2019 has been a year full of uncertainty in political, social, and economic matters. We could affirm that this climate, in its majority, has been caused by the decisions of the government rather than by external factors. It is the first time that a left party comes to power with a majority in Congress and, in addition, has a very high citizen approval. However, the actions that the Federal Executive has implemented have generated important pressures for the country’s industrial activity .
Specifically, the pharmaceutical industry in our country faces important challenges that are worth considering for decision making during this year. On the one hand, we must study the changes that will take place when the new T-MEC free trade agreement comes into force, particularly the chapter on industrial property. On the other hand, the National Chamber of the Pharmaceutical Industry Affiliation (CANIFARMA), reported in recent days the lack of import permits that could result in shortage of medicines.
Our country represents the second largest market in Latin America for the pharmaceutical industry, generating 65,204 jobs in national companies. It is expected that by 2020 the consumption of medicines in our country will amount to 26,276 million dollars; However, the risks mentioned can be obstacles to achieving these projections.
Since the current government took office, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) has not granted any import permit or sanitary registration. The aforementioned has caused the delay in the delivery of the tendered medicines in December and a shortage of medicines in the private sector is beginning to be felt, due to the lack of raw materials for their production. Between 2006 and 2018, the pharmaceutical sector grew by 100%; being these permits granted by COFEPRIS key to the development of the industry and promote a balance between generic and patent medicines. However, the lack of permits by COFEPRIS can become a brake on the growth of the industry.
Another challenge for the pharmaceutical sector is the upcoming entry into force of the T-MEC, since prices and access to medicines in Mexico may be affected. These effects are generated because the practice of accepting new uses of known medical substances and registering their patents is regulated. That is, if a chemical molecule is created to cure a specific disease, but later other people find that it serves to take care of another disease, the second people can register the patent for a second use, even if they are not the owners of the original patent . This is known as a secondary patent.
This new protection represents an advance in scientific innovation and technology, but experts say that it will be US pharmaceutical companies that will benefit the most due to their extensive experience in the development of chemicals and pharmaceuticals. It is worth remembering that it is precisely EE. UU who dominates the registration of patents worldwide.
On the other hand, pharmaceutical companies that produce generic drugs will be affected by the increase in patents’ duration, from seven to 10 years. This will represent an important challenge for the industry in Mexico since we are the country that consumes the most generic medicines worldwide, representing 90% of the total purchases of medicines.
Are you interested in knowing what other challenges the pharmaceutical companies and the medicine market will face in Mexico? Does your company need advice to determine the risks it faces by provisions contained in international treaties or national