Because human health is one of the highest values, the pharmaceutical industry is one of the most regulated industries in the world. There are standards in place to regulate the approval of pharmaceutical products to comply with safety, effectiveness and quality requirements to avoid health risks to patients,
These rules should be clear, certain, consistent and effective both in the technical and legal aspects to achieve the main purpose of the regulation: avoid health risks to consumers of medicines and medical supplies.
Other inherent quality that a good regulation of medicine should be proud of is equity and the establishment of a proper balance between the different stakeholders, namely: innovators, generics, distributors, importers, national and transnational companies doing business in Mexico, manufacturers and others.
A latest Presidential Decree to expedite the importation and approval of pharmaceuticals from abroad and generics by disregarding some domestic rules, proceedings and time frames applicable to the companies doing business in Mexico long time ago, clearly disrupts the balanced system.
Aforementioned Presidential Decree is grounded on the forthcoming international public tenders for pharmaceuticals in Mexico managed by UNOPS. Our Government supports the intervention of UNOPS as a way to prevent corruption in public tenders of medicines in Mexico.
No one would challenge any actions to prevent corruption; the question would be: Why is this process of procurement with the Mexican Government only established for the procurement of medicines but not for materials, supplies and services for building trains, refineries and contracts with PEMEX, CFE and others?
There must not be excuses to jeopardize the health of Mexicans by shortcuts in the regulatory path that may endanger the health of millions of Mexicans.
There is no reason to ignore the various chapters of Government Procurement in many of the free trade agreements subscribed by Mexico with different countries that attracted longstanding and not only business opportunities and investment in Mexico.
There must not be excuses to conduct an undue priority treatment to foregoing companies or products in detriment and discrimination of national and international companies incorporated in Mexico that have bet their business perspectives and estimations in our country and on the regulatory frame in force.
There is no reason either to contempt other applicable laws such as patent linkage established now in the new Federal Law for Protection of the Industrial Property that must be considered during the regulatory approval process of medicines and the data package exclusivity provided in various international treaties in force in Mexico, that in the times provided by the Decree, there is no way that they would be observed properly.
Eventual enactment of new rules to expedite the importation of foreign pharmaceutical products infringing the rules of fair competition, exclusive rights, equity, international obligations in free trade agreements and most important, the health concerns would be considered as infringements to the Mexican Constitution that provides the legal remedies to face unlawful actions by the authority without distinction of the subscribing Officer of the Government, in this case the Mexican President.
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