World Law Group member companies not too long ago collaborated on a Global Cannabis Guide that gives a quick overview of legal guidelines and insurance policies concerning using hashish in numerous jurisdictions. It briefly outlines data on an important authorized points, from related laws and basic data to particular necessities and dangers. The information doesn’t declare to be complete, and legal guidelines on this space are rapidly evolving. In explicit, it doesn’t exchange skilled and detailed authorized recommendation, as information and circumstances fluctuate on a case-by-case foundation and country-specific rules could change.
[co-authors: Martin Draebye Gantzhorn, Gundula Maria Kjaer]*
This chapter covers Denmark. View the full guide.
1. Identify the geographic scope and limits of your solutions to the questions beneath.
2. Please present hyperlinks to relevant statutes and rules.
Act no. 1668/2017 on the Medicinal Cannabis Pilot Programme, as amended
Executive Order no. 695/2019 on cultivation, manufacturing and distribution of hashish bulk and manufacturing of hashish major merchandise, as amended
Executive Order no. 694/2019 on import of hashish major merchandise and manufacturing of hashish intermediate merchandise, as amended
Executive Order no. 1334/2019 on euphoriant substances, as amended
In addition to the aforesaid laws, the Danish Medicines Agency (the Authority) has revealed a number of pointers masking particular matters below the Programme and improvement scheme. The stated pointers can be found (in Danish solely) on the website of the Agency.
A. Is there any pending laws that would materially alter relevant statutes or rules?
On January 1, 2018, a four-year medicinal hashish pilot program (the Programme) was launched. The Programme is ruled by the Danish Act no. 1668/2017 on the Medicinal Cannabis Pilot Programme, as amended (the Act). Parallel to the Programme, a four-year improvement scheme was additionally launched. According to the event scheme, the Authority authorizes analysis and improvement actions by way of cultivating and dealing with hashish, which can kind a part of the Programme at a later stage. The Programme can be evaluated all through its length to find out whether or not it ought to be prolonged or made everlasting.
Expectations are that the Danish medicinal hashish trade will develop and evolve. At this level, nevertheless, we’re not conscious of any draft rules and, accordingly, don’t anticipate any rapid authorized adjustments.
B. Is there any proposed laws that would materially alter relevant statutes or rules?
No laws has been proposed that would materially alter relevant statutes or rules.
3. Are hashish legal guidelines in your jurisdiction fairly effectively settled or are they consistently altering in materials methods?
The hashish legal guidelines in our jurisdiction is fairly effectively settled, although we’re nonetheless inside the four-year pilot Programme.
III. General data (e.g., governing our bodies, licenses, import/export)
4. What governing physique regulates/licenses or enforces actions which are allowed in your jurisdiction?
The governing and competent nationwide authority for implementing the Programme is the Authority, which is an company below the auspices of the Health Ministry.
The Authority has powers to draft and oversee the implementation of the laws, i.e. granting authorizations for cultivation, import, manufacturing and export of hashish major merchandise and manufacturing of hashish intermediate merchandise in addition to analysis and improvement actions regarding hashish cultivation and dealing with.
5. What hashish capabilities are allowed in your jurisdiction? E.g., rising, processing, retailing.
Under the Programme, the next actions could also be approved:
- Import, manufacturing and export of hashish major merchandise and manufacturing of hashish intermediate merchandise
- Cannabis cultivation for medicinal use and producing hashish bulk and hashish major merchandise from Danish-grown hashish
- Cannabis cultivation and dealing with with a view to producing at a later stage hashish appropriate for medicinal use in response to the Programme (consists of import, receipt, cultivation, possession, producing preparations for analyses, distribution, export, and so on.)
All of the above-mentioned actions require authorization.
6. What gross sales or use is allowed in your jurisdiction? E.g., edibles, vaping, tinctures, meals components, and so on.
Cannabis for medicinal use is allowed in our jurisdiction: Any medicinal hashish product that’s to be comprised by the Programme should be admitted to an inventory that’s revealed on the web site of the Authority. For extra data, please see this page on Admission of merchandise to the Programme.
A. Are the foundations totally different for medical vs. grownup leisure use?
The guidelines for medicinal vs. grownup leisure use differ as hashish for leisure use will not be permitted in Denmark.
B. Are retail gross sales of any hashish merchandise restricted to particular retail channels? E.g., medical dispensaries, government-owned shops, and so on.
In Denmark, the retail sale of medicinal hashish is restricted to particular retail channels. Accordingly, medicinal hashish could solely be disbursed by a pharmacy primarily based on a doctorís prescription.
C. Are there zoning restrictions on the place medical, wellness, or adult-use (leisure) shops could be positioned? Applicable to all hashish merchandise?
No zoning restrictions apply, please see above below 6.a.
7. What import and export is allowed in your jurisdiction?
Import allowed into Denmark:
An organization desiring to import hashish major merchandise should acquire authorization to fabricate hashish intermediate merchandise. It will not be doable, by itself, to distribute imported hashish major merchandise. Furthermore, it isn’t doable to import hashish bulk with a view to producing merchandise to be included within the Programme.
Export allowed from Denmark:
Export actions regarding hashish bulk or major merchandise should be in accordance with the necessities laid down in Chapter Eight of Executive Order no. 695/2019. Cannabis bulk or major merchandise should be exported to nations solely which enable import of medicinal hashish. The firm within the import nation should have the mandatory native permits in place to deal with the hashish bulk or major merchandise in response to native legal guidelines.
The export of medicinal hashish below the event scheme is permitted just for evaluation functions. Any export of euphoriant substances, hashish included, is topic to import and export certificates, and the corporate should have been granted an authorization pursuant to the foundations on euphoriant substances, which covers export for evaluation functions.
A. Are there restrictions in relation to the nations of origin, i.e. which nations of origin are permitted?
Denmark has restrictions as to the nations of origin of sure hashish merchandise. Import of hashish major merchandise should be in accordance with Chapter 5 of Executive Order no. 694/2019 on import of hashish major merchandise. The hashish intermediate merchandise producer should e.g. be sure that the hashish used within the major product is grown and obtained in accordance with the 1961 United Nations Single Convention on Narcotic Drugs and is cultivated in a rustic which is get together to the Convention.
B. Please describe restrictions on the import of hashish seeds.
Seeds from the hashish plant will not be regulated as euphoric substances. An import certificates is subsequently not required to import seeds. However, firms importing seeds should be sure that the seeds are free from quarantine pests, however it’s our understanding that no additional phytosanitary necessities are imposed on the import of hashish seeds. The Danish Agricultural Agency is the authority accountable for the foundations on phytosanitary necessities.
8. Does your area distinguish between various kinds of hashish merchandise? (E.g., excessive or low concentrations of
A. If so, what distinctions exist?
B. If so, briefly describe the variations.
C. Identify any associated legal guidelines that ought to be thought of when answering this query.
As of July 1, 2018, the tetrahydrocannabinol (THC) restrict was modified within the govt order on euphoriant substances. As a consequence, hashish merchandise with a content material of 0.2% THC or much less are not topic to the foundations on euphoric substances in Denmark. Hence, it’s doable to provide and promote cannabis-based merchandise containing as much as 0.2% THC with out contravening the manager order on euphoriant substances.
9. Are there authorized necessities on Cannabidiol (CBD) merchandise (with out THC)?
It is feasible to market cannabidiol (CBD) merchandise with a THC content material beneath 0.2% in Denmark with out contravening the manager order on euphoriant substances. CBD merchandise could, nevertheless, be lined by the foundations on medicinal merchandise, meals merchandise, beauty merchandise, and so on., and such guidelines should nonetheless be noticed.
Hemp could also be utilized in meals, together with in meals dietary supplements. However, the EU novel meals laws should be revered. The following merchandise of hemp will not be thought of novel meals: Hemp seeds, seed flour, protein powder from seeds and seed oil from types of the hemp plant (hashish sativa L.) listed within the EU Community catalogue of sorts, that are free from or comprise low ranges of THC. Other elements of the hemp plant, together with extracts of hemp merchandise, are thought of novel meals as a historical past of consumption has not been demonstrated. This applies to each the extracts themselves and any merchandise to which they’re added as an ingredient, similar to hemp seed oil. The Danish Veterinary and Food Administration (DVFA) subsequently considers such merchandise as novel meals, and the inserting available on the market requires prior EU threat evaluation and authorization below the EU novel meals regulation.
A course of is ongoing within the EU to establish whether or not different elements of the hemp plant (leaves, flowers, extracts of various plant elements, and so on.) have been lawfully positioned available on the market as a meals within the EU earlier than 15 May 1997. The DVFA recommends contacting the Danish Medicines Agency previous to notification of a meals complement containing CBD with the intention to make clear that the product will not be a medicinal product.
IV. Patients and prescriptions
10. What particular medical situations, if any, are acknowledged for therapy with hashish?
The Authority assesses that medicinal hashish ought to be thought of just for the next indications supported by some proof that medicinal hashish might have an impact. The related indications are:
- Painful spasms attributable to a number of sclerosis;
- Painful spasms attributable to spinal twine harm;
- Nausea after chemotherapy;
- Neuropathic ache, i.e., ache as a consequence of a illness of the mind, spinal twine or nerves.
The Danish Medicines Agency has chosen the above indications after finding out and assessing the related scientific research performed worldwide to research the impact of medicinal hashish. According to the Authority, the particular merchandise comprised by the Programme haven’t essentially been investigated. Nor have the doable uncomfortable side effects within the brief and long run been sufficiently recognized, which is one thing medical doctors and sufferers should concentrate on and settle for.
11. Is there a licensed practitioner requirement with the intention to prescribe hashish for medical functions?
All medical doctors are approved to prescribe the merchandise included within the Programme. They may prescribe magistral preparations of hashish, whereas solely neurologists are allowed to prescribe the pharmaceutical product Sativex.
12. Are there affected person registration or cardholder necessities?
It is our understanding that no necessary affected person registration or cardholder necessities exist. However, a prescription is required with the intention to acquire medicinal hashish. Prescriptions for medicinal hashish should be registered within the Shared Medicine Card (in Danish: det FÊlles medicinkort (FMK)) in response to Executive Order No. 1615 of 18 December 2018 (in Danish solely) regarding entry to and registration of medication and knowledge on vaccines. The Shared Medicine Card works as a nationwide prescription server.
V. Special necessities
13. Does your jurisdiction require any recordkeeping from seed planting to the time of finish person sale? For all hashish merchandise?
In Denmark, necessities of traceability and accounting guidelines are in place.
Companies with an authorization to develop hashish should, of their accounts, be capable of account for the realm the place the hashish is grown. This consists of data on what number of hectares they’ve planted and what number of hectares they’ve harvested, in addition to the quantity of hashish ensuing from the manufacturing. This data should be included within the annual reporting of the accounts to the Danish Medicines Agency.
The guidelines on traceability concern seeds and propagating materials. Traceability to the unique seed and propagating materials from the harvested hashish should be ensured. This implies that types of seeds or different propagating materials should be traceable to origin, portions, selection and possession. The firms ought to be capable of present this data always.
14. Are particular taxes imposed? On what and when?
15. Are there any particular guidelines or limitations that apply to the trade? E.g., banking, patent or trademark safety, labeling necessities.
Labeling necessities exist and they’re described in Chapter 7 of Act no. 1668/2017 on the Programme.
Moreover, it’s unlawful to promote for hashish merchandise lined by the Programme. This follows from part 57 of the Act. Advertisements are prohibited for hashish end-products, hashish intermediate merchandise included on the revealed checklist of hashish intermediate merchandise and hashish major merchandise included on the revealed checklist of hashish major merchandise.
16. What is the authorized standing of entry to monetary companies, together with banking, service provider companies, and money dealing with?
17. Is knowledge collected to find out the social or well being impression of the foundations in your jurisdictions? E.g.,
A. Impact on use by below age/minors.
Yes, such knowledge is collected by the Crime Prevention Council.
B. Impact on beer, wine and spirit gross sales.
Not by the federal government.
C. Tax income.
D. Impact on crime, together with drug and alcohol habit.
Yes, by the Crime Prevention Council.
VI. Risks and enforcement
18. What are probably the most vital points at the moment going through the trade in your jurisdiction?
There has been a substantial amount of debate in regards to the Programme. The debate consists of criticism by well being professionals of the premises for the implementation and analysis of the Programme, that are claimed to not be sufficiently clear. The Programme is, for instance, accused of not giving the sufferers vital entry to medicinal hashish opposite to the political intentions behind the Programme. This is because of the truth that medical doctors – as a part of the Programme – should take full accountability for the product they prescribe and decide the dose for the person affected person. Consequently, only some medical doctors prescribe medicinal hashish, though the demand from sufferers is nice. It can be attention-grabbing to see whether or not the controversies will have an effect on the choice to increase the Programme for added years
19. What is the present enforcement panorama with respect to hashish? E.g., strict enforcement, low-enforcement, decriminalization, legalization.
A relatively new four-year Programme on medicinal hashish has been applied. The laws could also be revised in mild of the approaching analysis of the Programme. Cannabis for leisure use is illegitimate.
A. Does enforcement differ primarily based on amount?
Only possession of medicinal hashish which has been prescribed by a physician is allowed.
For all different varieties of hashish, the enforcement doesn’t differ primarily based on amount. Possession of hashish is prohibited irrespective of the quantity, and additionally it is prohibited to purchase, promote, obtain, provide and produce hashish.
B. Does enforcement differ primarily based on product kind?
Cannabis for leisure use is illegitimate, i.e. possession of hashish is prohibited irrespective of the quantity, and additionally it is prohibited to purchase, promote, obtain, provide and produce hashish. Only possession of medicinal hashish which has been prescribed by a physician is allowed.
VII. Your apply and helpful hyperlinks
20. Tell us a bit about your hashish apply and the way it interacts with different practices at your agency. Remember to incorporate any recognition awards your agency has acquired on this apply space. How a lot expertise does your agency have offering companies to hashish firms and the way a lot curiosity does your agency should develop its hashish apply?
Bech-Bruunís life sciences group presents our purchasers authorized and strategic skilled recommendation within the areas the place the life sciences (together with the medicinal hashish sector) trade and traders want it. Our dimension and trade expertise enable us to offer authorized recommendation for a lot of Danish and non-Danish pharmaceutical and biotech enterprises, medical system firms and enterprise funds and others who need to spend money on or purchase life sciences enterprises. Our ardour, experience, availability and variety of devoted life sciences attorneys guarantee our purchasers a technological, authorized and business understanding that’s distinctive inside the Danish regulation trade.
We know the trade, together with the political and administrative decision-making ranges, which permits us to optimize your place and make sure you the absolute best answer for a technological, authorized or business concern.
Our companies inside the medicinal hashish sector embrace, amongst different issues:
- Acquisition of inexperienced homes
- Corporate help, together with drafting shareholders agreements, letters of intent ñ joint ventures and so on.
- Building permits
- Leasing contracts
- Management and technical agreements
- Assistance on the Danish Cannabis Pilot Programme and the event scheme, together with on
- Project descriptions
- Application for licences
- Import/export issues
- Competent individual (QP)
21. Please present hyperlinks to any agency web site, blogs, respected commerce publications, or attorneys that will assist others perceive the state of the regulation in your jurisdictions.
A. Are there any related commerce organizations?
B. Are there any related lobbying organizations?