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Germany healthcare news | 2023 | Bundestag reforms | Digital Health | iPharmaCenter

The Cabinet has given the green light to two key laws: the "Digital Act" (Digital-Gesetz - DigiG) and the "Health Data Utilization Act" (GDNG), both designed to foster digital solutions for improved patient care and research opportunities.

Under the Digital Act, a significant component is the introduction of the electronic patient record (ePA) for all statutory health insurance holders who do not opt-out. Starting in 2025, the ePA will facilitate the exchange and utilization of health data and initially focus on digital medication management. Additionally, the e-prescription will be standardized for medication supply.

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The GDNG establishes the foundation for better access to health data to position Germany as a global leader in health, research, and business. A decentralized health data infrastructure, including a central access point, will be established to facilitate the use of health data for public welfare purposes. The law also aims to bolster the development of a globally competitive health data infrastructure.

Key highlights of the digital healthcare legislation include:

  1. Electronic Patient Record (ePA): The ePA will be available to all statutory health insurance holders from early 2025, with the option to opt out. Privately insured individuals may also have access to an ePA with opt-out capabilities provided by private insurance companies. The ePA will offer a comprehensive digital medication overview, aiding in preventing drug interactions and supporting healthcare providers in treatment.

  2. e-Prescription: The e-prescription will be further developed and standardized for medication supply starting January 1, 2024.

  3. Digital Health Applications (DiGA): Integration of DiGAs into healthcare processes will be enhanced, including digital medical devices of risk class IIb, enabling their use in more complex treatment processes, such as telemonitoring.

  4. Telemedicine: To promote telemedicine as a fundamental part of healthcare, quantity limits will be lifted, and assisted telemedicine will provide easy access to care.

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Under the Health Data Utilization Act (GDNG), provisions include:

  1. Central Data Access and Coordination Point: A centralized point will be established for accessing and coordinating health data, reducing bureaucratic hurdles and enabling data linkage from different sources.

  2. Data Protection Supervision for Research: Extended data protection supervision for transnational research projects encompassing all health data coordinated by a state data protection officer.

  3. Health Research Data Center (FDZ): The FDZ at the BfArM will be enhanced, and eligibility for access will be based on the common good's purposes rather than the applicant's.

  4. Opt-Out Procedure: An opt-out procedure will be introduced to facilitate the release of data from the ePA for research or other authorized purposes at the FDZ, with a simplified administration for patient objections.

  5. Data Processing by Insurance Companies: Health and long-term care insurance companies will be allowed to process data when it can be demonstrated that such processing protects the individual health of the insured

The German Bundestag has passed the "Act to Combat Supply Bottlenecks for Off-patent Drugs and to Improve the Supply of Pediatric Drugs" (ALBVVG) in response to the ongoing supply bottlenecks. The new legislation includes measures to ease price regulations for children's medicines and ensure the availability of discounted drugs in the future.

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Under the new law, pharmacies will have greater flexibility in providing alternative medicines when there is a shortage. Additionally, sick leave by telephone, which proved successful during the pandemic, will be implemented indefinitely. The legislation also grants federal states the authority to introduce drug-checking initiatives.

Key provisions of the Supply Bottleneck Combating Act include the relaxation of price regulations for children's medicines. For children's treatments, fixed prices and discount agreements will be abolished, allowing pharmaceutical companies to increase their prices by up to 50 per cent of the last applicable fixed price or the price moratorium. Fixed price groups for pediatric medicines will no longer be permitted.

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The Act also addresses the price pressure resulting from co-payment exemption rules. The co-payment exemption limit will be reduced from the current 30 per cent to 20 per cent, enabling the National Association of Statutory Health Insurance Funds to exempt pharmaceuticals from co-payment if the price is at least 20 per cent below the fixed amount. This adjustment aims to alleviate price pressure on fixed amounts.

To simplify medication exchange procedures, pharmacists can dispense drugs with the same active ingredient when the prescribed medication is unavailable. Pharmacies and wholesalers will receive a surcharge for such exchanges. Additionally, if medications can only be dispensed in small packs or a partial quantity is required, the insured person's co-payment will be limited to the amount dispensed.

The legislation also provides flexibility in pricing instruments for critically needed medicines during market shortages. If there is a shortage of essential medications due to insufficient suppliers, the fixed price or price moratorium can be increased by 50 per cent once.

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To address the issue of delivery bottlenecks, pharmaceutical companies will be required to store discounted medicines for a minimum of six months. This measure aims to prevent short-term supply disruptions, accommodate increased acute demands, and ensure a reliable supply. Hospital pharmacies and pharmacies supplying hospitals must also increase their stocks of parenteral drugs and antibiotics for intensive care. When shortages of cancer drugs are anticipated, pharmacies producing ready-to-use preparations from these drugs will also be subject to increased stockpiling requirements. Wholesalers must increase their stockpiles of children's medicines for four weeks.

The Act also strengthens existing structures for managing delivery bottlenecks. The Federal Institute for Drugs and Medical Devices (BfArM) will receive enhanced information rights from manufacturers and hospital pharmacies. An early warning system will also be established to identify potential delivery bottlenecks in advance.

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Other provisions of the law include adjusting pricing rules to provide financial incentives for pharmaceutical companies to research and develop new reserve antibiotics and authorizing emergency paramedics to administer narcotics based on standardized medical guidelines in emergencies where a doctor is not immediately available.

Furthermore, the law allows for sick leave by telephone, instructing the Federal Joint Committee to permit this method when the doctor is familiar with the insured person and the symptoms are not considered "severe."

Lastly, the legislation creates legal provisions for drug-checking model projects to be carried out in the federal states. The objective is to enhance education and advice for drug users, minimize harm, and better understand the situation at the local level. The implementation of these projects will be the responsibility of the respective federal states.

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