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Home to only 1.2% of the world’s population,1,2 Germany participates in approximately 7% of world’s clinical trials.3 The country is the most populous in Europe,1 but Germany’s involvement in clinical trials goes beyond its demographics. Its strong medical tradition, long history of leadership in clinical research, and broad governmental support and funding for biomedical sciences has made the country a desirable location for pharmaceutical research and development (R&D), production, and sales. Germany’s relationship with clinical research includes many positive factors as well as a few challenges that may modify the landscape in next few years.
Germany’s 82 million inhabitants1 enjoy a high standard of living that continues to increase the demand for innovative and high-quality pharmaceutical products.4 Health care standards are high and insurance coverage is universal, either through state-sponsored plans or private companies.4 In 2010, the German statutory health insurance plans spent $37.6 billion on prescription drugs,5 and the market is projected to grow to $54 billion by 2015.6
Clinical trials conducted in Germany most commonly involve cancer, cardiovascular disease, nervous system disorders, and infectious diseases.4 Along with the number of patients and demand for quality health care, clinical research benefits from Germany’s established and comprehensive infrastructure for transportation, communication, energy, and public services. The Global Competitiveness Report from the World Economic Forum ranked Germany’s infrastructure first in the world in 2009-2010 and second only to Hong Kong in 2011-2012.7,8
Government Support and Regulation
Germany has a strong medical tradition with a long history of excellence in biomedical research among individuals, universities, institutes, and associations. Clinical research became a priority in the mid-to-late 1990s, when a new funding program within the Federal Ministry of Education and Research established Coordinating Centers for Clinical Trials to “strengthen academic clinical research.”9
The German government invests in health care and biomedical research, as indicated by the 1.2 billion EUR for R&D projects in this sector through 2011.4 Numerous initiatives support clinical research by pharmaceutical and biotech companies as well as academic research groups, primarily through the Federal Ministry of Education and Research, the German Research Foundation, and German Cancer Aid. The government also provides labor-related incentives, such as recruitment support, training support, and wage subsidies, to help offset the costs of medical research.4
With respect to clinical trials, the German government views studies as an important part of providing high-quality medical care to its citizens.4 As part of the European Union (EU), clinical trial approval processes in Germany are standardized, reliable, transparent, and allow for relatively short study start-up timelines. Germany has two regulatory authorities with separate responsibilities. The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for clinical trials with drugs and medical devices, while the Paul Ehrlich Institute (PEI) is responsible for vaccines, medicinal products containing antibodies, allergens for therapy and diagnostics, blood and blood products, tissue and medicinal products for gene therapy, somatic cell therapy and xenogenic cell therapy.
Established Industry Presence
In the 1990s, the German government made a significant investment in the pharmaceutical industry by sponsoring a contest in which 17 local regions were invited to compete for funds to stimulate start-up biotechnology companies and encourage international investment. The contest created three BioRegions, concentrated areas of pharmaceutical R&D, and is widely credited with “kick-starting” the biotechnology industry in Germany.10 There are now 20 BioRegions,11 many of which are home to the more than 240 pharmaceutical companies with facilities in Germany.4
These companies range from large, multinational corporations (e.g., Bayer, Merck, Roche) to small start-ups that, together, employ approximately 126,000 people.4 In addition to strong governmental support and an established infrastructure, companies are attracted by Germany’s highly educated workforce and labor costs that are lower than in the United States.5 As a result, Germany is a global leader in both clinical trials and the production of chemicals, pharmaceuticals, and biotechnology products.4,12
The pharmaceutical industry often collaborates with universities (e.g., Bayer-Schering Pharma with the University of Cologne) and is a major source of support for investigator-initiated trials. Overall, pharmaceutical companies fund 70% of all clinical trials performed in Germany.5 Industry associations, including the Association of Research-Based Pharmaceutical Companies (vfa), the German Pharmaceutical Industry Association (BPI), and the Federal Association of the Pharmaceutical Manufacturers (BAH), are closely involved in discussions with the government regarding laws, regulations, and guidelines.
The clinical trial environment in Germany has several challenges that necessitate up-front planning: recruitment, EU policy, and pricing controls. As in many developed countries, the pool of eligible clinical trial participants in Germany is shrinking due to saturation. Patients who might be willing to enroll have already participated in a trial or received treatment from their provider. With universal health insurance in Germany, patients are unlikely to be swayed by free examinations or treatments. However, one study indicated that 25% of potential German clinical trial participants are motivated by altruism,13 and recruitment does appear to be faster if unmet medical needs are under investigation or if the potential benefits of the trial are very clearly explained by investigators.
As part of the EU, Germany is bound by the Clinical Trials Directive, legislation designed to harmonize requirements, improve the collection of high-quality data, and set a global benchmark for ethical and medical standards. The Directive introduced the Investigational Medicinal Product Dossier (IMPD), a single document that can be submitted to any EU competent authority for approval of a clinical trial,14 and other processes that have resulted in more predictable clinical trial timelines. One downside of the Clinical Trials Directive is an increase in the administrative burden and costs of clinical trials for both pharmaceutical companies and academic research centers.12,15 Overall, the number of clinical trials in Germany has decreased only slightly since the Clinical Trials Directive was adopted in 2004,12 a positive outcome attributed to the German government’s investments in academic clinical research.9
Finally, the implementation of German healthcare reform (known as AMNOG) in January 2011 introduced a new pricing structure that links the cost of a medication to its perceived benefit, effectively equating innovative therapies with generic drugs. In addition, the legislation included Greece in the list of countries used as a reference for pricing negotiations. The industry objects to that comparison because the severe economic crisis in Greece has prompted many pharmaceutical companies to temporarily lower their prices in that country. The net effect of these pricing changes is that several pharmaceutical companies have opted not to introduce new drugs to the German market until the situation is resolved.16,17
Germany’s strong medical tradition, long history of leadership in research, and broad governmental support and funding for biomedical sciences has made the country a desirable location for clinical trials. Home to only 1.2% of the world’s population,1,2 Germany hosts approximately 7% of world’s clinical trials.3 Many pharmaceutical companies, both large and small, have facilities in Germany, encouraged by the country’s high medical, technical and ethical standards, standardized and reliable approval processes for clinical trials, and relatively short timelines for study start up.
However, clinical research in Germany is not without its challenges. The Clinical Trials Directive, which has helped to harmonize requirements, improve the collection of high-quality data, and set a global benchmark for ethical and medical standards throughout the EU, has also increased the administrative burden and costs of performing clinical trials. More recently, the German government has strengthened price controls on innovative medicines, and, as a result, several pharmaceutical companies have opted not to introduce new drugs to the German market.
As the clinical research environment in Germany evolves, pharmaceutical companies and contract research organizations cannot afford not to keep pace with the changes. By 2013 Germany is projected to be world’s fourth largest pharmaceutical market, outspent only by the United States, Japan, and China.18