Dáil Éireann debate -
Thursday, 5 Jul 1990

Vol. 401 No. 2

Control of Clinical Trials and Drugs Bill, 1990: Committee and Final Stages.

Section 1 agreed to.

SECTION 2.

Question proposed: "That section 2 stand part of the Bill."

Mr. Yates

The new part is section 2 (a) (ii) which states that the principal purpose of that administration is to prevent disease in, or to save the life, restore the health, alleviate the condition or relieve the suffering of the patient.

Regarding the administration of drugs such as DDI to AIDS patients, or certain new drugs for leukaemia or terminal cancers, would that be considered exempt? Could the Minister give a practical example of something that was considered to be a clinical trial under the old Act which will now be considered normal clinical practice, not subject to the rigours of this legislation? It is important to clarify this matter. There must be a public assurance that unsafe drugs are not being used. Consultants have told me about the amount of paperwork they would have to go through in order to get approval for the use of a drug whose efficacy is fairly well known in other countries. In the context of new developments, this could be vital to individual patients. I should like an assurance that such administration of drugs would be considered as normal clinical practice and therefore exempt.

Dr. O'Hanlon

The purpose of amending the section is to clarify the circumstances in which a drug would be exempt from the scope of the 1987 Act. It was not very clear in that Act and is much clearer now in section 2 of this Bill. It refers to a person who would be terminally ill and the possibility that the use of a particular drug might be lifesaving. Obviously the drug would be used as a matter of urgency, as distinct from using the drug in the nature of a trial to see what its effect would be. If a patient was terminally ill in a hospital in the country and the clinician looking after the patient believed that the administration of DDI would be lifesaving, I would envisage that the clinician would not come within the scope of the Act. However, if somebody was trying the drug on HIV patients in the course of scientific research to establish the value of the drug in the treatment of a particular illness, it would certainly fall within the scope of the legislation. Sometimes new drugs which have never been licensed are flown in from around the world in an attempt to save life. One drug was flown in from Japan because it was thought it might be lifesaving. It would be fairly clear to the clinician but if there is any doubt there are many resources which can be tapped for an opinion, such as the Minister and the Department of Health and the National Drugs Advisory Board. I do not think it would cause a problem in practical terms.

Mr. Yates

The exemption is to do with the condition of the patient rather than the drug itself. It could be a clinical trial if administered to one person but the same drug administered in other circumstances might not constitute a clinical trial.

Dr. O'Hanlon

That is correct. There is some difficulty for the clinician, who would obviously be very conscious of what is already known about the drug. For instance, DDI has toxic side effects of which the clinician would be conscious. The decisions have to be left to the clinician looking after the patient. The reason the drug is being used is of central importance. If it is used as one last chance to save a life, that would fall outside the Act; if it is used to see how it will perform, it is very much within the scope of this legislation.

Mr. Howlin

It is very important to tease out this point. I welcome the Minister's clarification but there is a grey area here. Ultimately the responsibility falls back on the doctors. How does the Minister intend to clarify the matter for them? In a litigious society people are afraid of legal action and if there is any ambiguity in this matter it is possible that innovative procedures which, potentially, could be lifesaving might not be tried because the clinician involved feels there is a legislative bar or a procedure he has to go through. How does the Minister intend to clarify this matter for the medical profession so that there is no ambiguity?

Dr. O'Hanlon

It will be referred to in the guidelines. It is important that there should be no ambiguity and the Deputy is correct in saying it is a grey area. One physician might feel justified in using a drug in certain circumstances while another might have a reservation. The National Drugs Advisory Board, the Medical Council and the Department of Health are important resources. If a doctor were to take a short cut and go ahead and use the drug for a trial without going through the procedures outlined, that doctor could well be leaving himself in some difficulty. Traditionally in medicine, doctors have used drugs which had not been fully tested as one last effort to save a life. We would not want to interfere with that in any way or to place any restrictions. Deputies will appreciate that there is a balance to be struck. The legislation takes account of this balance and it is now clearer in this section that there are exemptions for a lifesaving purpose. We are not in any way diminishing the very necessary powers under the Act to deal with clinical research and clinical trials.

Mr. Byrne

Section 2 (b) states:

Where the substance or preparation concerned is to be administered to persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner or as a registered dentist or as a registered pharmaceutical chemist and where it is to be administered as part of such a course of training, or

Could the Minister explain this? I am sure there is a very reasonable answer. Who would engage in that type of activity?

Dr. O'Hanlon

Section 2 (b) applies to students who are undergoing a course of training and this would apply to students who might make something themselves in a laboratory and then taste it. For example, a pharmaceutical student might make hydrochloric acid or vinegar and then taste it. This gives them a perception of the taste of the substances they are working with and in that way they might be involved in a trial. This subsection allows for that in very controlled circumstances and they would not need to go off and seek authority under the Bill from the Minister for Health.

Mr. Howlin

We should run the whole gamut and perhaps the Minister would clarify the final exemptions covered in section 2 (c). Perhaps the Minister would explain what is a normal dietary constituent. There are many health products coming on the market which are classified as a food rather than a preparation, and one such thing that springs to mind is "Royal Jelly" or a product of that nature. Would that be considered a normal dietary constituent? What particular products had the Minister in mind in that subsection?

Dr. O'Hanlon

This relates to products which are not medicines but are normal dietary constituents, for example, vitamins that are in the normal diet.

Mr. Howlin

The point I am trying to raise is that some people would classify certains products as a food, for instance, "Royal Jelly", but I am sure there are other products also, and if you would go into a health food shop there are products which are not medicines or drugs but are described as food. I wonder if that global category entitles people to classify what may well be considered a drug as food and would the Minister be concerned that such a product would be exempted?

Dr. O'Hanlon

Yes, I share Deputy Howlin's concern, and I have been concerned about products on the market. We have drawn up a list of products that have to be licensed because we believe they are medicines and drugs. Indeed, we have had discussions with people involved in promoting the sale of these products and we are monitoring this very carefully. A great many of these products now have to have product authorisation from the National Drugs Advisory Board, so that if we have the slightest concern about a product we refer it to the board. The Deputy is quite right that many products are coming on the market and it is very important that they are monitored closely and that if we have any doubt about them they should be referred to the National Drugs Advisory Board for product authorisation before they can be sold.

Question put and agreed to.

SECTION 3.

Question proposed: "That section 3 stand part of the Bill."

Mr. Yates

Will the Minister state the specific requirements to be met in order to gain his approval for the conduct of a trial, as it is not set out in the Bill in lines 20 to 25? I think it is important that it is established in the House what the criteria will be and it should be clear whether we are talking about a bond of £10,000 or £1 million or a bond that covers the dependants of a person engaged in a clinical trial in the case of injury or loss of life, or would it merely cover the cost of medical treatment of the participants until they are well again? We need to be assured that there will be an orderly legal framework for the conduct of clinical trials and that there will be ample protection and financial compensation in the event of a disaster. I ask the Minister to put on record exactly what will be necessary to get his approval.

Mr. Howlin

A Cheann Comhairle——

An Ceann Comhairle

Perhaps we should hear the Minister's reply to Deputy Yates's query.

Mr. Howlin

If we have a related query it might save time if it was taken now, as we have very little time.

An Ceann Comhairle

That is fine. Deputy Byrne wishes to come in also.

Mr. Howlin

Has the Minister already prepared the draft regulations, and if so, will he make them available to us at this stage, as it might help us to understand exactly what he has in mind?

Mr. Byrne

Perhaps the Minister could tell me what written commitments or contracts are given to the volunteers as to the duration of monitoring and the extent of the insurance cover available to them. In other words, are the volunteers just walking in off the street, signing a form and then walking out, or is there an enforceable agreement established between the person being tested and the agency or hospital carrying out the test?

Dr. O'Hanlon

I agree with the point raised by Deputy Yates, although obviously one cannot be specific in a Bill because all trials are different. However, I agree with the Deputy that it is important that there is sufficient compensation to take account of the participant and the obligations to their dependants in the event of a mishap.

On the question of the draft regulations, we do not have them available at present, but we will be working on them and I am taking account of this amendment to the 1987 Act.

Deputy Byrne raised the question of contracts and under section 9 of the principal Act each participant has to give his or her informed consent. In fact, the whole purpose of the 1987 Act was to protect the participants in a trial while at the same time ensuring that we did not impede legitimate research. Section 9 of that Act went to great lengths to ensure that the participant in the clinical trials gives his or her informed consent, and sets out the preliminary steps to be taken to ensure that the person is medically fit and has been examined by an independent medical practitioner. There is good protection for the participant and somebody could not just walk in off the street and say: I would like to participate in a trial. That is totally against the spirit of the Act and in fact it would be illegal for a clinician to take somebody off the street because the Act is very specific in order to ensure that we deal with the very point that Deputy Byrne has raised, that is, to protect the interests of the participant. In addition, there is a six day cooling off period after the participant gives his or her consent, so there is no danger of somebody being walked into participating in a trial for whatever reason.

Mr. Yates

I appreciate the Minister cannot be specific but perhaps he could give us some idea of what is meant by "insurance", "indemnity", "a guarantee", "a surety" and whether the figure involved is £10,000 or £1 million? Would the Minister give us some idea of the type of bonds involved? Second, the reason that section 10 of the principal Act failed is that insurance was not available to ethics committees and individuals, and will insurance be made available now? Has the Minister had discussions with the Medical Protection Society and the Medical Defence Union to see that both the clinicians and the participants are covered by insurance?

Dr. O'Hanlon

The activities of the doctors are covered by the two professional organisations, the Medical Defence Union and the Medical Protection Society. With regard to the question of the exact amount, it is very difficult to be specific on this. I will be taking actuarial advice on how we can, depending on the nature of the trial and the risk, ensure that the appropriate provision has been made. This is the sort of issue on which I would take professional advice. I would be doing an injustice to Deputy Yates and the House if I were to give a figure off the top of my head. I want to ensure that there is proper protection for the participant and, as I have said, I will be taking actuarial advice on this.

Question put and agreed to.

SECTION 4.

Question proposed: "That section 4 stand part of the Bill."

Mr. Yates

The difference between section 4 of this Bill and section 13 of the 1987 Act is in the phrases "or by a person purporting to act on behalf of a body corporate" and "the person so purporting to act". Why were these phrases included in the Bill? Were they included to cover a loophole?

Dr. O'Hanlon

The purpose of this amendment to section 13 of the 1987 Act is to extend the defences provided for in section 13 (2) (b) to unincorporated bodies of persons, in particular, the ethics committees.

Question put and agreed to.

SECTION 5.

Question proposed: "That section 5 stand part of the Bill".

Mr. Yates

The Minister was absent when I spoke on Second Stage. This is the section about which I am most concerned. While I am very anxious to let the ethics committees off the hook and allow the research to proceed, I am not anxious to let everybody off the hook so that when something goes wrong people will find it impossible to claim.

The Minister referred to the question of negligence in his reply on Second Stage. If, to give a hypothetical example, the Minister gives approval to St. James's Hospital to carry out a trial in which I am the participant and it suddenly transpires that something went wrong — the insurance was not in order because someone in the Department made a mistake in checking it — this would mean that approval could not be given to my claim for £1 million when it should have been given. Section 5 (1) does not make any reference to negligence or an error; it just says "... have been caused or contributed to by reason of or arising from the discharge of any of their functions... .". This would include the Minister, the Department and the NDAB. If something goes wrong, who will carry the can? In other words, who will the aggrieved participant sue? This is such a global immunity for everybody, I wonder what form of redress there will be in the event of something going wrong.

Dr. O'Hanlon

Obviously the case outlined by Deputy Yates is one where the approval would be given in error and should never have been given. Of course, this would be covered by the words "wilful neglect or default", depending on which it was.

Mr. Howlin

"Wilful."

Dr. O'Hanlon

Section 5 (1) states: "No action or other proceeding shall lie or be maintainable (except in the case of wilful neglect or default) against (a) the Minister, (b) the National Drugs Advisory Board or any person acting as a member, officer or servant thereof, (c) an ethics committee or any member thereof...".

Mr. Howlin

It need not be wilful, it could be accidental. Would there be any redress for the patient in those circumstances?

Dr. O'Hanlon

Obviously, it would either be negligence or it would not. If it was not negligence there would not be a basis for an action against the Minister or the National Drugs Advisory Board.

Mr. Howlin

The word "wilful" implies that it was done willingly. In view of what the Minister has said it might be better to remove the word "wilful" from the section. Wilful neglect is very hard to prove in court. In the case referred to by Deputy Yates, there would be clear neglect, whereas wilful neglect means that there was a conspiracy almost to be neglectful and it was a matter of free will.

Mr. Yates

A deliberate error.

Mr. Howlin

Absolutely. In the case referred to by Deputy Yates it would seem at the end of the day that the patient would have no redress because there will be no one left to carry the can. We need to look at this point carefully.

Mr. Yates

Would the Minister consider removing the word "wilful"?

Dr. O'Hanlon

If the words "wilful neglect" were in the Bill alone I certainly would be prepared to look at it, but as section 5 refers to "wilful neglect or default" I think that covers the point made by Deputy Howlin.

Mr. Yates

The whole situation will be changed vis-á-vis the 1987 Act, where the ethics committees were responsible. Under this Bill the Minister will be responsible for approving the claim, but it is very difficult to see how one could take a case against him under section 5. Will the Minister outline the circumstances where he would see any of the groups under paragraphs (a), (b) or (c) having any responsibility for their actions in overseeing clinical trials?

Mr. Howlin

While the Minister is collecting his thoughts on that point, I want to pursue one step further the words "wilful neglect or default". Any court looking at this section could go with both categories. This would weaken a case to the point of making it extraordinarily difficult for anybody to take action against the Minister or anybody else.

Dr. O'Hanlon

I think both categories stand alone in section 5. I have an open mind on this. The only difficulty I would have in removing the word "wilful" from section 5 is that I would have to go back to the Seanad and possibly come back to this House. I think it is clear that the two categories stand alone. If it was intended to cover wilful default the word "wilful" would be included the second time. I do not think it is necessary to remove the word "wilful". As I have said, if the word "default" was not included in section 5 I would have the same reservations as the Deputies.

On the question of the right to sue, there is always the option to sue in civil law even where negligence is not involved.

Mr. Yates

Could the participant take a civil action against the Minister?

Dr. O'Hanlon

Yes.

Question put and agreed to.

Title agreed to.

Bill reported without amendment and received for final consideration.

Question proposed: "That the Bill do now pass."

Dr. O'Hanlon

I should like to thank my colleagues in the House for the expeditious way in which they have dealt with this important legislation which is obviously necessary in the context of the clinical research which is presently awaiting approval. I should particularly like to thank my colleague, the Minister of State, and also Deputy Yates, Deputy Howlin and Deputy Byrne for their contributions. It is also appropriate to thank Mr. Michael Lyons, an official from my Department, for his work and contribution to the preparation of this legislation.

Question put and agreed to.