PANAMA

On December 8, the Minister of Health (MINSA in Spanish), Luis Francisco Sucre, presented a roadmap and diagnosis of the situation of the pharmaceutical sector in the country which, according to the Executive Branch, establishes the objectives and measures for the country to become a regional drug hub. The strategy will have 3 axes: national drug manufacturing; clinical trials; and value-added distribution, with emphasis on collaboration with the private sector.  In the short term, the entity could begin to promote the aforementioned measures to achieve this goal. On the other hand, on December 2, MINSA issued a decree regulating the prescription and dispensing of non-substitutable drugs for use in the health sector. The regulation is already in force.

Ministry of Health works to establish drug hub

During the presentation, Sucre highlighted that this initiative is part of the Government Plan (2019-2024) of President Laurentino Cortizo, where the promotion of the regional center for the production and distribution of medicines would be in line with the pillar of competitive economy. In this sense, he said that “the promotion of this Value Added Pharmaceutical Hub, accompanied by an innovative drug processing center based on industrial and technological goods, has been established among the priority activities”.

From the Executive Branch, they expressed that with this strategy they seek to solve the problem of drug shortage and the high cost of medicines that afflicts the country. Thus, they intend to expand the distribution of medicines by improving the distribution of added value, especially by collaborating with the private sector, expanding the customer base and establishing productive relations with multinational pharmaceutical companies. They also seek to obtain a greater variety and quantity of inputs and finished products for packaging, as well as to remove regulatory obstacles to the establishment of joint ventures.

In order to achieve value-added distribution, they propose the establishment of new companies for the regional distribution of medicines that collaborate with national companies. In this regard, they explained that they will compile information on the pharmaceutical market at the regional level together with the Central American Integration System (SICA) to identify the most important suppliers and the main country supplying drugs to the region.

In addition, they mentioned the main problems identified in order to turn the country into a pharmaceutical hub: infrastructure limitations; shortage of pharmaceutical professionals; delays in the registration of medicines and weaknesses in public procurement.

Decree regulating non-substitutable drugs

The regulation governs the prescription and dispensing of non-substitutable drugs for use in the health sector.  These consist of drugs that cannot be replaced in the dispensing process without the express authorization of the prescribing physician. Among these drugs are biological drugs; those containing any of the active ingredients considered to have a narrow therapeutic margin; those containing active ingredients subject to special medical control or requiring specific follow-up measures for safety; and those for the respiratory system.

The list of medicines that fall into this category will be prepared by an Interinstitutional Committee created by MINSA, whose access will be public and disclosed. Based on this, the prescription of these drugs must be made and the prescription must expressly include the phrase “Non-substitutable”. When the treating physician substitutes these products, it must be done under therapeutic supervision. Finally, it is indicated that the Ministry will have a period of 3 months to publish the aforementioned list.