1. Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules?
The relevant legislation includes the following:
The regulators entrusted with enforcing these rules include:
In 2017, the CMU, by revising the Resolution on State Regulation of Prices for Medicines, No. 862 2016, abolished maximum price mark-ups on wholesale purchase prices and retail prices of drugs, and introduced a reference pricing system. Under the new rules, threshold prices are determined with reference to prices in a basket of reference countries (ie, the Czech Republic, Hungary, Latvia, Poland and Slovakia); and in Ukraine.
The reference pricing system only applies to certain types of drugs (ie, drugs for the treatment of cardiovascular diseases, type II diabetes and asthma that are purchased or reimbursed by public sector entities for state or municipal funds) and does not cover the drugs purchased under the e-procurement system.
The above legislative acts mainly regulate technical requirements.
Dominance, anticompetitive conduct and mergers are regulated by the Law on Protection of Economic Competition 2001, while unfair competition issues are addressed in the Law on Protection against Unfair Competition 1996.
Competition legislation is enforced by the Antimonopoly Committee of Ukraine (AMC), which has quite broad powers that cover mergers, arrangements and practices in the pharmaceutical sector. Its activity is regulated by the Law on the Antimonopoly Committee of Ukraine 1993.
The AMC issues regulations and guidelines comprising a substantial part of the national competition legislation. The most relevant are:
There is no special authority in charge of competition issues in the pharmaceutical sector. The AMC conducts investigations and decides pharmaceutical cases and mergers following general rules and procedures.
These can be split into interim measures and decisions. During a case investigation the AMC can request that an undertaking refrain from certain practices if, in the authority’s opinion, these practices may qualify as a violation of the competition laws. The AMC may also obligate an undertaking to perform certain actions that are required to ensure the rights and interests of third parties.
Where the AMC identifies that conduct or agreements have characteristics of violation of the competition laws, it may also issue recommendations to cease such practices without opening a case investigation. If the undertakings comply with the recommendations and, where applicable, take measures to remove the AMC’s concerns, it can avoid the case investigation and sanctions that would be problematic, should the AMC complete the investigation and issue a statement of objection.
Following the case investigation, the AMC can issue a decision containing an order to bring the violation to an end and also to eliminate the consequences of the violation.
It should be noted, however, that often the AMC’s recommendations and decisions lack precision and the addressees face difficulties in understanding what exactly in their conduct raises competition concerns and how best to resolve the problematic issues. For this reason, remedies usually require follow-up negotiations with the AMC.
8. Can private parties obtain competition-related remedies if they suffer harm from anticompetitive conduct or agreements by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?
Yes, private parties can lodge complaints with the AMC. If the AMC finds that certain conduct raises competition concerns, it may impose remedies. For details on the remedies, see question 16.
Yes, the AMC does this quite regularly. The focus of the inquiries varies from year to year. Recent hot topics are:
Most of the concerns relate to abuse of dominance where the AMC tends to define markets very narrowly, both by product and geography. See question 12.
The AMC issued recommendations as a result of most of the sector inquiries. In some cases it opened investigations into suspected violations, with a few cases resulting in fines. The vast majority of fining decisions concerned abuse of dominance. The AMC also often requests or suggests remedies in its decisions, usually to refrain from increasing prices.
The AMC welcomes cooperation with such groups, but this is mainly limited to an exchange of opinions. The AMC has made an attempt to find effective ways to resolve some of the most problematic issues in marketing in the pharmaceutical sector by creating a working group with representatives of NGOs.
As regards enforcement, complaints can be lodged by parties suffering from an alleged violation that appreciably limits the mechanisms available to the groups to influence the AMC. However, various round tables and public discussions are usually taken into account by the AMC, and there have been cases where the issues raised by the groups resulted in investigations and decisions.
There are no sector-specific rules in Ukraine. Given that pharmaceutical deals are normally large-scale, a great deal of the mergers reviewed by the AMC are not domestic transactions. Still Ukrainian merger control rules capture many foreign-to-foreign transactions and there have been many decisions in such cases.
The AMC actively encourages third parties to express their opinions with respect to notified mergers by publishing short notices on its website and sending information requests to selected respondents. From a competition analysis perspective, the effectiveness of such an approach is questionable; it also makes the review process more complex and less predictable for the notifying parties, as the law is generally silent as to what extent such third parties shall be heard, and scope of their involvement is at the AMC’s discretion. Judging from past cases, the notifying parties may need to address negative opinions that are not always substantiated (eg, the authority may not have sufficient resources to do a fast and proper analysis of such responses).
Another issue is that the AMC approach to defining the relevant markets and assessing possible effects on competition is still developing, and may vary from case to case.
Historically, the AMC reviewed most mergers referring to ATC classification. In most cases, it used ATC level 3 as a starting point; recent merger cases show that the authority tends to examine at ATC4 or even ATC5 level. Over the past year, the AMC has conducted many sector inquiries that led to alternative market definitions. While the AMC continues to predominantly use ATC3 in merger cases, in other cases it would rather initiate an in-depth substitutability analysis.
The AMC often relies on various scientific studies and opinions of the competent Ukrainian associations and institutes. Where switching to an alternative product is problematic (eg, because of the established practice or other reasons why the procuring public authorities would normally stick to specific brands), the AMC is likely to consider such product as a separate market, even though there could be substitutes at the same ATC level. Other factors that are often seen as differentiating between products are, for example, galenic form, dosage or even the price. There have been cases where competing products were each considered as a separate product market because they were marketed under different brands.
As regards geography, the AMC would often consider the national market. In mergers it may also take a wider approach and look at the market more globally (in particular, with regard to APIs), especially when it comes to overlaps or claimed efficiencies.
For mergers involving retail distributors and pharmacies in particular, the markets may be defined much more narrowly (eg, within a particular city or region). In many abuse of dominance cases pharmacies were considered as having a dominant position on selected streets or other small areas. Needless to say, such an approach is heavily criticised.
In mergers, efficiencies may be taken into account, but they would not outweigh serious competition concerns at the AMC review stage. The legislation, however, provides for the possibility of seeking CMU clearance of a transaction prohibited by the AMC. This procedure is very complex and rarely used (there are no precedents in the pharmaceutical sector), but the efficiencies or other advantages should be taken into account by the CMU.
There are two tests for assessment of mergers in Ukraine. The merger can be prohibited if it either results in monopolisation or substantial restriction of competition on the market. There is no established practice on assessing the competition concerns raised by a merger, but historically the AMC has analysed whether such merger may lead to monopolisation on the relevant market.
Monopolisation is defined as obtaining or strengthening of a dominant position without further elaboration; the AMC considers any increase in the market share above the dominance threshold (irrespective of the increment) as monopolisation. Dominance is presumed to exist if the market share exceeds 35 per cent, unless the undertaking proves that it faces significant competition from its rivals; for other cases where dominance can exist, see question 29. For this reason, transactions where either party has close to or over a 35 per cent market share can be problematic, while market shares of 15 to 35 per cent are likely to draw additional attention. Still, under the Horizontal Mergers Guidelines, high market shares provide only first indicators of the competition concerns, and when assessing the merger, the following aspects should also be taken into account:
Information on the products in the pipeline is not strictly required. However, if the notifying parties seek to be as compliant as possible and include respective discussions in the notification, the AMC would likely pick up on this issue and request that the parties evaluate any possible effects.
For domestic mergers notified to the AMC, the authority may request parties not to exceed a certain level of prices for selected medicines (usually socially sensitive, eg, anti-flu drugs, over-the-counter medicines), not to limit their production without sensible reasons; it would also usually impose reporting obligations to monitor overall compliance and see how the situation develops with respect to problematic products with a view to intervene where necessary. Structural remedies are also possible. In foreign-to-foreign mergers, the AMC often imposes reporting obligations and requests that the undertakings concerned refrain from unjustified price increases; these requirements only concern products present on the Ukrainian market.
It is unclear whether acquisitions of licences constitute mergers. If, in addition to the licences, there are other assets being acquired, the merger requirement is likely to apply (assuming that the reporting thresholds are hit). If only the licence is being acquired, clearance may still be required in some situations. Additionally, if the transfer of the licence includes restrictions or may otherwise have potential effects on competition, separate antitrust clearance may be required. See question 18.
An agreement or practice can be considered anticompetitive if it has the prevention, elimination or restriction of competition as its object or effect. Below is a non-exhaustive list of practices that are hardcore restrictions:
There are also general exemptions (exempting horizontal, conglomerate and mixed arrangements) and block exemptions (exempting vertical and R&D arrangements).
Prohibition of anticompetitive practices will not apply:
However, it appears that, in practice, the value of assets or turnover test does not serve as an appropriate benchmark for the AMC to assess potential competition concerns, where effects on competition primarily depend on the market position of the parties (for example, their market shares).
If the parties are at least potential competitors, the general exemptions do not apply to horizontal or mixed hardcore restrictions, including:
The recently adopted Vertical Block Exemption Regulation generally exempts vertical restraints (save for hardcore restrictions) where the market shares of the supplier and the buyer on the market where they, respectively, sell and buy the contract goods or services, do not exceed 30 per cent.
The following practices, however, are not covered by the exemption:
The exemption under the R&D Regulation applies when the combined market share of the parties on the relevant market does not exceed 25 per cent and the parties meet a set of other criteria (ie, all parties have equal access to the results of the R&D activity; such activity does not go beyond a certain industry, etc).
When assessing their practices, undertakings may obtain advice from the AMC regarding their compliance with competition legislation. It is also possible to seek authorisation (individual exemption) of certain potentially anticompetitive concerted practices if:
Such agreements would not normally be considered anticompetitive, as far as they contain standard permissible restrictions, such as duration or territory of use of the licence, types of activities and sphere of use, as well as minimal volume of production.
However, minimal volume of production may raise the AMC’s concern if it limits the competitiveness of the undertaking, or, for example, if there exists an unreasonably high quota that may oust other companies from the market or limit their market access.
This may be the case if the cooperation removes or lessens competition between the parties having appreciable market presence (eg, securing marketing channels or control over sales). Achieved advantages, such as extra discounts or exclusivity, may also be problematic.
Any agreement or behaviour that satisfies criteria outlined in question 18. The confidentiality provisions between the parties may reduce the likelihood of the agreements coming to the AMC’s attention; still, they will not resolve the underlying issue of whether there is any anticompetitive conduct.
It is also worth mentioning that in the AMC’s opinion confidentiality provisions may be anticompetitive. The AMC has been encouraging companies to make their conditions transparent, available to third parties and end customers, justifiable and non-discriminatory. It is assumed that by having access to such conditions an interested party can better plan its activity and benefit from them generally.
Exclusivity is one of the most problematic issues. Other common problems include retroactive discounts, individualised sale terms and conditions (eg, special discounts), unreasonable additional services (eg, marketing) coupled with unjustified level of compensation for them.
There are no relevant cases or rules; general restrictions apply. The settlement will qualify as an agreement. See question 18.
There are no relevant rules or cases; the general rules apply.
This issue is not directly regulated within the framework of anticompetitive agreements and there are no relevant cases. However, public communications might be found anticompetitive if they enable the undertakings to coordinate their market conduct.
26. 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?
Exchange of information is not expressly regulated by competition laws, and general rules on concerted practices apply. In the investigations conducted by the AMC so far, the information exchange has not raised substantial concerns. However, the issue may attract more attention as the AMC’s enforcement practice evolves.
Any conduct (actions or failure or refraining to take certain actions) of a dominant (or monopolist) undertaking that resulted or may result in the prevention, elimination or restriction of competition or harm to the interests of other undertakings or consumers may be regarded as abuse of dominant (or monopolist) position on the market. In order to be found abusive, such conduct should not be possible in a highly competitive environment.
When investigating a potentially abusive conduct, the AMC must first assess whether the undertakings concerned are dominant on the relevant market. For that purpose, the AMC will primarily define the relevant product and geographical market (see question 12 for the market definition) and calculate the market share of the undertakings concerned on that market.
As a general rule, the following unilateral conduct is considered abuse of a dominant position:
The above list is indicative; it only outlines the AMC’s approach to assessment of unilateral conduct in the context of dominance. Any other type of harmful restrictive behaviour of an undertaking with market power may be found to be abusive.
There is no specific threshold; the market share test applies (see question 29).
An undertaking will be presumed to hold a dominant position if its market share on the relevant market exceeds 35 per cent, unless such undertaking proves that it faces significant competition from its rivals.
Collective dominance is presumed if the three largest market players jointly have more than 50 per cent of the market, or the five largest market players jointly have more than 70 per cent of the market.
In rare cases, a company with a smaller market share may be found dominant if such undertaking does not face significant competition from other market players, for instance, because of competitors’ considerably smaller market shares.
There are no relevant rules or cases. By analogy to other cases, a company may be found dominant, but there are many other factors that need to be analysed. Essentially, this may be the case if the patent is in use and the product is present on the market and holds a dominant position.
A patent application does not provide exclusive proprietary rights to the applicant. Limited right to compensation arises when the patent application is published; however, such compensation may only be sought after the patent has been granted. At the same time, Ukrainian patent laws are clear that the patent owner has the exclusive right to prohibit the unauthorised use of an invention or utility model by others, and is entitled to apply to court in order to enforce his or her patent rights.
Therefore, an application for, or the actual grant of a patent alone, as well as bona fide application for enforcement, cannot be viewed as an antitrust violation. However, applying for the enforcement of a patent may be considered by the AMC as unfair competition practices where the purpose of the enforcement is to prevent other companies from the legitimate business operations. For example, ‘patent trolling’ may expose the patent owner to liability for an antitrust violation.
General restrictions for unilateral conduct apply; see question 27.
There are no relevant cases. However, such communications or recommendations may be considered by the AMC as unfair competition (eg, compromising or misleading information).
34. May a patent holder 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?
Such actions are not prohibited under the Competition Law as far as they do not contradict requirements established for concerted practices (see questions 18 and 27), though there is no relevant practice.
No special restrictions, general rules or prohibitions apply (see questions 18 and 27).
The AMC considers a parallel behaviour as important evidence of antitrust practices when it does not correspond to normal conditions of the market. There is no available AMC practice on this issue in the pharmaceutical sector. Such cases predominantly concern markets for fuel and liquefied natural gas.
In the most recent cases in the pharmaceutical sector, the AMC fined the undertakings for anticompetitive concerted practices through the overpricing of pharmaceuticals sold through public tenders as compared to other sales channels. More specifically, such entities gave additional discounts to the distributors after winning public procurement tenders. However, the discounts did not decrease the price at which the products were sold as the amounts of the discounts were deducted from future purchases.
Setting prices or conditions that could not have been established in a considerably competitive market environment or applying different prices or conditions to identical agreements without valid justification are considered abuses of a dominant market position. In the analysis of the pricing practices, the authority insisted that, normally, the price is justified from the economic perspective if it includes all related costs and an adequate, for the analysed market, profit level. Price below cost is likely to be considered predatory if the setting of such a price would not have been possible in a highly competitive environment. Setting prices at such a low level with a view to hinder competitors’ access to the market or oust them from the market will increase the likelihood of such a conclusion. Even if this purpose cannot be verified, the AMC will assess whether the prices applied for the period were sufficient for the above outcome to be realised. Exploitative abuses, especially as regards the setting of unjustifiably high prices (excessive pricing), are the most typical violations investigated by the AMC.
Pursuant to the Competition Law, the general test applies: whether the analysed price would have been possible in a highly competitive environment.
There are no specific rules, but various efficiencies are more likely to be accepted by the AMC as justification than in other industries.
Current proposals for antitrust regulation and enforcement in the pharmaceutical sector include the following.
Adoption of the guidelines on the assessment of non-horizontal mergers
In mid-December 2017, the AMC shared the draft guidelines on the assessment of non-horizontal mergers looking for public opinion on the draft.
The draft document covers vertical and conglomerate mergers and envisages the review process to be followed by the AMC in assessing such mergers with the criteria for defining relevant product and geographical markets, as well as evaluating the impact of a merger on the competition. Generally, the draft document incorporates the relevant provisions of the Guidelines on the assessment of non-horizontal mergers, issued by the EU Commission.
Market definition methodology
At the end of 2017, the AMC published the draft methodology of market definition developed in accordance with EU legislation. The draft methodology outlines the approach to relevant market definition (including antitrust violation) and would be the starting point in any investigations into potential infringements.
If the proposed draft methodology is adopted, the hypothetical monopolist testing and the method of indicators of price flexibility of demand will be applied alongside the existing analysis of the interchangeability of goods.