Medicinal Product Regulation And Product Liability In Mexico: Overview

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

   Legislation

   The primary legislation for medical products is the:

   General Health Law (Ley General de Salud) (General Health Law). Health Supplies Regulation (Reglamento de Insumos para la Salud). Official Mexican Norms (Normas Oficiales Mexicanas) (NOMs)). Mexican Pharmacopoeia. Regulatory authorities

   The regulatory authority in this field is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS) (https://www.gob.mx/cofepris) which is an administrative agency of the Ministry of Health (Secretaria de Salud).

2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

   Both biologics and combination products must have marketing authorisation from COFEPRIS. Roughly, biologics are classified into:

   Biologics of reference (usually innovators). Biocomparables, a term used instead of biosimilars, in view of social context issues with the term “similars” in Spanish (similares). Requirements and application timeframes differ in each case.

   Given their particular features, combination products can be classified as either drugs (drug/biologic) and/or medical devices (drug/device). Requirements and application timeframes differ in each case. A combination product may require separate drug or biologic and medical device approvals (see Question 3 and Question 9).

3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

   The primary legislation for medical devices and diagnostics is the General Health Law, its regulations and the NOM for good manufacturing practices regarding medical devices (NOM-241-SSA1-2012).

   According to their use, Article 262 of the General Health Law classifies medical devices into:

   Medical equipment. Prosthetics, orthotics and functional supports. Diagnostic agents. Dental supplies. Surgical and healing materials. Hygiene products. Marketing authorisation requirements for these devices depend on the level of risk involved in their use, according to a threefold classification:

   Class I. Products well-known in medical practice for which safety and efficacy have been proven. They are not usually introduced into a patient's body. Class II. Products well-known in medical practice, but may have material or strength modifications. If introduced, they remain in a patient's body for less than 30 days. Class III. Products either recently accepted in medical practice or remain in a patient's body more than 30 days. COFEPRIS analyses both medical devices and, if applicable, software that enables them to work. Conversely, mobile medical applications are a new area that COFEPRIS may address in future by particular regulations, especially if they represent health risks.

   As an incentive, applicants can benefit from a special procedure for certain devices to be approved in Mexico, which have been previously approved by the:

   US Drug and Food Administration. Health Canada. This procedure is essentially based on the dossier filed with the foreign regulatory agency, to reduce approval timeframes by up to 30 working days. Industry participants have welcomed these new rules, but they are still being tested.

   Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

   The Ministry of Health governs the health system in Mexico. The Mexican healthcare system comprises of public (social security institutions) and private institutions, insurers and independent professionals.

   Individuals and private insurers fund the private sector. Private health insurance generally covers professional, executive and higher levels of the private sector. Enrolment in private health insurance have increased considerably over the past six years. According to official figures, up to 50% of annual health spending in Mexico comes from out-of-pocket expenses 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) (Instituto Mexicano del Seguro Social) (IMSS). This represents social security for the self-employed and employees in private companies. Institute of Social Security for State Workers (ISSSTE) (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado) (ISSSTE). specialised public institutions for members of the military and navy force (SEMAR); PEMEX Medical Services, for Mexican petroleum workers. Public institutions exclusively directed to attend people not covered by social security, in which the funding comes from the federal government, states and patients. The public health sector normally deals with financial problems and implements measures to limit costs by, for example, pressing for price reductions in consolidated public tenders (involving the most important health institutions) and encouraging competition. In the public sector, social security and public institutions provide medicines. However, if the medicine is not available when required, it can be dispensed in a private registered drugstore.

5. How are the prices of medicinal products regulated?

   Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies' participation is voluntary. Under the price control each product's MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. There are no established sanctions for violations of the MRP.

   In 2008, the government created the Committee for the Negotiation of Drug Prices (CNDP) to:

   Support public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies. Evaluate cost-benefits of new medicines and therapies in view of prices and other comparable products in the market. 6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

   Commonly, public insurers dispense medicinal products prescribed by their healthcare professionals. Products are prescribed from a basic medicinal products list, which public insurers essentially base on the National Compendium of Health Supplies issued by the Ministry of Health. Public insurers acquire those listed products mostly by public tender processes. IMSS is the largest public sector buyer of drugs.

   For direct purchasing of patented products, CNDP analyses the effectiveness of the drugs and relevant therapeutic alternatives, and the feasibility and implications of an eventual substitution with equivalent medicines. Also, CNDP conducts an economic evaluation of the cost-effectiveness of patented medicines compared with those potential substitutes.

   For ISSSTE, a prescribed medicinal product can be dispensed in a private drug store registered with this public insurer, provided that this is not available within ISSSTE facilities and under certain conditions. ISSSTE reimburses the cost of that product according to previous agreements.

   In the private sector, most payments are made on an out-of-pocket basis. Private insurers are currently improving the level of pharmaceutical coverage as the private market in medicines has grown considerably.

   Clinical trials

7. Outline the regulation of clinical trials.

   Legislation and regulatory authorities

   The primary legislation for clinical trials is the Health Law Regulations for Health Research (Reglamento de la Ley General de Salud en Materia de Investigación para la Salud) (RLGSMIS) and the NOM for Health Research in Human Beings (NOM-012-SSA3-2012). The Guideline for Good Clinical Practice E6(R1) is taken into account.

   This legislation is enforced by the Ministry of Health through COFEPRIS.

   Authorisations

   Any research on human beings must be approved by COFEPRIS. This research can include testing new medicinal products or new uses, dosages or administration routes for already approved medicinal products. Essentially, the main requirements for an application for authorisation from COFEPRIS are:

   Approval by an independent ethics committee registered with the Ministry of Health. Approval by the medical institution or institutions where the clinical trials will be conducted. These institutions must be approved by COFEPRIS to conduct clinical trials. Clinical trial protocol (including schedule and approximate amount of medicinal products to be imported). Written informed consent templates. Preclinical and clinical data that justifies conducting the research. Description of available resources to conduct the research and to address emergencies (including a statement of sponsorship). Written letter by the qualified investigator acknowledging his responsibilities, and data from both him and his staff. Medical assistance and financial indemnification for damage caused by the clinical trial must be provided to research participants. Consent

   Investigators have to collect informed consent from research participants in a formal written document, also signed by two witnesses. Basically, the validity requirements for consent are that a participant grants it on a voluntary basis, with capacity to do so and sufficient information (knowing potential risks and benefits). Participants keep the right to give up the research anytime. Investigators must ensure post care for them, until it is clarified that there are no damages derived from the research.

   Trial pre-conditions

   Preclinical data must be collected to justify whether clinical trials can be conducted...