Medication Supply in Germany: Fundamentals

The German healthcare system is characterized by a complex medication supply. Previously, there were few regulations, especially concerning prices. The era of change began with the Health Insurance Cost Containment Act of 1977.

The Medicines Act of 1976 introduced significant innovations. It established criteria for market approval: efficacy, safety, and therapeutic quality. In 1988, fixed amount regulations for cost control were introduced.

Today, medication supply includes both over-the-counter and prescription medications. Insured individuals often need to make co-payments. This structure shapes the German healthcare system and significantly impacts the quality of care.

Definition and Legal Foundations of Medication Supply

In Germany, there are strict rules for medication supply. The Medicines Act (AMG) regulates how medicines can be manufactured, sold, and used.

Definition of Medicines According to AMG

The AMG defines what constitutes a medicine. These are substances intended for humans. They are meant to cure, alleviate, or prevent diseases.

Distinction from Other Products

Medical devices are different from medicines. They do not act within the body but support diagnoses or therapies. Dietary supplements are not covered by the AMG because they are only intended for nutrition.

Approval Requirements for Medicines

A medicine must prove many things before it can be marketed. The manufacturer must demonstrate that it is effective, safe, and of good quality. The Federal Institute thoroughly examines this.

Over-the-counter medications are freely priced. Health insurance usually does not cover these costs. However, there are exceptions for children and very ill individuals.

Structure of the German Medication Market

The German medication market is complex and highly regulated. It includes various actors and products. Together, they ensure the population has access to medications.

Pharmacy and Prescription-Only Medicines

In Germany, almost all medicines require a pharmacy prescription. This means they can only be sold in pharmacies. Some medications also require a doctor's prescription.

These medications can only be obtained with a doctor's prescription. Prescription requirements protect against misuse and side effects from risky substances.

Role of the Pharmaceutical Industry and Wholesale

Pharmaceutical companies develop new active ingredients and produce medicines. They invest in research and receive temporary patent protection for innovative drugs. Wholesalers distribute medicines to pharmacies across the country.

Importance of Generics and Brand Medicines

After patent protection expires, other manufacturers can bring generics to the market. These contain the same active ingredient as the original but are often cheaper. Generics make up a significant portion of the medication market.

They contribute to cost control in the healthcare system. Brand medicines are important for the development of new active ingredients.

Medication Supply within the Framework of Statutory Health Insurance

The SHI (Statutory Health Insurance) is crucial for medication supply in Germany. It ensures that insured individuals have access to medications. However, they must pay a small fee, known as the medication co-payment. This fee is 10% of the price, with a minimum of 5 euros and a maximum of 10 euros per medication.

Children and teenagers under 18 do not pay extra. For people with chronic illnesses, the costs are lower. This keeps the supply fair and the financial burden manageable.

Health insurance funds make rebate agreements with pharmaceutical manufacturers. Pharmacies must then preferentially sell these medications. However, the doctor can change the prescription to prevent this.

The SHI aims to provide good medical care while saving costs. Patients have access to many medications. The system uses co-payments and rebate agreements to control costs.

Pricing and Reimbursement of Medicines

The pricing and reimbursement of medicines in Germany are complex. They help to balance patient care and cost control.

Fixed Amount Regulation

Fixed amounts limit costs. They determine how much health insurance funds are allowed to pay. The Joint Federal Committee decides which medicines fall into which groups. The SHI Association then sets the exact amounts.

Manufacturers often align their prices with these fixed amounts.

Medicines Price Regulation

The Medicines Price Regulation governs the prices of prescription medicines. Since 2004, pharmacy fees have often been determined by flat-rate payments. This aims to ensure fair remuneration for pharmacies.

There is no price binding for over-the-counter medicines.

Discount Contracts

Discount contracts between health insurance funds and manufacturers save additional costs. Health insurance funds and pharmaceutical manufacturers enter into these contracts. They commit to preferentially prescribing certain medications.

In return, they receive discounts. This leads to lower costs for the healthcare system.

These mechanisms help control medication costs. They also ensure that patients have access to necessary medications. Pricing is a significant issue in German health policy.

Quality Assurance in Drug Supply

The safety of medications is crucial. The Medicines Act and strict approval procedures ensure this. Pharmaceutical companies must conduct extensive studies to prove the safety of their products.

After approval, pharmacovigilance is essential. It monitors the safety of drugs on the market. Doctors, pharmacists, and patients can report side effects, allowing risks to be identified and assessed early.

The Institute for Quality and Efficiency in Health Care (IQWiG) plays a significant role. It evaluates whether medications are effective and cost-efficient. IQWiG's recommendations assist the Joint Federal Committee in its decisions.

• Evaluation of the benefits and cost-effectiveness of new drugs
• Creation of patient information
• Conducting benefit assessments

The Joint Federal Committee can make decisions based on IQWiG evaluations. It can restrict the use of medications, improving drug supply and ensuring safer medications for patients.

Challenges and Current Developments

Drug supply in Germany faces new challenges. Supply shortages, digital innovations, and advanced therapies shape current developments.

Supply Shortages and Security of Supply

Supply shortages of medications are increasing. To secure supply, reporting systems are being improved, and inventory management optimized. Doctors and pharmacists work closely to find alternatives.

Digitalization and E-Prescriptions

E-prescriptions are revolutionizing the prescription of medications. Patients receive their prescriptions digitally and can redeem them at any pharmacy. This innovation saves time and reduces errors in medication dispensing.

Personalized Medicine and Innovations

Personalized medicine is gaining importance. Treatments are tailored to the individual patient. New therapies, such as gene and cell therapies, require adapted approval and reimbursement rules. These innovations promise better treatment outcomes for severe diseases.

The drug supply system is evolving. Supply shortages, e-prescriptions, and personalized medicine present new challenges but also offer opportunities for improved patient care.

Patient Safety and Medication Therapy Safety

Patient safety is of utmost importance. Good medication management helps achieve this. It ensures medications are well-coordinated, avoiding unwanted interactions and providing better treatment.

Electronic systems assist doctors in prescribing medications safely. They alert to interactions and prevent dosing errors. In pharmacies, systems check medications for risks.

Doctors, pharmacists, and patients need to work well together. Training for all improves knowledge about medications, reducing errors in medication use and making therapy more effective.

By adhering to these safety measures, we improve drug supply in Germany. Our goal is to provide the best care while minimizing risks for patients.

FAQ on Drug Supply in Germany

What is the definition of medications according to the Medicines Act (AMG)?

Medications, according to the AMG, are substances intended to heal, alleviate, or prevent diseases in the body. They differ from medical devices, dietary supplements, and cosmetics.

What types of medications are there in Germany?

Germany recognizes prescription-only and pharmacy-only medications. Prescription-only drugs are subject to stricter regulations due to their risks.

What role do generics and original preparations play in the German drug market?

The industry develops new active substances with 20 years of patent protection. After that, generics can offer cheaper alternatives. Analog preparations are new molecular variants that can also be patented.

How are drug prices regulated under the statutory health insurance (GKV)?

Health insurance companies set fixed amounts that limit costs. Patients pay co-payments for medications. Insurers can negotiate discounts with manufacturers.

What role does the Medicines Price Ordinance play in price formation?

The ordinance regulates prices, with stronger flat-rate fees for pharmacy surcharges since 2004. Non-prescription medications are not price-bound.

How is the quality and safety of medications ensured in Germany?

IQWiG evaluates the benefits and cost-effectiveness of medications. The AMG and approval procedures ensure safety. Pharmacovigilance systems continuously monitor safety.

What are the current challenges and developments in drug supply?

Drug supply faces issues such as shortages. Digitalization brings e-prescriptions and digital health applications. Personalized medicine and new therapies require new rules.

How is patient safety and medication therapy safety improved?

Measures include better medication management and training. Electronic prescription systems and safety checks in pharmacies enhance safety.