Pharmaceutical regulatory law

Regulatory framework and authorities

What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?

The Human Medicines Regulations 2012 (SI 2012/1916) (as amended) (the HMRs) implement Directive 2001/83/EC and Regulation (EC) No. 726/2004 and regulate the authorisation and marketing (as well as manufacturing, distribution and packaging) of medicinal products in the UK.

The National Health Service Act 2006 (as amended) (the 2006 Act) and the Health Service Medical Supplies (Costs) Act 2017 (the 2017 Act) relate to the control of prices of medicinal products in the UK.

In March 2017, the UK expressed its intention to leave the European Union (Brexit). Depending on the form of relationship with the EU post-Brexit, there may be significant impact on the regulatory framework in the UK. At the time of writing, the timing and terms of Brexit remain unclear.

Brexit was originally scheduled for 29 March 2019, two years after service of the ‘Article 50’ withdrawal notice; but that date has been postponed, currently with an outer deadline of 31 October 2019. And the date may be accelerated, or postponed further.

The UK and the EU have a Withdrawal Agreement on hold, and pending approval on the UK side. Under its terms, Brexit would be followed by a period of transition during which EU law would de facto continue to apply in the UK, that period running at least until the end of 2020, and very possibly for longer.

In addition to the Withdrawal Agreement, there is a Political Declaration pending on the terms of the future EU-UK relationship, to be fully negotiated post-Brexit. There is, though, continuing debate in the UK on whether it should seek a relationship that is as close as possible to continuing EU membership (sometimes called ‘soft Brexit’), or a more limited relationship (‘hard Brexit’).

The formal possibility exists that Brexit occurs simply by expiry of the extended Article 50 period, without any withdrawal agreement to smooth the path to non-membership. The experience of the past months indicates this to be an unlikely outcome, but should such a ‘cliff-edge Brexit’ occur, there would be a sudden rupture in the applicable legal rules, and one that requires detailed separate treatment.

For present purposes, this chapter treats the UK as a continuing member of the European Union, as it currently is (and would for most practical purposes continue to be during any transition period). The relevance of Brexit is noted at various points, but without any other commentary or speculation on the rules that would then apply.

Regulatory authorities

Which authorities are entrusted with enforcing these rules?

The Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care (DHSC), is responsible for the regulation of medicinal products in the UK. The MHRA considers applications for marketing authorisations submitted through the national, mutual recognition or decentralised procedures. In contrast, any application for a marketing authorisation submitted under the centralised procedure falls within the remit of the European Medicines Agency. The centralised procedure may not be available depending on the terms of Brexit.

The Secretary of State has powers to control the prices of medicinal products under the 2006 Act (as amended). Such measures must comply with the requirements under the EU Transparency Directive 89/105/EEC.

The National Health Service (NHS) issues commissioning policies, and the National Institute for Health and Care Excellence (NICE) and similar bodies produce guidance, controlling access to medicines in practice.

Pricing

Are drug prices subject to regulatory control?

The prices of branded health service medicines supplied for use in the UK are subject to control through the voluntary scheme for branded medicines pricing and access (the Voluntary Scheme) or the statutory scheme established under the Branded Health Service Medicines (Costs) Regulations 2018 (as amended) (the Statutory Scheme).

The Voluntary Scheme (previously the Pharmaceutical Price Regulation Scheme (PPRS)) is a voluntary scheme negotiated between the DHSC and the Association of the British Pharmaceutical Industry (ABPI) under section 261 of the 2006 Act. The scheme is subject to renegotiation every five years. The Voluntary Scheme limits profits generated through the NHS businesses by member companies and any excess expenditure over the limit obliges the companies to make payments to the DHSC, calculated as a percentage of sales. Small companies with NHS sales income of less than £5 million in the previous calendar year are exempt from the payment obligation. New active substances may be freely priced by the manufacturer while the prices of other products to be placed for sale on the UK market must be approved by the DHSC. Price increases require the DHSC’s prior approval.

Companies who choose not to join the Voluntary Scheme are automatically subject to the Statutory Scheme under sections 263 and 264 of the 2006 Act and the Statutory Scheme. However, the scope of the Statutory Scheme only extends to prescription-only medicines. The Statutory Scheme introduces a payment system similar to the PPRS. Small companies with annual NHS sales income of less than £5 million in the previous calendar year are exempt from the payment requirement. The Statutory Scheme also sets out the methodology for setting maximum prices for branded medicine falling within its scope.

Unbranded medicines are not subject to the Voluntary or Statutory Schemes, with the prices charged determined by competition. Under the 2006 Act and the Health Services Medical Supplies (Costs) Act 2017, the Secretary of State may intervene and limit the price charged for unbranded medicines.

Distribution

Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?

The distribution and wholesale dealing of medicinal products in the UK is subject to the HMRs. Wholesale dealing is defined as selling, supplying, procuring, holding or exporting a medicinal product to a person who receives it for the purpose of onward sale or supply, or for the administration of the product to human beings, in the course of a business carried on by that person. Wholesale dealing requires an authorisation from the MHRA.

Intersection with competition law

Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?

The aspects raising most competition law issues are those relating to:

  • pricing of medicines, including excessive pricing, and discount or rebate schemes by dominant companies;
  • distribution, import and supply of medicines, such as restrictions in numbers of wholesalers and direct-to-pharmacy models, parallel trade and the imposition of quotas; and
  • agreements to prevent or limit competition, including arrangements to prevent or delay generic entry.

Competition legislation and regulation

Legislation and enforcement authorities

What are the main competition law provisions and which authorities are responsible for enforcing them?

The main UK competition legislations are the Competition Act 1998 (СА98) and the Enterprise Act 2002 (EA02).

Restrictive agreements and abuse of dominance

СА98 prohibits the following:

  • any agreements, concerted practices or decisions by associations of undertakings that have the object or effect of preventing, restricting or distorting competition and that may affect trade in the UK (Chapter I (section 2)); and
  • unilateral conducts, which amount to an abuse of a dominant market position that may have an effect on trade within the UK (Chapter II (section 18)).

If the Chapter I or II conduct also affects trade between EU member states, it may also violate articles 101 or 102 of the Treaty on the Functioning of the European Union (TFEU), which contains corresponding provisions for the EU.

Merger control

EA02 contains UK merger control laws (sections 22 to 130).

Sector inquiries

EA02 also sets out provisions for market studies and investigations (sections 130А to 184).

Public competition law enforcers

The UK competition law is enforced by the Competition and Markets Authority (CMA), and certain sectoral regulators that have concurrent competition powers. The Competition Appeal Tribunal (CAT) hears appeals against the decisions adopted by the CMA or the sectoral regulators. In the area of criminal cartel offences, the CMA shares its powers of investigation and prosecution with the Serious Fraud Office (or the National Casework Division of the Crown Office in Scotland).

Currently, the European Commission (the Commission) has exclusive jurisdiction over mergers that meet the EU jurisdictional thresholds while mergers that meet the UK thresholds but not EU thresholds are subject to the CMA’s jurisdiction. In the field of anticompetitive conduct, the CMA has jurisdiction to investigate conducts that breach either UK or EU competition rules, but the Commission retains the right to investigate the breach of the latter. Typically, the CMA and the Commission will agree in advance which authority is best placed to investigate conduct that potentially breaches the EU competition rules.

Depending on the terms of Brexit, the CMA and the Commission may have parallel jurisdiction over a merger or an investigation of anticompetitive conduct.

Public enforcement and remedies

What actions can competition authorities take to tackle anticompetitive conduct or agreements in the pharmaceutical sector and what remedies can they impose?

The СМА can impose fines of up to 10 per cent of an undertaking’s annual worldwide group turnover for infringing rules on restrictive agreements and abuses of dominance. In determining the level of fine, the CMA takes into account several factors, including the nature, seriousness and duration of the infringement, and any mitigating and aggravating factors. The largest fines the СМА has imposed on pharmaceutical companies include fines totalling £89.4 million imposed on Pfizer and Flynn Pharma in relation to excessive pricing at both the manufacturer and distributor levels (Phenytoin Sodium Capsules - Case CE/9742-13 (2016)); and fines totalling £44.99 million imposed on GlaxoSmithKline (GSK) and certain generics companies for reverse payment settlement agreements in respect of paroxetine (Paroxetine - Case СЕ/9531-11 (2016)).

Individuals involved in price-fixing, limiting supply of production, market sharing or bid-rigging may be subject to up to five years’ imprisonment or an unlimited fine, or both (section 188 of EA02). The requirement to prove that the individual acted ‘dishonestly’ has been removed by the Enterprise and Regulatory Reform Act 2013, thus lowering the threshold for finding an individual liable for a criminal cartel offence. Additionally, a director of a company found in breach of Chapters I or II of the CA98 (or the equivalent TFEU articles) may be disqualified from serving as a director for up to 15 years.

Immunity from fines may be available to companies and directors, and protection from criminal prosecution and director disqualification proceedings to directors where the first cartel member provides substantial evidence and the CMA is not already investigating the cartel or does not have sufficient evidence to establish a cartel. Reduction in penalties may be available to other companies.

Private enforcement and remedies

Can remedies be sought through private enforcement by a party that claims to have suffered harm from anticompetitive conduct or agreements implemented by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?

Competitors, suppliers or customers who have suffered losses as a result of a violation of UK or EU competition law can seek damages, an injunction or both. An action may be brought as ‘stand-alone’, requiring the claimant to prove the anticompetitive conduct, or ‘follow-on’, relying on the CMA’s or the Commission’s decision establishing the existence of an infringement and only needing to show loss and causation. Depending on the terms of Brexit, it may not be possible to rely on the Commission’s infringement decision for a follow-on action.

Claimants typically can choose whether to bring a claim either in the High Court before a single judge or the CAT with a specialist competition judge supported by two additional professionals, who normally are economists, accountants, lawyers or business persons.

The remedy can be sought by means of a private claim or a collective action with other victims of the infringement. Collective actions can be brought by an authorised representative on behalf of the claimant class (EA02 and the Consumer Rights Act 2015). Any damages awarded are apportioned between the claimants.

Collective actions can be brought as either:

  • an opt-in claim on behalf of every class member who joined the action; or
  • an opt-out action that automatically includes all eligible claimants domiciled in the UK, unless a claimant chooses to opt out.

There are a number of past and ongoing damages actions in the pharmaceutical sector, including an ongoing action brought in 2011 and 2012 by the health authorities in England, Wales, Scotland and Northern Ireland against Servier for alleged losses of £200 million relating to Servier’s conduct in respect of perindopril, brought after the European Commission opened an investigation into whether Servier breached articles 101 and 102 of the TFEU. In April 2019, the High Court rejected Servier’s argument that the trial should be put on hold until Servier’s appeal before the Court of Justice of the European Union (CJEU) has been ruled on.

Sector inquiries

Can the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?

The СМА has the power to conduct market studies (Phase I) and a more detailed market investigation (Phase II) under sections 130A to 184 of the EA02.

Market studies are used to determine whether particular markets are working well by examining the regulatory and other economic drivers and patterns of consumer and business behaviour. Market studies may lead to a range of outcomes, including the CMA:

  • concluding that there are no competition concerns in the market;
  • taking actions to improve the quality and accessibility of information to consumers;
  • recommending businesses in the market to self-regulate;
  • making recommendations to the government to change regulations or public policy;
  • taking competition or consumer enforcement actions; and
  • making a market investigation reference (Phase II) or accepting an ‘undertaking in lieu of reference’ (UIL).

Market investigations are in-depth examinations into whether a feature or a combination of features of a market has an adverse effect on competition (AEC) in the market. The СМА has wide discretionary powers to impose remedies to address AEC, including structural remedies (such as divestment of a business or assets) and behavioural remedies (such as the imposition of a price cap).

There have been several investigations into the pharmaceutical and the healthcare sectors in the past. In 2015, the СМА opened an investigation into the supply of medicines following concerns raised about medicine shortages in the UK, seeking information to determine whether there are shortages and their likely causes. The CMA examined the following possible causes for shortages:

  • distribution arrangements;
  • the exportation of medicines and the impact of exchange rate fluctuations;
  • quotas introduced by manufacturers;
  • difficulties in sourcing the required raw materials;
  • problems with the manufacturing process; and
  • regulatory interventions in the country of manufacture.

The investigation was terminated on grounds of administrative priorities as there was no persuasive evidence that the extent of shortages in the UK justified further investigation. Moreover, the CMA did not find reason to believe that a significant proportion of any existing shortages could be attributed to causes originating in the UK, or that the CMA was the best placed authority to investigate or address those causes that originated in the UK.

Between 2012 and 2016, the СМА investigated the market for privately funded healthcare services. The СМА found an AEC in the market in central London and that ACA Healthcare’s prices were higher than would be expected in a well-functioning market. Remedies included the appointment of the Private Healthcare Information Network as a provider of information on consultant fees and the healthcare performance via an independent website, and limits on benefits and incentive schemes provided to referring clinicians by private hospital operators.

In 2016, the CMA conducted a market study into the care homes for the elderly. It found a number of issues in the market, including the lack of sufficient funding, and, among other things, recommended improved long-term planning and oversight over local practices for commissioning new care homes.

Health authority involvement

To what extent do health authorities or regulatory bodies play a role in the application of competition law to the pharmaceutical sector? How do these authorities interact with the relevant competition authority?

The Health and Social Care Act 2012 gives NHS Improvement (NHSI) concurrent powers with the CMA to enforce Chapters I and II of the CA98 and articles 101 and 102 of the TFEU in relation to the provision of healthcare services in England. Where concurrent jurisdiction arises, the CMA and NHSI decide which one of them would be the best placed authority to undertake the investigation, taking into account a number of factors such as securing the maximum benefit for patients and the sectoral knowledge of the CMA or NHSI.

NHSI also has a concurrent power with the CMA to conduct market studies in relation to activities concerning the provision of healthcare services and to refer single or multiple markets for the CMA’s in-depth investigation. NHSI can also agree UILs and make recommendations to the government.

Although the merger control review is primarily the CMA’s responsibility, NHSI and the CMA provide each other with their views during pre-notification discussions and throughout the formal merger review process. If the activities of two or more NHS foundation trusts cease to be distinct, NHSI must provide advice to the CMA on relevant customer benefits and any other matter that it considers appropriate.

NGO involvement

To what extent do non-government groups play a role in the application of competition law to the pharmaceutical sector?

The СМА encourages individuals and NGOs to submit complaints. In addition, ‘designated consumer bodies’ can make ‘super-complaints’ under section 11 of the EA02. The CMA is obliged to investigate super-complaints and decide within 90 calendar days whether to:

  • take no action;
  • take enforcement action under competition or consumer law;
  • agree voluntary changes with the industry;
  • launch a market study or make a market investigation reference, or both; or
  • recommend action by the government, a regulatory body or other organisation.

Review of mergers

Thresholds and triggers

What are the relevant thresholds for the review of mergers in the pharmaceutical sector?

The CMA has jurisdiction over any merger or acquisition where:

  • the target has a UK turnover exceeding £70 million; or
  • the transaction leads to the creation or strengthening of a 25 per cent share of supply for sale of goods or services in the UK or a part of the UK.

The share of supply test is not a market share test. The share of supply refers to a particular category of goods and services that may not correspond to the relevant product market. Acquisitions involving any overlapping activities should be reviewed with caution against the 25 per cent threshold. There are de minimis exemptions for smaller transactions that are limited in scope.

The merger control in the UK is voluntary and non-suspensory. However, the CMA can investigate mergers and acquisitions that meet the jurisdictional thresholds following a complaint from a third party or on its own initiative. It can also impose ‘hold separate’ orders for the duration of its investigation, preventing the parties from integrating their respective businesses.

Is the acquisition of one or more patents or licences subject to merger notification? If so, when would that be the case?

A notifiable event in the UK is defined as two or more enterprises ceasing to be distinct. Although a transfer of intellectual property rights such as patents or licences does not normally fall under this definition, a notifiable event may arise where the intellectual property rights are transferred with customers, suppliers or other contracts to which a turnover can be attributed.

Market definition

How are the product and geographic markets typically defined in the pharmaceutical sector?

The CMA (including its predecessor, the Office of Fair Trading) generally follows the Commission’s approach to product and geographic market definition for pharmaceuticals.

The CMA typically tends to define the product market based on the anatomical therapeutic chemical (ATC) classification developed by the European Pharmaceutical Marketing Research Association. A pharmaceutical’s therapeutic indication or intended use, the third ATC level (ATC3), is used as a starting point. However, other wider or narrower levels such the fourth ATC level (pharmacological criteria such as mode of action) or the fifth ATC level (the specific molecule) or a combination of classes may be used if specific circumstances indicate that ATC3 is not the most appropriate level for product market definition. A range of other factors may also be considered when assessing the demand substitutability, including dosage strengths, pharmaceutical form, whether the pharmaceutical product can be purchased over-the-counter (OTC), route of administration, as well as product-specific factors that influence physicians’ choice of treatment (eg, safety and efficacy, treatment burden and stage of disease).

The CMA generally defines the geographic market for finished pharmaceutical products as national in scope. In the case of pipeline products, the CMA tends to follow the Commission’s precedents, defining the market as at least European Economic Area-wide or global, but in some circumstances may assess such products on a national basis, out of caution.

In Actavis/Auden Mckenzie (Case ME/6513/15 (2015)), the CMA assessed generics using the frame of reference based on the molecule level, apart from where evidence supported a wider product market definition. The CMA ultimately left open the precise product market delineation and whether the market needed to be further subdivided by prescription or OTC. The geographic market for the finished pharmaceutical products was defined as national in scope. Out of caution, the CMA examined the pipeline products on a national basis.

In LEO Pharma/Astellas Pharma Inc (Case МE/6581-15 (2016)), the СМА assessed pharmaceutical products using three alternative frames of reference: products belonging to the same АТС3 level; products of a similar composition (ie, dermatological products containing hydrocortisone) but in different АТС3 categories; and products prescribed for the same therapeutic indication but in different АТС3 categories. The geographic market was defined as national in scope.

After Brexit, the CMA may depart from the Commission’s approach to the product and geographic market definition in the pharmaceutical sector.

Sector-specific considerations

Are the sector-specific features of the pharmaceutical industry taken into account when mergers between two pharmaceutical companies are being reviewed?

The CMA takes into account in the market definition and the competitive assessment the specific features of the pharmaceutical industry such as the specific structure of demand (characterised by consumers, prescribers, pharmacies and health insurance schemes) and supply (originators, generics, wholesalers and different types of pharmacies such as online, ‘brick and mortar’, and hospital pharmacies) and the highly regulated environment in respect of supply, marketing, pricing, procurement and reimbursement of pharmaceuticals.

Addressing competition concerns

Can merging parties put forward arguments based on the strengthening of the local or regional research and development activities or efficiency-based arguments to address antitrust concerns?

The CMA will examine any efficiency claims put forward by the parties to address antitrust concerns. These may include arguments that the merger will lead to efficiencies such as increased R&D activities. However, the CMA must be satisfied on the basis of compelling evidence that any efficiencies are timely, likely and sufficient to prevent a substantial lessening of competition (SLC) from arising, as well as merger-specific, meaning they are a direct consequence of the merger. In practice, the CMA has rarely accepted that efficiencies outweigh any SLC.

Horizontal mergers

Under which circumstances will a horizontal merger of companies currently active in the same product and geographical markets be considered problematic?

The CMA will consider as problematic any horizontal mergers that have resulted or may be expected to result in an SLC within any markets in the UK for the relevant goods or services.

Horizontal mergers give rise to an SLC where they either remove an important competitor and, as a result, allow the merged entity to profitably raise prices without the need to coordinate with competitors (unilateral effects), or enable or increase the ability of two or more businesses to coordinate prices (coordinated effects). Unilateral effects are more likely when the parties are close competitors, while coordinated effects will likely occur in oligopolistic markets.

Vertical mergers are generally less likely to raise competition concerns. An SLC arises in vertical mergers where the merger may result in a restriction on the downstream competitors’ access to a key input or the upstream rivals’ access to important customers.

Product overlap

When is an overlap with respect to products that are being developed likely to be problematic? How is potential competition assessed?

The CMA (including the Office of Fair Trading) is broadly influenced by the Commission’s approach to pipeline products. The Commission has considered pharmaceutical products at Phase III clinical trials (tests involving 1,000-5,000 patients in clinics and hospitals to confirm the efficacy and safety of the drug) or at a later stage of development (post-drug approval) to generally be at a sufficiently advanced stage of development to be considered as a possible competitive constraint, excluding products at Phase I (tests involving 20-100 healthy volunteers to study a drug’s safety profile) and Phase II (controlled trials of 100-500 volunteers with the disease to assess the drug’s effectiveness) from the assessment. The CMA considered Phase II to be an early developmental stage for pharmaceutical products in GlaxoSmithKline/Pfizer (Case ME/4136/09 (2009)), owing to factors such as the relatively low success rate (around 30 per cent) and the length of time from Phase II to obtaining marketing approval. The CMA also considered a potential theory of harm whereby the merged entity may decide to discontinue or slow down the development of one of the overlapping products in the development (so as not to cannibalise sales of existing pharmaceutical products), which in turn may reduce the probability of a new product reaching the market to the detriment of patients.

In Actavis UK Limited/Auden Mckenzie Holdings Ltd (Case МЕ/6513/15 (2015)), the СМА took a broader approach to pipeline products and examined the various stages of their development, the outcome of clinical trials and stability tests, the number of other parties holding marketing authorisations for products in the same space, and the length of time needed to develop a pharmaceutical product and obtain requisite regulatory approvals.

Remedies

Which remedies will typically be required to resolve any issues that have been identified?

When considering remedies, the CMA must have regard to the need to achieve as comprehensive a solution as is reasonable and practicable to remedy the SLC and any adverse effects resulting from it. The CMA may impose either structural remedies (that cause a permanent change in the structure of the market such as divestitures) or behavioural remedies (that regulate the way the merged entity carries on business such as pricing), with a preference for structural remedies.

In Phase I, the CMA can accept UILs that are sufficiently clear-cut and certain to address an identified SLC. The CMA is generally unlikely to consider behavioural UILs as sufficiently clear-cut in Phase I. In Phase II, the CMA may decide whether to impose either structural or behavioural remedies.

In Celesio/Sainsbury’s Pharmacy Business (2016), the parties’ initial offer of behavioural remedies was rejected. The СМА deemed that only a structural remedy would be effective in addressing the SLC and the parties eventually offered a divestiture package. In Reckitt Benckiser/K-Y (2015), the CMA, however, accepted a behavioural remedy in the form of brand licensing arrangements.

Anticompetitive agreements

Assessment framework

What is the general framework for assessing whether an agreement or concerted practice can be considered anticompetitive?

Section 2(1) of the CA98 (see question 6) prohibits restrictive agreements including price-fixing, resale price maintenance, bid-rigging and the exchange of sensitive information. Types of agreements that are excluded from the section 2(1) prohibition are listed in section 3 of the CA98, for example, mergers, services of general economic interest and agreements or contracts entered into to comply with a legal requirement.

The criteria for an efficiency defence to the section 2(1) of the CA98 prohibition is set out in section 9 of the CA98 and requires that an agreement improves production or distribution or promotes technical or economic progress, allows consumers a fair share of the resulting benefits and does not impose any unnecessary restrictions on competition or allow the parties to the agreement the opportunity to eliminate competition.

Moreover, section 10 of the CA98 exempts from the section 2(1) CA98 prohibition any agreement that falls under an EU block exemption regulation, irrespective of whether it affects trade between member states. The EU block exemption regulations that apply to agreements include Regulation No. 330/2010 on vertical agreements (in place until 31 May 2022), Regulation No. 316/2014 on technology transfer agreements (TTBER) (in place until 30 April 2026), Regulation No. 1217/2010 on R&D agreements (in place until 31 December 2022) and Regulation No. 1218/2010 on specialisation agreements (in place until 31 December 2022). There are a number of sector-specific EU block exemption regulations applying to sectors such as the automotive, insurance and liner shipping industries. After Brexit, the UK will retain the block exemptions with their current expiry date, apart from the insurance block exemption, which will no longer apply in the UK.

Technology licensing agreements

To what extent are technology licensing agreements considered anticompetitive?

There is no UK legislation that specifically regulates technology licensing agreements. Such agreements are assessed under the TTBER and the Technology Transfer Guidelines.

Under the TTBER, technology licensing agreements benefit from a safe harbour (ie, the agreements are deemed in line with competition law) where the contracting parties have limited market power (a share below 20 per cent if they are competitors and 30 per cent if they are not competitors) and the agreement does not contain any hardcore restrictions of competition such as price restrictions, output limitations, or market or customer allocation. Excluded restrictions such as clauses preventing challenges to intellectual property rights (no-challenge clauses) do not benefit from a safe harbour and, where severance is possible, will not remove the TTBER protection for the remainder of the agreement.

Co-promotion and co-marketing agreements

To what extent are co-promotion and co-marketing agreements considered anticompetitive?

Co-promotion agreements are agreements whereby contracting parties agree to promote a product under the same brand name and under a common marketing strategy. In contrast, co-marketing agreements are agreements between companies to promote the same product under different brand names. Such co-commercialisation agreements are commonly used by pharmaceutical companies looking to penetrate new markets while sharing the risk.

Co-promotion and co-marketing agreements are not considered intrinsically anti-competitive, but may violate competition rules in certain circumstances. In its investigations, the CMA is likely to look to the EU Commission’s guidelines on horizontal co-operation agreements and the existing Commission case law. For example, the Commission fined Johnson & Johnson and Novartis €16.3 million in 2013 for concluding a co-promotion agreement in the context of which Sandoz (Novartis’ Dutch subsidiary) agreed to abandon its independent effort to enter the market with a generic version of Johnson & Johnson’s pharmaceutical product, thus, delaying the entry of a cheaper generic medicine by 17 months and keeping the prices of the Johnson & Johnson’s product artificially high in the Netherlands.

Other agreements

What other forms of agreement with a competitor are likely to be an issue? How can these issues be resolved?

Agreements involving an exchange of competitively sensitive information (ie, non-public strategic information about business’s commercial policy such as future prices and other commercial conditions applied to customers or suppliers) between competitors may raise competition concerns. Such agreements include as follows:

  • joint venture agreements (companies pooling their resources to achieve a specific task, such as a joint development of a new product or a new business activity);
  • joint purchasing agreements (companies jointly purchasing all or part of their product requirements); and
  • joint selling agreements (companies jointly determining all commercial aspects of the sale of a product).

To minimise the competition risk, companies should make sure before entering into the agreement that they have a legitimate business justification and put in place a framework with appropriate information barriers and confidentiality obligations, as well as ensure that any information exchange relates to historic, aggregated data.

Technical cooperation may also give rise to competition risk where, for example, companies agree to restrict or delay the development of a technology or the introduction of a new technology to the market. R&D agreements in the pharmaceutical sector may, however, benefit from a safe harbour under Commission Regulation (EU) No. 1217/2010. After Brexit, the safe harbour will be available until the expiry of the block exemption.

Issues with vertical agreements

Which aspects of vertical agreements are most likely to raise antitrust concerns?

Vertical agreements such as distribution and supply agreements are subject to the Chapter I prohibition in the CA98. Such agreements benefit from a safe harbour under the EU Vertical Agreement Block Exemption (Regulation No. 330/2010) where:

  • the combined market shares of the supplier and the buyer do not exceed 30 per cent of the market in which the goods or services covered by the agreement are sold and purchased; and
  • the agreement does not contain hardcore restrictions, for example, resale price maintenance, territory or customer allocation.

Outside of the safe harbour, companies must self-assess whether their vertical agreements comply with competition law, on the basis of the guidance and existing case law of the CMA and the Commission. Vertical agreements do not generally give rise to competition concerns, unless the supplier or the buyer (or both) possess market power or will obtain market power as a result of the agreement.

Although companies cannot notify agreements to the CMA for clearance or exemption, the CMA can issue a non-binding short-form opinion that provides guidance to parties on the application of competition law on specific agreements. This option is, however, available only in a limited number of cases.

Patent dispute settlements

To what extent can the settlement of a patent dispute expose the parties concerned to liability for an antitrust violation?

Patent dispute settlement agreements have the object of restricting competition (ie, per se harmful without a need to prove anticompetitive effects) where:

  • the agreement is made between actual or potential competitors;
  • the agreement includes a ‘value transfer’ from the patent holder to the patent challenger; and
  • the value transfer is made in return for a restriction on the patent challenger’s entry on the market (typically in the form of a non-compete or no-challenge clause).

In 2016, the CMA imposed a total fine of £44.99 million on GSK, the supplier of branded paroxetine (anti-depressant medicine) called Seroxat, and on Generics (UK) Limited (GUK) and Alpharma Limited (Alpharma), who were taking steps to enter the UK market with a generic version of paroxetine, for entering into pay-for-delay agreements. GSK held certain patents in relation to Seroxat, a ‘blockbuster product’, and commenced litigation proceedings against GUK and Alpharma alleging that their products infringed its patents. Before the litigation went to trial, the companies entered into patent settlement agreements that allegedly included terms prohibiting GUK’s and Alpharma’s independent entry into the market and total payments of over £50 million from GSK to GUK and Alpharma.

Joint communications and lobbying

To what extent can joint communications or lobbying actions be anticompetitive?

Trade association or lobbying actions or other joint actions by a group of companies may amount to an infringement if they involve an anti-competitive conduct such as exchange of competitively sensitive information or restrictive agreements.

The CMA has previously scrutinised rules and conduct of trade associations and imposed fines on a number of occasions. In 2016, the CMA fined five fashion model agencies and their trade association over £1.5 million for colluding on the prices charged for modelling jobs. The trade association helped the agencies share confidential and commercially sensitive information and, in some cases, urged members to reject prices offered by their customers in order to force a higher price.

The CMA’s predecessor levied a fine of more than £7.9 million (after appeal) on six recruitment agencies for collectively boycotting a competitor (Parc UK) and fixing prices. Parc entered the market in 2003 with a new business model, acting as an intermediary between a construction company and recruitment agencies to supply potential candidates. The recruitment agencies agreed to boycott Parc and to fix the rates charged to intermediaries such as Parc and a certain construction company.

Public communications

To what extent may public communications constitute an infringement?

Public announcements are generally unlikely to raise competition concerns, provided they are not used to signal future market behaviour. For example, the CMA issued an order prohibiting suppliers of cement and cementitious products from sending generic price announcement letters to their customers and restricting the disclosure and publication of certain market data, due to concerns on coordination and price signalling.

Exchange of information

Are anticompetitive exchanges of information more likely to occur in the pharmaceutical sector given the increased transparency imposed by measures such as disclosure of relationships with HCPs, clinical trials, etc?

A number of measures have been introduced or are in the process of being introduced to increase transparency in the pharmaceutical sector, including:

  • A public disclosure of any transfers of value made to HCPs and healthcare organisations by pharmaceutical companies is obligatory for ABPI members under the ABPI Code of Practice and is also considered as a good industry practice outside the ABPI. Such disclosures allow pharmaceutical companies to see the extent that rivals are supporting HCPs and healthcare organisations, including amounts paid to specific individuals and organisations.
  • Clinical and non-clinical data of the UK pharmaceutical companies is subject to disclosure in line with the EU legal requirements under the Transparency Regulation (Regulation No. 1049/2001), unless narrowly applied exceptions apply.
  • There are increased transparency requirements, such as the public registration of information concerning new clinical trials under the Clinical Trial Regulation (No. 536/2014), which is expected to enter into force in 2019.

All of the above-described practices increase market transparency in the pharmaceutical sector and may prompt scrutiny from the СМА under Chapter I of the СА98 and article 101 of the TFEU.

Anticompetitive unilateral conduct

Abuse of dominance

In what circumstances is conduct considered to be anticompetitive if carried out by a firm with monopoly or market power?

While holding monopoly or market power is not unlawful, a firm is generally prohibited from using its dominant position in an abusive way. Abusive conduct generally falls into one of the following categories:

  • conduct that exploits customers or suppliers (eg, excessive pricing or discrimination between customers); or
  • conduct that excludes or weakens actual or potential competitors (eg, tying, exclusive dealing, predatory pricing or refusal to supply).

Some conducts are categorised as ‘by nature’ abuses (eg, exclusive dealing), meaning that there is a presumption of unlawful conduct that can be rebutted by a dominant firm adducing evidence that the conduct is not capable of restricting competition. Outside the ‘by nature’ infringements (eg, tying, product design, pricing abuses and refusals to supply), a fully-fledged effects analysis must be carried out.

Some examples of an abuse include the following:

  • limiting production, market or technical development;
  • applying dissimilar conditions to equivalent transactions;
  • tying or bundling the supply of a product or service to the mandatory purchase of an unrelated product or service; and
  • imposing unfair purchase or selling prices or other unfair trading conditions.

The CMA’s most recent investigations in the pharmaceutical sector have primarily focused on the last category. For example, the CMA has separately investigated Pfizer and Flynn Pharma (Phenytoin sodium capsules (2016)), Actavis UK (Hydrocortisone tablets (ongoing)) and Concordia (Liothyronine tablets (ongoing)) for alleged excessive pricing, and MSD for an allegedly exclusionary discount scheme (Remicade (2019)). The investigation against MSD was closed owing to the lack of grounds for action.

Other types of abusive conduct such as ‘pay-for-delay’; vexatious litigation; the dissemination of misleading information to regulatory authorities, healthcare professionals or the general public; product denigration or other strategies designed to foreclose competitors have been previously sanctioned at the EU-level or in other EU member states and could also be scrutinised closely in the UK.

De minimis thresholds

Is there any de minimis threshold for a conduct to be found abusive?

There is no de minimis threshold to establish abuse in public enforcement. Market coverage and duration of the abuse, however, are relevant when assessing the severity and likelihood of anticompetitive effects. The CMA may also take these factors into account when determining whether an investigation is an administrative priority.

Conduct of a small business (ie, with an annual turnover of up to £50 million) may be considered to have minor significance and, thus, benefit from immunity from financial penalties (but not liability). Immunity has been previously granted only in two cases in the past (Cardiff Bus (Case СЕ/5281/04 (2008) and JJ Burgess & Sons Limited (Case 1044/2/1/04 [2005] САТ25)).

Market definition

Do antitrust authorities approach market definition in the context of unilateral conduct in the same way as in mergers? If not, what are the main differences and what justifies them?

Generally, the CMA tends to take a similar approach to the product and geographic market definition in the context of an investigation of mergers and unilateral conducts in the pharmaceutical sector. For example, the CMA’s predecessor expressly adopted in a merger case, Shire/Viropharma (Case ME/6331/13 (2014)), the methodology used to define the product market in the antitrust case Gaviscon (Reckitt Benckiser - see question 34) (ie, relying on the ATC classification system of EphMRA and the World Health Organization and considering guidelines and literature used by prescribers, as well as internal documents and sales trends).

However, in some recent unilateral conduct cases, the CMA carried out qualitative and quantitative analyses for the purposes of product market definition, taking into account the ATC classification as part of the qualitative limb (Paroxetine - Case СЕ/9531-11 (2016)), or started the product market definition from the product under investigation, rather than the ATC3 level. The Phenytoin sodium capsule case is an example of the latter approach. The CMA defined the markets as the manufacture and the distribution of Pfizer-manufactured phenytoin sodium capsules, and then considered whether other products (such as NRIM capsules or tablets and other anti-epileptic drugs) could be viewed as substitutes based on, for example, internal contemporaneous documents, responses from pharmacies dispensing the capsules to the CMA’s surveys, and average selling price and volume sales data.

The geographic market has been generally defined by the CMA as UK-wide in mergers and unilateral conduct cases. However, in Remicade, the CMA proceeded on the basis that the geographic market was England.

Establishing dominance

When is a party likely to be considered dominant or jointly dominant? Can a patent owner be dominant simply on account of the patent that it owns?

A party is considered dominant when it holds economic strength that affords it the power to behave to an appreciable extent independently of its competitors, customers and ultimately of consumers.

The CMA will only find that a party is in a dominant position if it has ‘substantial market power’. In its assessment, the CMA first defines the product and geographic market in which the alleged conduct took place and then analyses whether the firm has substantial market power on the relevant market, taking into account market shares, barriers to entry and expansion, and customers’ buyer power. According to the CMA’s guidance, market power can be thought of as the ability to profitably sustain prices above competitive levels or to profitably restrict output or quality below competitive levels.

There is a presumption stemming from the EU precedents that a party is deemed dominant if its market share is persistently above 50 per cent, although high market shares are not determinative. The CMA’s guidance state that dominance is unlikely to be found where the market share is below 40 per cent.

Separate parties may also be found to collectively hold a dominant position where certain conditions are met. For example, two or more legally independent parties may be deemed to be collectively dominant if they are linked (eg, structurally) in such a way that they adopt a common policy on the market.

IP rights

To what extent can an application for the grant or enforcement of a patent or any other IP right (SPC, etc) expose the patent owner to liability for an antitrust violation?

An application for the grant or enforcement of a patent or any other IP right generally does not amount to an abuse of dominance. Certain conducts that were already deemed abusive at the EU-level, however, may be scrutinised by the CMA. Such conducts include providing misleading information to regulators as part of applications for supplementary protection certificates (AstraZeneca v Commission, Case C-457/10 P (2012)), enforcing a patent in the knowledge it lacks merit (the Commission Decision in Perindopril (Servier), Case AT 39612 (2014)) or filing patents for new pharmaceutical treatments without scientific merit (the Commission Decision in Boehringer, Case AT 39246 (2012)), where the sole or primary purpose or aim of the conduct is to foreclose competitors.

When would life-cycle management strategies expose a patent owner to antitrust liability?

Life-cycle management practices such as improving the method of delivery or formulation, changing labelling or indications, replacing an original drug with a successor drug or withdrawing an original drug are typically legitimate business strategies used by originator companies and do not generally raise competition concerns, unless part of an anticompetitive foreclosure strategy. For example, life-cycle management could be used to foreclose generic competition since generic versions for first-generation product cannot be automatically substituted for the second-generation product.

In 2011, the CMA’s predecessor fined Reckitt Benckiser £10.2 million for withdrawing and delisting alginate and antacid heartburn medicine (Gaviscon Original Liquid (GL)) from the NHS prescription channel in 2005. GL lost patent protection in 1997, the same year that Reckitt launched GL’s second-generation version, Gaviscon Advance Liquid (GA). Reckitt withdrew GL in advance of the publication of a generic name relevant to GL, which would have facilitated full generic competition. After the publication, general practitioners (GPs) could have written the generic name on prescriptions (an ‘open script’), thus allowing pharmacies to dispense any pharmaceutical product satisfying the requirement of the generic name, irrespective of whether an originator or generic product. Owing to the withdrawal and the lack of generic alternatives as a result of GA’s patent protection, GPs had to refer to the brand name in prescriptions (a ‘closed script’), forcing pharmacies to dispense the branded product and not allowing them to substitute a generic equivalent.

Communications

Can communications or recommendations aimed at the public, HCPs or health authorities trigger antitrust liability?

Communications by a dominant company to the public and HCPs do not typically raise competition risks. Disparagement and other practices curbing demand for generics such as dissemination of misleading, false or incomplete information can, however, amount to an abuse, if, for example, they are part of systematic campaign aimed at casting doubts on the efficacy and safety of the generic versions to reduce the competitive pressure from the generic.

The CMA may treat the dissemination of misleading information in the same way as at the EU-level. The CJEU ruled in January 2018 that two companies agreeing to disseminate misleading information relating to adverse reactions resulting from the use of a pharmaceutical product with a view to reducing the competitive pressure may constitute a restriction of competition ‘by object’ (F Hoffman-LaRoche and Others, Case C-179/16 (2018)).

Authorised generics

Can a patent owner market or license its drug as an authorised generic, or allow a third party to do so, before the expiry of the patent protection on the drug concerned, to gain a head start on the competition?

An originator launching its own ‘authorised’ generics or allowing a third party to do so is a relatively common practice in the pharmaceutical sector. It is a commercial strategy intended to better control the loss of revenues from the sale of the originator medicine after the generic competition enters the market. Such strategy may, however, raise competition risks if it constitutes a pay-for-delay arrangement with actual or potential competitors, involving a value transfer in return for a restriction on generic entry.

Restrictions on off-label use

Can actions taken by a patent owner to limit off-label use trigger antitrust liability?

The CMA is likely to be influenced by the approach taken at the EU-level to actions to limit off-label use of medicines. The CJEU held in F Hoffman-La Roche and Others (2018) that agreements between two pharmaceuticals companies, who marketed similar medicine, to disseminate misleading information about the safety of off-label use of one of their products to prevent the off-label use of such product was anticompetitive by object.

Pricing

When does pricing conduct raise antitrust risks? Can high prices be abusive?

High or low prices (including discount or rebate schemes) may amount to an abuse of dominance under certain circumstances.

To determine whether a high price can be deemed excessive, the CMA applies a legal test that stems from United Brands v Commission (Case C-27/76 (1978)). The CAT has set out in Flynn and Pfizer v CMA (2018) (Cases 1275-1276/1/12/17 [2018] CAT 11) the steps involved in applying the test:

  • The benchmark price, or range, that reflects the price that would pertain under conditions of normal and sufficiently effective competition must be established on the basis of a range of possible analyses that reflect market conditions and the extent and quality of the available data. The criteria for selection and application of a benchmark must be objective appropriate and verifiable, and the analysis must be done on a consistent basis.
  • The price charged in practice must be compared with the benchmark price (or range) to determine whether it is excessive. A price can be excessive if the differential is significant and persistent. The factors that are taken into account include as follows:
    • the absolute size and stability of the differential;
    • the reasons for it, taking account that excessive pricing will only usually occur where the market is protected from competition (eg, owing to barriers to entry), or where there is regulatory failure and the relevant regulator has not intervened;
    • previous decisions finding other differentials excessive, weighted for the markets applicable in those cases; and
    • the wider market conditions, including the evolution of pricing over time.
  • If the differential is excessive, it is necessary to consider whether the price is unfair in itself or when compared to competing products, but due consideration must be given to any prima facie convincing argument that the pricing is actually fair under either alternative.
  • If there is a finding of unfairness, it is necessary to assess the economic value of the product and whether the price charged in practice bears no reasonable relation to it as well as whether the dominant business is reaping trading benefits that it would not reap under conditions of normal and sufficiently effective competition.
  • If all the conditions above are fulfilled, it is necessary to give appropriate consideration to any objective justification.

Excessive pricing has been the focus of many recent CMA investigations into the pharmaceutical sector.

Low prices may amount to predatory pricing if the price charged is below costs so that equally efficient rivals cannot profitably price at the same level. Prices below average variable cost (AVC) or average avoidable cost (AAC) are presumptively abusive, while pricing below average total cost but above AVC or AAC is abusive if it is part of a strategy to foreclose a rival. The CMA (including its predecessor) has not investigated predatory pricing in the pharmaceutical industry since 2001 (Napp Pharmaceutical Holdings Ltd v Director General of Fair Trading, Case 1001/1/1/01 or [2001] CAT 1).

Lower prices through discounts and rebates may also raise competition concerns if they are subject to a customer obtaining all or most of its requirements from a dominant company or have a loyalty-inducing or fidelity-building effect. In 2019, the CMA closed an investigation into whether the discount scheme introduced by MSD for Remicade (used to treat chronic illnesses such as Crohn’s disease and rheumatoid arthritis) in England was likely to have an exclusionary effect. Although the CMA did not find grounds for action, its decision contains useful guidance on rebate schemes, set out below.

The CMA stated that pure quantity rebates (ie, discounts linked solely to the volume of the purchases) are not, in principle, liable to raise concerns whereas exclusivity rebates (ie, discounts linked to an obligation or promise to obtain all or most of the requirements exclusively) are per se abusive, irrespective of whether they are requested by the customer.

Non-exclusivity discounts that offer customers financial advantages may raise concerns. Such discounts are subject to a case-by-case assessment of all relevant circumstances such as the criteria and rules governing the grant of the discount; whether the discount is based on any economic service justifying it; and whether the discount tends to remove or restrict the buyers’ freedom to choose their sources of supply, to bar competitors from access to the market, to apply dissimilar conditions to equivalent transactions with other trading parties, or to strengthen the dominant position by distorting competition. Some signs of likely competition concerns are the following:

  • discounts apply to all volumes purchased once a volume threshold is met (‘retroactive rebate’), and not only to the volumes exceeding the threshold (‘incremental rebate’);
  • volume threshold for the discount is individually set and, in particular, if the threshold is based on the customer’s (total or a large proportion of) estimated requirements or past purchasing volumes;
  • discounts apply without distinction to every unit purchased by a customer, including both:
    • volumes that the customer can purchase either from the dominant company or a rival (‘contestable share’); and
    • volume that the customer is required or has a strong preference to purchase from the dominant company (‘assured base’);
  • discounts cover the majority of customers on the market; and
  • the price charged under a rebate scheme or discount scheme is below the dominant company’s costs of production so that there is a concern that an equally efficient competitor would be foreclosed.

Moreover, even if the discount is not directed at the ultimate purchaser, it may raise concerns where the financial incentive is likely to influence purchasing behaviour. Also, discounts negotiated on behalf of a number of different individual purchasers and calculated on the basis of their aggregate purchases may be found abusive.

Sector-specific issues

To what extent can the specific features of the pharmaceutical sector provide an objective justification for conduct that would otherwise infringe antitrust rules?

The features of the sector can be invoked as an objective justification for anticompetitive conduct. However, the CMA is not likely to be easily convinced by such arguments. For example, the CMA’s predecessor rejected the argument in Napp Pharmaceutical Holdings Ltd that prices regulated by the PPRS (the scheme that was replaced by the Voluntary Scheme) were incapable of being excessive.

Update and trends

Current trends and developments

40Are there in your jurisdiction any emerging trends or hot topics regarding antitrust regulation and enforcement in the pharmaceutical sector?

Emerging trends and hot topics40 Are there in your jurisdiction any emerging trends or hot topics regarding antitrust regulation and enforcement in the pharmaceutical sector?

Over the past few years, the pharmaceutical sector has been increasingly scrutinised by the CMA. Six investigations into pharma companies were opened in October 2017 alone. Currently, 10 of the 26 ongoing CA98 cases are in the pharmaceutical sector. Moreover, the CMA’s annual plan 2019-2020 also expressly makes a reference to the pharmaceutical industry, stating that the CMA’s work to tackle possible breaches of competition law in the sector is directed at ensuring trust in the pharmaceutical businesses.

The ongoing CA98 cases in the pharmaceutical cases include the following.

Investigations of generic pharmaceutical products

The CMA opened four investigations into anticompetitive conduct and agreements in relation to generic pharmaceutical products in October 2017. The CMA expected to conclude the investigation phase in 2018 and decide whether it had sufficient evidence to issue statements of objections. However, the period for the information gathering and analysis was extended to 2019.

Although the CMA has not publicly named the companies under the investigation, Aspen and Concordia have announced that they are under investigation. Aspen stated that its investigation relates to the supply of two pharmaceutical products, fludrocortisone acetate and dexamethasone.

Liothyronine tablets

In November 2017, the СМА issued a statement of objections alleging that Concordia breached Chapter II of the CA98 and article 102 of the TFEU by charging excessive and unfair prices in relation to the supply of liothyronine tablets in the UK. The CMA’s preliminary finding was that Concordia was the only supplier of liothyronine tables in the UK between January 2009 and July 2017, and the price paid by the NHS for liothyronine tablets rose by 1,605 per cent during the relevant period while production costs remained broadly stable.

Hydrocortisone tablets

The СМА issued a statement of objection in December 2016 alleging that Actavis UK (formerly Auden Mckenzie) violated Chapter II of the CA98 and article 102 of the TFEU by charging excessive and unfair prices in relation to the supply of hydrocortisone (a corticosteroid) tablets in the UK. The CMA issued another statement of objections in August 2017 to new addressees. Following the consideration of the parties’ written and oral representations on the statement of objections, the CMA is engaged in further evidence gathering and analysis that is expected to conclude by June 2019.

Phenytoin sodium capsules

The CMA imposed fines totalling approximately £90 million on Pfizer and Flynn, alleging that each of them had abused their respective dominance in breach of Chapter II of the CA98 and article 102 of the TFEU by imposing unfair prices for phenytoin sodium capsules in the UK. The case was based on unusual facts. Pfizer had transferred its marketing authorisation for the capsules to Flynn but continued to manufacture and supply the capsules exclusively to Flynn. Following the genericisation of the product by Flynn (ie, excluding the capsules from price regulation) and Pfizer’s and Flynn’s price increases, NHS expenditure on phenytoin sodium capsules increased from approximately £2 million a year in 2012 to approximately £50 million in 2013. Pfizer and Flynn appealed the CMA decision to the CAT in 2017. The CAT upheld the finding of dominance but set aside the parts of the decision relating to abuse and any consequential findings, including penalties, and remitted the case back to the CMA. In December 2018, the CAT also granted the CMA permission to appeal the judgment.

Hydrocortisone tablets II

In March 2017, the СМА issued a statement of objections alleging that Concordia and Actavis UK breached Chapters I and II of the CA98 and articles 101 and 102 of the TFEU by entering into anticompetitive agreements in relation to the supply of hydrocortisone tablets in the UK. In doing so, the CMA also alleges that Actavis UK abused its dominant position by inducing Concordia not to enter the UK market independently. Written and oral representation on the statement of objections took place between April and May 2017. The CMA is engaged in further evidence gathering and analysis that is expected to conclude by June 2019.

Hydrocortisone tablets III

In February 2019, the CMA issued a statement of objections alleging that Auden Mckenzie and Waymade breached Chapters I and II of the CA98 and articles 101 and 102 of the TFEU by entering into anticompetitive agreements in relation to the supply of hydrocortisone tablets in the UK and by Auden Mckenzie making monthly payments to Waymade not to enter the market. The investigation is ongoing and the receipt of written and oral representations on the statement of objections is expected by June 2019.

Paroxetine

The CMA imposed total fines of £44.99 million on GSK (the supplier of the branded anti-depressant, paroxetine), GUK and Alpharma for a violation of Chapters I and II of the CA98 and article 101 of the TFEU. The parties appealed the CMA’s decision to the CAT in 2016. The CAT dismissed a number of the grounds of appeal and decided to refer a number of legal questions to the CJEU in March 2018.