Many generics, i.e. medicines for which patent protection no longer exists, are no longer manufactured in Germany and also not in Europe. Germany is now in danger of falling behind in international competition as a location for research into new medicines. “The erosion of Germany as a location for pharmaceutical innovation has long since begun,” according to a study published on Monday by the Association of Research-Based Pharmaceutical Companies vfa and the consulting firm Kearney.
The authors use the number of clinical studies carried out in Germany as a measure of this. Before a drug is approved, it is tested in clinical trials in several phases with an ever-increasing number of participants for tolerability, quality and effectiveness. For a long time, Germany was number one in Europe and number two in the world after the USA. According to the study, the USA was ahead in 2021 with around 12,500 clinical studies. China followed in second place with almost 7700 studies. France, Spain, Great Britain and Canada also overtook Germany, with only a good 2700 studies being carried out in this country in 2021.
In the medium term, this will have significant consequences for “several tens of thousands of patients” in Germany, says Matthias Meergans, one of the authors of the study and responsible for research and development on the vfa board. “Because they cannot take part in studies, they only get access to innovative medicine years later, only in standard care, i.e. when the drug is approved in Germany.” According to a study in Germany, almost 180,000 patients took part in clinical studies in 2021. There could be more, but in this country it is difficult to get national information about the possibility of participating in ongoing studies, doctors rarely point this out to their patients.
Why Germany loses in the competition
According to Meergans, there are many reasons why Germany is losing in the competition. The procedure for approving clinical trials is too complex. For example, there is data protection, which the ethics committees have to monitor, without whose approval clinical studies cannot take place. As of February 2023, around three dozen such commissions alone were registered with the Federal Institute for Drugs and Medical Devices (Bfarm). Among other things, they check whether the risks and burdens for the participants are in good proportion to the expected benefits. If there are conflicting data protection requirements in different federal states, then the process takes too long, says Meergans. There is also room for improvement in the contracts between the sponsor, i.e. the pharmaceutical company that applies for the study, and the university where it is carried out. Actually, there are text modules for the clauses in the contracts, but the universities and companies often draw up individual contracts, explains Meergans. According to the study, it takes 128 to 298 days in Germany and 24 to 76 days in France to sign a contract.
If nothing happens, the study paints a bleak scenario for the future. Germany is still “one of the most important innovation locations” for research-based pharmaceutical companies. Measured by sales of prescription drugs, 80 percent of the world’s 21 leading corporations operate at least one research and development site in Germany, making the Federal Republic the leader in Europe and number two worldwide after the USA. There are also many small, “highly innovative” companies such as Aicuris, Adrenomed, Atriva and Inflarx.
Pharmaceutical companies are in an intense “race” for market approval of innovative therapies. According to the study, they evaluated the location policy framework more critically than ever before in order to optimize their investment and resource allocation. The Statutory Health Insurance Financial Stabilization Act has “further dampened” Germany’s attractiveness as a sales market for innovative medicines. Newly launched drugs whose additional benefit is rated as minor in Germany should no longer receive a surcharge compared to the comparative therapy. The new regulations mean a “significantly increased risk” for research-based pharmaceutical companies to obtain market access at an acceptable price.
The experts also give recommendations on what to do. For example, the requirements for the ethics committees as well as the data protection guidelines for clinical studies would have to be harmonized nationwide. The authors recommend setting up a central study register that creates transparency for doctors and patients. And medical data would have to be collected systematically and made usable for research purposes. There are a lot of recommendations.