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by Astralsideria » Thu Apr 08, 2010 11:13 pm
by Mousebumples » Thu Apr 08, 2010 11:20 pm
Astralsideria wrote:His Majesty's Government in Right of the United Kingdom of Astralsideria have communicated to the Leader of His Majesty’s Permanent Delegation to the World Assembly, The Rt. Hon. Sir Gottschalk Hannibal, Baron Hannibal of Port-au-Prince in the Region of West Ravenslaw, the absolute refusal of His Majesty's Government to allow him permission to vote in favour of this proposal. His Majesty's Government feel the increasing tendency within this noble forum to attempt to curb National Self-Determination to be tremendously worrying. His Majesty's Government accept that it is a tremendously well-intentioned Bill, but also feel that it must be taken into consideration that there are nations who routinely make use of recreational drugs, and that several of these might be driven from the World Assembly were this Bill to become law. His Majesty's Government accept that curbing unlawful use of recreational drug use is a worthy aim, and fully commend the Honoured Ambassador for attempted so to do, but do feel, most strongly, that this is hardly a matter for the World Assembly, and should be handled by National- or Devolved-Level Government, not Transnational-Level Authority.
by Astralsideria » Thu Apr 08, 2010 11:33 pm
Mousebumples wrote:.... How does this curb the use of recreational drugs? It encourages research into the risks and benefits of recreational drugs - and some recreational drugs may be later legalized as a result of this research, depending on what is discovered.
Nowhere in the legislation does it distinguish between (or even specifically mention!) legal and illegal drugs. It distinguishes between medical/therapeutic and recreational drugs, but both types are included in the research/education side.
I appreciate your support - but this proposal in no way attempts to curb recreational drug use - which happens to be legal in my own nation, for whatever that's worth. (They're not highly promoted or popular, but we're something of a libertarian society, and my citizens are given the right to make that decision for themselves.)
If you can quote specific clauses that you feel are specifically working to "(curb) unlawful use of recreational drug use," I'd appreciate if you could quote them back at me, so I can evaluate those clauses and perhaps make some edits, if needed. That is certainly not the intent of this proposal.
Yours,
Ambassador Lizzy Hall
Leader of the Doctoral Monkey Feet of Mousebumples
WA Delegate for Monkey Island
by Mousebumples » Fri Apr 09, 2010 12:40 am
Astralsideria wrote:We accept, in the light of this, that some of this proposal may have been misinterpreted in a rush of over-enthusiasm, for which we apologise. Our initial comment will be stricken.
Again, apologies.
by Bears Armed » Fri Apr 09, 2010 4:22 am
by Mousebumples » Fri Apr 09, 2010 11:22 am
Bears Armed wrote:I think you need to re-word this so that it requires -- or at least urges -- that the WA's member nations, actually do something: Otherwise, it would almost certainly be ruled illegal on the basis that "It only creates a committee"...
by Bears Armed » Sat Apr 10, 2010 3:03 am
Mousebumples wrote:Bears Armed wrote:I think you need to re-word this so that it requires -- or at least urges -- that the WA's member nations, actually do something: Otherwise, it would almost certainly be ruled illegal on the basis that "It only creates a committee"...
I'm not sure if that's true. It accomplishes similar "effects" to my ULC proposal - just this one is medical based. Granted, I presumed that medical professionals who have access to IDEA/DOCTUS would use that information to impact their health care decision-making. Additionally, it adds funding for further research on established drugs.
If you have any specific ideas about what should be added, "actionable"-wise, I'm more than willing to consider them. I'm happy to specify recommendations for nations and/or national health advisory boards or individual doctors within WA nations or .... something else. However, I'm not sure what (if anything) you had in mind.
Thanks for your consideration!
which could explain the increased national expenditure... whereas I'm dubious as to whether this draft'sENCOURAGES all nations to join the ULC, to allow for the spreading of information and ideas across the Nation States universe. Participating nations will have the Universal Library made available to all of their internet portals. Member nations may also choose to provide content filters for their citizenry. Participating nations may build physical libraries within their borders at their own cost. Each participating nation will maintain a backup of their national data archived within the ULC.
would suffice.individual nations may provide this information to others within their own borders as they deem appropriate
by Mousebumples » Sat Apr 10, 2010 6:21 am
Bears Armed wrote:OOC: The problem is that, because each resolution that passes has automatic effects on all member-nations' stats (in the case of 'Education' resolutions, an increase in their spending on Education of course...) every resolution has to include something to justify this... and your current draft really only has the WA setting up this agency, and what this agency will do, with no clear justification for that effect. ULC, after all, included a clause thatwhich could explain the increased national expenditure... whereas I'm dubious as to whether this draft'sENCOURAGES all nations to join the ULC, to allow for the spreading of information and ideas across the Nation States universe. Participating nations will have the Universal Library made available to all of their internet portals. Member nations may also choose to provide content filters for their citizenry. Participating nations may build physical libraries within their borders at their own cost. Each participating nation will maintain a backup of their national data archived within the ULC.would suffice.individual nations may provide this information to others within their own borders as they deem appropriate
ESTABLISHES the Database Of Clinical Treatments Under Study (DOCTUS) as a drug education branch of the Universal Library Coalition (ULC);
1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.
2. Said data will be made available to, at minimum, all medical professionals within WA nations; individual nations may provide this information to others within their own borders as they deem appropriate.
3. All research data within DOCTUS will be accompanied by a link to the relevant journal article, if the research has been published;
(a) IDEA will provide appropriate monetary reimbursement to journals that are not currently archived in the ULC so that their research can be accessed through DOCTUS by credentialed individuals.
(b) If a journal and/or individual article is not available through DOCTUS or the ULC, appropriate citations will be listed so that the information in question can be accessed through alternate avenues.
RECOMMENDS that Health Research & Development Division of the WHA accept applications for funding from WA member nations for further research regarding already discovered medication therapies to better understand their safety and efficacy with long-term use;
ALLOWS for IDEA professionals to issue non-binding recommendations regarding suggested changes to currently established medication therapy standards
Bears Armed wrote:Maybe you could make the national governments specifically responsible for collecting the original data and passing it to DOCTUS, and then for making DOCTUS's reports available to any interested [& relevant] professionals within their territories?
by Bears Armed » Sat Apr 10, 2010 6:41 am
Mousebumples wrote:I understand the rule. However, as I tried to explain (without quote) in my original response, there are at least two obvious things that the proposal *does* within a WA nation. Some of it may be implied (as what medical professionals do with the additional education/information that they receive isn't specifically legislated upon), but this proposal is facilitating the spread of information.ESTABLISHES the Database Of Clinical Treatments Under Study (DOCTUS) as a drug education branch of the Universal Library Coalition (ULC);
1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.
2. Said data will be made available to, at minimum, all medical professionals within WA nations; individual nations may provide this information to others within their own borders as they deem appropriate.
3. All research data within DOCTUS will be accompanied by a link to the relevant journal article, if the research has been published;
(a) IDEA will provide appropriate monetary reimbursement to journals that are not currently archived in the ULC so that their research can be accessed through DOCTUS by credentialed individuals.
(b) If a journal and/or individual article is not available through DOCTUS or the ULC, appropriate citations will be listed so that the information in question can be accessed through alternate avenues.
RECOMMENDS that Health Research & Development Division of the WHA accept applications for funding from WA member nations for further research regarding already discovered medication therapies to better understand their safety and efficacy with long-term use;
I clearly cut out a few parts - but all WA medical professionals will be provided access to this information. It's not a specific action by a nation, but the increase in education funding is used to further/better educate these individuals, at minimum. (See also, the clause regarding reimbursement for the journals that are not archived in the ULC.)
Additionally, there is further funding of research within WA member nations - although, granted, that does not contain a government mandate/recommendation either.
by New Rockport » Sat Apr 10, 2010 12:23 pm
Mousebumples wrote:New Rockport wrote:Mousebumples wrote:SPECIFIES that IDEA will collect all drug-related data, including both medication therapy and recreational drug use research to allow for a better understanding of the risks and benefits all drugs.
[...]
1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.
These two clauses might be problematic, as some of these data might be proprietary and confidential. Perhaps IDEA should "...collect all publicly available drug-related data..." and "...archive all publicly available research data..."
(My main concern arises from a RL situation. Some drug companies have stalled on releasing this information for as long as possible. I could search out actual links if needed, but I can think of at least 3 examples off-hand ...The point of this proposal is to expand education and knowledge of drug products - and I'm not sure how data points are proprietary and confidential. If the drug isn't on the market yet, I could see the point, perhaps - and I could definitely add in a clarifying clause for that. (Although - again IRL - drugs are patented in the US loooong before drugs even get near patient testing, so I wasn't concerned about drug product intellectual property; however, NS patent laws are not as clear, which I neglected to consider.) However, if the drug is being taken by patients worldwide, I am of the opinion that individual safety is more important that protecting company profits in these cases.
- Purdue Pharma claimed to the FDA, when originally marketing Oxycontin (Oxycodone Extended Release) that it would be *less* addictive and *less* likely to be abused due to the new formulation. Actual use of Oxycontin in the market showed that to be demonstrably false. (I'm not positive if there was "hidden data" here, but at the very least, there was no *valid* supporting data for the original claim that was made.)
- Some antidepressant manufacturers declined to publish certain Drug versus Placebo studies as there was not statistically significant benefit versus the placebo.
- The makers of Vytorin stalled (and stalled ... and stalled) on publishing the data from their comparison with Zocor (Vytorin is a combination drug of Zocor + Zetia) as it did not have any statistically significant improvement over the single drug of Zocor ... which is generic.)
I'm not sure if I'm really addressing your concern - or that I'm clear on what your objection is. I've accounted for providing monetary reimbursement (I believe) to account for the intellectual property rights. What other concerns do you have regarding the release of unpublished data? (Additionally, why would drug studies be "confidential" ? If there's a precedent in your nation/other nations that I'm unaware of, please enlighten me.) I could also add in a clause stating that IDEA/DOCTUS subscribers are not allowed to publish studies based on not-yet-published data without the express consent of the involved scientists, but I'm not sure if that's what you're getting at.
I very much appreciate your consideration of this subject, and I look forward to further discussing this issue with you.
by Sionis Prioratus » Sat Apr 10, 2010 5:49 pm
Mousebumples wrote:Council: General Assembly
Category: Education and Creativity
Area of Effect: Education
UNDERSTANDING that safety and efficacy are important standards with regards to drug therapy.
ACKNOWLEDGING that a single drug may cause different benefits and/or side effects in each of the many species that are native to WA member nations.
DESIRING to more fully understand the potential benefits and harms with regards to using drugs among different species.
CREATES the International Drug Education Agency (IDEA) as a sub-committee of the World Assembly Food and Drug Regulatory Agency (WAFADRA).
SPECIFIES that IDEA will collect all drug-related data, including both medication therapy and recreational drug use research to allow for a better understanding of the risks and benefits all drugs.
ALLOWS for IDEA professionals to issue non-binding recommendations regarding suggested changes to currently established medication therapy standards.
ESTABLISHES the Database Of Clinical Treatments Under Study (DOCTUS) as a drug education branch of the Universal Library Coalition (ULC);
1. IDEA will archive all research data within DOCTUS, including research data from studies and trials that have not been published, for whatever reason.
2. Said data will be made available to, at minimum, all medical professionals within WA nations; individual nations may provide this information to others within their own borders as they deem appropriate.
3. All research data within DOCTUS will be accompanied by a link to the relevant journal article, if the research has been published;
(a) IDEA will provide appropriate monetary reimbursement to journals that are not currently archived in the ULC so that their research can be accessed through DOCTUS by credentialed individuals.
(b) If a journal and/or individual article is not available through DOCTUS or the ULC, appropriate citations will be listed so that the information in question can be accessed through alternate avenues.
4. Non-WA nations may apply for access to DOCTUS; a nominal fee may charged by the IDEA for access, as determined on a case-by-case basis.
DETAILS that IDEA medical professionals will publish quarterly IDEA newsletters;
1. The newsletters will be written by health care professionals and will detail the most significant discoveries in drug therapy, such as new indications for an already discovered drug, new concerns regarding side effects for an established drug, new recommendations for use in certain populations, etc.
2. The IDEA Quarterly will be provided to all interested nations free of charge and will be archived within DOCTUS with the appropriate reference citations.
RECOMMENDS that Health Research & Development Division of the WHA accept applications for funding from WA member nations for further research regarding already discovered medication therapies to better understand their safety and efficacy with long-term use;
1. Applications for funding must include details of how the study would be conducted and what drug(s) would be studied.
2. Funded studies must receive the informed consent of all participants in the study.
3. Studies are strongly encouraged to have a control group of some nature.
CHARACTER COUNT: 3,078
by Urgench » Tue Apr 13, 2010 11:02 am
by Unibot » Tue Apr 13, 2010 3:04 pm
Urgench wrote:We are rather concerned that the findings of the IDEA will be injurious to national pharmaceutical industries and established and efficacious drug therapies, and that its recommendations will appear to have greater authoritative value than the recommendations of national drug therapy regulatory authorities. Is there any way in which national governments may challenge the recommendations of the IDEA should they have genuine concerns that its recommendations are not efficacious or appropriate?
Yours,
Vocenae wrote:Unibot, you have won NS.
by Mousebumples » Sun May 30, 2010 7:19 am
Bears Armed wrote:OOC: Well, yes, but all but the first of the points that you highlighted (or should that be "highlit"?) specify WA spending rather than national spending and thus don't really help to explain the proposal's potential [automatic] effects on national budgets...
New Rockport wrote:Some of these data might be legally privileged. For example, data gathered in anticipation of litigation would be privileged under the work product doctrine.
Additionally, some jurisdictions recognize a self-critical analysis privilege. Suppose a drug manufacturer conducted an internal investigation which prompts it to take a corrective action regarding its product. This investigation might be privileged.
So, perhaps there should be an exception for data that are privileged under international or domestic law.
Sionis Prioratus wrote:IC: Oh, wonderful! We just love (well-written) health resolutions. This is one of them.
For now, minor remarks... We know character count is always a challenge, but the highlighted parts, in our view, may engender a loophole as some nation(s) can claim the impact of each drug in each and every species, every single one of them, is necessary to release a drug into the market. From elephants to algae. This could bring the industry to a halt and destroy it. In short, a little bit loosely defined, maybe "sapient species" would remedy it?
We have no issues with freedom of information, but we understand it can be a thorny issue for some Delegations, as said by some respected ones.
And maybe: "better understanding of the risks and benefits of all drugs"?
Urgench wrote:We are rather concerned that the findings of the IDEA will be injurious to national pharmaceutical industries and established and efficacious drug therapies, and that its recommendations will appear to have greater authoritative value than the recommendations of national drug therapy regulatory authorities. Is there any way in which national governments may challenge the recommendations of the IDEA should they have genuine concerns that its recommendations are not efficacious or appropriate?
Unibot wrote:"Use a combination of propaganda, junk science, and spin marketing techniques to combat the 'truth'. Unibotians have been utilizing these wholesome tactics for years." Pascal explained causally, while smoking his tobacco pipe.
by Mousebumples » Mon May 31, 2010 8:13 pm
by Mousebumples » Wed Jun 02, 2010 8:32 pm
by Unibot » Wed Jun 02, 2010 8:37 pm
Mousebumples wrote:Is it wrong that that doesn't really surprise me at all?
Vocenae wrote:Unibot, you have won NS.
by Glen-Rhodes » Wed Jun 02, 2010 8:44 pm
by Mousebumples » Wed Jun 02, 2010 8:46 pm
Glen-Rhodes wrote:OOC: You'll need to add a clause that encourages or mandate nations to do something, or else this will fall foul of the committee rules.
by Glen-Rhodes » Wed Jun 02, 2010 8:50 pm
Mousebumples wrote:As stated above, I believe that that section qualifies.
by Unibot » Wed Jun 02, 2010 8:55 pm
Glen-Rhodes wrote:Mousebumples wrote:As stated above, I believe that that section qualifies.
I'm not sure it would stand up to scrutiny. You're directing a committee to do something in regards to nations, but you're not directly encouraging or requiring nations to do something. I don't think using the General Fund as a bridge is concrete enough to pass the committee rules. Might want to get a mod to OK that, if you haven't already.
Vocenae wrote:Unibot, you have won NS.
by Mousebumples » Wed Jun 02, 2010 9:00 pm
Unibot wrote:Glen-Rhodes wrote:Mousebumples wrote:As stated above, I believe that that section qualifies.
I'm not sure it would stand up to scrutiny. You're directing a committee to do something in regards to nations, but you're not directly encouraging or requiring nations to do something. I don't think using the General Fund as a bridge is concrete enough to pass the committee rules. Might want to get a mod to OK that, if you haven't already.
OOC: Did you read ULC? GR? I was personally surprised that it was legal, I would use that as precedent, if I were you, Mouse.
by Glen-Rhodes » Wed Jun 02, 2010 9:05 pm
Unibot wrote:OOC: Did you read ULC? GR? I was personally surprised that it was legal, I would use that as precedent, if I were you, Mouse.
by Airport Motor Lodge » Fri Jun 04, 2010 10:52 am
Mousebumples wrote:New Rockport's concerns regarding legality/privacy issues. If I'm misunderstanding your concerns and have not addressed the point at all, please let me know. I read the links that you provided; however, as they seem to deal with more general court cases, I'm not certain how they'd pertain here.
Mousebumples wrote:(Specifically since the second link mentioned that some/many courts have thrown out such claims to the self-critical analysis privilege.)
Mousebumples wrote:I'm unclear what sort of information should be protected, if not what I've now provided for in the new draft.
by Mousebumples » Fri Jun 04, 2010 1:50 pm
Airport Motor Lodge wrote:Suppose that an attorney in a product-liability case against a drug manufacturer commissions a study on the possible harmful effects of the defendant's drug. This study would be privileged under the work-product doctrine.
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