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 colleague, Maria Egan, who is a pharmacist in the medicines and controlled drugs unit. I thank the committee for the opportunity to provide the Department of Health’s observations on the Cannabis for Medicinal Use Regulation Bill 2016.

By way of background, this Private Members' Bill was published by Deputy Gino Kenny and Deputy Bríd Smith in July 2016. Much of the text is similar to that contained in the Cannabis Regulation Bill 2013 published by Deputy Luke 'Ming' Flanagan, though there are important differences between the two Bills. In early November the Minister for Health announced a review of policy on the use of cannabis for medical purposes. He requested the Health Products Regulatory Authority, HPRA, to provide him with expert advice. On 1 December, Dáil Éireann debated Deputy Kenny's Bill. During the debate the Minister expressed his concerns about elements of the Bill and noted he was awaiting the HPRA’s report on medicinal cannabis. The Bill passed Second Stage and was referred to the select committee. The Minister received the HPRA’s report on 31 January. He published the report on 10 February and announced that he will establish a medicinal cannabis access programme for certain medical conditions. Last month the Minister established an expert reference group which is drafting guidelines to facilitate the prescription, supply and use of cannabis treatments for qualifying patients under the access programme.

The regulation of medicinal products and drugs is currently achieved by an array of enactments, including the Misuse of Drugs Acts, the Irish Medicines Board Acts and the Pharmacy Act, all of which aim to ensure medicines that reach the patient are of an acceptably high quality and are safe and effective for use by that patient. The research, manufacture, marketing, distribution and promotion of medicinal products is regulated by European Union legislation, which has been implemented in Ireland by various regulations and orders. The misuse of drugs framework already defines systems of control for the production, supply, import, export, record-keeping, research and destruction of controlled substances, including cannabis and its psychoactive extracts. It also sets out the criminal sanctions that apply for possession, sale, supply or trafficking in controlled substances, including cannabis.

Members of the committee will be aware that cannabis is currently a schedule 1 controlled drug under the Misuse of Drugs Act and it is the most widely used illegal drug in Ireland. Cannabis is not an authorised medicine and it 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. It is important to note that while there is a view that there is a legal impediment to prescribing cannabis, it is not the case. The Minister for Health may grant a licence for cannabis, containing THC, where the licence application has been endorsed by a consultant.

The Department is of the view that the current Bill is not necessary and is not in the public interest as it proposes to establish a parallel regulatory process for cannabis and undermines the regulatory frameworks already in place for controlled drugs, medicines authorisation and the operation and oversight of retail pharmacies. The Bill proposes to establish two new agencies, one of which, the cannabis regulation authority, will to a large extent duplicate functions already being carried out by other State agencies, in particular the HPRA and the Pharmaceutical Society of Ireland.

While the Department does not believe the legislation is appropriate or necessary, should the Oireachtas decide to proceed with the Bill, there are a number of issues which we would like to bring to its attention. I have already referred to the cannabis regulation authority which is dealt with in Part 2 of the Bill and our concern that it establishes a parallel system of regulation cutting across the functions of existing agencies.

We are also concerned about the reference to the development of a consumer oriented licensing system in section 6(2)(b). Cannabis is not a normal consumer product; it is a controlled drug. We must ensure that any system that is established is patient oriented rather than consumer oriented and that it protects patients and the wider public.

There is a reference to fees in respect of the grant of a retail licence in section 27. Retail licences are confined to pharmacies. It is noted that retail pharmacies already pay a fee to register with the PSI and it difficult to see the justification for this additional fee on pharmacies to support a system of parallel regulation by the cannabis regulation authority. There is also a reference to fees for “signs relating to a licence” in section 27(3). This is a puzzling reference and suggests that pharmacies could be advertising by way of signage that they are licensed to sell cannabis products. In our view, unless it is expected that a very large number of licences will be issued, the fee income is unlikely to meet the running costs of the proposed authority.

Part 3 establishes a cannabis research institute. In the view of the Department, it is not necessary to establish such an institute. There is already a considerable amount of research into the illegal or recreational use of cannabis. If a researcher wishes to conduct clinical trials on cannabis, that is already permitted under existing legislation.

We note that one of the functions of the institute is to encourage employers to review drug-free workplace policies, as provided for in section 12(1)(b). There are good reasons many employers have drug-free policies in place and we are unclear as to why a research institute would encourage them to review these policies.

We also note that it is a function of the institute, in section 12(1), to commission and publish research in the areas of safety, risks and benefits of medicinal and-or recreational use. We are unclear why the institute would be mandated to commission research into the benefits of recreational cannabis. There is a further reference to recreational cannabis in section 41.

Section 23(1) deals with disqualifications for holding a licence on conviction of certain offences. It is noted that trafficking or sale or supply of illegal drugs is not specifically mentioned and that, according to section 23(7), a conviction for possessing cannabis will not disqualify a person from being granted or continuing to hold a licence under this legislation.

The Department notes that in Part 7, it is intended that a doctor will issue a certificate to patients, as provided for in section 32. In the interests of patient safety, we believe that a prescription is more appropriate and that it should include details that are currently required to be present on prescriptions for controlled drugs. The Department notes that the HPRA report recommends that for the access programme, patients should be under the care of a consultant and we would support this position.

The Department is particularly concerned about section 42 which removes cannabis from the Misuse of Drugs Acts. This means that possession, sale or supply of cannabis would no longer be an offence under the Misuse of Drugs Act. Cannabis would no longer be a controlled substance with the misuse of drugs framework. While there are a number of offences created in the Cannabis for Medicinal Use Regulation Bill in sections 8, 16, 17, 20, 21, 22, 23, 27, 31, 33, 34, 35, 36, 37 and 39, I would point out that there are no penalties in terms of fines or imprisonment specified for any of the offences outlined in this Bill.

There are other issues of concern and also technical problems with the Bill, for example, the use of the imperial system rather than the metric system in sections 16, 17 and 33. However, it would take some time to go through the Bill on a section by section basis.

To conclude, the basic position of the Department is that we do not see this Bill as being necessary or in the public interest. Cannabis has not gone through the normal regulatory procedures for medicines which are designed to protect patients. The Bill places the regulation and oversight of medicinal cannabis under a unique and separate legislative and regulatory framework from all other health products. This Bill attempts to circumvent existing regulatory regimes and establish a parallel system for cannabis. Given that there is currently insufficient clinical evidence in respect of the efficacy and safety of many cannabis products we should proceed cautiously. It is the view of the Minister for Health and the Department that at this time, the cannabis access programme is the responsible way to proceed.

I thank the Chair. We will be happy to address any follow up questions.