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Energy Boardroom

The healthcare system and regulatory framework in Mexico

11.02.2014 / Sandra Sánchez, President of the Mexican Association of Pharmaceutical Research Industries (AMIIF), for PharmaBoardroom

Despite the considerable progress made towards an effective public health system in Mexico, all healthcare actors, from government to pharmaceutical companies and health providers, recognize that much more needs to be done. Too many patients still suffer from delays and insufficient availability of high quality care. Only by working together more closely, we will find better solutions for healthcare in Mexico.

It is a complex task, and, even within the pharmaceutical industry, opinions vary as to which is the best way to achieve this. Nevertheless, there is a consensus around the need to expand access and promote innovation. Regarding these two key issues, in AMIIF we are proud to say that we think Mexico is on the right track, with a number of positive initiatives underway. There is still, of course, work to be done – specifically, in offering access to innovation. Out of the three necessary steps – regulation, inclusion in the National Basic Formulary (NBF) & institutional formularies, and supply of innovative drugs for the population– we have made substantial progress in regulation through COFEPRIS. However, we still need to focus on moving forward with inclusion into NBF and Institutional formularies, as well as securing supply of innovative drugs. It is important to ensure that any improvements in any of these areas, quality, cost and effectiveness can be sustained in the long-term.

Within AMIIF, we are working on a number of proposals and I would like to share our top line thoughts with PharmaBoardroom.

The regulatory framework in Mexico: improvements, drawbacks, and future perspectives

In terms of improvements, drawbacks and future perspectives in the regulatory framework in Mexico, there are three key areas to work on. First of all, the efficiency and effectiveness of the regulatory authority must be maintained and guaranteed. To this effect, a series of factors should take place under this new administration.

There is still work to be done to guarantee the adherence to deadlines for regulatory approvals, but there are also high expectations in regards to the improvements Mr. Arriola is planning to achieve during his new tenure.”

To begin with, the improvement that started last year by COFEPRIS (especially the PAHO certification) should continue. It should be noted that all improvements took place under Comissioner Mikel Arriola’s leadership, and as a result of his performance, he was reappointed in this position. There is still work to be done to guarantee the adherence to deadlines for regulatory approvals, but there are also high expectations in regards to the improvements Mr. Arriola is planning to achieve during his new tenure.

Biotechnology and biosimilars

COFEPRIS has taken significant steps towards developing a regulatory and legal framework for “Biocomparables” (as they are called in Mexico) drugs, potentially creating the standard for Latin America and being one of the most robust on an international scale. However, this regulation still needs continued review and effective implementation as the nature of each class of drugs is complex and very different between them. We believe science-based standards offer the best opportunity for expanding access and protecting patient safety.

The biosimilar approval pathway presents opportunities and challenges. Stringent guidelines will play a key role in advancing the safety of biologics and improving the lives and productivity of Mexican citizens.”

Patient safety is a collective effort. Making biologic medicines – whether innovative or biosimilar – is neither straight forward nor easy. Biologics have highly complex manufacturing processes and today require significant investment in order to deliver high quality and reliable supply – both important to patient safety. Complex products require high standards.

We believe that sound science-based regulations must start and finish with rules that protect and preserve patient safety, including:

• Appropriate standards for the approval of biosimilars /”biocomparables”;

• Strict rules about substitution and interchangeability;

• A focus on the need for medical providers and patients to make individualized decisions; and

• A process that ensures that each biologic product whether innovator or biosimilar—enters the marketplace in a manner that permits its use to be tracked and traced to assure that any safety issue can be addressed promptly, and that products are monitored and used responsibly (pharmaco-vigilance)

The biosimilar approval pathway presents opportunities and challenges. Stringent guidelines will play a key role in advancing the safety of biologics and improving the lives and productivity of Mexican citizens.

Intellectual property

Respect of intellectual property rights encourages the research and development of new innovative drugs. The most recent improvement in this area is that the ‘linkage mechanism’ has taken a step forward with the inclusion of formulation patents, eliminating court orders that forced authorities to respect them. However, this protection still needs to be established in the proper legal precepts as this mechanism today does not explicitly consider formulations or secondary use patents when COFEPRIS validates with the Patent Office (Instituto Mexicano de la Propiedad Intelectual – IMPI), whether a drug registration application violates patent rights or not.

Combating the illegal market (counterfeit, adulterated and / or expired)

There is a need to strengthen interagency collaboration with industry participation to eliminate it and raise awareness on the health risks it entails; hence it has not only become a national priority but a worldwide one in recent years.

The R&D pharmaceutical industry has been very proactive at taking steps to combat these illegal activities by maintaining a close collaboration with various government agencies (COFEPRIS, IMPI, PGR, Internal Revenue Service “SAT” through its customs offices and the States General Attorneys). Albeit, both industry and Government have shown a strong determination to combat and reduce the problem, and their actions have resulted in benefits to patients, the medical community, and the industry, mechanisms for more efficient and continuous collaboration still must be identified.

Recommendations for the healthcare system in Mexico

One of the biggest hurdles and challenges of the Healthcare system in Mexico is access, ensuring availability to innovative drugs to most of the Mexican patients who need it, which entails securing a lengthy formulary reimbursement process to get on the “National Basic Formulary” (NBF) and “Basic Formularies” (BFs) of all government institutions / payers.

Transparency, redundancy and consistency in the evaluation of dossiers remain a concern and limits patients to have access to innovative drugs. There are still important changes that could be made to the review process to eliminate redundancies in the system and establish a unified set of criteria for determining cost effectiveness that will have an even greater impact and increase access to new life saving medicines.

Recommendations for the healthcare system in Mexico include the need for clear, transparent and streamlining the inclusion process for NBF and BF, as well as comprehensible mechanisms for purchasing and supply. The roadmap for achieving these goals consists of 4 key actions.

  1. Standardization of criteria for the development and evaluation of health economic data (pharmacoeconomics) needed for the inclusion of new therapeutic options in the NBF.
  2. Streamlining evaluation process and reducing duplicative reviews
  3. Transparent bidding and negotiation of drug prices
  4. Effective purchasing and efficient supply / distribution / Rx filling of drugs.


amiif-logo.pngThe Mexican Association of Industrial and Pharmaceutical Research (AMIIF) is comprised of 30 Mexican companies with global capital, focused on the commercialization of innovative medicines.

To read more articles and interviews from Mexico, and to download the latest free report on the country, click here.



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