Sustaining Generic Medicines Markets in Europe

Sustaining generic medicines markets 7514 Strengthening generic medicines marketsBased on the experience of developing generic medicines markets in selected countries, this partof the report proposes a number of recommendations to strengthen generic medicines markets.The guiding principle used here is recommendation 4 of the report prepared by the G10 HighLevel Group on Innovation and Provision of Medicines in the European Union in 2002:“To secure the development of a competitive generic market. Member States – facilitated by theCommission – should explore ways of increasing generic penetration in individual markets(including generic prescribing and dispensing. Particular attention should be given to improvedmarket mechanisms in full respect of public health considerations.”General recommendations for the group of selected countries as well as recommendations foreach individual country are suggested.14.1 General recommendations1. Introduce a coherent generic medicines policyPolicy intervention is required to develop a competitive generic medicines market. A genericmedicines policy requires both supply-side measures (pricing and reimbursement) and demandsidemeasures (incentives for physicians, pharmacists, patients). Attention needs to be paid tointeractions between policy measures. Different policy measures need to reinforce each otherand be part of a coherent generic medicines policy.2. Encourage price differentiation / competition within existing regulatory frameworksAll countries studied have introduced pricing regulation to some extent. This has taken the form ofdirect fixed price controls, profit controls or reference pricing. Countries can establish a system offixed minimum price differences between generic and originator medicines in the context ofexisting RPS. This approach has the benefit of guaranteeing savings to health insurance funds,although it is not clear at what level maximum prices need to be set. Health insurance funds willlose out if they have established prices at a higher level than would have been observed in acompetitive market.An alternative approach is to establish a free pricing system within the context of existing RPS.The RP can be set at the average price level of generic medicines in the reference group or at a