![]() ![]() This level is normally used as a starting point in the definition of relevant product markets. These groups of drugs normally have the same therapeutic indication and may not be substituted with products under a different ATC3. The third level (ATC3) allows the grouping of drugs based on their therapeutic indications and may be used as an operational market definition. The first level (ATC1) is the most general one and the fourth one (ATC4) is the most detailed one. How are the product and geographic markets typically defined in the pharmaceutical sector?Ī specific feature of the pharmaceutical market consists of the existence of a classification system in which drugs are grouped as per functional substitutability in other words, as per therapeutic indications, the anatomic therapeutic chemical (ATC) system is hierarchically organised and comprises 16 categories (A, B, C and D) each having up to four levels. ![]() In contrast, the grant of a licence would not be deemed a notifiable operation if there was no current revenue generating activity associated with it (eg, a licence for the global distribution of a future pipeline pharmaceutical would not normally amount to a notifiable merger). In other words, the acquirer would be taking over an existing market position of the seller. Thus, for the acquisition of a patent to be subject to merger control, such patent or licence needs to generate revenues for the seller and be attributed a market share. Similar to EU legislation, only a transfer of business is deemed an economic concentration and thus subject to merger control. Is the acquisition of one or more patents or licences subject to merger notification? If so, when would that be the case? There are the same thresholds as for any other merger: worldwide turnover of over €10 million of all parties involved and at least two parties involved each with over €4 million Romanian turnover (both turnovers having been obtained in the financial year prior to the transaction). What are the relevant thresholds for the review of mergers in the pharmaceutical sector? Review of mergers Thresholds and triggers ![]()
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