Cooperative Agreements: a Private Practitioner’s Perspective

Introduction

Cooperative agreements have always played a particularly significant role in the pharmaceutical industry, with companies partnering from early stage research and development (R&D) through to late stage commercialisation.

The covid-19 pandemic has been an opportunity for actors across the pharmaceutical supply chain to demonstrate the benefits that swift and flexible cooperation can bring. Faced with lockdowns and other restrictions, companies have come together to help avoid or unblock shortages of, and increase access to, medicines. The need for this cooperation was swiftly recognised by competition authorities. They pointed to the wider societal benefits that certain joint efforts could deliver, and showed a willingness to take this into account when assessing cooperation under their competition laws. Several regulators have issued general guidance in this context, and some have offered and provided case-specific comfort in this regard.

Looking beyond the crisis, the pharmaceutical industry is facing increasing pressure to boost access to, and ensure the affordability of, new medicines. In Europe, for example, when the European Commission (EC) launched its new Pharmaceutical Strategy, it noted concerns that access to innovative medicines is not equal across Member States.[2] Companies are not obliged to market centrally approved medicines in all Member States, and many choose not to in light of differences in, and challenges associated with, national pricing and reimbursement systems, for example. The EC also holds a view that current incentive models do not provide an adequate solution for orphan and unmet medical needs or appropriately incentivise investment in innovation, and the EC is considering whether the system of incentives linked to intellectual property (IP) or the grant of a marketing authorisation (MA) should be ‘conditioned’ by, for example, an obligation to launch the product in most, if not all, EU Member States. Should these proposals succeed, or should the EC otherwise succeed in its ambition to ensure broader launches, small and medium-sized innovative companies – in particular those focused on rare disease – may increasingly need to partner with others for commercialisation purposes. These trends are also likely to be felt in other geographies, as the debate on access and affordability intensifies.

Another area of focus for the EC is ensuring the resilience of medicine supply chains. In Europe, the role that parallel traders can play in facilitating access, as well as in potentially contributing to risks of shortages, represents an area of emphasis. This is not new, but the covid-19 pandemic accentuated this concern as supply chains came under increased stress. Some governments have resorted to regulation prohibiting, or at least making more difficult, exports of products for which a risk of shortages is identified. We may see more of that going forward, while pressure on manufacturers to manage supply and avoid shortages is also likely to increase. Any obligation to market across all Member States would only add to the complexity.

Given these trends, cooperation agreements will remain of central importance to pharmaceutical companies, perhaps increasingly so. Most licensing and commercialisation agreements should not raise significant competition law concern if entered into to create efficiencies, whether through increased use of technology or broader access to finished products. The practical difficulty principally lies in the concrete balancing of pro-competitive effects and necessary restrictions of competition. The author’s experience is, however, that through discussions with the business, a reasonable balance can usually be found when the purpose of the agreement is to pursue legitimate objectives. The greater compliance risk lies where these agreements risk being used in pursuit of restrictions that go beyond their legitimate objectives.

Covid-19 response to cooperative agreements

Guidance

Early in the covid-19 pandemic, competition authorities in major jurisdictions, such as the EU, the US, Australia, Canada, Japan, Mexico and the UK, responded to the crisis by providing guidance on the parameters of lawful competitor cooperation seeking to address the challenges posed by the crisis.

Practically all the guidance made it clear that the approach to classic hardcore restrictions of competition, such as agreements on price, markets, customers and volumes, would not change, and that attempts to profit from the crisis by restricting competition would not be tolerated. The guidance provided, with a view to removing the uncertainties associated with self-assessment by companies, an explanation of the types of lawful collaboration that could be helpful in addressing the steep rise in demand for certain products and services, notably in the health sector, in a context of supply chain disruptions as manufacturing and distribution was hit by lockdowns and other restrictions.

As noted by the Organisation for Economic Co-operation and Development in its discussion paper on cooperation between competitors in the time of covid-19, ‘These kinds of [collaborations] have the potential to yield significant benefits for consumers, which would be lost if, in fear of falling foul of competition provisions, companies would refrain from entering into efficient and lawful co-operation agreements’.[3]

The EC, the US Department of Justice (DOJ) and the US Federal Trade Commission (FTC), have also said that where uncertainty remains, they would be open to providing specific guidance and comfort on an expedited basis, thereby helping ensure that pro-competitive collaborative efforts to counter the pandemic could be implemented without delay. For example, the DOJ and FTC announced that they would accelerate the review of requests for FTC advisory opinions and DOJ business review letters related to cooperative conduct aimed at addressing covid-19 and its effects.[4] The EC also noted that it ‘understands that cooperation between undertakings might help in more efficiently addressing the shortage of essential products and services during the covid-19 outbreak and, in this context, undertakings might need specific guidance on their cooperation initiatives in order to facilitate their self-assessment’.[5]

Perhaps more interesting were statements by some authorities that measures that otherwise might be subject to scrutiny would exceptionally be accepted. Other authorities seemed willing to potentially go a step further, and not enforce the competition laws in relation to this conduct. For example, in its Temporary Framework, the EC noted that while exchanges of commercially sensitive information between competitors in connection with adaptations to production, stock management and, potentially, distribution, as well as a certain coordination of which sites produce which medicines would ‘in normal circumstances [be] problematic under EU competition rules’, in view of the ‘emergency situation and temporary nature’ it would not give rise to an enforcement priority.[6] The EC furthermore noted that cooperation must be ‘designed and objectively necessary to actually increase output in the most efficient way to address or avoid a shortage of supply of essential products’ and ‘not exceeding what is strictly necessary to achieve the objective of addressing or avoiding the shortage of supply’.[7] The DOJ and FTC also noted that they also would account for exigent circumstances in evaluating efforts to address the spread of covid-19 and its aftermath.[8]

Comfort letters

A number of comfort letters, exemptions or opinions have been issued, but their role appears to have been more limited than one might have expected. In April 2020, the EC blessed Medicines for Europe’s initiative to address the risk of acute shortages caused by the sudden surge in demand for covid-19 intensive care medicines.[9] In March 2021, the EC also approved and hosted a matchmaking event to accelerate covid-19 vaccine production.[10]

Part of the explanation for the limited use of these instruments may lie in a hesitance to provide comfort that is too broad, the need to take decisions relatively quickly thereby limiting the scope for a full and detailed review, and limited resources, all of which are likely to mean that where specific guidance is provided it will tend to be less permissive, for example. That said, the guidance and comfort letters no doubt signalled that cooperation was to be encouraged, and that agencies would take a flexible approach in their assessment and enforcement. The focus now appears to be on ensuring that lessons learned can be leveraged in responding to any future health crisis. That is certainly important but solutions should be worked out within the normal confines of the antitrust rules.

Licensing agreements between competitors – restrictions beyond the scope of the licence

Early stage licensing agreements for the purpose of R&D often raise no competition concerns, even when entered into between competitors, provided the parties remain free to exploit their own IP (background IP) and are not unduly restricted in their access to the technology resulting from the collaboration (foreground IP).

Later stage collaboration through licensing of IP is generally also recognised as potentially giving rise to significant efficiencies. Licensing of patents and know-how for the purpose of production and sale may allow a licensor to capitalise on the surplus value of its innovation. Most technology licensing agreements between non-competitors raise little antitrust concern, and even between competitors non-reciprocal licences are often benign, provided certain hardcore restrictions are avoided and the licensor and licensee do not have significant market power.

Where antitrust scrutiny does result, the type of restrictions most commonly at issue include limitations on pricing and output, field of use and customer and territorial restrictions. Those are well known and understood concerns, not dissimilar to what is known from vertical and horizontal collaboration not involving IP. In practice, the complexity in assessing these agreements typically lies in the need to understand the practical impact of collaboration in relation to products not yet on the market, and understanding when a restriction is in fact not justified by the access granted to shared IP.

Below we discuss two specific situations on which the European Court of Justice (ECJ) has opined and that are illustrative of the concern that licensing arrangements may have been used to impose restrictions beyond those justified by the access granted to the shared IP. In addition, scrutiny may result from clauses that may protect weak IP rights or undermine the incentive to carry out further R&D, such as grant backs, no-challenge obligations, restrictions on the licensee to use its own technology and restrictions preventing either party from carrying out R&D.

Avastin – Lucentis

In the context of entry and commercialisation, in the EU a licensor will have significant freedom to limit the rights granted to a licensee. For example, a safe harbour is available under the EU Technology Transfer Block Exemption Regulation for non-reciprocal licenses limited to a particular field of use and requiring a licensee not to produce with the licensed IP, and not to sell, actively or passively, products incorporating the licensed IP, into the territory that the licensor reserves exclusively for itself or third-party licensees.[11] As the licensor is under no obligation to grant a licence, these restrictions may encourage the dissemination of technology. A licensor can also decide to retain one use for itself, and license the technology only for a specific alternative use, either worldwide or for a specific geography. This can be particularly useful if the licensor does not have its own commercialisation infrastructure and needs to rely on third parties for broad commercialisation.

In Avastin–Lucentis, the Italian Competition Authority (AGCM) investigated conduct by Roche and Novartis on the back of a patent licence. Genentech, a subsidiary of Roche, developed Avastin, which was approved for the treatment of certain cancers. Genentech later developed Lucentis, a derivative of Avastin (both derive from the same anti-vascular endothelial growth factor monoclonal antibody), approved for chronic eye disorders, specifically wet age-related macular degeneration (wet AMD), a common cause of blindness. Genentech did not have a commercialisation infrastructure in Europe, and licensed the right to commercialise Avastin to its parent, Roche, while European rights to Lucentis were licensed exclusively to Novartis.

Lucentis was sold at a price many times above that of Avastin. The AGCM began an investigation into practices by Roche and Novartis allegedly designed to discourage continued off-label use of Avastin, thereby protecting sales of higher priced Lucentis. The companies were specifically alleged to have colluded to implement a communications plan that artificially differentiated the two treatments and cast doubt on the safety of off-label use of Avastin to treat wet AMD.

The case led to a referral to the ECJ.[12] One question put to the ECJ was whether two drugs, derived from the same compound, but approved for different indications, might belong to the same market if one approved drug is lawfully used off-label and regarded as therapeutically substitutable for the other. The ECJ held that, in principle, medicinal products that may be used for the same therapeutic indications belong to the same market unless they are sold unlawfully. Where a product is lawfully used off-label, however, it may be considered to be in the same market as lawfully authorised products treating the same indication.

The second question was whether arrangements between Novartis and Roche regarding off-label use of Avastin were contrary to competition law, on the basis that they were designed to reduce the off-label prescription of Avastin in ophthalmology, thereby protecting sales of Lucentis.

The companies had argued that the conduct was justified as ancillary to their licensing agreement. The ECJ rejected that view, holding that the arrangement was not designed to restrict the commercial autonomy of the parties to the licensing agreement, but rather aimed at the conduct of third parties – in particular, healthcare professionals. In those circumstances, the arrangement could not be considered ancillary and objectively necessary for the implementation of the licensing agreement.

Royalty obligations

Parties to a licence agreement are normally free to determine the royalty payable by the licensee and its mode of payment. Concerns may, however, arise if royalties are used to achieve other restrictive aims not related to the licence as such. For example, concerns may arise if royalty agreements are used to compensate competitors for staying out of a market. That might be the case with running royalties between competitors that cross-license their technology but the licence is a sham, or with royalties extending to products produced solely with the licensee’s own technology rights.

Royalties may also give rise to concern where they serve to increase prices; for example, where competitors cross-license and agree running royalties that are linked to pricing and are clearly disproportionate compared to the market value of the licence.

A specific question dealt with by the ECJ is whether royalty obligations can lawfully extend beyond the validity of the patent. In Ottung, the ECJ looked at royalty obligations running after patent expiry.[13] This type of obligation does not give rise to a restriction of competition provided the licence agreement (1) can be terminated with reasonable notice, and (2) does not otherwise seek to impose obligations or restrictions on the licensee’s freedom to act after the licence is terminated. In Hoechst v. Genentech, the ECJ found that this principle extends to situations where the patent is later declared invalid, but the licence remains in place, provided that the purpose of the licence agreement is to avert all litigation on the validity of patents.[14] In that case, it affords the licensee a certainty that third parties that do not enter into a licence do not enjoy, and the licensee is not disadvantaged compared to those third parties so long as it can terminate the agreement with reasonable notice.

Commercialisation agreements

Collaboration in commercialisation may be particularly important for new biotech companies bringing their (first) products to market and in cases where there are opportunities in combination therapies, to treat, for example, autoimmune disorders, cancers and other complex diseases.

For biotech companies that do not yet have a (sufficiently established) commercial operation, strategic commercialisation agreements can help reduce costs and risks, fund the commercialisation and leverage the partner’s resources and reputation. They may be the only way to effectively introduce a new product to market within a timeline and at a cost that allows R&D investments to be recouped.

Regarding combination therapies, collaboration with a partner providing one of the products in the combination may be essential in ensuring that the complementary products reach a maximum number of patients.

Providing effective competition law advice in those situations can be complex, however. The agreements may involve close collaboration with a potential competitor, and are typically long term, multifaceted and involve significant investments. Furthermore, the arrangements may not strictly fit within standard (albeit, admittedly, flexible) enforcement guidelines or guidance derived from administrative or judicial rulings such that a critical and close analysis is required of likely competitive impact and efficiencies engendered.

Strategic partnerships, co-promotion and co-marketing agreements

Where a commercialisation agreement is concluded to enable the launch of a product in late-stage development, and the product owner does not have the necessary commercial infrastructure or standing – the creation of which may entail significant upfront costs, risk and potential delay – there are important efficiencies that can be leveraged by a strategic partnership. The counterfactual may be no entry at all, or at least entry only on a much smaller scale or over a much longer time frame.

Where the product owner decides to rely on a commercialisation partner at European Economic Area level, or even worldwide level, the agreement may reflect a decision by the owner not to commercialise the product itself (not dissimilar to an exclusive patent licence for the purpose of production and commercialisation). Particularly where the partner is not a competitor or potential competitor, there may be room to structure agreements with significant protections, such as longer running exclusivity and non-compete obligations that help support the necessary investments.

The recently adopted new EC Vertical Block Exemption Regulation and the associated guidelines have also introduced further flexibility.[15] For example, the Regulation now acknowledges that the hold-up that exclusivity helps solve may extend to distribution models, with up to five ‘co-exclusive’ distributors permitted in a territory. The Regulation also acknowledges that the foreclosure concerns that a non-compete obligation can create may be addressed by an undertaking that is tacitly renewable after the expiry of the standard five-year period, so long as the buyer can effectively switch by terminating or renegotiating within a reasonable notice period. These developments will no doubt help encourage increased and more fruitful collaboration by removing the uncertainties associated with the self-assessment of a cooperation, ultimately yielding potentially significant consumer benefits.

Rather than marketing the new product itself, the product owner may also decide to team up with a partner under a co-promotion or co-marketing arrangement. In a co-promotion scenario, two companies promote the same drug under the same brand. In a co-marketing scenario, they both promote the same drug but under different brands.

Often these agreements are pro-competitive. A well-known example is the EC’s exemption in 2000 of a co-promotion arrangement between Pfizer and EISAI for the Alzheimer drug Aricept.[16] EISAI was first to market with an Alzheimer treatment. Almost none of the competing pipelines had been successful. Pfizer had an Alzheimer pipeline development, but as part of the collaboration agreed to drop that in favour of undertaking most of the commercialisation activities for Aricept. The EC found that EISAI accounted for a dominant share. The EC nevertheless exempted the arrangement for a duration of seven years. It appears to have been satisfied that the significant consumer benefits that resulted from enabling broad and rapid access to the first Alzheimer drug outweighed the loss of competition brought about by Pfizer abandoning its own pipeline. The relatively short seven-year limitation was explained by a fairly limited investment, which could be recouped in a shorter period of time.

Despite the generally positive assessment of these arrangements, one potential concern where the parties are competitors or potential competitors is that they could give rise to unlawful exchange of commercially sensitive information. Careful safeguards are therefore required.

Another possible concern is that parties use co-promotion or co-marketing agreements as a cover for market or customer sharing. That was the issue in Fentanyl, which, while an exceptional case, serves as a reminder to assess these agreements in their full context.[17] Johnson & Johnson (J&J) had developed and commercialised Fentanyl. When J&J faced the loss of patent protection in the Netherlands and the entry of Sandoz with a generic fentanyl patch seemed imminent, Sandoz, according to the EC, decided to refrain from marketing its generic and at the same time concluded a co-promotion agreement with J&J’s Dutch subsidiary. That agreement guaranteed Sandoz profits that exceeded what it could have obtained from selling its own generic product, for as long as there was no generic entry. The EC concluded that the co-promotion agreement was a sham, masking an agreement between J&J and Sandoz not to compete.

Commercialisation of combination treatments

Commercialisation agreements linked to combination therapies are typically also pro-competitive. To be effective, however, the parties with complementary products may need to exchange substantial amounts of detailed information. That might include information about ongoing clinical trials for the products in the combination, obtaining or updating MAs, negotiating pricing and reimbursement (notably in European markets), defining commercialisation materials, informing and training doctors and healthcare professionals, possible patient engagements, design of supply chain configuration and scaling up production.

As the combination products typically do not compete, these concerns should be possible to manage. Concerns about unlawful information exchange may nevertheless arise if, for example, one party also has a pipeline product competing in the same indication. Information exchange concerns may also arise where the party with the ‘lead’ product collaborates with additional partners that, in turn, have competing combination products. Safeguards may then be required to avoid a ‘hub-and-spoke’ type indirect information exchange between those competing undertakings.

Parallel trade

It is by now broadly accepted that the normal presumption that parallel trade will tend to eliminate price differences between national markets within the EU, reduce prices in importing Member States and increase consumer welfare, does not quite hold true for pharmaceutical products that are subject to price regulation. Many of the arbitrage opportunities leveraged by parallel traders are the result of pricing and reimbursement regulation, rather than company conduct, and while there may be some benefit from parallel trade to payers in importing countries, it appears that most of the price difference is absorbed by traders.

The EU courts have acknowledged these dynamics and explained how they impact the competition law analysis under Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU).

GSK Greece

The ruling in GSK Greece is particularly significant.[18] The ECJ confirmed that despite price regulation by Member States, pharmaceutical companies have the ability to influence national prices through their role in pricing and reimbursement negotiations. It also held that the risk of supply chain shortages owing to wholesalers exporting some of their product supply falls to Member States to deal with, not pharmaceutical manufacturers. It also held that, while parallel trade in the pharmaceutical sector has only a limited impact on final consumer prices, that cannot excuse conduct that prima facie is an abuse of dominance.

The ECJ also clarified that the specific features of this sector are indeed relevant when assessing conduct that may restrict parallel trade. State intervention in pricing is one of the significant factors contributing to arbitrage opportunities that parallel traders leverage, and unlimited parallel trade carries a risk of disrupting pharmaceutical supply chain planning. Pharmaceutical manufacturers are therefore permitted to take reasonable and proportionate steps to address the impact that parallel trade may have on their supply chains. Specifically, a refusal by a dominant company to meet full orders that are unusual or ‘out of the ordinary’ is not an abuse. This must be assessed by reference to historic orders from the wholesaler and the size of the order in relation to ordinary in-market demand.

The ruling in GSK Greece, together with the teachings of the ECJ judgment in Bayer–Adalat,[19] forms the basis for supply quota schemes widely applied by pharmaceutical manufacturers to limit supply to wholesalers to volumes necessary to satisfy national in-market patient needs, plus a safety margin.

Glaxo Spain

The EC had held that Glaxo’s dual pricing policy infringed Article 101(1) TFEU by object and by effect, and that it could not be justified under Article 101(3) TFEU.[20] On appeal to the EU General Court (GC), that decision was overturned. The GC held that dual pricing is not a by-object infringement and that the EC had not carried out a sufficient assessment of the arguments Glaxo had advanced in support of an exemption under Article 101(3) TFEU. The EC appealed to the ECJ.[21] While the ECJ overturned the GC on the restriction-by-object analysis, it also found that dual pricing can potentially be justified under Article 101(3) TFEU.

The ECJ therefore sided with the GC in holding that an examination of an agreement in the light of the factual arguments and evidence provided in connection with the request for exemption under Article 101(3) TFEU, the EC may require that the nature and specific features of the sector concerned be taken into account if its nature and those specific features are decisive for the outcome of the analysis. The GC therefore had not erred in criticising the EC for not taking sufficient account of the specific structural features of the pharmaceuticals sector.

On the question of a causal link between safeguarding profits by limiting the adverse impact of parallel trade and investing more in R&D, the ECJ did not find fault with the GC’s criticism of the EC’s decision, which it said did not take into account all the relevant evidence produced by GSK and therefore did not amount to a proper examination.

The EC as a result was sent back to the drawing board, but never undertook a full Article 101(3) TFEU analysis as GSK had withdrawn its application for individual exemption. Except for certain developments specific to Spain, the judgments have not led to widespread use of dual pricing schemes. The question of whether all the criteria of Article 101(3) TFEU are met in a given case undoubtedly is a higher threshold to overcome, not least given the ECJ’s confirmation that dual pricing is a by-object restriction of competition.

National legislative intervention

Despite these developments, parallel trade remains a challenge for pharmaceutical manufacturers and increasingly also for national health authorities because of the risk of product shortages. This is a particular concern in low-price Member States that see product allocated to their markets being exported in significant volumes. Spain is one such Member State. Spain took the initiative following the EC decision in Glaxo Spain to amend its legislation regulating national prices. It adopted measures providing that lower regulated prices apply only to products dispensed in Spain and subject to reimbursement. Through a multitude of appeals, the approach ultimately paved the way for manufacturers to set one (higher) ‘free’ price, applying irrespective of product destination, while lower prices applied in Spain were held to be the result of national regulation and hence not a restriction of competition caught by the Spanish equivalent of Article 101 TFEU.

Other Member States have followed a different approach, as described below. In this regard, Article 81 of Directive 2001/83/EC provides that persons placing medicinal products on the market have a public service obligation to ensure appropriate and continued supplies to meet patient needs.[22]

This applies to MA holders as well as wholesalers, whose obligation it is to ensure ‘within the limits of their responsibilities, appropriate and continued supplies of medicinal product[s] to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered’.

The EC describes these obligations in the ‘Paper on the obligation of continuous supply to tackle the problem of shortages of medicines’.[23] It provides that MA holders are required to:

  • ensure supply of the medicinal product sufficiently in advance and in adequate quantities to cover demand from patients in a Member State; and
  • ensure a continued supply of the medicinal products that covers the need of wholesale distributors of medicinal products (including full-line distributors) and persons entitled to supply medicines to the public.

The Paper highlights that the MA holder must ‘be particularly vigilant’ if there are no or limited alternatives to the medicinal product in question and where a ‘discontinuation of supply will result in a potential risk for public health’.

MA holders are not, however, responsible for shortages caused by the export or supply by a distributor of medicinal products to another customer in a different Member State of which they are not aware. The Paper states explicitly that MA holders are only responsible to ‘meet ordinary orders in relation to the size of the market of the Member State concerned’.

On the other hand, wholesale distributors ‘should ensure continuous supply to pharmacists and the person entitled to supply to the public to cover the needs of the patients on the territory where the distributor is established’. The result is that wholesalers are obliged to meet local patient demand but remain free to export excess stock.

The Paper clarifies that the limits of the responsibilities of MA holders and wholesale distributors should be evaluated on a case-by-case basis by the Member States. This statement opens the door for EU Member States to adopt additional guidance and rules. Case-by-case enforcement to determine if a manufacturer or wholesaler has failed to fully live up to their public service obligations is difficult in practice, and national authorities have generally shied away from this.

Instead, where national authorities have identified a genuine risk of shortages, they may take measures to ensure security of supply. A number of national authorities have done so (e.g., Poland, Bulgaria and Slovakia), imposing measures such as mandatory pre-export notifications, consent requirements imposed on wholesalers, restrictions on pharmacists’ wholesale activities and potentially limited export bans where there is a risk to patient safety.

These developments are unique to the pharmaceutical industry where Member States retain authority to organise and regulate national health systems. The pandemic accentuated concerns about supply chain resilience, and it will be interesting to see if more governments will resort to this type of regulation.


Notes

1 Niels Christian Ersbøll is a partner at Arnold & Porter Kaye Scholer LLP.

2 European Commission (EC), ‘Pharmaceutical Strategy for Europe’, 25 November 2020.

3 Organisation for Economic Co-operation and Development, ‘Co-operation between competitors in the time of COVID-19’, 26 May 2020, p. 2.

4 US Department of Justice (DOJ) and Federal Trade Commission (FTC), ‘Joint Antitrust Statement Regarding Covid-19’, March 2020.

5 EC, ‘Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak’, Communication from the Commission (2020/C 116 I/02), paragraph 4.

6 id., paragraph 15.

7 ibid.

8 See ‘Joint Antitrust Statement Regarding Covid-19’, footnote 4.

9 EC, ‘Comfort letter: coordination in the pharmaceutical industry to increase production and to improve supply of urgently needed critical hospital medicines to treat COVID-19 patients’, 8 April 2020.

10 EC, ‘Comfort letter: cooperation at a Matchmaking Event – Towards COVID-19 vaccines upscale production’, 25 March 2021.

11 Commission Regulation (EU) No. 316/2014 of 21 March 2014 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of technology transfer agreements (TTBER), OJ L 93, 28.3.2022, Article 4(1)(c)(i).

12 Case C-179/16, F. Hoffmann-La Roche Ltd and Others v. Autorità Garante della Concorrenza e del Mercato, ECLI:EU:C:2018:25.

13 Case 320/87, Kai Ottung v. Klee & Weilbach A/S and Thomas Schmidt A/S, ECLI:EU:C:1989:195.

14 Case C-567/14, Genentech Inc. v Hoechst GmbH and Sanofi-Aventis Deutschland GmbH, ECLI:EU:C:2016:526.

15 Commission Regulation (EU) 2022/720 of 10 May 2022 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices, OJ L 134, 11 May 2022, pp. 4–13; Guidelines on Vertical Restraints (2022/C 248/01) setting out the principles for the assessment of vertical agreements under Article 101 of the Treaty on the Functioning of the European Union, OJ C 248, 30 June 2022, pp. 1–85.

16 Case No IV/36.932/F3, EISAI/Pfizer, 1999/C 36/05.

17 Case AT.39685, Fentanyl, 10 December 2013.

18 Joined cases C-486/06 to C-478/06, Sot. Lélos kai Sia EE and Others v. GlaxoSmithKline AEVE Farmakeftikon Proïonton, formerly Glaxowellcome AEVE, ECLI:EU:C:2008:504.

19 Joined cases C-2/01 P and C-3/01 P, Bundesverband der Arzneimittel-Importeure eV and Commission of the European Communities v. Bayer AG, ECLI:EU:C:2004:2.

20 EC Decision of 8 May 2001 relating to a proceeding pursuant to Article 81 of the EC Treaty, cases: IV/36.957/F3, Glaxo Wellcome (notification), IV/36.997/F3, Aseprofar and Fedifar (complaint), IV/37.121/F3, Spain Pharma (complaint), IV/37.138/F3, BAI (complaint), IV/37.380/F3, EAEPC (complaint), OJ L 302, 17 November 2001, pp. 1–43.

21 Joined Cases C-501/06 P, C-513/06 P, C-515/06 P and C-519/06 P, GlaxoSmithKline Services Unlimited v. Commission, ECLI:EU:C:2009:610.

22 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28 November 2001, p. 67, Article 81.

23 EC, ‘Paper on the obligation of continuous supply to tackle the problem of shortages of medicines’, 25 May 2018.

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