June 6, 2023 –WILLEMSTAD – On May 2nd, the Council of Ministers agreed with the petition to modify the LBHAM (National Decree, containing general measures) for packaged medicines. This modification allows for the registration of more medicines in Curaçao.
The 2019 report of the Market Regulation and Financing Sector Task Force (TMFZ), it is aimed to save a total amount of NAf 70 million, from medicines (NAf 34 million), medical specialists (NAf 17 million), and medical service trips (NAf 19 million). These savings need to be realized to close the gap in the operating expenses of the new CMC hospital, which are higher compared to those of the old Sehos hospital.
Four years have passed, and out of the planned savings, only NAf 20 million has been realized for various reasons. Particularly, the adjustment in the area of medicines has practically not been achieved. The elimination of barriers to achieve the planned savings for medicines has become even more difficult, considering the higher operating expenses of CMC and the delay in reducing medical service trip expenses and adjusting medical specialists.
The government is of the opinion that the modification of Article 13 of the LBHAM for packaged medicines can significantly contribute to achieving the planned savings of NAf 34 million on medicines. This concerns a modification in the climate zone conditions for medicines. The requirement stating that the climate zone conditions must be exactly the same as those in Curaçao to ensure the quality of medicines was a point of intense discussion and required a solution.
The LBHAM for packaged medicines regulates, among other things, the requirements for the registration of medicines. Within this framework, the quality of the medicines must be safeguarded. Therefore, the medicines must be able to withstand tropical conditions in terms of durability and effectiveness. In practice, many medicines are guaranteed under certain subtropical climatic conditions that do not differ significantly or differ at all from the local climatic conditions. Where there are differences, they can generally be reduced by controlling the temperature during storage, transportation, handling, and use of these medicines. By ensuring the correct temperature ranges, these medicines are just as safe and effective as they have been tested and registered by international registration authorities in Europe, America, and Canada.
In practice, these medicines have demonstrated that they can be perfectly used locally if they are stored, handled, and transported under the correct preservation conditions, namely by keeping them fresh.
Through this simple modification or supplement of Article 13 (e), a large quantity of medicines, including a significant amount of generic medicines widely used in Europe, America, and Canada, have come to attention in order to be formally registered in Curaçao.
Prior to the ratification of the LBHAM amendment, the Council of Ministers accepted a tolerance approach to allow the registration of medicines from different climate zones outside of Curaçao, under strict conditions where necessary adaptations in transportation, storage, inventory management, and use are guaranteed and instructed to ensure the quality of the medicines, according to instructions from the Public Health Inspection for importers, pharmacies, and healthcare institutions.
With these decisions, the government aims to achieve the planned savings on medicines and contribute further to the reform and improvement of healthcare, benefiting our vulnerable patients, taking into account the financial limitations of the country of Curaçao.