PHP45 Impact of Generics Policy on the Generic Penetration

Abstract

IMPACT OF GENERICS POLICY ON THE GENERIC PENETRATION Ammar H1, Remuzat C2, Toumi M3 1Creativ-Ceutical, Paris, France, 2Creativ-Ceutical France, Paris, France, 3University Claude Bernard Lyon 1, Lyon, France OBJECTIVES: There is an important heterogeneity in generic penetration among EU countries. A North-South gradient in generics market share is often quoted with no reference to policy. Our aim was to compare policies, conditions of penetration and impact of the generics entries in selected countries to represent large and small, Northern and Southern, Eastern and Western EU countries. METHODS: We identified policies and generics market share in volume and value in France, UK, Germany, Poland, Greece, Hungary and Portugal. We browsed websites of EU and national (when applicable) drug agencies, ministry of health, HTA bodies, payers, manufacturer unions etc. We completed our research with literature search and grey reports, as well as Datamonitor reports, IMS data and proprietary pharmavitae database. RESULTS: There is a wide variability between countries concerning generics entry policy. Generics are available from date of their market approval up to 180 days after. Generics prices range from par price to 60% lower than branded product. In some countries, the generics entries impact the price of the whole class by regulatory rules, while it may be company free decision in others. In Hungary, brands are excluded from the market at generic entry. Besides, discount on brands vary from 0 to 50%. Generic substitution is driven by either local mandatory requirements or financial pharmacist incentives. As a consequence, the generic market share varies between 25 to 80% in volume and 20 to 70% in value. The lowest savings are found in Southern EU while UK and Germany have the largest savings. Even though Hungary eliminates brands after generic entry, the mix keeps favouring remaining brands in the same class. CONCLUSIONS: Generics policy varies dramatically from one country to another. This explains the major differences observed across countries on the drug budget associated with generic entry.