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Cannabis Law – reveals legal uncertainty one year after its entry into force. A top-class group of experts debated the 22nd Eppendorfer Dialog on April 11, 2018 in Hamburg

http://www.eppendorferdialog.de/veranstaltungen/medizinischer-cannabis-zwischen-hoher-nachfrage-und-regulatorischen-huerden.html

Well meant, but from the perspective of many not concretized to the end. § 31 para. 6 SGB V, the “Law on the Amendment of Narcotic and Other Regulations” – in short: the Cannabis Law – reveals legal uncertainty one year after its entry into force. A top-class group of experts debated the 22nd Eppendorfer Dialog on April 11, 2018 in Hamburg in front of a large and dedicated participatory auditorium the experiences made so far. With increasing expectations of the patients, numerous construction sites reveal themselves: Disconcerting doctors due to missing indication formulations, high numbers of application rejections by the health insurance funds, supply bottlenecks in the medical cannabis and questions regarding the pricing. But there are also noteworthy achievements: Estimated 14.

speakers

The Eppendorfer Dialogue on Health Policy this time asked the question “Medical cannabis between high demand and regulatory hurdles: where do we stand?” Chairman Prof. Dr. med. med. Achim Jockwig had succeeded in inviting a group of experts to cover the entire range of questions surrounding the cannabis law.

Therapy benefit for patients outweighs evidence deficit

It all started with the representative of the Federal Ministry of Health, which is responsible for the realization of the law. The spokeswoman for health policy of the CDU / CSU parliamentary group Karin Maag explained the background to a legal adoption of a therapy in which the usually required evidence standards could not be applied. Maag: “There are many patients with serious illnesses, for whom there is no alternative recognized by medicine, if the standard therapy does not help.” It has been shown – according to Maag – that cannabis is a good treatment option in diseases such as multiple Sclerosis, AIDS, epilepsy or chronic pain can be. These people should be helped. Another impetus was given by the new legal situation and the critical question of self-cultivation. Politics had to act and, in March 2017, passed a law of high political significance and relevance for the everyday care routine. Since then, the use of cannabis for medical purposes is possible – but only to these. The Cannabis Law controls and controls the manufacture and distribution of medicinal hemp. All parties involved must comply with the narcotic and drug legislation. The Cannabis Law controls and controls the manufacture and distribution of medicinal hemp. All parties involved must comply with the narcotic and drug legislation. The Cannabis Law controls and controls the manufacture and distribution of medicinal hemp. All parties involved must comply with the narcotic and drug legislation.

“Once again, we make it clear that a patient does not have to endure serious side effects for many years before he can get approved for the therapeutic alternative of a cannabis drug, and we have strengthened the therapy sovereignty of the doctors. In the future, they will prescribe on the basis of their own examination that any exemption will be waived. “(Karin Maag)

Health policy has found a viable solution in their view by setting very definite standards for the supply of medicinal cannabis. Furthermore, the law is open to rework, says Maag.

Health insurance companies feel overwhelmed by the law

In addition to standardization requirements for cultivation, processing, active substance content and delivery, the standards stipulated in the law include the description of the parameters under which patients are reimbursed for a cannabis therapeutic. And here lies the crux, because the formulations are too concretely many doctors as well as the health insurance companies. This leads to uncertainty at the regulation level and substantiates a large number of the application rejections by the health insurance companies. Dr. Detlev Parow (Business Unit Product and Payroll Management at DAK-Health) describes the decision-making process at the health insurance fund, which according to the law may only refuse a pension application in justified exceptional cases. But what does exceptional case mean? “As the disease is very vague and the indications are completely open, With the exception of palliative care, we see ourselves in the situation of having to obtain nearly 100 percent of the MDK’s assessment. Due to the assessments, which also take time to annoy all beyond the defined deadlines, currently about 30 percent of the applications are rejected, “said Dr. med. Parow. Like other insurers, the DAK sees itself, to a certain extent, in the protective position of the solidary community of insured persons. Dr. Parow puts the treatment costs per patient per year at up to 30,000 euros and at the same time alludes to the lack of treatment evidence. He demands a time limit for the approval with subsequent verification. However, this statement was objected to in the discussion

“The health insurance companies are not the dark side of power when it comes to obstructions. The path from application to approval is too many pitfalls. “(Dr. Detlev Parow)

Cannabis therapy in practice: Pain patients benefit in the first place

The renowned palliative physician and Federal Cross of Merit Professor Winfried Hardinghaus, chief physician of the Clinic for Palliative Medicine Franziskus Hospital at the Charité Berlin and Chairman of the German Hospice and PalliativeVerband, emphasizes at the beginning of his presentation on the therapeutic benefits of cannabis medication that he neither the thin Evidence still the unconcrete indication description holds bad. Finally, one has the meta-analysis and the results of the CaPRis study. In addition, Prof. Hardinghaus considers the side effect potential of medicinal cannabis to be low – especially in comparison to many classic medicines. Prof. Hardinghaus describes the influence of cannabis drugs on the cannabis receptors and points out It is precisely the combination of THC and CBD that has a positive effect on chronic pain, the improvement of nausea and vomiting, as well as an increase in appetite. However, interactions with, for example, amphetamines, antihistamines, barbiturates and, in particular, psychotropic drugs and dronabinol must be taken into account at low organic side effects and low addictive potential in medical applications. As the effect of medicinal cannabis is known, Prof. Hardinghaus welcomes the fact that the legislator does not specifically specify the indications and thus does not further regulate the therapeutic use. This opens up opportunities, especially for oncological concomitant therapy. “If we get 30 percent pain improvement, that’s a lot and relevant,” said the palliative care physician. Many colleagues would shy away from the regulation because they would not be able to handle cannabis therapy. He advises him to use the offered prescription aids for doctors. Doctors in the auditorium ask why, given the high level of side effects associated with the treatment of pain, it is justifiable that these should be prescribed if medical cannabis is the alternative.

“I do not want to give up cannabis on my palliative care ward.” (Prof. Winfried Hardinghaus)

Regulatory conflicts fuel legal uncertainty in the handling of cannabis medication

He is surprised that one wonders that in Germany so far no one has researched cannabis therapy, said the medical lawyer and board member of the German Society for Palliative Medicine. Oliver Tolmein. Given the current legal situation of cannabis in our country, it is in no way surprising that there is no evidence. Which claim should you have invested in research? Dr. Tolmein explains the regulatory situation of prescribers, pharmacists, manufacturers, and patients with the entry into force of the cannabis law. This is characterized by a high degree of legal uncertainty. The conflicts are primarily related to a crisis in evidence-based medicine. In the case of the complex herbal medicine, this leads to cannabis, Regulatory restrictions and unconcrete formulations have to be carried out on the shoulders of all stakeholders. Tolmein: “To deal with this conflict, we have to ask ourselves whether we want to have evidence as the only criterion, or whether there are other criteria for patient benefit, which ultimately lead to legal certainty.” At this point, the in Auditorium present protection police and reports on the uncertainty, for example, in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “To cope with this conflict, we need to ask ourselves if we want evidence as the only criterion, or if there are other criteria for patient benefit that ultimately lead to legal certainty.” This is where the audience present at the auditorium announces Protective police to word and reports on the uncertainty, for example, in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “To cope with this conflict, we need to ask ourselves if we want evidence as the only criterion, or if there are other criteria for patient benefit that ultimately lead to legal certainty.” This is where the audience present at the auditorium announces Protective police to word and reports on the uncertainty, for example, in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “At this point, the protection police present in the auditorium speaks up and reports on the uncertainty, for example in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “At this point, the protection police present in the auditorium speaks up and reports on the uncertainty, for example in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn.

“It has been contested by the patients up to the Federal Administrative Court that today we can talk about the regulation of cannabis.” (Dr. Oliver Tolmein)

It has become clear that the cannabis law has set in motion medical advances accompanied by a great wave of questions and uncertainties. There is still much to be done for medical cannabis therapy to do what it can do: to relieve people of their suffering.

Presentation of the speakers

Dr. med. Detlev Parow on cannabis as a medicine

Prof. Dr. med. Winfried Hardinghaus on cannabis as a therapy

Dr. Oliver Tolmein on the subject of cannabis as medicine

Flyer to the event

Author: Cenedella.de

Over the last 4 decades I have been involved in the fight for patient rights in America, and now here in Germany. During my career I have served as a Board of Director for the World Trade Center San Diego and as a Lead Consultant for Deutsche Telekom's Executive Board, Co-Founded the San Diego Software Council and the Dayton Human Trafficking Accords and was Director of LawInfo's Lead Council Program. Previously I was a C-Level Business Development Executive in the technology sector, but also involved with the cannabis industry since 1977. More recently I have been fulltime in the legal medical marijuana industry here in Europe, helping international companies navigate the biggest potential market in the world. This website is light on details due to confidentiality issues with clients but be rest assured I am knowledgeable, professional and with street cred in the industry that can immediately assist your growth in some way. Consulting Services: Sales and Business Development Assist with Strategic Direction Professionally represent your firm Special Projects management Licensing and compliance Sales and Distribution networks Qualify potential partners I am your resource on the ground in Europe, contact me directly to schedule an initial discussion on the German Cannabis-as-Medicine market. Thank you, Philip J. Cenedella IV Call +1.888.206.3264 USA +49.0.151.720.17652 GERMANY Skype: philip.j.cenedella eMail: phil@cenedella.de LinkedIN: https://www.linkedin.com/in/cenedellade/

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