Life Sciences: Product Regulation And Liability In Mexico

Co-authored by Laura Medina

Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction's pharmaceutical industry?

It is expected that the North American Free Trade Agreement will be soon reviewed, renegotiated or terminated. However, there is a degree of uncertainty about the issue.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The main regulatory framework in relation to medicinal products is set out in the following federal laws:

the General Health Law; the Health Supplies Regulation; the Official Mexican Standards; and the Mexican Pharmacopoeia. Are any legislative changes proposed or expected in the near future?

The Trans-Pacific Partnership (TPP) is a trade agreement among 12 Pacific Rim countries. It was signed on February 4 2016 in Auckland, New Zealand, after seven years of negotiations. It has not yet entered into force in Mexico.

There is a multiparty scheme in place for the TPP to enter into force. However, considering that the United States has recently withdrawn from the ratification process, there is a degree of uncertainty about the issue.

In this regard, it is possible that Mexico will execute bilateral agreements with some of the 12 Pacific Rim countries. It is expected that the eventual bilateral free trade agreements will have a TPP standard.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The authority responsible for enforcing the regulatory framework in relation to medicines is the Federal Commission for Protection Against Sanitary Risk, which is part of the Ministry of Health.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

Other legal regimes applicable to the trade of medicinal products include:

competition; antitrust; transparency; data protection regarding clinical trials and other activities involving patents or clinical data; consumer protection; and industrial property. Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No medicinal products are exempt from regulation.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

Companies manufacturing medicines and medical products in Mexico must be approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS) through a manufacturing licence or authorisation.

What is the fee for obtaining authorisation?

Government fees for analysing a manufacturing approval application are around $3,000.

What is the validity period for authorisation?

Drug manufacturers must renew their licence every five years, subject to the relevant test, including the presentation of a certificate of good manufacturing practice.

How robust are the standard good manufacturing practices followed in your jurisdiction?

Good manufacturing practices are well adhered to in Mexico.

COFEPRIS can make onsite visits at any time to inspect premises and verify compliance, and can initiate ex officio legal proceedings to penalise non-compliance. Ultimately, these legal proceedings can result in the revocation of marketing authorisation.

Good manufacturing practices, stability, labelling standards and all other applicable provisions must be complied with. A programme to recall and destroy products that do not meet quality standards must be in place.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

COFEPRIS is entitled to implement measures on behalf of public health, such as:

the seizure of products; and ordering partial or total suspension of activities, services or advertisements. Under certain conditions, COFEPRIS has statutory authority to revoke any manufacturing approval and impose penalties, ranging from a fine of up to 16,000 times the minimum wage (approximately $3,523) to closure of the establishment.

The imposition of administrative penalties does not exclude civil and criminal liability.

Distribution

How are the distribution and storage of medicinal products regulated?

The Official Mexican Standard (NOM) for the good manufacturing practice of medicinal products (NOM-059-SSA1-2015) requires a programme to recall products that do not meet quality standards in an appropriate and efficient manner. This programme must include:

activities planned for recalling products in a rapid and effective manner; storage; and a list of authorities to be notified according to the product distribution. Marketing authorisation holders must report any product recall decision to COFEPRIS, providing details of the products and the causes leading to the recall.

Import and export

How are the import and export of medicinal products regulated?

A marketing authorisation granted by COFEPRIS is required when importing medicinal products.

Foreign marketing authorisations are not valid in Mexico. However, COFEPRIS has set a special procedure for drugs requiring first-time approval in Mexico, but that have been approved by equivalent regulatory authorities abroad. In this procedure, the approval requirements of the foreign agencies are recognised as equivalent to those in Mexico.

Are parallel imports permitted in your jurisdiction?

Any import of drugs, health products or raw materials for drugs must be approved by COFEPRIS. Marketing authorisations are required. The import of a minimum quantity of products without a marketing authorisation can be approved in certain circumstances (eg, clinical trials and orphan drugs).

Regarding IP rights, parallel imports are allowed in Mexico in relation to trademarks where:

the product was legally introduced in the country of origin; and the trademark is owned by the same company or a related company in Mexico. The IP Law does not specifically address patents in this context, as it does for trademarks. However, it is likely that the principle of exhaustion of rights also applies to patents.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

Price control in the private sector is based on a self-regulated maximum retail price (MRP) scheme covering patented products, which is overseen by the Ministry of Economy. The participation of pharmaceutical companies 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 penalties for MRP violations.

In 2008 the government created the Committee for the Negotiation of Drug Prices to:

support public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies; and evaluate cost benefits of new medicines and therapies in view of prices and other comparable products in the market. Are there any restrictions on the online sale and purchase of medicinal products?

Unless they are over-the-counter products, medicines must be made available only in authorised drug stores and can be sold to patients only with a physician's prescription. Dispensers must keep original prescriptions regarding antibiotics.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

The following rules govern named patient supply of pre-launch medicinal products:

the Code of Good Practices of Advertising of the National Chamber of the Pharmaceutical Industry (CANIFARMA); the CANIFARMA Code of Ethics; the Health Law Regulations; and the NOM-072- SSA1-2012 for medicinal products labelling. Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in...