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1.
Regulatory framework
What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?To read more
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2.
Regulatory authorities
Which authorities are entrusted with enforcing these rules?To read more
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3.
Pricing
Are drug prices subject to regulatory control?To read more
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4.
Distribution
Is the distribution of pharmaceutical products subject to a specific framework or legislation? Do the rules differ depending on the distribution channel?To read more
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5.
Intersection with competition law
Which aspects of the regulatory framework are most directly relevant to the application of competition law to the pharmaceutical sector?To read more
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6.
Legislation and enforcement authorities
What are the main competition law provisions and which authorities are responsible for enforcing them?To read more
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7.
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?To read more
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8.
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?To read more
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9.
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?To read more
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10.
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?To read more
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11.
NGO involvement
To what extent do non-government groups play a role in the application of competition law to the pharmaceutical sector?To read more
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12.
Thresholds and triggers
What are the relevant thresholds for the review of mergers in the pharmaceutical sector?To read more
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13.
Is the acquisition of one or more patents or licences subject to merger notification? If so, when would that be the case?To read more
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14.
Market definition
How are the product and geographic markets typically defined in the pharmaceutical sector?To read more
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15.
Sector-specific considerations
Are the sector-specific features of the pharmaceutical industry taken into account when mergers between two pharmaceutical companies are being reviewed?To read more
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16.
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?To read more
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17.
Horizontal mergers
Under which circumstances will a horizontal merger of companies currently active in the same product and geographical markets be considered problematic?To read more
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18.
Product overlap
When is an overlap with respect to products that are being developed likely to be problematic? How is potential competition assessed?To read more
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19.
Remedies
Which remedies will typically be required to resolve any issues that have been identified?To read more
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20.
Assessment framework
What is the general framework for assessing whether an agreement or concerted practice can be considered anticompetitive?To read more
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21.
Technology licensing agreements
To what extent are technology licensing agreements considered anticompetitive?To read more
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22.
Co-promotion and co-marketing agreements
To what extent are co-promotion and co-marketing agreements considered anticompetitive?To read more
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23.
Other agreements
What other forms of agreement with a competitor are likely to be an issue? How can these issues be resolved?To read more
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24.
Issues with vertical agreements
Which aspects of vertical agreements are most likely to raise antitrust concerns?To read more
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25.
Patent dispute settlements
To what extent can the settlement of a patent dispute expose the parties concerned to liability for an antitrust violation?To read more
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26.
Joint communications and lobbying
To what extent can joint communications or lobbying actions be anticompetitive?To read more
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27.
Public communications
To what extent may public communications constitute an infringement?To read more
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28.
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?To read more
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29.
Abuse of dominance
In what circumstances is conduct considered to be anticompetitive if carried out by a firm with monopoly or market power?To read more
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30.
De minimis thresholds
Is there any de minimis threshold for a conduct to be found abusive?To read more
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31.
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?To read more
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32.
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?To read more
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33.
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?To read more
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34.
When would life-cycle management strategies expose a patent owner to antitrust liability?To read more
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35.
Communications
Can communications or recommendations aimed at the public, HCPs or health authorities trigger antitrust liability?To read more
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36.
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?To read more
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37.
Restrictions on off-label use
Can actions taken by a patent owner to limit off-label use trigger antitrust liability?To read more
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38.
Pricing
When does pricing conduct raise antitrust risks? Can high prices be abusive?To read more
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39.
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?To read more
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Updates and trends
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