Generic prescribing of medicines in Denmark?
From generic substitution to generic prescribing?
Generic substitution has existed in Denmark since 1991 and requires pharmacies to dispense the cheapest interchangeable medicinal product with the same active substance, in the same strength and in related pharmaceutical forms, unless (i) the prescriber or (ii) the patient requests otherwise, or (iii) substitution is not permitted due to a patent-protected indication. The Danish Medicines Agency ("DMA") assesses which products can be substituted and ensures that generics meet the same quality and efficacy standards as originator medicines. A list of medicinal products approved for substitution is publicly available, see the list here.
Generic prescribing is going one step further, requiring doctors to prescribe the medicine only by its active substance rather than by brand name. At pharmacy level, the role remains the same as with generic substitution, with the pharmacy selecting the specific product based on the relevant substitution group and price.
In 2006, the DMA also assessed generic prescribing, concluding at the time that, based on the available evidence, it could not recommend its introduction.
The current analysis was initiated at the request of the Ministry of the Interior and Health, following sustained interest from several stakeholders in the pharmaceutical sector in exploring the potential of generic prescribing. One key argument set forth by these stakeholders is improved patient safety and greater efficiency for healthcare professionals, as the active substance is consistent and recognisable - unlike trade names, which can vary and cause confusion. The new analysis revisits the issue and explores the feasibility of a potential shift towards generic prescribing.
The DMA particularly assesses one model, which, according to the DMA and the Danish Patient Safety Authority, will not pose any risks to patient safety. The model provides for the use of generic prescribing, which will be voluntary and applicable across both the primary and secondary healthcare sectors, and doctors can choose either to prescribe medicines by their generic name (i.e. the active substance) or by brand name; a so-called "dual prescribing system". Doctors will continue to specify dosage, strength, pharmaceutical form and packet size, and certain therapeutic classes will be excluded from generic prescribing altogether for reasons of patient safety.
If generic prescribing were to be introduced, the DMA recommends that it should take the form of the above described dual prescribing system.
Benefits, risks and implementation considerations
The DMA finds that generic prescribing could help reduce medicine expenditure and promote more consistent use of generics, particularly in primary care.
However, the analysis also points to several challenges, including a risk of patient confusion, increased counselling demands on pharmacies, and the possibility of reduced treatment adherence. In addition, it is noted that prescribers, pharmacists and patients would all require clear and targeted guidance to support safe implementation.
The DMA further emphasises that implementation would require significant system adaptations, including changes to electronic prescribing infrastructure and the development of clinical guidelines to support prescribers. Successful implementation would also rely on improved patient communication and engagement.
In conclusion, the DMA finds that while generic prescribing is feasible under a voluntary, dual prescribing system, the overall benefits would likely be relatively limited.
Industry response
The analysis report notes that most consultation respondents were generally supportive of introducing the option of generic prescribing in Denmark. However, the Danish Patient Safety Authority and a few other stakeholders highlighted potential risks and practical challenges. In its consultation response, the Danish Association of the Pharmaceutical Industry (LIF) expressed the concern that generic prescribing may compromise patient safety, citing the risk of reduced compliance, such as instances of double medication or missed treatment due to name confusion and similar factors. Read LIF's full response (in Danish).
Potential impact on the pharmaceutical market
Should the model be implemented, companies marketing originator medicines will likely face intensified competition, potentially requiring adjustments to their market access strategies.
Next steps
The analysis is intended to serve as a basis for further political discussions, including the decision on whether to move forward with implementation. Thus, no formal political decision has been made at this stage.
Plesner is closely following regulatory and political developments in this area.