[SUBMITTED] Repeal "Universal Clinical Trials Act"

[Mesogiria]

Bear with me, friends, while I spin this out for you:

Repeal "Universal Clinical Trials Act"
Category: Repeal | Resolution: #82 | Proposed by: Mesogiria

Argument: The World Assembly,

Reviewing Resolution #82, "Universal Clinical Trials Act",

Applauding the goal of improving the safe research and development of medications,

Accepting that the testing of medical substances is a vital part of the research and development process,

Noting that the resolution fixes an exact and inflexible system of drug trialing,

Aware that scientific standards and practices can and do frequently change and evolve in light of new discoveries and inventions,

Concerned that such a fixed system may not reflect the best scientific practices in rapidly advancing areas of medicine, now or at any point in the future,

Further concerned that key term 'drug' is not defined within the resolution, promoting ambiguity over what substances are regulated therein,

Fearing that the mandating compiling of unedited trial results for 'access from any state or healthcare authority' could severely compromise the privacy of trial participants, particularly as the term 'healthcare authority' is not defined,

Hoping that a less restrictive, better defined resolution promoting the same ends can be drafted in the future with all due care and diligence,

Hereby repeals Resolution #82, "Universal Clinical Trials Act."

Second Draft

Repeal "Universal Clinical Trials Act"
Category: Repeal | Resolution: #82 | Proposed by: Mesogiria

Argument: The World Assembly,

Reviewing Resolution #82, "Universal Clinical Trials Act",

Applauding the goal of improving the safe research and development of medications,

Accepting that clinical trialing of medical substances is a vital part of the research and development process,

Disappointed that, contrary to its stated purpose, the resolution lacks a mandate for the performance of clinical trials, fatally undermining it,

Noting that the resolution fixes an exact and inflexible system of drug trialing,

Aware that scientific standards and practices can and do frequently change and evolve in light of new discoveries and inventions,

Concerned, therefore that fixing such a system in international law may be detrimental to the cause of scientific research, as it may not reflect the best practices of medical research now or at any point in the future,

Further concerned that the key term 'drug' is not defined within the resolution, promoting ambiguity over what substances are subject to regulation,

Fearing that the mandating compiling of unedited trial results for 'access from any state or healthcare authority' could severely compromise the privacy of trial participants, particularly as the term 'healthcare authority' is not defined,

Recognizing that these flaws combine to make the resolution arbitrary and inflexible where it should be more general, unacceptably lax where it should be firm, and overall fatally undermined and dangerous,

Hoping that a less restrictive, better defined resolution promoting the same ends can be drafted in the future with all due care and diligence,

Hereby repeals Resolution #82, "Universal Clinical Trials Act."

OOC: I would also note, as an aside, that the resolution itself contains at least a couple errors of grammar (the use of it's in "...who receive no drug at all, to measure it's effects....", but I don't know if mention of poor spelling is worth including in this proposal).

This is really my first ever shot at WA Resolution stuff, so any and all comments, positive and negative, are sought and welcomed. I believe I was around for the passage of this one in the first place, but that would have been a long time ago. My thought is that a replacement of this resolution by the creation of a similar commission charged with ascertaining and promoting the best standards of clinical drug trials would be the best thing, rather than nailing WA member states to one particular method now and forever.

[Philjia]

I'd be wary of repealing any WA resolution with a view to passing an improved version, as thee main goal of a large number of the delegtes seems to be to remove all the existing restrictions, and prevent new ones being passed.

[Mesogiria]

I'd be wary of repealing any WA resolution with a view to passing an improved version, as thee main goal of a large number of the delegtes seems to be to remove all the existing restrictions, and prevent new ones being passed.

I wouldn't have proposed the repeal if I didn't think that just blowing it up and sending it to the bottom with all hands wasn't okay by me too. Writing exact scientific procedure into a resolution seems incredibly clunky and restrictive, and we'd all be better off without it. Better off even further by having a nice commission to study and promote good clinical standards, but that's icing.

[Louisistan]

"Is you delegation planning on proposing a replacement? Also, we don't believe the missing definition of drug is a problem. When reading the operative clauses, I think we can reasonably assume what "drug" means in those clauses. I am more surprised by the fact that the resolution does not seem to mandate clinical trials to be made! It reads more like, 'IF you do clinical trials, do them by these rules'. To be quite honest, we would wish for a resolution mandating such tests."

[Mesogiria]

"Is you delegation planning on proposing a replacement? Also, we don't believe the missing definition of drug is a problem. When reading the operative clauses, I think we can reasonably assume what "drug" means in those clauses. I am more surprised by the fact that the resolution does not seem to mandate clinical trials to be made! It reads more like, 'IF you do clinical trials, do them by these rules'. To be quite honest, we would wish for a resolution mandating such tests."

"We do have plans for a replacement, but they are in the earliest stages at this point. Criticisms of "Universal Clinical Trials Act" that are highlighted here will be especially important in drafting the replacement, so any and all of those that delegates have to share would be welcome."

"In regards to your point, would adding a clause such as:

Disappointed that the resolution lacks a mandate for the performance of clinical trials, undermining its stated purpose,

cover you observation?"

[Mesogiria]

I'm wondering if it might be worth it to include a further criticism of the process for seeking exemptions, as it is not well-defined what sort of 'extenuating circumstances' would be necessary for granting an exemption. To my mind, such a passage would have included language like 'in case of an overwhelming threat to public health' or something similar.

[The Dark Star Republic]

I am more surprised by the fact that the resolution does not seem to mandate clinical trials to be made! It reads more like, 'IF you do clinical trials, do them by these rules'.

"We can't assume even a little common sense here? We might support a repeal, but taking it to this kind of ridiculous extreme is not compelling.

"The repeal argument as written is a bit contradictory. On the one hand, you accuse the resolution of creating an 'inflexible' system; on the other, of failing to define key terms. Now, both those arguments might be reasonable, but putting them together makes it seem like you find the resolution both flexible and inflexible. I would suggest picking out the stronger argument and trying to make one consistent string rather than picking at it piecemeal. The privacy concern is quite valid, for example."

~ Daisy Chinmusic
Legislative Intern to the Dark Star WA Office

[Mesogiria]

I am more surprised by the fact that the resolution does not seem to mandate clinical trials to be made! It reads more like, 'IF you do clinical trials, do them by these rules'.

"We can't assume even a little common sense here? We might support a repeal, but taking it to this kind of ridiculous extreme is not compelling.

"The repeal argument as written is a bit contradictory. On the one hand, you accuse the resolution of creating an 'inflexible' system; on the other, of failing to define key terms. Now, both those arguments might be reasonable, but putting them together makes it seem like you find the resolution both flexible and inflexible. I would suggest picking out the stronger argument and trying to make one consistent string rather than picking at it piecemeal. The privacy concern is quite valid, for example."

~ Daisy Chinmusic
Legislative Intern to the Dark Star WA Office

"Thank you for your interest. You are right that we've chosen to accuse the resolution of being both flexible and inflexible, but that is because it is flexible where it should be inflexible, and should be inflexible where it is flexible. Perhaps if the language of the repeal were to be altered to explicitly express this point?"

[The Dark Star Republic]

"Thank you for your interest. You are right that we've chosen to accuse the resolution of being both flexible and inflexible, but that is because it is flexible where it should be inflexible, and should be inflexible where it is flexible. Perhaps if the language of the repeal were to be altered to explicitly express this point?"

"Yes, I think that's a good idea."

[Mesogiria]

2nd draft

Repeal "Universal Clinical Trials Act"
Category: Repeal | Resolution: #82 | Proposed by: Mesogiria

Argument: The World Assembly,

Reviewing Resolution #82, "Universal Clinical Trials Act",

Applauding the goal of improving the safe research and development of medications,

Accepting that clinical trialing of medical substances is a vital part of the research and development process,

Disappointed that, contrary to its stated purpose, the resolution lacks a mandate for the performance of clinical trials, fatally undermining it,

Noting that the resolution fixes an exact and inflexible system of drug trialing,

Aware that scientific standards and practices can and do frequently change and evolve in light of new discoveries and inventions,

Concerned, therefore that fixing such a system in international law may be detrimental to the cause of scientific research, as it may not reflect the best practices of medical research now or at any point in the future,

Further concerned that the key term 'drug' is not defined within the resolution, promoting ambiguity over what substances are subject to regulation,

Fearing that the mandating compiling of unedited trial results for 'access from any state or healthcare authority' could severely compromise the privacy of trial participants, particularly as the term 'healthcare authority' is not defined,

Recognizing that these flaws combine to make the resolution arbitrary and inflexible where it should be more general, unacceptably lax where it should be firm, and overall fatally undermined and dangerous,

Hoping that a less restrictive, better defined resolution promoting the same ends can be drafted in the future with all due care and diligence,

Hereby repeals Resolution #82, "Universal Clinical Trials Act."

I've tried to take account of some of the feedback I've received so far, and hope you all find this version to be much improved.

[Louisistan]

"You now have our delegation's support. Not that it carries much weight in these halls, but still..."

[The Dark Star Republic]

Recognizing that these flaws combine to make the resolution arbitrary and inflexible where it should be more general, unacceptably lax where it should be firm, and overall fatally undermined and dangerous,

"I really like the way that clause is written.

"Some other points from the original resolution:

4) All participants in a Clinical Trial must be made fully aware of any and all possible risks associated with the drug being trialled.

"This is clearly nonsense and demonstrates a lack of understanding about what a clinical trial actually is. The possible risks associated with the drug cannot be known until the trial itself is completed.

"I also wonder if it's worth exploring condition 5:

5) Any persons who by way of age, disability, or mental competence are unable to give consent for the trial themselves, may be able to have a parent, guardian or ward of the court enter a consent on their behalf, if it is shown that there is a benefit to them participating in the trial.

"This is written so loosely as to create significant ambiguities. It even seems to allow one parent who is not the legal guardian of a child to overrule the wishes of the one who legally does have responsibility and enter their child into a clinical trial! I am not sure this is an error that the Medical Research Ethics Act covers, either."

~ Daisy Chinmusic
Legislative Intern to the Dark Star WA Office

OOC: A point I didn't pick up in the OP:

OOC: I would also note, as an aside, that the resolution itself contains at least a couple errors of grammar (the use of it's in "...who receive no drug at all, to measure it's effects....", but I don't know if mention of poor spelling is worth including in this proposal).

No, probably not. "Its"/"it's" bugs the crap out of me, but it's not exactly grounds for a repeal.

[Mesogiria]

"You now have our delegation's support. Not that it carries much weight in these halls, but still..."

"Well, it's appreciated anyway. Any vote's a good vote."

"I really like the way that clause is written.

"Thank you. I had to whip my legal interns mercilessly, but they did eventually put out a good phrasing for it."

"Some other points from the original resolution:

4) All participants in a Clinical Trial must be made fully aware of any and all possible risks associated with the drug being trialled.

"This is clearly nonsense and demonstrates a lack of understanding about what a clinical trial actually is. The possible risks associated with the drug cannot be known until the trial itself is completed.

"A good point, but I'm presently unsure how we could incorporate this criticism into the proposal."

"I also wonder if it's worth exploring condition 5:

5) Any persons who by way of age, disability, or mental competence are unable to give consent for the trial themselves, may be able to have a parent, guardian or ward of the court enter a consent on their behalf, if it is shown that there is a benefit to them participating in the trial.

"This is written so loosely as to create significant ambiguities. It even seems to allow one parent who is not the legal guardian of a child to overrule the wishes of the one who legally does have responsibility and enter their child into a clinical trial! I am not sure this is an error that the Medical Research Ethics Act covers, either."

"While you raise a good point here, I'd actually like to say that, in checking into the terms a 'ward of the court' is typically defined as a minor or legally incapacitated person who is under the legal protection of a court. So this resolution, apparently, allows people to have a parent, guardian, or minor/incapacitated person under the protection of a court consent on their behalf to join a drug trial. This seems... not the best idea."

[Mesogiria]

5) Any persons who by way of age, disability, or mental competence are unable to give consent for the trial themselves, may be able to have a parent, guardian or ward of the court enter a consent on their behalf, if it is shown that there is a benefit to them participating in the trial.

Looking further at this, I am at a loss as to how it was missed in the first place when the resolution was being debated. Wards of the court have no legal authority over anybody, and this just conjures up the image of orphaned nine-year-olds signing people into clinical drug trials in exchange for candy bars.

[Mesogiria]

I'm looking at ways to incorporate the criticism of having orphaned 8 year olds signing people into drug trials. In the meantime, does anyone else have a comment?

[Mesogiria]

So, um, apparently I decided to take this draft for a walk last night, and see if anyone thought it was a good idea, and so far about 26 or so of you have, which makes me feel all warm and fuzzy inside.

[Pennswald]

Noting that the resolution fixes an exact and inflexible system of drug trialing,

Aware that scientific standards and practices can and do frequently change and evolve in light of new discoveries and inventions,

Concerned, therefore that fixing such a system in international law may be detrimental to the cause of scientific research, as it may not reflect the best practices of medical research now or at any point in the future,

The only requirements are a placebo group, a control group, and a double blind study. So the law requires:

elimination of the placebo effect
verfication that any therapeutic effect is actually due to the drug
elimination of bias thorugh knowledge of which subjects have actually received the drug

Given that these requirements do not "fix an exact and inflexible system", nor would they be invalidated by future discoveries and inventions, I submit to you that your core argument for repeal is invalid. Indeed, these requirements ensure that drug trials are conducted scientfically. Remove these requirements and even homeopathic "remedies" could be proclaimed to have had successsful trials.

We cannot support a repeal on these grounds.

[Mesogiria]

The only requirements are a placebo group, a control group, and a double blind study. So the law requires:

elimination of the placebo effect
verfication that any therapeutic effect is actually due to the drug
elimination of bias thorugh knowledge of which subjects have actually received the drug

Given that these requirements do not "fix an exact and inflexible system", nor would they be invalidated by future discoveries and inventions, I submit to you that your core argument for repeal is invalid. Indeed, these requirements ensure that drug trials are conducted scientfically. Remove these requirements and even homeopathic "remedies" could be proclaimed to have had successsful trials.

We cannot support a repeal on these grounds.

I think it is merely a difference of opinion that separates us on these points, but I am disappointed that you completely ignored the other problems highlighted with this resolution, such as the lack of any mandate to actually perform drug trials, which means that any such substance can neatly avoid this regulation simply be refusing to undertake a drug trial.