The Standing Committee on Health and Care Services is reviewing a private member's bill from Sylvi Listhaug and others seeking to give ALS patients real access to the compassionate use exemption for experimental drugs in early development. The committee is calling on the government to establish a fast-track expert group to examine how early access to medicines can be made available to patients with serious, life-threatening conditions who have no other treatment options, and to ensure that lack of documentation in early phases does not by itself block assessment of applications.
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The Storting calls on the government to establish a fast-track expert group with expertise in health law, medical ethics, pharmaceuticals, clinical trials, health research, and patient perspectives. The group shall examine how early access to medicines can be made available to patients with serious, life-threatening conditions with a short life expectancy and no available treatments. The expert group shall: evaluate and propose changes to the current compassionate use exemption framework for drugs in early phases, addressing the need for medicines to be available for approval even without approval in other countries; examine the ethical and legal implications of using the compassionate use exemption in early phases before approval elsewhere, where the health administration deems it medically sound based on the treating physician's recommendation; propose any changes to administrative practice that would ensure experimental drugs lacking early-phase documentation are not automatically disqualified from the compassionate use framework, provided the patient has a fatal disease without available treatment alternatives, the health administration deems it medically sound based on the treating physician's recommendation, and the patient has given informed consent; and deliver recommendations and any proposed regulatory changes to the Ministry of Health and Care Services within five months.
The Storting calls on the government to ensure that, pending the expert group's report, patients with ALS and other serious, life-threatening conditions are given real opportunity to use the compassionate use exemption for experimental drugs in early phases following individual assessment, where the health administration deems it medically sound based on the treating physician's recommendation. Lack of documentation in early phases of the approval process shall not by itself be a barrier to assessment under the compassionate use framework. If legislative change is required, the Storting urges the government to return with proposals as soon as possible.
The Storting calls on the government to ensure that section 2-5, eighth paragraph of the Medicines Regulation is applied in accordance with its wording, so that both general practitioners and specialists can apply for compassionate use exemptions.