On 24 August, the British Chamber of Commerce, in collaboration with the European Chambers of Commerce, welcomed Julio Sánchez y Tépoz, Federal Commissioner for Protection against Sanitary Risk. Until earlier this year the Commission (COFEPRIS, for its acronym in Spanish) was led by Mikel Arriola who modernised the organisation and its processes during his time. Julio Sánchez y Tépoz was very positive about the work of his predecessor in opening up the organisation and appeared keen to continue this trajectory. The Commissioner showed he was very much in favour of deregulation, the elimination of trade barriers and simplification of processes to promote development in his sector by making the commission still more ethical, technical, efficient, competitive and global. His presentation outlined how he intended to achieve these five goals.
For Julio Sánchez y Tépoz, being ethical is more than just “a call to mass”. It means being transparent, accessible and consistent. He explained that the commission is committed to sharing any non-sensitive information with the public through the COFEPRIS website (http://www.cofepris.gob.mx). There is also a dedicated line to attend to enquiries and questions from any individual. Julio Sánchez Tépoz even invited the audience to call 01800 0335050 to see for themselves that the service has improved. In terms of consistency, this means working more closely with states to ensure they are working to the Commission’s standards and protecting its integrity. He gave an example of a recent arrest and subsequent criminal charges against a COFEPRIS official and their brother for extortion of a pharmacy (by asking for money in exchange for allowing them to reopen). This incident demonstrates that corruption will not be tolerated.
Julio Sánchez y Tépoz explained proudly that the organisation has just 100 full-time lawyers (including himself) meaning the majority of the Commission is made up of scientists and technical experts. He spoke of the need to facilitate and promote clinical research in Mexico by greater collaboration with the pharmaceutical sector. The Nacional Quality Control Laboratory is undergoing expansion and modernisation to incorporate the most advanced technologies. This is due to be finished by December this year. COFEPRIS is also working to improve pharmacovigilance through the implementation of the New Mexican Official Standard 220 to assure the quality of medications on the market.
This means providing greater access to products and services for the population who cannot always find what they need. These include innovative medicines, generics, medical devices, biotech, and more. COFEPRIS will also continue to remove “irregular” products (those that can put health at risk) from the market. Prevention is also key to efficiency as non-communicable diseases are on the rise, most of which can be avoided by lifestyle choices. Julio Sánchez Tépoz made specific mention of the “6 Steps to Health through Prevention” programme that COFEPRIS is supporting alongside the National Healthcare Service (for private sector employees; “IMSS”), the Social Development Secretariat (as this programme can also fight poverty), the Public Education and Culture Secretariats.
To open up the market, COFEPRIS is simplifying and digitalising processes to make them simpler and reduce the need for lawyers and intermediaries. The commission is also strengthening its strategy to promote exports:
- Extending the validity period of Export Certificates from one to 5 years
- Publishing a Simple Exporting Guide and creating a “one stop shop” to facilitate exports with specialised personnel
- Carrying out a campaign to promote exporting
This means following international best practices, recertifying the COFEPRIS with the National Regulatory Agency of Regional Reference Level 4 and constantly improving the COFEPRIS Centre for Excellence (recognised by the WHO).
Question and Answer Session
Julio Sánchez y Tépoz’s presentation was followed by a question and answer session expertly moderated by Chamber Board Member and Sector Expert Louise Batchelder.
The session covered topics such as:
- The digitalisation of prescriptions. This can reduce duplication and better control the release of medicines
- The Commission’s excellent relationship with their British Counterpart, the Medicines & Healthcare Products Regulatory Agency
- The evolution of pharmacies in Mexico where many have doctor’s surgeries next door to the pharmacy following the restriction of various drug sales to prescription only in 2010. These surgeries have been investigated and carefully monitored by COFEPRIS to ensure that they are satisfactorily separated from the pharmacy and meet sector standards. The commissioner defended the industry as it is a growing sector that attracts international investment (e.g. Alliance Boots Walgreens)