On 25 July 2024, Colombia’s left-wing President Gustavo Petro signed Law 2386 of 2024, which declared the pharmaceutical sector as strategic, at least in writing. This legislation establishes the framework for the National Policy on Scientific Research, Technological Development, Innovation and Production of the Pharmaceutical Industry and is intended to promote technological development, innovation, and pharmaceutical production in Colombia. The law emphasises the importance of ensuring the availability of effective medications by preparing the country for any future health crises. In fact, one of the main reasons that this legislation was prioritised was because people were concerned about the supply of medicines and the constant risk of drug shortages. The law is envisioned as an essential tool to combat this challenge.
Overall, the law emphasises that now there will be incentives to produce biological, radiopharmaceutical, other high-tech medicines, and medicines for neglected diseases. Moreover, the document encourages pharmaceutical companies to implement a strategy to supply high-cost medicines that are not included in the Health Benefits Plan (PBS). While it provides for the creation of tariffs, customs, and promotion mechanisms to strengthen local pharmacovigilance efforts, it also has a section to improve human talent in the pharmaceutical sector. Additionally, the law lays out methods to establish collaboration agreements with other countries and international organizations to share technologies and knowledge.
Specific objectives:
- Promote international cooperation for the development of the pharmaceutical industry.
- Ensure access to and supply of pharmaceutical products and other necessary supplies.
- Strengthen the capabilities of the national pharmaceutical industry through specialised training of human talent and the promotion of scientific research.
- Stimulate pharmaceutical production through tariff incentives and development credits.
- Promote the appropriate use of medicines through educational and pharmacovigilance measures.
- Facilitate intersectoral coordination to strengthen good practices in pharmaceutical production.
In Colombia, there is an ongoing health crisis caused by a shortage of essential medicines. This problem has been attributed to structural issues related to the manufacturing of medicines and the lack of timely reporting of the status of products. Notably, Colombia’s vulnerability to shortages and its dependence on other countries for supplies was exposed during the Covid-19 pandemic. As a result, international organizations such as the World Health Organization (WHO) and the Pan-American Health Organization (PAHO) urged countries to take urgent measures to increase the domestic production of medicines and to advance towards health autonomy. Therefore, each objective in this new law is an effort to stimulate pharmaceutical production and reduce Colombia’s dependence on imports.
In other words, the law is designed to strengthen the capacity of the country's pharmaceutical sector to respond to health emergencies. However, although the law promotes and encourages scientific research and the development of the pharmaceutical industry, it remains to be seen if this legislation will address the constant drug shortage concern throughout the country. At the same time, the government has not defined strategies aimed at improving the efficiency in the use of financial resources allocated to the pharmaceutical industry. The national policy has not been written yet and instead, the law specifies that the Ministries of Science, Health, and Commerce along with the National Institute for the Surveillance of Medicines and Food (INVIMA) will oversee designing the policy over this year.
It is important to note that the signing of this law comes after President Petro’s Health Reform collapsed in Congress in April of this year. Through the bill’s journey through Congress, it faced constant opposition and various questions about its logistical and legal implementations. Following this failure, Petro’s party began operating with a sense of urgency to pass policy changes before the end of the legislative period. Therefore, it can be deduced that the contents of this law are an effort from the current party to have a successful law focused on addressing health concerns by appealing to the pharmaceutical sector. However, similar to the failed reform, this law lacks a framework and specificity of how the pharmaceutical sector will become strategic.
Nevertheless, through the passing of this law, Colombia is taking a step towards self-sufficiency within the pharmaceutical sector. It is working to achieve this sovereignty by recognising the pharmaceutical industry as a strategic factor that is vital to guarantee the availability of safe and effective medicines. This is in line with Colombia's recent efforts to draw attention towards policies that reduce dependence on drug imports. In fact, following Colombia's first pharmaceutical forum, Colombia called for measures to strengthen its pharmaceutical industry for the sustainability of the system and to ensure economic development.
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