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Do Germany's New Hemophilia Regulations Have Wider-reaching Implications?

In July 2019, the Drug Safety and Supply Law (GSAV) was passed by Germany’s Higher Chamber of Parliament, bringing about substantial changes to Germany’s health policy.

Since the GSAV’s implementation in August of this year, the distribution, and consequently the pricing of hemophilia treatments in Germany have been subject to more regulation under the law.

In addition, the manufacturer’s ability to distribute directly to doctors and hospitals, avoiding the pharmacy distribution channel, was officially withdrawn, thereby allowing patients to receive their hemophilia products from regular pharmacies and ultimately meaning that manufacturers had to report their confidential sales prices to physicians.

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