EGA Press Release

Monday, 20 June 2005

EU PRICING & REIMBURSEMENT SYSTEMS HINDER GENERIC COMPETITON AND INCREASE HEALTHCARE COSTS

“Europe’s pricing and reimbursement systems for pharmaceutical products are hindering competition in the sector and interfering with the creation of optimum conditions for delivering affordable quality healthcare in the EU”.

Speaking today at the 8th Annual IGPA International Generics Conference in Malta, Emile Loof, president of the European Generic Medicines Association (EGA), delivered a clear message: “Europe’s pricing and reimbursement systems for pharmaceutical products are hindering competition in the sector and interfering with the creation of optimum conditions for delivering affordable quality healthcare in the EU”.

While recognising that healthcare delivery is the exclusive competence of the individual Member States, Mr Loof pointed out that it is in their own national interest to work together to overcome the complex patchwork of pricing & reimbursement systems that create unnecessary delays entry onto the market for affordable generic medicines. Depending on the Member State, these post-market authorisation delays typically take from as little as 3 to 4 weeks in countries like Denmark and the Netherlands to as much as 36 weeks in Belgium and the Slovak Republic. More worryingly, this wide spread in time taken up in P&R negotiations bears little or no relationship with how healthcare systems are organised, nor with the pricing mechanisms or reimbursement methods employed.

The question must be asked why market entry is blocked for a product whose quality, safety and efficacy has already been proven, that has received market authorisation and that, by definition, is less expensive to healthcare systems than its originator competitor? Current Member State pricing & reimbursement systems effectively restrain market competition longer than necessary and hinder the optimal production and delivery of pharmaceutical products. This results in excessive prices for the country’s sick fund, excessive fees and taxes on industry and excessive co-payments for patients.

In order for the generic medicines industry to continue stimulating competition — which drives the development of newer products, reduces pharmaceutical prices and frees up funds to increase overall healthcare services — P&R systems must be reformed to provide generic products with timely entry onto the market in order to ensure the rapid and widespread availability of generics to doctors and patients.

Mr Loof went on to affirm that:

“Without generics, healthcare systems cannot afford to provide optimal levels of quality healthcare. A sound generic medicines industry delivers significant benefits to the EU economy, to national economies and to the level of health in the individual Member States. If the Member States want to continue benefiting from lower-priced generic medicines in their efforts to promote better health at affordable prices, they need to take care of the industry by simplifying and accelerating pricing and reimbursement procedures.”

Summary of Emile Loof's Presentation

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