AMLO: Regulator Consolidator

COFEPRIS being folded into Health Super-Secretariat in Mexico.

Andrés Manuel López Obrador (AMLO) continues his quest to centralise decision-making and concentrate power under the guise of ridding the Mexican government of ‘corrupt’ and ‘profligate’ institutions. The latest victim is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is to be placed under the control of Hugo López-Gatell, Undersecretary of Prevention and Health Promotion at the Mexican Secretariat of Health, alongside 12 other offices.

We spoke to sources within COFEPRIS and the pharmaceutical industry, both think this is a bad idea.

A senior official at the Secretariat of Health believes there will be collateral damage, “COFEPRIS has many functions, this decision is focused mainly on medicines, which is where most problems exist, but it will have a negative impact on the other regulatory powers, generating greater bureaucracy and paralysis. It is a sign of ignorance about how the institution works and a bad diagnosis!” When asked to explain the root cause of this our source replied, “Authorities think the pharma companies are corrupt but the real problem is with the distributors.”

“This change is an institutional nonsense, a legal monstrosity to take away autonomy from COFEPRIS.”

Former Pharmaceutical Executive.

A former executive and consultant in the pharmaceutical sector told us, “The negotiation of codes and prices for the public sector is left in the hands of a single person who also authorises the medicines. It’s stupid. They will lose all their negotiating power. This change is an institutional nonsense, it’s a legal monstrosity to take away autonomy from COFEPRIS.”

The same source continued to explain that this move will make it even harder than it already is to develop new, high-value medicines. “The result will be a departure of the innovators and a prevalence of cheap drugs of low quality and efficacy, to the detriment of patients. It is unlikely that the innovators will take legal action, fearing further attacks.” The Mexican government has always been close to the generics companies and although they will never admit it, our sources estimate that generics are 80% of the market in Mexico.

“Authorities think the pharma companies are corrupt but the real problem is with the distributors.”

Senior Official at the Secretariat of Health.

Centralisation often creates bottlenecks and this is a further concern of both our sources, “Mexico already has one of the longest regulatory access to market processes in the world. That means there are cures for serious diseases, but they are not available in Mexico and that will not change with the new reform,” reports the former pharmaceutical executive.

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