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 (IMSS);
- the Institute of Social Security for State Workers (ISSSTE);
- specialised public institutions for members of the military and navy; and
- PEMEX medical services, for Mexican petroleum workers; and
- public institutions exclusively
directed to people not covered by social security, in which the
funding comes from the federal government, states and patients,
- public health insurance; 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 authorization
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. It has a committee on new molecules and a subcommittee on biotech products to assess biological medicinal products.
The regulatory framework is set out in the following federal laws:
- the General Health Law;
- the Health Law Regulations; and
- Official Mexicans Standards (NOMs).
The products are classified in accordance with the definitions provided in this legal framework.
3. Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.
Essentially, applicants for marketing authorisations must prove the safety and efficacy of their products through standard clinical trials, according to the rules set out by the General Health Law, its Regulations and NOMs related to good manufacturing of medicines and active ingredients. Concurrently, they also have to request approval of their products as new molecules from the New Molecules Committee of COFEPRIS.
Research and development (R&D) companies benefit from a special procedure for first-time approval in Mexico, for drugs that have been previously approved by a regulatory authority abroad.
Applicants for marketing authorisations have to prove that their products are bioequivalent to the innovator product. They have to provide information concerning dissolution profiles or bioavailability studies regarding the reference product. COFEPRIS periodically issues a reference list of medicinal products. The NOM setting the test to prove that a generic drug is interchangeable with a reference drug was recently updated (NOM–177–SSA1–2013). Legally, COFEPRIS should not grant marketing authorisations for generics that breach exclusivity rights.
There is a linkage system between COFEPRIS and the Mexican Institute of Industrial Property (IMPI), which aims to prevent the granting of marketing authorisations in violation of patent rights. According to the Intellectual Properties Regulations, every six months IMPI must publish a gazette that lists patents protecting allopathic medicines (Linkage Gazette).
Under the linkage system, at the time of filing the application, the applicant must either prove that he or she is the owner or licensee of the patent of the active ingredient in the product (recorded before IMPI), or state under oath that his or her application does not violate the list of products published in the Linkage Gazette, and observes patent law.
Further to legal and administrative information, the essential dossier submission requirements for innovative products manufactured Mexico are preclinical and clinical trials, certificates of good manufacturing practices (GMP) of the active pharmaceutical ingredient and the medicinal product, analytical methods, summaries, manufacturing licence, prescribing information, label and a pharmacovigilance programme.
For innovative products manufactured abroad, additional requirements apply, which include a certificate for export, a letter of representation with apostille, and details of a legal representative with an address in Mexico. If the GMP certificates are not issued by an agency recognised by COFEPRIS, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), an inspection in situ will be required.
As an incentive for innovation, R&D companies can benefit from a special procedure for innovative biotech products that have been approved by the FDA, the EMA, Health Canada, the Swiss Agency for Therapeutic Products (Swissmedic) or the Australian Therapeutic Goods Administration.
The essential dossier submission requirements for biosimilars are almost the same as those for innovative biotech products, except for the requirements to prove safety, efficacy and quality. For these purposes, biosimilar applicants must submit, essentially:
- in vitro studies or comparative non-clinical studies;
- a report of comparative test of pharmacokinetics, if determined by the Ministry of Health, to show pharmacokinetic comparability on key parameters between both the follow-on and the product of reference;
- pharmacodynamics test reports; and
- comparative efficacy and safety clinical tests to show similarity between both the follow-on and the product of reference. Once approved, close pharmacovigilance should be followed.
COFEPRIS has been working on guidelines to perform biosimilarity studies. They have issued guidelines for etanercept, filgrastim, infliximab, insulin and its analogues, rituximab and somatropin.
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