Cannabis-containing finished medicinal products have been available on prescription in Germany for some time. In 2017 the amendment of various acts permitted the state-controlled cultivation of cannabis and allowed the production of cannabis-containing medicinal products in pharmacies. This article provides an overview of the legal framework applicable to cannabis products – especially cannabis-containing medicinal products – and the current discussions and developments relating thereto.
According to Section 24(1) of the German Patent Act, a compulsory licence can be granted to a patent infringer. Recent case law suggests that this possibility is becoming increasingly relevant. Further, in a recent originator-originator pharma case, the enforcement of a recall obligation was for the first time suspended for a certain period for public health reasons.
Two recent Federal Civil Court decisions strengthen the strict understanding of Section 7(1.1) of the Act on the Advertising of Medicinal Products, under which the granting of gifts constitutes a violation of German pricing regulations. These decisions also reiterate that the unequal treatment of national pharmacies is justified due to the particularities of the German pharmacy market and the minor impact that this has on German pharmacies.
To safeguard against potential liability claims under the EU Product Liability Directive, the EU Medical Device Regulation stipulates that medical device manufacturers must have measures in place to provide sufficient financial coverage. However, as medical software can hardly be considered a 'product' under the German Act on Product Liability and the EU Product Liability Directive, it is conceivable that no liability applies under the respective provisions and, therefore, there is no need for financial coverage.
The EU Medical Device Regulation (MDR) was introduced in May 2017 and sets out the legal framework for medical devices in Germany. However, the MDR provides no definition of 'medical software' and limited rules on liability. Medical software liability under the existing regulatory framework requires that medical software be classified as a product; however, this classification is highly controversial and has been widely debated.
Parliament recently passed a law revising the safeguarding of secrecy where third parties are involved in the exercise of professional duties by persons with a duty of confidentiality. The legislature responded to calls for a long-overdue reform and finally updated the criminal rules on secrecy for certain professionals. For the healthcare sector, this reform opens up a number of new opportunities for using the services of external service providers without facing the risk of criminal liability.
The government has introduced a draft bill to amend the Criminal Code, which will make corruption a criminal offence for anyone with a job in healthcare if that job requires state-regulated education. It will also implement a standardised procedure for exchanging experiences between all functions that monitor bribery in the healthcare sector. According to this procedure, the public prosecution departments of the various federal states will be expected to participate.
The government plans to put a stop to the trend of online medical consultations before it gains momentum and has passed a draft law to amend regulations governing drugs and medicinal products. The government intends to prohibit online doctors from prescribing prescription-only drugs to patients. 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.
An opposition was filed against the word and figurative mark FEDAMED based on the earlier mark SEBAMED. The Trademark Division denied a likelihood of confusion, because the word beginnings were clearly different and were more distinctive than the descriptive sound 'med'. However, the Federal Patent Court took a different view and affirmed the likelihood of confusion. It attributed an average degree of distinctiveness to the earlier mark SEBAMED.
The Federal Supreme Court recently decided that pharmaceutical prescribing information is subject to competition law and, under certain circumstances, can be assumed to be misleading. Competitors may raise objections to prescribing information based only on new insights or insights which were not accessible at the time of authorisation. It is impossible to object based on an incorrect assessment of the documents submitted in the authorisation process.
A Munich court recently had to decide whether the statement "running out of the doctor's office" on a rating platform was protected by freedom of opinion or a factual claim. It held that the statement had merely expressed a patient's dissatisfaction with his treatment. Although a statement may appear factual, it could prove otherwise on closer inspection. Physicians can be assessed on rating platforms, as long as the assessment is truthful.
Parliament recently voted for a new law on the culpability of individuals who assist in another person's suicide and a new Section 217 of the Act for Criminal Law was implemented. Both the Federal Constitutional Court and the Cologne Administrative Court have now issued decisions relating to the new law.
The Federal Patent Court recently issued a judgment dealing with a sequence of letters that a pharmaceutical company wanted to register as a trademark. According to the court, a sequence of letters is not eligible for registration when it is a descriptive term's common acronym and is understood as such by the relevant public.
Parliament recently voted on the culpability of individuals who assist in another person's suicide. However, it remains unclear whether an assisting doctor will now be held guilty. Some members of Parliament argued that doctors act commercially and should therefore face repercussions under the new criminal law. Others argued that it is the purpose of doctors to alleviate suffering and as a result they should not be guilty of an offence.
The Federal Patent Court recently outlined in detail its position on the similarity of goods and services in the pharmaceutical field. The trademarks MELVITA and MEVIDA were held to be so similar as to be capable of causing confusion with regard to part of the goods and services. While the decision may be unsurprising, it was detailed and well reasoned.
The government recently resolved the first step for a draft bill of the E-health Act that will introduce new possibilities in electronic health card use and digital networking in the healthcare sector. From 2018, important data may be saved in the new system with patient approval, so that doctors handling emergencies can access it. Doctors adding relevant data will receive an additional fee for this service.
Corruption is set to become a criminal offence for most individuals working in the healthcare sector. This development will affect the assessment of business practices and significant changes to the medical device sector can be expected. Healthcare companies should consider carefully the extent to which the changes will affect their businesses, especially established marketing methods.
The Federal Patent Court recently held that a likelihood of confusion existed between the marks SANDTER 1953 and SANDER. Despite low sales volumes, the SANDER mark was capable of preserving rights. However, the mark was phonetically confusingly similar to the trademark SANDTER 1953.
In a recent decision, the Munster Higher Administrative Court considered whether a further development of a reference medicinal product which contains a different therapeutic indication, effective strength or dosage – and thus has its own authorisation – enjoys protection from the date of its own authorisation, or whether the principle of global authorisation applies to such further development.
Manufacturers of pharmaceutical products not only sell products themselves, but also use external partners to get their products to market and to patients. In order to standardise these relationships, a manufacturer should set down standard agreement structures with its distribution partners.