Controversy continues over new generic drug law in Germany

By Ned Stafford

FRANKFURT, Germany (Reuters Health) – Physicians in Germany this week fired the first shots of what could be a war over whether doctors or pharmacists will control the selection of drug brands used to fill patient prescriptions.

Sharply worded press statements from physicians came after the Bundesrat, or upper house of Parliament, on Friday approved German Health Minister Ulla Schmidt's "medicine savings package." Drug prices increased in Germany in 2001; and Schmidt claims that her package will save Germany's public health insurance system 1.3 billion euros this year.

Germany's doctors, as well as leading drug companies, have been vehemently opposed to a major component of the package, which in most cases would require doctors to prescribe the generic brand of a drug. Pharmacists then would be required to fill the prescription with a product in the lower third of the price range for that specific drug. Schmidt says the measure will result in savings of 230 million euros this year.

Various doctors groups put up fierce political resistance to the generic drug law, arguing that they–not pharmacists–should have ultimate authority of which product is used to fill a prescription. Supporters of the new law contend that doctors are opposed to the legislation for personal financial reasons. They contend that some doctors receive gifts and excessive free drug samples from some drug companies, and that the new law would interfere with this relationship.

Health Minister Schmidt declared victory last Friday, and in a written statement declared: "Today's approval of the medicine savings package has guaranteed that in the future drugs will be available at reasonable prices."

Doctors wasted no time attacking the new regulation, which will go into effect in the next few weeks. Dr. Hans-Juergen Thomas, head of the national doctor's association Hartmannbund, issued a statement calling the new regulation an "affront to the therapeutic responsibility of doctors."

But despite the outrage by doctors, the new regulation does allow them to name a specific brand of drug on prescriptions in cases where there is a valid medical reason. In such cases, the doctor needs to check a box on the subscription, which informs the pharmacist that no substitutions are allowed.

Dr. Thomas, in his statement, appealed to all doctors to always check the box to ensure that their "therapeutic responsibility" is not taken over by pharmacists.

Florian Lanz, a Health Ministry spokesman, told Reuters Health that doctors had a duty to adhere to the new law, and only check the box for a valid medical reason. "We think that they will follow the law," he said.

Dr. Thomas could not be reached for comment, but Hartmannbund spokesman Peter Orthen-Rahner told Reuters Health that the organization felt strongly about its responsibility to patients and was prepared for a confrontation.

He declined to quantify how many doctors would participate in the battle against the law, saying only: "We think we will have a broad front." Orthen-Rahner added: "We have been talking to a lot of doctors, and not one has yet spoken against always checking the box."

Rainer Braun, head of the Federal Union of Pharmacist Associations (ABDA), said pharmacists strongly support the new generic law because, in addition to helping brake the rise in drug prices, it will allow them to keep fewer drugs in stock.

He is skeptical of the doctors' reasons for opposing the new law. "It is not for the interest of the patients," he said. "It is for the interest of the physicians."

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