In brief

On 20 May 2024, Law No. 32033 was published. This law guarantees and promotes access to generic drugs in International Nonproprietary Names (INN), as an essential part of the right to health.

In more detail

The relevant aspects of this law are as follows:

• It includes the following definitions: essential drug (“product determined to be comparatively safe, effective, cost-effective and available”); generic drug in INN (“product manufactured and marketed by third parties after patent expiration under INN”); and branded generic drug (“product manufactured and marketed by third parties after patent expiration under a brand determined by the manufacturer”).
• It provides a list, the approval of which is pending, of generic essential drugs in INN to be offered in pharmaceutical offices and the pharmacies of private health facilities. In the meantime, the list of generic essential drugs in INN approved by Ministerial Resolution 220-2024-MINSA remains in force.
• It establishes the duty of the personnel of the pharmaceutical establishment, apothecary or pharmacy of private health establishments to report, at the time of selling, whether the product offered has been manufactured or distributed by a company linked to that pharmaceutical establishment.
• The General Health Law (Law No. 26842) has been amended to establish that, in private health services, the chemist-pharmacist must dispense drugs by offering generic drugs in INN, branded generic drugs and, if there is no applicable generic drug, innovative drugs. This applies to all sales channels.
• The Pharmaceutical Products Law (Law No. 29459) has been amended.

1. It includes the obligation of pharmacies, drugstores and pharmacies of private health establishments to keep at least 30% of their supply of brand-name drugs available for the alternative generic essential drugs in INN from the list approved by the Ministry of Health.

Noncompliance constitutes an infraction punishable with a warning or fine of up to 2 UITs.

2. It states that the use of generic essential drugs in INN will be prioritized.
3. It states that the chemist-pharmacist should offer the patient generic drug alternatives, prioritizing generic drugs in INN first.
4. It establishes that the promotion and advertising of pharmaceutical products and medical devices for sale under medical prescription (i) must be directed exclusively to professionals authorized to prescribe and dispense these products, (ii) must be advertised through media exclusively directed to these professionals, and (iii) its purpose must be to report the sale price. This advertising includes comparative information regarding quality, price and relevant technical information.
5. It establishes that medicines and medical devices dispensed through pharmacies, drugstores and pharmacies of private health establishments must compulsorily contain in the labeling of their primary and secondary packaging a statement mentioning that those products have been manufactured by a laboratory linked to the pharmaceutical establishment that dispenses them. This will be enforceable within 180 calendar days from the date of entry into force of this law.

The regulations of the General Health Law and the Pharmaceutical Products Law, as applicable, must be adapted within 60 calendar days from the effective date of this law.

We hope this information will be useful to you and your company. If you have any questions or concerns, please do not hesitate to contact us.

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