- One of the biggest problems facing Mexico is the high dependence on pharmaceutical innovation from countries like the United States, Japan or regions like Europe.
- The Pharmaceutical Regulatory Certainty Plan promotes regulatory actions to guarantee effective access to medical treatments.
- It also promotes the strengthening of industrial activities for the pharmaceutical sector.
Mexico, through the Federal Commission for the Protection against Sanitary Risks (Cofepris), presented during the XXXIV Meeting of Ambassadors and Consuls the Pharmaceutical Regulatory Certainty Plan 2022-2030. It is based on stable regulatory ecosystems and transparent and efficient governance mechanisms that seek to make our country an attractive country for investment in the Health sector.
The holder of the regulatory authority, Alejandro Svarch Perez, explained that the plan offers regulatory certainty to companies in the pharmaceutical sector to provide medical innovations. Also the productive development of the Mexican market through a 2022-2030 work agenda. In addition, it promotes a regional integration mechanism that is inspired by the Health Self-Sufficiency Plan of the Economic Commission for Latin America and the Caribbean (ECLAC).
Objectives of the 2022-2030 Pharmaceutical Regulatory Certainty Plan
For this reason, Mexico, through Cofepris, seeks to promote clinical research in the region; regulatory harmonization; creation of a single model for inspection of establishments; promote the intraregional supply of raw materials; and the creation of a unified drug authorization route through flexible mechanisms in the event of health emergencies.
During his speech at the international cooperation table to strengthen the health sector, Alejandro Svarch explained that, although the COVID-19 pandemic deepened the gaps in the continent with the restriction of supply due to hoarding of vaccines, Mexico, like than other countries in the region, demonstrated extensive technical and infrastructure capacity to develop and manufacture health supplies.
“Proof of the above is that the collaboration between our country and Argentina benefited the health of millions of people by offering a prompt response during the pandemic by packaging and releasing 114 million doses of AstraZeneca biologicals.”
Main barriers to face
However, there are complex, problematic situations, such as the high dependence on pharmaceutical innovation in countries such as the United States, Japan or regions such as Europe. ECLAC calls these facts oligopoly, since research and technological development are concentrated in large transnational companies.
In addition to this circumstance, there is also the loss of sovereignty in the supply of inputs. For example, Cofepris has identified that Mexico imports more than 36 percent of its pharmaceutical supplieswhich reduces the country’s competitiveness and puts it in a situation of vulnerability in the face of geopolitical dynamics.
To finalize this proposal and added to the actions described, the regulatory agency reported on the creation of a Regional Sanitary School as an additional element to the regulatory certainty plan.
With this teaching space, the development of professionals in health regulation will be facilitated; the exchange of knowledge in the development of regulatory harmonization processes and the transfer of technology to strengthen the analytical capacities of national laboratories.
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