Medicine Acquisitions Through UNOPSBy Rafael Gual | Wed, 08/26/2020 - 09:14
Changes to the Law of Acquisitions, Leases and Services of the Public Sector (LASSP) were recently passed to allow the government to acquire pharmaceutical goods and medical devices through intergovernmental international organizations, specifically the United Nations Office for Project Services (UNOPS). This represents major risks of at least three levels: first and foremost, for patients; for the health system as a whole; and for the pharmaceutical industry in Mexico. While countries around the globe are fostering the development of local manufacturers, Mexico seems to be choosing to do the opposite.
Mexico is one of the few countries in the world with an industry that ensures high self-sufficiency with regard to pharmaceuticals and health supplies. It is, therefore, contradictory that the government, considering the emphasis that this administration has claimed to put on strengthening national sovereignty, has chosen to supply the National Health System through third parties, such as the Revolving and Strategic Funds of the World Health Organization, which is not a manufacturer, nor is it responsible for the quality of the products included in both funds, as is stated in its disclaimer.
Considering the recent change to the law, the acquisition of pharmaceuticals in 2021 would be carried out by UNOPS, according to the agreement signed by the Mexican government. The agency would develop the international bidding process but the products are those from the aforementioned WHO funds. The WHO Revolving Fund was created in 1980 to assist the poorest countries, and the therapeutic goods it comprises are destined to alleviate the conditions that affect these countries, mainly vaccines, tropical diseases, HIV and influenza, as they have limited institutional sanitary infrastructure. The array of products these funds include is not in the least comparable to the 3,400 different pharmaceutical items [ref1] considered in the Compendio Nacional de Insumos para la Salud (the national formulary) in Mexico to respond to the therapeutic needs of our country.
To clarify and contrast the dimension of the needs of the Mexican Health System and what the government would be able to acquire from those funds, it is important to consider the following:
- The value of the pharmaceutical market in the Mexican public sector in 2019 was over MX$70 billion (US$3.2 billion) (MMDP, by its initials in Spanish).
- During the same year, over 1.7 billion units (MDU, by its initials in Spanish) [ref2] were required and/or consumed by the National Health System.
- Considering the total expense in pesos, and consumption in units in Mexico in 2019, the medicines and vaccines that it would be possible to procure from international and intergovernmental agencies correspond to just over MX$3.5 billion and about 65 million units, which represent 5.09 percent and 3.82 percent of the total requirement, respectively.
To say the least, it is utopic to state that the needs of the National Health System would be regularly met through these funds, as the medications that Mexican patients require, including oncology products, antihypertensive and glucose-regulating medications, are not included.
Additionally, it is paramount to consider that there would be heavy financial implications for the public budget, for a substantial part of the purchase would have to be paid in advance, and a 4.25 percent administrative commission would have to be paid (3 percent to WHO and 1.25 percent to UNOPS). As for logistics, there does not seem to be an assessment of the viability of this measure, since the delivery, in the best-case scenario, would be Free on Board (FOB) at a Mexican port. In contrast, the pharmaceutical companies established in Mexico have supplied the products they have been required to supply, and so far, many have not received the corresponding payments.
Regarding pharmacovigilance, it is the companies established in the country that report and follow up on any adverse effects. If there is no responsible entity in Mexico, there will be no monitoring, evaluation or prevention of safety issues associated with the administration of these medicines.
The health and safety of Mexican patients would be at stake, and in the hands of opportunistic companies that have no commitment to invest in our country, generate local employment, pay local taxes and fully comply with regulatory standards.
The main function of UNOPS is to provide guidance to poor countries in the acquisition of infrastructure. In recent years, the agency has carried out some international bids for medicines for countries in Central America, the amount of which is nothing compared to the magnitude of the Mexican process, which would be the largest such process in the history of UNOPS and a huge challenge in which patients’ well-being could be jeopardized.
The foreseeable consequences for the months ahead are an even greater shortage of pharmaceutical goods, lack of control and traceability with the inherent sanitary risk for patients, and even worse, the loss of jobs in these critical times, which in some cases would be irreversible.
[ref1] Pharmaceutical item, “clave” in Spanish, is the classification number given to each product in the Compendio Nacional de Insumos para la Salud: http://www.dof.gob.mx/2020/CSG/CSG_DOF_29042020.pdf
[ref2] Units: finished product for final consumption.