• Debate "The patient does not want to be under the psychotropic effect all day, we want to receive the medicinal properties of the plant and lead a normal life"

  • Health Oils, capsules, vaporization... Routes of administration of medical cannabis (and none is smoking a joint)

The term is up.

This Tuesday marked

six months

since the Health and Consumption Commission of the Congress of Deputies approved the opinion of the Medical Cannabis Subcommittee and that was the time that the Spanish Agency for Medicines and Health Products (Aemps) had to carry out "

the necessary work so that the aforementioned recommendations fit into the regulations

and are viable, allowing the availability in the pharmaceutical market of extracts or standardized preparations of cannabis," the report stated.

According to what Aemps sources told this newspaper days ago,

the roadmap is very advanced and the Agency's idea is to meet the deadline

, so they intend to publish it before the end of the year or the first days of January.

"Everything indicated by the Subcommittee has been collected, and it has been compared with all the European Union guides and models from other countries. They are looking at the best way to guarantee the quality, safety and efficacy of the drug, avoiding the use illegal. Despite the fact that

we know that not everyone is going to be happy, we have to act as a scientific-technical body

, "they pointed out from Aemps and stressed that it is not the final regulatory framework, but where it is headed.

Although we must wait to see the indications published by Aemps, patients are concerned because they recognize that it

is a great step that has been taken, but they fear that when it comes to reality it will be useless

.

"We are very happy because since 2017, when we started this process, we are finally going to see the result, there are five years of battle in Congress that have borne positive fruit. But

there is a chaos of information and misinformation

, many people take it for granted .

that it has already been in force since June or is going to have it soon and we really see that it is not. So, our message is: please, do it well in a timely manner, make it easy for doctors and pharmacists, try to give all possible avenues , the greatest possible indications

so that the patient is always protected, which is what we are all looking for

", emphasizes Carola Pérez, president of the Spanish Observatory of Medicinal Cannabis (OECM), an association made up of patients, researchers and doctors.

After the approval in June by the Subcommittee, the Observatory held a meeting with María Jesús Lamas and Manuel Ibarra Lorente, director and head of the Department of Inspection and Control of Medicines of the Aemps, respectively.

We made ourselves available to you if you wanted more experts because we not only work in Spain, but also collaborate with international organizations and scientific associations that work with cannabinoids.

We offered all that evidence and experience, and they told us that the technicians were going to take care of it.

It is assumed that there was going to be a patient in the group of experts, but we do not know if this has happened

, "says Pérez.

From the Aemps they point out that the group of

experts that has been working on the roadmap are technicians

from the Department of Inspection and Control of Medicines and the Department of Medicines for Human Use of the Agency, they do not mention patients at any time.

Apart from the disappointment over this matter, at that meeting the Observatory tried to convey the

concern of the patients that a very restrictive model is going to be made

in which access is not easy or fast and in the end the patient

continues to resort to the black market, without a minimum guarantee of security

.

"The pain is not going to wait. And the patient with chronic neuropathic pain, the one with sclerosis or the one with cancer and chemotherapy, needs to sleep, needs to eat and alleviate their pain, and they are going to resort to the black market," Perez points out.

The president of the Observatory stresses that it seems unbelievable that they have encountered "rigid, opaque, inaccessible" classes and sectors of society, being widely accepted by society that there are different uses, "

just as it is understood that heroin is one thing and morphine is another and they come from the same plant

, which is the poppy".

A few days after knowing the content of this roadmap, Carola Pérez analyzes

some of the aspects that most concern

patients.

Simple model that does not depend on the postal code

For the Spanish Observatory of Medicinal Cannabis, the model must be "very simple".

"Both for the patient and for the doctor to prescribe it because

there are many times that if the bureaucracy that the doctor has to do is very complicated, then in the end they will not opt ​​for cannabinoids

as a treatment, and that the greatest possible indications be prescribed because If not, that patient will go to the black market the same, but without the appropriate security and traceability environment", explains Pérez, who adds that

it cannot "depend on the postal code

because then there will be patients in different conditions, some who have it easier and others, complicated".

Being last should have advantages

All European countries, except Belgium and Spain, had already legislated on the subject of therapeutic cannabis.

Being the last can have advantages

to "take advantage of their mistakes and successes, transferring it to the model of Spain with the autonomies, because that is going to be another question. But since we are the last, you can see what has gone well and what has gone wrong in other countries, what can be improved and make an affordable model.But after the meeting with Aemps, and in the absence of reading the document yet, the feeling we have is that we have been working on this law since 2015 and

in the end to be so restrictive that it is not going to be useful for the patient

", emphasizes Pérez.

Use of the flower with the vaporizer as a rescue

"One of the issues that they already told us that it would be difficult to include is the

use of the flower with the vaporizer as a rescue

. We asked the Agency that we did not quite understand why this is not going to enter if it

is in the rest of European countries

and the evidence that other countries have used is one.We also do not understand that Aemps is granting

licenses for the cultivation of cannabis flowers so that this flower can be inhaled by patients in other European countries

and the world and here, instead , where there are also standards to produce this flower with one of the strictest GMP quality in Europe (to ensure the safety of the product), it is not going to include it in the uses. If things are not done right now, it will be take a long time to correct them."

Specialists only, not family doctors

Already in the report of the Subcommittee in June it was indicated that the prescription will only be carried out by specialist doctors, which

in principle leaves out family doctors

.

"Primary care doctors made some statements saying that they also wanted to prescribe, that they are not allowed does not make sense. Why can't a GP who

prescribes me doses of opioids, antidepressants and benzodiazepines learn to handle cannabinoids

as one more treatment? That would make everything go faster and be more accessible," Pérez points out.

In this sense, the president of the OECM gives the example of some treatments to alleviate pain, such as intravenous ketamine, "for which there is a year-long waiting list at Hospital La Paz, for example. Or it is done privately, which is 3,000 euros in a clinic in Barcelona (and in many cases transfer and stay will have to be added), or there are no options because not everyone has that money".

"If family doctors don't prescribe too, only specialists - Pérez concludes - seeing how the Health is right now

with waiting lists of a year for urgent treatment

, we don't even want to think

how long it will take for the first oil to come out cannabis from a hospital...

".

Prescription in public health, but not in private

That of primary care physicians is not the only inconsistency in the prescription, another of the main ones occurs if only public health is recognized.

"Why can't private hospitals prescribe if some specialists work in the public hospital in the morning and in the private hospital in the afternoon?

It's the same specialist with the same training, but he can prescribe medical cannabis in the morning and in the afternoon in the private one, no

. The Quirón or HM clinics, for example, have their own pain units, they give neurostimulators or intravenous ketamine, they do all the same treatments, but with cannabis it will not be like that," argues Pérez, who adds that this situation is only going to cause

the waiting lists to get fatter

of public hospitals, saturate them more.

Dispensing only in hospital pharmacies, not in community ones

No less important is the dispensing.

"Limiting it to the hospital pharmacy seems to us to be another mistake. Going to the neighborhood pharmacy next to your house is not the same as having to go to the hospital, which is not always close, to pick up a medicine. If, in addition

, the community pharmacy already dispenses opioids, benzodiazepines

or antidepressants, they are used to working with narcotics,

not allowing them to dispense cannabinoids is not trusting their professionalism and work

(apart from the fact that they will not be able to give it to you without a prescription, just like an opioid) and nonsense."

In addition, Pérez cannot avoid certain doubts: "If any political group believes that what the Aemps collects is insufficient or does not agree and they throw it back, does that mean that they have to start over from scratch?"

Waiting to see what the report from the Medicines Agency includes or not,

cannabis is not going to be an immediate reality

that relieves the pain of chronic patients because it takes time to start all the machinery, train doctors (and perhaps pharmacists), etc.

But regardless of the time factor,

patients need the law to be truly useful

.

Legislating just to stick out your chest and making a restrictive law that prevents or hinders access to patients will only increase their pain in the end.

According to the criteria of The Trust Project

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