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Promotion of generics

Generics are seen as important products in the context of promoting the rational use of medicines. Two key measures for promoting generic use are international non-proprietary name (INN) prescribing and generic substitution.

• In the case of INN prescribing, doctors are encouraged to prescribe by INN instead of the brand name. This measure exists in 22 EU Member States. In four countries (Estonia, Lithuania, Portugal and Romania) INN prescribing is mandatory.
• In 21 EU Member States pharmacists may substitute an equivalent cheaper product, e.g. a generic or parallel imported product, for a prescribed medicine (in general an original product). In six countries (Denmark, Germany, Finland, Malta, Sweden and Slovakia) pharmacists are obliged to apply generic substitution—unless the patient or doctor opposes substitution, the latter only being possible under clearly defined conditions.

Survey on rational use of medicines in 27 EU Members States

Measures for promoting the rational use of medicines in the 27 EU Member States were surveyed in a report by the Gesundheit Österreich GmbH / Österreichisches Bundesinstitut für Gesundheitswesen (GÖG/ÖBIG – Austrian Health Institute) [Rational Uses of Medicines in Europe].

Their results showed that there are many different practices between the different Member States in the EU with regard to generic medicine policies. An overview is given in the table below:

For example, while most countries (22) advocate international non-proprietary name (INN) prescribing, relatively few (4) have made this obligatory, whereas generic substitution by the pharmacist is practiced in the majority of countries (21).

Some important details about "INN groups”

• An "INN Group” is defined by the combination of three major characteristics: active substance (or combination of active substances), dosage and route of administration.
• In some INN groups additional specifications may be important, such as modified release or the different vehicles for dermatological medicines. In these cases, the prescriber is required to make a choice. For other specifications (e.g. breakable, soluble, gastro-resistant ...), the prescriber must indicate freely his choices and preferences.
• For some groups of medicines it is recommended to maintain the initial choice of medicine for continuing the treatment and to avoid shifts. These groups of medicines are designated by the code "NO_SWITCH”.
• Some groups of medicines are not included in the INN prescription system. They are listed in the list of medicines ordered by the INN group with the code "NO DCI" / "NO VOS”.

Other relevant information can be found in the aforementioned note (DOC, 130 Kb). Clarification (PDF, 21.37 Kb) of some points of the note. List (PDF, 75.46 Kb) of authorised and marketed biological medicines.

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