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  • 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?

  • 2.

    Are drug prices subject to regulatory control?

  • 3.

    Is there specific legislation on the distribution of pharmaceutical products?

  • 4.

    Which aspects of this legislation are most directly relevant to the application of competition law to the pharmaceutical sector?

  • 5.

    Which legislation sets out competition law?

  • 6.

    Which authorities investigate and decide on pharmaceutical mergers and the anticompetitive nature of conduct or agreements in the pharmaceutical sector?

  • 7.

    What remedies can competition authorities impose for anticompetitive conduct or agreements by pharmaceutical companies?

  • 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?

  • 9.

    May 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.

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

  • 11.

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

  • 12.

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

  • 13.

    Is it possible to invoke before the authorities the strengthening of the local or regional research and development activities or efficiency-based arguments to address antitrust concerns?

  • 14.

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

  • 15.

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

  • 16.

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

  • 17.

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

  • 18.

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

  • 19.

    To what extent are technology licensing agreements considered anticompetitive?

  • 20.

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

  • 21.

    What other forms of agreement with a competitor are likely to be an issue? Can these issues be resolved by appropriate confidentiality provisions?

  • 22.

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

  • 23.

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

  • 24.

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

  • 25.

    To what extent may public communications constitute an infringement?

  • 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?

  • 27.

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

  • 28.

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

  • 29.

    When is a party likely to be considered dominant or jointly dominant?

  • 30.

    Can a patent holder be dominant simply on account of the patent that it holds?

  • 31.

    To what extent can an application for the grant or enforcement of a patent expose the patent owner to liability for an antitrust violation?

  • 32.

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

  • 33.

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

  • 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?

  • 35.

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

  • 36.

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

  • 37.

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

  • 38.

    Has national enforcement activity in relation to life-cycle management and settlement agreements with generics increased following the EU Sector Inquiry?

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Arnold & Porter is a leading law firm, with over 1,000 lawyers practising in its thirteen American and European offices in virtually every transactional, regulatory, and dispute resolution discipline.

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United Kingdom
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