Side event: Cannabidiol oil for medical purposes: The Brazilian regulatory experience

Organised by the Government of Brazil.

Camilla Gomes (Brazilian Health Regulatory National Agency – Office of Controlled Substances)

Good afternoon and welcome – in Brazil we have the Office of Controlled Substances – which includes unregulated substances. We’ve held consultations with international regulatory agencies about unregulated substances. We’re holding this side event as we wanted to show what we are doing in Brazil.

Anvisa – Agencia Nacional de Vigilancia Sanitaria

Renata Souza (Manager, Controlled Substances Advisa)

We have the honour of presenting on controlled cannabidoil in Brazil. Most requests are about children with refractory epilepsy. The right of health is embedded in our constitution. This is an option for when regular medications no longer work. Reaching a decision with regulatory agencies on this issue was not easy. This issue was brought up by Brazilian civil society and is widely discussed in Brazilian media. Import is permitted if it is carried out by individuals – commercial companies are not able to conduct this work in Brazil. We will not discuss any pharmacological or toxicological issues in this presentation.

Thiago Silverio (Import and Export Anvisa)

Analysing the requests for CBD imports in Brazil. The beginning was 2014 – patients started to import from overseas – products were being seized. When the situations became known, there was public pressure – intensive requests from patients and their families, organisations and the media. ‘Ilegal – a vida nao espera’ a documentary available on Netflix.

Right to access medical treatment – the right to health is a constitutional guarantee – Anvisa issued permits for allowing access to CBD rich oils in exceptional conditions – products containing CBD and THC were included. Change of the status of CBD – Anvisa evaluated the situation and moved the substance cannabidiol. The change in CBD status allowed the publication of Resolution RDC 17/2015 (exceptional use for cannabidiol oil), which regulates the exceptional use of products containing CBD – it now sits on the same level as antidepressants. Local oil production or cannabis growing is not allowed at the present moment – they must be prescribed by a physician, only be imported, and for personal use only. Importing goods is not a daily business for most people – so others can intermediate – including hospitals, a government unit linked to the health sector, a health insurance company, a legally constituted civil representative body. The product must: be composed of vegetal extracts, have low THC levels, be produced by establishments duly authorised in the place of origin, be accompanied by a certificate of analysis. Parts of the plants, cosmetics smoking products, health products or edibles are not allowed to import. We have a list of products with declared compliance to the necessary minimal requirements – this list is updated whenever necessary. The products were not evaluated regarding their quality, safety or efficacy.

Requirement process – electronic form/letter; medical report justifying the prescription including information on previous treatment and registered products used by the patient), prescription by a physician (which is hard, as they have no reference for dosage), statement of responsibility signed by the physician and the patient (or person legally responsible for the patient).Amendments occur as well. Authorisations are valid for one year and state a specific amount of product that might be imported by a single patient (‘quota’), and the renewal of an authorisation is possible after presenting a new prescription and updated medical report. All the information for patients is available on the website.

2424 requests since 2015 – products from 15 companies (13 of which are based in the USA).

Product indications – Anvisa does not regulate medical indications – the physician is responsible for the indication of use. The vast majority of authorisations are for refractory epilepsy.

Challenges – discussing the use of cannabis is a sensitive matter. Products are unregulated – lack of evidence for safety and efficacy. No GMP oversight over producers. Quality standards cannot be guaranteed. The National Health System cannot distribute non-registered products to patients, but courts have been obligating the Government to provide them (at high cost to local authorities). There is a lot of misconception here. Commercial issues – producers want to have their products included in the list, and some are claiming they are authorised to sell in Brazil, which is not true.

Anvisa does not authorise companies or products – it authorises patients mindful of their right. Products are used for health purposes but are outside the regulatory framework – moving beyond the ‘exceptional use’ requires a new framework.

Anvisa has authorised Sativex, under the name Mevatyl. Two local pharmaceutical companies have publicly announced that they are intending to register medicines that contain CBD for treatment of refractory epilepsy. After 3 years, the importing process is now considered insufficient – expensive products, concerns over quality, bureaucracy to import – there is pressure for local production.

The current scenario is not ideal and discussions must continue – there is a recognition by the regulatory authority of the need to enhance the model.

Questions

Jim – FA, US – what is the threshold/THC level allowed in your product?

Answer – 0.1% of THC – but we are not assessing these level. THC level must be lower than CBD level.

Estonian Civil Society – regarding high cost of medication – which medications are you talking about?

Answer – the medications that the patients are importing themselves.

Gabriel (Brazilian Drug Policy Platform) – we are surprised to hear of this event in Vienna – families struggle to undeniable that healing properties of these products – cannabis frees our relatives of symptoms – but we are risking imprisonment if we grow it ourselves. Access to health is denied for thousands of people – health becomes a privilege, not a right. They ask the Brazilian government for a regulatory framework which provides the opportunity to grow the product at home – I have a letter from civil society to the Government

Singapore – regarding the amount of requests since 2015,do you charge for every request,where does the liability fall,THC levels? Singapore allows the import, as long as the product is absence of THC.

Answer – we were not expecting the demand – we now have 3 or 4 people assigned to meeting this demand. The bills are received online, and the application is free of charge. We take an average of 6 days to authorise the requests. The physician writes the amount that the patient needs. Liability – there is a liability document that the patients and physicians have to sign – the authorisation is in exceptional circumstances. The regulatory framework is not enough to meet the current demand situation. The liability falls on the physician, and they have their own set of recommendations.

Question – lowest THC content in Austria is 0.3%, but this can come up in urine testing – how do you managed this with driving licences?

Answer – this is a question for law enforcement, and not within our area of expertise.

Question (Hungary) – I have a number of questions – I have been looking into this for a long time. Could we please discuss it together. I have a chemistry question – CBD can be transformed to THC – this needs to be addressed.

Question – Hemp oil with higher CBD than THC is not controlled. CBD is not psychoactive – why is it controlled in Brazil – why not synthetic CBD? If you obtain CBD from hemp oil, you obtain THC.

Answer – cannabidiol is not prohibited – it is a special substance, it is controlled under national – we do not have enough information. Synthetic CBD was not available at the time. This framework is strictly for non-regulated products. The limitations are only for products

Question (Drug Policy Futures (USA)) – is there a plan to migrate this program, assuming the FDA approves certain products – do you plan to move to that drug?

Answer – it’s up to the company – if it goes within the resolution – it depends on the product. As a regulatory process, they can present the information to Brazil, we will wait for it to be available in another market first.

Question – is there a concept of fast tracking this process?

Answer – we usually have a gap, once they are approved in another market they may come to Brazil –  it has to do with the public interest. If the Ministry of Health come to us, and say it’s public interest that you come to us, then we would do that. That’s where the public pressure goes. If they manage to prove the need, it would be approved by the Ministry of Health. Th only way we can know what is being given to patients in Brazil is through the regular pathways, which is not the process we currently have.

Question – is medical prescription usually correct, or has there been a mistake in the past? Does anyone evaluate the medical prescription?

Answer – we don’t have standards to compare – we check that the product exists. It’s the responsibility of the physician.

 

 

 

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