The PSOE proposes to limit the dispensing of medical cannabis to hospitals

Only in hospital pharmacies, exclusively within the public system, and the creation of standardized preparations and master formulas (usually in the form of oil), but not the inhalation of buds, will be allowed. The PSOE already has its proposal for the regulation of medicinal cannabis, which it planned to send this Monday to the parties in Congress. A period of ten days is now open in which the groups will be able to contribute and negotiate a text for the House to approve, which seems like the end of the “inexorable” road – in the words of the Socialists – at this point.

Keys for the regulation of cannabis for medicinal use that Congress is beginning to address

Know more

The document is based on five strong ideas that constitute the axis of what the PSOE believes should be the model for the regulation of cannabis for medicinal purposes in Spain, according to what is read in the text: guarantee the availability of medicines derived from cannabis; the preponderant role of the Spanish Agency for Medicines and Health Products (AEMPS); public service and hospitals (not pharmacies) as pillars of the system; avoid “increased availability of cannabis outside the clinical context”; and evaluate the program regularly.

The proposal has fallen like a bucket of cold water among some of the actors involved. Patient associations lament that limiting the program to hospital pharmacies – in the absence of possible regulatory development by the autonomous communities – will cause many people keep going to the black market before the difficulties that this type of legal circuit can pose.

"The fact that dispensing is only in hospitals is a huge problem," says Carola Pérez, president of the Spanish Observatory of Medicinal Cannabis (OECM), "it is a horrible bureaucracy, every month you have to go to the hospital to collect the medication." In other European countries such as Italy, he says, pharmacies do dispense: the specialist doctor makes the plan, the family doctor the prescription based on the first's report, and the patient picks it up at the neighborhood pharmacy.

An idea similar to the one pointed out by the PSOE's government partner, United We Can: "What we want is an effective regulation that achieves its objectives," explains Lucía Muñoz Dalda, the UP spokesperson in the subcommission that studies the regulation. “And this report doesn't entirely put the patient at the center; I think that if we make it very difficult for them they will continue to go to the illicit market, but we have ten days to negotiate”, she is conciliatory. "The PSOE has been brave in taking this step, but we must ask it to be more so and to prioritize efficiency in this document," she adds.

The keys of the proposal

The PSOE wants a system under strict control, as is clear from its proposal, which draws a restricted system in access and dispensing –only in the public hospital network–. Party sources explain that the framework sought is based on "medical prescription, health and legal security and that the AEMPS approve the entire process." The what, the how and to whom are some of the keys to future regulation, which the text deals with in part.

Regarding the "to whom", the socialists, in line with their thinking in recent years, maintain that "the available scientific evidence is limited in relation to the therapeutic uses of cannabis and its products, and is restricted to some diagnoses", among which he mentions "spasticity in patients with multiple sclerosis, some forms of epilepsy, and chronic non-cancer pain (including neuropathic pain)". These would be, in principle, the uses to which it would be limited, although the document opens the door to further investigation.

The where is one of the elements that has generated the most rejection. The socialist proposal maintains that "the prescription must be carried out exclusively by health professionals, in a context free of potential conflicts of interest, such as that offered by the public services of the National Health System", a measure that would force network patients private to go to the public.

In this framework, the dispensing of the products would be done exclusively in hospital pharmacies, leaving out in principle the neighborhood ones. “Mechanisms may be arbitrated to facilitate patient access to the magisterial formulas dispensed by hospital pharmacy services, in coordination with the autonomous communities, when the patient's conditions or the distance to the services require it”, says point 3.7 of the document.

Communities will be able to regulate

But the PSOE explains that this point leaves the door open for the communities to regulate it on their own so that it can be dispensed in common pharmacies. "The base is hospital pharmacy so that the prescription is by the specialist health professional who cares for you," explain socialist sources, but there is "an autonomous competence framework," they add, which would be developed in a second phase.

Pérez, from the OECM and decades-long user of cannabis for therapeutic purposes, believes that the formula will not work. “We have the products that we patients use in the neighborhood pharmacy, not in the hospital one. In addition, it is being given a category that is not given to a benzodiazepine or an opioid, drugs with which you also have to be very careful and with which pharmacies make an accompaniment. This complicates things a lot, the hospital prescription is a very complicated process that on many occasions involves a court... The direct doctor-patient treatment is lost, many people will continue on the black market in the face of so many obstacles. Or what happens if you go away for a month?” he wonders.

Patients do have a joy in the “what” part. In addition to the two medications already on the market –Sativez and Epidyolex– the socialist proposal includes treatments with extracts or standardized preparations and opens the door to assessing "the way in which the competent pharmacy services can prepare master formulas from extracts or standardized cannabis preparations for direct use in certain cases”, a measure that future users had requested.

"That there is no greater availability"

The socialist proposal also devotes an entire chapter to issues that could be included in security with the program. On the one hand, to "ensure not to take actions that lead to greater availability and consumption of cannabis outside the clinical context", one of the main fears of the party. "It is absolutely necessary to prevent the therapeutic use of standardized cannabis extracts or preparations for certain patients with specific indications from being confused with a generic invocation of the general use of cannabis by the population," the document states.

It also establishes that the Congressional Health Commission will evaluate the program every year for a decade and that the AEMPS "will prepare a report on the therapeutic use of standardized cannabis extracts or preparations." This information will be complemented by "a report on the use of cannabis and standardized cannabis extracts or preparations in Spain, with information on the frequency of use in the adolescent and adult population, signs of intensive use, signs of problematic use, people who go to specialized treatment with cannabis as the main substance” by the National Plan on Drugs to ensure that there is no unjustified growth in consumption.

The subcommittee meets another deadline with the presentation of the PSOE proposal, which has adhered to the margin that had been given. From now on, there are 10 days left to negotiate the document and present a definitive version that, ideally, will be voted on June 23. If approved as planned, the ball will remain in the hands of the Government, which will have the (non-binding) mandate from Congress to regulate medical cannabis. The Ministry has promised to do so and the document, when approved, will have the support of the PSOE. If nothing strange happens or the negotiations stall, Spain will no longer be one of the few European countries without a therapeutic marijuana program during this legislature.

Source link