Slow process: 48 treatments awaiting approval in the Netherlands already used in Germany

The Netherlands takes much longer than other countries to give patients access to new medicines and treatments. The Netherlands currently has 51 treatments and medicines awaiting approval. 48 of these are already available in neighboring Germany, including two developed in cooperation with Dutch hospitals, AD reported.

The vast majority of these are cancer treatments. They have already been approved by the European Medicines Agency (EMA), but the Netherlands has placed them in the “pipeline” for approval due to how expensive they are.

According to AD, the delay stems from the Netherlands first re-examining all drugs in the pipeline to see if they add value compared to existing treatments and whether the health benefits outweigh the price. Then, the Netherlands negotiates prices with the pharmaceutical companies involved. On average, medicines spend 665 days - one year and nine months - in the pipeline before approval.

In Germany, the drug enters the market almost immediately after EMA approval, and price negotiations happen after that. The country set a maximum of six months for these negotiations, and they almost always reach an agreement with the pharmaceuticals involved, Mark Kramer of the Association of Innovative Medicines told AD.

Remarkably, two medicines in the Dutch pipeline that are already being used in Germany - drugs to treat the bone marrow cancer multiple myeloma - were developed in close cooperation with Dutch hospitals. These medicines keep the cancer dormant for longer and improve the patient’s quality of life.

According to Kramer, the Netherlands is taking longer and longer to approve medicines and is also increasingly failing to reach an agreement on price. He called it good that the country conducts tough price negotiations, but points out that these have not led to enormous price differences compared to neighboring countries.

It will take years to determine whether the Netherlands’ slow approval process is costing lives, Kramer said. "If a tumor remains in remission longer, we will only know that later. It will also become clear then what the effect is if the quality of life improves or if there are fewer side effects."