Merger Control: Procedural Issues

In recent years there have been a number of significant procedural developments that have affected merger review of life sciences transactions. At EU level, the European Commission (EC) has sought to ensure that it has the ability to review ‘killer acquisitions’ that do not meet the EC Merger Regulation (EUMR)^[2] turnover-based thresholds, using the power of Member States to refer transactions. In March 2021, the EC published new guidance regarding these Article 22 referrals, setting out the circumstances in which a Member State may request the EC to accept referral of concentrations over which the Member State does not have jurisdiction. As a result of appeals arising out of the Illumina/Grail review, the General Court will consider the extent to which the EUMR supports the EC’s approach during the course of 2022.

In parallel with this potential broadening of the EC’s jurisdiction, the long-running review of the simplified review procedures under the EUMR will also come into effect in 2022, reducing the burden for notifying parties where concentrations do not raise substantive concerns.

At Member State level, there have been further refinements in the application of the German and Austrian size-of-transaction tests (also introduced to address the perceived risk of killer acquisitions going unreviewed), and practice under the foreign direct investment regime has continued to evolve.

Finally, as the UK Competition and Markets Authority (CMA) continues to develop its jurisdictional practice post-Brexit, its application of the share-of-supply test warrants careful consideration by acquirers (even of minority non-controlling interests), as does the potentially broad-reaching National Security and Investment Act.

Referrals under the EUMR

EUMR jurisdictional scope and historic referrals

The EUMR provides the regulatory framework for the assessment of concentrations that meet prescribed turnover thresholds, such that they have a ‘Community dimension’.^[3] A concentration occurs when a change of control occurs on a lasting basis.

The ‘one stop shop’ principle means that transactions that fall within the scope of the EUMR are not subject to parallel merger review in the Member States. Concentrations not covered by the EUMR in principle remain under the jurisdiction of the Member States. However, the EUMR provides a framework for ‘referrals’ between the EC and Member State authorities in certain circumstances:

• at the request of the parties or a Member State, the EC may refer a case in whole or in part to the competent authorities of a Member State;^[4] and
• the parties may ask the EC to assume jurisdiction where at least three Member States would have jurisdiction^[5] or one or more Member States may request the Commission to examine any concentration not having a Community dimension if it affects trade between Member States and threatens to significantly affect competition within the territory of the requesting Member State.^[6]

Illumina/Grail has firmly refocused attention on referrals. The EC has only accepted the referral of one other concentration in the pharma sector in the past 10 years under Article 22 (i.e., at the request of the Member States): in 2019, the French and German competition authorities referred Johnson & Johnson’s (J&J) proposed acquisition of Tachosil to the EC. The EC considered both the substantive criteria and appropriateness of referral before accepting jurisdiction. First, it concluded that the transaction could have an appreciable impact on cross-border economic activity involving several Member States, given that the parties had sales of products in almost all Member States. Second, it concluded that the transaction threatened to significantly affect competition at least in France. On a narrow market limited to haemostatic patches with dual effect, while J&J had no marketed products, Tachosil was the market leader with an 80 per cent to 90 per cent share, and the EC found that the transaction would have a negative impact on the market as it would reduce J&J’s incentives to restart distributing its product (the closest potential competitor of Tachosil) in the European Economic Area (EEA). As a result, the EC concluded^[7] that a referral was appropriate because:

• the transaction was notifiable in three Member States, such that review at Member State level may increase legal uncertainty and lead to conflicting assessments;
• there was a need to examine why J&J decided to exit the EEA with its haemostatic patch in 2017;
• the parties’ competitors were active throughout the EEA and it would be more efficient to centralise contacts; and
• a coherent handling of the case in relation to potential remedies was desirable.

In the past 13 years, the EC has reviewed eight cases in the pharma sector that were referred under Article 4(5) of the EUMR (i.e., at the request of the parties). Three of them were cleared unconditionally following a simplified review.^[8] The other five^[9] were reviewed under the normal procedure and cleared without commitments. In CSL/Novartis Influenza Vaccines Business,^[10] the EC identified its recent experience in reviewing human vaccine cases as an additional reason for accepting the referral. Similarly, in the past 16 years, the EC accepted the referral under Article 4(5) of three medical instruments/devices concentrations. Two were cleared unconditionally following a simplified review,^[11] and the third^[12] was reviewed under the normal procedure and cleared unconditionally.

In contrast, the EC has only referred two cases in the sector to Member States at the request of the parties under Article 4(4) of the EUMR. In Boots/Alliance Unichem,^[13] the relevant geographic market was limited to the UK^[14] – the concentration would have given rise to one horizontally affected retail pharmacy market, if defined on a national basis, or several horizontally affected markets if defined on a local basis. The EC concluded that the principal impact on competition was likely to be on distinct markets in the UK, warranting referral. In Brocacef/Mediq Netherlands,^[15] the EC found that the transaction gave rise to several affected markets for wholesale medical products and the retail sale of pharmaceuticals in the Netherlands. Accordingly, the EC referred the concentration.

The EC has only referred two medical instruments/devices concentrations to Member States under Article 4(4). In Helios/Damp,^[16] the EC found factors indicating regional or local markets for acute hospitals, considered national markets for elderly care facilities and concluded that the transaction may have had a significant impact on competition in a distinct market in Germany. In Fresenius/Rhön Klinikum,^[17] the EC also found factors indicating the existence of regional or local markets for acute hospitals, but also considered national markets. Once again, it concluded that the transaction may have had a significant impact on competition in a distinct market in Germany.

The EC has only referred two cases in the pharma sector to a Member State under Article 9 of the EUMR (i.e., at the request of the Member State). In GEHE,^[18] it found that the geographic market for pharmaceutical wholesaling was no wider than the UK, and could have been regional, and the geographic market for pharmaceutical retailing was local. Accordingly, the EC referred the concentration to the CMA.

In Alliance Unichem,^[19] the EC found that the relevant market was limited to full-line distributors supplying pharmacies on a fast (within a few hours) and frequent basis and with a legal obligation to keep a wide range of pharmaceuticals in stock. The EC concluded that the market was regional because the regulatory regimes applicable to distribution were differentiated across the EU and because of regional demand differentiation. It referred the concentration to the Italian Competition Authority.

Broader application of Article 22

Article 22 of the EUMR, also known as the Dutch clause,^[20] enables the EC to accept the referral of concentrations that do not have a Community dimension where the concentration involves an undertaking supplying cross-border goods or services (such that it is likely to have an actual or potential effect on trade between Member States) and the national competition authority can provide prima facie evidence of a significant adverse effect on competition in its jurisdiction.

On 26 March 2021, the EC published new guidance on Article 22 referrals (the Article 22 Guidance),^[21] addressing the circumstances in which a Member State may request that the EC accept referral of a concentration over which the Member State does not have jurisdiction. The Article 22 Guidance reflects the EC’s view that there has been an enforcement gap in relation to transactions in certain innovative sectors (e.g., life sciences and the digital economy).

It is intended to apply to concentrations where ‘the turnover of at least one of the undertakings concerned does not reflect its actual or future competitive potential’, such as start-ups or recent entrants with significant competitive potential that have yet to generate significant revenues, that represent actual or potential important competitive forces. The EC is concerned that these companies could be acquired without scrutiny. In short, the Article 22 Guidance is intended to enable review of ‘killer acquisitions’. However, the breadth of the scope for review has the potential to materially reduce transactional predictability and certainty.

This expansive interpretation of Article 22 was first applied to Illumina’s proposed acquisition of Grail.^[22]

On 19 April 2021, the EC accepted the referral,^[23] finding that the proposed transaction could affect trade within the European single market and threatened to significantly affect competition within the territory of France, and that a referral was appropriate as Grail’s competitive significance was not reflected in its (lack of) turnover. Illumina sought the annulment of the EC decision to assert jurisdiction by the General Court.^[24] The General Court has upheld the EC’s decision.^[25]

On 13 July 2022, the General Court confirmed the EC’s interpretation of Article 22, on the basis that the words ‘any concentration’ make it clear that a Member State has the right to refer any concentration to the EC (if it satisfies the cumulative conditions), irrespective of whether the concentration is notifiable under national law. The General Court characterises the provision as a ‘corrective mechanism’ to ensure effective review of all concentrations with significant effects on competition in the EU, including those that would otherwise escape review at either EU or national level.

The General Court examined Illumina’s plea that the referral request was submitted out of time (given that a referral request must be made within 15 working days of a concentration being ‘made known’ to the Member State concerned, if no notification of that concentration is required). It held that the expression ‘made known’ should be understood as the active transmission of information to the Member State concerned, where that information is appropriate for the national competition authority to be able to assess, on a preliminary basis, whether the necessary conditions for a referral have been satisfied.

The General Court found that the principles of legal certainty and ‘good administration’ require the EC to comply with a reasonable time limit in the conduct of administrative procedures, including merger reviews. Nevertheless, even if the EC fails to act within a reasonable time limit, that would not have been a failure that affected the capacity of the undertakings concerned to defend themselves effectively.

The confirmation of the EC’s guidance by the General Court reduces predictability for the parties to concentrations in terms of transaction timelines, conditions precedent to closing (including measures enjoining closing or implementation), appropriate triggers for break-up fees and other important deal parameters.

Illumina has announced that it will appeal the judgment to the European Court of Justice.

The EC opened a Phase II review of Illumina’s proposed acquisition on 22 July 2021,^[26] and adopted interim measures on 29 October 2021, following Illumina’s decision in August 2021 to close the acquisition pending the EC’s review.^[27] In December 2021, Illumina appealed^[28] the imposition of interim measures to the General Court.

The judgment on the appeal of the interim measures is expected in the second half of 2022. On 19 July 2022,^[29] the EC sent a statement of objections to Illumina and Grail relating to their decision to close in August 2021.

Reform of the EU simplified procedure rules

The EC began to review its simplified procedure rules in 2016, seeking to identify additional types of concentrations eligible for simplified review and to streamline certain procedures. The new rules are expected to come into effect in 2022.

One of the proposed revisions will increase the market share thresholds that apply to the simplified procedure. Another proposed revision covers transactions in which two or more undertakings acquire joint control of a joint venture without current or expected turnover within the EEA, where the undertakings will not transfer assets within the EEA to the joint venture.

Importantly, it is proposed to provide the EC with discretion to apply the simplified procedure to concentrations in which certain markets relevant to the concentration are eligible for review under the simplified procedure, but others are not.

New safeguards and exclusions will apply to concentrations in which there are horizontal overlaps or vertical relationships between the parties to the concentration and it cannot be excluded that the concentration will raise serious concerns. Further, the EC will have the discretion not to apply the simplified procedure where one party to a concentration has a significant non-controlling shareholding in companies active in the market or markets where another party is active.

Finally, several procedural changes are proposed, including the introduction of a ‘super simplified procedure’, enabling notification using a short Form CO without pre-notification, and formalisation of the potential for clearance in less than 25 working days for certain concentrations.

Developments in Germany and Austria

German and Austrian value-based threshold

In Germany, even when the turnover threshold is not met, a transaction can be notifiable if the transaction value exceeds €400 million and the target has ‘significant domestic operations’. In its most recently published activity report, the Federal Cartel Office (FCO) referred to pharmaceutical cases in which the value-based transaction threshold (and, as a result, the significant domestic activity concept) was considered.^[30]

• One transaction was notifiable as a result of the target’s conduct of clinical studies and research cooperation in Germany, and the expectation that approximately 25 per cent of the patients to be treated with the product in the future lived in Germany.^[31]
• Other transactions were not notifiable, even though the targets’ lead products were in Phase III clinical trials globally (including in Germany) and there were clinical trial sites in Germany. Where there was no research group leader in Germany and no patients enrolled in trials at the time of notification, such that no drugs had been administered, the FCO has declined jurisdiction.^[32]

Between 2017 and the end of September 2020, 45 per cent of the 31 notifications to the FCO under the value-based transaction threshold related to the pharmaceutical sector.^[33]

In 2021, the Austrian Federal Competition Authority published a sector inquiry report highlighting the importance of the value-based threshold for transactions in the pharmaceutical sector,^[34] noting that pharmaceutical companies often acquire innovative rivals at substantial valuations (killer acquisitions).^[35] The value-based thresholds enable review of these transactions.

Revised Joint Guidance – nexus criteria

In January 2022, the German and Austrian competition authorities published updated joint guidance regarding transaction value thresholds (Joint Guidance).^[36] The ‘nexus test’ is met if the target is ‘significantly active in Germany’ or ‘to a relevant extent active in Austria’. The revised Joint Guidance makes a number of changes that are important in determining whether the ‘significantly active’ test is met.

The location of the target is not sufficient. Rather, the focus is on whether the asset is used in an entrepreneurial activity.

Further, while using research and development (R&D) facilities and infrastructure in Germany can provide the nexus, the research results need not only be marketable in principle. The products or services at issue need to be likely to be marketed in Germany, and there needs to be activity in Germany relating to either or both market access and distribution, including the presence of personnel engaged in seeking authorisation or establishing distribution (including negotiation of distribution agreements).

The domestic activity must also be more than marginal. For R&D, various criteria are considered to determine materiality, including the number of employees involved in R&D, the R&D budget and the number of patents or patent citations.

In relation to Austria, the Joint Guidance provides that, in the context of the acquisition of a company whose business activity relates to a newly authorised medicinal product, there is no relevant nexus if no sales have been made in Austria and market entry has not been prepared.^[37] However, a nexus may be assumed, even if sales have been low, if the product is authorised as the sales likely do not reflect market potential.^[38]

Exclusive licensing agreements considered to be on all fours with ‘asset acquisitions’ by Joint Guidance

The Joint Guidance brings new types of transactions within the scope of the German merger control regimes, including exclusive licences. Previously, the grant of a licence was not notifiable if it was not associated with current revenue-generating activity. For example, in National Geographic I,^[39] the parties had concluded a licence agreement for the initial publication of the magazine National Geographic in the German language. The Federal Supreme Court confirmed that this agreement did not constitute a concentration because the licensors had not yet marketed the magazine in the German language, so there was no existing market position. The Joint Guidance provides that a transaction may be notifiable under the value thresholds if a future market position is acquired, including cases in which the turnover potential of the target only develops after the licence is granted.

To be notifiable, an exclusive licence would ordinarily need to lead to a lasting change in the market structure, excluding short-term licences. However, in the context of innovative and fast-changing markets, a shorter term licence might have a lasting impact.^[40] The Joint Guidance is silent on this point.

The value of the concentration comprises all assets, including payments to the seller that are conditional on the achievement of certain turnover or profit targets in the future.^[41] In life sciences licences, payments are ordinarily a mixture of upfront and milestone payments and royalties or a revenue share of commercialised products. The value of the transaction includes all these elements, discounted to reflect their net present value.^[42]

In Austria, an exclusive licence must constitute a concentration to be notifiable.

Germany foreign direct investment

Life sciences transactions are potentially reviewable under the cross-sector regime (under the Foreign Trade and Payments Ordinance and the Ordinance on the Determination of Critical Infrastructure, both adopted under the Act on the Federal Office for Security and Information Technology).^[43]

Developments in the UK

Merger review

The UK share-of-supply test requires the merger to have a sufficient UK nexus as a result of the creation or enhancement of a share of supply of at least 25 per cent. In several recent cases, the CMA has taken a broad view of the metrics and services that can be used to calculate shares of supply, considering services that are complementary in Roche/Spark, indirectly supplied in Sabre/Farelogix and vertically related in Google/Looker.

Roche/Spark

The CMA found that Roche and Spark overlapped in the supply of novel non-gene therapy and gene therapy haemophilia A treatments, and that the 25 per cent threshold was satisfied on the basis of the number of workers employed to undertake activities related to novel non-gene therapy and gene therapy haemophilia A treatments in the UK.^[44]

First, the CMA found that an entity engaged in R&D activities, particularly if the activities are at a relatively advanced stage, should be considered to be active in supplying pharmaceutical treatments in the UK, even in cases where there are no actual sales. On this basis, the CMA found that the parties overlapped in the supply of novel non-gene therapy and gene therapy haemophilia A treatments in the UK.

Second, the CMA decided that it was reasonable to focus on non-gene and gene therapy haemophilia A treatments, including commercialised treatments and pipeline treatments in at least Phase II clinical development, rather than all actual and potential, novel or non-novel haemophilia A treatments in the UK.

Third, the CMA noted its discretion under the Enterprise Act 2002 to calculate shares of supply, including using criterion such as the ‘number of workers employed’. It collected data on full-time equivalent employees from the parties and third parties, and estimated that the parties had a combined share of approximately 40 per cent to 50 per cent of employees involved in relevant R&D in the UK, with an increment of 5 per cent to 10 per cent resulting from the transaction.

The CMA also applied the share-of-supply test to the parties’ procurement of patents relevant for novel non-gene therapy and gene therapy haemophilia A treatments, including commercialised treatments and pipeline treatments in at least Phase II clinical development. It found that the 25 per cent threshold may have been satisfied by the number of UK novel non-gene therapy and gene therapy haemophilia A patents procured, estimating that the combined share was approximately 40 per cent to 50 per cent, with an increment of zero per cent to 5 per cent resulting from the concentration.

Broad application of the share-of-supply test in other sectors

While Google/Looker ^[45] and Sabre/Farelogix^[46] are not related to the life sciences sector, they are of relevance to the application of the share-of-supply test to transactions in the sector. In the first case, the CMA applied the test to the supply of vertically related services, and in Sabre/Farelogix it relied on indirect supply by Farelogix (in that British Airways accessed services supplied by Farelogix to American Airlines). Accordingly, life sciences players should be alert to the fact that the CMA has considered both indirect supply and supply of vertically related services to be sufficient to assert jurisdiction.

Proposed amendments to merger review

In April 2022, the UK government proposed a number of amendments to UK merger review. These include increasing the turnover test threshold (from £70 million to £100 million), to preserve the original effect of this test by adjusting for inflation,^[47] and introducing a new jurisdictional threshold, aimed at enabling review of killer acquisitions and other mergers not involving direct competitors. The CMA would have jurisdiction where at least one party has an existing share of supply of 33 per cent in the UK or a substantial part of the UK and the acquiring party generated UK turnover of £350 million in the previous financial year.

The proposals also include a small merger safe harbour that will preclude the CMA from reviewing mergers in which each party’s UK turnover is less than £10 million.

The proposal package also includes procedural changes, including fast tracking of certain cases at any stage of pre-notification and Phase I investigation (effectively providing a statutory basis for the current non-statutory fast track procedure). The fast-track procedure will be accompanied by safeguards to prevent public interest intervention cases from being fast tracked (to ensure that they receive appropriate scrutiny). The CMA will retain discretion over fast-track referral requests. When these requests are approved, the CMA will conduct a full Phase II investigation, to include the type of information normally gathered in Phase I, and will be able to extend the timetable to 11 weeks (compared to the eight weeks allowed for a standard Phase II investigation).^[48] Finally, the proposals would also give the CMA the discretion to refer a merger straight to Phase II at the parties’ request, and powers to accept commitments to resolve concerns at any stage in Phase II.

National Security and Investment Act – mandatory pre-notification of acquisitions in 17 ‘sensitive’ sectors

The National Security and Investment Act enables the UK government to intervene in acquisitions that could harm the UK’s national security. The UK government identified 17 sensitive areas of the economy that may require mandatory notifications, including synthetic biology, artificial intelligence and advanced robotics. Mandatory notifications are required for the acquisition of certain rights or interests in qualifying entities carrying out activities in those sensitive areas.^[49]

Mandatory notifications are not required if the qualifying entity carries out activities that include the use of microorganisms to remove harmful contaminants, pollutants or toxins from the environment (bioremediation), including bio-based reagents that enable testing for contaminants.^[50]

Notes