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Economic and International Affairs
Regulations for the licensing, production and export of Medicinal Cannabis in Jersey
Witness: Minister for Health and Social Services
Monday, 14th June 2021
Panel:
Deputy D. Johnson of St. Mary (Chair) Deputy S.G. Luce of St. Martin Senator S.W. Pallett
Ms. J. Borg, Adviser to the Panel
Mr. W. Pisani, Adviser to the Panel Mr. M. Galea, Consultant to the Panel
Witnesses:
Deputy R.J. Renouf of St. Ouen - Minister for Health and Social Services Mr. P. McCabe - Chief Pharmacist, Health and Community Services.
[12.03]
Deputy D. Johnson of St. Mary (Chair):
Good morning, everyone, and welcome to this public hearing of the Economic and International Affairs Scrutiny Panel in relation to our review of the medical cannabis industry. I will begin by introducing the members of the panel who are myself, Deputy David Johnson as Chair, the Deputy of St. Martin , Steve Luce , and Senator Steve Pallett. We also have with us representatives of our advisers Grant Thornton Malta, who are Wayne Pisani, Jessica Borg and Mario Galea, who is acting as a consultant on this particular matter. Minister, can I invite you to introduce yourself and any colleagues.
The Minister for Health and Social Services:
Thank you, Chair. I am Deputy Richard Renouf , the Minister for Health and Social Services.
Chief Pharmacist, Health and Community Services:
I am Paul McCabe, I am the Chief Pharmacist at Health and Community Services.
The Deputy of St. Mary :
Thank you both and thank you all for coming. I should perhaps begin by saying it is a slightly unusual situation we find ourselves in that I was not expecting this panel to be asking questions of the Minister for Health and Social Services but the nature of the beast is such that a lot of the work or responsibility is in your area, and particularly I see of the Chief Pharmacist. Minister, as we are here to interview Ministers perhaps you could very briefly explain what your role is in the overall equation?
The Minister for Health and Social Services:
The Minister for Health and Social Services is responsible for the licensing of any cannabis cultivation and production, and generally the use of any cannabis plants grown in the Island. That authority given to the Minister to licence arises out of the provisions of the Misuse of Drugs (Jersey) Law, which is 1971 or something like that. It is an old piece of legislation. I do not think it envisaged the sort of uses for licensing that are now being seen but nevertheless that is the structure that is in place. The Chief Pharmacist also has statutory duties under that legislation. Where a cannabis product is to be refined into a medicine in Jersey then a licence needs to be obtained under the Medicines (Jersey) Law, which of course also then involves me and the Chief Pharmacist. That is just a brief background to the reasons why the Minister for Health and Social Services is involved.
The Deputy of St. Mary :
Thank you for that. We have a question plan, as it were, and there are 3 main areas relating to licences, resourcing and also the role of the Chief Pharmacist, who will have more than his fair share of questions, I am afraid. I leave it to you as to who answers them. If I can start with the questions we have licences. Will licences issued by the Minister stipulate whether a medicinal cannabis cultivator has received a G.A.C.P. (good agricultural and collection practice) certificate, a G.M.P. (good manufacturing practice) certificate or a combination of both?
The Minister for Health and Social Services: I will ask Paul McCabe to answer that.
Chief Pharmacist, Health and Community Services:
The licence itself would not have any of those stipulations on it, the licence would be effectively granting authorisation to cultivate cannabis. In granting such a licence we would want to know what the end use of the cannabis was going to be, looking to make sure that was going to be used in use as part of the production of the medicinal products. Obviously any entity wanting to either manufacture the raw substance to be used in the medicine or the medicine itself would need to have a G.M.P. certificate, which would be a separate assessment.
The Deputy of St. Mary :
Thank you. A related question, can a medicinal cannabis cultivator operate a licence with G.A.C.P. certification only?
Chief Pharmacist, Health and Community Services:
They could but their customer base would be limited. We would only grant such a licence if we were assured that they would be supplying that product to an entity that has a G.M.P. certificate so they can process it into either an active substance to be used in the manufacture of medicine or a medicine itself. The basic tenet through all of this is that the cannabis is cultivated, has to go through a G.M.P. certified producer and manufacturer at some point because that is the only way you can produce the medicine from it.
The Deputy of St. Mary :
A follow on question from that. Are there clear rules in place to designed to identify which activities require a G.A.C.P. certificate as opposed to the G.M.P. certificate and who is responsible to make such a determination?
Chief Pharmacist, Health and Community Services:
I cannot comment much on G.A.C.P., that is more of an agricultural practice and not my area but certainly anybody wanting to manufacture a medicine or to manufacture the active substance needs to be G.M.P. certified. There are standard international guidance and regulations around good manufacturing practice. We would engage the services of the U.K. medicines regulator, the Medicines and Healthcare Products Regulatory Agency to assess any potential applicants for a G.M.P. certificate because they have the expertise to do that.
The Deputy of St. Mary :
That will go through you as Chief Pharmacist, is that correct?
Chief Pharmacist, Health and Community Services:
That is correct, yes, we had M.O.U. (memorandum of understanding) with the M.H.R.A. (Medicines and Healthcare products Regulatory Agency) around G.M.P. inspections and also G.D.P. (good distribution practice) for the companies that want to distribute medicinal products.
The Deputy of St. Mary :
I have a question from Deputy Luce .
Deputy S.G. Luce of St. Martin :
Thank you, Chair. If I could just ask the Chief Pharmacist, if I may, he referred the end products or where these medicinal products were going to end up, if he is aware that the licences that have been issued in Jersey so far are for different types of end products or are they both going to cultivate in exactly the same way.
Chief Pharmacist, Health and Community Services:
There are a range of end products that could be manufactured from the cannabis that is cultivated. The most common one is a dried flower medicinal product which is used but you can also use the cannabis that you cultivate to extract oil and produce liquid evaporation. The 2 companies with licences at the minute have variations on a theme regarding the final medicinal products they would be involved in producing.
The Deputy of St. Martin : Thank you for that.
The Deputy of St. Mary :
Again, a more general question. Is the necessary infrastructure in place to ensure that export licences are granted only once an import authorisation has been received from competent authorities in the destination jurisdiction?
Chief Pharmacist, Health and Community Services:
Yes, there is. We have a process for licensing import and export of controlled drugs at the minute and that is provided for under the Misuse of Drugs (Jersey) Law. Any application for a licence to export any controlled drug, cannabis being one of those, will only be issued once we have seen the import authorisations from the competent authority in the destination jurisdiction. Anybody exporting without that authorisation will be doing so in contravention of the law.
The Deputy of St. Mary :
Moving on from that then, what role will customs and immigration play in monitoring licences for consignments passing through Jersey's borders?
Ultimately the lawful importation or exportation will be a matter for customs. The licence will accompany the consignment and we would expect that the person with either the import or export licence to liaise with customs. We would share copies of licences with customs as well so they would be aware that there is a lawful export or import taking place.
The Deputy of St. Mary :
So there is co-operation between yourself as pharmacist and the customs, they will be alerted to the fact that this transaction is going through then?
Chief Pharmacist, Health and Community Services:
They would. At the minute where we have individuals who are getting cannabis based medicines from the U.K. (United Kingdom), we issue import licences for those at the minute and copies of those licences are shared with customs.
The Deputy of St. Mary :
Moving back, as regards the visit by the Chief Pharmacist jointly with the Home Office, can you elaborate on the aspects that are then addressed during those visits? Is there a checklist or guidance on what criteria are to be checked through the visit?
Chief Pharmacist, Health and Community Services:
Yes, the Home Office have a checklist which they go through, I am just trying to find it for you. They have a standard process that they go through. So the people who are undertaking the business, the purpose for which the licence is granted, so the Home Office, in order to make sure they meet their obligations under the U.N. (United Nations) Convention, need to be sure that it is going to be bought ultimately for medicinal use. The Home Office will also ask about potential suppliers and customers to make sure that any sort of cannabis that is acquired or distributed is doing so to appropriately authorised entities. The Home Office will also look at the security arrangements for the site that is in question, both in terms of cultivation but also storage and handling of the harvested cannabis once it is harvested.
[12:15]
We also want to seek assurance around security for transport arrangements for moving products on and off site. We will also look at the standard operating procedures around the business to make sure or to assure ourselves that the company has procedures that govern all operations they undertake. Indeed that is a prerequisite if they want to get into manufacturing medicinal products
anyway. We would also want to examine their arrangements around destruction of controlled substances and disposal of controlled substances as well. The Home Office will also, as part of the report provide after an inspection give a view on whether the cultivation is in line with the principles of the U.N. Convention as well.
The Deputy of St. Mary :
Thank you, that is quite a comprehensive checklist. I am not sure the panel have seen a full guidance, does that exist?
Chief Pharmacist, Health and Community Services:
The checklist is in annexe D of the addendum to the M.O.U., which is the template for the Home Office report that they provide to the Minister. There is a list of headings there of things that they will review and comment on and provide their view on in their inspection reports.
The Deputy of St. Mary :
Okay, I have not looked at the M.O.U. for the moment. I have some more questions on this theme but, first of all, can I refer you to Senator Pallet who has a question?
Senator S.W. Pallett:
Yes, just very briefly. Paul, could I just ask whether obviously the visit with the Chief Pharmacist, were you actually part of the site visits when these took place?
Chief Pharmacist, Health and Community Services:
I was, yes. So it is a joint visit of myself and there were 2 officers, 2 officials from the Home Office, that came over to undertake the inspection so we went together. The process is we would meet beforehand to discuss the application and go through it and agree any questions that we might reasonably want to ask and then we will meet with the applicants and quiz them on various matters and then do a site visit to understand what their plans are with regard to cultivation. It is joint all the way.
Senator S.W. Pallett:
Obviously you went through quite a comprehensive list of things that you will check when you visit a site. I presume all that will be included in the licence application. I just wondered whether the licence applications could be provided to the panel on a confidential basis so that we could see the depth of information provided.
Chief Pharmacist, Health and Community Services:
I do not see why we could not. We have one application that is pending at the minute so we could potentially share that one.
Senator S.W. Pallett: That would be great.
Chief Pharmacist, Health and Community Services:
Obviously on a confidential basis, there would be some commercial sensitive stuff in there as well but absolutely we could share that.
Senator S.W. Pallett:
It is really just to see the nature of the information provided more than anything.
Chief Pharmacist, Health and Community Services: Sure.
Senator S.W. Pallett: Thank you. I am done.
The Deputy of St. Mary :
Steve Luce , would you like to ask your question?
The Deputy of St. Martin :
It is just about the 2 licences that have been approved thus far. I am aware that there is still considerable infrastructure work being done on at least one of these sites. How far down the line does the applicant need to be in order to attain a licence?
Chief Pharmacist, Health and Community Services:
The applicant needs to have a site and plans for that site. Obviously we need to understand where and how they are going to cultivate the cannabis. It is a bit of a chicken and egg situation. In order to undertake the investment they need to develop they need some assurance that they would have a licence. Effectively the detail is the same as if they had a finished facility other than you would be looking at plans for the facility rather than the actual facility itself. In terms of all the operating procedures and all the other arrangements, we would expect to see those fully detailed in the application, the detailed plans of how they look to develop
The Deputy of St. Martin :
Okay, thank you for that. Sorry, could I just ask who is responsible
The Minister for Health and Social Services: Can Paul finish his answer?
The Deputy of St. Martin : Sorry.
Chief Pharmacist, Health and Community Services:
It is just to say that any licence that is granted on the basis of the plans has a condition in there that no cultivation can take place until the final site has been inspected again to make sure that it has been delivered as per the specifications. So there is a caveat within the licence that they would get at the early stage.
The Deputy of St. Martin :
Thank you. My apologies for cutting in, my connection cannot be great this morning, I thought you had finished answering previously. Can I just ask the question then, once you are happy with the plans and you issue a licence, who is responsible for making sure that the structures, buildings, whatever they are, are developed in accordance with the plans? Is it then the Planning Department?
Chief Pharmacist, Health and Community Services:
I would assume the Planning Department and the applicants. Certainly once the facility is finished then we would back and visit again to inspect it as a finished entity. They would not be able to grow anything until we come back and do that visit as well, so there would be another joint visit and the end of the build out process.
The Deputy of St. Martin :
Okay, so to be absolutely clear, nobody is growing any medicinal cannabis on Jersey until they have had their licence approved and the premises have been finished?
Chief Pharmacist, Health and Community Services: Correct.
The Deputy of St. Martin :
That is very interesting, thank you.
The Deputy of St. Mary :
Okay, going back to the inspection. As you said, it covers quite a large number of things to be looked at during that inspection but before I go back to that, I see the guidance in respect of the Jersey Licence Application does make reference to the applicant having to provide an environment impact assessment. Does that happen before you inspect or does it take account of the matters you raise during inspection or perhaps you could elaborate on that, please?
Chief Pharmacist, Health and Community Services:
Yes, that is something which, as we progress through this, we felt would be a useful addition to an application so the current application, we expect that to be delivered with the application so in advance of any inspection and in advance of everything else so that we would have sight of it and we could raise any questions that we need to around that. One of the current licence holders, when their licence was being considered, it was a condition upon granting the licence that they provided one because we had not fully developed the application process at that stage. All future applications would include that assessment with the application upfront.
The Deputy of St. Mary :
Just to clarify, are you saying therefore this E.I.A. (environmental impact assessment) is a relatively new idea and that applications might have already been granted without one having been issued?
Chief Pharmacist, Health and Community Services:
No one has been issued a permission to grow or cultivate anything without having submitted an E.I.A. Yes, it a new thing, the Home Office do not require it in the U.K., it is something we felt might be helpful in Jersey given that land is constrained and we want to make sure that applicants are given due consideration to the impact of what they are doing.
The Minister for Health and Social Services:
It is something I wanted to see happen because I understand that typically in the U.K. these operations are quite distant from built up areas, whereas Jersey is a very different place and there have been suggestions about obnoxious smells and where there is a close proximity of residential property it is quite appropriate and the right thing to do that applicants should satisfy myself, Mr McCabe as the licensing authority really, that there will be no impact on the neighbourhood. That is the reason why the assessments are requested.
The Deputy of St. Mary :
Thank you for your intervention there, Minister. I appreciate the reasons for it. Before I had over to Steve Luce for his question, with these impact assessments they will obviously cover a number of matters but you correctly pointed out that these developments, if that is what they are, are happening in rural areas. The concern I have, which is clear from the emails we have had on the matter, is that certain activities are carried out without local residents knowing about it. What I am asking I suppose is, is this environmental impact assessment publicised and do the public have the right to contribute and make representations as to what their concerns are, or is purely behind closed doors?
The Minister for Health and Social Services:
I think it would only be given publicity if it was also part of any planning application but not if it is simply prepared for the purposes of an application to me, because there is no public notice given of these applications under the Misuse of Drugs (Jersey) Law. It is entirely an internal process. There is no opportunity for the public to comment or likewise. There is, of course, in the planning application, if there are changes needed to premises then that would be apparent and public, but where it is use of an existing building or glasshouse then it is simply a case of an internal - internal within the Government - application to cultivate cannabis plants.
The Deputy of St. Mary :
I understand what you say but going back to your earlier comment, the reasons you thought that an income assessment was useful on matters such as noise, smell, et cetera, but from what you say now those are decisions which you, Minister, or your department will take without reference to any neighbours who might have valid concerns. Is there no intention to obtain their views on such things so you could shoot them down if necessary or is reassure them?
The Minister for Health and Social Services:
Once or twice neighbours who had become aware of the use of premises nearby have written to me. It is just that there is no facility, no option within the Misuse of Drugs (Jersey) Law to make public the fact an application has been made. It may be that should change, I do not express any particular view. I am not the Minister who is responsible for the policy but you will know that the policy approach is that this is an agricultural use and merely by growing cannabis instead of any other crop there is not necessarily a change in use or intensification. That is why we have particularly wanted to make an environmental impact assessment a requirement so that we could go some way towards addressing these questions and getting an independent review as to whether there was likely to be any risk to neighbouring properties.
The Deputy of St. Mary :
Thank you for that. I do understand the reason why you are making this requirement. I am sure that is to be welcomed. The further point I am making is that decisions are then taken internally without the opportunity for the public to contribute, that is a question you said needs to be raised elsewhere. Steve Luce wants to ask a further question in this area.
The Deputy of St. Martin :
If I could just ask the Minister, just so I am absolutely clear because it is not clear to me at the moment, we have issued 2 licences but did those licences come with environmental impact assessments, irrespective of whether they were made public or not?
The Minister for Health and Social Services: Yes, they did.
The Deputy of St. Martin : Thank you for that answer.
The Minister for Health and Social Services:
Of course they would not have been granted had the assessment shown any serious impact in environmental terms.
The Deputy of St. Martin :
That is reassuring to hear, Minister. Can I just ask further to that then? In granting the licence after seeing the environmental impact assessment, can I ask which officers advised you on the environmental impact assessment? Were they officers from the Environment Department?
The Minister for Health and Social Services:
I took my final advice from the Chief Pharmacist. The environmental assessments went to him first, I think, is that right? I looked at them with him and the licences were granted in those cases.
[12:30]
The Deputy of St. Martin :
If I might just press a little further.
The Minister for Health and Social Services:
I am sorry, I could not hear your question, Deputy Luce .
The Deputy of St. Martin :
I am sorry I do seem to have a bad connection this morning. Can I just go back to the designation of medicinal cannabis as being grown under an agricultural banner rather than an industrial banner? Is it your understand then that the crops grown will not be processed
The Minister for Health and Social Services:
Sorry I heard "will not be processed" and then you fell away.
The Deputy of St. Martin :
Okay, sorry, I will try again. Is it your understanding that the crops being grown will not be processed on the Island?
The Minister for Health and Social Services: I will ask the Chief Pharmacist to confirm.
Chief Pharmacist, Health and Community Services:
My understanding from the applications is that some of the applicants do intend at some point in the future to process the product on the Island. They are various levels of processing that can take place from simply drying and trimming the dried flower itself to extracting the controlled cannabinoid such as T.H.C. (tetrahydrocannabinol) or C.B.D. (cannabidiol) from the dried flower, which is more of an industrial process in itself. I think there is certainly an appetite for licence holders to process on Island.
The Deputy of St. Martin :
Can I just ask then, how are they allowed or how have they been permitted thus far to be granted a licence under an agricultural banner rather than an industrial banner?
Chief Pharmacist, Health and Community Services:
A lot of the licences are under the Misuse of Drugs (Jersey) Law and comply with the Misuse of Drugs (Jersey) Law. Their agricultural and industrial concerns would be for another department to consider.
The Deputy of St. Martin :
That is a very useful answer. There has always been a question mark over whether the product being grown was going to be an agricultural or an industrial and it is very clear - and I think it always has been - that the growing of the crop itself and the first few little processes, if you like, may be the taking off of leaves and drying of flowers, could well be agricultural but when it comes to extracting a completely new product from the leaves and flowers it is quite clearly industrial. I am grateful for your answer, thank you.
Senator S.W. Pallett:
On the same type of lines in terms of the licence application, in the licence application what is meant by registered smallholder and bona fide agriculturalist? Who makes the decisions that those applying fit into those particular areas. Are these definitions set out in law?
Chief Pharmacist, Health and Community Services:
My understanding is that they are and my understanding from colleagues in agriculture that to occupy to agricultural property you need to be a bona fide agriculturist and recorded as such. That is in the application guidance at the request of the Department for Agriculture.
The Minister for Health and Social Services: That is my understanding too.
Senator S.W. Pallett:
Okay, well, I think we can ask further questions. I thought it might be a difficult one for yourselves. Thanks.
The Deputy of St. Mary :
Before we leave that particular question and thank you for raising it, Senator, certainly as far as the tax situation is concerned my information is that the entity cultivating cannabis in whatever form has to be separate from any other business, so that does perhaps present a potential conflict with what you have just said about existing agricultural smallholders having to make the application. Are you able to throw any light on that at all?
Chief Pharmacist, Health and Community Services:
The applications we have so far have been from, as I understand it, companies specifically established in order to cultivate cannabis, so standing slightly aside from any existing agricultural business.
The Deputy of St. Mary :
You are therefore confirming that the applications you have received are effectively from new entities set up, but you are saying that their bona fides or their qualification is perhaps transposed from what they did previously? Is that a fair summary?
Chief Pharmacist, Health and Community Services:
Or they will have an arrangement with somebody who is a bona fide agriculturist, which means they can utilise the land. That is my understanding.
The Minister for Health and Social Services:
They will, I understand, have received a consent to occupy agricultural land but that is within the other department, the Infrastructure or the Economic Development section of Government. Under the agricultural control of land laws the occupation of agricultural land is limited, restricted and licences must be obtained. I understand all the applicants for a cannabis licence have had that licence granted to them.
The Deputy of St. Mary :
Okay, and I am thinking on my feet here, which perhaps gives scope for enquiries to remain at that stage as to whether the new activity is agricultural or industrial, but that is not for you to comment on, I am afraid. Okay. Senator Pallett, would you like to ask your further question?
Senator S.W. Pallett:
Yes, please. Following on the same theme, what credentials, if any, are expected of the person responsible? It is mentioned in the application process "person responsible" so what credentials are expected of the person responsible for the legal and regulatory requirements under the requisite laws, the Misuse of Drugs (Jersey) Law for example?
Chief Pharmacist, Health and Community Services:
There are no stipulated credentials as such, but as part of the site visit we undertake with the Home Office we will meet with the person who is designated to be that person responsible for regulatory affairs to determine whether they have the requisite knowledge, experience and understanding of the legal requirements around this and certainly again if they are looking to produce medicinal products around the medicines-related aspects. There is nothing predetermined in terms of the qualifications you must have but their understanding and knowledge is determined through interview with the person involved.
Senator S.W. Pallett:
Thank you, so you would expect and I presume you have met the person responsible for the applications to date?
Chief Pharmacist, Health and Community Services: Yes, that is correct.
The Minister for Health and Social Services:
I can add, if it is relevant, that background checks would also have been conducted on that person.
Senator S.W. Pallett:
While you mention background checks, could I ask one further question? In terms of the advanced D.B.S. (Disclosure and Barring Service) checks why are they only required for the named on the application and not for example other directors or shareholders?
Chief Pharmacist, Health and Community Services:
That is advice from the Home Office and the Home Office used the same wording in their application guidance, that some of the key individuals required to be named on the licence you require enhanced D.B.S. checks for, so we have effectively followed the Home Office lead on that.
Senator S.W. Pallett:
I know this is getting to the area of Economic Development a little bit but we did have a discussion with the Minister around the level of shareholding. Has there been any discussion between yourselves and E.D.T.S.C. (Economic Development, Tourism, Sport and Culture) around what would be a reasonable level of shareholding for checks to be done?
Chief Pharmacist, Health and Community Services:
No formal discussion. I know that the 20 per cent shareholding has been mentioned, so that is potentially an area for further work to see what might be appropriate.
The Deputy of St. Mary :
I think the questions raised by the Senator were more or less similar to ones that I was going to ask about the experience in the field of cannabis being taken into account when deciding on the granting of a licence and their expertise generally, but you are saying that that is something that you do look into at the time of the application?
Chief Pharmacist, Health and Community Services:
It is, and in fact we declined one application last year because we did not feel that the applicants had that requisite knowledge and experience.
The Deputy of St. Mary :
Okay, thank you for that. Some relatively small matters, does the process allow for an applicant to modify his licence once it has been granted, either by removing some of the activities or wishing to extend them by increasing additional ones or is that the subject of a new licence application completely?
Chief Pharmacist, Health and Community Services:
They would need to make application for any change or amendment to their existing licence. Also, licences are granted on an annual basis so there is always an opportunity at each annual review to look at whether the company is doing or wants to do anything different, and that can be accommodated at that time.
The Deputy of St. Mary :
Is it always the case that the licences are granted for a year only?
Chief Pharmacist, Health and Community Services:
That is currently the case, yes, and that follows again Home Office policy regarding licences they issue in the U.K.
The Deputy of St. Mary :
It is perhaps not your area but I think if I was involved in this I would like a bit more security than one year. Is there any intention to broaden it at all or are you convinced that will always be retained at the one-year level and nothing beyond?
Chief Pharmacist, Health and Community Services:
There is always scope to review that in the future. I think at this stage, which is very early in this industry, it is probably appropriate to be stricter rather than not and it may be something that will be looked at in future years, particularly with applicants who develop a history of compliance and good practice.
The Minister for Health and Social Services:
I agree, but I would say I think it would also be important to keep in broad step with the approach in the U.K. because they are the signatories to the international convention on our behalf, so we must be careful where we might diverge.
The Deputy of St. Mary :
I appreciate that, Minister. Thank you for that confirmation. My next question is perhaps an unfair one, but do you have any indication as to how many new licence applications are being anticipated to be submitted either in the next 12 months or annually thereafter?
Chief Pharmacist, Health and Community Services:
I do not have any idea about how many might be submitted, but I know that we have one application pending at the minute and as far as I am aware there might potentially be one more later this year.
The Deputy of St. Mary :
The one pending and the one to come, are they new to the industry, if you can call it that, or are they associated with the existing organisations involved in the area?
Chief Pharmacist, Health and Community Services: No, they are new to the area.
The Deputy of St. Mary :
A couple of final things on the licensing point specifically, I think you have said, Minister that in terms of licensing it seems that extensive reliance is made on existing laws, the Misuse of Drugs (Jersey) Law 1978 and the Medicines (Jersey) Law 1995. Are you able to confirm that medicinal cannabis project applicants are subjected to the same rules and process as any other drug producer, manufacturer and that therefore there is not a special ad hoc regime being set up to cater for this industry?
The Minister for Health and Social Services:
No, I confirm that the applications fully comply with the requirements of the legislation and throughout the process of these applications being brought forward we have received legal advice from the Law Officers' Department to ensure that things were kept on track and fully compliant.
The Deputy of St. Mary :
My final question in this area before I hand you over to a different area, and again it might not be something for you to answer, but did Jersey as a whole, and what part did you have in this if so, establish a risk appetite framework or parameters in terms of acceptance of projects? That might well come up in terms of resources later on but to what extent has your department, Minister, been involved in the overall setting up of this fledgling industry?
The Minister for Health and Social Services:
We have not been involved in assessing a risk appetite as you suggest, not in those terms. We have more so been involved in ensuring that we have a robust regulatory process around the industry, which has involved the Chief Pharmacist liaising with the Home Office and ensuring that the M.O.U. was in place and we were established as a cannabis agency able to regulate the providers. As to the policy behind it, I have had no particular input apart from the items that have been brought to the Council of Ministers where all other Ministers share. I was not seeking an input, I must say.
[12:45]
The Deputy of St. Mary :
Before I leave this section I think the Senator would like to make one further, maybe final, question. Senator Pallett?
Senator S.W. Pallett:
You did mention very early on in the briefing that the Misuse of Drugs (Jersey) Law goes back 50 years and you just mentioned wanting to work under a tight regulatory regime. Was there any thought of looking to set up a completely separate new set of regulations, purely to cover cannabis rather than try to work within pieces of legislation that probably were not put together for this type of industry?
The Minister for Health and Social Services:
I was not involved in that thinking, if it took place. From my viewpoint it has been a case that you are the Minister who has the authority under the present legislation to grant licences and this is what needs to be put in place. As to whether officers at any time have considered another regime, perhaps I can ask the Chief Pharmacist.
Chief Pharmacist, Health and Community Services:
No, we have not, although that has cropped up informally recently about now that we are clearer on what the whole process end-to-end looks like, that that might be a consideration as to whether there is scope or powers to have a separate set of regulations under the Misuse of Drugs (Jersey) Law for example, which encompasses the whole package.
The Deputy of St. Mary :
Thank you for that question, Senator. To add on to that, Minister, you did earlier on say that you felt it appropriate to insist on an environmental impact assessment and your comments in that area leave me to wonder whether it would be helpful to ensure whether some of the matters you are concerned about would be better addressed in a separate piece of legislation, rather than relying on various specific areas applicable to different industries that we have at the moment. Do you have any views on that?
The Minister for Health and Social Services:
Yes, I think that is quite possible. If this becomes a large part, a mainstay of Jersey's agricultural offering, then we should ensure that there is a framework that meets all the needs around it. I am not saying the present one does not, but there is probably always room for some improvement and I would not be averse. Indeed, whether it should be the Minister for Health and Social Services who grants licences or some other Minister, because we are essentially dealing with the growing of a crop here. Maybe the Minister for Health and Social Services should be involved if the process becomes nearer to a creation of a medicine and that is where perhaps Health comes into play, but in terms of the simple cultivation the duties to regulate could be put elsewhere. I am open to that if there was that thinking and a determination made that there should be change.
The Deputy of St. Mary :
Thank you for that. That is useful, thank you. That probably leads us quite neatly on to the question of resources, which Deputy Luce is going to raise a few questions about.
The Deputy of St. Martin :
Thank you, Chair. Before I start, can I ask a couple of final questions on licensing? Minister and Chief Pharmacist, you mentioned transport on and off site and you also mentioned the destruction of the crop. Have you seen evidence of liaison with the freight and logistics industries about the movement of these products? Also, when it comes to the destruction of the crop at the end of its growing life, are there strict rules in place or is that going to be local advice that is given?
Chief Pharmacist, Health and Community Services:
In terms of the destruction of the controlled parts of the plant, we would look for the same sort of assurances that we have around the destruction of controlled drugs and medicines now, so it is likely that there would be a witnessed destruction, probably by incineration. I have not seen anything with companies liaising with logistics companies. The security of the product is that of the licence holder, so they have to make sure they have got arrangements in place. Companies obviously transport controlled drugs to and from the Island on a regular basis because they supply our pharmacies over here, so it is not too dissimilar to those arrangements.
The Deputy of St. Martin :
Thank you for that, and if I could go back to the Minister very briefly for a last question maybe on E.I.A.s. Minister, in your answer, the last answer you gave the Chair a minute ago, you hinted that maybe in the future it might be a different Minister that says yay or nay on E.I.A.s. Are you concerned that in these first 2 licences you may be slightly outside of your comfort zone in granting licences and making decisions on environmental impact assessments?
The Minister for Health and Social Services:
Yes, I take the point, Deputy . I am not used to reading E.I.A.s or interrogating any meanings behind them. It is a point well made. It may be that there is another input needed at that stage.
The Deputy of St. Martin :
Okay, thank you. I will move quickly on to resourcing if I may, because I have a few questions in that line. Could you provide a few more details about additional resources that you are going to need to fulfil the roles in respect of medicinal cannabis products? It is very clear to us that the Chief Pharmacist is a busy bloke, putting it bluntly, a very busy person and this industry could soak up an awful lot of his time. Could you tell us where we are with resources and what we might need?
The Minister for Health and Social Services:
Yes. Can I just open by saying that I am very grateful to the Chief Pharmacist? He has been directly involved and spent a lot of time in assessing the applications that have come forward and giving guidance to applicants and liaising with the Economic Development team. It has concerned me that if this industry grew significantly then we do need extra resource and that is something that I have talked about also with the Director General of Health and Social Services. I will pass over to Mr. McCabe because he knows the plans in detail that are in place.
Chief Pharmacist, Health and Community Services:
Yes, I think the point is well made that there will inevitably be requirement for additional resource if this industry continues to grow. So far I guess a lot of the work has been in establishing the framework and things like that but going forward we will need to ensure that we can provide adequate oversight, inspection, compliance visits to guarantee that people are operating in accordance with their licences. While there are only one or 2 licence holders it is manageable. If we have significantly more then we will need to look to secure additional resource. The doubling of licence fees will go some way to help with that and it is a case of determining exactly what type of additional resource we might need to best support the industry.
The Deputy of St. Martin :
Is there going to be any delegation of responsibility from the Drugs and Firearms Licensing Unit at the Home Office or the regulatory authorities to the Jersey Cannabis Agency to monitor the quality and to ensure that the E.U. G.M.P. standards are being met?
Chief Pharmacist, Health and Community Services:
The Home Office themselves do not have an interest in G.M.P. specifically because that is in relation to production of medicinal products and the active substances in medicinal products and in the U.K. that is the M.H.R.A. who look after that. You have 2 agencies in the U.K. who are involved in this business, the Home Office and the M.H.R.A. Certainly if applicants are licensed either just for cultivation or production of medicines I think a lot of the day-to-day regulation and inspection would be delegated to local enforcement officers with the option at all times to be able to consult and liaise with the Home Office or the M.H.R.A. for advice or external oversight inspection if necessary.
The Deputy of St. Martin :
Thank you, so the cannabis agency over here will receive training from the D.F.L.U. (Drugs and Firearms Licensing Unit), M.H.R.A., to ensure that compliance is undertaken or adequate?
Chief Pharmacist, Health and Community Services:
Yes, certainly the expectations or what happens at the minute is that the inspections are joint currently, so undertaking those joint inspections with the M.H.R.A. or the Home Office allows myself or potentially others in the future to build up that experience and expertise in undertaking inspections. That will always be an ongoing process.
The Deputy of St. Martin :
Do you see that in the future the D.F.L.U. and M.H.R.A. will continue to meet with Jersey cannabis cultivators in person, or will that eventually be completely delegated over to the J.C.A. (Jersey Cannabis Agency)?
Chief Pharmacist, Health and Community Services:
I think there will always be that need to meet for 2 reasons. The Home Office will want to meet to satisfy their obligation under the U.N. Convention as the regulator and the M.H.R.A. because it involves the production of medicinal products especially that could end up in the U.K. market would also have an interest. I do not think that we would ever look to develop a level of expertise around the G.M.P. inspections that is required locally and we would always refer to the U.K. Medicines and Healthcare products Regulatory Agency as the internationally recognised expert body in that area.
The Deputy of St. Martin :
Does the J.C.A. have an organisational structure? Is it regulated by means of statute or equivalent document?
Chief Pharmacist, Health and Community Services:
The J.C.A. is established by the Home Office as the body that is required under the U.N. Convention to oversee activities in Jersey. In the absence of the M.O.U. and the establishment of the J.C.A. the U.K. national cannabis agency would be the regulator for all these matters, so as it stands at the minute the J.C.A. and the Minister for Health and Social Services is designated as the J.C.A. as the person who issues the licences, so has the licensing authority under the Misuse of Drugs (Jersey) Law.
The Deputy of St. Martin :
To be clear, at the moment the J.C.A. is not constituted to have a particular set of rules or laws, but it works under the M.O.U. from the Home Office?
Chief Pharmacist, Health and Community Services: That is correct.
The Minister for Health and Social Services:
Sorry, could I refer to I think it was a useful summary of the legislative provisions that we provided to you last week, I believe, with our answers to your written questions? I hope that explains the J.C.A. role.
The Deputy of St. Martin :
No, that is fine, Minister. I thought it was important that we get these answers even more on record than they were previously. Do you plan to recruit any additional qualified pharmacists to assist yourself, Chief Pharmacist, in managing applications to cultivate medicinal cannabis?
Chief Pharmacist, Health and Community Services:
Yes, I am currently looking at whether it is a pharmacist or some other form of support to help with this industry. In terms of issuing licences to cultivate under the Misuse of Drugs (Jersey) Law that does not necessarily need to be a pharmacist. You do not necessarily need knowledge of medicines to be able to do that. Certainly when it comes to the production of medicinal products and the requirements around that then a pharmacy background would be extremely beneficial. It is a case of trying to weigh up what is the most appropriate skill set in terms of the support that is required.
The Deputy of St. Martin :
My last question is on a not dissimilar subject and it is about business feasibility and plans for these businesses moving forward. Do you do those business feasibility studies yourself or are you getting help from other departments and which other regulatory bodies might be assisting you in looking at the business cases that are put forward?
[13:00]
The Minister for Health and Social Services:
I do not believe that function is carried out by myself or the Chief Pharmacist. It would be carried out by the Minister for Economic Development.
The Deputy of St. Martin :
Okay, that is very clear. Thanks very much, Minister and Chief Pharmacist. I am going to hand over now to Senator Pallett who has got some questions and then a further question on the role of the Chief Pharmacist. Senator Pallett?
The Deputy of St. Mary :
Sorry, could I dare interrupt? Before we move away from resources I think the Minister mentioned earlier on, and I ought to clarify it, it seems clear to me that this is a new activity that perhaps was not contemplated too long ago. On the question of resources is there a bid already in for further resources or is one being contemplated for the next Government Plan or where do we sit on that?
The Minister for Health and Social Services:
I will pass over to the Chief Pharmacist in a minute. Just to say though that part of the reason for the licence fees is to enable an income stream that would contribute towards the budget for those additional resources. Can you add on resourcing, Paul?
Chief Pharmacist, Health and Community Services:
Yes, just to say that as I said previously I am looking at what type of additional resource would be best placed to support this industry and I am looking at how I can utilise the income we are now receiving from licence fees to support that. If we can manage it from within licence fees then potentially there would not be a need for an additional bid for resourcing but it is possible that if the industry grows significantly that we may need to look at a formal bid of some description.
The Deputy of St. Mary :
It does seem to me that what is involved at the time of application is comprehensive, involving various people, but perhaps you cannot comment further on that at the moment. It would not surprise me if you do have to require further resources, bluntly, but that is an aside comment. Sorry, Senator, over to you now.
Senator S.W. Pallett:
To finish that section off, in regards to the J.C.A. you have explained it extremely well but is there any intention to expand the membership of the J.C.A. in the short to medium term? Just to be clear, politically it is the responsibility of the Minister for Health and Social Services.
The Minister for Health and Social Services:
I would be open to that. I think that might be helpful at some stage. Initially it has been necessary to work our way through the initial applications, referring for legal advice where necessary and understanding how applicants are approaching this. As it becomes more the norm it could well be appropriate to establish a body of people who might assess. I think the Chief Pharmacist has had discussions around this, so if I pass over to him.
Chief Pharmacist, Health and Community Services:
Yes, there is potentially scope to have a slightly broader group, potentially under the auspices of the Jersey Cannabis Agency to provide additional support and guidance around licensing and that is something that I think we need to look at as we go forward.
Senator S.W. Pallett:
My first question in many regards you have answered, but in terms of the specific advice provided by the Chief Pharmacist, you have given us some background as to the advice you give the Minister, but is there anything that you would want to add in regards to advice maybe that we have missed this morning so far?
Chief Pharmacist, Health and Community Services:
I do not think so. In terms of the point of considering applications, at that point we have the application, we have a report from the Home Office that will be provided under the M.O.U. and then it is really a case of myself providing advice and interpretation around that to facilitate a licensing decision being made.
Senator S.W. Pallett:
Next question, please can you describe the dispute resolution process in the event of a disagreement between the Chief Pharmacist, Health and Community Services and the Drugs and Firearms Licensing Unit, Medicines and Healthcare products Regulatory Agency in the U.K. and any disagreement that may come up? Who holds the whip hand in regards to that decision-making process?
Chief Pharmacist, Health and Community Services:
That is a very good question and not something we have tested as yet. We have not had any disagreements. If it came down to issues around the U.N. Convention, which the Home Office is ultimately accountable for, then I think we would be taking legal advice on that around interpretation and probably would make that formally if we could not come to an agreement between myself and the head of the D.F.L.U.
Senator S.W. Pallett:
Have you put a formal dispute resolution process in place, or is that something that almost you will play by ear when it comes up?
Chief Pharmacist, Health and Community Services:
Thinking about it now I think it would probably be wise to work with the Home Office about putting something in place. I think it was acknowledged at the time of writing the M.O.U. that there needed to be some process, which is why it is referenced, but I would probably prefer to have something in place in advance of having to use it, than have to develop something in time of need.
Senator S.W. Pallett:
Moving on, once a determination is made by the decision-making authority following a dispute what accountability mechanisms are in place to ensure that the decision is in line with established practices for the cultivation of medicinal cannabis, such as the E.U. (European Union) G.M.P. standard, for example?
Chief Pharmacist, Health and Community Services:
The E.U. G.M.P. standard we would invite the M.H.R.A. to determine whether something is or is not in compliance with that, because they are the experts. We would not have to rule on that ourselves.
Senator S.W. Pallett:
So that is advice you receive from the U.K.?
Chief Pharmacist, Health and Community Services: Yes.
Senator S.W. Pallett:
In relation to the ultimate decision-making power to issue a licence to cultivate medicinal cannabis, will ministerial input always be required before a decision is taken?
Chief Pharmacist, Health and Community Services:
As things currently stand the Minister for Health and Social Services is the licensing authority and therefore yes. Whether at any point in the future a mechanism to provide for licence decisions by way of delegation is something that could be looked at, certainly in the U.K. the N.F.L.U. have delegated responsibility from the Home Office Minister over there for making those licensing decisions. Currently our legislation requires the Minister for Health and Social Services to make the decision.
Senator S.W. Pallett:
So that is something that potentially could fall to the J.C.A. or a relevant body?
The Minister for Health and Social Services:
I agree that would be a potential way of doing it, to establish a formal licensing authority.
Senator S.W. Pallett:
There is a question from the Chair?
The Deputy of St. Mary :
Thank you. I thought it was the best way of getting your attention. Going back to the decision- making power, again it touches on the idea of an environmental impact assessment, which will cover a multitude of things and I do not think we have yet mentioned the question of security. To what extent is security a potential problem and to what extent do you get appropriate advice from the police force?
The Minister for Health and Social Services:
It is one of the considerations that come from the Home Office and that we have adopted and I know the Chief Pharmacist has worked closely with the local police and I will ask him to give detail.
Chief Pharmacist, Health and Community Services:
We as part of the application require a security assessment to be submitted by the applicant to address the issues that are contained in Home Office guidance on security arrangements and that is available at the time the Home Office come to do their inspection. We are very strongly guided by the Home Office in terms of the basic principles being satisfied and then we have the option to consult with local agencies as we need to, to see whether there are any local factors that should be considered.
The Deputy of St. Mary :
Thank you for that. You say it is an option. Is it a question that as a matter of course you would get local advice or would you take a view yourself if there did not appear to be any particular problem?
Chief Pharmacist, Health and Community Services:
I think if the view from the Home Office was that everything was acceptable and in order then you would perhaps not necessarily need to take advice. The Home Office are the experts on this. They do it regularly in the U.K. They assess the security arrangements around these businesses in this industry, so they provide a very strong steer on whether the security arrangements are appropriate or not.
The Deputy of St. Mary :
Thank you. I am not suggesting for one moment anything untoward on that, but I go back to the Minister's earlier comment that in a jurisdiction like England it is quite possible if it is an industrial activity it will be away from residential areas, whereas in Jersey that is not going to be the case. It does seem to me that more often than not a more local assessment might be required.
Chief Pharmacist, Health and Community Services:
I think that is fair. I think the principles around security arrangements can be met in a number of ways and it is about ensuring that whatever way the applicant determines is the best for the local situation and is first and foremost advised of the biosecurity and that takes into account other factors as well.
The Deputy of St. Mary :
Okay, thank you. Sorry, Senator. Over to you again.
Senator S.W. Pallett:
Thank you, Chair. This is really about some clarity. In the event of a dispute between the Chief Pharmacist, H.C.S. (Health and Community Services) and the D.F.L.U. and M.H.R.A. could an application for a licence to cultivate medicinal cannabis still be considered where the M.H.R.A. have refused to grant an E.U. G.M.P. or a G.A.C.P. certificate?
Chief Pharmacist, Health and Community Services:
The M.H.R.A. would not grant a G.A.C.P. certificate. That would just be the G.M.P. ones. If someone was cultivating to G.A.C.P. standards for example but wanted to supply another company who was G.M.P. certified to improve the process that would potentially be possible.
Senator S.W. Pallett:
Okay, so there are workarounds within that scenario?
Chief Pharmacist, Health and Community Services:
There are. The underlying premise, though, is to be sure that the destination for anything that is cultivated is for the medicinal market to be used in the production of medicines rather than any other market.
Senator S.W. Pallett:
Thank you. With respect to applications that are aimed exclusively at cultivation are these also initially vetted by the Chief Pharmacist?
Chief Pharmacist, Health and Community Services:
Yes, they are and for cultivation they fall under the M.O.U. auspices as well, so it would be exactly the same procedure whether you are applying just for cultivation or cultivation and further processing.
Senator S.W. Pallett:
Okay, and the same checks and balances process is in place as well?
Chief Pharmacist, Health and Community Services: Correct.
Senator S.W. Pallett:
I have a couple of extra questions. We touched on before the Jersey Cannabis Services Advisory Group. Does that work under any sort of terms of reference and could you explain the role of it? I think it is one of those that works outside of an official remit.
The Minister for Health and Social Services:
Senator, were you referring to the team within the Department for Economic Development that you may have once been involved with?
Senator S.W. Pallett:
I have never been involved with it unfortunately, or fortunately I should say. I think it probably does, yes.
The Minister for Health and Social Services:
Yes. I think that is different. That is about perhaps promoting the business, encouraging it, whereas in Health we are the regulatory process and as previous questions have alluded to there is not an advisory body yet in that role, although it might be appropriate to set one up to assist around the licensing and the regulation of people who are cultivating cannabis.
Senator S.W. Pallett:
My last question runs into that. Have you been involved at all with the Economic Development framework for cannabis investment? Is that something in which you have had a role to play?
The Minister for Health and Social Services:
I cannot recall any involvement other than what has come to the Council of Ministers in the normal course of lodging papers for the Council of Ministers. I cannot remember any particular involvement as the Minister for Health and Social Services.
Senator S.W. Pallett:
Okay, that is understood. That concludes my questions. Chair or Deputy Luce , do you have any other questions?
[13:15]
The Deputy of St. Mary :
I have got one general point on research I will raise right at the end but before that, as I said at the outset, we do have our colleagues from Grant Thornton online. Can I ask if any of them have got any further questions they wish to raise out of the replies we have received, for which we thank the Minister and the Chief Pharmacist? Over to Malta. Does anyone have any further questions?
Consultant to the Panel:
I have a question for the Chief Pharmacist. To be able to have traceability of the finished product would you allow exportation in bulk or will exportation be done in specific smaller doses?
Chief Pharmacist, Health and Community Services:
I think it depends on the product. If a local business was producing a finished product, packaged and labelled, it would obviously be in unit packaging, but I think there is not necessarily a limit per se on the amount that could be exported in one consignment. We would look to ensure that it is not unreasonable and that it is covered by an appropriate import authorisation of the destination jurisdiction. It could be that a company over here produces an A.P.I. (active pharmaceutical ingredient) for use by a local company to put into a finished medicinal product and that would perhaps lend itself more to bulk distribution in a finished medicinal product.
The Deputy of St. Mary :
If no one else has any questions can I ask my final question, which you may not be able to help me on? You touched on the question of research. Are there any specific requirements or limitations on licence holders wishing to undertake research into medicinal cannabis, whether that is as starting materials, active substances and finished medicinal cannabis projects?
Chief Pharmacist, Health and Community Services:
I think it depends. The nature of research is quite wide-ranging. It could range from plant genetics to look to develop certain strains of cannabis to produce a certain profile, through to clinical trials in medicines and there is a whole load of other regulations that surround that. I think it is difficult to provide an answer as there is such a broad base that can be covered by research.
The Deputy of St. Mary :
Given that some licences have been issued already and given that it is perceived that this could be a growth industry where the medicinal product is the icing on the cake or is the more lucrative area have you had any sense from the licence applications made as to whether they are intending to carry out such research over here, which would presumably require the import of appropriately qualified personnel?
Chief Pharmacist, Health and Community Services:
There has been no indication as yet that anybody is wanting to establish clinical trials over here. It would be not necessarily the manufacturer of the products themselves who undertake the trials, although they could with appropriate support from medical colleagues and things like that. I think the manufacturers would probably do more research into the product development, product stability, looking to develop easier to use products where the dose is more consistent, around that area, but it is potentially that clinics who are prescribing cannabis could look at research into the benefits and side effects and the relative merits of various cannabis products in different conditions. It is a very broad, complex area. It is much more difficult to undertake clinical trial type research in a finished medicinal product than it is to do research into product development type work.
The Deputy of St. Mary :
Okay, I will leave it at that, but from what you say you are not necessarily anticipating much activity in the provision of a product on the Island?
Chief Pharmacist, Health and Community Services:
I suspect that companies who are growing cannabis here would want to produce a finished medicinal product that they could then supply to pharmacies for dispensing prescriptions. Doctors could effectively prescribe those products and they could be supplied via pharmacy to patients. I think the production of a medicinal product itself does not require any research per se other than around the product itself. It is then a clinical decision whether or not to prescribe it.
The Deputy of St. Mary :
Okay, I will leave it at that. I see that Senator Pallett has a further question so over to you, Steve.
Senator S.W. Pallett:
I know that we have touched on this and the capacity of the Chief Pharmacist and almost certainly the need for additional resources. Does the Minister or the Chief Pharmacist have an idea of a timeframe for providing those additional resources and where any funding for that would come from?
The Minister for Health and Social Services:
As I mentioned earlier funding or part-funding can come from licence fees. As the Chief Pharmacist has mentioned additional resources need not necessarily hold a pharmacy qualification, because this is around making sure there is good governance and regulation and not necessarily yet in the medical field. That does not need necessarily to come as an extra pharmacist, so we might be able to draw on some assistance elsewhere. It is something I have spoken about pretty regularly with the Chief Pharmacist. I do not want him to become overwhelmed. I want to make sure that he has got capacity to do all the other work that he needs to do and that we have capacity as well to make sure that these licences are fully researched, looked into and assessed. That is an ongoing matter for us that we are considering.
Senator S.W. Pallett:
In terms of timeframe are you thinking weeks, months?
The Minister for Health and Social Services:
It would certainly be months I am afraid. I do not know if you have got anything to add?
Chief Pharmacist, Health and Community Services:
No. In order to secure additional resources the process if there is nobody immediately available that we could move around a little bit if you are looking for a new appointment is going to take months.
Senator S.W. Pallett:
Minister, you mentioned fees. By that I presume that there is an element of the cost of the Chief Pharmacist within the current fees. Is that something that you might look to extend if you had to bring on additional resource? Could that mean higher fees or just more taken out of the fees towards the pharmacist?
The Minister for Health and Social Services:
I think the fees are payable to the Chief Pharmacist at the present time. Is that correct?
Chief Pharmacist, Health and Community Services:
The fees are available for me to utilise to again secure additional resource. The challenge so far is being able to secure that additional resource, so the small period of time taken to review, at best we could use those licence fees to support the regulatory processes.
Senator S.W. Pallett:
Just to be clear, the licence fees are specifically for the remit of the Chief Pharmacist? It is not to pick up any other costs that might be incurred within the application process or checking things such as form filling and stuff like that?
The Minister for Health and Social Services:
That would all be done by the Chief Pharmacist or his department so it is all included in that.
The Deputy of St. Mary :
To follow on from that, I am sorry to keep on about the fee, is no part of that paid to the Home Office as such and how are they rewarded?
Chief Pharmacist, Health and Community Services:
Yes, there are 2 elements to the fee. There is a fee that is to cover purely the local licensing involvements that all applicants are required to pay and then they have to pay that plus the other fee, the Home Office levy as well, so the applicants pay the Home Office fees as well as ours.
The Deputy of St. Mary :
Again that is out of your fee for what you say it is for you, but if you come under pressure I can envisage that someone like the Environment Department might be saying to you: "This involves us in work" and similarly with the police. Have there been overtures in that direction?
Chief Pharmacist, Health and Community Services:
Nothing as such and obviously we can revisit the fees and the level and scale of those and apportion them if we need to.
The Deputy of St. Mary : Thanks for that.
Senator S.W. Pallett:
Sorry, Chair, just to be clear, it has been talked of previously, are these recurring fees each year or is this just a one-off fee? I presume there is a recurring fee for these businesses.
The Minister for Health and Social Services:
Yes, and there is a separate, reduced fee for a renewal of licence, so the fees order stipulates a fee for the initial granting of licences, it makes clear that any fee levied by the U.K. Home Office is in addition, so that is a requirement on the applicants to pay that, and then for each renewal there is a fee that is approximately half of the initial application fee.
The Deputy of St. Mary :
If there are no further questions from either of the panel or advisers may I finish by thanking you, Minister, and you, Chief Pharmacist, for your answers? I am sorry they were so detailed but it is a new area for us and as you will be aware we have further public hearings from other Ministers, so hopefully we will end up with some positive review at the end of it. Thank you for your time this morning.
[13:26]