United Kingdom: key jurisdiction for compliance amid post-Brexit regulatory divergence

Introduction

In the United Kingdom there has been a focus on competition law enforcement in the life sciences sector in recent years, both from an antitrust and a merger control perspective. Going forward, companies in the sector would be well advised to carefully consider the UK as a key jurisdiction from a compliance point of view, particularly as, following the UK’s exit from the EU, the UK’s Competition and Markets Authority (CMA) and UK courts can now diverge from EU case law. Regulatory divergence between the UK and EU has also started to take place, for example on rules applying to vertical agreements.

Regulatory developments

Digital Markets, Competition and Consumers Bill

The UK government introduced the Digital Markets, Competition and Consumers Bill (the Bill) into Parliament in April 2023.^[2] The Bill is expected to be enacted in late 2023 or early 2024, and proposes important changes to UK competition law as well as making significant changes to the enforcement of consumer protection law in the UK.

The Bill will introduce revised merger control jurisdictional thresholds, in particular a new jurisdictional threshold for ‘killer acquisitions’ that will be relevant to the life sciences sector. The new ‘killer acquisition’ jurisdictional threshold is intended to provide the CMA with jurisdiction to review mergers where a large company acquires control of an innovative company that does not have significant current turnover, but whose intellectual property, R&D programme or business model gives it the ability to act as a market disrupter in the future. The threshold would give the CMA jurisdiction over transactions where one party has:

• a 33 per cent or greater share of supply of goods or services of any description in the UK or a substantial part of it; and
• UK turnover exceeding £350 million.

In addition, the Bill proposes to amend existing merger jurisdictional thresholds. Currently, the CMA can assert jurisdiction if:

• the UK turnover of the target exceeds £70 million (the turnover test); or
• the merger creates or enhances a 25 per cent share of supply or purchases of a particular good or service in the UK, or a substantial part of it (the share-of-supply test).

The amended thresholds will be as follows:

• the threshold for the turnover test will be increased to £100 million; and
• the CMA will not have jurisdiction unless a party to the transaction has UK turnover exceeding £10 million, even if the share-of-supply test is otherwise met.

The competition law provisions in the Bill also have the following important features:

• the CMA will have increased powers during dawn raids, particularly in relation to requirements to produce electronic documents;
• in private actions for damages against cartel participants, exemplary damages may be awarded;
• certain procedural fines will be increased, for example for failure to comply with certain directions issued by the CMA during a merger investigation; and
• a new criminal offence for the intentional destruction or alteration of documents required to be produced as part of a merger investigation.

Given the extent of enforcement of competition law in life sciences, the Bill is likely to have significant impact on the sector.

Vertical Agreements Block Exemption Order^[3]

The UK’s Vertical Agreements Block Exemption Order (VABEO) came into force on 1 June 2022, and sets out rules on what may be exempted in vertical agreements between two parties acting at different levels of trade (e.g., a pharmaceutical manufacturer and a distributor). The VABEO is a relatively early example of regulatory divergence in competition law between the EU and UK, meaning that companies can no longer be certain that what is permitted by EU law in vertical agreements will be permitted under UK law, and vice versa. Differences between the VABEO, and the EU’s Vertical Block Exemption Regulation (VBER)^[4] include that non-compete obligations in vertical agreements that are renewable beyond five years are not block exempted under the VABEO – whereas they are under the VBER provided that certain conditions are met – and rules on appointing multiple ‘exclusive’ distributors. In addition there are differences between the rules on combining shared and exclusive distribution at different levels of trade within the same territory.

Main merger control matters

Following the UK’s departure from the EU, the CMA now separately investigates mergers even if they have been notified to the European Commission (EC) under the EU Merger Regulation. This has not led to an increase in the number of mergers reviewed by the CMA: 42 cases were opened in 2022, compared to 64 in 2019, the last year in which the CMA did not have powers to review cases independently to the EC that was unaffected by covid-19.^[5] However, there is some evidence that the CMA may be adopting a more interventionist approach: less than 50 per cent of cases closed in 2022 received unconditional Phase I clearance, a lower figure than for any of the preceding four years.^[6]

Notification in the UK is voluntary and no penalties can be imposed for not pre-notifying, even where the jurisdictional thresholds are met. However, the CMA is vigilant about identifying unnotified mergers for investigation.

Under the share-of-supply test, the CMA can consider a very broad or narrow scope to take jurisdiction, and has applied the share-of-supply test expansively. For example, in Roche/Spark, the parties argued that the CMA did not have jurisdiction, as the turnover test was not met and Spark did not generate any turnover in the UK in the year preceding the transaction.^[7] However, the CMA considered that firms compete well before products are fully commercialised and considered that Spark’s UK activities overlapped with Roche’s, given the following:

• Spark was in the process of developing two gene therapy products that could constitute a competitive constraint on certain Roche products;
• Spark had already engaged in marketing in the UK through UK-based employees; and
• Spark intended to have UK patients participating in clinical trials at UK sites.

As the parties’ combined share of supply exceeded 25 per cent, based on full-time equivalent employees engaged in research and development activity relating to the treatments in question, the share-of-supply test was considered to be triggered.

In addition, the ‘particular good or service’ over which the CMA determines that the parties have a combined share of supply may be very specific. For example, in Stryker/Cyrus, the relevant good was ‘intrasaccular devices used for the treatment of intracranial aneurysms’.^[8] Therefore, the application of the UK merger control regime may need to be considered even if the competitive overlap between the parties appears minimal.

The new threshold for killer acquisitions, discussed above, could enable the CMA to investigate transactions without overlaps, increasing its ability to review mergers between non-competitors (e.g., vertical transactions between companies operating at different levels of the supply chain), which often fall outside the CMA’s jurisdiction under the current thresholds. While this has been considered particularly relevant in tech acquisitions, the new threshold could also capture life sciences acquisitions, including of small companies holding or developing valuable IP that has not yet been commercialised, even if there is no overlap.

Overlaps and substantive assessment

Similar to the EC, the CMA applies the Anatomical Therapeutic Chemical (ATC) classification^[9] for defining the product scope of relevant pharmaceutical markets. The CMA considers ATC3 as a starting point for an overlap analysis, as ATC3 groups together pharmaceuticals based on therapeutic indications, but typically also assesses overlaps at molecule level and pipeline product stages where a product launch appears likely within a reasonable time frame.

Recent cases show the application in practice of the CMA’s revised merger assessment guidelines,^[10] and in particular the importance of assessing how closely parties compete. Evidential weight has been given to parties’ internal documents assessing their competitors, rather than relying on a ‘traditional’ market definition and market share analysis. As a result, the CMA may be more likely to raise issues with mergers where the parties compete, or may compete in the future, for the same types of customers, or where one party has identified the other party as an important competitive constraint in its internal documents.

The CMA has also focused generally on the importance of future developments when conducting its competitive assessments, and therefore parties may be able to argue that the development of a new third-party product will provide an important competitive constraint in the future, although such arguments may only be successful if the product is at a sufficient stage of maturity.

An analysis of closeness of competition for the supply of intrasaccular devices was carried out in Stryker/Cerus. In this case, the purchaser had not fully commercialised its device in the UK, and therefore the CMA assessed how closely the parties would compete in the future. It found that the purchaser could become a strong competitor to the target in the future. However, it also found that a new third-party device was expected to be launched in the near future, and that evidence obtained from competitors to the parties indicated that this device could place a significant constraint on the merged entity. As a result, the merger received unconditional Phase I clearance.

In contrast, in Cochlear/Oticon,^[11] a partial prohibition of the acquisition of the target’s bone conducting solutions (BCS) business was made following a Phase II investigation. The CMA found that the parties were close competitors, and that the merger would lead to a loss of future competition, as there was evidence that the market was shifting from ‘passive BCS’ products to ‘active BCS’ products – the target was developing a new active BCS product to compete with the purchaser’s existing product.

Main infringement proceedings

The CMA has enforced competition law actively in life sciences sectors, particularly in relation to pharmaceuticals. Fines imposed have been at record levels and directors have been disqualified under the Company Directors Disqualification Act 1986.

Many CMA cases have concerned ‘niche generics’ and the type of conduct challenged has often concerned forms of market sharing or exploitation through excessive pricing. Examples include:

• suppliers entering profit-sharing arrangements to encourage would-be competitors to stay out of a market;
• agreeing with competitors to share downstream supply to a wholesale-level customer;
• exchanging commercially sensitive information;
• withdrawing supply of a product to force patients to switch to more expensive treatments; and
• pricing at levels that were excessive and unfair, and which bore no reasonable relation to their economic value.

Cartels and anticompetitive agreements

The CMA has issued the following decisions in recent years.

Prochlorperazine

The CMA decided that Alliance Pharma (AP) had infringed competition law by effectively paying two would-be competitors (Lexon and Medreich) not to compete in the supply of prochlorperazine.^[12] The CMA found that the arrangements had resulted in prices rising by 700 per cent over a four-year period. Having learned that it was about to face competition from Lexon and Medreich, which had taken steps to launch and had obtained licences to supply prochlorperazine, AP appointed Focus Pharma as a distributor of its own prochlorperazine and agreed a profit-sharing arrangement relating to AP’s product in return for Lexon and Medreich agreeing not to compete.

The CMA fined the firms (AP, Lexon, Medreich and Focus) over £35 million in total. The decision has been appealed to the Competition Appeal Tribunal (CAT).

On 2 September 2022, the CMA also announced that it is issuing proceedings to seek competition director disqualification orders against seven directors of the four companies. This continues the trend of the CMA seeking to take action against individuals as well as companies. The appeal and director disqualification proceedings were scheduled to be heard by the Competition Appeal Tribunal in July and August 2023.

Fludrocortisone

The CMA found Aspen Pharma had paid its competitors Amilco and Tiofarma to stay out of the market, leaving Aspen as the sole supplier for fludrocortisone, a corticosteroid, thereby breaching competition law.^[13]

The case was settled with fines totalling approximately £2.3 million. The CMA also secured a director disqualification undertaking from a director of Amilco not to act as a director of any UK company for five years.

Aspen also agreed to pay an £8 million ex gratia payment to the National Health Service (NHS), to seek to mitigate the risks of a damages claim from the Department of Health.

Nortriptyline

The CMA found that King Pharmaceuticals and Auden Mckenzie, two suppliers of the antidepressant nortriptyline, had engaged in ‘brand equalising’ (i.e., agreeing to supply a customer at wholesale level at a low price to dissuade it from bringing in parallel imports).^[14] The suppliers also agreed to share downstream supply to that customer and fixed the prices of supply, thereby breaching competition law. The CMA characterised this as market sharing, although the ‘sharing’ was limited to dividing supply to one customer with its agreement. The companies also exchanged commercially sensitive information (e.g., on market entry intentions) with each other and with another competitor, Alissa Healthcare Research.

The CMA fined the firms over £3.4 million in total and secured director disqualification undertakings.

Accord-UK (previously Auden Mckenzie/Actavis UK) also agreed to make a £1 million ex gratia payment to the NHS.

Hydrocortisone

The CMA found that Accord-UK (previously Auden Mckenzie/Actavis UK) had effectively paid two would-be competitors, AMCo (now Advanz Pharma) and Waymade, to stay out of the market, thereby breaching competition law.^[15] Under the alleged conduct, payments were concealed by an arrangement whereby Auden ‘sold’ hydrocortisone packs to Waymade at discounts of 87 per cent to 97 per cent and then immediately ‘bought back’ these at market prices, without the product leaving Auden’s warehouse.

The CMA fined Accord-UK (and Allergan as the former parent) approximately £66 million, Waymade £2.5 million (for their part in the collusion) and Advanz and the private equity house Cinven (which had exercised decisive influence over the infringing entity for a certain period) a total of approximately £43 million.

An appeal was heard by the CAT in late 2022 and early 2023, but no judgment had been issued at the time of writing.

Pay-for-delay settlements

Pay-for-delay settlements are agreements between originator pharmaceutical companies and generics manufacturers in which the generics manufacturer agrees to delay market entry of its generic in return for payment from the originator. The CMA’s approach to the legality of pay-for-delay settlements is similar to the EC’s. As regards the view on potential competition in pharmaceutical markets, the CMA considers that if there are ‘real concrete possibilities’ for a generic supplier to enter the market and compete with the originator, they are at least potential competitors. The issue of what constitutes a ‘potential competitor’ in pay-for-delay cases was considered in the CMA’s Paroxetine case^[16] and, on appeal, the CAT referred this question to the Court of Justice of the European Union (CJEU) in light of the then ongoing Lundbeck case.^[17] In its judgment,^[18] the CJEU concluded that a generic manufacturer preparing to enter the market is a potential competitor of the originator where:

• the generic manufacturer has a firm intention and inherent ability to enter the market. This will be the case if, when the agreement was concluded, it had taken sufficient preparatory steps to enable it to enter the market concerned within such a period as would impose competitive pressure on the originator. These preparatory steps might include:
  • obtaining the necessary marketing authorisation (MA) and an adequate stock of generic medicine;
  • legal steps undertaken to challenge the originator’s patents; or
  • marketing initiatives to market its product; and
• there are no insurmountable barriers to market entry. While this is for the national court to assess, the CJEU found that the existence of a patent, which protects the manufacturing process of an active ingredient in the public domain, cannot of itself lead to a conclusion that there is an insurmountable barrier to entry, as:
  • the uncertainty as to the validity of patents covering medicines is a fundamental characteristic of the pharmaceutical sector;
  • the presumption of validity of an originator’s patent does not amount to a presumption that a generic version is illegal;
  • ‘at risk’ launches of generics and consequent court proceedings commonly take place in the period before or immediately after a generic market entry;
  • to obtain an MA for a generic, there is no requirement to prove that the marketing does not infringe any originator’s patents; and
  • in the pharmaceutical sector, potential competition may be exerted before the expiry of a compound patent protecting an originator, as generic manufacturers want to be ready to enter the market as soon as that patent expires.

The definition of a ‘potential competitor’ in pay-for-delay cases is likely to continue to follow that established on an EU level, despite the UK’s exit from the EU. In its Paroxetine decision, the CMA took a similar view to the EC’s in considering that patent challenges in themselves were part of the competitive process.

‘By object’ infringement

Another crucial issue in pay-for-delay cases has been whether these agreements give rise to an infringement ‘by object’.

In considering what constitutes by-object restrictions in pay-for-delay cases, the CAT included questions on this in its referral to the CJEU in Paroxetine. In its judgment the CJEU held that a settlement agreement between potential competitors, whereby a manufacturer of generic medicines undertakes not to enter the market or challenge a patent in return for transfers of value, has the object of restricting competition if the net gain from the value transfers can have no other explanation than the commercial interest of the parties not to engage in competition on the merits, unless the settlement agreement has proven pro-competitive effects capable of giving rise to a reasonable doubt that it causes a sufficient degree of harm to competition.

The CMA is thus likely to regard a patent litigation settlement as a by-object breach if:

• there is a delay to generic entry (e.g., any agreed entry after patent expiry will almost certainly be regarded as a delay); and
• there is any significant value transfer to the generic supplier, particularly if the originator’s patent appears to be weak. Any payments by the originator to the generic supplier beyond litigation costs or anticipated damages are likely to be seen as a payment to stay out of the market.

Abuse of dominance

Excessive pricing

The CMA has focused on excessive pricing in the pharmaceutical sector in recent years, and has imposed fines in Phenytoin,^[19] Hydrocortisone^[20] and Liothyronine.^[21]

The definition of excessive pricing as an abuse of dominance under competition law remains largely that outlined in the United Brands case^[22] (i.e., the price bore ‘no reasonable relation to the economic value of the product’, which is assessed through a two-limb test of demonstrating that the price charged was excessive (excessiveness limb) and the price was unfair either in itself or when compared to competing products (unfairness limb)).

In August 2023, the CAT upheld the CMA’s excessive pricing analysis in an appeal of the CMA’s Liothyronine decision, which related to price rises of an unbranded generic produced by a monopolist of over 6,000 per cent.^[23]

The CMA relied on a ‘cost-plus’ analysis to demonstrate that the excessiveness limb of the United Brands test had been met, as it had in other excessive pricing cases such as Phenytoin and Hydrocortisone. This involves comparing the prices actually charged with relevant direct and indirect costs, plus a reasonable rate of return.

It also found that the unfairness limb of the United Brands test had been met for a number of reasons, including that it was a very old, unbranded generic that would not be expected to create enhanced value in the eyes of consumers, the therapeutic value of the drug was unrelated to the price charged, and the price increases had resulted in a significant adverse impact on the NHS and patients.

The appellants raised a number of arguments in their defence. They argued that there were errors in the CMA’s approach to cost-plus, as it had understated the cost of product rights (manufacturing know-how and marketing authorisation), had allocated costs incorrectly and had understated the cost of capital. They also argued that the ‘plus’ element should have taken account of patient benefit and portfolio pricing, and that the CMA, for the purpose of the unfairness limb, should have made an adjustment to reflect the hypothetical costs that would have been incurred if there had been multiple suppliers on the market (multi-firm cost-plus approach).

The CAT concluded that there were no material errors in the CMA’s cost-plus calculation. In particular, it found that the CMA was correct to take a volume rather than value-based starting approach to the allocation of common costs: a value based approach can give rise to a circularity problem as common costs will be allocated to the product for which abusive prices have been charged on the basis of the abusive prices charged. It left open the question on whether portfolio pricing practices – where one product is priced at a level that generates high profit margins in order to ‘subsidise’ other products – might be taken into account as it found no evidence that the price was set on this basis. It also rejected the multi-firm cost-plus approach advanced by the appellants as:

it would enable an incumbent to retain as pure profit the costs of operating in a hypothetical multi-player market even though the higher prices produced by the adjustment are unrelated to the incumbent’s actual costs incurred in a single-party market.^[24]

Following the Court of Appeal’s decision in Phenytoin,^[25] if methods other than cost-plus that inform a comparator price against which the excessiveness of prices should be measured are advanced, the CMA should evaluate these other methods. The appellants also contended that the CMA should have used alternative comparators. They contended that the prices actually charged after the entry of other competitors (post-entry prices), pre-entry forecast prices of competitors (forecast prices) and prices at which entry onto the market would be incentivised (entry incentivising prices) were all plausible alternative comparators. All of these alternative comparators were rejected by the CAT on the basis that:

• post-entry and forecast prices did not represent prices that would have arisen on a workably competitive market, as they were still tainted by the pre-entry, abusive prices; and
• treating entry incentivising prices as a comparator would be incorrect as a matter of legal principle. On a market with very high barriers to entry, the entry incentivising price could be very high. Therefore, a dominant undertaking would be able to charge very high prices below an entry incentivising price lawfully if entry incentivising prices could be used as a comparator. The CAT considered that the rules on excessive pricing are not simply intended to protect the competitive process, but are also designed to protect consumers from unfairness. The CAT also considered, in response to arguments advanced by certain appellants, that entry incentivising prices should not be considered as the dividing line between ‘fair’ and ‘unfair’ for the purpose of the unfairness limb.

Certain appellants also raised arguments that no dominance existed as the NHS and Department of Health and Social Care (DHSC) had sufficient countervailing buying power and the NHS and DHSC had acquiesced in the prices charged. The CAT considered that it was not sufficient to show that the purchaser has market power, but it also must be shown that the effect of this power constrained pricing conduct in practice: on the facts, this was not the case. It rejected there being a principle of acquiescence whereby prices may be considered lawful until objections are made.

The CAT’s conclusions in Liothyronine are likely to mean that:

• while the CMA will still be required to analyse alternative comparators to cost-plus if advanced by the parties, cost-plus is likely to be relied on by the CMA in future excessive pricing cases, and there is likely to be a high bar to successfully arguing that a method other than cost-plus should be used; and
• suppliers in generic markets where price regulation does not exist should nonetheless be very careful in relation to the pricing of products in respect of which market power may be argued, particularly as this has been an issue on the CMA’s radar for some time. Arguments that high prices can be considered pro-competitive, as they incentivise third-party entry and innovation or subsidise the monopolist’s entry and innovation in other markets, may not be likely to be successful.

Further clarity on the law surrounding excessive pricing is expected in the next year. An appeal of the CMA’s remittal decision following the Court of Appeal’s judgment in Phenytoin is listed to be heard by the CAT in late 2023, and a judgment on the appeal of the CMA’s decision in Hydrocortisone is outstanding.

Rebates

In recent cases, the CMA has not concluded that any loyalty rebates infringed UK competition law. In Remicade, the CMA closed an investigation in which MSD’s discount scheme with the NHS was thought to have been aimed at foreclosing biosimilars.^[26] However, the scheme was found to have been unlikely to limit competition in practice.

Product hopping/evergreening

In the UK, the CMA’s position as regards product hopping (or evergreening) is that it can constitute an abuse of dominance. For example, in Reckitt Benckiser, the CMA held that the firm had infringed competition law by replacing its original product with a new version after the original patent had expired, but prior to generic names for the original product being published. The conduct meant that prescriptions could only be issued for the new branded product, and the CMA considered it would have been irrational to withdraw the original product had it not been for the benefits of delaying generic competition.^[27]

Similarly, in Priadel, the CMA took an initial view that Essential Pharma had planned to withdraw supply in the UK of Priadel, a bipolar medication, which would have meant patients had to switch to more expensive similar treatments and then impose higher prices for supply of medication in that product’s class.^[28] It should be noted that this case concerned a strategy that had not yet been implemented, and there was no CMA infringement decision. Instead, the case was resolved through commitments whereby Priadel would continue to be supplied on terms agreed with the Department of Health, meaning Priadel could not be withdrawn to obtain any allegedly unjustified price increase.

National Security and Investment Act

A significant development impacting life sciences in the UK was the introduction of the National Security and Investment Act 2021 (the NSI Act).^[29] Due to concerns over the shifts in balance of both global economic and military power, the increasing competition between states and the emergence of powerful non-state actors, the UK government has considered it necessary to modernise its powers to intervene in certain transactions that could threaten the UK’s national security. While the Secretary of State previously held powers to intervene on national security grounds in mergers subject to the regular merger control regime, these were not considered adequate to protect national security and safeguard the economy’s success and the safety of citizens.

The ‘national security’ scope under the NSI Act is wide and could cover areas such as security of supply in life sciences (e.g., potentially, vaccines).

Under the NSI Act, acquirers must notify a transaction (including internal restructuring) pre-completion to the Investment Security Unit if that target carries out activities in the UK or supplies goods or services to persons in the UK within one of 17 identified sectors.

Among the sectors that could capture transactions within life sciences are synthetic biology, artificial intelligence and advanced robotics.

Sanctions for failure to comply with the NSI Act include the risk of transactions being void if completed prior to clearance, fines and imprisonment.

For certain transactions that fall outside the mandatory regime, there is a voluntary notification regime and ‘call-in’ powers. This includes acquisitions of qualifying assets, which can include acquisitions of intellectual property rights.

Outlook

When enacted, the Digital Markets, Competition and Consumers Bill’s provisions on killer acquisitions may result in a greater number of transactions in the life sciences sector being reviewed under the UK’s merger control regime, and a close analysis of how mergers may affect conditions of competition that are likely to develop in the future may be expected in merger reviews in the life sciences sector.

Although not a life sciences case, the Microsoft/Activision^[30] decision by the CMA shows that the CMA is willing to adopt divergent decisions to the EC on merger control matters.

The CMA is also likely to continue to closely monitor the sector, and continue to enforce infringements, with a continued focus on market sharing and excessive pricing.

Notes