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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?
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2.
Are drug prices subject to regulatory control?
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3.
Is there specific legislation on the distribution of pharmaceutical products?
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4.
Which aspects of this legislation are most directly relevant to the application of competition law to the pharmaceutical sector?
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5.
Which legislation sets out competition law?
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6.
Which authorities investigate and decide on pharmaceutical mergers and the anticompetitive nature of conduct or agreements in the pharmaceutical sector?
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7.
What remedies can competition authorities impose for anticompetitive conduct or agreements by pharmaceutical companies?
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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?
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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?
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10.
To what extent do non-government groups play a role in the application of competition rules to the pharmaceutical sector?
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11.
Are the sector-specific features of the pharmaceutical industry taken into account when mergers between two pharmaceutical companies are being reviewed?
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12.
How are product and geographic markets typically defined in the pharmaceutical sector?
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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?
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14.
Under which circumstances will a horizontal merger of companies currently active in the same product and geographical market be considered problematic?
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15.
When is an overlap with respect to products that are being developed likely to be problematic? How is potential competition assessed?
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16.
Which remedies will typically be required to resolve any issues that have been identified?
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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?
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18.
What is the general framework for assessing whether an agreement or practice can be considered anticompetitive?
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19.
To what extent are technology licensing agreements considered anticompetitive?
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20.
To what extent are co-promotion and co-marketing agreements considered anticompetitive?
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21.
What other forms of agreement with a competitor are likely to be an issue? Can these issues be resolved by appropriate confidentiality provisions?
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22.
Which aspects of vertical agreements are most likely to raise antitrust concerns?
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23.
To what extent can the settlement of a patent dispute expose the parties concerned to liability for an antitrust violation?
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24.
To what extent can joint communications or lobbying actions be anticompetitive?
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25.
To what extent may public communications constitute an infringement?
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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?
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27.
In what circumstances is conduct considered to be anticompetitive if carried out by a firm with monopoly or market power?
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28.
Is there any de minimis threshold for a conduct to be found abusive?
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29.
When is a party likely to be considered dominant or jointly dominant?
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30.
Can a patent holder be dominant simply on account of the patent that it holds?
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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?
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32.
When would life-cycle management strategies expose a patent owner to antitrust liability?
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33.
Can communications or recommendations aimed at the public or HCPs trigger antitrust liability?
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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?
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35.
Can actions taken by a patent holder to limit off-label use trigger antitrust liability?
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36.
When does pricing conduct raise antitrust risks? Can high prices be abusive?
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37.
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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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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