Drugmakers in Germany are expected to pay over 1 billion euros in mandatory rebate contracts this year, and this is risking the future of the small and medium-sized enterprises (SMEs) which account for over 70% of the sector, warns industry group the BPI.

In the first nine months of 2010, the industry paid more than 700 billion euros through the rebate contracts, which are mandatory under the government’s health reforms and apply to medicines not included in the reference price system operated by the statutory health insurance system, the Gesetzliche Krankenversicherung (GKV). The rebates, which were increased from 6% to 16% in August, are expected to create savings for the GKV of over 1 billion euros by year-end, the Health Ministry has forecast.

Last year, spending on pharmaceuticals by the GKV rose 4.5% to 30.7 billion euros. Drug prices increased just 0.3% for the year, while volume sales were up 1.5% and structural growth in the market increased 2.7%. Sales of products which are covered by the mandatory rebate contracts fell 2% in terms of value during the period, while patented brand-name drugs’ sales soared 8.9%.

In 2011, sales of new medicines which are not covered by the reference price system are expected to reach some 11 billion euros, but it is forecast that the GKV will claw back around 16% of this amount, and other measures - including the rebate contracts, the three-year price freeze and a widening of the reference price system - will allow it to make total savings of around 2 billion years for the year, according to the industry group.

In addition, from next January manufacturers of innovative new medicines will be required to enter into price negotiations with the GKV.

Prices of drugs which are reimbursed by the statutory health system have fallen around 10% during 2000-9, due to the continual introduction of cost-containment measures over the period, while those of products which are not reimbursed have increased more than 20%, notes a commentary from IHS Global Insight.

It also points out that the top-selling drugs in the GKV market last year were human insulins and analogues, rising 1.03% in the period, followed by: antipsychotics (+16.68%); antiulcer drugs (-8.48%);  bacterial vaccines (-17.65%); and anti-TNF therapies (+23.87%).

- Meantime, a new report from RNCOS forecasts that the German pharmaceutical market will grow by “a stupendous” 4.8% a year on average to 2012, driven by the nation’s increasing incidence of chronic and lifestyle diseases. It is also projects that the industry’s export trade is set to grow, in line with the nation’s economic recovery.