Supply of Therapeutic Goods in Mexico in 2021By Rafael Gual | Thu, 01/07/2021 - 09:00
In previous contributions, the modifications to article 1 of the Law of Acquisitions, Leases and Services of the Public Sector (LAASSP, by its acronym in Spanish) were analyzed, as well as the substantial changes to the supply scheme of therapeutic goods and the implications of the agreement signed by INSABI and UNOPS. Also, in August, the Mexican regulatory agency, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS, by its acronym in Spanish), became affiliated to the Deputy Minister of Health Promotion and Prevention and is no longer under the Minister’s supervision.
The consequences of the modification to the LAASSP can be summarized as the exclusion of the acquisition of medicines and health supplies from public bids, which led the industry to file an appeal for protection, and a large group of senators to submit an Action of Unconstitutionality to the Supreme Court of Justice of the Nation. The agreement between INSABI and UNOPS for the 2021 supply of medicines sets the ground for foreign companies to participate in an open international bid, with no regard for the commercial agreements Mexico has signed.
To make matters more difficult, an agreement was recently published that urges COFEPRIS to grant a sanitary product registration to any foreign therapeutic product, as long as it meets the condition of having such registration in its country of origin. What is more, the agreement establishes this registration should be granted in only five days; otherwise, it would be approved through the legal principle known as affirmative action (afirmativa ficta). From the outset, this hascould represent a potentially exacerbated sanitary risk for the population, since it would allow importing products without indispensable quality analyses, and without meeting the requirements that are demanded of the industry established in Mexico to guarantee the quality, safety and efficacy of the goods.
This set of actions complicates even more the problems that the country is already facing because of the COVID-19 pandemic and could seriously jeopardize supply in the first months of 2021, at least.
At present, there are substantial delays in the acquisition process announced by UNOPS, and even though health institutions are seeking to assure supply for the first quarter of 2021 independently of the UNOPS mechanism, INSABI, in turn, has severe budget, operational, planning and payment issues. These facts seriously threaten the timely supply of pharmaceutical goods for the 32 states, and there is no contingency plan in place to address the eventual shortage. The delay in the schedule set by UNOPS makes the supply considerably more difficult as far as even May, according to their own statements.
In addition, with this third-party supply scheme through UNOPS, there will not be an expeditious and direct communication mechanism among health institutions and the supplying industry to require, if it is the case, the provision of the goods that UNOPS does not cover.
The aforementioned agreement also does not specify the procedures to follow if there are products for which there are no bids, nor how these would be allocated, who would be responsible for such acquisition and allocation, or the legal principles under which the contracts are to be formalized, which also poses a significant risk of not having a systematic supply of these goods, since there is no legal certainty. The contracts that the companies established in Mexico will sign with UNOPS depend on an extra national legal and administrative order, so the defense of the legitimate interests of the local pharmaceutical industry will have to take place in a legal environment outside the Mexican legislation.
After several attempts to explain this situation, the agreement established that INSABI, through BIRMEX, would be responsible for the distribution of the health supplies acquired. However, this entity does not have the necessary infrastructure to carry out this function, nor the budget to undertake it, so it is foreseeable that there will continue to be contracts for nonspecialized logistics and distribution companies in the private sector that do not have the necessary expertise and capabilities, as has been evident with clear inefficiencies in the last two public tenders. Even if there were a timely supply of pharmaceuticals, the efficient operation of the supply chain is key to the effective provision to the entire National Health System.
To sum up, the agreements that have been published from March 2019 to November 2020 have modified the sanitary regulatory framework, expecting to facilitate and streamline the processes of registration and importation of pharmaceutical products and medical devices under the equivalences scheme. However, the same agreements establish measures that are discriminatory and inequitable for the pharmaceutical companies established in Mexico, which is likely to discourage the national production of medicines and will hinder the possibility of meeting the demand in the event of supply problems or health emergencies.