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

In recent weeks, we saw press reports on a recommendation from the Attorney General to loosen federal restrictions on marijuana – reclassifying it by moving it off Schedule I (an illegal controlled substance with no medical uses and a high degree of potential abuse) to Schedule III, where many other drugs, including some requiring a prescription, are listed.  No official announcement about any reclassification action has been released, and even when it is, there are apparently other administrative steps that need to occur before any re-scheduling is final.  So, there are many regulatory hurdles still to come.

While a rescheduling to Schedule III may have an impact on research and marijuana’s medical uses, broadcasters need to continue to take a very cautious approach to marijuana advertising while the details of any possible change are worked out and likely even after any re-scheduling as, even as a Schedule III drug, advertising may still be restricted under federal law.

While many states have, as a matter of state law, legalized medical and even recreational marijuana use, there is still concern for broadcasters, as federal licensees, in accepting advertising for dispensaries and other marijuana sales, as we have noted many times before (see, for example, our articles here, here, and here).  That is because the sale and distribution of marijuana still remains a felony under federal law. Under 21 USC § 843 (b) and (c), to use communications facilities, including radio and the internet, to facilitate any sale of any Federally controlled substance is a felony.  The fear continues to be that, if the FCC is faced with a complaint about a broadcaster “facilitating” the sale of marijuana thought running advertising – an act illegal under federal law – the FCC might feel a need to take action against the broadcaster.  A move to Schedule III does not automatically solve that issue.

While we don’t claim to be lawyers who are experts in FDA law, from our review, Schedule III drugs include many that require prescriptions to use – including anabolic steroids and barbiturates – not exactly the kind of drugs one usually sees advertised on TV.  Schedule III drugs generally require FDA approval before marketing and are subject to restrictions as to how they are distributed.  Warning labels may be required.  Federal registration is required for those who dispense and manufacture these controlled substances, and users must be tracked as well unless the Attorney General decides that such user registration is not in the public interest.  These kinds of restrictions are certainly not in line with the ways that marijuana is sold in states that have “legalized” it under their state laws.

This proposed regulation is different than that applied to alcohol, or even hemp-based CBD.  Neither of these substances are on the schedules of controlled substances.  CDB (which contains less than 0.3% THC, the psychoactive ingredient in marijuana) was removed as a result of the 2018 Farm Act (see our articles here and here).  Even with its removal from the schedules of controlled substances, the FDA and FTC expressed concerns about advertising CDB’s use in a way that suggested that it had medicinal properties, the FDA does not authorize it for use as a food additive (see, for instance, our articles here and here).  While the FDA promised to review those restrictions soon after the Farm Bill was enacted, it finally threw up its hands last year and decided that it could not determine that CDB was safe as an additive to foods and beverages, or that health claims could be made (other than for the limited drugs actually approved by the FDA derived from the cannabis plant, such as Epidiolex).  The FDA instead asked that Congress provide instructions as to the rules that should be adopted in these areas (see FDA announcement here).  Of course, Congress has not yet acted, so these concerns for CDB remain.

If CDB, which is not a scheduled controlled substance is still subject to these federal concerns 6 years after being de-scheduled, one can only imagine the concerns that will continue to be expressed about marijuana distribution and marketing even if it is moved to Schedule III.  Plus, we have already begun to see pushback on whether this change is a wise move – and a change in administration could well mean an even stricter regulatory environment for marijuana in 2025 (see our article here on the greater restrictions under the first Trump administration).

Perhaps these concerns are overblown, and any rescheduling will be accompanied by a more hands-off regulatory environment.  But all these considerations take time – so broadcasters should not just yet be counting on any immediate windfall from an influx of marijuana advertising dollars.  Many details remain to be worked out, and many real issues remain before all issues are resolved.  Caution remains necessary.

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.