Pharma & Medical Device Regulation 2021

• Published date: 27 October 2020
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Biotechnology & Nanotechnology
• Law Firm: OLIVARES
• Author: Ms Ingrid Ortiz and Luz Elena Elías

HEALTH SERVICES FRAMEWORK AND COMPETENT AUTHORITIES

Healthcare bodies

1 Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

The Mexican healthcare system comprises public (social security institutions) and private sectors.

The private sector comprises private institutions, insurers and independent professionals, the users of which are not restricted. Individuals and private insurers fund this sector. Private health insurance generally covers professional, executive and higher levels of the private sector. Enrolment in private health insurance has increased considerably over the years. According to official figures, up to 50 per cent of annual health spending in Mexico comes from out-of-pocket payments related to private doctors, insurance and drug acquisitions.

The public sector comprises:

• social security institutions exclusively directed to formal workers, in which the funding comes from contributions by the federal government, the employer and the employee, such as the:
• • Mexican Institute of Social Security;
  • Institute of Social Security for State Workers;
  • specialised public institutions for members of the military and navy force; and
  • PEMEX Medical Services, for Mexican petroleum workers; and
• public institutions exclusively directed to attend people not covered by social security, in which the funding comes from the federal government, states and patients, such as:
• • the Wellness and Health Institute; and
  • state health institutions.

In the public sector, social security and public institutions provide medicines. However, if the medicine is not available when required, some public insurers allow private registered pharmacies to supply prescribed medicines and to request a refund for these.

Competent authorities for authorisation

2 Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?

The Mexican authority responsible for enforcing the regulatory framework relating to medical products is the Federal Commission for Protection against Sanitary Risk (COFEPRIS), which is part of the Ministry of Health. Within it is the New Molecules Committee and the Subcommittee on Biotech Products, which assess biological medicinal products.

The regulatory framework is set out in the following federal laws:

• the General Health Law;
• the General Health Law Regulations for Healthcare Products;
• the Official Mexican Standards (NOMs);
• the Mexican Pharmacopoeia; and
• COFEPRIS's Rules listing...