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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?

  • 2.

    Regulatory authorities
    Which authorities are entrusted with enforcing these rules?

  • 3.

    Pricing
    Are drug prices subject to regulatory control?

  • 4.

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

  • 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?

  • 6.

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

  • 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?

  • 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?

  • 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?

  • 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?

  • 11.

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

  • 12.

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

  • 13.


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

  • 14.

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

  • 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?

  • 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?

  • 17.

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

  • 18.

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

  • 19.

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

  • 20.

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

  • 21.

    Technology licensing agreements
    To what extent are technology licensing agreements considered anticompetitive?

  • 22.

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

  • 23.

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

  • 24.

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

  • 25.

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

  • 26.

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

  • 27.

    Public communications
    To what extent may public communications constitute an infringement?

  • 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?

  • 29.

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

  • 30.

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

  • 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?

  • 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?

  • 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?

  • 34.


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

  • 35.

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

  • 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?

  • 37.

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

  • 38.

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

  • 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?

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Caiado Guerreiro, previously named Franco Caiado Guerreiro, has a general practice in all areas of law. However, the firm is better known for its services in areas such as: commercial and corporate law, mergers and acquisitions, banking, finance tax and fund law, labour and social security law, real estate law and intellectual property, as well as the areas of telecommunications, Media and Technology (TMT).

View more information about Caiado Guerreiro, SP, RL


Lisbon
Rua Castilho, 39–15
1250-068
Lisbon
Portugal
T: +351 213 717 000


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