Proposals for new Pharmaceutical Legislation
New proposals for amendments to the Medicines Act, the health Act and the Committee Act have been presented.
In the proposal to amend the Medicines Act, it is suggested, among other things, to insert a new section 2 into § 29, which would allow the Danish Medicines Agency, under special circumstances, to permit the sale or dispensing of medicines that are not covered by a marketing authorization or are not marketed in Denmark.
The explanatory notes to the bill emphasize that such special circumstances may, for example, arise in cases of supply shortages or when there is a risk of such a shortage of a medicine, where it is deemed appropriate to dispense a non-marketed medicine, or a medicine not covered by a marketing authorisation without delay.
This relates to the main purpose of the new proposal, which is to create a process that enables the dispensing of medicines without undue delay if health authorities recommend that treatment with a not yet marketed medicine should occur shortly after the discovery of symptoms, i.e., before a potential marketing authorisation can be attained.
Furthermore, it is proposed to insert a new provision in § 75 a, which imposes an obligation on various companies, individuals, etc., to report their inventory of approved critical pharmacy-restricted medicines for use in humans.
It is further proposed that a § 175 a be inserted into the Health Act concerning the transportation of patients from countries in a humanitarian crisis to Denmark for treatment when the country requests it.
In the proposal to amend the Act on the Health Research Ethical review of Health Science Research Projects and Health Data Science Research Projects and the Health Act (Committee Act), it is suggested in § 3 a, paragraph 1, that when submitting a health science research project, the competent scientific ethical review committee may allow for the omission of consent under §§ 3-5 if the project concerns clinical low risk studies comparing established standard treatments, provided that a number of specific conditions are met.
The term "clinical low risk studies" refers to cases where the only purpose is to investigate already established and equivalent standard treatments in Danish hospital departments, where subjects are not subjected to any other experimental intervention, including procedures. It is specified, however, that it is not a requirement that the patient treatment in question itself be low risk.
In the same bill, there are provisions proposed to be added to Chapter 5a of the Committee Act.
The various new proposals can be accessed (in Danish) here:
Want to know more?
For further questions concerning the new proposals, you are always welcome to contact Plesner's team for Life Science.