhere, regardless of the price difference between markets [1][2][3].
A non-dominant manufacturer can lawfully ration supply into a low-price market to blunt parallel exports; a dominant manufacturer cannot refuse a wholesaler’s ordinary orders for that purpose [7][10].
EU parallel trade reached an estimated €6,497 million in 2023, with Denmark’s 26.7% share of pharmacy sales the highest among the ten countries EFPIA tracks [4].
External reference pricing is associated with a 73% reduction in the likelihood a drug launches within nine months of approval, and with launch delays of up to three years in some markets — the same deliberate sequencing decision that later becomes the parallel-trade arbitrage window [25][26].
The US Most Favored Nation pricing initiative is now producing a comparable delay dynamic in reverse, with GlobalData recording a 35-37% decline in European drug launches in the ten months after the policy’s announcement [39].
Regulatory authorization to import or distribute a drug does not guarantee the trade actually happens on any predictable timetable, as Florida’s Section 804 program — authorized in January 2024 and still not importing as of its third extension in November 2025 — demonstrates [34][36].
FAQ
What is pharmaceutical parallel importing?
Parallel importing is the resale of a genuine, manufacturer-authorized drug across national borders by a third-party wholesaler or distributor with no relationship to the brand owner, typically to profit from a price difference between the two markets [12].
Is parallel importing pharmaceuticals legal?
Within the EU and EEA, yes, subject to an EMA notification procedure for centrally authorized medicines and to repackaging and trademark rules set out in EU case law [12][15]. In the US, the Supreme Court’s 2017 Impression Products v. Lexmark ruling establishes that patent rights are exhausted by an authorized foreign sale, though FDA import rules separately govern whether a specific shipment can lawfully enter the US market [3][6].
Can a patent stop parallel imports?
No. Once a patent owner sells, or consents to the sale of, a patented drug, the exhaustion doctrine bars using that same patent to block the item’s resale elsewhere, as established in Centrafarm v Sterling Drug and reaffirmed in Merck v Stephar [1][2].
How big is the EU parallel trade market?
EFPIA estimated EU pharmaceutical parallel trade at €6,497 million at ex-factory prices in 2023, up from earlier estimates of roughly €5.5 billion in 2012 and €5.7 billion in the wider EEA in 2019 [4][20][21].
Why did Ozempic and Wegovy shortages worsen across Europe in 2023 and 2024?
Demand for GLP-1 drugs, driven partly by off-label weight-loss use, outpaced Novo Nordisk’s manufacturing capacity, and the company temporarily cut supply of its older drug Victoza to redirect capacity toward Ozempic, while several countries, including Germany, France, and Austria, restricted or considered restricting exports to protect domestic diabetes-patient supply [28][30].
What is external reference pricing and how does it affect launch timing?
External reference pricing sets or negotiates a country’s drug price partly by referencing prices in other countries, which gives manufacturers an incentive to delay launching in low-price, heavily-referenced markets to avoid dragging down prices elsewhere. One study found ERP associated with a 73% reduction in the likelihood of a launch within nine months of approval [26].
Does the US allow parallel imports of prescription drugs from Canada?
Only through a narrow, FDA-authorized Section 804 state importation program. Florida is the only state whose program has been authorized, in January 2024, and as of a November 2025 FDA extension letter it had still not begun actual importation [34][36].
What is the Most Favored Nation drug pricing policy and how does it affect European launches?
The US Most Favored Nation (MFN) policy ties US drug prices to the lowest price a manufacturer charges across a defined basket of other developed countries, creating an incentive to delay or skip launches in low-price reference markets, mirroring the EU’s own external-reference-pricing dynamic. GlobalData recorded a 35-37% decline in European pharmaceutical launches in the ten months after the policy’s mid-2025 announcement [39][43].
Can a manufacturer refuse to supply a wholesaler to stop parallel exports?
A non-dominant manufacturer generally can, under the Bayer Adalat ruling. A manufacturer with a dominant market position generally cannot refuse a wholesaler’s ordinary orders for that purpose, under the Sot. Lélos kai Sia v GlaxoSmithKline ruling [7][10].
How does repackaging by a parallel importer avoid trademark infringement?
Under the Bristol-Myers Squibb v Paranova “BMS conditions,” repackaging avoids infringement only if it is necessary for market access, does not alter the product’s original condition, clearly identifies both the manufacturer and the repackager, does not damage the trademark’s reputation, and is preceded by advance notice to the trademark owner [15][16].
References
Centrafarm BV and Adriaan De Peijper v Sterling Drug Inc, Case 15/74, [1974] ECR 1147, Judgment of the Court of Justice of the European Communities (31 October 1974).
Merck & Co Inc v Stephar BV and Petrus Stephanus Exler, Case 187/80, [1981] ECR 2063, Judgment of the Court of Justice of the European Communities (14 July 1981); principles restated in EUR-Lex 61995CJ0267. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:61995CJ0267
Impression Products, Inc. v. Lexmark International, Inc., 137 S. Ct. 1523 (2017). SCOTUSblog. https://www.scotusblog.com/cases/impression-products-inc-v-lexmark-international-inc/
European Federation of Pharmaceutical Industries and Associations (EFPIA). The Pharmaceutical Industry in Figures, Key Data 2025. https://www.efpia.eu/media/uj0popel/the-pharmaceutical-industry-in-figures-2025.pdf
Cleary Gottlieb. “The Supreme Court’s Lexmark Ruling On Patent Exhaustion” (5 June 2017). https://www.clearygottlieb.com/-/media/organize-archive/cgsh/files/2017/publications/alert-memos/the-supreme-courts-lexmark-ruling-on-patent-exhaustion-6-5-17.pdf
IPWatchdog. “Patent Exhaustion at the Supreme Court: Industry Reaction to Impression Products v. Lexmark” (31 May 2017). https://www.ipwatchdog.com/2017/05/30/patent-exhaustion-supreme-court-industry-reaction-impression-products-v-lexmark/id=83822/
Bundesverband der Arzneimittel-Importeure eV and Commission of the European Communities v Bayer AG, Joined Cases C-2/01 P and C-3/01 P, ECJ Judgment (6 January 2004). Distribution Law Center. https://distributionlawcenter.com/documentation/case-cards/bai-and-commission-v-bayer-c-2-01-p-and-c-3-01-p/
Bayer AG v Commission of the European Communities, Case T-41/96, Court of First Instance Judgment (26 October 2000). CURIA Press Release No 78/00. https://curia.europa.eu/en/actu/communiques/cp00/aff/cp0078en.htm
The Pharma Letter. “Bayer defeats EU in parallel imports case.” https://www.thepharmaletter.com/article/bayer-defeats-eu-in-parallel-imports-case
Sot. Lélos kai Sia EE and Others v GlaxoSmithKline AEVE Farmakeftikon Proionton, Joined Cases C-468/06 to C-478/06, ECJ Grand Chamber Judgment (16 September 2008). EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62006CJ0468
GlaxoSmithKline Services Unlimited and Others v Commission, Joined Cases C-501/06 P, C-513/06 P, C-515/06 P and C-519/06 P, ECJ Judgment (6 October 2009). EUR-Lex 62006CJ0501. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:62006CJ0501
European Medicines Agency. “Parallel distribution.” https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/parallel-distribution
European Medicines Agency. “Frequently asked questions about parallel distribution,” EMA/303963/2025 Rev. 6. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution
European Medicines Agency. “Procedure for Notifications of Parallel Distribution of Centrally Authorised Medicinal Products,” EMEA-H-30313-98 Rev. 2. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-notifications-parallel-distribution-centrally-authorised-medicinal-products_en.pdf
“ECJ answers questions on Bristol-Myers Squibb conditions in relation to parallel imports.” Lexology (16 May 2008), summarizing Bristol-Myers Squibb v Paranova A/S, Joined Cases C-427/93, C-429/93 and C-436/93 (1996). https://www.lexology.com/library/detail.aspx?g=75c403a9-df28-42df-8d19-9b3ab1d0a415
Boehringer Ingelheim KG and Others v Swingward Ltd and Others, Case C-348/04, ECJ Judgment (26 April 2007). IPCuria. https://ipcuria.eu/case?reference=C-348/04
Dubois, P. and Saethre, M. “The effects of parallel trade of drugs in Europe.” CEPR VoxEU column, citing Dubois, P. and Saethre, M., “On the Effect of Parallel Trade on Manufacturers’ and Retailers’ Profits in the Pharmaceutical Sector,” Econometrica. https://cepr.org/voxeu/columns/effects-parallel-trade-drugs-europe
cepInput No 11. “Parallel Trade of Pharmaceuticals and its Problems in the EU.” Centre for European Policy (cep) (11 May 2021). https://www.cep.eu/fileadmin/user_upload/cep.eu/Studien/cepInput_Parallelhandel/cepInput_Parallel_Trade_of_Pharmaceuticals_and_its_Problems_in_the_EU.pdf
Affordable Medicines Europe. “Reports and studies.” https://affordablemedicines.eu/reports-and-studies/
“External Reference Pricing for Pharmaceuticals — A Survey and Literature Review to Describe Best Practices for Countries With Expanding Healthcare Coverage.” ScienceDirect / Value in Health Regional Issues (2019). https://www.sciencedirect.com/science/article/pii/S2212109919300688
“Does external reference pricing deliver what it promises? Evidence on its impact at national level.” European Journal of Health Economics, Springer (2019). https://link.springer.com/article/10.1007/s10198-019-01116-4
Maini, L. and Pammolli, F. “Reference Pricing as a Deterrent to Entry: Evidence from the European Pharmaceutical Market” (Harvard University / Politecnico di Milano working paper, 2 April 2019). https://www.kellogg.northwestern.edu/-/media/files/healthcare-at-kellogg/market-conference2019/maini_luca_pammolli_erp_04-02-19.ashx
“The impact of external reference pricing on pharmaceutical costs and market dynamics.” ScienceDirect (2023). https://www.sciencedirect.com/science/article/pii/S2590229623000059
European Medicines Agency / Heads of Medicines Agencies. Presentation by Klaus Kruttwig, “Update and feedback on Multistakeholder workshop on GLP-1 receptor agonist shortages.” https://www.ema.europa.eu/en/documents/presentation/presentation-joint-hma-ema-big-data-steering-group-real-world-evidence-rwe-methods-klaus-kruttwig-ema_en.pdf
Fierce Pharma. “Germany considers banning the export of Novo Nordisk’s Ozempic.” https://www.fiercepharma.com/pharma/germany-considers-banning-export-novo-nordisks-ozempic
SupplyChainBrain. “Novo Sees European Ozempic Shortages Continuing into 2024.” https://www.supplychainbrain.com/articles/38549-novo-sees-european-ozempic-shortages-continuing-into-2024
Malay Mail. “Novo rations diabetes drug Ozempic amid surge in use for weight loss” (22 November 2023). https://www.malaymail.com/news/world/2023/11/22/novo-rations-diabetes-drug-ozempic-amid-surge-in-use-for-weight-loss/103404
Health Canada. “Canada announces new measures to prevent drug shortages” (28 November 2020). https://www.canada.ca/en/health-canada/news/2020/11/canada-announces-new-measures-to-prevent-drug-shortages.html
CBC News. “Canada blocks some bulk prescription drug exports to U.S. to prevent shortages” (29 November 2020). https://www.cbc.ca/news/world/bulk-exports-prescription-drugs-blocked-1.5821137
Congress.gov, Congressional Research Service. “FFDCA Section 804.” https://www.congress.gov/crs_external_products/IF/HTML/IF11056.web.html
U.S. Food and Drug Administration. “Section 804 Importation Program Policies and Authorizations.” https://www.fda.gov/drugs/importation-program-under-section-804-fdc-act/section-804-importation-program-policies-and-authorizations
Jones Day. “Canadian Drug Importation May Undermine Intellectual Property Protection” (23 May 2024). https://www.jonesday.com/en/insights/2024/05/canadian-drug-importation-may-undermine-ip-protection
U.S. Food and Drug Administration. “Letter of Third Authorization Extension for Florida’s Section 804 Importation Program” (7 November 2025). https://www.fda.gov/media/190518/download
Arnold & Porter. “Will FDA’s Section 804 ‘Enhancements’ Really Speed Up Drug Imports from Canada?” (22 May 2025). https://www.thefdalawblog.com/2025/05/will-fdas-section-804-enhancements-really-speed-up-drug-imports-from-canada/
BioSpace. “Trump’s MFN Pricing Expected To Delay More European Drug Launches” (2026). https://www.biospace.com/business/trumps-mfn-pricing-expected-to-delay-more-european-drug-launches
Pharmaceutical Technology. “The Most Favored Nation Policy: early insights into Europe’s response,” citing GlobalData Price Intelligence (POLI) analysis (31 March 2026). https://www.pharmaceutical-technology.com/analyst-comment/most-favored-nation-policy-early-insights-into-europe-response/
Reuters, cited in BioSpace. “Pharma’s Reluctance To Serve Europe To Dodge MFN Drug Pricing Is Chilling” (2 April 2026). https://www.biospace.com/business/editorial-pharmas-reluctance-to-serve-europe-to-dodge-mfn-drug-pricing-is-chilling
Insmed Incorporated. “European Commission Approves BRINSUPRI (brensocatib) as the First and Only Treatment Approved for Non-Cystic Fibrosis Bronchiectasis in the European Union” (18 November 2025). https://investor.insmed.com/2025-11-18-European-Commission-Approves-BRINSUPRI-TM-brensocatib-as-the-First-and-Only-Treatment-Approved-for-Non-Cystic-Fibrosis-Bronchiectasis-in-the-European-Union
Insmed Incorporated, via Seeking Alpha. “FDA Approves BRINSUPRI (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis” (12 August 2025). https://seekingalpha.com/pr/20198268-fda-approves-brinsupri-brensocatib-as-the-first-and-only-treatment-for-non-cystic-fibrosis
Arnold & Porter. “Most-Favored Nation Drug Pricing: What U.S. Pricing Initiatives Mean for International Commercial Contracts” (16 March 2026). https://www.arnoldporter.com/en/perspectives/advisories/2026/03/most-favored-nation-drug-pricing
