On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved in the third debate Bill 1007, which regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions were enacted.
This law was approved with 45 votes in favour and one abstention. With this, Panama adopts modern legislation on medicines with parliamentary support. The law updates the regulatory framework to ensure the quality, safety, and effectiveness of medicines.
The new Medicines Law, outlined in Bill 1007, aims to reduce the prices of medications by 20% to 30%, representing one of the largest investments in health.
Health Minister Luis Francisco Sucre stated that the new law will provide greater opportunities to lower drug prices for both the Ministry of Health of Panama (MINSA) and the Social Security Fund (CSS). This is because they will be able to make joint purchases, allowing them to acquire larger quantities of medications and supplies at a more economical price for both entities.
The regulation stipulates that pharmaceutical establishments will be required to update the prices of their products included in the Basic Medications Basket on the open digital platform for these items. Additionally, the Ministry of Health may review and update them as necessary.
Furthermore, in Panama, the legal regulations advocate addressing medication shortages through the implementation of the National Medication Supply Guarantee Plan.
The National Drug Observatory is also established, which will be responsible for publishing reference prices for medicines in national or international procurement processes, following the example of countries with high-standard regulatory authorities and international reference organizations.
Another relevant aspect that promotes access to healthcare products in the Panamanian territory is streamlining the analysis processes, and in response to increased demand, a network of supporting laboratories is created.
In Bill 1007, Article 8 of Law 24 of 1963 was amended, which establishes the National College of Pharmacists and regulates pharmaceutical establishments. The amendment aims to eliminate legal barriers that restrict the participation of additional providers in the national market, thereby promoting free competition and greater market participation.
Panama is one of the Latin American countries that has regulations for the approval of biosimilars [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Regulations of the registration of biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 29]. Available from: www.gabionline.net/biosimilars/research/regulations-of-the-registration-of-biosimilars-in-latin-america
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