Key Policies

Sat, 09/05/2015 - 12:31


Since 2010, COFEPRIS has used regulation as a tool for market transformation. The commission has an impressive reach, regulating MX$151 billion worth of pharmaceutical products per year. The interventions into health regulation have not only made higher-quality medications more freely available to consumers, but have also revolutionized pharmaceutical production. FDI into Mexico has reached US$350.6 billion since 2000, and the commission has focused on smoothing the regulatory path to market for investors. With 390,000 people employed directly and indirectly in the industry, the removal of barriers to market entry will bring with it higher employment. Mexican pharmaceutical companies view COFEPRIS approval as a springboard to FDA certification, while major players have identified Mexico as a regulatory benchmark for the Latin American market. A number of flagship policies stand out as the main achievements to date.


COFEPRIS’ generics’ policy pivots on making quality drugs accessible to the Mexican consumer, both in the public and private sectors. By focusing on drugs which treat the main mortality causes – cardiovascular diseases, diabetes, and cancer – the benefit passed on to Mexicans is clear. Drugs intended to treat these illnesses now cost less than a tenth of that prior to new regulation. According to figures, treatments for diabetes, cancer, and cardiovascular illnesses have dropped in price by a similar margin. Since October 2011, the commission has released 32 active substances, for use in 357 new generic medications. The new drugs address 71% of mortality causes to the estimated 1 million Mexican patients that have used the drug. Meanwhile, competition between new products has resulted in a 61% drop in prices to the buyer – and a US$1.5 billion saving to the economy as a whole.

Outlook: COFEPRIS is likely to push this further. As of 2014, generics accounted for 84% of market volume and 52% of market value. Application processes for drugs with FDA and EMA approval are now under 60 days. With three new molecules registered in 2010, and an average of 50 per year registered between 2012 and 2015, the streamlining of regulatory processes is likely to continue.


Biotechnological medicines have found themselves in a phase of latency. While only 26 biotechnological and two biosimilar drugs have been approved for the market over the last six years, 35% of all of all applications for sanitary registration for new molecules are for biotechnological drugs. This has to do with the cautious pace of legislative reform for biotechnologicals. While legislation did clear up uncertainties around the requirements for biotechnologicala, further amendments were required to smooth out regulatory processes. Legislation has now brought regulations in line with best international practice on pharmacovigilance, manufacturing, and labeling. A major opportunity exists for potential investors. Per capita consumption of biodrugs stands at US$1 per year, while developed countries’ per capita spend is US$120.

Outlook: Legislation has made a point of holding biotechnological and biosimilar drugs to high international safety standards, while the dropping of barriers to market entry means that the Mexican health sector would appear to be bidding to become a global leader in this new field.


Between 2011 and 2014, 133 new innovative medicines – across 20 different therapeutic classes – were launched, targeting 73% of the main causes of death in Mexico. Tadalafil, the heart medication, is an example of an innovative drug which has flourished in Mexico. Prior to entry into the market, domestic consumers had to pay MX$20,670 for the product, with customs clearance and importation spiking the price. After regulation, Tadalafil costs the consumer MX$8,100. Cancer drug Prolia and diabetes medicine Empagliflozina also saw price-drops of an average of 70% Another major change has been the removal of the local plant requirement. Until 2011, Mexican law required drug companies to have a manufacturing plant on Mexican territory to enter the market. Since the repeal of this law, 387 pending registrations have been cleared for entry.

Outlook: Innovative drugs are expected to draw investment of US$100bn over the next five years, as barriers to entry are cleared and regulations become easier to navigate. COFEPRIS also predicts a 100% increase in the workforce of innovative firms operating in Mexico.


COFEPRIS’ 2011 risk assessment led to the deregulation of 14,000 registered medical devices, lowering a major barrier for entry. 1,669 devices were cleared for the market in December 2011, and a further 573 products released in January 2015. The deregulation freed up a total of MX$1.4 billion, representing more than a sixth of the total medical devices market. New policies allow medical devices from Japan, the US, and Canada to enter within 30 working days.

Outlook: Better regulation is improving utilization of medical devices amongst the public as well as increasing access to new technologies. With significant related reductions to both family and governmental medical expenditures the market is set to grow.