Authorized generic drugs (AG’s) : η διείσδυσή τους στη φαρμακευτική αγορά, η ΄΄υβριδική στρατηγική΄΄ ματαίωσης του ανταγωνισμού και οι οικονομικές επιπτώσεις στο δημόσιο σύστημα υγείας και τους ασθενείς, από την καθυστερημένη εισαγωγή των ΄΄true generics΄΄ στην αγορά
Authorized generic drugs (AG’s) : their penetration in the pharmaceutical market, the ΄΄hybrid strategy΄΄ of thwarting competition and the economic impact on the public health system and patients, from the delayed introduction of ΄΄true generics΄΄ on the market
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Keywords
Εξουσιοδοτημένα γενόσημα ; Κοινόχρηστα γενόσημα ; Στρατηγικές ματαίωσης ; Ανταγωνισμός ; Γενόσημα ; Πολιτική υγείαςAbstract
The high prices of original medicines are particularly affected by the timely availability of generic medicines on the market, which is a central issue for healthcare, since medicines represent the third largest cost element in the healthcare budgets of the European Union Member States. Several practices/strategies have been used to delay the availability of affordable generic drugs into the world markets. These include reverse payment or pay-for-delay patent settlements, "authorized generics", restrictive distribution based on abuse of risk assessment and enhancement policies to mitigate drug side effects, product hopping, lobbying against cross-border drug importation, buying out the competition, and others.
The scope of this study is to analyse these practices/strategies and how they can be prevented. The study relies on qualitative research based on a wide literature review on the issue. It analyses the delay in the availability of affordable generic drugs as a global problem and examines the specific case of the European Union and Greece. It also develops a theoretical model of explaining the production and promotion strategy of "authorized generics" by branded pharmaceutical companies. The study is particularly useful for policy makers and health care policy scholars.