Netherlands: Price and Supply Security Remain Regulator’s Top Priorities

Relevant regulatory developments

Providing consumers with access to medicines at a reasonable price is the key driver of regulatory and legislative change in the life sciences sector in the Netherlands. Therefore, when it comes to regulatory developments, the main developments revolve around two topics: price and security of supply.

For instance, an amendment of the Dutch Medicines Prices Act in 2019 resulted in the inclusion of Norway as one of the four reference countries (at the expense of Germany).[2] Similar to many other European Economic Area (EEA) Member States, the Netherlands uses a reference price system to set the maximum allowable prices for medicines. As the prices are lower in Norway compared to Germany, the amendment has effectively resulted in lower maximum prices, which in turn secured estimated savings of over €100 million in 2021.[3]

Moreover, there has been a strong push from both the government and the public to reduce the cost of the most expensive treatments. One particularly notable development is the ‘pharmacy exemption’ that came into force on 1 February 2019. This exemption limits the patent holder’s rights. Article 53(3) of the Dutch Patent Act 1995 provides that the patent holder’s rights do not extend to the preparation of pharmaceuticals by pharmacists, for direct use of prescription drugs for individual cases (also known as pharmacy compounding). As recognised by the Dutch competition authority (ACM), compounding can provide a lower priced alternative for ‘expensive pharmaceuticals’, whereby the ACM notes that it will pay particular attention to the question of whether manufacturers and suppliers create barriers to compounding.[4]

In addition to lowering maximum prices and allowing exceptions to the rights of patent holders, the Netherlands joined forces with a number of EEA Member States in the Beneluxa Initiative to ‘ensure sustainable access to innovative medicine at affordable costs’.[5] The Member States achieve this goal through, for example, policy exchange and joint pricing and reimbursement negotiations. In 2021, for instance, the Netherlands, Belgium and Ireland jointly reached an agreement on the pricing of Zolgensma, a gene therapy for the treatment of spinal muscular atrophy.[6]

Amid these developments, the ACM has closely monitored the life sciences industry. Since 2018, it has consistently reiterated that the price of medicines is one of its key focus areas. Against this background, the ACM performed a sector inquiry into rheumatic medicines, the results of which prompted an investigation into a pharmaceutical company. In addition, the ACM published two working papers on the price of medicines as well as a submission to the Organisation for Economic Co-operation and Development (OECD) Roundtable. These papers and investigations are discussed further below.

Main merger control developments

In its decisional practice, the ACM has reviewed a large number of mergers among hospitals and, to a lesser extent, among pharmacies. Notifiable transactions involving pharmaceutical suppliers or manufacturers of medical devices are highly uncommon in the Netherlands. Mergers and acquisitions involving these companies are likely to meet the EU thresholds and are therefore typically reviewed by the European Commission.

Aurobindo/Apotex

One notable exception is Aurobindo’s acquisition of part of Apotex’s commercial operations in 2018. This is, to date, the only transaction between two pharmaceutical suppliers that has been reviewed by the ACM.[7] The transaction was cleared in Phase 1, subject to the divestment of one of the parties’ products. In its press release, the ACM was keen to re-emphasise its focus on pricing in the healthcare sector, noting that competition in the pharmaceutical sector contributes to innovation and affordable medicines.[8]

The transaction concerned Aurobindo’s acquisition of Apotex’s ‘commercial operations and certain supporting infrastructure’[9] for its generics business in Poland, the Netherlands, the Czech Republic, Spain and Belgium. In the Netherlands, the Dutch Apotex entities commercialised a portfolio of over 180 generic products and operated a production facility.[10] The transaction only met the thresholds in Poland and the Netherlands.

In its assessment of the transaction, which to a large degree focused on generic finished dose pharmaceuticals (FDPs), the ACM followed the methodology developed by the European Commission in its extensive pharmaceutical merger control practice from the past two decades. Concretely, this meant that:

  • the ACM relied on a classification scheme to group the therapeutically interchangeable medicines together at various levels of aggregation: molecule, ATC4, ATC3[11] or at the Nielsen Group[12] level;
  • the ACM took additional segmentations based on pharmaceutical forms into account and considered separate markets for prescription-based and over-the-counter drugs;
  • in line with the European Commission’s practice when assessing (mature) generic markets, the ACM used the molecule market as its starting point;[13] and
  • in its substantive analysis, the ACM applied the approach set out by the European Commission: categorising FDP overlaps in four groups and using market share thresholds, the date of entry and the number of remaining competitors to focus the analysis on those overlaps, which are more likely to give rise to competition concerns.[14]

Although the ACM generally followed the same approach as the European Commission, the main difference (or nuance) related to the analysis of the competitive constraint exercised by licensees when analysing FDP overlaps. For instance, in relation to the product lactulose (a laxative), one of the competitors was a licensee of Aurobindo. During its market investigation, and contrary to the approach taken by the Commission, the ACM investigated in detail to what degree licensees are credible and effective competitors. Ultimately, this did not affect the ACM’s conclusion, as sufficiently strong competitors remained active post-transaction in all but one market (see below). This suggests that while the ACM plays close attention to the Commission’s framework for analysing pharmaceutical mergers, it may approach some issues differently.

The only overlap that gave rise to competition concerns related to a diazepam enema, for which the parties were the only two suppliers in the Netherlands.[15] In line with the European Commission’s practice, a structural remedy was offered in the form of an asset carve-out. The divestment business included a number of rights and assets, without the inclusion of manufacturing assets. In its review of the potential buyer, the ACM considered – among other things – the fact that the buyer was already active in the FDP space and could incorporate the divestment business in an existing portfolio. Moreover, the envisaged buyer already had experience with the tender-based model of Dutch healthcare insurance companies. The ACM’s considerations align with the trend at the European Commission level of increased scrutiny of potential purchasers, which are in part expressed through more detailed purchaser criteria.

Finally, the above-mentioned focus on security of supply played an important role post-transaction. In October 2019, Aurobindo announced its intention to close the Apotex production facility in the Netherlands by September 2020, to move production outside of the Netherlands.[16] The former Apotex facility produced around 2.5 billion pills per year (mainly ibuprofen and paracetamol), making it the largest production facility of generics in the Netherlands.[17] That same month, the Dutch parliament adopted a motion stating that the Netherlands had become too dependent on countries outside Europe for the production of medicines. The motion also included a request to the cabinet to investigate the possibilities for bringing production sites for medicines to the Netherlands.[18] The outbreak of covid-19 exacerbated the government’s concerns for the security of supply. In light of these concerns, the Dutch government decided to grant state aid in the form of a loan of €6.7 million to a Dutch company (InnoGenerics) to acquire the former Apotex facility. In return for the financial support, the Dutch government made various arrangements with InnoGenerics, aimed at guaranteeing the security of supply of medicines.[19]

This development fits into a wider trend of governments using state funds to secure the supply of pharmaceuticals.

Main infringement proceedings

The ACM’s focus on the pharmaceutical sector led to three investigations over the past five years, each relating to a (potential) abuse of a dominant position. However, these investigations resulted in only one fining decision. The ACM closed the other investigations after receiving informal commitments from the relevant companies.

A number of papers from the ACM preceded its investigations. In 2018, it published two working papers and an OECD background note that focused on excessive pricing of medicines.[20] These three documents have proven to be early indicators of the ACM’s upcoming investigatory efforts and have been informative about its approach on excessive pricing. Below, we discuss a couple of particularly noteworthy arguments from these papers.

ACM working papers

In the first working paper, the ACM authors argue that they see no objection in principle to a finding of excessive pricing prior to patent expiry.[21] This position seems to deviate from the current enforcement practice of competition authorities, which focuses on sudden significant price increases of medicines that have been off-patent for a long time.[22] This focus can be explained by the more limited risk that competition law enforcement will undermine innovation in these cases, as innovators have had sufficient time to recoup their investment and make a profit.[23] Moreover, with off-patent medicines there is often a natural reference price (the price charged prior to the relevant price increases) for price comparison purposes. However, according to the working paper, the prohibition of excessive pricing can (and should) take the incentives for innovation into account, especially if enforcement takes place in relation to the pricing of on-patent drugs. To that end, they suggest that the probability of success of clinical research should be integrated into the first limb of the United Brands [24] test where costs and profit margins are examined.[25]

With respect to the second limb of the United Brands test in which the fairness of the price is examined, the working paper suggests a comparison between other types of drugs and healthcare expenditures. Currently, competition authorities often compare the price of the relevant product with the price of the same product in different geographical markets. To allow for their proposed comparison, the working paper suggests the use of a uniform measurement: the cost per gained quality-adjusted life year (QALY).[26] The QALY allows the price of a medicine to be compared with the price paid for other drugs and other medical treatments in terms of relative health outcomes and, therefore, value.

In the second working paper, the ACM authors argue that drug prices that exceed the value to society lead to inefficient innovation decisions.[27] In these instances, enforcing lower prices does not harm innovation but improves it, because as a result of lowering those prices, future investments will be geared towards projects that are more desirable for society. To identify whether prices exceed the value to society, the working paper proposes comparing the price to the above-mentioned QALY reference value used to assess the cost-effectiveness of drugs.

The working paper furthermore discusses how this approach could factor in to the application of the two-limb United Brands test to determine whether patented drug prices are excessive and unfair. According to the paper, a price of a patented medicine above the QALY threshold might be considered excessive as: (1) the price is higher than society’s willingness to pay, which may imply a lack of reasonable relation to the economic value of the medicine; and (2) investment incentives improve if that price is lowered. As to the fairness assessment, the paper notes that the goal of patent protection is to improve innovation incentives. A price may therefore be considered fair as long as it improves innovation incentives.

Finally, in its ‘Excessive Pricing in Pharmaceuticals’ submission to the OECD Roundtable, the ACM further builds on the two working papers by adding a fairness argument.[28] According to the ACM, more emphasis may be placed on a fair distribution between producers and consumers. In the context of such a distribution, it is both possible and justified to take different degrees of innovation into account. The ACM argues that a stricter cost-based test should be applied to medicines involving limited innovation compared to medicines requiring significant research and development (R&D) investment. According to the ACM, the two most important factors to take into account are costs of R&D efforts that did not lead to market introduction and the cost of capital.

Leadiant

In July 2021, the ACM announced that it had imposed a €19.6 million fine on drug manufacturer Leadiant for abuse of a dominant position through excessive pricing of its prescription drug CDCA-Leadiant.[29] This is the first time that the ACM has taken enforcement action against excessive pricing in the pharmaceutical sector. It hardly came as a surprise, however. As noted above, the ACM has consistently identified excessive prices of pharmaceuticals as one of its top priorities since 2018. Practitioners, pharmaceutical companies and potential claimants are following this case closely, as similar cases may follow suit. To date, only a summary of the decision is available.[30] While this provides some insight into the case, the specifics of the analysis remain unclear.

Background

In the Netherlands, approximately 60 patients suffer from cerebrotendinous xanthomatosis (CTX), a rare hereditary metabolic disorder. Patients often develop severe neurological problems and eventually die prematurely without proper treatment. Since the 1970s, CTX patients in the Netherlands have been treated with chenodeoxycholic acid (CDCA). Leadiant started selling a CDCA-based drug in 2008; the relevant timeline and price developments are shown below.

YearDescriptionPrice/unit (€)
2008Leadiant offered a chenodeoxycholic acid (CDCA)-based drug (Chenofalk) after acquiring the product46
2009Leadiant changed the name of the drug to Xenbilox and increased the price885
2014Leadiant applied for an orphan designation (granted in 2014) and marketing authorisation (MA) to treat cerebrotendinous xanthomatosis (CTX) and increased the price again3,103
2017Following the MA grant in 2017, Leadiant had the exclusive right for 10 years to supply a CDCA-based drug for the treatment of CTX to the European market. In June 2017, Leadiant pulled Xenbilox and introduced CDCA-Leadiant (at a higher price point), a drug that is biologically identical to Xenbilox14,000
2020Since January 2020, the Amsterdam University Medical Centre has successfully manufactured a CDCA-based product in its own pharmacy, which caused Leadiant to drop the price of CDCA-Leadiant 

ACM decision

According to the ACM, Leadiant abused its dominant position from June 2017 to December 2019. During this period, Leadiant charged and collected an excessive price for its prescription drug CDCA-Leadiant.

The ACM notes that Leadiant enjoyed a dominant position on the Dutch market for CDCA-based drugs for the treatment of CTX. During the entire infringement period, no alternatives were available for the treatment of CTX and patients were highly dependent on CDCA, given the severity and course of the disease.

To determine whether Leadiant abused its market position through excessive prices, the ACM applied the cumulative two-limb test from United Brands: (1) analysing the excessiveness of the price; and (2) analysing whether the price was unfair, in itself or when compared with competing products.

In applying the first limb (the excessiveness test), the ACM assessed the costs and revenues that could be attributed to Leadiant’s application for orphan drug status and marketing authorisation. In addition, ACM has taken into consideration the risk that the project could fail. The ACM notes that the CDCA project was characterised by low costs in comparison with the revenues, low investment risks and a very high return. In its assessment, the ACM took account of a required rate of return of 15 per cent. It is unclear whether the ACM took into account that pharmaceutical companies need to recoup the cost of unsuccessful R&D with revenue from successful medicines. While the summary of the decision does not address this point, the ACM has considered this topic extensively in its working papers on excessive pricing. The extent to which the ACM addressed this point in its investigation will become clear when the full decision is published.

The ACM concluded that the price was not only excessive but also unfair, as Leadiant did not introduce any innovation, nor does CDCA-Leadiant have any therapeutic added value compared with previous CDCA-based drugs. Moreover, the unfairness of the price was also assessed by looking at the prices of Chenofalk and Xenbilox, which were significantly lower despite being ‘molecularly identical’ products.[31] Moreover, the ACM compared the prices of CDCA-Leadiant with the price of the CDCA-based drug prepared by Amsterdam University Medical Centre (UMC) through compounding. According to Amsterdam UMC, it is able to produce the capsules at a price of €30,000 per patient a year, compared with over €150,000 for Leadiant (prior to its 2020 price decrease).[32]

Finally, the ACM considered it relevant that there were no indications that Leadiant was willing to agree to a non-excessive price. Leadiant itself had put forward that it was always its intention to accept a lower price after negotiations with the healthcare insurers and the Ministry of Health, Welfare and Sport (the Ministry), but that these latter parties intentionally frustrated the negotiations. The ACM dismissed Leadiant’s argument, noting that Leadiant did not do enough in its discussions with the health insurers and the Ministry. Meanwhile, Leadiant continued to charge its buyers the price of €14,000.

Next steps

Following the ACM’s decision, Leadiant indicated that it would file an administrative objection. After this objection, the decision can be appealed before the Rotterdam District Court. Based on public information, it appears that Leadiant – rather uniquely – has obtained an extension to pay the fine. It appears that this extension could relate to an additional investigation by the ACM into the alleged collective refusal of the healthcare insurance companies to negotiate with Leadiant.

Whether the ACM’s decision will hold will only become clear in a few years’ time. The highest court in competition law cases – the Trade and Industry Appeals Tribunal – has been critical of the ACM’s dominance findings in the past and is also known to heavily scrutinise the economic analyses used by the ACM.

The Leadiant case in a European context

The Leadiant case is relevant to an ongoing interest of competition authorities in excessive prices.[33] This case follows the surge in pharmaceutical excessive pricing investigations in Europe, including Aspen in Italy and in the EU, CD Pharma in Denmark and Pfizer/Flynn in the UK. Moreover, July 2021 appeared to be a particularly notable month for excessive prices. In addition to the ACM’s Leadiant fine, the UK Competition and Markets Authority (CMA) imposed fines on Accord-UK (£155 million) and Advanz Pharma (£100 million) for excessive prices.[34]

Although the lack of a detailed ACM decision hinders a more comprehensive comparison, a few points stand out. Cases in the past, such as Aspen and Pfizer/Flynn (or the more recent UK CMA fines imposed on Advanz Pharma and Accord-UK), involved products for which the patent had expired. The Leadiant case, however, concerns a product for which Leadiant held valid regulatory exclusivity under the orphan drug regulations. It does not come as a surprise that the ACM was willing to investigate a product that benefited from regulatory exclusivity, in view of its stance towards the application of the prohibition of excessive prices on patented drugs (see the ACM’s first working paper).

Another interesting element that stands out in the Leadiant case is the ACM’s observation on the negotiations between Leadiant, the health insurers and the Ministry. Based on the press release and the summary of the decision, it appears that the ACM considers it highly relevant that Leadiant was not willing to negotiate the price. The ACM does not indicate whether this in itself amounted to abuse of a dominant position, but it appears to have played a key role in the case as the ACM noted that Leadiant as a dominant company had the special responsibility to negotiate ‘effectively and seriously’. Given the importance awarded to the negotiations, the outcome of Leadiant’s enforcement request to the ACM against the healthcare insurers may become of particular importance. Based on publicly available information, Leadiant alleges that these healthcare insurance companies collectively agreed to refuse to negotiate with Leadiant.[35]

AbbVie

Background

For years, AbbVie’s anti-rheumatic drug Humira (based on adalimumab) was the best-selling prescription drug in the world, still generating over US$20 billion in sales in 2021.[36] AbbVie’s Humira life cycle management and pricing strategy has, however, been a source of contention.[37] AbbVie was involved in patent and antitrust litigation in the US and UK.[38] Notably, a UK court concluded on AbbVie’s patent litigation that its ‘intention and the objective effect is to shield its patent portfolio from examination of validity whilst continuing to file further divisionals and to threaten infringement proceedings against biosimilars, wherever they may be launched’.[39]

The ACM’s 2018–2019 sector inquiry concerning TNF-alpha inhibitors[40] is a prelude to the ACM’s investigation into Humira.[41] The ACM observed that, despite patent expiry and market entry of biosimilars, the list prices of TNF-alpha inhibitors remained relatively high, while the uptake of biosimilars was low. In particular, the uptake of biosimilars that have to be administered subcutaneously was lagging. The ACM identified two possible reasons: (1) the high switching cost; and (2) the conditional rebates applied by originators.

In its subsequent investigations of Humira, the ACM focused on conditional rebates. The ACM noted that the discount system incentivises a hospital to continue using the originator’s medicine for a large proportion of its patients; if the hospital switches to a different product, the discount is cancelled entirely. As some patients will not be able (or willing) to switch, the hospital will be forced to pay the full price for this residual patient group. The parallel Enbrel case provides an example of an almost quadruple price increase after a hospital forfeited its rebates (see below).

In its 2018–2019 sector inquiry, the ACM concluded that the practice of originators offering conditional rebates to hospitals might be anticompetitive under certain circumstances. It invited market participants to share any indications of potentially exclusionary practices, announcing it would investigate these indications and start enforcement action where necessary. Apparently, the ACM did receive this information and consequently commenced investigating AbbVie’s conditional rebates for Humira.[42]

Facts of the case

According to the ACM, Humira was the highest turnover-generating drug in the Netherlands prior to patent expiry in 2018. After patent expiry, AbbVie offered high rebates to hospitals under the condition that all existing patients would continue to use Humira. If the hospital did not meet this condition in full, it would forfeit the entire rebate.

According to the ACM, this approach hindered the uptake of biosimilars by exploiting a residual group of patients that would continue to use the originator. However, the ACM did take into account that any harmful consequences of AbbVie’s behaviour were limited, as AbbVie dropped the exclusivity condition immediately after a competitor complained. The ACM’s press release includes a brief summary of AbbVie’s response to the ACM’s findings. While AbbVie disagreed with these findings, it did undertake to stop including direct or indirect exclusivity obligations in its contracts. In addition, AbbVie undertook to remove reciprocal termination clauses from its contracts with hospitals and to refine its compliance policy and yearly compliance training with a specific focus on procurement proceedings. With these undertakings, the ACM closed the file.

Pfizer (Enbrel)

Pfizer’s rheumatic medicine Enbrel (based on etanercept) was also included in the scope of the sector inquiry. Pfizer’s patent on etanercept expired in 2015. According to the ACM, Enbrel generated the second-highest turnover per medicinal product in the Netherlands – after Humira – before patent expiry. After the patent expired, two competitors entered the market with biosimilars.

In the autumn of 2021,[43] the ACM found that Pfizer included a clause in its contracts with several hospitals that allowed it to significantly reduce its rebate for future volumes if the decrease in off-take was more than a specified percentage. Specifically, if hospitals switched most of their patients to a biosimilar, the price of Enbrel for the non-switching patient group could become almost four times as high as before. According to the ACM, this conduct could raise a financial barrier for hospitals to switch patients to competitor products and thereby hinder the uptake of biosimilars.[44]

Similar to AbbVie, Pfizer disagreed with the ACM, but undertook to remove the rebate clauses from its current and future contracts. Pfizer also offered hospitals the option to switch to a biosimilar with retention of the existing rebate for the patients that would not switch. With these undertakings, the ACM closed the file.

Thoughts on the AbbVie and Pfizer cases

The Abbvie and Pfizer cases are quite similar. Both cases concerned firms that sell anti-rheumatic drugs, while giving significant conditional rebates to hospitals. Moreover, in both instances, the ACM agreed to close its investigation in response to the informal commitments offered by the parties. The key difference is the timing of the rebates: AbbVie’s competitors were still trying to enter the market, whereas Pfizer’s competitors were already established players.

The ACM’s decision to informally deal with both cases results in limited insight into its reasoning and the facts of the case. For example, the press release in the Enbrel case does not clarify where the ACM draws the line regarding rebates based on a percentage of the hospital’s total demand. However, one thing is clear: the ACM is determined to tackle abuse of dominance in the pharmaceutical sector.

The conclusion of these investigations might be regarded as a missed opportunity to inform pharmaceutical companies and the broader public about the lawful use of rebates in the supply of medicines. Private litigants in particular will mourn the lack of an ACM decision in which an infringement is established. On the other hand, the ACM’s approach is consistent with its goal to make an impact on the market. Through the informal commitments, the ACM succeeded in altering the potentially anticompetitive conduct while avoiding a long and likely complex investigation.

Outlook

The ACM’s interest in the pricing of pharmaceuticals is unlikely to waver in the coming years. For 2022, the ACM indicated that it would intensify the detection and enforcement of abusive behaviour in relation to pharmaceuticals. The ACM notes that it will pay particular attention to excessive prices and the obstruction of entry following the expiry of patents.[45] Further investigations into excessive prices cannot be ruled out.

In addition, the publication of the non-confidential version of the ACM’s decision in the Leadiant case will provide more insight into how the ACM built its excessive pricing case and how it compares to the approach taken in European or UK cases and in its working papers. Moreover, Leadiant’s appeal against the ACM’s decision will allow the Dutch court to take a position on the analysis of excessive prices relating to medicines.

Covid-19 will furthermore continue to remain relevant. However, the ACM’s covid-19 response has mainly related to healthcare insurers, hospitals and pharmaceutical wholesalers rather than manufacturers. For example, the aforementioned stakeholders have been allowed to jointly procure and distribute essential medicines. A change in direction is not expected.

Finally, the ACM has begun to include employment considerations in its merger control review. This may also apply to pharmaceutical mergers and can be relevant if a proposed merger includes plans to close production facilities in the Netherlands. Additional scrutiny is expected.


Notes

1 Jan Truijens Martinez is a counsel and Florentine Snoeker is a junior associate at Stibbe.

2 The amendment of the law was signed on 4 December 2019 and published on 16 December 2019; see https://zoek.officielebekendmakingen.nl/stb-2019-479.html.

3 Dutch Health Care Institute, 31 March 2022, ‘Nederlandse zorgkosten blijven stijgen, vooral in de langdurige zorg’; www.zorginstituutnederland.nl/actueel/nieuws/2022/03/31/nederlandse-zorgkosten-blijven-stijgen-vooral-in-de-langdurige-zorg.

4 Dutch competition authority (ACM), 19 February 2019, ‘ACM ziet kansen voor lagere prijzen van dure geneesmiddelen’; www.acm.nl/nl/publicaties/acm-ziet-kansen-voor-lagere-prijzen-van-dure-geneesmiddelen#:~:text=De%20Autoriteit%20Consument%20%26%20Markt%20(ACM,prijzen%20van%20’dure%20geneesmiddelen.

5 The partner Member States are Belgium, Luxembourg, Netherlands, Austria and (as of 2018) Ireland. See https://beneluxa.org/.

8 ACM, 24 December 2018, ‘ACM akkoord met fusie farmaceutische bedrijven Aurobindo en Apotex’; www.acm.nl/nl/publicaties/acm-akkoord-met-fusie-farmaceutische-bedrijven-aurobindo-en-apotex.

9 Aurobindo, 14 July 2018, ‘Aurobindo Signs a Definitive Agreement to Acquire Apotex’ Businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium’; www.aurobindo.nl/wp-content/uploads/2018/07/Aurobindo-Amarone-Press-Release_vF.pdf.

10 ACM, 21 December 2018, ACM/18/033946, Aurobindo/Apotex, paragraph 12.

11 The Anatomical Therapeutic Chemical (ATC) system is a hierarchical coded four-level system (ATC1–4) that classifies drugs according to their (main) indication, therapeutic use, composition and mode of action. This system was developed by the European Pharmaceutical Marketing Research Association to determine therapeutic equivalency.

12 AC Nielsen classification for over-the-counter drugs sold in the retail channel.

13 Generic companies typically produce copies of originator drugs that can normally be seen as the closest substitute to those drugs; see, e.g., Case M.9517 Mylan/Upjohn [2020], paragraph 17.

14 Group 1: the parties’ combined market share (CMS) exceeds 35 per cent and the increment of the smaller party exceeds 1 per cent; Group 1+: the CMS is below 35 per cent, but only one competitor remains; or the CMS exceeds 35 per cent, the increment of the smaller party is below 1 per cent and this party is a recent entrant; Group 2: the CMS exceeds 35 per cent and the increment of the smaller party is below 1 per cent; and Group 3: the CMS is between 20 per cent and 35 per cent.

15 As is the case for the overwhelming majority of European cases, no vertical concerns were identified. This could be explained by the high degree of competition that characterises upstream markets, such as the active pharmaceutical ingredient and contract manufacturing markets. Moreover, the European Commission’s approach to screening may be too broad, as it leads to a large number of affected markets that are unlikely to lead to substantive concerns.

16 Aurobindo, 1 October 2019, ‘Voorgenomen sluiting van Apotex in Leiden’; www.aurobindo.nl/wp-content/uploads/2019/10/Apotex-Persbericht-FINAL-Dutch-version-1-October-2019-CG.pdf.

17 T Vaessen, ‘Kabinet schiet te hulp bij doorstart farmafabriek Apotex’, Het Financiële Dagblad, 7 August 2020, p. 7.

19 Ministry of Economic Affairs and Climate Policy, letters to the Chairman of the Parliament on 6 August 2020 and 18 December 2020; https://open.overheid.nl/repository/ronl-7c93ad03-534e-47de-8a7a-e791b009906a/1/pdf/kamerbrief-over-voornemen-tot-verstrekken-van-lening-ten-behoeve-van-doorstart-apotex.pdf and https://open.overheid.nl/repository/ronl-37c8c706-750f-42fb-89c3-410af1128d5b/1/pdf/kamerbrief-over-overname-apotex-afgerond.pdf. See also T Vaessen, ‘Kabinet schiet te hulp bij doorstart farmafabriek Apotex’, Het Financiële Dagblad, 7 August 2020, p. 7.

20 The first working paper was published in a personal capacity by its authors, which included the then president of the ACM, Chris Fonteijn.

21 C Fonteijn, I Akker and W Sauter, ‘Reconciling competition and IP law: the case of patented pharmaceuticals and dominance abuse’, ACM Working Paper, www.acm.nl/nl/publicaties/mededingingsrecht-ook-van-toepassing-op-medicijnen-onder-patent.

22 The Leadiant case concerned an off-patent medicine, although Leadiant had regulatory exclusivity to market the product for 10 years in Europe for the treatment of cerebrotendinous xanthomatosis.

23 See F ten Have, 26 March 2018, ‘First Dutch excessive pricing case in pharma may be expected soon’; www.stibbe.com/en/news/2018/march/first-dutch-excessive-pricing-case-in-pharma-may-be-expected-soon.

24 Case 27/76, United Brands Company and United Brands Continentaal BV v. Commission of the European Communities – Chiquita Bananas (1978).

25 See also ACM, 28 November 2018, ‘Excessive Pricing in Pharmaceutical Markets – Note by the Netherlands’, paragraph 26, https://one.oecd.org/document/DAF/COMP/WD(2018)108/en/pdf.

26 A quality-adjusted life year-based threshold could also function as a benchmark; see the Court of Appeal in its 2018 judgment in Pfizer/Flynn on the need to use a benchmark to determine excessive prices; Competition Appeal Tribunal, 7 June 2018, Case Nos. 1275–1276/1/12/17, Flynn Pharma and Pfizer v. Competition and Markets Authority, [2018] CAT 11.

27 M Canoy and J Tichem, ‘Lower drug prices can improve innovation’, ACM Working Paper, www.acm.nl/sites/default/files/documents/2018-05/lagere-medicijnprijzen-hoeven-innovatie-niet-in-de-weg-te-staan.pdf.

28 ACM, 28 November 2018, ‘Excessive Pricing in Pharmaceutical Markets – Note by the Netherlands’, https://one.oecd.org/document/DAF/COMP/WD(2018)108/en/pdf.

29 ACM, 19 July 2021, ‘ACM beboet fabrikant Leadiant voor excessieve prijs geneesmiddel CDCA’, www.acm.nl/nl/publicaties/acm-beboet-fabrikant-leadiant-voor-excessieve-prijs-geneesmiddel-cdca.

31 In in its first working paper, the ACM indicated that the comparison of the price levels of the same drug before and after the award of a new orphan indication could prove a useful method to determine the fairness of a price.

32 Amsterdam UMC, 11 May 2021, ‘CDCA: een onwaarschijnlijke prijsstijging’, https://amsterdamumc.org/nl/vandaag/cdca-een-onwaarschijnlijke-prijsstijging.htm.

33 Leadiant is currently being investigated in Spain and Belgium. On 31 May 2022, Leadiant was fined by the Italian competition authority for abusing its dominant position by charging excessive prices for CDCA.

34 CMA, 15 July 2021, ‘CMA finds drug companies overcharged NHS’, www.gov.uk/government/news/cma-finds-drug-companies-overcharged-nhs; CMA, 29 July 2021, ‘CMA fines pharma firm over pricing of crucial thyroid drug’, www.gov.uk/government/news/cma-fines-pharma-firm-over-pricing-of-crucial-thyroid-drug.

35 T Vaessen, ‘Hoge boete omstreden farmabedrijf Leadiant opgeschort door ACM’, Het Financiële Dagblad, 23 December 2021, p. 5.

36 See AbbVie’s press release on its financial results: https://news.abbvie.com/news/press-releases/abbvie-reports-full-year-and-fourth-quarter-2021-financial-results.htm. AbbVie noted that the international net revenues for Humira decreased by 9.6 per cent on a reported basis due to biosimilar competition.

37 See, for example, D Hakim ‘Humira’s Best-Selling Drug Formula: Start at a High Price. Go Higher’, New York Times, 6 January 2018.

38 See, for example, Z Brennan, ‘Six Lawsuits Target AbbVie’s Humira and its Patent Thicket’, 2 April 2019, www.raps.org/news-and-articles/news-articles/2019/4/six-lawsuits-target-abbvies-humira-and-its-patent; B Pierson, ‘Alvotech sues to invalidate AbbVie’s Humira patent “minefield”’, Reuters, 11 May 2021, www.reuters.com/business/legal/alvotech-sues-invalidate-abbvies-humira-patent-minefield-2021-05-11/.

39 England and Wales High Court (Patents Court), 3 March 2017 [2017] EWHC 395 (Pat) Fujifilm Kyowa Kirin Biologics Company, Samsung Bioepsis, Biogen Idec/AbbVie Biotechnology, paragraph 388.

40 TNF-alpha inhibitors are biological prescription drugs that are mainly used by patients with rheumatic disorders, but also for psoriasis and Crohn’s disease, among other conditions. Examples of these drugs include adalimumab and etanercept.

41 ACM, September 2019, ‘Sectoronderzoek TNF-alfaremmers. Concurrentie voor en na toetreding van biosimilars’, www.acm.nl/sites/default/files/documents/2019-09/sectoronderzoek-tnf-alfaremmers.pdf.

42 ACM, 24 September 2020, ‘ACM sluit onderzoek naar geneesmiddelenfabrikant AbbVie, nu meer ruimte voor concurrentie’, www.acm.nl/nl/publicaties/acm-sluit-onderzoek-naar-geneesmiddelenfabrikant-abbvie-nu-meer-ruimte-voor-concurrentie.

43 ACM, 11 February 2022, ‘Geneesmiddelenfabrikant Pfizer stopt met sturende prijsstructuur voor Enbrel na gesprekken met ACM’, www.acm.nl/nl/publicaties/geneesmiddelenfabrikant-pfizer-stopt-met-sturende-prijsstructuur-voor-enbrel-na-gesprekken-met-acm.

44 ibid.

45 ACM, 27 January 2022, ‘ACM’s focus areas. This is what ACM will do in 2022’, www.acm.nl/sites/default/files/documents/acm-focus-areas-2022.pdf.

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