Bill 686.

Summary.

The bill seeks to promote the development, strengthening and competitiveness of the domestic pharmaceutical industry. It proposes to encourage local production, technological innovation and the capacity of pharmaceutical medicine laboratories established in the Republic of Panama (República de Panamá). It amends Article 8 of Law 24 of 1963 (Ley 24 de 1963) to classify pharmaceutical establishments as medicine laboratories or laboratories for nonmedicinal chemical products. The first category covers activities involving medicines and products for human or veterinary health, including pharmaceutical specialties and medicinal compounded preparations. The second covers chemical products without a medicinal purpose, including perfumery items, cosmetics and disinfectants.

The bill amends Article 194 of Law 419 of 2024 (Ley 419 de 2024) to set minimum notice periods for procurement of medicines, products or services related to human health according to contract value. The required periods are no less than four, five, fifteen or twenty business days before the public procurement event, depending on the applicable value bracket. The amendment to Article 203 requires electronic bids in Spanish or translated into Spanish, duly authenticated and signed. Bids submitted through PanamaCompra would use the tamper resistant electronic identification method employed by the General Directorate of Public Procurement (Dirección General de Contrataciones Públicas) and would have binding and evidentiary effect. Bidders could withdraw, replace or amend bids before the public event, but not afterward. The procuring entity could request explanations, supporting documents and samples without changing the offered price, subject matter or original bid. Corrections would be limited to documents already submitted that are not subject to scoring.

The amended Article 207 lists the procedures for contracting the supply of medicines, medical devices and supplies, and services related to human health: expedited small purchases, small contracts, public tenders, best value tenders for highly complex contracts, reverse auctions, single price tenders and framework agreement tenders. It specifies value thresholds for the initial procedures. The amendment to Article 230 gives the procuring entity’s legal representative, or a delegated public official, authority to impose penalties for breach of contracts or purchase orders. It provides for fines or disqualification from public contracting, taking account of the violation, repeat conduct, the contractor’s behavior and resulting harm. In specified serious or very serious cases, disqualification could extend to the contractor’s corporate group and related companies. The Executive Branch (Órgano Ejecutivo) would regulate the classification of violations, progression of penalties and procedure for extending disqualification.

New Article 256-A limits industry incentives to laboratories established under the laws of the Republic of Panama whose ultimate beneficial owners are Panamanian nationals by at least eighty percent (80%), and that are registered with the Social Security Fund (Caja de Seguro Social) and current on their obligations. The bill restates the amendments and directs the Executive Branch to issue implementing regulations within no more than three months after commencement. It would take effect the day after promulgation. Its provisions concern the Social Security Fund, the General Directorate of Public Procurement, procuring entities, and the pharmaceutical, health care and public procurement sectors.