Oireachtas Joint and Select Committees
Tuesday, 7 March 2017
Joint Oireachtas Committee on Health
Cannabis for Medical Use: Discussion
12:00 pm
Michael Harty (Clare, Independent)
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This meeting will be carried live on Saorview channel 22, Virgin Media channel 207, eir Vision channel 504 and Sky channel 574 and Vodafone channels - Oireachtas TV 201, Dáil 207 and Seanad 208. Members are requested to switch off their phones or switch them to airplane mode so as not to interfere with the recording of the meeting. All public meetings are broadcast in a replay loop over the following week if anyone wishes to review the contents of the meeting.
I thank everyone for attending. We have an apology from Senator Keith Swanick.
This meeting is with representatives of the Health Products Regulatory Authority, HPRA, and officials from the Department of Health. The purpose of the meeting is to engage with representatives from both organisations on the report, Cannabis for Medical Use - A Scientific Review. On behalf of the committee, I welcome Dr. Lorraine Nolan and Dr. Elaine Breslin of the HPRA. I also welcome Mr. Eugene Lennon, Ms Maria Egan, Dr. John Devlin and Dr. Ronan Glynn of the Department of Health.
I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, they are protected by absolute privilege in respect of their evidence to the joint committee. However, if they are directed by it to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him or her identifiable. Any submissions or opening statement submitted to the committee may be published on its website after the meeting.
Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official, either by name or in such a way as to make him or her identifiable.
I call Dr. Lorraine Nolan to make her opening statement.
Dr. Lorraine Nolan:
My name is Lorraine Nolan and I am the chief executive of the Health Products Regulatory Authority, HPRA, which is the regulator of medicines and other health products, with a primary role in the protection of public health. I am joined by my colleague, Dr. Elaine Breslin, the clinical assessment manager. Further to our statement to the committee on 24 November 2016, we are pleased to discuss the HPRA report, Cannabis for Medical Use - A Scientific Review, which was submitted to the Minister for Health on 31 January and subsequently published by the Minister on 10 February.
As the committee will be aware, the Minster asked the HPRA in November last year to provide scientific advice on the use of cannabis for medical purposes. We were also requested to review the situation regarding the medical use of cannabis in other countries. The role of the HPRA includes the evaluation of the benefits and risks of medicines on the basis of scientific evidence, prior to granting a marketing authorisation. The evidence for the use of many cannabis products is insufficient to permit a conventional benefit-risk evaluation, or authorisation as medicines. As such, we have concluded as an outcome of our review that we cannot recommend widespread access to cannabis for the treatment of a range of medical conditions. However, we have advised that access could be facilitated under appropriately controlled circumstances where adequate assurance of patient safety and follow-up can be provided.
Since the publication of the report, a policy decision has been made by the Minister to provide access to cannabis for medical purposes for defined medical conditions. He has indicated his intention to proceed with the advice of the HPRA. In conducting our review of the medical use of cannabis, the HPRA convened an expert working group comprising relevant clinical experts and patient representatives. The working group provided valuable support and context through the sharing of insights from both patient and clinical perspectives on this issue. The conclusions of the review are comprehensively outlined within the published report which has been circulated to the committee with my opening statement. I would like to outline the key considerations for today's discussion.
To date, there is an absence of scientific data demonstrating the effectiveness and safety of cannabis products. A point of importance is that there is insufficient information on the treatment of long-term medical conditions, such as those for which there is a public focus. Most cannabis products available under international access schemes do not meet pharmaceutical quality requirements for medicines.
The review highlighted significant gaps between the public perception of effectiveness and safety, and the regulatory requirement for scientific data, which is mandatory to determine the role of cannabis as a medicine. Any proposal to circumvent the medicines regulatory system, established by law, would require careful consideration to avoid unintended consequences and lower standards of patient protection.
The best outcome for patients is the development of authorised, or those capable of being authorised, cannabis-based medicines where the safety, effectiveness and quality can be assured, and understood by the patient and health care professionals.
In this way, doctors can take account of side effects and interactions with other medicines, and patients have medical oversight for their cannabis treatment.
If cannabis products that are not capable of being authorised as medicines, are made available through an access programme, patients and health care professionals will need to be conscious of the limitations of the programme in assuring the safety, quality and effectiveness, as compared with what would be expected for an authorised medicine.
Access to cannabis for medical use should recognise patient need, be evidence-based, and fit with clinical practice. Therefore, it is advised that treatment with cannabis is only permitted under a controlled access programme for the treatment of patients with: a. spasticity associated with multiple sclerosis resistant to all standard therapies and interventions while under expert medical supervision; b. intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under medical supervision; and, c. severe refractory, which is treatment-resistant, epilepsy that has failed to respond to anti-convulsant medications while under medical supervision.
In respect of the possible use of cannabis for the three specified medical conditions, the HPRA has not only reviewed the scientific literature, but has also advised on the practical steps that could be taken to provide access for Irish patients.
To this end, we recommend the introduction of a monitored five-year cannabis access programme. Such a programme is necessary both to maximise the safe and effective use of cannabis as a medical therapy for an individual patient and to minimise the potential negative impact of wider access on society.
It is proposed that the programme should run for a period of five years with a centralised data collection point and regular reports to the Department of Health. This information will provide data on the medical use of cannabis and the supply needs in Ireland. The programme will also provide an appropriate level of monitoring and accountability for the cannabis products supplied.
Specific elements of the access programme should include the following: Patients treated with cannabis should be under the care of a medical consultant who has expertise and experience in the treatment of the specified condition, and who is responsible for the monitoring and follow-up of the patient; authorised cannabis-based medicines should be considered for treatment in the first instance. This includes medicines not authorised in Ireland but approved for use in other countries. Investigational cannabis-based products subject to appropriate quality control requirements, could be sourced and used in the treatment programme when standard treatments have been unsuccessful and alternatives are not available in Ireland; doctors, pharmacists and patients should be registered under the programme, and data collected on the use of cannabis in these patients; patients should be educated on the correct use of the cannabis for medical purposes, the benefits and risks involved, how to report side-effects, and the care and safe disposal of cannabis products; and, doctors and pharmacists should be supported to facilitate prescribing and dispensing.
This proposal for a cannabis access programme provides a strong framework that can inform the future direction of access to cannabis for medical purposes. Further scientific research will be key to determining that future direction. While there is significant involvement of scientific researchers in Ireland, more clinical, human-based research is needed. We envisage that this access programme can be adjusted and widened as clinical experience and scientific knowledge develops, and as more cannabis-based medicines become available.
The HPRA is committed to assisting access to cannabis for medical use, in so far as we can, within the context of our remit. The implementation of the access programme would be a significant move for Ireland, as we align ourselves with a number of our European neighbours. In the course of the HPRA review, 40 countries were surveyed. In Europe, 16 countries do not have any access programmes, nine have programmes for exceptional use similar to that advised by the HPRA, and three countries have wider access programmes.
I have previously highlighted that the proposals in the report were accepted by the Minister, who has committed to progress the implementation as a priority. There are a number of factors that will be required including legislation, support for patients and health care professionals, and identification of suitable quality-controlled cannabis products.
A new legal framework for cannabis for medical use will require time to develop, and needs to be done in a manner that is effective and best meets both patient and societal needs. There is already provision within the existing legislation for prescribing in limited circumstances, subject to a licence from the Minister.
Supporting patients and health care professionals is vital to its implementation. To that end, the HPRA understands the Department of Health will consult relevant stakeholders. As part of its review, the HPRA has identified potential product sources and further work is under way.
Since publication of the report, the HPRA has met patient representatives, Deputies and their advisers and responded to queries from members of the public and the media. We consider it important that patients and health care professionals have access to the information we can provide on medicines and the background to the HPRA’s proposals. In addition, we are committed to continuing to engage with the Department of Health to achieve effective and timely implementation of the proposals.
The HPRA advises that cannabis for medical use should only be initiated as part of a structured process of formal ongoing clinical evaluation of patients with clearly defined medical conditions. This position is based on current scientific evidence and will be kept under review.
I thank the Chairman for giving us this opportunity to make a presentation to the committee. We will be happy to address follow-up questions.
Michael Harty (Clare, Independent)
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I thank Dr. Nolan. I ask members who came into the room after the meeting commenced to turn off their mobile phones because they will interfere with the recording of the proceedings of the meeting.
Mr. Eugene Lennon:
I am a principal officer in the medicines and controlled drugs unit in the Department of Health. I am joined by my colleagues, Ms Marie Egan, a pharmacist in the medicines and controlled drugs unit; Dr. John Devlin, deputy chief medical officer; and Dr. Ronan Glynn, specialist registrar in public health medicine.
Members of the committee will know that cannabis is a Schedule 1 controlled drug under the Misuse of Drugs Act and the most widely used illegal drug in Ireland. It is worth remembering that it is not currently an authorised medicine and has not gone through the normal regulatory procedures for medicines which are designed to protect patients and ensure treatments are supported by good evidence of their effectiveness and safety. However, the Department is aware that some patients believe cannabis should be a treatment option for their medical condition. It is also aware that a number of countries have changed the law or introduced programmes to allow access, under strict conditions, for certain groups of patients.
Against this background, on 3 November 2016 the Minister for Health announced a review of policy on cannabis for medical use. He requested the Health Products Regulatory Authority, HPRA, to provide him with expert advice. On 10 February he published the HPRA’s report, Cannabis for Medical Use - A Scientific Review, and announced that he would establish an access programme for standardised cannabis-based treatments for the following conditions: spasticity associated with multiple sclerosis, resistant to all standard therapies and interventions; intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes; and severe, refractory treatment resistant epilepsy that has failed to respond to standard anticonvulsant medications. The Minister has thanked the HPRA and the members of the expert review group for their work on the report which he has described as a milestone in the development of policy on medicinal cannabis.
Patients accessing cannabis under the programme will be required to be under the care of a medical consultant. Officials will consult stakeholders on how the access programme will operate. It will be important to engage with the clinical community in the development of a framework to operationalise the access programme for the implementation of medicinal cannabis in health care. Officials are also examining legislative changes that will be required to underpin the access programme.
The Minister intends to progress the establishment of the access programme as a priority. However, to be clear, patients accessing cannabis under the cannabis access programme will need to be recommended for cannabis treatment by a relevant medical consultant involved in their care. This recognises the relevance of such treatment in the overall care planning and management of the underlying medical condition.
For the period during which the access programme is being established, it remains open to the Minister to grant a licence under the Misuse of Drugs Act for access to cannabis for medical purposes in individual cases. Such applications will be considered on a case by case basis. The granting of a licence must, however, be premised on an appropriate application being submitted to the Department which is endorsed by a consultant who is responsible for the management of the patient and prepared to monitor the effects of the treatment over time.
I thank the Chairman for giving us the opportunity to make a presentation to the committee. We will be happy to address follow-up questions.
Michael Harty (Clare, Independent)
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I thank Mr. Lennon. I will open up the discussion to members of the committee. Two members are offering, Deputies Kate O'Connell and Jonathan O'Brien. We will take their questions together.
Kate O'Connell (Dublin Bay South, Fine Gael)
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I thank the delegates for coming before us again. What they are recommending is that, within certain parameters, the use of cannabis-based products be authorised but on foot of a prescription from a medical consultant or somebody at that level, for want of a better word.
What the witnesses are saying is that it is allowed, but if I needed it, I would have to get a medical consultant to prescribe it for me. I would like that point to be clarified.
A doctor is entitled to his or her professional judgment and that decision that is made by a prescriber. Would the representatives of the Health Products Regulatory Authority, HPRA, consider it appropriate for a Minister to ignore or move towards ignoring its advice? Would they see that as being the role of the Minister or is it the role of the HPRA to do what it is doing in this regard?
Is access to cannabis products for medical use in other countries currently on foot of a medical consultant's prescription? I would welcome some information on that. It happens regularly enough that a doctor prescribes an unlicensed medicine in this country. In my job I am aware that unlicensed medicines, usually ones which are licensed in other countries, are prescribed. There is no reason they are not licensed here but it is more an issue concerning paperwork. One could ask what that would leave us open to in this country if we were to circumvent the licensing. In other countries are such products always made available on foot of a consultant's prescription? If a consultant or regular GP prescribes a product off-licence, where does the liability lie? My understanding is that if a doctor prescribes something in Ireland off-licence, he or she is solely liable for the effects of the medicines, and takes it upon himself or herself professionally.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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The HPRA is now saying that we should look at establishing an access programme for three specified medical conditions. An outline was given of what the potential access programme could look like. It was said that the programme would be monitored, that it would be for five years and that there would be a centralised data collection point. It was also said that a new legal framework would be needed in order to establish the access programme. On page 32 of the report there is reference to the 1961 UN convention on narcotic drugs, to which Ireland is a party. It says that under the convention the production and distribution of controlled substances must be licensed and supervised and the rationale for that is outlined. In terms of the legal framework, do the witnesses from the HPRA expect the changes will have to be made in primary legislation or if they can be made in secondary legislation? Did they make any recommendations to the Minister or was that left to the Department?
The witnesses from the Department stated that the Minister has accepted the establishment of a new access programme and that it will take time to implement. We heard that the Department is looking at options in terms of legislation. Will the legislative changes be made in primary legislation or by means of statutory instrument? It was also outlined that in the absence of an access programme it remains open to the Minister to grant a licence under certain circumstances. Could the witnesses outline what those circumstances are because there seems to be much confusion in terms of how someone can get a licence from the Minister before the access programme is established? Could they indicate exactly what are the criteria? What conditions does someone have to fulfil in order to be granted a licence? Only one licence has been granted to date.
It is important to put on the record exactly how someone achieves the criteria to get that licence while we are awaiting the establishment of the access programme. In regard to the access programme, it is important that the witnesses give us some knowledge of their consideration of the type of legislation that will be required.
Billy Kelleher (Cork North Central, Fianna Fail)
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I thank the witnesses for the presentation. There is a lot of emotive debate around this topic. A woman from Cork is coming to the Dáil today, and it is important that we acknowledge the work and effort she has put into campaigning on this particular issue. However, just because people are campaigning does not mean that what is being sought can be provided by political decisions.
We are discussing the health implications of individuals and, more broadly, society in the context of making cannabinoid oils with THC available through an access programme at some stage. That will require a lot of monitoring, evaluation and correlation of medical and scientific data over the next number of years.
In the context of what is being discussed, and given the backdrop of Vera Twomey arriving in the Dáil in the next hour or so, there has been a lot of confusion about the use of cannabinoid oils with THC. Parliamentary questions were been tabled and there was a perception that a registered doctor could prescribe oils with THC in them. Reference has been made to a number of parliamentary questions asked last October, replies to which stated an application could be made for a licence if a registered doctor made an application. However, it was not made clear that a consultant paediatric neurologist had to make such applications.
I can understand the need to ensure there is proper scrutiny in the prescribing of drugs. There should also be proper scrutiny of Dáil questions and replies to ensure that they are accurate and do not mislead people, in particular in sensitive matters. For a long period of time, the parliamentary questions gave a family hope they could access something they believed could change the life of their daughter but were subsequently refused on the grounds that a paediatric neurologist was not prescribing the drug.
I refer to the access programme. How far has the European Medicines Agency gone in terms of examining the issue? What other countries are making cannabinoid oils with THC available to patients under various licensing systems? Are some countries more proactive than others? Is there a lot of resistance in other countries? I ask the witnesses to expand on the international comparators, primarily within the European Union, North America and Australia. Did the witnesses consider that when compiling the report, for which I compliment them on bringing forward expeditiously? It highlights issues such as spasticity, nausea and vomiting associated with chemotherapy and epilepsy. Why were those three areas highlighted in the report? Was it because there is a body of research available or are the witnesses saying that other medicines may not work? Are they suggesting that because they do not work something else should be tried? Is there a strong body of international evidence to show that there is an improvement in outcomes in the three areas mentioned?
How many people have applied for licences in Ireland? Without breaching confidentiality rules, how were such drugs prescribed? Did consultants, GPs or other individuals prescribe cannabinoid oil with THC? At what level were the clinicians who prescribed such drugs?
Michael Harty (Clare, Independent)
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Thank you very much, Deputy Kelleher. Dr. Nolan, will you start by taking some of those questions?
Dr. Lorraine Nolan:
I will start with the questions put by Deputy O'Connell. She asked whether a medical consultant was required in the context of the access scheme we are proposing. One of the conditions we have set out is that the patient should be under the supervision of a specialist medical consultant. The conditions for treatment would include severe epilepsy, cancer and multiple sclerosis. All patients treated in those cases would be under the care of a specialist consultant. They would also be under the control of a general practitioner – I wish to make that point straight and upfront.
The reason we have outlined the need for specialist medical consultant oversight relates to the fact that one of the requirements of the access programme is to ensure that all the conventional forms for treatment have been tried. There is a view that specialist knowledge is required to ascertain whether that is the case. We are taking about cannabis being used in addition to an established treatment programme for a patient. Specialist medical oversight is important to monitor the effects of cannabis on the patient and how the effects might interact with the current medical regime of the patient. We really believe this approach will bring about the best outcome for patients and that is what we have recommended. In other words, the patient needs to be under the supervision of a medical consultant as well. We have not necessarily said that the consultant has to prescribe. It is a question of monitoring the effects of cannabis on the patient in view of the complexity of the issues that I have outlined.
Reference was made to medical prescriptions in other countries. There are several variations in the approaches taken in other countries. It is generally the case that the medical prescriber is required to be a specialist and have specific training. That is generally the case throughout the European system and also in the international context.
Reference was made to the access programme and whether cannabis would be authorised. We need to be clear that this is not an authorisation of cannabis as a medicine that we would conventionally view as being an authorisation of a medicine, because the data is simply not available and we have no submission to work on. Cannabis would not be authorised as a medicine in the sense that we would see a medicine as being authorised in this regard.
If I recall it correctly, another question related to off-label use of medicines. It is certainly possible for a doctor to prescribe a medicine off-label. That could include an authorised cannabis medicine for treatment of another condition.
Deputy O'Brien asked about our views on the legislation that would be required to implement the access programme and the role of the International Narcotics Control Board. I wish to be clear at the outset that the role of the International Narcotics Control Board is a supervisory and monitoring role. The fundamental purpose of the board is to ensure that for whatever purpose a country permits consumption of a controlled substance, including cannabis, all the elements of consumption, including the manufacturing process and consumption by patients, are appropriately monitored and that monitoring can prevent diversion. It is usually the case that we have to declare medical needs and consumption to the International Narcotics Control Board. The board then gives us what is known as a quota or estimate system to which we must adhere in terms of the consumption requirements of the controlled substance. We need to know the medical uses in terms of adhering to the system of monitoring provided and set out.
I was asked specifically for the view of the Health Products Regulatory Authority on legislation and I am willing to answer that point. Committee members are aware that the progression of legislation is under the remit of the Department of Health. I imagine officials from the Department will give their views to the committee as well. Our report has indicated that primary legislation may be required. Again, it is for the Department to determine whether primary legislation is required to implement these measures, whether secondary legislation is a more appropriate route or whether it can be managed under existing provisions.
That is our statement on the matter.
Deputy Kelleher asked about the position in Europe, in particular the position of the European Medicines Agency, EMA, on the use of medicinal cannabis. I need to be very clear that the EMA has had no position on medicinal use of cannabis and, simply put, in terms of the current data, the EMA would not be endorsing the medicinal use of cannabis in any way. The requirements are not there to authorise this as a conventional medicine, which is the business and role of the EMA, and the medicinal use of cannabis simply would not meet the requirements. Throughout Europe nine countries currently have an access programme that is similar to what we are proposing, which is that it would be available in exceptional circumstances for the treatment of patients who are under specialist medical control and that it would be an exceptional rather than a conventional and widespread use. Three countries have a wider access programme than we are proposing. These include The Netherlands, which has a well established programme, Italy and the Czech Republic. These countries have more widespread prescribing for a range of conditions. The methodologies these countries use to secure the cannabis-based products that they are using, which are pharmaceutically controlled materials, are also different. For example, The Netherlands would grow its own cannabis. A contract is issued by the State to a company to generate the stocks of the cannabis and procure them and then these stocks are supplied to pharmacies that dispense them for patient use. Sixteen countries have a prohibitive system that would be similar to the current system in Ireland.
I will hand over to my colleague, Dr. Elaine Breslin, who will speak about the conditions that were selected and the rationale and basis to the selections.
Dr. Elaine Breslin:
I thank Deputy Kelleher for his question. He asked about the three conditions that we have selected. We carried out a scientific review of the evidence for the three conditions, namely, spasticity associated with multiple sclerosis, nausea and vomiting associated with chemotherapy and intractable severe treatment resistant epilepsy. The evidence is modest across all of the conditions. In our review of cannabis, in general we found that the evidence is poor and often conflicting for all of the indications. When we say conflicting, we mean that different reviewers consider the information to be different. For example, in the case of pain, one reviewer considered the evidence to be moderate while another stated that it is substantial, although the same data set was used. It is, therefore, difficult to reconcile those positions when trying to make a recommendation.
We have recommended that cannabis could be considered for the three conditions. We are not recommending treatment with cannabis because there are only three authorised medicines available. If patients were to have exhausted all available treatments and the feeling was that cannabis could be effective for a particular patient, cannabis treatment could be considered for those particular conditions. Authorised medicines are available for two of the three conditions and for one of the conditions, which is epilepsy, a cannabidiol oil is currently under development. Deputy Kelleher asked about the European Medicines Agency. The medicine has been accepted as an orphan medicine for the conditions of Dravet and Lennox Gastaut because it is recognised that there is an unmet need. Those are very rare-----
Billy Kelleher (Cork North Central, Fianna Fail)
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Does it have THC in it?
Dr. Elaine Breslin:
No; it is pure plant-derived CBD. That medicine is currently under development and is going through clinical trials. One paper has been published that gives evidence of some efficacy across a group of epilepsy disorders and other trials are currently under evaluation by the company, which has issued press statements, but we cannot draw any conclusions on the basis of that. The committee will understand that the normal process is for the papers to be published in peer reviewed journals and the medical community will discuss the evidence that is available. We understand, however, that the company developing the medicine is planning to make an application in Europe and the US later this year.
The conditions we have chosen have objective end-points that can be measured by consultants monitoring a patient. Reductions in spasticity and the number of seizures as well as the control of the nausea and vomiting associated with chemotherapy can be assessed. These are, therefore, objective end-points. One of the problems one sees with the studies is that cannabis is found to be effective on subjective end-points or patient related effects, whereas when a consultant or doctor treating the patient examines the objective end-points, he or she finds that the efficacy and effectiveness are not necessarily shown. There are objective end-points for the three conditions. This is terribly important because this is a monitored pilot programme which will be available to a limited number of patients with the specified conditions under consultant care. It is important that at the end of the five-year pilot programme, data will be available to show how the cannabis was used for the conditions in question and whether it worked for the individual patients. This is not the type of data that would be suitable for publication in the sense of allowing others to draw conclusions. However, it will inform the future direction of cannabis use in Ireland.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Why does the Health Products Regulatory Authority have a preference for primary legislation?
Dr. Lorraine Nolan:
One of the reasons we suggested primary legislation is that the misuse of drugs legislation, on which I am focusing, currently treats cannabis as a Schedule 1 drug. It is usually the case that if a substance or drug is to be used medically, it is rescheduled into Schedule 2. This has been the case, for example, for Salivex, which is an authorised cannabis based medicine. In the case of Salivex, the confidence in terms of rescheduling it was largely generated by the fact that it was authorised as a medicine. On the basis of this authorisation, which means it met the full data requirements in terms of quality, safety and efficacy, it was moved into Schedule 2. There was full confidence in allowing all prescribers to prescribe the drug in line with the conditions that it set out for treating it.
The issue here is that we are not proposing a rescheduling of cannabis from Schedule 1 to Schedule 2 because we have not reached the point, except in the case of the three products Dr. Breslin mentioned, where they meet the requirements for authorisation of a medicine. That type of rescheduling is not appropriate in this case. The reason we suggested primary legislation would be necessary is that one needs to enable some form of prescribing provision for this because the access system currently operates under a licence granted by the Minister. This places the Minister very much at the heart of the clinical decision making process, which is not appropriate in the context of an access programme that we decide. Clinicians need to be allowed to use their clinical judgment. This limited provision allowing a Schedule 1 drug to be prescribed fundamentally changes the construct of the misuse of drugs legislation. For this reason, we consider that primary legislation would be required. Having said that, our role is not to develop legislation as the Department of Health has the expertise in this area.
Billy Kelleher (Cork North Central, Fianna Fail)
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If a licence were to be granted by the Minister on compassionate grounds, would a ratio of tetrahydrocannabinol, THC, and cannabidiol, CBD, be included in the licensing arrangement or is that a matter for the clinician? Who decides the ratio of THC to CBD?
Dr. Lorraine Nolan:
The current provision is exceptional and is really a public interest provision. It is set out in the legislation that if it is the Minister's opinion that it is in the public interest to grant a licence to a prescriber to prescribe, he or she can do so.
The provision is not specific to that. In general, what would be expected is that the applicant, who would be the prescriber, would set out the product required and would clarify the nature of the product, its CBD and THC content, and what level of reassurance of the pharmaceutical quality of that product can be given, given that it is not likely to be an authorised medicine.
Michael Harty (Clare, Independent)
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Thank you. Would Mr. Lennon or his colleagues from the Department like to answer some of the questions posed?
Mr. Eugene Lennon:
As to whether we need primary or secondary legislation, the current situation is not ideal. There is a desire to get the access programme up and running. We are looking at whether secondary legislation under the Misuse of Drugs Act could be dealt with in a number of months, maybe six months, in contrast to going for primary legislation. If we go for primary legislation, we will also have to go for secondary legislation from that primary legislation as well. I would foresee, if the primary legislation route is pursued, that it could take up to 18 months before something is in place. If one goes for secondary legislation it could be done within about six months.
The misuse of drugs area is extremely complex. As Deputy Jonathan O'Brien is well aware, in the last two and a quarter years my unit was on its third Bill in this area through the Oireachtas, and also a lot of regulations. It is complex. We are working our way through to see what is possible. We are open to finding a solution that gives us a quicker result. That may be through secondary legislation under the Misuse of Drugs Act.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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But we are still talking a minimum of six months for the establishment of an access programme, even if we go down the secondary legislation route?
Mr. Eugene Lennon:
I think so. It is not one regulation. We would need at least one new regulation and to amend a number of existing regulations. There are also many complexities about cannabis being a schedule 1 drug.
There were a number of questions about the current licensing arrangement, what is required for an application for a licence, and how many licence applications there have been. There have only been two licence applications. They are both from GPs. In terms of who makes the licence application, there is obviously an applicant, but the applicant may include supporting documentation or information from others involved in the case. In a number of parliamentary questions, the Minister has set out what one might generally expect to see in an application for a licence. This includes an outline of the treatment the patient has received to date, and a justification from the doctor as to why it is appropriate, in their patient's specific circumstances, to prescribe cannabis, a schedule 1 drug.
The point Dr. Nolan has made is that schedule 1 drugs are not intended for medicinal use, so it must be an exceptional case. One is always asking why, in any specific case, a licence should be granted for cannabis. We also require the details of the cannabis-based product which it is proposed to prescribe and administer to patients, the source of the cannabis-based product and the arrangements for the ongoing monitoring and care of the patient once the cannabis-based treatment has commenced. I refer members to the statement from the chief medical officer yesterday. He said that an appropriate application, endorsed by a consultant who is responsible for the management of the patient and is prepared to monitor the effects of the treatment over time, has to be submitted to the Department of Health. A consultant does not have to personally apply in each case, but certainly the consultant should endorse the course of treatment that is proposed and be able to take responsibility for the overall treatment of that patient. People with the conditions mentioned most frequently in regard to the use of cannabis, such as epilepsy or multiple sclerosis, are already under the care of a consultant.
Those are probably the main points on the licence and the applications that have come in to date.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I am a little confused. The witness has said there have been two licence applications.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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One has been accepted while one has been denied.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Were both applications from a doctor?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Is Mr. Lennon stating that a licence has been granted in one case because the application was from a doctor with an input from a consultant who was willing to monitor the ongoing administration of cannabis?
Mr. Eugene Lennon:
I would prefer not to get into the individual cases, but in each case, an initial application was submitted, and there was contact between the Department and the applicant. Often additional information is forwarded to the Department at a certain point.
From the time the application was received in these cases, each case was dealt with in 24 hours and a response was made to the applicants. In one case before Christmas, the process took approximately three weeks. Another application was received around the 31 January 2017 and the Department has made contact with the applicant since then but in that case, the point at which it is possible to make a recommendation to grant a licence has not been reached.
Michael Harty (Clare, Independent)
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I thank Mr. Lennon. We will proceed to the next group, Deputy Bernard J. Durkan, Senator Colm Burke and Deputy Richard Boyd Barrett.
Bernard Durkan (Kildare North, Fine Gael)
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I thank the Chairman. I thank our guests for appearing before the committee. I have a number of questions.
The countries that have introduced the medicinal use of cannabis under strict control were listed. Are the witnesses aware of any side effects or issues that must be attended to, arising from the use of cannabis in those countries?
Do we have the views of conventional pharmaceutical manufacturers on the use of medicinal cannabis, with particular reference to those companies that manufacture cannabis-based medicines? Have their views been sought in respect of the use of cannabis? Has there been a comparison of the benefits of cannabis-based medicines versus the use of cannabis for medicinal reasons?
Dr. Lorraine Nolan in the course of her address stated, "To date there is an absence of scientific data demonstrating the effectiveness and safety of cannabis products". We must take this into account. I remember how we dealt with hepatitis C some years ago, where the plan we followed was proven to be incorrect and proved to be costly and detrimental to the quality of life of the patients concerned.
In respect of the patients who have been authorised to use cannabis based products, have any ill-effects been detected since they started to use these products? Does Dr. Nolan have reservations on the use of cannabis based products?
We have covered the licence to some extent. How does the licensing system operate in the countries that have authorised the use of cannabis? Have problems arisen, or are there issues that we should bear in mind in the context of its use in Ireland?
Dr. Nolan set out three conditions, when she, sounding a note of caution, recommended the use of cannabis. In regard to the side effects of the use of cannabis, is Dr. Nolan satisfied that she has identified and is aware of the side effects? Has there been an evaluation of the potential side effects from the possible use of cannabis in the way in which it is proposed to be used in this case?
I have already raised the question on cannabis based pharmaceutical products. How did other countries decide in the first instance on who should have access to the use of cannabis for medicinal reasons? Did they start with an access programme or did they authorise it in a general way?
We are familiar with some of those countries and their drug regimes but I will not go into that at the moment.
The HPRA advises that cannabis for medical use should only be initiated as part of a structured process of formal ongoing clinical evaluation in patients with clearly defined medical conditions. That is a serious statement. Is the HPRA satisfied that it is possible to adequately monitor the potential uses given the proposals that are already on the table?
I refer to ministerial prerogative. Reference was made to the fact a Minister can make a decision at any time. That is correct in theory but a Minister must try to avoid a decision that could be detrimental to the public good, the health of the general public or whatever the case may be. He or she must have regard to those issues at all times. The point has been covered but I am interested in hearing anything the witnesses wish to add.
Colm Burke (Fine Gael)
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I thank the witnesses for their presentations and for all the work they have done on this over a very short period. The witnesses will agree that a parent will do everything possible to get the best possible care for his or her child. I refer to a situation where all available medicines have been used but have proved unsuccessful. The parent then feels the only option is to use a cannabis-based product but the medical adviser is unhappy about coming on board. The witnesses will understand the frustration of the parent in that situation. They have outlined where the Minister has the right to issue a licence. Who is the licence issued to? Is it the parent, the GP or the medical consultant? Who is accountable for issuing and monitoring a licence? It has been mentioned that medical consultants monitor the licence. Do medical consultants report on the matter? This aspect has been discussed but it needs to be clarified. What does one do with a parent who finds it difficult to get his or her medical adviser to come on board? Is there a mechanism that can be put in place to assist the parent in cases where all other forms of treatment have proved unsuccessful but where there is clear evidence that a cannabis-based treatment might be of assistance?
The matter needs to be clarified because this problem will arise repeatedly if we are talking about having a five-year programme. Not many medical consultants would be very familiar with this matter. What do we need to do to ensure there is an adequate level of care for the patient and support for the patient where his or her advisers are reluctant to become involved? It is extremely important that we clarify this matter.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I will start with the recommendations made by the HPRA. Dr. Nolan mentioned that the Netherlands, Italy and the Czech Republic have all followed an approached access to medicinal cannabis. It is more extensive than the programme proposed by the HPRA and is in line with the proposals for access contained in Deputy Gino Kenny's Bill. The HPRA has chosen a more conservative approach than the one adopted by the Netherlands, Italy and the Czech Republic.
That happily dovetails with the Government's desire to kill Deputy Gino Kenny's Bill and only allow access in the cases that it decides. Why? What is wrong with the approach adopted in the Netherlands, Italy and the Czech Republic? Why did the HPRA make a recommendation in line with opinion No. 14 instead of something that was in line with what had been adopted in those countries? Has it any evidence to suggest there was anything irresponsible in the way the Dutch, the Italians or the Czechs had done things? I suggest it does not. Is the HPRA even qualified to adjudicate on this matter? The delegates made the point that Ireland did not have experience. Countries such as the Netherlands, Italy, the Czech Republic, Canada and so on do. They have set up cannabis regulatory authorities similar to the one included in Deputy Gino Kenny's proposal and are developing specific expertise. Those regimes make a distinction between cannabis and other pharmaceutical-type drugs. It was a political decision.
At the very least, we need to debate which is the better option and hear arguments on both sides instead of just one view. Other countries which are just as responsible as this one and which have more experience of this issue have made different decisions. Will the delegates respond to these points?
Why has the question of pain relief been omitted? Of the 800,000 people who suffer from chronic pain, 40% report that none of the medications they have tried addresses their condition. They include cancer sufferers who have been left out in the cold in this regard. Only those who suffer from nausea related to chemotherapy will be allowed into the trial programme. Why are the 800,000 people mentioned being left out in the cold? How can that be justified? It is not only me who is asking the question. I ask the delegates to respond to David Finn, professor of pharmacology and therapeutics at the Centre for Pain Research in NUI Galway, who is undertaking research in this area. According to him, it is disappointing that the report does not include a reference to chronic pain because a significant number of patients who suffer from chronic pain could be denied the opportunity to trial cannabis or cannabinoids as a consequence unless the case for their use to treat chronic pain can be strongly argued with the Government such that they will be included in the final legislation. He points out that one in five people suffers from chronic pain, or approximately 800,000 in Ireland alone, which is of an epidemic scale and all the more reason to do what we can to introduce new treatments that could benefit them, especially when we consider that 40% currently report that their medications are inadequate. In addition, he believes the concerns about misuse and diversion in the wider community are not unique to the use of cannabis and cannabinoids, as they also apply to opiates which have been the mainstay in pain treatment for decades. According to him, cannabis has significantly less potential for abuse than opiates and any concern could be mitigated to a large degree were the legislation to allow consultants to prescribe cannabis medicines for the treatment of chronic pain. Ms Vera Twomey was mentioned. She has said this, as has Professor Michael Barnes. I spoke to Ms Twomey in great detail in recent days. She will not mind me saying she is the person who has been denied medicinal cannabis. She believes we are taking too conservative an approach, which is why she has been denied access to it. She does not believe others who are suffering should be denied access to it in whatever approach we take.
On the legislative issue, my heart was sinking while the delegates discussed the time that would be required.
I do not understand this. We have a Bill before us, Second Stage of which was passed by the Dáil before Christmas, which acknowledges the need for much more research in this area, states we have to have a regulatory authority, states medicinal cannabis should be accessed through a doctor's prescription and attempts to deal with the removal of cannabis from schedule 1, which is an obstacle as has been alluded to. Why would it take six months, a year or even two years, rather than dealing with the legislation before us?
Mr. Eugene Lennon:
Originally we understood the Private Members' Bill would be dealt with by the committee in April and we were not prepared to go into it in any detail today. When it was discussed on Second Stage in the Dáil before Christmas the Minister stated he had some concerns about the Bill, particularly with regard to Part 12 and the removal of cannabis from the Misuse of Drugs Act. The Bill does not propose to move it from one schedule to another but to remove it from the Misuse of Drugs Act, which would have the effect of decriminalising cannabis for all purposes and not just medicinal purposes. It is also worth noting the Bill tends to circumvent the system for the regulation of medicines as it stands. We are not speaking about authorised medicines going through the normal regulatory system, which exists to ensure medicines are safe for public use, we are speaking about a separate system for cannabis products. The committee will deal with the Bill at a later date and we will go into it more detail section by section then. These are general points. We all know how long it takes to legislate at present. We began the injecting rooms Bill several weeks ago and it is still on Second Stage. The Private Members' Bill to which the Deputy referred went through very rapidly. I wish my injecting rooms Bill could go through as rapidly. Legislation takes time.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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We do the same on Committee Stage.
Mr. Eugene Lennon:
It will have to go to Committee Stage also but we are not yet through Second Stage. Legislation takes time. If we go for primary legislation, which will also have to have regulations, it may take up to 18 months. This is based on experience in drafting legislation, getting it through the Houses and then doing regulations. Even the Private Members' Bill proposed will require many regulations. It is not as if we can run through legislation that quickly. I am giving the Deputy a fair assessment of how long it would take if we were to legislate for the access programme outlined in the HPRA report and which the Minister has accepted.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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The authors of the Bill have made it clear from the outset that we understand the rescheduling of cannabis would have to happen. Any suggestion we simply want to decriminalise cannabis is not true. We have made it absolutely clear to the Department, and anybody with whom we have discussed it, that we did not feel qualified to make a decision about precisely how to reschedule it, but we have stated clearly the rescheduling should be debated on Committee Stage. I want to make this clear. The Bill states that doctors, and only doctors, should be able to prescribe it. I want this clarified.
Mr. Eugene Lennon:
The Deputy has made the point and the Bill probably goes further than removing cannabis from certain sections of legislation. The Bill also removes the offence of growing cannabis plants. The Bill raises more than a scheduling issue. It includes a number of issues outside Government policy and the Minister referred to these concerns. He did not oppose Second Stage but he stated he had concerns which he would deal with on Committee Stage. I presume we will deal with them in a more detailed way in April or whenever Committee Stage is taken.
Dr. John Devlin:
Questions were asked about who has overall responsibility for the clinical care provided and whether it is GPs or the Minister. With regard to the clinical autonomy issue, doctors are bound by the ethical guidelines of the Medical Council.
It is clear from the Medical Council guidelines that the doctor-patient relationship is absolutely sacrosanct whether it is in the context of general care or the appropriateness of any clinical treatments and so on. It would not be appropriate, therefore, for anybody to try to influence the decision-making process in this regard because it is between the doctor and the patient. The Medical Council is clear in respect of the guidance on prescribing and clinical autonomy with regard to those provisions.
There were questions about the current process of making a licence application. I am talking in generalities and not in terms of confidentiality. The advice of the Chief Medical Officer, which issued yesterday, is that consideration must be taken of any unintended consequence associated with the prescription of cannabis as a schedule one controlled drug for medical purposes and its use must be endorsed by a consultant who is familiar with the care of the individual on behalf of whom the licence application is being made.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Where is that set down?
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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By?
Dr. John Devlin:
The Chief Medical Officer. With regard to an application, it would mean the normal routine clinical information should be provided including, for example, an outline of treatment to date, the justification from the doctor as to why it is appropriate in the patient's circumstances to require a schedule one drug, the consultant supervision details, the details of the source of the cannabis-based product and how it will be administered and, more important, the arrangements for the ongoing monitoring and care of the patient once the treatment has commenced. Given the nature of their condition, these patients have underlying medical conditions and are possibly on other drugs and from a safety point of view and a drug interaction point of view, it is important that those interactions are measured and monitored.
I refer to what is intended going forward. We have the current licensing arrangement and we are talking about legislation. This week, we are establishing a medical cannabis reference group, which will provide answers to many of the operational questions that have been identified to date. The group will have an independent chairperson and it will take into account HPRA and other relevant evidence. Its membership will be broad-based with all the relevant medical specialties, including oncology, palliative care, neurology, psychiatry, anaesthesia, which includes pain management, general practice, pharmacy, the HPRA, patient representatives and ourselves. The focus of the group is to provide an operational framework as to how a scheme will work into the future. It needs to answer clear questions, for example, the clinical criteria for patient access for medicinal purposes, the forms of cannabis that can be used, the roles and responsibilities of doctors, nurses, pharmacists and other health care professionals who may be involved in the dispensing of cannabis for medical purposes, the requirements for a registry through which the scheme can be monitored and the mechanisms through which further scientific developments in the area can be monitored over time. This work has started and we anticipate that the first meeting of the group will take place in the coming weeks while we expect a report to be made available within four months. It will take that time to generate the answers to these fundamental operational issues that need to be addressed.
Dr. Elaine Breslin:
Deputy Durkan asked about the side effects. This is an important area because in many of the countries we have referred to where there are broader access programmes - the Netherlands, Czech Republic and Italy - cannabis is not considered a medicine and, therefore, its side effects are not collected in the same way we collect side effects for conventional medicines. Part of our role is to collect the side effects. That is quite different and, in many cases, the establishment of those broader programmes is outside the remit of the regulatory authorities such as ourselves; they are based in the Ministry of health.
The perception of cannabis is quite different. It is not seen as a medicine but as something else. Formal data are therefore not collected.
We have data on use in recreational circumstances. There are many pieces of literature about that. The safety in short-term use is quite well known. The side-effects associated with short-term use of cannabis include euphoria, hallucinations, anxiety, paranoia, psychosis, impaired short term memory and confusion, impaired motor co-ordination, altered judgement and increased risky behaviour. There are some gastro-intestinal side-effects such as diarrhoea. The effects of long-term use, either recreational or heavy use, are of interest. We are aware that there is addiction in 9% of cases. The addiction rate rises to approximately 17% if one begins to use cannabis in adolescence. If one uses it regularly or is a heavy user, the addiction rate rises to about 50%. There is an increased risk of chronic psychotic disorders such as schizophrenia, particularly in adolescence and in people who are at risk because of a strong family history of psychosis. We do not know that cannabis causes psychosis. The literature is not saying that, but it says clearly that cannabis is a preventable risk factor for psychosis. It is a particular risk for young people who have a family history of psychosis and who use cannabis that is associated with a higher level of tetrahydrocannabinol, THC, which is the psychotogenic component of cannabis.
Another risk associated with long term use is cognitive impairment. This is important if it is used in young people in adolescence. There is a potential for cannabis to affect neuro-development and cause neuro-developmental delay. We see cognitive impairment in older people, with lower intelligence quotient, IQ, among those who are frequent users during adolescence. I have referred to altered brain development. It is also associated with poor educational outcomes, increased likelihood of dropping out of schools, a diminished life satisfaction with achievement and what is referred to as the amotivational syndrome. It is also associated with increased risk of suicidal ideation and attempts and with the symptoms of chronic bronchitis. All of those side effects are really associated with recreational use. We do not have good data on the medical use of cannabis.
Dr. Lorraine Nolan:
To support comments made by Dr. Devlin in response to Senator Burke, an issue associated with this access programme will be the system of implementation and the supports put in place for implementation. The Department will be taking the lead on that role. Supporting the clinical community and patients will be important when setting up this access programme. That comes from many perspectives. Explaining the availability of products and how to report side effects as Dr. Breslin has outlined are important matters, even at that simple level. With regard to setting this up, we have come from a situation where we have had very restricted access and are working off a licensing provision. The support and education of both clinicians and patients will be important in moving forward with the access programme.
With regard to progressing the situation and medical thinking, I do not want to undermine what Dr. Devlin said, that the relationship between a patient and clinician is sacrosanct and should not be interfered with. That is where clinical expertise and judgement should come from. However, increasing knowledge and awareness of where scientific evidence is, what products are available and how this can be used in a treatment programme are important and will be vital for the implementation.
How would Dr. Nolan deal with a situation where every mechanism has been used for treatment of a patient and the only thing left is the use of a cannabis-based product, but the medical practitioner is not prepared to come on board? How does one deal with a person like that who has difficulty in identifying a medical practitioner to assist him or her?
Dr. Lorraine Nolan:
In that circumstance it is really important to try to understand what the doctor's reservations might actually be. It is his or her clinical judgment. What his or her clinical reasoning is in regard to a particular situation, and why he or she may not feel that this may be an appropriate form of treatment for the patient, is hugely important in that discussion. If I were the patient in that circumstance, that is something I would be keen to try to understand also.
Second opinions are part of medical oversight and they can happen. As an access programme is established, what may happen is where one consultant may not have experience, and I am not commenting on any particular case in saying this, he or she can refer to another consultant who may have more experience or has potentially treated another patient for advice. Those types of support may be available and could actually bring this along as well.
Michael Harty (Clare, Independent)
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Thank you, Dr. Nolan. Deputy Boyd Barrett felt that one of his questions had not been answered.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Two of my questions were not answered at all. Why has pain been left out? Can Dr. Nolan respond to the points made by Professor Finn that I read to her? I want to stress this, particularly after Dr. Breslin's intervention. Professor Finn said that the long list of adverse side effects of recreational cannabis use have very little to do with what we are discussing here, which is about medicinal use. Is it not the case, as alluded to by Professor Finn, that we have a whole range of authorised drugs at the moment where the adverse side effects - there is strong evidence of this - are as bad as, or in many cases much worse than, any evidence we have for adverse effects from medicinal cannabis?
OxyContin opiate, known as hillbilly heroin, is widely prescribed as an end-of-the-line painkiller. It is authorised and is highly addictive. Benzedrine and Prozac are highly addictive and there is much evidence of adverse effects. Their efficacy is questionable and it is certainly a debatable issue, but they are authorised. There is a much lower bar for how they can be prescribed and who can prescribe them. A general practitioner can prescribe those things, so why and on what basis have we decided that only a consultant can prescribe cannabis for medicinal use? A GP is a registered specialist so why can a GP not prescribe cannabis? None of these things is being explained.
A view is being put here but we are not hearing the counter view. We need to hear the counter view as expressed by Professor Finn, Professor Barnes and many other eminent people. No doubt people from the Netherlands, Italy and the Czech Republic would come in here and give a pretty different perspective on all this. That needs to be acknowledged in any debate. That is not to say who is right or wrong. People have their opinions but what we are getting here are opinions, not definitive positions. Nobody can claim to have the absolutely correct position because there are diverse opinions across the medical area and in how states deal with this by way of legislation or regulation. That needs to be acknowledged.
Perhaps Dr. Nolan could deal with the specific issue of pain, given the points that Professor Finn has made.
Dr. Lorraine Nolan:
I want to reassure Deputy Boyd Barrett that we had intended answering his questions; I just happened to answer Senator Burke's questions first. The Deputy asked why we would choose to align ourselves with those nine countries that have a restrictive access programme versus those three countries in Europe that have a wider access programme. We need to be clear that we have not aligned ourselves with any particular country or position taken by a European country with regard to this. What we have done is review the available scientific evidence on this issue. We have also reviewed the position in other countries but what we have ended up with, in terms of the proposals for the access programme, is based upon a review of the available science. However, it is also taking into account the Irish context, the Irish health care system and the view of those clinicians who are practising within the Irish health care system because whatever comes from this has to be implementable in the Irish context. That is an important point to make at the outset.
The position, and it is not a question of alignment, is that none of those three countries in Europe changed to a very wide access programme in one move. No country has moved from a position where it had very strong prohibition to a position where it has a wide programme of access in one change. Those three countries have all moved through this process of having a restricted form of access programme in which they can gather and generate information on their needs. They know their needs and requirements before they move to a wider access programme and they also know, coming back to the International Narcotics Control Board, INCB, issue I spoke of earlier, their consumption needs in that context, which is an important point in this regard.
The Deputy mentioned pain. I want to say at the outset that in the course of conducting our review we had a number of discussions with Professor David Finn. He has contacted us since the Irish Pain Society's statement has come out and we are in the process of discussing it with him.
With regard to pain, the Deputy is right. One in five or 800,000 people suffers from chronic pain, so we acknowledge the number of people who are impacted by pain. In that context, we can understand that people suffering from pain are looking for alternative approaches to treatment. However, when we reviewed the data on that, and the Deputy mentioned the Barnes review, including the Corcoran review, the national academy's report and those of the Journal of the American Medical Association and others, we saw that they all look at pain. Twenty-eight pain studies have been conducted in this area and when we look at those pain studies we see that pain is a symptom associated with many conditions. It is not ring-fenced in the way epilepsy or spasticity associated with multiple sclerosis can be. It is an outcome of very many diseases and conditions. Those studies are looking at pain across a variety of contexts. They are also looking at a wide range of products including some of the medicines that are authorised that we spoke about such as Nabilone and Dronabinol. The nabiximols, which would be Satifex, would be one of those also. They are also looking at cannabis, which is smoked and inhaled. We are looking at no standardisation in terms of the type and the form of the product used or investigated in those pain trials and no standardisation of the conditions. It is incredibly difficult, therefore, to draw objective evidence from that.
Coming back to objective evidence, the outcomes for patients in those trials is very different when we look at the detail, depending on whether it is the doctor who is reporting on those outcomes versus the patient. That is because pain is subjective. If I experience pain I may say mine is ten on a scale of one to ten whereas the Deputy's might be five. That is very much down to the individual. That is the problem in looking at all of those pain studies. All of the reviews we have looked at clearly cite the need for more research in pain.
The Deputy mentioned the context of other alternatives in addition to opiates. He is saying that, potentially, opiates may offer-----
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Professor Finn is saying that.
Dr. Lorraine Nolan:
Professor Finn is saying they may offer a less addictive alternative than cannabis. Nobody is denying the fact that opiates can be addictive medicines but the big difference in terms of opiates is that they are authorised medicines.
The Deputy mentioned products like OxyContin. That is a fully authorised medicine and the major difference in that is that we know OxyContin works; it treats pain. We also know it has side effects and negative impacts on one's health but we know the doses that should be given to patients.
We know how that should be monitored, how patients should be escalated and how it may interact with other medications they are on. If a patient adheres to a correct medically supervised regime in taking these medicines, they are very good forms of treatment. That is the first thing I have to say.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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On the points Dr. Nolan is making, Professor David Finn makes exactly the same points about what we do know. I take the point that we do not have all of the evidence. He said, in response to the exact point Dr. Nolan is making, the cases of pain could be diverse, but we know that peripheral and central sensitisation are the neurobiological mechanisms underlying most types of chronic pain and that these mechanisms are reduced by cannabinoids. Does Dr. Nolan disagree?
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Does Dr. Nolan disagree with what Professor David Finn said?
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Should they not be included in the trial and not excluded, as proposed?
Dr. Lorraine Nolan:
In terms of their inclusion within the trials, one has to remember that what we are saying is that there should be an access programme that provides access to small groups of patients. The problem is the risks have not been appropriately qualified. If one wants to have a system under which one potentially expose 800,000 people to risks, that is a huge jump in moving forward. What we are saying is that in order to ensure the correct levels of patient protection it is more important to look at the issue in a different way. We are certainly not closing the door on use for pain relief. We are simply saying the evidence is currently not strong enough to move forward because their use cannot be ring-fenced in the way that it can be for other patients.
I would like to come back to the point Dr. Elaine Breslin made about end points, namely, that for all of the conditions chosen under the access programme there are measurable end points that can be determined. A doctor can look at how a patient's spasticity is responding to the treatment and make a decision on whether the treatment is working and if it is not, it is not acceptable or appropriate to expose him or her to an unqualified risk. It is the same issue in the treatment of nausea associated with chemotherapy. It is obvious whether the use of cannabis is working in the treatment. Similarly, in the treatment of epilepsy. There are measurable end points, but there are no end points in the treatment of pain which fundamentally is one of the problems.
The point on opiates to which I would like to come back concerns the idea of whether they provide a less addictive alternative. I am not saying it does not have validity, but it simply has not been studied. Nobody has looked at the effects in switching patients from opiates to cannabis and determined whether it is less addictive. Nobody knows what dose of cannabis one could try for a patient. The evidence is simply not available. It needs to be studied and the evidence brought forward. The access programme can give a lot more information and confidence in how the system could be worked. Nobody is saying clinical research should not be encouraged alongside it. In this country, much of it due to Professor David Finn's efforts, a huge range of preclinical research has been conducted. We really need to harness, work with and back it from a policy perspective and carry out more properly conducted trials on pain subjects. Including within the programme pain patients will not generate data in the way needed to bring them forward because it is not a formal clinical trial programme. That is an important distinction in this respect.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Professor David Finn does not agree.
Dr. John Devlin:
As I mentioned, what we are trying to do in this group is bring the clinical community with us.
We have national standards for clinical development, under the ages of the national clinical effectiveness committee. This work has been prioritised for the next four months and clinicians will be put through it. There are various standards. What will come out at the far end will be standards which, we hope, will be robust and understood and worked by clinical professionals. Part of the remit of the group is education and general awareness. These are new developments and there may be differences across the medical profession regarding the value of certain new agents, therapies and so on. It is very important that the clinical community buy into them. The way that can be done is by engaging with professional bodies to make sure they are part of the processes. When the report is done and dusted, there will be a job of work to be done in education at undergraduate and postgraduate level to ensure the guidance developed is workable and will be implemented.
Michael Harty (Clare, Independent)
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I wish to ask the delegates a number of questions to seek clarification. If primary legislation is required, it will take up to 18 months to complete. If secondary legislation is introduced, it will take six months. People can only access medicinal cannabis products via the licensing process. Is there sufficient confidence, based on the report, that the Minister can issue licences provided he or she has received an application from a specific consultant?
On applications for licences, does each individual patient or each interaction between a patient and a consultant require a licence? Can a consultant receive a licence to be used at his or her discretion for a number of patients?
I refer to the authorised cannabis products available. The document refers to Nabiximols which is Sativex, Nabilone and Dronabinol. Some or all of these products contain a certain amount of THC. Does the concentration of THC in medicinal cannabis products limit their availability in terms of licensing, as the Minister would have power to do under existing legislation?
I ask the delegates to keep these questions in mind.
Bernard Durkan (Kildare North, Fine Gael)
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I refer to a question around which the Chairman skirted. Were the manufacturers of cannabis-based drugs consulted?
I ask the delegates to give us some idea of their views on the side effects. To what extent would they expect there to be side effects from the use of the drugs, given their knowledge of cannabis as a component of drugs?
What would the consequences be of the Minister making a decision because of a motion or demands based on the serious issue of chronic pain to which others have referred? I agree entirely with the levels of pain being determined by the individual rather than in some general application of rules. One person could be in very severe pain but at a level which another person because of their pain threshold would be able to control within reason. As a person who suffers from back problems from time to time, I can tell the committee all about it. If the Minister makes a decision because of pressure to make some changes against the advice of clinicians, what will the consequences be?
I refer to the hallucinatory effects of a number of drugs and seek further elucidation on the level of pain balanced against the negative side effects.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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The delegates were asked about side effects.
The only studies available relate to recreational use. It is unfair to try to bring them into this debate because we are talking about two completely different scenarios. For example, Deputy Boyd Barrett referred to some prescribed medicines, for example, Prozac. If a person was to take the drug in an unsupervised setting the side effects could be considerably more harmful than if it were prescribed while being monitored by a doctor. We cannot compare like with like in that regard and I do not believe we should be muddying the waters on the issue. Anyone who has ever seen someone who is addicted to Prozac will know that it is completely different from someone who is taking Prozac for a short period.
We have now established that we are looking at a minimum of six months for legislation with the possibility of 18 months. The only option available at the moment is the licensing arrangement. The Chairman has asked for clarification and it is important we get it. I understand a doctor can prescribe it but a consultant has to endorse the application and the consultant is also responsible for the monitoring of the cannabis. However, the consultant need not prescribe it himself or herself; a doctor can prescribe it. Can the witnesses clarify this point?
The Chairman made another point relating to a consultant. If a consultant gets a licence, is it universal to other individuals or must it apply on a case-by-case basis?
My final point relates to costs. If we are considering whether to bring forward legislation for people to access cannabis-based medicines, then obviously a cost arises. In the normal way of things, drugs are reimbursed through public health schemes provided it is an authorised medicine. That is my understanding. In this case, we have cannabis for medicinal purposes. While a trial period is under way, it is not going to be recognised as a medicine. Does this have implications for reimbursement costs? Have we examined that? If we are looking to provide a scheme for the coming five years, then will some reimbursement programme be put in place? Is that even possible without it being classified as a medicine?
Michael Harty (Clare, Independent)
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Thank you, Deputy O'Brien. Deputy O'Connell is next and then Deputy Boyd Barrett. Please keep your interventions brief, if you can.
Kate O'Connell (Dublin Bay South, Fine Gael)
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I am sorry I had to leave earlier. I apologise if I am repeating points that have been dealt with in my absence.
I wish to clarify the answer given by Dr. Nolan before I left. Dr. Nolan said that the patient who claims to require this medication must be under the supervision of a consultant but that, in theory, the prescription could be written by a registered medical practitioner. This applies only under three specified conditions, namely, resistant epilepsy, nausea to do with cancer treatment and multiple sclerosis.
One requirement to access the programme is that those involved have exhausted or used all other forms of medication. Perhaps the pharmacist, Ms Maria Egan or whoever is most suitable could outline the answer. There are examples of interactions that arise between medications and common foods, such as the interaction of certain medications with grapefruit. Often people do not identify the interaction between warfarin and spinach. Interactions with medicines are not simple. Obviously, there are the effects of medicines on other medicines but other issues can emerge through the use of certain medicines. This is not straightforward. If something has not been trialled correctly and is mixed in with other mediations or foods, then the data are not available. People can actually die from the use of some over-the-counter products with warfarin. I say as much simply as an example to show that it is not as clear-cut as ticking a box.
As I was leaving, it was stated that the European Medicines Agency has no position on this and does not endorse CBD as the evidence is not suitable. Is that correct? Have I understood that correctly?
As a pharmacist and on Deputy O'Brien's point on side effects of Prozac, having a prescription does not change the side effect profile of something. It does not really matter if one is taking Prozac or anything else with a prescription; the side effects will be the same. It just means that someone is responsible and the person is part of a care pathway.
On reimbursement costs, many unlicensed medicines are reimbursed. They get special reimbursement. My concern is that Holland, whose pharmacy system I am quite familiar with, has specific pharmaceutical grade product with specific concentrations that are used. Perhaps I am not understanding it, but will the witnesses elaborate on what exactly we are saying is okay in these three conditions? Is it an arbitrary concentration of a product or an arbitrary derivative? Are we looking at a specific breed of plant, extract or concentration? What do we have when it comes to dosage and indication? I know the evidence is poor, but have we any dosing parameters to work with?
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I thank the witnesses for the lengthy briefing. I hope there is agreement on it but, as we are concluding, it would be helpful to clarify or acknowledge that the job of the HPRA is, as I understand it, to work within certain EU directives and frameworks to approve a drug to be used an dispensed. As I understand it, it is not about deciding the efficacy of a particular product for a particular patient. I think that is an important distinction and perhaps those from the HPRA or others might want to confirm it. Notwithstanding the clear differences of opinion, I also hope it is acknowledged that other choices have been made and that other opinions exist. These include those of medical professionals as well as regulatory authorities and Legislatures in other States. There is no particular reason to believe that whatever recommendations or opinions are adopted here are superior to the opinions or decisions that have been made by other States. This is, in fact, a matter to be debated. I hope the witnesses agree, and ask them to agree, that to be the case.
The distinction between the role of a consultant and that of a GP has not been explained to my satisfaction. When we asked political questions to the Minister in November, we were told it would be a registered doctor but now we are being told it will be a consultant. However, the paediatric neurologists are telling Vera that they do not enough about this stuff and are suggesting visiting Canada to find out from people who do know. The idea that a consultant knows more than a GP has not been explained to my satisfaction. Why is that distinction being made?
The witnesses seem to be saying that we need more data and information on the relationship between cannabinoids and pain, yet they are recommending that we do not include them in a trial where we could gather that data.
It is a fundamental contradiction that, on the one hand, we need more information, data and evidence and, on the other, we choose not to gather this evidence by allowing people who suffer from pain into the trial. Perhaps one of the witnesses will explain that contradiction.
Mr. Eugene Lennon:
I will comment on licensing and whether it would be possible to cover more than one patient. In our view, the patients to which the licence refers would have to be named if there were more than one patient. The reason is that possession of a schedule one drug is illegal for an individual. The licences we have dealt with thus far have been for an applicant to prescribe, possess, administer, etc., and it names the patient for whom the cannabis based treatment will be prescribed. This provides protection for the patient because there are normally legal consequences for those who are found to be in possession of cannabis. We need to name the individual patient or patients to whom the licence refers.
Michael Harty (Clare, Independent)
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In that scenario, the license would only refer to products containing THC.
Michael Harty (Clare, Independent)
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No such requirement is in place for products containing CBD.
Mr. Eugene Lennon:
A licence is not required if the product contains CBD only. If the product contains CBD but does not contain THC, it is not a controlled drug and the licence issue does not arise. People are accessing CBD, perhaps as a food supplement, and certain CBD only products are undergoing clinical trial and may become authorised products in the not too distant future.
Michael Harty (Clare, Independent)
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Is there an acceptable level of THC?
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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That would no longer apply if the legislation was changed.
Michael Harty (Clare, Independent)
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With regard to products that are or could be authorised, what level of THC is acceptable in cases where a licence is obtained?
Mr. Eugene Lennon:
A licence is not necessary for an authorised product, for example, Sativex or Nabilone. My colleagues probably know what level of THC is in these products but I do not know off hand. A licence is not required for such products because they are authorised medicines. Both Sativex and Nabilone are schedule one rather than schedule two products because they are authorised products.
Michael Harty (Clare, Independent)
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If a patient travels abroad and is stabilised on a cannabis based product before returning to this country, is a distinction made between initiating a treatment in Ireland as opposed to maintaining somebody who is already on a medication?
Mr. Eugene Lennon:
That would be a matter for the medical specialist involved in the case. It is a question of whether the specialist recommends that the treatment be continued. That is the position we are in today. One possible scenario is that a person who has been on a treatment in another country for some time returns home. In such circumstances, the person will have to discuss the matter with his or her medical practitioner in Ireland because it is not possible to personally import cannabis or cannabis based products to this country. Currently, a licence can only be granted to a medical practitioner, which means the person must be under a practitioner's care. The view of the Chief Medical Officer and Minister is that this care must be endorsed by a consultant. It would, therefore, be a matter for the consultant to decide whether it was appropriate to continue with the cannabis based treatment the patient had been receiving in another country.
Michael Harty (Clare, Independent)
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Would the same licensing application process apply?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I wish to have an issue cleared up because Vera Twomey will be at Leinster House in 20 minutes. It is still not clear how someone can obtain a licence for cannabis based medicines that include THC.
Is it a doctor can prescribe it but a consultant has to sign off on it? Does a consultant has to oversee the administration of it? Can we just be very, very clear exactly what criteria have to be established in order to access that licence because-----
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Do we need legislative change?
Jonathan O'Brien (Cork North Central, Sinn Fein)
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There are so many different scenarios being put out. People have letters from a consultant in support of the application but not necessarily willing to monitor it. Exactly what are the criteria?
Mr. Eugene Lennon:
The key thing is not so much who prescribes it, it is whether the consultant is endorsing the treatment. A consultant who is responsible for the management of the patient and is prepared to monitor the effects of the treatment has to be involved in this scenario and has to be endorsing the proposed course of treatment. The consultant can apply themselves or somebody else can apply, but the consultant has to be-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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A doctor can apply for the licence-----
Jonathan O'Brien (Cork North Central, Sinn Fein)
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-----provided they have the supporting documentation from a consultant?
Mr. Eugene Lennon:
Yes. However, the licence is unlikely to get through unless there is clear endorsement from the consultant and the consultant is prepared to oversee the treatment and ongoing monitoring of the patient. If that is not the case, the application is unlikely to be successful at the moment. Sometimes there is a period of discussion between the applicant and the Department where more information is sought and sometimes more documentation is produced. Sometimes an application can come in at the start without much substance, but it builds up over time until it can cross the necessary hurdle. To return to the earlier point, we are not talking about an authorised medicinal product, we are talking about an exception. We are talking about a Schedule 1 controlled drug. We are talking about patients that can be quite ill and on a lot of other medications. If their lead consultant is not endorsing the course of treatment there is a difficulty in bringing another substance, which is not an authorised medicine, into the equation.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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Without discussing any specific case, in a situation where a patient wishes to access medicinal cannabis and their consultant is not of the same opinion, Mr. Lennon says that the patient can get a second opinion. However, for a consultant to be familiar with that patient's condition is a long process in itself. One cannot just change consultant. One can change GP, but to change consultant is a completely different proposal. If a person's consultant is not willing to endorse the application and is not willing to monitor it, it is not as easy as just changing a GP.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Especially if those consultants are saying they do not know enough about it.
Mr. Eugene Lennon:
I might get my colleague, Dr. Devlin, to speak in a moment. I accept it is not easy to get a second opinion, but it does happen. In the scenario where a patient does get a second opinion and one or other consultant does not want to endorse a particular form of treatment, there is no role for the Minister or officials to tell the consultant they should prescribe a particular form of treatment which in their judgment they do not believe is correct.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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The licence is not granted.
Michael Harty (Clare, Independent)
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It will probably make up part of his answer, but before Dr. Devlin comes in I would like to ask if there is sufficient confidence in this report, or could consultants obtain sufficient confidence in this report to prescribe medicinal cannabis? If they cannot, and the consultant felt they were opening themselves to litigation by prescribing a product, could the Department indemnify a consultant from any adverse effects resulting from their prescribing this product?
I presume that one of the difficulties that consultants have is that they are being asked to prescribe a product which has not got authorisation. There seems to be an unmet need to make this product available to some patients. Could the State indemnify doctors against adverse outcomes by recommending or prescribing these medications?
Mr. Eugene Lennon:
I will comment briefly before Dr. Devlin responds. One can probably say from the Health Products Regulatory Authority, HPRA, report and the Minister's acceptance of that report, there is a clear political direction - the Government has decided this is the way it is going and has set out the three conditions under which the access programme will be available. If one is a consultant working in those areas, one will know the Government has made a policy decision in that direction.
The issue of liability has not been raised directly with us. Consultants who work in the public system are in the clinical indemnity scheme and sometimes they prescribe products that are not authorised, but their employers are aware of the treatment that is proposed and have approved it. Consultants cannot decide to prescribe, but if the authorities are aware that one is trying a product, for which one has a licence from the Minister, that is a different scenario.
Those issues can be explored further. I am not sure that is the absolute barrier in the case of a consultant working in a public hospital. My belief is that in some cases, the fact that they are not dealing with an authorised medicine, the evidence may not be sufficient for some consultants at this stage to use such a medicine. Possibly the Health Products Regulatory Authority, HPRA, report and the work of the group that Dr. Devlin has referred to may provide further confidence in these medicines.
Dr. Devlin may elaborate further.
Dr. John Devlin:
If a doctor or a consultant is unable to provide a treatment for whatever reason, the Medical Council is very clear that the doctor must co-operate with whoever provides it, to include transfer of notes. That depends on the interaction between the patient and the doctor. The doctor is then obliged to go along with that. The possibility is there for a second opinion.
The other issue that has been raised is the role of doctors and consultants, as two separate entities. Of course it is not like that in practice. Whether it is this or any other aspect of clinical care, most care is provided on a shared care basis, so the doctor is working together with the GPs. Shared care means that the roles and responsibilities for consultants and GPs are clearly identified so the GP knows what he or she is doing and the consultant knows what he or she is doing. The difference between consultants who work in acute hospitals and general practice is just in respect of their training programmes. Consultants have great expertise and training in specific disease clinical areas and have developed a competence and expertise which may give them greater knowledge in relation to particular issues, whether it be neurosurgery, and so on. General practitioners on the other hand are generalists. When it comes to dealing with complex drug interactions, it is quite relevant and clinically appropriate that one would have the advice of the consultant available who would have an understanding of the condition, which may be a rare condition, which the GP may or may not have and be able to manage that. In other words that is a clinically appropriate way of dealing with a very complex case. Certain patients may often be on multiple medications. The consultant, by virtue of the training and expertise has a good understanding of those interactions, hence it is reasonably appropriate that there is consultant supervision in terms of what is now essentially a new treatment being proffered.
There needs to be an education on this and that is part of the work of this group. When the procedures, operating clinical protocols and everything else are put in place these are communicated to the relevant specialties including general practice and will be part of the training on an ongoing basis.
Michael Harty (Clare, Independent)
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I thank Dr. Devlin. Deputy O'Connell wants to come back in.
Kate O'Connell (Dublin Bay South, Fine Gael)
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I think it was the Chairman who questioned whether the State is to indemnify consultants. I am concerned at the direction we are taking on this issue.
Consultants have a level of competence and experience that has been developed over many years in a particular area, which is exactly what Dr. Devlin has said. Where are we going if we circumvent the clear advice and research of the Health Products Regulatory Authority? The HPRA is not a mean organisation that wants to stop people getting medication, rather it safeguards the health of the nation regarding medicines.
When thalidomide was first launched a good few years ago, it was deemed a wonder drug that would relieve morning sickness. As it turned out, the trial data for the medication did not exist but I will not bore the committee with the details. Anybody who suffers hyperemesis will happily take whatever one is handed. Let us say the trial data did not exist but we had a person or two in Ireland who suffered severe hyperemesis as a result of pregnancy. Theoretically, we could have a case where somebody who is suffering from severe morning sickness could approach the Minister and say, "I want this drug prescribed". If we go ahead with the proposal for the State to indemnify consultants and children are born without limbs, the onus will be on the State.
As the committee will know, I am familiar with the framework which was not developed to be mean to people or to avoid giving people things. It exists to safeguard the health of the people of this country. To my mind, it is a very robust system. I have never had a difficulty with it. As a pharmacist, I am quite uncomfortable with the three conditions that have been recommended. I am fine with the framework and can see where it comes from, but what about the sanctity of the doctor's position, be it a GP or a consultant?
It is a bad state of affairs when the State starts telling medical professionals what they should do and that it will provide insurance if a person's arm falls off or whatever. What are we at here? We have good systems in place, yet we are trying to get around them. What happens if a child or an adult suffers from an overdose of CBD or whatever product he or she is taking in the next few weeks? We must be conscious that such a scenario could happen. His or her blood would be on our hands to some extent.
We must be careful. I support the initiative once a process has been gone through. I am not a party pooper. I want everyone to get what they can get if it is right for them to get it and it will improve their lives, but let us not rip up the rule book. Medication can cause terrible unintended consequences. We could spend all night talking about this matter. The witnesses know, some committee members know and I know that terrible side effects have been caused by medications that were never anticipated. That is why we have robust trials and assessment of medicines. Everyone thought thalidomide was great until the second isomer emerged. The committee must be conscious of what can happen if we ride roughshod over everything.
Jonathan O'Brien (Cork North Central, Sinn Fein)
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I asked about cost.
Mr. Eugene Lennon:
We must consider cost. Part of the work of the expert group will be to assess how many patients might avail of the treatment. It is hard to get a handle on the cost. Products are available in certain countries and it is a little difficult to find out the exact cost for a particular condition. We have not made a decision about cost or reimbursement.
As has been said, normally a company comes along with an authorised medicine and it applies for its product to be reimbursed. That is generally how things work. In this situation, it is a little difficult. Companies approach us asking for their product to be reimbursed but we do not have information on how much they normally charge for their product in differing markets. Whatever products are used we want to have ones that are standard quality controlled products. Therefore, we will have to go to legitimate producers that operate in other markets under some sort of authority.
We will have to revert to the Deputy on the reimbursement question at a later date.
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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I have a one-line question. Mr. Lennon stated that this was ultimately a policy decision. Can he-----
Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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Stating that was important.
Michael Harty (Clare, Independent)
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I will ask one more question before we wind up. What criteria will be used to approve products? How will the HPRA go about approving products that will be used in the access programme? A product that suits one illness might not suit another in terms of the combination of CBD and THC. How will the HPRA adjudicate on this matter?
Dr. Lorraine Nolan:
This possibly overlaps with Deputy O'Connell's question on what products are under discussion. From our review, we know that a number of products could be supplied using this route. Some are effectively cannabis flowering tip itself, where the cannabis plant is grown in carefully controlled conditions that comply with the European good manufacturing practice, GMP, requirements. While a product would not necessarily meet the full standard requirement for authorisation of a medicine, we have a reassurance of the quality of the product. This relates to the content of the cannabinoids in it, namely, the CBD and THC content. Knowing the products' content will provide a basis for working out a dosing regime. This might answer the Deputies' questions.
There is also the potential for a number of processed oils that are extracted from the plant and contain cannabinoids to be sourced. Some of the companies that manufacture these products are interested in considering these and putting them through clinical trial programmes so that they may become authorised as medicines.
Regarding Deputy Boyd Barrett's question on opinions on this matter, we are a medicines regulatory authority. Our job is to ensure that the medicines that are available in our market are safe, appropriate and work for patients. Our fundamental reason for being is the protection of public health. It is difficult to have any discussion on cannabis for medicinal use without the question of it being a medicine on the table. This is about the best outcome for a patient. The medicines system and framework exist in Europe in order to protect public health. For example, Deputy O'Connell mentioned the thalidomide disaster. Everything we do is founded on that principle. Were I, as chief executive of our authority, asked to put any other substance on the market for access to a wide group of patients when I could not say whether it worked or was fully safe, committee members would ask me why I did that and why I was negligent.
Other countries that have examined this topic outside of a medicines programme ended up with two parallel systems and ran into difficulties. That has been the experience in Australia and Canada, where policy has seen an access programme set up but clinicians do not know whether the substance works and clinical societies have advised that, from a clinical perspective, it is not safe and they do not know whether it treats anything. That is confusing for patients and is not helpful to the argument.
Michael Harty (Clare, Independent)
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On behalf of the committee, I thank Dr. Breslin, Dr. Nolan, Mr. Lennon, Ms Egan, Dr. Devlin and Dr. Glynn for attending. I also thank those committee members who attended at short notice. As there is no other business, we will adjourn until tomorrow at 1.30 p.m.