Philmans Pharm, Cenedella.de, The German Patient Roundtable

Est. 1977


German cannabis lawyer KFN+ with good update on the German Cannabis As Medicine Cultivation, revised bid.

After the first award procedure for the cultivation of medical cannabis in Germany had been banned by the Higher Regional Court of Düsseldorf now the time has finally come and the Cannabis Agency has published the details of the new award procedure.

The Federal Republic of Germany, represented by the Federal Institute for Drugs and Medical Devices (BfArM) and the Cannabis Agency, continues to be the contracting authority for the award procedure for the cultivation, further processing, storage, packaging and supply of cannabis for medical purposes. This concerns the award of a public contract by way of an open procedure in accordance with §§ 97 et seqq. GWB (German Act against Restraint of Competition) and § 15 VgV (Regulations on the Award of Public Contracts and Procedures).

Prospective parties must prove their economic and financial capacity of the last 3 years when filing an application. Information must also be provided on sales in the cultivation, processing and supply of cannabis for medical purposes (THC content ≥ 1%) for the last 3 financial years, if available. Turnover in the cultivation, supply and processing of medicinal plants which have been placed on the market as medicinal products or active agents in a medicinal product after processing may also be considered as commendation now. The minimum condition for affirming suitability is then at least one cannabis reference for the cultivation of medical cannabis or one cultivation and processing reference for medicinal plants. The services provided must have been performed in accordance with both the GACP standard (Good Agricultural and Collection Practice) and the GMP standard (Good Manufacturing Standards), i.e. in accordance with the „Eudralex: Volume 4 Medicinal Products for Human and Veterany Use and Annex 7: Manufacture of Herbal Medicinal Products“, whereby approval for the manufacture of medicinal products must have been obtained from the competent authority ex ante.

If the contract is awarded Information must also be provided on how the financing of the contract is secured, and that the named land plot is available for the production site.

With regard to economic, financial, technical and professional capacity, a bidder may make use of the capacities of other companies within the framework of the so-called qualification hire. Thus, bidding consortia are also permitted, where the minimum conditions set must be fulfilled by at least one member of the bidding consortia.

The services are awarded by lot. The delivery quantity per batch is 200 kg per year. The following lots are set up:

Lot 1 to lot 8: cannabis flowers type 1

Lot 9 to lot 11: cannabis flowers type 2

Lot 12 and lot 13: cannabis flowers type 3

The cannabis flowers to be delivered must – depending on type respectively lot – contain the following concentration of tetrahydrocannabinol (THC) and cannabidiol (CBD):

type 1 with definition: THC between 18 and 22%, CBD < 1%

type 2 with definition: THC between 12 and 16%, CBD < 1%

type 3 with definition: THC between 5 and 9%, CBD between 5 and 9%.

Bidders may submit tenders for all lots, whereby one bidder may receive a maximum of 5 lots.

The delivery shall cover the following periods and quantities in total:

Delivery schedule of total quantity for the defined types

  1. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)
  2. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)
  3. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)
  4. Delivery year 2600 kg (type 1 1600 kg, type 2 600 kg, type 3  400 kg)

The award criteria are determined by a scoring system. The bidder with the lowest price offer for medical cannabis in the specified quality (detailed in euros per gram) receives 40 points. Another maximum of 5 points can be achieved by the quality of:

– the concept of technical facilities of the plant,

– the structural standards,

– the concept for GACP and GMP- standard,

– the concepts for cultivation, processing and delivery (e.g. with regard to prevention of failed harvests),

– the concept for production cycles,

– the concept for selection and training of personnel,

– safety and security concept.

When bidding, a concept for scheduling in the starting phase up to the first harvest with the respective intermediate steps must be submitted. The concept of the site and production must be described in detail for all stages to enable the cannabis agency to evaluate the award criteria. The origin and characteristics of the seed or plant material used must also be described in detail. The crucial technical facilities must also be particularised in concrete terms.

At the time of purchase capacity, the cannabis flowers must be appropriate for medical use. They must comply with the legal requirements of the current monography for cannabis flowers of the German Pharmacopoeia and the European Pharmacopoeia. With regard to heavy metal contamination certain limit values must be satisfied. The cultivation must also have been carried out according to the currently valid European GACP and GMP standards (see above) of course.

Conclusion: the new tender procedure slightly increases the quantities to be produced, which of course constitutes improvement. A cultivation and processing reference for medicinal plants is also sufficient to meet the minimum requirements. The quantities put out to tender however are still so meagre that it remains in doubt whether or not the production of medical cannabis in Germany can actually be of economic interest to interested companies. In view of the already approved import quantities of 21 tonnes in 2018 and a further increase in demand it remains cloudy why the German Federal Government is blocking the production of medical cannabis in their own country by tendering out such small quantities rather than giving a new and emerging industry in the country a chance.