Limitation on Compulsory Licensing Sample Clauses

Limitation on Compulsory Licensing. Relating to this flexibility, the TRIPs Agreement imposes specific conditions on Member States to admit compulsory licenses: • authorization of such use will be considered on its individual merits; • authorization will be granted in some cases only if the proposed user has made efforts to obtain the license on reasonable commercial terms; • the scope and duration of the authorization must be limited; • authorization is non-exclusive; • the predominant objective of the authorization must be to supply the domestic market; • the authorization may be suspended if the circumstances that led to it cease to exist, while protecting the interests of the authorized party; and • the patent holder will be given adequate remuneration, taking into account the economic value of the authorization.148 These are the minimum conditions stipulated by the Agreement, and Member States must fulfill them when they grant compulsory licenses. The conditions must, therefore, be included in the new national patent legislation.149 Besides those expressly mentioned minimum standards, the main limitation of a compulsory license, in practice, is that a country needs to have a reasonably sophisticated pharmaceutical industry in order to produce the medicine concerned, and must be able to achieve economies of scale to bring the price down to affordable levels.150 The great majority of developing countries fail on both counts. The solution might be to import from a generic manufacturer in a larger country but this is unlikely to be economically viable 148 See Article 31 in TRIPs Agreement.