Online medical consultations are a worldwide internet trend. Without visiting a doctor's office, patients can talk to a doctor online, describe their medical problems and receive a prescription from a non-German doctor. If these consultations and prescriptions from non-German doctors are accepted, medication can be sold by German pharmacies to patients based on EU regulations. Preference given only to prescriptions issued by German doctors would be discriminatory.
DrEd is one such online doctor offering medical advice, but many more are likely to enter this promising market.
However, the government plans to put a stop to this trend before it gains momentum. On March 9 2016 the federal cabinet passed a draft law concerning a change in the regulations governing drugs and medicinal products. The new law is expected to become effective in August 2016.
The draft makes the following amendments to German law in relation to the EU Regulation on Clinical Trials on Medicinal Products for Human Use (536/2014):
- Candidates must be informed by a doctor before participation in a clinical study.
- Adult patients unable to give consent must have a patient decree in order to participate in a study which benefits the group.
- Security regarding delivery and supply bottlenecks concerning drugs and medical products must be implemented.
- It must be possible to recall drugs and medical products in case of suspected drug counterfeiting.
- Comprehensive job descriptions for pharmacists must be available.
- Teleshopping for medicinal products and the promotion of teleshopping are prohibited.
- Prescription-only drugs cannot be given to patients without direct contact with a doctor.
The government intends to prohibit online doctors from prescribing prescription-only drugs to patients. It is clear from the draft that medical products must be delivered to patients only if there has been previous direct contact between the patient and the doctor. It is expected that patients will be protected from any risk resulting from a prescription which has been issued without an in-person examination by a doctor.
The draft states that pharmacies cannot issue prescription-only medicine if it is clear that there has been no direct contact with a doctor. This prohibition is expected to ensure the quality of medical care. Online and over-the-telephone treatments and diagnoses are insufficient and risk endangering patient health.
The draft emphasises that an exclusive remote treatment will also become prohibited by professional regulations. However, exceptions remain possible (ie, a follow-up prescription for chronic disease).
The draft illustrates that the government views online treatment and prescriptions sceptically. If the existing draft is adopted, online doctors will no longer be allowed to operate in Germany. Once the new law is effective in August 2016, it will become clearer what the long-term effects will be for pharmacies and how exceptions will be handled. It is also possible that DrEd and other market participants may have to start a court case at EU level in order to avoid ceasing business following the draft's implementation.
For further information on this topic please contact Tatjana Schroeder or Franziska Ladiges at SKW Schwarz Rechtsanwälte by telephone (+49 69 630 001 0) or email (firstname.lastname@example.org or email@example.com). The SKW Schwarz Rechtsanwälte website can be accessed at www.skwschwarz.de.
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