Generic substitution - questions and answers
What is generic medicine?
Generic medicines are different medicinal products containing the same active substances.
What is generic substitution?
The Danish Health and Medicines Authority decides which generic medicines are suitable for substitution. Pharmacies must then give the least expensive products to patient, unless the doctor and/or the patient prefers another product. Due to competition between the manufacturers of original medicine and generics, the prices of the generics often vary greatly. Reimbursement from the National Health Service is organised to fit the substitution rules. This means that the National Health Service only pays reimbursement for the price of the least expensive product.
Generic substitution has existed in Denmark since 1991.
Is a generic product of the same quality as the original medicine?
Yes. Manufacturers of generic medicines must document to the Danish Health and Medicines Authority that the medicinal products live up to the same standards as a new original medicinal product as regards chemical and pharmaceutical manufacturing, purity and shelf life. The Danish Health and Medicines Authority ’s requirements are equivalent to the requirements of other European medicines agencies and they are based on common European legislation.
Does a generic product have the same effect as the original medicine?
The manufacturer of an original medicine must perform tests on humans to document that the medicinal product has the intended effect for specific illnesses or symptoms. After this, the Danish Health and Medicines Authority evaluates whether there is satisfactory documentation that the active substance in the form in question (tablet, suppository, injection, etc.) is effective for a given illness/symptom. It would be unethical to demand that the manufacturer of a generic medicine should repeat such tests on humans if it can be avoided at all. Therefore, it is sufficient for most generics if it can be documented that the active substance is absorbed in the body in the same quantity and at the same rate from the generic product as the original medicinal product.
However, for a range of medicinal product forms it is not possible to use this method (for example medicinal products for inhalation, creams and ointments for local use). In such cases, it is therefore necessary to repeat some of the tests conducted for the original medicinal product in order to examine whether they have comparable effects.
What criteria does the Danish Health and Medicines Authority use to evaluate whether a generic can be used instead of another medicinal product (substitution)?
Decisions concerning substitution are based on a concrete evaluation of each individual medicinal product. The first prerequisite is that it is proven that the individual generic product releases the active substance to the body in the same quantity and at the same rate as the original medicinal product. Alternatively, a test must show that the same effect can be achieved in patients with the same illness/symptom, no matter whether the original medicinal product or the generic medicine is used.
In addition, it is important that the different generics are therapeutically replaceable. This means that the patient can change between the original product and the different generics without having to follow any particular instructions for the different products. For example, ordinary tablets and capsules to be swallowed can often be substituted, whereas a suppository with the same active substance will not be approved for substitution, as it is used differently.