A group of regulators from Germany published in the British Medical Journal a recommendation on how drug companies should design clinical trials. These “recommendations” curiously align with Germany’s unwillingness to pay for efficacious drugs.
There are two regulatory bodies in Germany that check whether a new drug is better than an old treatment and pay accordingly, IQWiG and the G-BA. Not surprisingly when the Germans decided to check most new drugs they found that a majority of them (56%) showed “no added benefit.” Notwithstanding the obvious conflict of interest with the German government both approving and paying for new drugs, there are two major problems with Germany’s approval process. The unnecessary cost they are asking the drug companies to absorb and the capricious way they judge whether a drug is efficacious.More