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.
The EU Regulation on Clinical Trials on Medicinal Products for Human Use recently entered into force. In Germany, it is expected that a complete revision of the clinical trials provisions in the Medicinal Products Act will be necessary. Germany will have to create a new mechanism to determine the competent ethics committee that enables immediate, automatised assignment.
A pharmaceutical producer's determined price for new innovative drugs is applicable for one year. Thereafter, the applicable price (to both public and private payers) is based on the results of an early compulsory evaluation by the Federal Joint Committee of the additional benefits of the new drug compared with appropriate comparable therapies.
To allow generic drug companies to enter the market as seamlessly as possible after expiration of patent rights, the Bolar exemption allows certain actions while the patent is still in force. While it is undisputed that companies are allowed to produce the protected substance to obtain marketing authorisation, it is unclear whether active pharmaceutical ingredient producers or contract manufacturers can also invoke this privilege.
The new German government intends to increase competition in the healthcare sector by varying insurance premiums. It plans to overcome deficits in the triage system by regulating physicians' access to the outpatient medical sector, seizing the offices of retiring doctors and ensuring that kickbacks are a punishable offence.
Competition law is finally becoming established in the German healthcare market and is paving the way for equal opportunities for medicine producers. As yet, however, the market has not become fully accustomed to its implementation and interpretation. Medicine and other healthcare producers would be well advised to keep an eye open for potential breaches of antitrust law.