Study Shows EU Generics Opportunities on the Rise

A recent report by European Union (EU) media portal EuroActiv.com places the value of the EU's generics market at EUR7bn (US$8.80mn), and notes that generic prescribing remains well below that in the US. However, greater use of generics in some large markets is now looking inexorable.

The study notes that generics account for 41% of the drug market in Germany, roughly 22% in the UK and less than 4% in France and Spain. Although this is variously attributed to market conditions for new medicines, historic pricing and prescribing patterns and differing incentive structures, new EU laws bode well for the industry. Notably, EuroActiv calls the latest EU legislation a sound compromise, which advances the cause of generics as well as boosts protection granted to originator pharmaceutical companies.

A number of specific EU measures favour generics, such as the so-called Bolar Exemption, which allows generics makers to submit their own versions for approval prior to the expiry of the ethical equivalent. Meanwhile, national governments are also implementing their own rules to encourage generics, such as France's requirement that doctors write 12.5% of all prescriptions generically. Nevertheless, there are exceptions to this positive outlook. The study notes that overall drug prices are currently so low in Spain, Greece and Italy that local health insurance organisations do not actively promote generics as a low-cost alternative.

However, the expiry of several blockbuster medicines could change this picture in the short term. Major products set to lose protection in the EU include Bristol-Myers Squibb's Pravachol (pravastatin); Merck & Co.'s Zocor (simvastatin); TAP's ulcer treatment Prevacid (lansoprazole); sanofi-aventis' antithrombotic Lovenox (enoxaparin), beta interferon; and Pfizer's Zoloft (sertraline) antidepressant.