Michael Harty (Clare, Independent) | Oireachtas source

I move:

That Dáil Éireann accepts the recommendation of the Joint Committee on Health in its Report entitled 'Report on Scrutiny of the Cannabis for Medicinal Use Regulation Bill 2016 [PMB]', copies of which were laid before Dáil Éireann on 12th July 2017, that the Bill should not proceed to Committee Stage for the reasons set out in the Report, and orders accordingly.

I should say at the outset that the Joint Committee on Health has been interested in the medicinal benefits of cannabinoids since November 2016. It set the issue as a priority and devoted a meeting to examining these benefits on 24 November 2016. At this meeting the committee heard evidence from the Health Products Regulatory Authority, a specialist neurologist with an interest in epilepsy and the mother of a young girl who suffers from intractable epilepsy. The Joint Committee on Health is very supportive of making medicinal cannabinoids available to patients who do not respond to conventional medication. On 19 January 2017 the committee produced a report on medicinal cannabinoids. In that report the committee noted that, despite the encouraging medicinal possibilities offered by cannabis and cannabinoids, there is still a shortage of peer-reviewed evidence for the efficacy and safety of cannabinoid treatment for many conditions and that potential benefits had to be balanced against risks. The report stated that we should therefore pursue a careful yet committed course of action in engaging with medicinal cannabinoids.

Also in November 2016, the Minister for Health tasked the HPRA with producing a report on the subject of cannabinoids and their medicinal efficacy. That HPRA report, Cannabis for Medicinal Use - A Scientific Review, was completed on 31 January 2017 and published by the Minister for Health on 12 February. The health committee held a meeting to discuss the report on 7 March. Thus, it has demonstrated a commitment to making available regulated, safe, efficacious cannabis-based products for patients through prescription for conditions that have a proven response and in respect of which the products are well tolerated.

The Cannabis for Medicinal Use Regulation Bill 2016 was debated in the Dáil on Second Stage on 1 December 2016, after which it was referred to the health committee without a vote. The committee decided to conduct a detailed scrutiny of the Bill before it proceeded to Committee Stage. In that regard, it met on 5 April 2017 when it heard evidence from the Bill's sponsor, Deputy Gino Kenny, who was accompanied by a consultant psychiatrist and a professor of pharmacology.

The committee held a second meeting on 13 April when it heard evidence from officials of the Department of Health, together with officeholders from the Pharmaceutical Society of Ireland, on their respective views on the content of the Bill. Thus, the committee has held four meetings on this issue in the past year.

Based on its consideration, the committee has determined that the Bill has technical issues and implementation difficulties, that it may have unintended policy consequences, including leakage of supply of cannabis to recreational markets and a lack of safeguards against harmful use of cannabis by patients. It also determined that there were major legal issues, given that the numerous amendments that would be necessary to reconcile the Bill with existing law would be onerous, and that access to medicinal cannabis in Ireland would be better achieved through an access programme and secondary legislation, which the committee has been informed is under preparation. Therefore, it recommended that the Cannabis for Medicinal Use Regulation Bill 2016 not proceed to Committee Stage.

The purpose of the Bill is to make cannabis available as a medicinal product for individuals who receive certification from a registered doctor. To that end, it proposes the foundation of a cannabis regulatory authority that would regulate the sale of medicinal cannabis and oversee a system allowing pharmacies to receive licences to sell medicinal cannabis.

While the committee appreciates Deputy Gino Kenny's statement that his aim in sponsoring the Bill is to alleviate unnecessary suffering, aspects of the Bill cause it to be concerned that it may not be possible to reconcile the Bill with its above-mentioned careful approach to medicinal cannabis. The committee is concerned that the Bill proposes the removal of cannabis from the Misuse of Drugs Act 1977 as a controlled substance, meaning that it could have major unintended policy consequences, decriminalising cannabis in non-medicinal circumstances. This seems to conflict with the intention of the Bill which is to make cannabis available specifically for medicinal use, as expressed in the Title. It is the view of the committee that the decriminalisation of cannabis is not a safe course of action as the cannabis plant has many psychoactive effects that are potentially harmful. The Bill is as much about decriminalising the use of cannabis as it is about promoting it for medicinal use. The Minister for Justice and Equality is the relevant Minister quoted in the Bill, indicating that decriminalisation is the Bill’s main focus.

The committee is also concerned that the Bill's proposal to establish a cannabis regulatory authority to regulate cannabis would establish a parallel system of regulation, duplicating the functions of the HPRA, and allow a substance that has not received authorisation from the HPRA to be considered a medicine. This would be an unusual departure which would subvert the agency’s regulatory authority and ignore its expert advice that herbal cannabis is not capable of being authorised as a medicine and could create an undesirable precedent.

Advocates of the Bill state the HPRA is not willing to regulate cannabis. It is not possible, however, to regulate the whole-plant extract of the cannabis plant which has over 100 varieties and several hundred components. Authorised medicines must be of high quality, safe and effective. Furthermore, the system of access to medicinal cannabis proposed in the Bill appears to the committee to be too loose to guard effectively against leakage of supply to recreational users, could lead to overuse by patients and could have unanticipated harmful effects owing to side effects and interactions with other medicines.

The Bill would allow a doctor to certify a person as having a condition that could be reasonably treated by cannabis without having to stipulate a dosage or a finite period for treatment. There is no provision in the Bill for stipulating the type of cannabinoid product a patient should be treated with. There is no reference in the Bill to the medical indications for cannabis certification by a doctor. A lack of specific indications for a product that has no authorisation from the HPRA would raise many legal and medical indemnity issues.

A certificate is fundamentally different from a prescription. Evidence was given to the committee by the Bill's sponsor that a doctor's certification was to be used as evidence to protect the holder of the certificate from prosecution and unnecessary criminalisation if found in possession of cannabis. Doctors could be pressurised to provide certificates for reasons other than medicinal purposes. Evidence was given to the committee that regulation of medicinal cannabis was key to its availability, yet the Bill does not define what the term "medicinal cannabis" means. Therefore, it would be very difficult to regulate an ill-defined product.

Embedded in the cannabis plant are cannabinoids which act on the endocannabinoidal system in the human body and have medicinal properties. Whole-plant extract, however, also contains many other chemicals that are psychoactive and potentially harmful. The isolation of cannabinoids which have proven medicinal beneficial effects and scientifically proven efficacy and safety is the key to developing medicinal cannabis products that can be legally prescribed and dispensed.

Although the Bill limits the maximum amount of cannabis to be sold per transaction as one ounce, the committee cannot identify any provision which limits the number of transactions. The committee cannot identify any provision in the Bill for medical follow-up or supervision beyond initial certification, to monitor potential negative side effects or interactions with other medications. It is, therefore, worried that any individual who receives certification from a doctor would then be able to buy as much cannabis as he or she wanted indefinitely, without continued medical supervision.

Normally medication is prescribed with reference to strength in milligrams and instructions are given on frequency and length of use. Such stipulations are not mentioned in the Bill.

The sponsor of the Bill proposes that whole or full plant extract be made available in whatever form, including smoking cannabis, when used for medicinal purposes. The method of consumption would the patient's prerogative. That is entirely unacceptable to the committee. Smoking cannabis is not recommended as an acceptable method of use for medicinal purposes.

The committee also wishes to draw attention to the use of the word "consumer" rather than "patient" in the Bill to describe medicinal users of cannabis. The Bill's use of imperial measurements which implies selling cannabis by weight rather than strength in milligrams which is the convention in medical prescriptions is unacceptable. Also, the Bill suggests the proposed cannabis research institute commission research on cannabis for recreational use, as well as medicinal use. Additionally, the institute would promote public awareness of cannabis as to its safe use. This element of the Bill seems contrary to its purpose.

Although the committee has outlined a number of discrete problems in the drafting of the Bill, some of which may be more easily fixed through amendments than others, the underlying approach of the Bill proposes a system of access to medicinal cannabis that would be much looser than the committee considers prudent. Therefore, a central element of the Bill is irreconcilable with the committee's views on how medicinal cannabis should be approached. The committee favours a gradual introduction of medicinal cannabis that is evidence-led for each condition for which access is approved, as endorsed by the usual regulatory authority for medicines in this jurisdiction and which has the benefit of close monitoring by medical professionals of the effects of treatment. The committee has been informed that such an approach is being pursued by the Minister for Health and his officials. Departmental officials told the committee members in their engagement with them on 13 April that an expert reference group had been established and that it was drafting guidelines to facilitate the use of cannabis treatments under an access programme. That work is being informed by the HPRA.

The committee understands the Department will progress statutory instruments to advance the access programme. The committee views such an access programme as a more careful and desirable method of introducing medicinal cannabis to Ireland and, therefore, views the continued advancement of the Bill under scrutiny as duplicative and undermining of the access programme proposed.

Having received legal advice, the committee is satisfied that enacting the Bill as it stands would create legislative contradictions between the Bill and existing Acts. Resolving such contradictions by amendment of this Bill or of other Acts appears to the committee to be an onerous undertaking, quite apart from the further redrafting which would be necessary to avoid undesirable policy consequences.

The committee understands that sections 42 and 43 of the Bill, as drafted, would legalise cannabis entirely, as the 1977 Act would cease to apply to cannabis. That seems to conflict with the intention of the Bill, which is to make cannabis available specifically in medicinal circumstances. If those sections were to proceed without significant amendment, they may also necessitate amendment of the Criminal Justice (Spent Convictions and Certain Disclosures) Act 2016, as well as having complicated implications for extradition law.

The Bill may necessitate amendment to the Health Acts 1947 to 2015, the Pharmacopoeia Acts 1931 and 1977, the Poisons Acts 1961 and 1977 and the Pharmacy Acts 1875 to 1977, and other legislation, affected by the medicinal prescription of cannabis. Differing definitions of cannabis between the Bill and the Misuse of Drugs Act 1977 creates a possibility that the differing interpretations could be exploited in the criminal justice context. The enactment of the Bill would possibly give rise to the need to amend the Criminal Justice (Psychoactive Substances) Act 2010 and Misuse of Drugs Act 1984.

The Bill's creation of offences without prescribing corresponding penalties conflicts with the 1977 Act which provides both offences and penalties. Sections 16, 18 and 19 of the Bill, respectively, provide for licences to wholesale, import, and cultivate cannabis. The committee understands that those would require the amendment of sections 3, 15, 15A, 15B, 17 and 19 of the Misuse of Drugs 1977 Act. Section 3 of the Criminal Justice Act 1994, which defines drug trafficking, might need to be amended. Section 15 of the 1977 Act would need to be amended to allow a parent to give medicinal cannabis to their child. Based on all the considerations, as outlined above, the committee recommends that the Cannabis for Medicinal Use Regulation Bill 2016 should not proceed to Committee Stage.

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