In its reference decision of 15 August 2023 (Ref.: 5 U 93/22), the Hanseatic Higher Regional Court of Hamburg ruled on the issuing of prescriptions for prescription-only medicines over the internet by doctors who have not previously treated the patient.

The plaintiff is a registered association that pursues commercial and independent professional interests. The defendant operated a software platform that advertised the issuing of prescriptions for prescriptions-only medicines over the internet by doctors who had not previously treated the patients (so-called follow-up prescriptions). The plaintiff was of the opinion that the issuing of prescriptions for prescription-only medicines by a doctor who had not previously treated the patient constituted a breach of competition law.

In its decision, the Hanseatic Higher Regional Court of Hamburg ruled that the Regional Court of Hamburg was correct to grant an injunction under competition law pursuant to Sections 8, 3a UWG in conjunction with Section 7 para. 3 of the Professional Code of Conduct for Doctors in Hamburg and pursuant to Sections 8, 3a UWG, 9 HWG. The issuing of a follow-up prescription for a prescription-only medicine without personal contact with the patient is in breach of the doctor’s professional duties. In the present case, Section 7 para. 3 of the Professional Code of Conduct for Doctors in Hamburg applies, which mandates personal contact and only exceptionally provides for exclusive counselling or treatment via communication media if this is medically justifiable and medical diligence is observed. This was not the case with the prescription service offered. A breach of medical diligence has been committed, as it is not possible to ensure that the purpose of the prescription obligation has been fulfilled. A prescription request by telephone may be sufficient for a follow-up prescription. However, it is necessary that the prescribing doctor has already treated the patient and is informed about the patient’s state of health and the necessity of prescribing this medicine. In addition, the doctor must also arrange for certain examinations of the patient at certain intervals for subsequent prescriptions. Section 7 para. 3 of the Professional Code for Doctors in Hamburg is a market behaviour regulation within the meaning of Section 3a UWG, since the doctor is not guided solely by medical considerations with a view to the patient’s welfare, but by extraneous economic self-interest. The fact that the defendant merely operates a software platform and does not itself practise the medical profession is irrelevant, as the defendant is directly responsible with regard to the claim for injunctive relief under competition law. It had offered and disseminated the business model via its website. A person who is not himself a norm addressee acts unfairly within the meaning of Section 3a UWG if he incites or supports third parties subject to the law to violate market behaviour regulations within the meaning of Section 3a UWG.

Furthermore, the advertising ban for remote treatments pursuant to Section 9 HWG was infringed. The issuing of a follow-up prescription is a remote treatment within the meaning of Section 9 sentence 1 HWG, as the patient is only personally perceived by the treating doctor if the possible examination methods can be applied with the simultaneous physical presence of doctor and patient in one room, which is not the case here. The exceptional provision of Section 9 sentence 2 does not apply either, as the defendant, which is burdened with the burden of presentation and proof, has not demonstrated that the general professional standard is met.

This is important | To Do:The decision must be supported, in particular for the benefit of patients, who must be protected from having access to prescription drugs that they do not (or no longer) need and can therefore cause harm/addiction. Without a physical presence, this cannot be easily ensured. However, the development of general professional standards for the purely digital issuing of follow-up prescriptions in the future, where patient safety is guaranteed, would be welcome. For instance, people with limited mobility would benefit from such an approach.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Source: Mondaq

https://www.mondaq.com/germany/life-sciences-biotechnology–nanotechnology/1468316/olg-hamburg-on-the-inadmissibility-of-issuing-pharmaceutical-prescriptions-over-the-internet

By Jason Adelstone

Apr 29, 2024

After listening to the House Oversight and Accountability Committee Hearing with the Commissioner of the FDA on April 11, one conclusion was reinforced—opponents of marijuana reform are misinformed and rely on misstating facts to support their position. Those against moving marijuana into schedule III are making their voices heard, but almost universally, those voices simply do not understand what schedule III would mean. Whether it’s Kevin Sabet, Sen. Mitt Romney, or Rep. Pete Sessions, opponents of schedule III don’t have legitimate ground to stand on, so they rely on false equivalencies and dangers of other drugs to push a narrative that marijuana doesn’t belong in Schedule III.

This was summed up perfectly by Rep. Sessions (R-TX) who chided FDA Commissioner Califf for his agency’s recommendation that marijuana should be moved into schedule III, by comparing marijuana to heroin, while at the same time agreeing with Commissioner Califf that marijuana is less dangerous than heroin. This exchange highlighted that science, statutory guidelines for scheduling, and reality have no impact on arguments being made by opponents of marijuana rescheduling.

A schedule I substance has no medical efficacy in treatment and a potential for abuse greater than other schedule II-V substances. Since HHS/FDA has concluded that marijuana has a medical efficacy in treatment, it cannot be placed in schedule I. Therefore, the analysis turns on whether marijuana has a risk potential that is less than substances listed in schedule II (the analysis is not whether marijuana has any risk potential, as many opponents try to phrase it). With fentanyl and cocaine being schedule II substances, and killing thousands of people every year, this analysis should be obvious as it is supported by substantial evidence. The use of marijuana has resulted in zero deaths, and according to the National Institute on Drug Abuse, cocaine use caused roughly 24,000 deaths between 2019 and 2021, and fentanyl overdoses caused 73,654 deaths in 2022. This alone should make it clear that marijuana belongs outside of schedule II. In fact, placing marijuana in schedule II, or leaving it in schedule I, weakens the US’ focus on combating the fentanyl epidemic around the world. This reality supports a schedule III recommendation for marijuana. With marijuana being on the same schedule as fentanyl, it weakens the US’ claim that countries need to stop the flow of fentanyl. Protecting children and reducing the risk of dangerous substances, requires promoting a commonsense approach to marijuana that acknowledges its medical efficacy while placing it in a schedule that doesn’t diminish the harms of substances that are actually killing our children and devastating our communities.

A frustrating aspect of the arguments being made by opponents is that they base the need for prohibition on perceived harms to children but ignore other substances that are truly harming our youth and communities. If harm reduction was truly their focus, one would assume that they would spend their time trying to prohibit (or place on schedule I) alcohol. Alcohol—a real gateway drug, if such a thing exists—is far more dangerous to children, families, and society than marijuana (read: Marijuana is Safer: So Why Are We Driving People to Drink?) Whether or not opponents of marijuana reform will acknowledge it, marijuana belongs outside of schedule II, as the facts and their own rhetoric support.

If you’re looking for ways that you can contribute to cannabis policy reform efforts, start by reaching out to your state and federal representatives and urge them to support commonsense cannabis regulation and legalization reforms.

As a proud member of the Coalition for Cannabis Scheduling Reform and its partnership with the American Trade Association of Cannabis and Hemp (ATACH), Vicente LLP has been a leader in scheduling reform efforts. Our firm was a key contributor to the group’s comprehensive report detailing the legal and policy arguments supporting the urgent need for scheduling reform and we continue to support reform efforts, including addressing relevant international treaty obligations and criminal justice reforms.

Watch our special briefing “Cannabis Rescheduling: Implications & Next Steps

The likelihood of marijuana’s federal reclassification to Schedule III status has Big Law leaders eyeing opportunities to expand relationships with clients who have historically lacked the same tax benefits and bankruptcy protections as other sectors.

Despite the growing number of states legalizing cannabis for recreational and medicinal use, the nascent legal cannabis industry has been hobbled by lack of traditional bank financing and a federal tax code prohibiting expense deductions enjoyed by most other sectors.

While the DEA’s reclassification of marijuana as a Schedule III drug won’t bring state-legal cannabis businesses into federal compliance, it has the potential to infuse the industry with millions in reinvestable capital, resulting in transactional and financing potential, lawyers say. Rescheduling could also provide cannabis clients with protection in the bankruptcy courts, which historically has been a hostile environment for distressed cannabis businesses.

“What makes reclassification a watershed event is that it frees up capital and allows for more growth and allows for potential consolidation and more successful companies, more competition with respect to multistate operators and get back to a place of equity investment,” said litigator Seth Goldberg, co-chair of the cannabis industry group at Duane Morris.

“We have been preparing for that, and lawyers in each of our practice areas—whether IP, corporate, employment—who have cannabis practices are already thinking about how they‘re going to advise clients in the cannabis industry and also outside of the cannabis industry with respect to how reclassification impacts that type of law,” Goldberg said.

Under cannabis’ current Schedule I status, Section 280E of the tax codes prevents businesses from deducting expenses involving the “trafficking” of Schedule I or II substances, restricting the amount of operating capital. […]

The combined impact on cannabis businesses of tax liabilities and lack of access to financing “can’t be overstated,” Goldberg said. Removal of 280E “will have an immediate impact on operator balance sheets,” he said.

“With the operators performing better, they can reinvest in the industry and more folks will invest,” he said. “A firm like Duane Morris will continue to do what it is doing, but now you have cannabis companies with hundreds of thousands of employees, and that raises the same level of labor and employment and union issues that every industry is dealing with. As the cannabis market starts to perform better, our services across our entire platform should be in greater demand.” […]

Risks of Dabbling in Cannabis for Lawyers

The development of cannabis practice groups in Big Law firms […] provides a view into how large firms expand an industry-focused practice area based on client needs.[…]

In the early days of Duane Morris’ cannabis industry group in 2015 and 2016, lawyers helped clients secure licensing and equity investment and, as the industry has grown, the firm has pivoted toward providing clients with debt financing and tax advice, Goldberg said.

“For the types of issues and questions that come up in the application for a cannabis license, there are a number of solo practitioners and industry consultants who have created cut-and-paste templates for applications,” Goldberg said. “It’s not the type of work that you would go to a large law firm for. What we do and where our clients find value is how do you set up the corporate structure so we can apply for the license.”

Opportunities to Expand Client Relationships

Lawyers are anticipating marijuana’s reclassification to entice clients from other industries to finance marijuana businesses or open product lines that would have otherwise been restricted, such as marijuana-infused beverages.

“We’ve had dozens and dozens of companies—consumer products goods companies, financial institutions, banks, lenders—who have been very anxious to get into the cannabis industry but have been reluctant to do so because of the Schedule I classification,” Goldberg said. “When reclassification happens, I think it’s reasonable to plan for a number of those kinds of folks who have been sitting on the sidelines to get involved in the industry in some way.”

One form of the industry’s legitimization would come in the restructuring process for distressed cannabis companies, who currently are unable to obtain protection through the bankruptcy courts, lawyers said. […]

Goldberg […] also pointed to the food and beverage market as an example of an industry looking for regulatory relief and certainty before developing cannabis product lines.

“In different parts of the country, cannabis beverages are becoming more popular,” Goldberg said. “It’s a really interesting segment of the cannabis industry, because people are more comfortable consuming beverages, so it might create more consumers of cannabis.”

To read the full text of this article, please visit The American Lawyer website.