Medications in the US Are More Widely Available than in Germany

A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine that access to medication was wider and quicker in the United States than in Germany.

Initially, researchers conducted this study to compare the impacts of drug approvals on drug costs.

In the publication, the researchers state, “One country that is often highlighted for its unique approach is Germany, which allows manufacturers to set unconstrained prices for medicines at launch but requires that all medicines undergo a systematic assessment of their effectiveness, permitting insurers to renegotiate prices after this assessment. This policy has guaranteed that almost 98% of effective medicines for specific indications are kept on the market and increased the likelihood 10-fold that medicines not deemed beneficial were withdrawn from the market.

The reviewers analyzed data on nearly 600 new medications and found that, in the US, 92% of all potential therapies were available. This is approximately 12% greater than Germany’s 80% available treatments. Additionally, they found that approval of drugs in the US occurred about four months sooner than in Germany.

“This analysis highlights two differences between the US and Germany — earlier approvals and more approvals in the US. We found that several medicines that were not ultimately approved by the FDA were available in Germany, and some were subsequently withdrawn by the European Union. Medicines with therapeutic substitutes were available in both markets. More research is needed to determine whether medicines that are available in the US but not in Germany offer added therapeutic benefits over the existing alternative,” stated the researchers in the publication.

Researchers were able to conclude some trade-offs of each health system of approvals. Despite the data collected in this study, further data needs to be collected on the outcomes of each kind of drug regulation. An additional cost analysis on the impacts on patients and payers would be beneficial.

The current FDA regulatory methods will continue until a universally better system is developed, tested, and implemented. Pharmaceutical companies, researchers, and providers will navigate this system accordingly.