Adverse effects of drugs and vaccines in Mexico

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

Under Mexican Law, the manufacturing, production, distribution, import, export, sale and even the prescription of drugs by Healthcare professionals is heavily regulated under the General Health Law and its secondary regulations (the “Mexican Sanitary Law”) and therefore under strict vigilance and compliance policies by Mexican Sanitary Authorities, which have broad jurisdiction to seize counterfeit or illegal drugs as well as to impose several economic sanctions and demand the closure of establishments. 

Therefore, under Mexican Sanitary Law, special authorisations are required for manufacturing, producing, selling, importing, and exporting drugs. 

The goal of such authorisations is to prove that a certain drug complies with several efficiency, quality, safety and health standards for it to be distributed and sold to the general population. 

Nevertheless, the use of non-regulated drugs may be authorised for clinical trials (especially during development phases for new and/or experimental drugs),  magistral drugs, which are drugs compounded in local authorised pharmacies to fit the unique need of a patient according to a detailed facultative prescription of a physician and in some exceptional cases, unauthorised drugs to treat specific conditions (Mexican Sanitary Law allows for patients to import of specific drugs not authorised in Mexico but only for personal use and under medical prescription). 

In relation to the aforementioned, administrative liability under Mexican Sanitary Law is the main source of responsibility that may be imposed to manufacturers, distributors and in some cases even healthcare professionals. 

In this sense, Healthcare Professionals must obtain special authorisations to prescribe certain types of controlled drugs (drugs with certain types of narcotics or psychotropic ingredients or other controlled substances under Mexican Sanitary Law). The prescription of controlled drugs without the proper authorisation may arise administrative and criminal liability against a Healthcare Professional prescribes. 

Mexican Sanitary Law also classifies as a Criminal Offense, the manufacture, sale, distribution of non-authorized drugs or the manufacture, sale and distribution of falsified, adulterated or impure drugs. 

Furthermore, civil liability, both contractual and extracontractual liability (Tort is a figure not explicitly regulated under Mexican Law and generally falls under non-contractual liability caused by illicit actions) may be imposed upon Manufacturers, and Health Professionals. 

State liability is usually considered a matter of administrative law, and any responsibility that may arise against the State is subject to special administrative procedures, as any harm, damages or affections caused by the State would constitute a violation of the human right to health, which is regulated in the Mexican Constitution. 

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:

Under Mexican law, the conditions for claiming compensation may differ regarding the type of liability. 

Under civil liability (includes contractual and non-contractual liability), the burden of proof is usually set against the claiming party, which must prove a cause-effect connection. In this sense, the party that denies a claim must also provide prove of its denial. 

In criminal liability, the burden of proof is set upon the District Attorneys which is the responsible party to conduct investigations and assess if a party is to be imputed before a criminal tribunal. 

Liability against the State can only be claimed if a person can prove that an action or omission by the state violates a human or constitutional right in favour of a person through a special administrative proceeding (“Juicio de Amparo”).  

Administrative liability imposed by Sanitary Authorities can be imposed after complaints are filed by the public before such authorities or by ex-officio administrative proceedings.

Mexican Sanitary Authorities usually conduct investigations, on-site and audits to manufacturers or distributions in order to assess imposing any liability. Upon the cases where the Sanitary Authorities determine that criminal liability may also arise, they must notify the Public Ministry in order for them to conduct and assess the possibility of imposing Criminal liability. 

2.2 Which are the grounds for exclusion of liability?

Regarding Manufacturers, if liability arises out of the sale, manufacture or distribution of non-authorised or illegal drugs, there is no exclusion of liability. 

On the other hand, off-label use by the public would exclude the liability of a manufacturer or a Healthcare Professional, so long as they do not encourage the use of the drug for other purposes than the ones authorised. 

Nevertheless, pursuant to Sanitary Law, clinical trial budgets should include compensation for the subjects of investigation in the case of damage directly related to the clinical trial. 

These funds can be covered by study insurances. 

Furthermore, regarding the Federal Law for the Protection of Consumers, distributors of products may avoid liability whenever they inform the buyers of the potential risks and adverse effects of the product, provided, in this case, that the product is an authorised drug and that the distributor holds the required authorisations. 

2.3 Which are the time limits for submitting a claim for compensation?

Pursuant to the Federation’s Criminal Code and the Mexican Sanitary Law, criminal offenses sanctioned with prison time (such as selling or manufacturing illegal or unauthorised drugs) prescribe, at least, nine years after the crime was committed. 

In regards with non-contractual civil liability, the damaged party has 2 (two) years to submit their compensation. If the claim arises out of contractual liability, the time limit is of 10 (ten) years. 

The jurisdiction of Mexican Sanitary Authorities to investigate and impose liability, prescribes in 5 (five) years upon the event took place. 

2.4 Which damages can be compensated?

Mexican Law only contemplates compensatory damages, nevertheless, there has only been one precedent where a tribunal awarded punitive damages. 

In regards with liability of the State, Mexico has a special law that regulates payments and compensations for irregular or illegal State actions.

Nevertheless, the nature of the compensations is that of compensatory damages. 

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

Yes. Under Mexican Law, the damaging parties can bring forth their claims to the responsible party or the insurance company. The process to claim compensation before an insurance company is regulated in a special law. 

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

Generally, no. However, in Mexico, compassionate use is not specifically regulated. 

The only way for patients to use unauthorised drugs are the following: 

• By acquiring a special permit to import unauthorised drugs in Mexico to treat specific conditions. (The drugs must be authorised in other countries and must be prescribed by an authorised Healthcare Professional). 
• Authorised Clinical trials. As mentioned above, Clinical trials are subject to special secondary regulation, nevertheless, such regulations establish that Clinical trial programs must be performed under authorised health institutions and under the supervision and oversight of Healthcare Professionals who have the legal obligation to assure the health and safety of the people subject to the programs. Furthermore, as mentioned beforehand, Clinical trials must include a compensation fund or an insurance policy to cover any possible claim. 

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

Mexican Sanitary Law establishes that Off-label use encouraged by Healthcare Professionals or any person is considered a criminal offense.

Upon such case, Healthcare Professionals may not only be subject to criminal liability but may also be suspended to practice medicine. 

Any Off-label use by the public would limit any liability against a Healthcare practitioner or a Manufacturer. 

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

No.

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

Not specifically.

6.1 Which liabilities can be insured? Is there any compulsory insurance?

Civil and professional liability insurances are available for Healthcare Professionals. 

Furthermore, there are specialised insurance policies for clinical trials that can be issued in favour of institutions and companies responsible for such programs.

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

As administrative and criminal matters are not subject to ADR in Mexico, only civil liability arising out of a contract may be disputed through ADR.

Furthermore, there is a special institution (Comisión Nacional de Arbitraje Médico) responsible for solving claims related to professional liability and erroneous practices by Healthcare Professionals.