STORY INLINE POST
According to the World Health Organization, six core components allow us to monitor the performance of a healthcare system: service delivery, health workforce, health information systems, access to essential medicines, financing, and leadership/governance. . Component No. 4, access to essential medicines, vaccines, and new biotechnologies, is one of the most important since it is correlated with service delivery and governance.
Understanding these components or building blocks becomes relevant when I ask the question: Should countries keep working toward creating the conditions to have a more competitive healthcare system? Even though I am sure the answer would be affirmative, from the perspective of the private and public stakeholders, even in volatile, uncertain, complex, and ambiguous (VUCA) times like that we are living in, the definition of “How?” would not be so easy.
Building robust healthcare systems requires long-term strategic planning and political commitment. This planning should include the definition of a roadmap to identify the top priorities for diseases where Mexican patients could participate in clinical trials. Therefore, clinical research is essential to accomplish our objective.
Clinical research has a central role in the sustainability of healthcare systems. It is the path to innovation in medicines and vaccines. It generates savings by reducing long-term costs through shorter hospital stays; it also facilitates identifying specific needs of patients in different countries, improving life expectancy, quality of life, and overall competitiveness.
Timing is everything, as is being in the right place. Mexico has the conditions to make the most of both: professional capabilities, robust healthcare infrastructure, the interest of different pharmaceutical companies, and patient availability to conduct more clinical trials and participate in the most innovative research. By participating in clinical trials, we gain insights and answers about the safety and efficacy of drugs and other therapies.
In terms of population, our diverse demographic, combined with access to 70 percent of the country’s patients through private and public health institutions, generates fertile ground for participant recruitment and retention in relation to a diverse range of diseases. Data shows that the number of people with chronic conditions is rising. We need innovative treatments to address this challenge in the long term, even for therapies that are mistakenly considered cosmetic like AD but have systemic implications; our participation in international clinical trials would make a difference in understanding the behavior of these diseases in Mexican patients.
We must address some barriers that stop us from making the most of these advantages. The latest issue of the study, Access: Evidence of timing to access innovative treatments in Mexico, conducted by the Mexican Association of Pharmaceutical Research Industries (AMIIF) and IQVIA, shows that it takes a Mexican patient an average of 4.3 years to access innovative treatments.
In Mexico, every new treatment has to go through four stages: sanitary registration, inclusion in the General Salubrity Council, inclusion in the institutional catalog, and availability of the treatment in the different public hospitals. The first stage takes approximately 19 months, while the other three take an average of 32 months. In addition, highly specialized drugs and innovative treatments with new molecules must pass an additional step before sanitary registration, which could take up to eight months.
Compared with Brazil or the US, Mexico has an access process between 2x and 4x longer. Brazil has become an example to the region in adjusting policies to develop a more agile path.
COFEPRIS has been doing a fantastic job ensuring every new drug has safety, quality, and efficacy. However, in the last five years, we have seen a delay of 3.4 percent in the time spent during the registration phase. There are incredible opportunities to have new treatments available in the public healthcare system in lesser time if the institution aligns with international benchmarks.
The study's final recommendations include redesigning the approval process and fostering collaboration between the different healthcare sector stakeholders. The current situation of our system restrains the inclusion of Mexican patients due to the timing required by our regulatory processes, while other countries become more competitive through agility.
Participating in developing life-changing solutions for our patients places Mexico in the central role of avant-garde research. What can we do to boost our participation in international research and become more competitive?
From my perspective, to move forward into competitiveness, we need to find a balance between responsible regulation and the alignment of our process with international standards. In other words, identify that middle ground in which every stakeholder feels comfortable and protected while seizing opportunities.
One possible way to find this middle ground could be by defining strategic therapeutic areas in which clinical research is a priority. To do so, a fluid collaboration between pharmaceutical companies, to know their research pipeline and healthcare institutions and to understand the prevalence and impact of certain diseases in the country is indispensable.
Through collaboration, we can anticipate a long-term plan, with enough time to develop a clinical research timeline aligned to the same objectives. On the same page, we require regulatory authorities’ insights to work in coordination from the earlier phases of the research and decide which treatments companies should bring into the country.
An exercise like this, based on coordination, clear priorities, and collaboration, would not only mean more efficient use of time, human, and material resources but also make a difference in the quality of life of our patients. In addition, Mexico would reinforce its competitiveness through access to state-of-the-art treatments.
The risk of not considering any adjustment in our regulatory processes is to have obsolete treatments. We do not live in an ecstatic world; circumstances change, population habits and characteristics change, and so does medicine. Innovation evolves as fast as the commitment of pharmaceutical companies to provide the best available medication, vaccines, and molecules.
Collaboration strengthens the healthcare system’s vision and commitment to the long term. In addition, multisectoral communication facilitates learning from our peers, taking advantage of international experience, and a better understanding of the role each of us plays. The benefits of acknowledging that we all need each other and placing healthcare as a priority on the public agenda will position Mexico at the forefront of the region, transforming the quality of life for generations.