- Jaap Erkelens temporary new plant manager
- New appointment at QA
- How far have we come with the GDPR?
- Demand for medicinal cannabis increases
- Safety first
- NHG: “Do not prescribe cannabis”
- A new floor for A2, processing temporarily closed
- Bedrocan is looking for new board members
- EMA-representatives impressed by A5
- Yield overview A2 and A5
Jaap Erkelens temporary new plant manager
Over the past few weeks a number of tasks within the organization have been redistributed. This is most visible in the operational area, where Hans Bartelds left. Jaap Erkelens will assume the tasks of plant manager for the coming period. Jaap, who also manages the Technology Transfer team, set up the production site in the Czech Republic in 2014 and was active as a troubleshooter at Bedrocan Canada. In addition, he was closely involved in the engineering and construction of A5.
New appointment at QA
The QA department is back on track with the arrival of Marcus van den Ende, who is working as QA officer in Veendam since 4 June. He will collaborate with Naiem Hakiemie, who is responsible for QA matters on A5. In connection with the absence of Wim Bouter, Naiem also temporarily takes over the management of the entire QA department. He is supported by Wouter Dijkstra of the Clinical Research department.
Quality Assurance is crucial within the pharmaceutical industry – and therefore also with Bedrocan. We make a product that is meant for patients and we can not afford quality and safety risks.
The QA department sets out the lines for quality assurance and then monitors them. QA members have an independent position within each pharmaceutical company, because they must be able to make decisions that place quality and safety above economic business interests, such as rejecting a batch.
What about the GDPR?
We are working hard to be compliant with the new European General Data Protection Regulation (GDPR), which came into effect last May. The GDPR must ensure that organizations deal more carefully with the processing of personal data. As a good employer, this is not only our duty, but also our express wish for the employees.
The employees within Bedrocan who process personal data have recently had a presentation / workshop from law firm Osborne Clarke, specialized in privacy protection. This meeting explained how to deal with the new legislation and what to look for when processing personal data.
Work is also being done on a practical guide for all employees. Here you can find out how you can contribute to the fact that Bedrocan meets and continues to comply with this new legislation. Did you know, for example, that a wrongly sent e-mail is already seen as a data breach? That sounds more serious than it is, but processes must also be organized for this. There too, hard work is currently being done!
Conclusion? We are on the right track, but as said, it remains a continually changing process. We will certainly keep you informed of the developments in this area.
If you have any questions or would like to know more about what the new legislation means for you(r) (department), please contact Roelien van der Wal (Legal Assistant).
Demand for medicinal cannabis increases
As we all know from our last newsletter, the German tender for the production of medicinal cannabis has been postponed. This means that the German government will import our medicinal cannabis via the Office of Medicinal Cannabis (OMC) in the coming months. It is quite possible that the German government wants to order a larger amount of medicinal cannabis at the BMC on an annual basis. At the same time, the Italian government has also approached the OMC for the supply of medicinal cannabis and we see a strong increase in demand from Poland. Growth, in short. And this probably means, according to CEO Tjalling Erkelens, that the expansion of Emmeloord will start in the third quarter of this year.
There will be more attention given at workplace safety. Everyone needs to know what to do when there is a fire alarm. But you also need to know how to prevent an accident on the work floor. Especially employees from the production and processing in Veendam have encountered a number of safety risks for some time. The compulsory risk, inventory and evaluation (RI & E) has now been carried out at Veendam and Emmeloord. The management, in consultation with HR and the plant manager a.i., will determine who will be responsible for implementing the recommendations in the coming period.
NHG: “Do not prescribe cannabis”
The Dutch General Practitioners Association (NHG) advises no longer prescribing medicinal cannabis for pain reduction or improvement of quality of life. According to the NHG this does not mean that medicinal cannabis does not work, but that there is currently insufficient scientific evidence for effectiveness. Meanwhile, several pharmacists, including Paul Lebbink of the Transvaal Pharmacy, have expressed their disagreement with the NHG’s advice, although they also state that scientific research is desperately needed.
“That fits in with Bedrocan’s vision,” says Tjalling. “There is a need for scientific research that meets certain requirements, such as applying a placebo. Earlier this year, the minister of Health indicated that he attaches great importance to knowledge about the effectiveness of medicinal cannabis and that he wants to investigate what additional research is still needed. Now we also hear from the Medicinal Cannabis Office that the government wants to play an active role in this. That is very hopeful.” Tjalling adds that the first results of clinical research into the effect of medicinal cannabis in fibromyalgia are promising. In this research of the Leiden University Medical Center (LUMC) cannabis and placebo from Bedrocan are used.
A new floor in A2, processing temporarily closed.
Processing in Veendam (A2) will close for three weeks because the space will be given a new floor. The current floor no longer meets the requirements and A2 will have the same industrial floor as A5. The planning has been adjusted in such a way that there is no need to pick and cut for three weeks in Veendam. The employees are therefore together with holiday. During the same period, the two vegetative cells on A2 receive an extra cleaning. Also, the so called fungus gnat, which lays eggs in the rockwool blocks, is additionally fought with a biological pesticide. Previously, the trips, a small insect that damaged the leaves of the cannabis, and the sewer gnats have been successfully tackled.
Bedrocan is looking for new board members
Bedrocan is looking for new board members. CEO Tjalling Erkelens and Ben Bronfman are currently on the board. This board sets the course of Bedrocan and ensures that this course is also followed by the daily management. Tjalling indicates that someone will be added to it in due course. “A person with knowledge, who has earned his or her spurs in the pharmaceutical industry and can contribute to the future vision of the company”, according to Tjalling.
In one of the previous newsletters we have already proposed Ben Bronfman. Ben is the ‘captain’ of the American investor Dioscorides Global Holdings (DGH). DGH manages a financial fund, which various other parties have also invested in. With this money, Bedrocan can realize certain ambitions, such as the development of new production locations, growth abroad and the improvement of existing production processes.
The board of directors also works on the business plan, in which the course of the organization is plotted. That course depends on developments in the market. The business plan is expected to be completed this summer, but during the meetings Tjalling already lifted the veil. He indicates that Bedrocan continues to focus on the production of medicinal cannabis that reaches patients through pharmacies, but we also see increasing demand from pharmaceutical companies that want to use our product as a raw material (Active Pharmaceutical Ingredient, API). For these companies our product (standardized and GMP) is ideal and the expectation is that raw material production – the industrial batches that we already make – will be more important in the future.
EMA-representatives impressed by A5
Recently, a delegation from the European Medicines Agency (EMA) visited the production site in Emmeloord. The EMA assesses the introduction of new medicines and monitors the quality of existing medicines. At the invitation of the Office of Medicinal Cannabis (OMC), the delegation learned how the availability of medicinal cannabis in the Netherlands is organised and how standardised medical cannabis of pharmaceutical quality is produced. The EMA representatives were very impressed with Emmeloord and the production processes. “In the production of medicinal cannabis I proposed a few simple greenhouses, but this is something different”, one of the delegation members said. “This shows that cannabis production really exists according to pharmaceutical standards. It’s top notch! “
Yield overview A2 and A5
The pie charts below indicate the types of varieties that have been produced in recent weeks.