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On 20 October , the bill passed the Bundestag and a week later, the Bundesrat. As such, the bill will affect almost all players within the German healthcare system, including health insurance, healthcare professionals, hospitals, pharmacies and, not least, the pharmaceutical industry.
Several of these stakeholders, as well as speakers from the opposition, have voiced their concerns that the bill is a short-term fix and not a long-term solution to solving the financial problems of statutory health insurance in Germany. Lindner has already severely restricted the financial leeway of the Health Minister for the current bill and it is not expected that the financial leeway for Health Minister Karl Lauterbach will be greater next year.
With this reform, Health Minister Karl Lauterbach is left with little space for maneuver on future reforms, where the pressure to cut costs is high. The fact that this reform happens in Germany, the country of two mRNA pioneers BioNTech and CureVac, that were critical to exit one of the worst health pandemics, questions the vision and leadership that Germany wants to play in the EU and globally in bringing future healthcare innovation to patients.
Trade associations representing the pharmaceutical industry rightly but unsuccessfully argued that the cost containment bill could lead to a reduction in innovation in Europe and restrict access to most innovative treatments and rare diseases therapies. It is more than ever time to rethink how the biopharma industry engages with stakeholders and get its messages across to key decision-makers.
The German Government will therefore have to introduce further reforms already next year to stabilise GKV finances. The short term and step by step approach to reforms will only lead to creating further uncertainty for all stakeholders at a time where the COVID pandemic highlighted that investing in health yields long term benefits overweighting short term savings.
The bill will likely impact innovative therapy pricing far beyond Germany as German price is often used by other EU and non-EU countries to set national price reference pricing.
Germany is used as a reference country by other European countries and markets outside of Europe, such as Canada, South Korea, and Japan.
Individually, each practice is a leader in its specific field, staffed with experts recognized for the depth of their knowledge and a track record of making an impact. We take a holistic view to help companies build, grow and defend their reputation, identify and address policy and regulatory hurdles, support complex product launches across various geographies and build company reputation with key stakeholders at a global scale.
Looking Forward insights how can we help about contact Menu. November 21, Germany, one of the most attractive EU markets for pharmaceuticals and often the first-to-launch market for innovative therapies in Europe is adopting cost-containment measures that will negatively impact the industry and all relevant stakeholders.
This reduces the period during which a pharmaceutical company is free to set its price for a new drug from 12 to 6 months. According to the new bills explanatory memorandum, the German government expects that future price negotiations will also consider price-volume components. This price freeze was originally scheduled to expire on 31 December , the GKV-FinStG extends the price freeze until the end of By removing the honoraria for clinicians to accept new patients, the wait-time for patients to get access to diagnosis and treatment could be further delayed.
These health kiosks should be placed in underserved areas and become part of standard care. Most of this is already well prepared and plans for a nationwide introduction is expected shortly. The German market for medical devices is regulated by German and EU directives, standards, and safety regulations.
After a one-year delay of the start date of the EU Medical Device Regulation MDR , which introduced increased testing, certification and compliance requirements, this regulatory framework came into full effect on May 26, Companies seeking market entry should also carefully map their distribution strategy depending on their target group s.
CE marking is mandatory for selling into Europe. Entry strategies to be considered are top-down or bottom-up marketing, picking the right partners and ensuring patient- and customer-centric system solutions and support.
A representation or distributorship agreement may be more difficult to arrange, but the German associate will, in fact, purchase the product to be sold, thus sharing the market risk. Licensing, partnering with large corporate partners or buying a local firm provide alternatives in times where traditional distributors are bought up by corporates and the market increasingly consolidates. All major U. Key industry drivers include the power of innovation, a solid financial basis of the industry 80 percent of which are SMEs and a vibrant startup scene, all based on a strong German economy and the commitment to a high-quality health system.
DiGA providers will be reimbursed by German insurance funds. Likewise, the telematics infrastructure, including 5G rollout, is being developed at a dramatic pace, and the electronic medical record in German, ePA is taking shape. From January 1, German health insurers are mandated to provide their insured with the ePA; and from July 1, all statutory health insurance accredited physicians and psychotherapists must be able to read and fill in the ePA.
This law also facilitates easier access to patient data for research purposes as healthcare providers transmit their patient records to a centralized government-owned server. The Hospital Future Act and its funding allow German hospitals to speed digitalization and remain competitive globally. So far, there has been an innovation gap in the German hospital sector because of lacking focus for digitalization among the German health policy makers and hospital management for years and there is still an insufficient number of dedicated digital solution providers.
Thus, this market is especially penetrable for U. It mandates doctors and dentists to issue prescriptions in digital format from January 1, The law also makes it clear that even with digital prescriptions, the free choice of pharmacy of the insured remains, and neither health insurance funds nor contract physicians have a right to assign or influence. The digital health ecosystem in Germany will be driven by cloud computing solutions, artificial intelligence AI , robotics, smart wearables, big data analytics, and the Internet of Medical Things IoMT.
The German Ministry of Health maintains a website on digitalization in healthcare ; the German Ministry of Education and Research maintains a website on the medical informatics initiative.
It is strongly recommended to open an office in Germany or work with a knowledgeable partner to enter the German HealthIT market, which is dominated by some large players in the various segments, i. These firms represent percent of the German dental market and employ more than 21, people.
A similar pattern can be seen with their evaluation of the German market. Over U. The major U. The United States is a technology leader and is competing with Germany in large markets such as China and India. Both the U. Traditionally the leading global trade fair for the dental community, the IDS-International Dental Show in Cologne proves to be an arena where both the U.
Doctors will, for the first time, be allowed to actively promote digital consultations on their websites before they were only allowed to discuss them in private conversations. Since October, health insurance companies have been providing start-up funding to doctors and physiotherapists who want to offer video consultation hours. It will gradually be replaced with an electronic variant.
Since an estimated 77 million certificates are issued nationwide each year, the move has been hailed as a blessing. The digitisation of healthcare in Germany reaches its peak with the electronic patient record ePA. From , all state-insured patients will be able to receive a digital copy of their medical records from their insurer, if they wish. The patient then has the power to decide which information should be kept in the file, and what they want to delete.
She has since worked as a writer, editor and content marketeer, but still has a soft spot for museums, castles Expat Info News. What is changing in German healthcare in ? Apps by prescription For the first time ever this year, doctors in Germany will be able to prescribe health-orientated apps to their patients. The service has been extended in an attempt to ease the pressure on doctors and emergency departments in hospitals. You should call if you feel unwell outside of normal surgery hours.
The staff will connect you to a doctor via telephone, direct you to your local on-call practice, or even send a doctor to your home. In the case of medical emergencies , should still be used to alert emergency services.
For the first time ever this year, doctors in Germany will be able to prescribe health-orientated apps to their patients. Any costs incurred will be reimbursed by statutory health insurance. The Federal Institute for Drugs and Medical Devices will check the quality and safety of the applications; the developers then have one year to prove that their app improves the quality of care.
The DVG also promotes the use of online consultations. Doctors will, for the first time, be allowed to actively promote digital consultations on their websites before they were only allowed to discuss them in private conversations. Since October, health insurance companies have been providing start-up funding to doctors and physiotherapists who want to offer video consultation hours. It will gradually be replaced with an electronic variant. Since an estimated 77 million certificates are issued nationwide each year, the move has been hailed as a blessing.
The digitisation of healthcare in Germany reaches its peak with the electronic patient record ePA.
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WebThe German healthcare system is a so-called dual healthcare system. German residencies can be insured through a statutory health insurance (GKV) or a private . AdGet access to private healthcare anywhere in the world. Find international medical insurance to suit you/5 ( reviews). WebApr 21, аи The healthcare sector in Germany has been facing regulatory strengthening since the pandemic, and authorities are pushing to ensure that all assets are maximum .