An innovative drug in Mexico takes up to four years to enter the public system

Up to 4.3 years is the time it takes for patients in Mexico to have access to the pharmaceutical innovation from the application for the sanitary registration, passing through the evaluation made by the General Health Council (CSG), its inclusion in institutional catalogs and even its availability in public sector hospitals.

This was demonstrated by the study “Access times to pharmaceutical innovation, 2015-2020 update”, carried out jointly by IQVIA, a consultancy that carries out the study of data, technology and analytics, and the Mexican Association of Pharmaceutical Innovation Industries (AMIIF).

Is this a lot or a little? If we consider that timely access to innovative medicines in health systems is vital, it translates into patients with a better quality of life and economic and social improvements, of course we are talking about a long period, of According to the study, there is experience that reveals how other countries do better, for example, Mexico does it in two more years than Brazil and up to 4 years more than United States, Germany, Japan or France.

Ángeles Martínez, consulting director for the North region of Latin America In IQVIA, it revealed that the time to obtain the health registration before Cofepris is 57% greater in 2019-2020 than between 2017-2018 and that the numbers that the country manages today are the same at least since 2015.

He also emphasized that the process of including medicines High specialty drugs by the CSG take 50% longer than the inclusion of drugs for primary care, and in general they take up to 50% longer to be available in hospitals. “Although 4.3 years is the average time for the inclusion of innovation in Mexico, supplies aimed at the oncology area take an average of 5.2 years to reach the patients who need it.”

Another example is the drugs for diabetes and cardiometabolic areas, which take an average of 3.2, in contrast, Mexico is one of the two countries in the world with the highest incidence of both diseases and are the main causes of mortality.

How can it be improved?

The study mainly aims to influence the fields of improvement, for this Martínez pointed out that there are two important areas in the short term: Reduce the time it takes Cofepris to issue the sanitary registration and the adoption of the National Compendium of Health Supplies.

In a calculation carried out in this study, if the previous actions were given, the waiting time could be reduced by 1.5 years (compared to Brazil) and 1.7 years (when compared to all other reference countries).

In this sense, Pablo Quiroga Adame, executive director of health promotion of Cofepris, acknowledged the lags in the regulatory agency: “Not doing it would be hiding something that cannot be hidden.” He said that before the fact from the federal commissioner, to the verifiers and dictators, they have had to be creative and open to implement a series of innovative actions in regulatory matters.

For example, they have implemented the internationalization of the agency with certifications, now they seek to be part of the International Council for the harmonization of technical requirements for the registration of medicines for human use (ICH), The optimization and regulatory modernization with the modification of agreements so that Cofepris stopped being a paperwork agency and became a surveillance agency. In addition to the renewal of the Committee for New Molecules

He added that the cornerstone is “reliance”, that is, trust between regulatory agencies in other countries and their certifications. Quiroga assured that this was a teaching of the pandemic to simplify the times. “We want to be the ones who allow the entry of innovation and monitor them effectively.” He also suggested a period of between six months and a year for IQVIA and AMIIF to repeat the study and the changes in the Cofepris related to the access times of innovative medicines can be reflected.

After the commitments made by the representative of Cofepris, Cristóbal Thompson, executive director of the AMIIF, celebrated that the regulatory agency take the issue in their hands and even invited them to participate in the Innovation Week, to be held in March 2022, to show the progress of the commitments.

He concluded by saying that the study seeks a shared understanding, based on evidence, of the root causes of delays in access to jointly build solutions between patient associations, the health system, the pharmaceutical industry and regulatory authorities.

The two main areas of opportunity to reduce access times are: Cofepris and the adoption of the National Compendium of Health Supplies.

Cofepris promised to improve the times in a period of six months to a year.

The time it takes for a drug to arrive could be reduced by up to 1.5 years with concrete actions.

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