It is very commendable that in the Cofepris of the 4T they are eradicating the internal mechanisms of corruption, that they promote transparency and scientific rigor. The message yesterday, June 7, in the morning from Alejandro Svarch, head of Cofepris, was undoubtedly music to the ears of President López Obrador, who will have been very pleased.
But something important was missing: about the respective complaints of the 32 officials who were fired and about all the irregularities or illegal actions that they found from previous years. It is very necessary that this also be transparent so that it truly is mission accomplished. Because in addition to combating corruption, it would be necessary to locate responsibilities and those responsible, as well as enforce the law on the faults that have been incurred.
Besides, another important thing that the 4T has not finished capturing is that in order to end corruption, it is not necessary to destroy what has been built by the country in decades.
We say this last because Cofepris insists on wanting to disappear at a stroke of a pen a segment of authorized third parties that carry out drug bioequivalence studies and that for the country has represented a significant boost to scientific development in the last 25 years.
We are referring to a project to change NOM 177 recently uploaded to the National Commission for Regulatory Improvement (Conamer) with which it is intended to definitively allow studies to demonstrate the bioequivalence and biocomparability of medications consumed by Mexicans to be carried out in abroad. It is a change that had been determined by emergency in May 2021, but now they want to leave it permanently.
With this, the current administration will finish hanging a sector of about 20 companies dedicated in Mexico to carry out said bioequivalence studies; It is a scientific branch that had been taking shape since the end of the 1990s, and with the aforementioned NOM reform, it will be practically out of work.
We do not defend the part of the corruption -which surely there was- among the authorized third parties in collusion with Cofepris officials, but what is not understood is why the current administration arrives with the scythe to want to destroy everything completely without doing any analysis about the redeemable.
The authorized third parties that carry out bioequivalence studies are a highly specialized industrial branch linked to research centers and highly specialized hospital centers that generate well-paid employment for scientists; if we already have little development of science, why deal it such a strong blow? The change to NOM-177 will imply that Cofepris accept bioequivalence studies (for generic drugs) and biocomparability studies (for biosimilars or biocomparables) carried out abroad, leaving all the centers that carry out said studies in Mexico without support.
Just as serious is the hard blow to health sovereignty by losing a lot of control over the quality of pharmaceutical supplies. In this regard, Fermín Valenzuela, a member of the National Academy of Medicine and an expert in these bioequivalence and biocomparability studies, since he was a member of an authorized third party that has already closed, explains that currently, a drug purchased at the pharmacy has an undeniable quality that can be demonstrated right here in our territory, but with the change to the aforementioned NOM, our health authorities are giving who knows who abroad that confidence and security about the health quality of the medicines that we Mexicans consume.
“We are simply letting someone else decide on the quality of our inputs.”
Who benefits? It is not even clear, but it is most likely that the studies that will no longer be carried out in Mexico will be carried out by centers in countries such as India, China, Romania or Bangladesh and the generics that we Mexicans consume will have been tested in Indians, Chinese, Romanians or Asians when it is well proven that our biology as Mexicans is different and we react differently to what we eat. That’s the tricky thing.
For the pharma, change of narrative
Something that caught the attention of the Health Pulse yesterday, June 7, Tuesday, is the conciliatory position regarding the pharmaceutical industry. In the speech of the health regulator Svarch, an attitude of openness towards the regulated production sectors in general was already noted, but the message was understood above all towards the industry that produces drugs and other health supplies -on which they had practically planted a stigma- and towards which are the highest demands of quality, efficacy and safety. In front of the president, Svarch spoke of a new strategy of linking with the regulated industry with direct, objective, clear and transparent communication. Two years ago that tone simply would not have had a place in a morning conference where the speech was the attack without understanding of the functioning of the pharmaceutical sector. After 4 years of Government it seems that the 4T already has a certain learning curve…
Journalist on economics and health issues
Health and Business
Communicator specialized in public health and the health industry. She is studying a master’s degree in Health Systems Administration at FCA of UNAM.
Founder in 2004 of www.Plenilunia.com, a concept on women’s health. I am passionate about researching and reporting on health, innovation, the industry related to science, and finding the objective business approach to each topic.