A global pharmaceutical company established in Greece for over half a century and Marketing Authorization Holder (MAH) for, among many, a medicinal product which was registered with the so-called “positive list” of prescription medicines, had applied for the removal of the specific drug from the “positive list”. The reason was that with the lapse of time, the essential financial conditions of public cover cost for the marketing of the drug had disadvantageously worsened.
Rokas Law Firm represented by partner Christos Theodorou filed an application for annulment before the Council of State, arguing against the legitimacy of the Decision of the Minister of Health which rejected the removal of the drug from the “positive list”. For reasons of wider significance, the Court heard the case in a seven-judge formation and issued decision n. 164/2020 which held that the contested administrative act had violated article 12 paragraph 1 of Law nr 3816/2010.
As a consequence a new precedent was formed, according to which the MAH of a pharmaceutical product for which the cost is covered by the State and the social security organizations, may decide for this product to be excluded from the “positive list”, and the sole will of the MAH is sufficient for such de-listing, unless any special provisions of the law provide otherwise, i.e. for a different procedure.