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Motivation
This is not a direct replacement for GA425: it deals only with experimental treatments that have not been already approved by a WA state. (GA425 has a blocker on this type of use, hence my proposal for repeal.)
GA425 repeal: https://forum.nationstates.net/viewtopic.php?f=9&t=549340
In the US, this is known as Right-to-try laws (a federal law was passed in 2018). The regulatory regime I am using is however closer to the EU/UK version than the US version.
en.wikipedia.org
The concept is simple: if a patient is in despair because that person is dying and yet the patient is aware a possible medicine is approaching the market - do the drug makers give access to the experimental drugs, knowing the patient may suffer from harm, but that the patient will soon die anyway? Some of these discussions started were related to AIDS patients trying to gain access to antivirals, from AZT in 1986 to ritonavir starting from 1996.
Note that the reference is to "experimental treatment" because it may include such things as newly developed medical devices etc., and not just drugs.
Note that general conflict of interest and ethics rules for doctors is in a separate resolution, as that also interacts with several other resolutions.
Investigative treatments
The text is somewhat based on the UK’s Nuffield Council on Bioethics guidelines.
www.ncbi.nlm.nih.gov
www.nuffieldbioethics.org
Clause (6)(b) is to avoid issues with GA22 (since diplomats are supposed to receive the best care ahead of other citizens, due to their status).
Category: pending - health related but pending as it’s slightly broader than GA425.
Draft 1
[box]
The World Assembly (WA),
Noting that new medical treatments (such as new drugs) go through lengthy processes such as clinical trials to ensure their safety and efficacy;
Acknowledging that some patients with critical, life-threatening diseases who cannot be treated satisfactorily by an existing medical treatment may want to try these new potential treatments in the hope that these new potential options offer the possibility, even if very modest, of being effective (such use referred to, hereafter as “compassionate use”);
Believing that rules on compassionate use work better at the WA level due to the need to define ethics across multiple WA states (such as for patients from one state seeking treatment in another state, or treatment from another state) for compassionate use;
The WA hereby enacts as follows:
Co-author: potential, pending
Greater Cesnica reviewed some parts of the resolution with regards to clause 3.
This is not a direct replacement for GA425: it deals only with experimental treatments that have not been already approved by a WA state. (GA425 has a blocker on this type of use, hence my proposal for repeal.)
GA425 repeal: https://forum.nationstates.net/viewtopic.php?f=9&t=549340
In the US, this is known as Right-to-try laws (a federal law was passed in 2018). The regulatory regime I am using is however closer to the EU/UK version than the US version.
Right-to-try law - Wikipedia
The concept is simple: if a patient is in despair because that person is dying and yet the patient is aware a possible medicine is approaching the market - do the drug makers give access to the experimental drugs, knowing the patient may suffer from harm, but that the patient will soon die anyway? Some of these discussions started were related to AIDS patients trying to gain access to antivirals, from AZT in 1986 to ritonavir starting from 1996.
Note that the reference is to "experimental treatment" because it may include such things as newly developed medical devices etc., and not just drugs.
Note that general conflict of interest and ethics rules for doctors is in a separate resolution, as that also interacts with several other resolutions.
Investigative treatments
The text is somewhat based on the UK’s Nuffield Council on Bioethics guidelines.
Ethics framework for treatment use of investigational drugs
Expanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded ...
www.ncbi.nlm.nih.gov
Ethical issues arising from the use of experimental treatments - The Nuffield Council on Bioethics
www.nuffieldbioethics.org
Clause (6)(b) is to avoid issues with GA22 (since diplomats are supposed to receive the best care ahead of other citizens, due to their status).
Category: pending - health related but pending as it’s slightly broader than GA425.
Draft 1
[box]
The World Assembly (WA),
Noting that new medical treatments (such as new drugs) go through lengthy processes such as clinical trials to ensure their safety and efficacy;
Acknowledging that some patients with critical, life-threatening diseases who cannot be treated satisfactorily by an existing medical treatment may want to try these new potential treatments in the hope that these new potential options offer the possibility, even if very modest, of being effective (such use referred to, hereafter as “compassionate use”);
Believing that rules on compassionate use work better at the WA level due to the need to define ethics across multiple WA states (such as for patients from one state seeking treatment in another state, or treatment from another state) for compassionate use;
The WA hereby enacts as follows:
- Definitions.
- “Experimental treatment” (“ET”) for compassionate use means the use of any medical treatment (such as drugs, alternative medicine, and experimental medical devices) prior to such treatment being authorised by a WA organ or by a WA state for wider usage.
- ETs include anything undergoing proof-of-concept trials, clinical trials, and other analogous investigations. Any treatment already authorised for use as part of a regular (or emergency) treatment programme is not considered “compassionate use”.
- “MD” means medical doctors with the requisite specialist knowledge.
- “WA organs” means any sub-committees of the WA.
- “WHA” means the World Health Assembly.
- Compassionate use.
- Each WA state is to determine its own procedures for authorising compassionate use programmes for ETs, in consultation with the WHA and other relevant WA organs.
- Such determinations shall be based on validated scientific means, such as the expected level of benefits and harm to a patient, and whether compassionate use programmes disrupt ongoing clinical trials, such as due to a lack of available doses of drugs to conduct a trial on a new drug.
- Knowledge sharing.
- Compassionate use of ETs may not be considered for any patient unless all other viable methods of treatment have been exhausted, according to the assessment of at least two MDs.
- The MDs, and anyone else involved in the ET, shall fully explain the potential benefits and harm of the compassionate use of the ET for that patient, to the best of current scientific knowledge, in an objective and unbiased manner. They should also explain the impact of any research on the ET, as well as all relevant relationships between parties involved in the development of the ET. They should also fully disclose details on all potential and actual conflicts of interest on the ET, such as the source of funding of the ET.
- A patient has the right to seek independent advice from another MD, or from relevant experts from the WHA, before making a decision.
- An affirmative written consent from a patient is required prior to the start of the ET. The relevant professionals are required to ensure that all patients have a full and clear understanding of the ET on the patients themselves, the impact of their participation on any research, and the relationships between parties involved in the research.
- A patient may decline to participate in the ET at any time. A patient needs to be fully aware of any potential (or additional) harm from withdrawing from the ET after it has started, prior to the start of the ET.
- Research sharing.
- Any medical facility that provides compassionate use of ETs shall fully record all relevant research knowledge obtained as if it is a trial of the ET, such as details on the patient, efficacy, side effects, and outcomes, subject to relevant laws such as those on privacy.
- The said knowledge shall be widely disseminated to the manufacturers of the ETs as well as through regular channels across all WA states to aid development of the said ETs and medical knowledge in general.
Individuals not legally competent. - A guardian of a patient not legally competent shall decide if the patient should receive compassionate use of ETs, after receiving all relevant information stated in clause (3).
- This resolution does not regulate whether decisions by guardians may be subject to judicial review or other judicial or juridical processes.
- Rationing.
- Each WA state is to develop its own protocol for allocating ETs for compassionate use if there is a shortage, in consultation with the WHA.
- ETs in shortage should be allocated based on independent criteria determined by the WA state, and not based on the status and resources of the patient, or whether the patient is from that WA state or from another state, unless otherwise provided for by extant WA resolutions.
Co-author: potential, pending
Greater Cesnica reviewed some parts of the resolution with regards to clause 3.