When a compulsory licence has been granted, regulatory data protection could prevent the effective use of the compulsory licence as it impedes the authorisation of generic medicinal products. That situation would have serious negative consequences for Union compulsory licences granted to tackle a crisis, as it could affect access to medicinal products needed to address the crisis or emergency. For that reason, it is important that the relevant Union law on pharmaceuticals provide for the suspension of data exclusivity and market protection, in particular where a compulsory licence has been granted to tackle a public health emergency. Such suspension should be allowed only in relation to the granted compulsory licence and its beneficiary and should be consistent with the objectives, the territorial scope, the duration, and the subject matter of that compulsory licence. That suspension means that the data exclusivity and market protection have no effect in relation to the licensee under the compulsory licence while that licence is valid. When the compulsory licence expires or is terminated, the data exclusivity and market protection should resume. That suspension should not result in an extension of the original duration of the regulatory data protection.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
