It is well known that the law often struggles to keep up with new products and activities, particularly those based on technological developments. In many cases, the legal provisions which apply to regulated activities lose their applicability due to the speed with which technology enables parties to operate outside the scope of the law or the jurisdiction of the relevant authorities. This is particularly true for physical research involving living organisms, such as humans, as advancements in communication and the transfer of data have significantly broadened the scope of such research.
Research involving humans is heavily regulated in most countries due to the ethical implications and risks that it may pose for the individuals concerned. The Mexican General Health Law establishes that medical investigations and research are subject to sanitary regulation by the health authorities. Particular attention is given to activities that constitute investigations involving humans or clinical trials.
Under the law, 'medical investigations' include all kinds of action that contribute to the collective knowledge of:
- human and biologic processes;
- links between illnesses and their causes;
- medical practice and processes;
- the prevention and control of health problems; and
- the effects of the environment on human health.
The General Health Law Regulations in Health Investigation Matters establish that 'investigations involving humans' include all types of research involving pharmaceutical products, medical devices, medical processes and all other data collection relating to human health.
In addition to the above law and regulations, other provisions set out guidelines and criteria regarding clinical trials or medical investigations, including:
- NOM-012-SSA3-2012 Criteria to Carry Out Health Investigations into Human Beings; and
- diverse criteria and guidelines issued by the health authorities.
As a rule, the regulations establish that clinical trials (and, in general, clinical research and investigations) involving humans may only be carried out in a health institution.
A 'health institution' is a place:
- where health investigations are carried out by legal entities or individuals duly authorised to do so; and
- which have the necessary legal, technical and material structure for such investigations to be carried out.
The conditions that must be satisfied to determine whether the latter criterion is met include the existence of:
- certain committees (including an investigation, ethics and biosafety committee); and
- "facilities and premises where medical attention or investigation activities are carried out" and which have been authorised for such purposes.
Thus, in order to carry out research and investigations regarding humans, parties must have:
- a physical premise where such activities (in a broad sense) may be carried out; and
- authorisation to carry out particular health-related activities in such premises.
These legal requirements and conditions apply only to activities carried out in the Mexican territory, as defined by the Constitution.
Use of new technologies and platforms
Notwithstanding the definition of medical investigations – including the relevant requirements and restrictions – the applicable provisions do not contemplate the possibility of obtaining, analysing, reviewing or performing diverse activities that constitute research and investigations involving humans through new technologies and platforms that do not require a physical presence, premise or place (ie, health institution) in Mexico.
Under the current provisions, it is questionable whether research and investigations which involve Mexican individuals located in Mexico (or data, facts, circumstances, evidence or any other information generated in Mexico), but which are undertaken by an individual or institution located abroad, are subject to the conditions and requirements to which health investigations (specifically clinical trials) are subject.
The use of new technological platforms through which data, images, test results, sounds and surveys, among other things, are transferred outside Mexico to be used in an investigation or research relating to human health falls outside the scope of the activities subject to sanitary regulation by the Mexican health authorities.
Under these new platforms, individuals and legal entities outside Mexico may collect data and information to develop, investigate, review, determine and increase their knowledge of, among other things:
- human, biologic and psychologic processes;
- links between illnesses and social factors;
- medical practices and techniques;
- the development of products, systems and services; and
- the prevention and control of health problems.
Since these activities are not carried out in Mexico or at a place or premises in Mexico, the current statute regarding health investigations could be deemed to not apply. However, in some cases, the processes for obtaining such data could be subject to legal requirements regarding privacy, intellectual property, telecoms or other specific legal issues.
The excessive burden on and requirements for parties undertaking medical investigations in Mexico may result in a loss of traditional channels due to the existence and widespread use of new technological alternatives that may avoid the physical presence requirement and associated costs.
The regulation of medical investigations has fallen behind in light of the available technological tools. As such, the legislation should be amended to lesson the burdensome and complicated requirements imposed on parties and reflect the reality of today's technological advancements.
For further information on this topic please contact José Alberto Campos Vargas at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
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