Decree signed in Costa Rica for the use of generic name in medicines

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The Costa Rican Ministry of Health has been pushing since 2018 the decree of the 'Regulations for the Prescription and Dispensing of Medicines in Conformity with their International Nonproprietary Name (INN)’ for the Costa Rican private market [1].

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This decree was subject to two public consultations, one in May 2019 and the other in August 2021.

But it is now that the President of the Republic of Costa Rica, Carlos Alvarado, together with the Minister of Health, Daniel Salas, have signed the new decree No. 43233-S, which will allow patients to know the available alternatives to the medicine prescribed by health professionals. The official decree can be consulted at: https://www.imprentanacional.go.cr/pub/2021/10/07/ALCA202_07_10_2021.pdf

It will enter into force 22 days after its official publication on 7 October 2021 in Scope No. 202 of the Diario Oficial La Gaceta No. 193.

This decree applies to private health services and establishes the obligation of medical, dental and nursing professionals to prescribe medicines by their international non-proprietary name or generic name and not by brand name.

Similarly, pharmacists must inform the consumer about the existence of all the different options corresponding to the prescribed medicine and the price of the different alternatives. This does not apply to over-the-counter medicines and medicines containing more than three active ingredients.

If the above is not complied with, patients or consumers may report the irregularity to the Ministry of Health.

The authorities will be in charge of controlling and verifying compliance with the provisions of the decree and applying the special health measures contained in the General Health Law.

There are currently 49 active ingredients for which the requirement to demonstrate therapeutic equivalence has been implemented, and 73 active ingredients in the process of meeting the requirements to be classified as therapeutically equivalent.

The official list of medicines approved as therapeutic equivalents, in accordance with the specific regulation on this matter, is available on the website of the Ministry of Health (https://www.ministeriodesalud.go.cr/index.php/listados-oficiales) and on the Regístrelo Digital Platform (registrelo.go.cr), which includes the necessary information for the unequivocal identification of each medicine and will be updated every time a new approval is granted.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Draft decree for prescribing generics in Costa Rica [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/guidelines/draft-decree-for-prescribing-generics-in-costa-rica

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