Oireachtas Joint and Select Committees
Wednesday, 29 September 2021
Joint Oireachtas Committee on Health
Medical Cannabis Access Programme Update: Discussion
I welcome the witnesses from the HSE, the Department of Health and the Health Products Regulatory Authority to our meeting. They will provide us with an update on the medical cannabis access programme. I welcome from the HSE, Mr. Shaun Flanagan, assistant national director, HSE primary care reimbursement service, PCRS, and Professor Bryan Lynch, consultant paediatric neurologist, Children's University Hospital, Temple Street; from the Department of Health, Mr. Muiris O'Connor, assistant secretary, research and development and health analytics division, Ms Anne Marie Seymour, principal officer, medicines, controlled drugs and pharmacy legislation unit, and Mr. Conor Brennan, assistant principal officer, medicines, controlled drugs and pharmacy legislation unit; and from the Health Products Regulatory Authority, Dr. Lorraine Nolan, chief executive, Ms Grainne Power, director of human products authorisation and registration, and Ms Aoife Farrell, health products distribution manager.
Members have the option of being physically present in the committee room or may join the meeting remotely from Leinster House. Members and all in attendance are asked to exercise personal responsibility in respect of protecting themselves and others from the risk of contracting Covid-19. They are strongly advised to practice good hand hygiene and leave at least one vacant seat between them and others attending. They should also maintain an appropriate level of social distance during and after the meeting. Masks, preferably of medical grade, should be worn at all times during the meeting, except when speaking, and I ask for the members' full co-operation in this regard.
Before we hear our witnesses' opening statements, I need to point out to them that there is uncertainty that parliamentary privilege will apply to their evidence from a location outside of the parliamentary precincts of Leinster House. If, therefore, they are directed by me to cease giving evidence on a particular matter, they must respect that direction. I call on Mr. O'Connor from the Department of Health to make his opening statement.
Mr. Muiris O'Connor:
I thank the Chair and members for the opportunity to address them on the medical cannabis access programme. To put cannabis in context, it is a Schedule 1 controlled drug under the Misuse of Drugs Act. It is, therefore, subject to strict levels of control and access is allowed under licence for limited purposes only.
As the name would indicate, the purpose of the medical cannabis access programme, MCAP, is to enable access to a controlled substance which otherwise would not be legally available to patients. In this case the controlled substance is tetrahydrocannabinol, known as THC, a psychoactive derivative of cannabis. Cannabidiol, known as CBD, another extract of cannabis, is not of itself a controlled substance and the MCAP is not intended as a means of accessing CBD-based products. The ministerial licence programme, in operation since 2017, is similar in that it enables, with the support of a consultant, a GP to prescribe cannabis-based products where the patient is regularly monitored by a consultant.
The committee will be aware that in recent years, in both Ireland and abroad, the subject of using cannabis products for medical reasons has become an issue of social and political debate, with calls for cannabis products to be made available to Irish patients. Owing to this increasing interest, in December 2016, the Minister for Health requested the Health Products Regulatory Authority, HPRA, to provide scientific advice on the use of cannabis for medical purposes. Our colleagues in the HPRA will be able to elucidate further their findings in this review. Following publication of this HPRA report, the Minister for Health established an expert reference group to provide clinical guidelines for the development of a medical cannabis access programme.
Acknowledging that some time has passed since the last review of the clinical evidence supporting the use of cannabis for medical reasons was done, the Department is currently working to commence a new clinical review that will continue the work of the previous clinical expert group. This review will seek to build on evidence found in the earlier study and will assess if there is new information to support the addition of any other clinical indications to the MCAP.
Following the recommendations of the HPRA review in 2017, and importantly the subsequent clinical guidance, the Department commenced work on developing a legislative basis for an access programme. This was done in consultation with the HPRA, and representatives from the expert reference group, and in June 2019 the legislation was enacted.
The SI 262 of 2109, the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019, sets out the legal provisions for the operation of the medical cannabis access programme and the legal obligations for healthcare professionals and commercial operators. It also sets out how the access programme will work, who can avail of it, how it will be operated by the HSE and how cannabis-based products, made from whole dried flowers of the plant, are accepted for use under the programme and placed on Schedule 1 of the regulation's statutory instrument. It is a pilot programme for five years and may be extended for a further period.
My colleagues from the HPRA can assist the committee with questions on the process leading to inclusion of a product on the schedule for use under the MCAP. It is the Minister for Health who ultimately decides if a product goes on the Schedule. However, it is the sole responsibility of the supplier to apply to be considered for inclusion on the MCAP. There are currently four cannabis products on the Schedule and two more are to be added to Schedule 1 of the regulations in the coming weeks. I understand that one of the products on the schedule, namely, Cannepil, is expected to be available in October.
Subsequent to the introduction of the necessary legislation the Department has been working with the HSE, which will, pursuant to the requirements of the statutory instrument, operate the register of consultants and patients who will access the programme. This engagement culminated in the MCAP being made part of the HSE delivery plan for 2021. In July, it was announced that the HSE was ready to accept registrations of clinicians and their patients as required under the regulations. Our colleagues from the HSE will be able to advise on how the MCAP will operate in practice.
On the ministerial licence programme, to meet the clinical demand for medical cannabis prior to establishment of the MCAP, the Minister for Health initiated in 2017 a programme whereby licences, granted under section 14 of the Misuse of Drugs Act, can be issued to practitioners on behalf of patients where the clinician could prescribe, import, possess, supply and administer the controlled substance listed in the licence. A detailed application is required from the clinician describing the indication the patient has, the fact that all other medications, meds, have been exhausted or are no longer adding value to the quality of life of the patient, and advising that the clinician is prepared to prescribe cannabis oils and monitor his or her patient while using such products.
Such applications must also comply with recommendations made by the Chief Medical Officer, CMO, who advised that the granting of an individual licence under the Misuse of Drugs Act for the use of cannabis for medical purposes by the Minister for Health sets aside the usual regulatory processes which are in place to protect the public and which ensure that only those medications which have been found to be both effective and safe are made available to the public.
Therefore, it is crucial that the granting of any such licence takes due care and consideration of the potential unintended consequences associated with the prescription of cannabis, a Schedule 1 controlled drug, for medical purposes, and that its use is endorsed by a consultant who is familiar with and responsible for the care of the individual for whom the licence application is being made. The CMO also noted that the independence of the doctor-patient relationship is a fundamental principle upon which medical practice is based and that it would be neither appropriate nor ethical for the Minister for Health to seek to influence this relationship.
Currently 192 licences have been issued in respect of 67 patients. The products prescribed are all sourced from a pharmacy in The Hague, called Transvaal Apotheek. The products are compounded by the pharmacy itself. Transvaal is a well-established good manufacturing practices, GMP, facility and is a reliable supply chain for clinicians and their patients. The Netherlands authorities, however, do not allow the export of cannabis oils from the Netherlands to wholesalers or pharmacies, but they allow individual prescriptions to be dispensed. Owing to the Dutch authorities' restrictions in this regard, it is not open to the manufacturers of those cannabis-based products to apply to the HPRA to have their products included in Schedule 1 of the regulations.
With that in mind, representations were made by the Minister for Health to the Dutch authorities to request that the products could be commercially imported for inclusion on the MCAP.
The Dutch authorities, however, stated, "magistral preparations may only be provided directly to patients or their representative on the basis of a prescription". Notwithstanding this, patients who are currently being treated with these products can continue to access them under the ministerial licence issued to their clinicians.
Due to Covid-related travel restrictions, in May 2020 the Department of Health put in place a courier system to facilitate the collection of products from the Netherlands for delivery directly to patients' homes. A decision has been made to retain this method of supply for patients accessing cannabis-based products in this way. Additionally, in July of this year, a direct funding scheme for eligible patients was commenced between the HSE and the dispensing pharmacy in the Netherlands. The pharmacy now directly invoices the HSE and this removes the need for eligible patients or their families to pay for products upfront and subsequently seek reimbursement.
I hope I have given you an overview of the MCAP and the ministerial licence arrangements. My colleagues from the HSE will speak on the operation of the MCAP and address any reimbursement questions members may have, while my colleagues from HPRA will discuss how products are accepted for entry onto the MCAP.
Mr. Shaun Flanagan:
I thank the Chairman and members for the invitation to meet the committee to discuss the medical cannabis access programme. I am joined by Professor Bryan Lynch, a consultant paediatric neurologist based in Temple Street Children's University Hospital, who will have a clinical perspective on the issues to be discussed. Members will be aware the primary care reimbursement service, PCRS, is responsible for ensuring that eligibility is in place for qualifying persons for most of the primary care schemes and other arrangements within the health service, while PCRS is also generally responsible for making payments of the order of €3.269 billion to primary care healthcare practitioners and HSE acute hospitals.
As Mr. O'Connor stated, under the HSE national service plan in 2021, PCRS was given responsibility, on behalf of the HSE, to manage the medicinal cannabis access programme, subject to the availability of suitable products, and, as part of that, to establish arrangements to approve their use in relevant cases and record relevant information on the register, as provided for in the legislation. PCRS also has the responsibility to consider, pursuant to the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013, applications for pricing and requests for reimbursement of MCAP products for individual patients. Currently, three specific therapeutic indications are set out in a Schedule to the misuse of drugs regulations 2019. I will not go through them because the committee will be aware of them.
On the operation of the register, a practitioner, who has to be a medical consultant, can issue a prescription for an MCAP product only where an individual's name has been entered into the register and what is called a cannabis for medical use register, CMUR, number will have been provided by the HSE in respect of that individual. Medical consultants are required, therefore, to provide the HSE with the following information before they issue a first prescription: the name, address, date of birth and specified therapeutic indication for the person being treated, that is, which of the three currently approved uses under the MCAP the person will be treated for; the name, registration number and medical specialty of the notifying consultant; and such additional information as the HSE may require.
A person supplying a specified control drug, such as pharmacist or a pharmacy, is required to provide his or her name and address to the HSE; the name and address of the person who supplied him or her; and the following details from the prescription: the date on which supply was made; the name, quantity and, where appropriate, the dosage form and strength of the product; the dose supplied; the name and registration number of the consultant prescriber; the CMUR number, name and address of the person who received the prescription; and the date of the prescription. Finally, within the legislation, there is a requirement to provide any further information required by the HSE. The HSE is then required to record all this information on the MCAP register and assign CMUR numbers as required. The HSE is required to preserve all the information on the register for at least five years from receipt.
Turning to supply, Schedule 1 to the misuse of drugs (prescription and control of supply for medical use regulations) 2019, as amended, sets out the products that can, subject to availability, be supplied under the MCAP. As Mr. O'Connor stated, four products are currently listed in Schedule 1. The HSE does not decide which products are included in Schedule 1; it is a ministerial function. At this point, the suppliers of two products, namely, Cannepil and Tilray oral solution, have submitted final pricing positions to the HSE and the HSE confirmed acceptance of those prices in writing to the suppliers in June 2021. The HSE expects that one product, Cannepil, will become available during October 2021. The suppliers of the second product, Tilray oral solution, have indicated their intention to supply the Irish market but, to date, have not confirmed when the product will be available. The HSE understands that the supplier of the other two products does not currently have plans to supply the Irish market.
In making general decisions on reimbursement, the HSE is required, under the Health (Pricing and Supply of Medical Goods) Act 2013, to consider nine criteria set out in the legislation. It is required to consider the health needs of the public; cost effectiveness; the availability and supply of items for supply and reimbursement; the proposed costs, benefits and risks of an item, relative to therapeutically similar items, and the level of certainty in respect of those costs, benefits and risks; the budget impact; the clinical need for the item; the appropriate level of clinical supervision required to ensure patient safety; the efficacy, which means the product's performance in clinical trials, and effectiveness, which means performance in real circumstances and added therapeutic benefit against existing standards of treatment; and the resources available to the HSE.
The Department has previously advised the HSE that it considers that section 23 of the health Act 2013 appeared to be the most suitable legislative option for reimbursement on a managed access basis of community supply of the MCAP products. That section allows the HSE discretion, subject to such conditions it considers appropriate, to make arrangements to supply an item to a patient notwithstanding that the item is not normally reimbursed, provided that the HSE is satisfied the patient requires the item for clinical reasons and that no reimbursed item is a suitable alternative for the patient. The intent of the HSE, therefore, is to utilise section 23 to enable the reimbursement of MCAP products where appropriate.
In practical terms, the HSE has designed an application form for prescribers to register a person to be treated. This form will include all the information required to register an individual on the MCAP. The HSE will then assign a CMUR number and provide the applicant prescriber with a specific, pro formaprescription form for the MCAP that will contain all the information legally required, including the relevant CMUR number for the operation of the MCAP.
We welcome any questions the committee may have.
Dr. Lorraine Nolan:
We welcome the opportunity to come before the committee again to provide it with information on the medical cannabis access programme, MCAP, the HPRA's role in this and to answer any questions members may have about the programme. In setting the context for our discussion, it is important to be clear on the status of the products that may be considered under this access programme, what they are and, importantly, what they are not.
In doing so, it may be helpful to return to some key aspects of the HPRA's 2017 review. The review considered the scientific data available at the time in respect of medical use of cannabis, which was very limited and fell well short of the standard required for a medicine to receive market access. The review concluded that, from a policy perspective, should the Minister consider it in society's interest to establish a cannabis access programme, it should be in a limited set of circumstances for three specified medical conditions where it can be considered. The committee will be familiar with these.
A key recommendation for the programme was that would need to take into account that access should be provided only where patients with the specified conditions have a clear unmet clinical need, meaning they have failed to respond to treatment with all available authorised medicines. These limited recommendations were also based on the fact the safety and efficacy data available did not support a wider form of access.
The report also advised that cannabis-based products that may be available through such a programme should not be confused with authorised medicines and are not equivalent to them. Authorised medicines undergo comprehensive clinical and quality evaluation, including clinical trials, to assess their safety and efficacy. The data generated from these studies are reviewed by scientists and companies to determine whether there is a positive benefit-risk ratio, and if so, these data are submitted as part of an application for marketing authorisation.
The application is then reviewed by medicines regulators, such as the HPRA, to establish if they agree with the conclusion of the benefit-risk assessment. Where this is the case, the medicine is authorised.
Not meaning to detract from the focus on cannabis, something perhaps the pandemic has shown in a very real way is how this process for authorisation of medicines works in practice. It has also increased the public understanding, appreciation and value of this process.
As the committee members are aware, there are two cannabis-based products that are authorised as medicines. These are Sativex oromucosal spray for the treatment of spasticity in MS and Epidyolex oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex. Both products have met the standards and level of data required to receive a marketing authorisation. As such, these are quite distinct and do not fall under the scope of the medical cannabis access programme, MCAP.
Provision for the MCAP was made under regulations developed by the Department of Health in 2019. These set out how the programme operates in terms of prescribing, supply to patients and subsequent patient monitoring. They also define the criteria a cannabis-based product must meet in order to be considered for inclusion. The regulations, importantly, are supported by clinical guidance that was generated by an expert reference group convened by the Department of Health in 2017. This publicly available guidance underpins the introduction of the access programme. It also highlights a very important point around the decision to enrol a patient in the MCAP, which is that the relationship between the patient and the doctor is paramount in terms of clinical oversight. That clinical oversight allows for consideration of critical issues, such as disease progression, whether all conventional treatment options with authorised medicines have been exhausted and the doctor’s decision as to whether these products may then be a suitable option for their patient.
The role of the HPRA in the MCAP is quite distinct and different from the role that we have with respect to the authorisation of medicines. While we receive and review applications from companies seeking to supply cannabis-based products in Ireland via the programme, the extent and nature of this is very different in terms of review. It involves initially reviewing the product applications against the criteria set out in the regulations. The key requirement for accepting a product onto the programme is that it must be approved for supply in another EU member state and is being supplied in that state. This is a way of providing access for Irish patients to cannabis-based products that are available to other EU patients and that could previously only be obtained by travelling out of the State. It acknowledges the reviews performed by other member states and does not seek to create additional barriers where these reviews have already been conducted. Other requirements are that the tetrahydrocannabinol, THC, limits are not exceeded and that the packaging and labelling is sufficient in terms of detail to support safe and effective dosing and product use. It is also our role to ensure that the products are aligned with the published clinical guidance.
When our review is complete, we make a recommendation to the Minister where an application meets all of the above criteria. The final decision as to whether or not the product is included on the MCAP rests with the Minister. It is important to note, as per the criteria in the regulations and the overarching principle of the clinical guidance, that applications can only be made under the MCAP where an equivalent authorised cannabis-based medicine is not available.
Since the regulations came into force in June 2019, we have received 34 product applications. Of these, four cannabis-based oils have been placed in Schedule 1 of the regulations and two dried herb products have concluded the HPRA final review and are with the Minister for his final decision. Five are currently under active review. In addition, 11 have been withdrawn or paused by the applicant company itself. In the case of the remaining 12 applications, the company has not met either the legislative criteria or the clinical guidelines, and these have been placed on hold by the HPRA as a result. We are continuing to work with a cohort of these companies on these issues.
The HPRA provides significant support to prospective applicants through guidance on both the legal framework and the product criteria to be met in advance of submission of an application. In all cases, we have direct meetings with these companies to advise and support their applications. The provision of this support also continues throughout the application review process. The first cannabis-based products are expected to be available to Irish patients through the MCAP from mid-October 2021, as outlined by other colleagues. Once these are accessed by Irish patients, the HPRA will receive any reports of suspected adverse events and review them for any signals of concern regarding the safety of the products. The HPRA will also have a role in investigating any quality issues that may arise and co-ordinating any action that might be subsequently required. I am very happy to take any questions.
It is a race against time every morning. I thank our witnesses for coming before the committee and for the detail given in their submissions. It is hugely important in respect of an issue of this nature that adequate information is made available and that the integrity of the treatment is protected.
The benefit-risk assessment carried out has been fairly thorough. Are the witnesses satisfied that it is sufficiently firewalled and that the products are sufficiently firewalled within the system to ensure they do not fall into the wrong hands or that access is not given to those who should not have them - in other words, that they are strictly for medicinal purposes by the authorised people? That is the first question.
The next question is in regard to reimbursement. Are we satisfied that the reimbursement system is sufficiently responsive and active in its dealings with the patients?
My third question is in regard to the patients deemed to be in need. I know there were 34 applications and I got the information in regard to the volumes so far. Are the witnesses satisfied that the patients who are deemed to be in need, and who will benefit from access to the treatment, are getting access in sufficient time? In other words, is there sufficient access without there being a danger of damaging the integrity of the whole process? Those are my three questions.
Mr. Muiris O'Connor:
I will ask Mr. Flanagan to come in on the reimbursement arrangements. The other two questions seem to be the different sides of benefit-risk, namely, whether we are allowing sufficient access where it is beneficial and whether we are managing the risk of it leaking beyond the programme as intended. I will bring in my own colleague on that and perhaps the HPRA will want to say something about it. I ask Mr. Flanagan to start on the reimbursement aspects.
Mr. Shaun Flanagan:
On reimbursement, the MCAP has not started yet because there has not been a product. The MCAP is due to start in the next few weeks. We expect reimbursement will be reasonably seamless under the MCAP because we have an approved product and an application system will be in place. Therefore, on the MCAP, that is probably going to be okay. I have no idea of the volume, scale or the numbers, but we have sufficient staff to be able to deal with large volumes or small volumes, whichever it is, and we will flex our staffing as needed from other teams.
Obviously, the licences are somewhat different in that they come in one by one, and they come from the Department. While that is not quite as seamless a process because it is an individual single approval for those products, we are doing our best to be as responsive as we can on those and the various arrangements have been put in place, including direct payment mechanisms.
Excuse me, is there an IT problem?
Mr. Shaun Flanagan:
Thank you. The other thing that has changed over the period of the introduction of the MCAP is that for one of the areas in particular, the epilepsy area, at the time that the MCAP was proposed, there was no medicine approved or authorised in the market. As Dr. Nolan said, there is now a medicine that is market authorised. The HSE obviously has a process around new medicines and how those are assessed, and that process is ongoing.
We are now at the stage when the health assessment is completed. Commercial negotiations are ongoing with the company. That is not part of the medical cannabis access programme, MCAP, as it is a licensed medicine. It is a separate medicine but some of the patients will in due course be covered, assuming it might be reimbursed. I am not sure if that answers the Deputy's question.
Mr. Muiris O'Connor:
I can come in on the Deputy's question about the risk of illegal access. Those risks are very carefully managed and controlled within the programme. Mr. Flanagan and Dr. Nolan spoke about the specificity about who receives the cannabis-based products and the clear clinical need identified by a medial professional that is required. The doctor-patient relationship is at the heart of the management of the treatment.
Benefit-risk analyses feed into the Health Products Regulatory Authority, HPRA, assessment of drugs. Such an analysis did inform the restriction of availability and a number of conditions at an earlier point. I will ask Dr. Nolan to speak a little more to be benefit-risk analysis and how that works.
Dr. Lorraine Nolan:
I thank the Deputy for the question, which is obviously a pertinent one in the context of the role we have. He is absolutely right that these MCAP products are not medicines in the conventional sense in which he and I would understand that word. The extent of the data behind these products is limited and I have been clear in that regard. We are, however, satisfied. What is here is in line with the recommendations we made in 2017. This is a very limited form of access for those three specified conditions. The cascade and progression to treatment under MCAP are important. These patients must have exhausted all of the available options so that when they are granted access to MCAP, there is a clear unmet need for those patients. In that context, there are different considerations regarding benefit and risk. We are satisfied with the programme.
There is a little bit of overlap between the benefit and risk at the individual patient level and the control of the system. In line with the clinical guidance to which I have referred, every time a patient is put onto the MCAP programme, it must be initiated by a consultant. The enrolment process has been outlined. A treatment programme must then be put into the medical record of each patient. That sets out the background to the decision to introduce the patient onto the programme and includes the product and dosage that are going to be used. It is important that there is an agreement on what the expected outcome should be in terms of improvement. Actual measurements are put in place. There is a monitoring plan for the patient. Patients are monitored at regular intervals to ensure that those improvements are being realised.
The overriding principle is that anybody who starts on one of these products starts low and goes slow. The dosage starts at the lowest level and is worked upwards. If the measurements I have spoken about are not met, there is also a work-down. The treatment can be stopped. It is an individualised programme that is supervised at an appropriate medical level, which is part of the control system. I do not want to overlap with what Mr. O'Connor already said. These substances are controlled under the misuse of drugs legislation and there is an additional tracking system. For example, if a wholesaler is bringing in stocks that must be held for onward supply to patients, a separate licensing system tracks them. A reconciliation process is done on the amounts that come in, are used and are in stock. The HPRA has a role in monitoring that as well. There are many levels of control across the system to prevent leakage. From the benefit-risk point of view, it comes down to an individual patient decision, closely supervised by a doctor.
I welcome all of our guests. We had a number of private briefings on this issue and I thank all of those who provided those briefings. This is a new area. I hope we are moving in the right direction to enable the availability of products under licence or prescription. I know it is going to take some time for this new process to bed in.
Dr. Nolan, in her opening statement, referred to the state of play around MCAP. She said that 34 products applied under MCAP to be placed in Schedule 1 and, of those, four have been approved. Is that correct?
I understand that. I am just trying to figure out how many products will be available. People will want to know when any of these products will be available under the programme. I know there is a process and there is a role for the providers but I want to know the number of products that will be available on prescription under this programme. We know that six will be listed in Schedule 1, which is great, but how many of them will be available this year?
Perhaps I will put those questions to Mr. Flanagan. Of those products that have been placed on Schedule 1, and I know there was reference to this issue in his opening statement, does he anticipate that only one will be available this year?
Mr. Shaun Flanagan:
That is correct. There are four products listed on Schedule 1 as we speak. We have engaged with all four of those companies. Two of the companies were interested enough to put forward pricing positions. One of the companies, which has two products, was not interested in putting forward a pricing position. Of the two companies for which we have approved pricing, one has confirmed it will launch this year and we are awaiting confirmation from the second.
Mr. Shaun Flanagan:
Until products are on the Schedule, the HSE will not be aware what those products are or which are approved. The minute products are on the Schedule, we will engage with the suppliers. There are four products on the Schedule and we have engaged with the supplier of each. Of those four, all I can tell the committee is that for two products, the supplier has stated it is not interested in entering the Irish market even though it went through the process. Two other suppliers have stated they are interested. One of those has confirmed October as its launch date and we are awaiting a date from the other. We will not know more until other products are added to Schedule 1 and we engage with those companies.
I accept that. Mr. Flanagan may be unable to say definitively what might happen next year. We are holding a hearing here today to try to get as much information as possible for the public. Is it fair to say that the best I can tell people if I am asked is that there is potential for six products to be placed on Schedule 1? In the best case scenario, one of them will be available to patients under the scheme this year. There is a possibility of another being added next year but we do not know. Based on what Mr. Flanagan is saying, I would imagine that the best case scenario would be that two products are available under the scheme next year, if that many. Is that a fair assessment?
Has the Department done any modelling of how many patients are likely to avail of the single product that may become available at some point this year or next year? Has any modelling been done on what the usage is likely to be?
Mr. Shaun Flanagan:
In the lead-up to the introduction of the legislation, HIQA did some work for the Department. It is important to flag that since the legislation was published, there has been a significant change in the market, in that there is now a licensed medicine, Epidiolex, for epilepsy indication. It is going through the standard HSE medicines pricing and assessment process.
In other words, a licensed medicine very similar to the CannEpil product is going through the pricing and reimbursement process. I cannot give any guarantee because I cannot make a decision until the process is complete. If it gets to the reimbursement list, it will obviously have an impact on the number of patients who might use the MCAP in the epilepsy indication in particular.
I was going to get to that in a few minutes. Epidiolex is important for epilepsy patients. I know it has been licensed and is going through the reimbursement process. I hope it will be successful and make a difference. I am trying to get a sense of how successful this programme will be. If there is only going to be one product this year we do not know how many products will be available next year. Mr. Flanagan said some modelling has been done but we do not really know how many of these products will be prescribed to patients. At this point it is hard to get a handle on how successful the MCAP programme will be. I would have imagined it was anticipated that more products would have been online by now and more products would have been not just on the Schedule but available for prescription. Is it fair to say it is a bit disappointing that for whatever reason, and obviously it is down to the companies themselves that have to engage, only one product will be available as a start for a programme as important as this is? We do not know how many products will be available next year and we do not know how many patients will be prescribed the drug this year or next year. This is not painting a good picture. There is not much information, it would seem, that I can give to the public or that will be given to the public arising from this session.
Mr. Shaun Flanagan:
It is important to flag that if Epidiolex were to be reimbursed we would expect in the order of at least 300 patients across the three indications would be prescribed it. Those patients would probably have been on the MCAP. This information is from the health technology assessments on Epidiolex which I have seen. I am a member of the HSE drugs group and I am required to review all of the information. Roughly from memory, and I do not have it in front of me, but it is of an estimate of 300 patients per annum who might benefit from Epidiolex if it were reimbursed. In the absence of Epidiolex all of those patients would be expected to come through the MCAP. I hear the criticism of the MCAP but against it the world has somewhat changed. We are all agreed, and I am not an expert on safety, quality and efficacy as that is more Dr. Nolan's role, that if there is a licensed medicine the preference would be that it would be the mechanism used, provided the HSE can agree pricing and reimbursement terms with the company. This changes the picture from where we were when the MCAP was contemplated. I should also-----
That would be a game changer and I accept that. Do we have any indication as to when that medication will complete the reimbursement process? When are we looking for it to be a product that will be reimbursed?
Mr. Shaun Flanagan:
We are expecting that it will get to the HSE drugs group in the fourth quarter of this year, so within the next three months. This would suggest a decision on reimbursement would be made late this year or early next year. I cannot indicate whether the decision will be "Yes" or "No" because I cannot get ahead of the decision-making process of the HSE, particularly given that I am a member of the drugs group.
My time is limited. I say again this is something that has to be done. I know there is a process but we need to look at the process. The drug approval process needs to be overhauled. It will go to the drugs group which will have to do its work. As Mr. Flanagan said, it will be sometime next year, and we do not know when, before a decision will be made on it. We are still some time away from a decision being made on it. This is brings us back to MCAP, which is one drug and one product this year. We do not know about next year and we do not know how many patients will be able to benefit from the process.
I have a question for Dr. Nolan on an issue that keeps arising. This is with regard to CBD products that have a trace of THC. It goes back to a European court ruling on this matter regarding traces of less than 0.2%. This comes from companies that sell these products which I am sure lobby all members on a regular basis. Their shops are raided. They say the products they sell have minimal traces of THC in line with the European court judgment. Will Dr. Nolan talk us through what the state of play is? According to one of the opening statements, it is currently unclear whether CBD-only products that contain only trace elements of THC can be processed for inclusion in the MCAP as per existing legislation. There seems to be confusion about this and we need clarity. When are we likely to see some clarity? Is it something the courts will have to decide or is it something the political system can decide?
Dr. Lorraine Nolan:
I thank Deputy Cullinane for the question. I will refer to the last question first. The experience of Ireland on a medicinal cannabis access programme is not that different from any European country. We followed closely the progression of the system in Denmark where to date only four products are included in its MCAP. We are certainly not out of kilter. At the end of the day, it is up to the companies to make the applications to us. It is up to the companies to meet the requirement that the legislation has set out. The regulations removed all regulatory burdens. The system has a low regulatory burden and I do not use the term fruitlessly. I want the Deputy to understand that at the end of the day the companies control whether or not something is placed on the market. I totally stand over everything Mr. Flanagan said. The availability of a licensed medicine is the best treatment option that can be given to any patient. The fact we now have Epidiolex which is a CBD-only product has really changed the landscape.
The question on the thresholds is a very good one. I need to be clear it is a policy area, so I am aware I am probably speaking on the Deputy's area but I am happy to do so and he can stop me if he wants to intervene at any point. Under the misuse of drugs legislation, by definition any product that contains THC, whether or not at trace level, is a controlled substance. This is the bottom line. The legislation is this clear-cut. The misuse of drugs legislation was put in place in the 1970s prior to the evolution of a hemp industry, if we want to call it that. The situation has moved on. We would also have to look at whether THC is having a pharmacological action if it is in there at those levels. It probably it is not because it is such a trace level. The policy in this area is complicated and it is not an easy thing to fix. It has knock-ons in the criminal justice system. When the gardaí are making street detentions, how can they can tell the difference between cannabis with no THC and cannabis that has THC? It is not a simple matter of changing the policy because it has an awful lot of consequences. This is something the Department is considering. Strictly speaking, they are products that contain THC and there are no thresholds in our legislation. This means they would be eligible for inclusion in the MCAP.
For a number of years I have had a very open mind on this and I approached the committee meeting this morning in the same vein. It is one of the most comprehensive presentations I have had the pleasure of listening to. Almost all of the questions one could ask have been answered. We have had the background to this, the international comparisons, the number of products, how the product is regulated, dealing with the companies, the review that took place, the consciousness that the review took place some time ago and there is now a further parallel review, and international best practice.
The reason I say all of this is that the previous speaker sounded a little bit disappointed that there are not more products on the shelves whereas the witnesses have made it very clear that the approach to this is very scientifically grounded. I always fear that people like to polarise this debate and that if people are not in favour of this they are somehow conservative and backwoods people who do not appreciate or realise the impact they are having on the quality of life of people. This is notwithstanding the very passionate pleas made through the years and the efficacy of some of the products. People on the other side of the argument are then portrayed as somehow progressive and enlightened and as wanting to enable people to break free from the shackles of terribly tedious illnesses. I am in the middle. The witnesses have answered many of the questions I had.
I have a couple of short questions.
Denmark has four products. We are not so much taking our leave from it as casting an eye to the Danish model. It has just four products. Is it consultants who prescribe in Denmark, and how long have they been in a position to do so? I want short answers to these first few questions, please.
Dr. Lorraine Nolan:
I will take that question. I cannot clarify for the Deputy whether it is initiated by a consultant in Denmark. There are other HPRA colleagues on the call and one of them, perhaps Ms Farrell, may know. I am very happy for her to come in on that. The Danish scheme is five years old at this stage.
Dr. Lorraine Nolan:
The Danes committed to a review at the time they introduced it, so they should now be at the point of beginning to embark on their review. We have contacted colleagues we work with in this area from the Danish agency and we are trying to find out more information on the status of where they are with that review because it will be very interesting.
On the THC references, it has been said our regulations around that are quite old. Are they generally mirrored across the EU right now or do they run counter to most others? I see heads nodding so I will take it as a "Yes" that our treatment of THC is generally mirrored in other EU countries.
On the companies manufacturing this, which I will not name, is the officials' experience that they are in the traditional pharma space? Would they be traditional manufacturers of pharmaceutical drugs or are they specifically in this space? I think that question is one for Mr. Flanagan.
Okay. I will move to my next question. I apologise because we always come across as rude. If the witnesses were here in person they would see we are smiling away but it is just about the time.
I wish to clarify something from Mr. Flanagan's contribution. Is the information consultants are required to provide in relation to use of any cannabinoids or related medicines standard? Would a consultant have to fill out these kinds of forms and report to the HSE on general prescriptions they are providing to people? We might say unusual or maybe very rare drugs, as opposed to cannabinoids.
Mr. Shaun Flanagan:
There is a very significant difference in that the legislation lays down that we are legally required to collect information in a register, so that in itself is different. The legislation lays down the things we must collect. Some of the information we collect, such as the name and address of the patient, would be normal information that would be on every and any prescription which anybody would have. There is information such as the use, which would not normally be on a prescription, for example. We would not normally see that even in our other reimbursement schemes. We would connect things. We would know the consultant. We would know their medical record number. All those types of things would be legal requirements as part of the prescription legislation for all medicines but therapeutic use in particular. The requirement to pre-approve is unusual but not unique.
That is grand. The suppliers of two products, namely, Cannepil and the Tilray oral solution, have submitted final pricing positions to the HSE. They were accepted by the HSE in June and one product is, as was said, expected in October. This question is again for Mr. Flanagan. The HSE has designed an application form for prescribers to register a person to be treated. Would that be standard practice for drugs?
Okay. I found it very reassuring to hear in the Department contribution that a review was undertaken, commenced around the then Minister's decision in 2016. The Department is now commencing a new clinical review that will continue the work. This is, therefore, constantly under review. When might we have that results of that review? I would like a simple, short answer to that from the Department officials.
Mr. Muiris O'Connor:
Work is beginning and is under way on setting that up and refreshing it. It is hard to put a timeframe on it. There will be an evidence synthesis, a review of international practice and a review of relevant clinical trials from the intervening years to see if further indications can be added. I expect the review will take six to eight months to complete, so by the middle of next year we will have that review refreshed.
Okay. Moving to the HPRA contribution, I notice it said: "The review concluded that from a policy perspective should the Minister consider it in societal interest ...". Is that the normal use of language the authority would associate with this? I mean as opposed to referring to the medical interest of society. It may not be significant, but it just stood out to me. It could equally say should the Minister consider it in the health interests of society but the authority said "societal interest".
I have very limited time left. We have the normal process medicines go through. Dr. Nolan made the point the virus has taught the layperson a lot about the process of approval. Are there any trials of these medicines the authority knows of? Is that part of the process of approval?
Ms Grainne Power:
Would that be in terms of these particular products or in general? With general clinical trial activity there is some activity within Europe. It is pretty much at the same level it was in 2017 when we completed our initial review. The areas of interest for those trials are chronic pain, psychiatric disorders and neurological conditions, including epilepsy. Many of those trials relate to products such as Sativex and also Epidiolex, in part. That is in the general context but in terms of the MCAP products themselves, the review of clinical data is not part of the assessment.
I thank the witnesses for being here. I apologise but the bells are going in the background here. I hope they are not too intrusive. I want to go back to the number of products are available at the moment. Four cannabis-based oils are already approved. Is it fair to say each oil relates to a specific company and thus for the four oils there are four companies?
Ms Aoife Farrell:
For the most part, pretty much all of these relate to being available in another EU member state. The reason these are on hold as opposed to being cancelled is the fact that we are talking about the UK and so we are hopeful that, in conjunction with our colleagues in the Department of Health, we will be able to make a legislative amendment to allow them to come into the programme. This is under way at the moment, which is why they are on hold.
Can I go through the relationship of the healthcare professional? I think Dr. Nolan said one of the requirements was that the patient must have exhausted all available options. How does that align with the healthcare professional being able to make a medical decision for his or her patient?
If the patient is being prescribed this medicine on the basis that the consultant believes it is the best treatment, in the normal way, there would be no requirement for the patient to try every medicine before a consultant chooses a particular medicine for him or her. I presume that the consultant will look at the particular requirements and make a clinical decision based on his or her expertise. I am wondering about the requirement that the patient must have exhausted all other available options.
Professor Bryan Lynch:
That is an excellent question. I was on the HPRA committee that initially looked at these products and I was on the advisory committee that ultimately produced the recommendation for MCAP. In the HSE document, we clearly stated the indications. I am an expert on epilepsy only and can only speak to that. On that document, we clearly stated that it involved severe epilepsy where there has been a failure to respond to five or more standard anti-epileptic drugs. Separately, there are two specific and very severe epilepsy syndromes of childhood - Dravet syndrome and Lennox-Gastaut syndrome - in that document. Those are two different criteria. If we look at what was available to treat epilepsy, it is perfectly reasonable to try better evidenced-based options first in general for severe medically refractory epilepsy. I would not apply those criteria to those two childhood syndromes, of which can be life-threatening. That is what is in the document and that is what we agreed as committee relevant to epilepsy.
There was a statement that a treatment programme and a report would be required. Sorry, it sounds like a report with regard to the treatment programme where you have to outline the background. Is this different from what would normally happen with a prescribed medicine? I presume it is not. Usually, you would give a background. There is also a statement that measurements would be required along the way. If we do not have the agreed medical research - it is not actually a medicine or recognised as a medicine - is it the consultative group that decides what the measurements and the response should be with a given patient?
Professor Bryan Lynch:
That stipulation came out of a recognition of a lack of available medical evidence for these products in a number of conditions. This is still true in my area of epilepsy. There is some medical evidence but we need an awful lot more. There was a recognition that if we were going to set up this programme, we should collect information. The Deputy is right. That would not be the norm and that requires administrative back up, etc., and more paperwork, which is an additional burden on the people providing prescriptions and their staff. It would not be the norm but there was a specific reason it was put in there and that is still a valid reason. It points to the need for resources to be put in place for people to collect, compile and process that information.
That requirement for measurement seems somewhat arbitrary. I would like to understand more about how we are agreeing levels of measurement. I know I am over time but I have one quick question and am not sure who can answer it for me. How many patients are we estimating will come through MCAP in the next 18 months or year? I am not sure if this question is for Mr. Flanagan.
Mr. Shaun Flanagan:
As I said earlier, it is very difficult to estimate because if will depend on whether Epidiolex is approved for reimbursement through the standard processes of the HSE regarding medicines because that could take of the order of 300 to 400 patients-----
Mr. Shaun Flanagan:
The epilepsy indication is the largest of the indications. That was where we expected the volume of patients to be. We were expecting something of the order of 300 to 600 patients that might come through that if Epidiolex was not approved but I will confirm that and come back with a note on that.
I thank the witnesses for their presentations. The past five years have been very protracted to say the least for those seeking access to medicinal cannabis for themselves or their children. It has been extremely frustrating and many people will be scratching their heads and asking why it has taken so long for this process to begin. The good news is that the process is beginning in a couple of weeks. My first question concerns MCAP itself. It is good that people will get prescriptions in the next couple of weeks but how many clinicians have registered for MCAP thus far and have they registered patients under their care?
Mr. Shaun Flanagan:
Clinicians do not register for MCAP themselves. We get application forms from clinicians. Given that there has been no product on the market for which people could register under MCAP, there have been no registrations to date.
I would expect it to commence once the product is available.
Once the product becomes available as of mid-October, the specialists, under the three conditions, will prescribe to the patients under their care the particular product, in particular CannEpil. I presume that is the way it will work.
Therefore, in the next three to four weeks, patients under the care of those specialists could be prescribed medical cannabis or at least the CannEpil product. They could have it on prescription in the next three to four weeks.
Are there any indications thus far as to whether there will be an uptake by clinicians in terms of them having an interest in the programme? A number of specialists came out in August to say they were very concerned in regard to some of the products that are available under the programme.
Mr. Shaun Flanagan:
Again, that would be my expectation in light of Epidiolex getting a market authorisation on the epilepsy side. Professor Lynch might be better placed to answer this but, from my perspective, my understanding is that Epidiolex is reimbursed and that clinicians are most likely to move towards that, given it would be a licensed medicine and clinical trials would have taken place around that. I should stop and let Professor Lynch speak as that would be more appropriate.
Professor Bryan Lynch:
I thank the Deputy, who has raised a very important point. For us, as clinicians, looking after patients with epilepsy, the evidence base is for pure CBD products and there is no evidence base for products which contain a component of THC. CannEpil, which is a product that has been mentioned a couple of times here, has a significant component of THC and there is no scientific evidence base for use of such a product for epilepsy. Epidiolex, which is the pharmaceutical product which has been mentioned, is a pure CBD product. From the very beginning going back to 2016, from when my colleagues and I engaged on this with the HSE and the Department of Health, what we have been looking for is a reliable, properly formulated, pure CBD, or as close to pure CBD as we can get, product that we can prescribe for our patients. That is not available through what is currently coming through the MCAP. As stated by my Department of Health and HSE colleagues, if Epidiolex is approved for reimbursement, that will solve that problem. We sincerely hope that will happen. However, I can speak for my colleagues when I say that we would not be prescribing CannEpil because that has a significant THC component and there is no evidence base for such a product to be effective for children and adults with epilepsy.
That is a strange statement if it is going to be prescribable in the next couple of weeks. If Professor Lynch, as a specialist, is saying he would not prescribe it to his patients, then who is going to prescribe it?
Professor Bryan Lynch:
I agree it is a strange situation. I have no control over what products have been applied for and approved through the MCAP. What I want very clearly is a pure CBD product. The HSE guidelines document which came out of our committee review very clearly stated that is what we wanted for epilepsy. While I am not an expert on legislation and on the niceties of what can and cannot be submitted, the MCAP, as set up, seems to be designed for products which contain a component of THC, and that is a problem that we have at present. None of it is of my desire or making. I want to be able to prescribe a pure CBD product for my patients and I want it as soon as possible.
In regard to the scientific review which was done in 2017, obviously, things have moved on in terms of the evidence base around medicinal cannabis. Does the HPRA envisage that other conditions will be included in the programme? The programme itself is very restrictive and we could have a situation where only a handful can get access. We could have a situation where more people could have access via the ministerial programme than via the programme itself. Is there a basis to include other conditions? The omission of chronic pain in 2017 was very controversial. My understanding is that the Danish cannabis access programme includes neurological pain as there is an unmet need for that condition. Will the review look to include other conditions over the next six months?
Professor Bryan Lynch:
I will leave that to the people who are working on setting up the new review. The previous review looked at all conditions, including chronic pain and cancer and palliative care situations, and it looked very carefully at the evidence in all of those areas. I will leave it to the people from the HPRA to answer on the new review.
Dr. Lorraine Nolan:
I am happy to start and I may bring in my colleague, Ms Power, on some of the questions. To answer Deputy Kenny's question, he is right that the Danish system includes chronic pain as one of the indications for which cannabis can be accessed. When we looked at this back in 2016 to 2017, we really felt that although at one level it appeared there were clinical trials that had looked at the area of chronic pain, the evidence base just was not there to stand over its inclusion as one of the indications, and there were many reasons for that. First, the quality of the clinical trials was quite poor. Many of them were not what we call randomised controlled clinical trials, which would really be considered best design, with the removing of bias. Therefore, one could not draw conclusions from them. Pain had been studied across multiple different areas, using different cohorts of patients, using different formulations, and the evidence just was not there.
Honestly, from what we know about this, I would say the situation possibly has not moved on a huge amount since that period. A comprehensive review has been carried out by the International Association for the Study of Pain, IASP. I will ask Ms Power to come in on this point because she has all the expertise on it. I would honestly say to the Deputy that, from our viewpoint, I do not think the situation would be different. As Mr. O'Connor indicated at the beginning, in the re-establishment of the clinical expert referencing group, from the Department's perspective, one of the first tasks will be to consider a piece of evidence on how that might be carried out because a comprehensive review is warranted, as I definitely acknowledge. Ms Power might like to come in with regard to the IASP review findings.
Ms Grainne Power:
I want to reiterate at a high level what Dr. Nolan said. The IASP review was the culmination of the work of multidisciplinary associations representing healthcare professionals and scientists from many countries. In March 2021, it published a meta-analysis and systematic review on the evidence around the use of cannabinoids under the topic of pain. I would respectfully suggest to members, if they have an hour, to Google it. It is very nicely constructed and broken down into the safety, the efficacy, the preclinical and clinical data, the animal studies and whether they can or cannot be translated into human or clinical impact, and also the societal and policy implications related to the use of these compounds for pain management. It is an extensive piece of work by global leaders and one of the work streams was, in fact, led by Professor David Finn of NUI Galway, who may be known to some of the committee members.
In summary, the major findings are on preclinical and clinical safety. As Dr. Nolan said, it identifies a range of important research gaps and the lack of high-quality clinical evidence for safety or efficacy means that this particular association does not endorse general use. This association recognises the pressing need for studies to fill the research gap.
As I said at the recent private session, none of us is questioning those for whom cannabinoids have provided relief from the lived experience of pain.
It is about the quality of evidence rather than the legitimacy of people's claims. There is lots in there. There was a recent publication in the British Medical Journal countering some of those claims but there are definite differences in methodologies and the methodologies used by IASP were robust. The HPRA is a single entity and we have done a quick review of the evidence in a general way, so I would not want to pre-judge the outcome of a whole-of-health system expert review that might happen, as Mr. O'Connor outlined earlier.
I have a quick question, which is important. I refer to those 67 individuals who have a ministerial licence. They would currently fall outside the MCAP. For logistical reasons and because of the product they get from the Netherlands, that cannot be included on the schedule. That could be overcome. Denmark has a third party licence company that provides that product to the Danish medicinal cannabis access programme. In this situation with 67 individuals, they are not monitored collectively, so in that situation could they be included in the programme as part of the monitoring process? The vast majority of them would in the programme because of refractory epilepsy. Could they be part of the programme, not be prescribed medicinal cannabis products under the schedule, but be monitored nonetheless?
Ms Anne Marie Seymour:
Every licence granted lays out the requirement for the clinician to monitor the patient. That is not information that the Department then collates; it is a doctor and patient relationship. Any adverse reactions to the products will be reported to the HPRA, which gathers all that data. On the clinical benefits seen from taking this product, that information is not gathered by us but that could be looked at in the MCAP scheme as a way of gathering information on the effectiveness of these products. It is not currently being considered to bring those patients in. As has been said multiple times, we would envisage that if Epidiolex becomes available for reimbursement, many of the patients will also leave the ministerial licence scheme. Overall there are the three indications. The vast majority of patients suffer from refractory epilepsy and if Epidiolex is available, they will be gone. Our understanding is that since the MCAP was first set up the clinical needs of patients with MS and severe nausea are largely met by other licensed and non-cannabis based medicines. We do not see a huge demand from patients with those clinical needs coming through either the MCAP or the ministerial licence programme.
I thank all of our guests for their presentations and for dealing with the questions. I refer to Tilray oral solution. Has any indication been given on when this will be available? Can it be followed up to see if a definitive timeline will be provided as to when it would be available, now that it should be available on the market?
I want to check the matter of the people who are prepared to prescribe and I am particularly talking about indemnity cover. Is it confined to consultants employed in the HSE only or can consultants who are working privately and outside of the HSE prescribe?
I mention the geographic location of those who are involved in prescribing. Are they all in Dublin or are there people outside of Dublin who are prepared to prescribe?
Mr. O'Connor outlined that there were 192 licences issued in respect of 67 patients. Why did we need 192 licences for 67 patients? I might get some clarification on that.
Mr. Muiris O'Connor:
Please do and I might bring Mr. Brennan in on the detailed questions about the consultants outside of the HSE, the geographic locations and the mismatch of licences and beneficiaries.
Mr. Shaun Flanagan:
On Tilray, we engage with companies on an ongoing basis but at this point, we do not have a date from the company on when it will be able to supply. I would be reluctant to make any commitment. When we were before the committee in private session, we said we expected that a company would be in a position to supply it in July and August, yet we will not have a supply until October. I am comfortable about the supply arriving in October but I am not comfortable making an estimate on when Tilray will definitively be in a position to supply us but we will keep in contact with the company and we will chase it again.
Mr. Muiris O'Connor:
I ask Mr. Brennan to come in on the consultants outside of the HSE and the geographic spread of prescribers under the ministerial licence or under the MCAP.
Mr. Conor Brennan:
The information that 192 licences have been issued for 67 people is correct. The first licence was issued at the end of 2016 so the rest of those licences have been issued since then. The first licence is for a period of three months and the second and subsequent licences are for six months. A licence is not infinite and after the first three months clinicians will need to apply every six months to renew the licence. As for the 67 individuals, there are currently approximately 40 patients actively being treated under the licence programme.
We have patients from all around the country in the scheme. It is on a national level and includes the north, south, east and west. I would have to come back to the Deputy in writing on the clinicians within the HSE. I am not certain about that.
My understanding is that there is a difficulty in getting indemnity cover. When this started back in 2017, I was on the then Joint Committee on Health and this issue came up. My understanding was that the HSE agreed that whatever cover was needed would be provided to the clinicians who were prescribing but I am not sure if that indemnity cover is available to people who are not employees of the HSE. It might be worth looking at that.
When I talk about geographic cover I am talking about medical personnel who are prescribing. It is that geographic spread that I am more concerned about. Are the people prescribing only based in Dublin or are there consultants outside of Dublin who are prepared to prescribe?
I have a follow-on question. I have come across a number of people who are accessing cannabis products and who are not necessarily doing so through the system. Has any study been done with GPs where they are aware of this happening in order to get a true picture of this particular challenge we have?
Could Mr. O'Connor answer that question?
One of the problems we have is that people are going down that road because they find the current system too complicated. We need to get a truer picture of challenges that are there and the challenges medical practitioners face as well where they know this is happening but do not want to intervene. Could a serious study be carried out on that area?
Mr. Muiris O'Connor:
That is something we can look into. I thank the Deputy for his advice regarding it. It warrants some investigation when we are framing the terms of a refreshed evidence base. I expect it will be difficult to gather solid evidence on it but maybe we could work through the GPs and so forth to determine the information available.
I am sure that if the Department engages with one university or even all of the universities, working with GPs on a confidential basis, it could get a more accurate picture of what we are really talking about because I do not believe we have an accurate picture of the challenges we have. I know we are looking at other jurisdictions, which is important as well, but we might learn from a very comprehensive study in this area, so that we can plan for the future of it.
I listened to the submissions this morning. It seems a very tortuous route to try to get access to a product. Mr. O'Connor said that in recent years, the use of cannabis products for medical reasons has been an issue of social and political debate in Ireland and abroad and there have been calls for cannabis products to be made available to Irish patients. My understanding is that trying to get this product involves a fairly tortuous route. Those patients believe that these drugs work for them and are transformative. In many cases, they have tried everything else and this is their last hope. I understand people travelling abroad to try to get access, particularly if a child is involved and the parent cannot get access to these products in Ireland. People at home will be asking whether the process needs to be this complicated.
The drug task forces have not appeared before this committee but we know the availability of cannabis, cannabis oil and various different elements of cannabis is widespread. We know that the THC level is 20 times higher than it was only a couple of years ago. Again, this is the information coming from experts. When we are talking about this tiny amount of THC, it reminds me of years ago when I was a kid and when there was a product called ginger beer that supposedly contained alcohol. Some kids thought they would have to drink all these ginger beers but to get a high out of it, you would be drinking ginger beer forever. I understand that it involves the Misuse of Drugs Act but it seems to involve a tiny amount. For people listening at home, THC is supposed to be the element in cannabis that gets you this high. We are talking about a tiny percentage so do we have an idea how much of this cannabis oil would you have to take to supposedly get a high under the current law if we are worried that people will use it willy-nilly as a backdoor to use cannabis in Ireland? Do we, as legislators, need to look at the THC in it? The committee would appreciate it the witnesses could come back to us with an answer today. Do we need to look at this area? I do not have a clue but I know the number of families that have approached us about this. It was their last hope. Is there anything we, as legislators, should be doing for families in that situation regarding the availability of these products? Is there anything we, as legislators, can do about the slow pace of trying to get these products through the system? I accept what the witnesses are saying, namely, that if pharmaceutical companies are not putting them into the system, there will be a difficulty. If there is a significant number of products there, is there anything we or the Minister can do in terms of resources or legislation?
The witnesses mentioned the Minister being in contact with his counterpart in Denmark regarding this issue. Is there a need for the Minister for Justice to talk to her counterparts because of the tortuous route and the difficulty people face trying to get products into Ireland? Would it be useful for this committee to talk to its counterparts in the Netherlands to smooth out some of the difficulties facing those families who are clearly in need of these products but find it extremely difficult to get them?
Mr. Muiris O'Connor:
I will start and will bring in Professor Lynch for clinical reasons along with Dr. Nolan. The Chairman described the process as tortuous and I acknowledge it is. The schemes involve a lot of processes but we really need to take a risk-based approach. The benefits of taking THC in particular need to be higher than the risks. It is really only a clinician who can make that call. I will bring in Professor Lynch.
Professor Bryan Lynch:
The Chairman echoed the concerns of patients and their families. I hear those concerns regularly and share many of them. First, many people access unlicensed versions of CBD in the community. The problem we have with those products is that we do not know what it is in them.
We know what is stated on the tin, but we do not know what is really in the tin. That is why we are looking for properly manufactured, verified and sourced products.
The point about the low content of THC is very good as well. The product I am accessing via ministerial licence for a couple of my patients - in total, I have had about eight applications for a ministerial licence - has a very low content of THC and that is why I am happy using it. It is a minuscule amount of THC, so that is an excellent point. Unfortunately, that still comes under the heading of a substance that is under the substance abuse guidelines. The Epidiolex product, which is a pharmaceutical product, is essentially a pure CBD product and does not. That is a very valid point. Unfortunately, CannEpil, which is the only product that we see coming through the MCAP now, is a high THC product. It is certainly not an insignificant content of THC, so it just not something that has any evidence base for prescribing for epilepsy.
You made a number of extremely valid points. I have met many families and I have many children under my care where families have accessed non-proprietary CBD-based products from various sources themselves. I share your frustration, Chairman, and I echo the frustration of my neurology colleagues, adult and paediatric, that we began this process in 2016 and it is a very slow process.
Dr. Lorraine Nolan:
Chairman, you have raised some very valid points. I take your point about the very small content of THC that is here. As head of the medicines regulatory agency, I am not necessarily looking at this from the point of view of the psychoactive substance content. We all acknowledge that what patients deserve most is evidence-supported treatments. For me, fundamentally, this is not necessarily about this being a THC-containing product or not. There are many controlled drugs under the misuse of drugs legislation that are regular conventional medicines. I refer to one of the opiate products, fentanyl. They have all reached the evidential standard that is required to achieve a medicines authorisation. Fundamentally, we have to preserve those standards. If cannabis wants to be a medicine, it has to reach the same evidential standards of all medicines. It has to prove it works and that it is safe. It comes back to that for us. It is about the lack of an evidence base. Unfortunately, being a controlled substance is one element of it, but the evidence base is not strong enough for this to be the more routine process in terms of access that we all know for other medicines. Until that advances further, they are the circumstances. This will never be a freely accessible programme.
I accept the point that we have started something with MCAP that needs to get under way. We have to reform that experience, and we can look at how we can route that along, support it and much of what Mr. O'Connor said. However, we must be careful in this debate that we preserve the standards we all expect for the medicines that we take and that we can rely on them to be safe and to work.
With regard to the difficulty with the Dutch authorities, is there anything we can do as a committee or as legislators in that regard? Does there have to be a conversation between the Department of Justice here and its equivalent in the Netherlands, or can anybody answer that question?
Mr. Conor Brennan:
Ministerial representations were made to the Dutch to ask them if they could facilitate us in importing the products as part of the MCAP or to be considered for use in the MCAP. The Dutch would not change their stance. They will not allow the commercial export of those products. They will allow the filling of individual prescriptions, which is what the patients in the licence programme are doing. Since April of last year, the Department has been operating a system where we are bringing the products in for the patients and delivering them to their homes. That programme will continue. The Minister announced last December that it would be a permanent fixture. That has made the measure a lot easier for our patients.
I was following proceedings in my office. In the first instance, I thank our guests for their comprehensive presentations. I have a few brief questions. First, the opening statements referred to scientific information, relying on scientific advice and so forth. The witnesses might give us a little more information on the sources on which that scientific advice is based. I am interested to hear that.
Second, it was stated that six suppliers were identified and that two of those decided, although they engaged in the process as the witness said to Deputy Cullinane, that they did not want to supply in Ireland. Is there any reason for that? They engaged in the process, but then opted not to bring it to its finality and supply to Ireland.
Dr. Lorraine Nolan:
I may be answering this in the wrong context, so Senator Conway should stop me if I am going off the point to answer his question. What we were saying in the opening statement is that it was the lack of evidence to support a demonstration of whether these products had an efficacy, meaning they would work, or they were safe. For us, that evidence is generated through a very long development programme for any medicine, and it can take a number of years for that to happen. That has been very well illustrated by the pandemic and much of the information that was in the public domain as to what contributes to the authorisation of vaccines. We all heard about the coverage of the pivotal clinical trials. One can see through that process that there is a comprehensive building of evidence which demonstrates the safety and efficacy. That is done through clinical trials but also in terms of characterisation of the manufacturing processes, so they can stand over the quality of these products. In the context of what is in the MCAP, the evidential base for those is not there. The contrast to that would be the other two authorised cannabis medicines which are Epidiolex and Sativex. They come onto the marketplace with that evidence wealth behind them and a confidence in the fact that the benefit-risk evaluation has been carried out, but by the company that has been independently reviewed by regulatory experts, and they have received a marketing authorisation. That, in total, is the type of scientific basis or scientific evidence we were addressing.
I hope that answers the Senator's question.
Was that because it did not have the volume? Did the witness say that 63 individuals throughout the country is the number of those benefitting from this programme? Is it that the volume was not sufficient to make it commercially viable or was there some other reason that it made that commercial decision?
Mr. Shaun Flanagan:
On the numbers, we need to separate the ministerial licence programme, which my Department colleagues have explained. That is where the number of 67 comes from. The medical cannabis access programme, MCAP, will be a different programme. They will be the products on the Schedule. I presume, from the perspective of the companies, that when they did the economics it just was not commercially viable in a small market for them, or they decided it was not a priority. As I understand it, on occasion companies say that one of the reasons there can be delays in supply is that they have manufacturing pipelines and they must get sufficient quantities available to supply different markets, but I am open to correction on this. It could be something as simple as that. Perhaps they were just not in a position to have sufficient stock. The Department would not be party to this as we would not be in the boardrooms of those companies.
I apologise that I had a clash of meetings but I have been able to follow a good deal of the deliberations today. I thank all of our guests. There are quite a number of witnesses today and it is good to see them participate in this meeting.
I will first turn to the Health Products Regulatory Authority, HPRA, and specifically to Dr. Nolan. Over the past 18 months or so, I have noticed there is a large array of CBD oils on sale in shops. I believe the HPRA has oversight of these. Will Dr. Nolan talk us through this? Over the summer I bought some of these for an elderly relative who wanted to try them in order to alleviate pain being experienced on an ongoing basis. The advice I received in the shop was a little bit substandard to what I would have wanted. What kind of regulatory oversight does the HPRA still have on these products as they enter the Irish system?
Dr. Lorraine Nolan:
It is a very good question. CBD itself is what we could consider a "borderline product". It is contained in cosmetics, foods, food supplements and in medicines. The products in the shops, to which Deputy Crowe referred, are classified as foods and they should not be making any medicinal claims. Certainly, because they are not qualified healthcare professionals, anyone working in those shops should not be giving any advice in relation to whether these products can control pain. They are not meant to do that at all.
CBD is listed by the European Commission as what is called a "novel food". Those products have a different concentration of the CBD in them. Epidiolex, for example, is a 10% weight by volume product. Those products can have up to more or less a maximum of 3% and below that of CBD in them. It is part of our market surveillance programme and it is an area in which we are very active. I will pass over to Ms Farrell because it is her team within the authority that would look over that programme. We have taken action on those products when we found them in shops and found them to have made claims.
Ms Aoife Farrell:
As part of our market surveillance programme around retail sales, we look at a lot of CBD projects. As the Deputy said, there are a lot of products out there, and from the HPRA's point of view, we are specifically looking to make sure that they do not make any medicinal claims. When we find that they do, either on the packaging, the labelling or the company website, we will take market action when required. For the most part, we engage with the suppliers and retailers with a view to removing those medicinal claims and bringing it back in line with the position of the Food Safety Authority of Ireland on the requirements it would need to meet as food supplements alone.
Maybe I differ from Ms Farrell on this but for a person who is experiencing a lot of pain and anguish daily with regard to their health concerns, I think CBD is something else that is worth trying. I hold this view. This is the reason I went in to buy it. That is the positive of it. When I was in the store, however, I felt the retail assistant was giving advice over and above what should have been given.
Another aspect is that we have all been in a situation when on Friday night we have had to run up to a local Tesco store to buy a bottle of Calpol or two, and then be told by the retailer that this is the most you can buy. It seems to me, however, that you can buy the whole shelf of CBD oils. From what I could see, there does not seem to be any cut-off in that regard. Maybe there is a cut-off with the CBD products, and perhaps the HPRA could enlighten me on that.
Head shops were very much in vogue a decade ago, on which there was a national debate. There has been an analysis of a number of products being sold in them. Dr. Pierce Kavanagh of the department of pharmacology in Trinity College Dublin recently highlighted the presence of naphyrone, which is being sold in head shops. Perhaps such shops are calling themselves something different these days, but that drug can be purchased in shops in Dublin city and throughout Ireland. Will Dr. Nolan clarify if the HPRA has regulatory oversight or concern on that?
Dr. Lorraine Nolan:
On the issue of paracetamol products, paracetamol controls exist for an entirely different purpose. Paracetamol is a drug that is very commonly used in suicide, so the retail sale restriction the Deputy experienced in relation to the purchase of paracetamol is designed as a measure to prevent or mitigate that.
I come back to the point that CBD products are foods and this is what they are being sold for. I can understand the limitations of the shop assistant's advice in relation to that. I can understand a request for an alternative but this is why we would always advise anybody suffering from pain that the best source of guidance on controlling pain is from a qualified healthcare professional.
On the head shops, it depends on the nature of the substance being sold. I will speak on this with a little bit more generality. If the substance being sold in the head shop is included under the Misuse of Drugs Act, or is a derivative in relation to that, the enforcement action comes from An Garda Síochána in that context.
This comes down to the question of whether the substance in question can be considered medicinal or whether it is something that can be used in medicine and is considered to be pharmacologically active, and if it is an unauthorised medicine that is being sold. It then comes down to the question of whether some medicines can be sold in general retail outlets, in the case of common analgesics being sold in retailers, for example, and the Deputy mentioned Calpol. Head shops can sell medicines that would fall into this characterisation, but anything that would warrant prescription control purely should not be sold in them and this is the focus of our enforcement work.
I will conclude with a few comments. It is a position I have held for a number of years. We need to have a national debate on cannabis overall. It is a fact that in many homes and many social outlets in Ireland people consume cannabis. As a society we have chosen to ignore this for a long time. I lived in Belgium and in Holland for some time where the drug is regulated by the state through the departments of agriculture, health and policing. I am not suggesting for a moment that we should move immediately to a model like that, but there needs to be a national debate where perhaps we can look at the level of criminality around the dealing of these drugs and ask if there is a way the State can intervene to remove this layer of criminality, to look at a problem that is out there and to look at regulating it by perhaps taxing it and using quality control as they do in some other countries vis-à-vistheir departments of agriculture and so on. At the very minimum, a debate needs to happen on it. I do not have firm views either way but the debate should happen, and we should not be shying away from it.
It is agus gabhaim buíochas leis an Cathaoirleach. I thank all of the witnesses for the information they have provided thus far. I have three questions to ask. What are the numbers of patients or individuals nationally who are availing of the MCAP treatment? I am aware that there are three qualifying conditions at the moment. Is the opportunity there to widen the conditions that qualify a patient for inclusion in the MCAP?
I am aware of a constituent in Clare who has a rare condition and is in the care of a consultant but has not been afforded the opportunity to be included in the MCAP. Instead, this patient has now spent several years going through various types of medical treatment that had adverse side-effects but did not resolve the matter. It did not have any kind of positive impact on the condition. Strangely enough, the consultant has not offered the opportunity to be included in the MCAP but wants to start the whole medical treatment again, with the individual prescribed every medication that has already been tried for the past number of years. Are the witnesses aware of such cases occurring and what are their thoughts on why they arise? I am conscious that this patient is based in Clare, so I wonder about an urban-rural divide with this kind of treatment.
A few of those questions were answered during the meeting. Perhaps the witnesses could concentrate on the last one, although it was touched on as well. We are running out of time. This is the health committee and we want to work to guidelines laid down by the Houses.
Ms Anne Marie Seymour:
I will just reiterate Mr. O'Connor's comments. That would be a clinical decision and there is a clinical relationship between a doctor and patient. It would not be appropriate for the Minister for Health or people in the Department to comment on that relationship. There is trust in the relationship when it comes to what is prescribed. The licensed programme is available to any patient once the clinical decision has been made.
We are not seeing a rural-urban divide that would have only Dublin-based consultants using this scheme. Location is not an issue with access to the programme. We are delivering cannabis-based products to patients all around the country. We are not seeing it from our side that anybody in a rural area is disadvantaged.
Dr. Lorraine Nolan:
I have an update. The question was asked earlier about the position in Denmark and whether a consultant was required to initiate treatment under its cannabis access programme. Any doctor may prescribe but for particular conditions, such as a neurological condition, such as epilepsy, multiple sclerosis or spinal cord injury, a consultant must be involved with the prescribing.
I thank Mr. O'Connor for guiding us through this morning's meeting and farming out questions to the others. It was a useful exercise for the committee and, I hope, for people listening at home and going through a process or seeking information. This morning's meeting has thrown up a number of questions for us, as legislators, but also as the committee dealing with health matters. We might come back with some sort of recommendations. This morning's meeting has been really helpful and I appreciate the witnesses coming in to give us the information. I thank everyone for their helpful contributions.