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: 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.
https://en.wikipedia.org/wiki/Right-to-try_law
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. Everything here requires affirmative consent of the patient.
Investigative treatments
The text is somewhat based on the UK’s Nuffield Council on Bioethics guidelines.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672838/
https://www.nuffieldbioethics.org/publi ... treatments
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
The World Assembly (WA),
Noting that new medical treatments go through lengthy processes such as clinical trials to ensure their safety and efficacy;
Acknowledging that some patients with extremely critical, life-threatening diseases who have exhausted all treatment options may want to try these new potential treatments in the hope that these new potential options offer the possibility, however remote, of being effective (such use referred to hereafter as "compassionate use" or "CU");
Believing that rules on CU work better at the WA level due to the need to handle patients travelling from/to different WA states to try to improve their survival odds;
The WA hereby enacts as follows:
- Definitions.
- "Experimental treatment" ("ET") for CU means the use of any medical treatment (such as drugs and medical devices) prior to such treatment being authorized by a WA organ or by a WA state for use by a patient.
- "ET" covers anything going through proof-of-concept trials, clinical trials, or other regulatory processes. Any treatment already authorized as part of regular (or emergency) treatment is not considered CU.
- "MD" means medical doctors with specialist knowledge relevant to the patient seeking use of ET.
- "WA organs" means any of the committees of the WA.
- "WHA" means the World Health Assembly.
- Compassionate use rules.
- Each WA state is to determine its own rules for authorizing CU programs for ETs, in conjunction with the WHA and other relevant WA organs. Such rules shall be tailored for the inhabitants of that particular WA state.
- Such determinations shall be based on validated scientific means, such as the expected level of benefits and harm to a patient, and whether CU programs disrupt ongoing clinical trials, such as due to a lack of available doses of drugs to conduct a trial on a new drug.
- Affirmative consent.
- CU 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 stop participating 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 CU programs 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.
- 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.
- Legal competence.
- A guardian of a patient not legally competent shall decide if the patient should receive ETs on a CU basis, after receiving all relevant information stated in clause (3).
- The guardian should also be offered independent medical advice if a request is made.
- This resolution does not regulate whether decisions by guardians may be subject to reviews under local laws.
- Rationing.
- Each WA state is to develop its own protocol for allocating ETs for CU 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.
Char count: 4,646
Co-author: potential, pending
Greater Cesnica kindly reviewed some parts of the resolution with regards to clause 3.