We were discussing amendment No. 30 in the name of Deputy Haughey.
SECTION 5.
Debate resumed on amendment No. 30:
In page 7, subsection 2 (b), line 2, before " manufacture " to insert " import, export, transport, ".
I think it was Deputy Haughey who wanted it looked into. This subsection is to safeguard the position of practitioners and pharmacists as far as the manufacture, compounding and prescribing of drugs is concerned. Section 5 (2) (a) covers the medical practitioner, the dentist and the veterinary surgeon. In the same way because they are described separately in the Bill, section 5 (2) (b) was to apply the same to the pharmacists. What Deputy Haughey wanted in the Bill was to require that regulations be made in any other case, for the purpose of his profession or business to import, export and transport. This would give an overall power to pharmacists to import, export or to transport controlled drugs. Certain agencies would be given a licence with proper safeguards. It is not a normal role of a pharmacist to import, export or transport, but if he wanted an import licence to import a particular commodity he could make application for it and it could be granted or refused.
So under the Bill as it stands I thought Deputy Haughey was putting in an amendment to include, in relation to the pharmacist's obtaining drugs, an import and export licence should also be included, that it is not mentioned.
It is not meant to be mentioned here, because the normal role of the profession is not to import, export or transport drugs.
He just makes them up.
These two subsections are to safeguard the position of practitioners and pharmacists.
Who would be responsible for importing or exporting?
There would be manufacturing companies for the raw material and the wholesalers and so on. Under this proposed amendment I would have to make regulations to enable all pharmacists to have the right to import, export and transport.
Yes, I see that.
This would be something, incidentally, that is not given to the practitioners.
The Minister has full control over companies at the moment if they wish to import certain drugs?
Yes. I must make regulations to regulate import, export, manufacture, transportation and so on.
It is a pity Deputy Haughey is not here.
He is not going to be here. He is speaking on the Local Government Planning and Development Bill in the Dáil and he will be there for the afternoon.
Is the Minister satisfied that there is adequate protection under another section to guard against abuse?
There is a section which provides for the making of regulations for the importation, exportation, manufacture and transport. As I said, this section gives the right to pharmacists also.
Would the Minister repeat that again, please? This amendment would give——
No, not this amendment. I would make regulations, as has been suggested here, to allow pharmacists to import, export and transport. But the purpose of this particular section is to cover them in respect of controlled drugs.
May I say, in the absence of Deputy Haughey, that perhaps he might have an opportunity of commenting on this on Report Stage?
He would have an opportunity.
He can repeat the amendment on Report Stage.
Question put and declared lost.
I move amendment No. 31:
In page 7, after line 7, to insert a new subsection as follows:
" A medical practitioner shall keep in relation to every prescription issued for controlled drugs a separate record specifying
(i) the quantity of controlled drugs prescribed, and
(ii) the name of the person for whom they are prescribed,
and shall permit such record only to be inspected by any person authorised by the Minister."
Under section 5 of this Bill there are regulations to prevent the misuse of controlled drugs. I want to insert this amendment as a new subsection for subsection (3). My purpose in tabling this amendment is to further the control and facilitate both the profession and the Department in seeing that this Bill is effective. I am not going into a lot of detail. I think it adequate that the practitioners keep on record (a) the amount of the drug that is prescribed to the person and (b) the name and address of the person and say, possibly age and sex, but nothing as regards the person's medical history or condition or the reason why the drug was prescribed. A simple statistical record of the amount and to whom supplied should suffice.
I would like to see in this also some form whereby there could be a tie-up with the retail pharmacists, and this is a very broad aspect. One does not know whether it is any way practical to apply it throughout the country whereby, say, a recommended retail pharmacist for an area could also be included as a follow-up. I would be very interested if the Minister has any comments to make.
I can see what is in Deputy Byrne's mind, but if you have a look at section 5 (1) (c) you will see, and I quote:
The Minister may make regulations (c) requiring prescribed records to be kept in relation to controlled drugs and regulations under this section may specify the manner in which the records are to be kept and maintained and such regulations may also provide for the furnishing of information relating to such records to the Minister.
I think this gives a Minister ample scope in which to do all the things that Deputy Dr. Byrne wants. Under the regulations we have at present with regard to drugs there is a weakness in the record-keeping requirements as far as doctors are concerned, and maybe Deputy Byrne has this at the back of his mind. Under these regulations I can provide for the type of information or the type of records that may be kept, I would certainly visualise the name, age, sex, quantity and so on would be specified in that regulation. The intention is to require doctors, dentists, veterinary surgeons and pharmacists to keep records such as I have mentioned. I do not know whether he has adverted to 5 (1) (c)——
I tabled this to clarify that some members of the medical profession are wary at times of authorities inspecting the individual patient record, from the point of view of the ethical position of the privacy of the patient and the patient/doctor relationship. Line 29 of page 6, " the furnishing of information relating to such records " more or less specifies that the actual medical record would not be in any way as it is at the moment. Many doctors if they were asked under the present system to furnish a record of controlled drugs under this Act would have to refer to the patient's chart. If this was the record that would have to be provided there could be a possibility of a breach of confidence. It was to avoid this that he would keep this as a certain separate record even within the patient's chart.
I just have it for the Minister's consideration. I am not——
The Deputy does not accept that I can by regulation require prescribed records to be kept in respect of the various types of information.
I do.
——which is set out to be included, but as far as confidentiality is concerned I do not think there need be any worry on that. The medical profession have been consulted, and they agreed that the subsection as drafted will not impinge on the confidentiality of the patient. But it is necessary of course to those I have provided for in 5 (1) (c) and I think what Deputy Byrne suggests here is more or less a repetition of what is contained in 5 (1) (c).
In other words the Minister would have something along the lines that I have suggested would be something like the regulations that you might introduce at the appropriate time?
Yes.
Amendment, by leave, withdrawn.
Section 5, as amended, put and agreed to.