Merger control

More Affordable and Innovative Medicines and Treatments in Europe – Has the Competition Enforcement Met the 2009 Objective?

A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and treatments. Concluding this inquiry by setting priority actions for the years to come, former Competition Commissioner Kroes called for “… more competition and less red tape …” (sic).

Since this statement, there has been intense enforcement activity in the sector not only by the European Commission itself, but also by the European Union Member States’ antitrust authorities.

In its report on “Competition enforcement in the pharmaceutical sector,”  issued on January 28, 2019, the European Commission takes stock of their actions in this space.

The past enforcement record (2009-2017): intense activity, hard stance towards pharmaceutical companies with the use of novel or less known theories of harm

Between 2009 and 2017, no less than 29 infringement decisions were issued by European antitrust authorities, leading to fines totaling over €1 billion, while the European Commission asked for structural remedies for 25% of the reportable mergers in the sector.

Antitrust enforcement

In total, European antitrust authorities investigated over a hundred cases during the 2009-2017 period. Their investigations related to a wide range of medicines and many of the actors involved in the pharmaceutical sector: manufacturers, wholesalers and retail distributors.

Applying Article 101 of the Treaty on the Functioning of the European Union (TFEU) (or its national equivalent), which prohibits anticompetitive agreements and cartels, European antitrust authorities condemned, for the first time, certain pay-for-delay agreements, whereby a generic company agrees to restrict or delay its independent entry onto the market in exchange for benefits transferred from the originator. They also condemned practices of collusion in tenders, price fixing, conduct aimed at excluding competitors or limiting their ability to compete, and other types of coordination between competitors.

Besides, European antitrust authorities found that the misuse of the regulatory framework, whereby a dominant company misleads public authorities and misuses the regulatory procedures, can infringe Article 102 TFEU (or its national equivalent). Similarly, disparagement and other practices curbing demand for generics were found to infringe Article 102 TFEU. Reviving the neglected notion of exploitative abuse, European antitrust authorities found that under certain circumstances, a dominant pharmaceutical firm may infringe Article 102 TFEU if it imposes unfair terms and conditions or excessive pricing. In these cases, the reward for innovation seemed to have weighed little in the balance against the alleged harm caused to patients.

Merger control

19 of the 80 mergers reviewed by the Commission over the 2009-2017 period were subject to structural remedies, namely divestitures, offered by the merging firms. Antitrust concerns in those cases related to the risks of (i) price increases for some medicines in one or several Member States, (ii) depriving patients and national healthcare systems of some medicinal products, and (iii) diminishing innovation in relation to certain treatments developed at the EU or even global level.

All in all, the Commission takes a positive view: it considers that active competition enforcement throughout the European Union has fostered innovation, choice and affordability by intervening where companies, unilaterally or jointly, relax competitive pressures that force them to innovate further or prevent others from innovating or illegitimately exploiting their market power.

What’s next?

After this positive assessment, the question that finally arises is whether pharmaceutical companies remain in the spotlight in Europe and should expect the same level of attention from the European antitrust authorities.

The response is, fortunately or unfortunately (depending on the standpoint), yes, definitely.

The now numerous precedents and case law have undoubtedly helped the sector to put some order into the practices implemented in the past. However, the critical challenges facing pharmaceutical companies for years (succession of blockbusters, very high cost and remuneration of innovation, very lengthy development process, etc.) weaken them and may still lead them to adopt either defensive or aggressive strategies at risk from an antitrust perspective. The European Commission remains fully aware of such risk and ultimately recommends that: “Authorities … remain vigilant and pro-active in investigating potentially anti-competitive situations, including where new practices used by companies or new trends in the industry are concerned, such as the growing relevance of biosimilars.”

So, it is most likely not the end of the story …

CMA Orders Parties to Unwind Integration During Ongoing Investigation

For  the first time, the UK Competition and Markets Authority (CMA) has flexed its regulatory muscles by ordering the unwinding – during the course of its ongoing investigation – of a completed acquisition. In a demonstration of its willingness to use all of the tools at its disposal – regardless of deal size or complexity – the CMA ordered Tobii AB (Tobii) to reverse any integration that had taken place as a result of its completed acquisition of Smartbox Assistive Technology Limited and Sensory International Ltd (Smartbox).

 

Background

Tobii announced its acquisition of Smartbox for £11 million in cash through a debt-financed deal in August 2018. Both are relatively small tech companies that provide specialist “augmentative and assistive communication” (AAC) for those with speech disabilities through hardware and software solutions, including eye-gaze cameras.

Following completion of the transaction, Tobii took various steps to integrate the Smartbox business, including entering into an agreement (Reseller Agreement) whereby Smartbox would act as reseller of Tobii products in the UK and Ireland, the discontinuation of certain Smartbox R&D projects, and the withdrawal of certain Smartbox products from the market.

CMA Investigation

In September 2018, the CMA opened an investigation into the completed transaction and subsequently found that it would lead to less choice, higher prices and reduced innovation for customers. The CMA gave the parties one week to submit undertakings to address these concerns, or the CMA would proceed to an in-depth, Phase 2 investigation.

Despite the parties offering various undertakings designed to alleviate the CMA’s concerns, these were not deemed sufficient and, on February 8, 2019, the CMA referred the transaction for Phase 2 investigation, simultaneously imposing an interim order preventing preemptive action.

Unwinding Order

Following further investigation during the Phase 2 process, the CMA issued – for the first time – an unwinding order. The order requires the parties to reverse integration and restore the parties to the positions in which they would have been had the integration not taken place. The parties are required to fulfil any open orders pursuant to the Reseller Agreement, but terminate it once these are fulfilled. Moreover, the unwinding order requires Smartbox to supply certain products which had been discontinued. Smartbox is also required to reinstate all R&D projects, including investment and staff allocations, which were discontinued due to the acquisition.

In imposing the unwinding order, the CMA concluded that the integration actions taken by the parties might prejudice the Phase 2 reference or impede the taking of any action by the CMA to rectify competitive harm caused by the transaction.

The CMA is scheduled to make its final decision on the transaction by July 25, 2019.

Practical Implications

The imposition of an order to unwind integration in a small tech deal could be seen as the CMA wielding a sledgehammer to crack a nut, but the Tobii/Smartbox case reflects several of the CMA’s priorities for 2019, including an increased focus on tech deals and the protection of vulnerable consumers.

The willingness of the CMA to use the full range of merger control tools at its disposal impacts not only tech deals, but deals in all industry sectors, regardless of size and complexity. Parties in completed transactions, which might affect competition in the UK, but which are not notified to the CMA, should consider carefully what steps to take in terms of integration, and whether and how those steps could be reversed if required to do so by a CMA unwinding order.

The CMA’s approach in this case also highlights the perils of not notifying transactions prior to completion. While the UK merger control regime is voluntary in theory, the consequences of not notifying are such that, in practice, the regime requires parties to carry out a careful pre-transaction assessment of the impact on competition in the UK and the risk of the CMA’s launching an investigation, instead of simply concluding that filing is not required because the UK regime is voluntary.

For more information, contact Douglas Lahnborg ([email protected]) or Matthew Rose ([email protected]).

 

A Boiling Frog? Merger Enforcement of Early-Stage Tech Companies

Fable has it that a frog placed in tepid water slowly brought to a boil will not perceive danger until it is too late to leap. According to some critics, U.S. high tech merger review has a similar problem insofar as it fails to adequately consider and challenge acquisitions of startups that, on their face, appear to constitute incremental changes to competitive dynamics but that over time may suppress competition. Indeed, a U.S. Federal Trade Commission (FTC) official confirmed last week that the agency faces “withering criticism of antitrust” and its enforcement with respect to competitor acquisitions of startup companies.

The comments were made during a conference in San Francisco by Michael Moiseyev, Assistant Director of the FTC’s Bureau of Competition and a leading enforcer with responsibility for merger and acquisition review. Without identifying particular transactions, he acknowledged that players in the venture capital (VC) space have characterized the U.S. antitrust agencies as “snookered” in permitting certain early-stage companies to be acquired.

Making the case that an existing competitor’s acquisition of a nascent, potential rival poses “a substantial lessening of competition” (Clayton Act, § 7) is a high hurdle for the U.S. agencies to clear. Mr. Moiseyev assessed the state of current case law as both “terrible” and “unforgiving.” The agency’s most recent challenge invoking a potential competition theory resulted in a district court concluding that the FTC had failed to provide evidence the target would have launched a new, competing technology. FTC v. Steris Corp., No. 1:2015cv01080 (N.D. Ohio 2015). In that matter, the FTC had sued and invoked the theory that the target, if it were not acquired, was poised to create “actual potential competition” for the U.S. market leader by importing technology currently offered by just one European facility. The merging parties undermined that theory by demonstrating a dearth of customer commitment to using the would-be-imported technology.

Yet criticism of a perceived lack of U.S. agency challenges in the tech sector continues to mount.

Under this pressure, will the U.S. agencies take a fresh lens to acquisitions of new and innovative competitors? The key analytical question is how to evaluate whether those companies would evolve to constrain actual, current competition. This fall, the FTC’s ongoing policy hearings devoted a day to acquisitions of potential competitors in tech markets. Nearly all participants endorsed studies of the effects of past transactions via merger retrospectives. Several panelists advised that the agencies scrutinize more closely transactions involving dominant platforms and whether the underlying deal removes a nascent competitive threat. Other participants in the hearings emphasized that the competitive analysis should focus on harms to innovation but that an information imbalance at times constrains the agencies’ ability to assess emerging industry developments.

We do not know whether a boiling frog is in our midst. Nevertheless, if you are advising VCs or a company that is considering an acquisition involving an innovative, new or potential competitor, reach out to antitrust counsel to consult on these issues.

European Competition Authorities Crack Down on Violations of Merger Control Procedural Rules

Is a wind of change blowing through the European merger control enforcement landscape?

The response is yes, certainly.

Very recent cases or investigations launched by the European Commission alleging potential violations of merger control procedural rules by notifying parties have sent a clear signal to companies: you’d now better think twice before breaking the merger control procedural rules.

It is even truer when one considers that this may well be a trend throughout Europe. These cases have echoed back to recent similar cases, pending or closed, at the member state level (the Altice case in France, the CEE Holding Group limited/ Olympic International Holdings Limited case in Hungary, the AB Kauno Grudai / AB Vievio Paukstynas case in Lithuania, and a very recent bakery case in Slovakia). READ MORE

CMA Launches Consultation on Proposed Changes to De Minimis Exception in UK Merger Control Regime

On 23 January 2017, the UK Competition and Markets Authority launched a public consultation on possible changes to the de minimis exception. The proposed changes would increase the upper threshold for markets considered to be sufficiently important to justify a merger reference from £10 million to £15 million, and would raise the lower threshold for markets not considered to be sufficiently important from below £3 million to below £5 million. Handshake of businessmen - greeting, dealing, mergers and acquisition concept

The UK Competition and Markets Authority (“CMA”) has a duty to refer a transaction for an “in depth” phase 2 investigation in instances where it believes that there is a realistic prospect of a transaction resulting in a “substantial lessening of competition”, subject to certain exceptions. This includes a de minimis exception in markets of “insufficient importance”, where the costs involved in investigating the transaction would be disproportionate to the size of the market concerned.

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Record-Breaking Fine for Gun-Jumping Imposed by the French Competition Authority

On 8 November 2016 the French Competition Authority (“FCA”) imposed the highest “gun-jumping” national and worldwide fine ever, €80 million, on Altice-Numericable, a major French telecommunications operator, in relation to its 2014 acquisitions of SFR (“Société Française du Radiotéléphone”) and OTL (“Omer Telecom Limited”). Image of French flag overshadowing Western Europe.

On November 8, 2016, the French Competition Authority (“FCA”) imposed the highest “gun-jumping” national and worldwide fine ever, €80 million, on Altice-Numericable, a major French telecommunications operator, in relation to its 2014 acquisitions of SFR (“Société Française du Radiotéléphone”) and OTL (“Omer Telecom Limited”).

This is a world first decision when considering the amount of the sanction and the seriousness of the circumstances,” commented Isabelle de Silva, the President of the FCA since last October.

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