G-BA statement: Who pays what for prescription drugs dispensed without a prescription?

In their statement on the draft bill from the Federal Ministry of Health (BMG), the three independent G-BA members, Josef Hecken, Karin Maag and Bernhard van Treeck, address two points that directly affect the committee – the “referral for follow-up care” and the “referral in the case of certain acute illnesses”.

The expansion of the powers of the Pharmacies are raising concerns following the planned amendment to the Medicines Act (AMG), according to The G-BA (Federal Joint Committee) raised "a number of fundamental and systematic questions." According to the new Section 48a of the German Medicines Act (AMG), pharmacies should, in narrowly defined cases, provide follow-up care with prescription drugs. They may also administer medications without a doctor's prescription, provided the patient is known and undergoing ongoing treatment and the continuation of the therapy cannot be postponed.

The independent members of the G-BA (Federal Joint Committee) find it unclear in the aforementioned exceptional circumstances whether the costs will be borne by statutory health insurance. This is because a corresponding amendment to the Social Code is currently lacking. Furthermore, the provision in the draft for dispensing the smallest package size in cases of chronic illness could lead to additional costs.

The G-BA would also like to see a more detailed definition of the conditions under which medications may be dispensed without a prescription. The specific "dispensing prohibitions" could be included in the German Prescription Drug Ordinance (AMVV), or alternatively, the "medicines authorized for dispensing" could be listed.

According to the planned Section 48b of the German Medicines Act (AMG), pharmacists should be permitted to dispense certain prescription drugs without a doctor's prescription, even for acute, uncomplicated illnesses. The Federal Ministry of Health (BMG), based on the recommendation of the Federal Institute for Drugs and Medical Devices (BfArM) and with the participation of the physicians' and pharmacists' drug commissions, is to issue a corresponding regulation specifying which illnesses and patient groups, which drugs, active ingredients, dosages, and pack sizes, and what requirements apply to counseling, documentation, and quality assurance.

The Federal Joint Committee (G-BA) again questions why the exceptional dispensing of prescription drugs without a prescription is not to be regulated in the German Drug Prescription Ordinance (AMVV), but rather in a separate legal regulation with different participation options. The question of reimbursement also remains unanswered, according to the statement. In cases of "acute care for non-serious illnesses," the G-BA leadership can also envision insured individuals paying for the prescription drugs themselves.