Sustaining Generic Medicines Markets in Europe

Sustaining generic medicines markets 489.2 Generic medicines policy9.2.1 Intellectual property rightsTo compensate for the delay between the date of filing the patent application and the date ofmarketing authorisation of the medicine, patent protection could be extended by up to sevenyears. This legislation was introduced in France in 1990, three years before the implementation ofthe EU Supplementary Protection Certificate for a maximum period of five years in 1993. Theconcept of a ‘generic medicine’ has only been defined as recently as 1997.9.2.2 PricingMedicine prices in France tend to be lower than in other EU countries (Le Pen, 2003). Genericmedicines need to be at least 30% cheaper than the originator medicine. In 2005, theGovernment imposed an additional price cut of 10% on existing generic medicines and the priceof new generic medicines was set at 40% below the price level of the originator medicine. Theminimum price difference between originator and generic medicines increases to 50% in 2006.Additionally, prices of off-patent medicines are reduced by 15%-19% in 2006.9.2.3 Reference pricingA RPS by active substance was launched for those active substances with generic medicinesubstitution rates of less than 45% in 2003. The average price of generic medicines determinesthe RP. Following the implementation of the RPS, the price of 65% of originator medicinesdropped to the level of the RP (Peny, 2005). Furthermore, as reference groups are organized byactive substance, re-allocation of demand away from a RPS group to patented medicines with asimilar therapeutic indication seems to have occurred (Le Pen, 2005).9.2.4 Incentives for physiciansIn France, physicians have tended to be reluctant to prescribe generic medicines because theyvalue their prescribing freedom, are visited by originator medicine companies, and are used toprescribing brand-name medicines (Blachier and Kanavos, 2005).Physicians face some incentives to prescribe generic medicines:• Clinical guidelines have been implemented, but no sanctions have been imposed on noncompliancewith guidelines (Durieux et al., 2000).