There are a number of matters to consider when carrying out mergers and acquisitions (M&A), asset sales, spin-offs and similar activities in the pharmaceutical, medical device and other health-related industries (for further details please see "M&A, asset sales and spin-offs in pharmaceutical and medical device industries: what you need to know"). One such matter is the nature and legal treatment of marketing authorisations.
It is common for the parties involved in a merger, acquisition, asset sale, spin-off or similar activity to treat marketing authorisations as assets which are subject to the general negotiation process. Such marketing authorisations are thus generally:
- included in the list of assets covered by the specific activity;
- included in the buyer or transferee's due diligence; and
- assigned a value or price.
However, this approach is controversial. If incorrect, an allocation of a monetary value to or a transfer of a marketing authorisation could be considered an invalid act between the relevant individuals or legal entities.
The health authorities have implemented the so-called 'transfer of marketing authorisations' procedure, which transferees must follow in order to carry out any act or activity concerning a product covered by an authorisation. However, marketing authorisations are not necessarily assets which are subject to a sale or transfer by the holder to another individual or entity. The mere fact that the name of the procedure specifically refers to a 'transfer' of marketing authorisations does not imply that these operations are, legally speaking, a transfer of assets. The legal nature of an operation is not determined by its name, but rather by its specific characteristics – a situation that has been recognised by the Mexican courts in a number of resolutions.
Arguably, the legal nature of a marketing authorisation is that of a permit or authorisation issued by the competent authority that permits or allows its holder to carry out specific acts or activities involving a determined product within Mexico.
To obtain a marketing authorisation, the requesting party must duly evidence before the competent authorities that:
- the product complies with the necessary requirements; and
- the requesting party has duly complied with the requirements to hold such an authorisation.
If these requirements are not duly met, the competent authority will deny the authorisation or, preferably, issue a resolution whereby the requesting party will be granted the possibility to prove due compliance with the applicable requirements pending the submission of further evidence.
In this regard, until a permit or marketing authorisation has been duly issued or recognised by the authority in favour of a specific party, that party will not be legally entitled to carry out any act or activity relating to the corresponding product.
In case of pharmaceutical and other products subject to this requirement, it must be proven that the product does not represent a sanitary risk. Further, the requesting entity must duly evidence that it has the necessary authorisations and legal standing to hold the permit or marketing authorisation.
As such, a marketing authorisation is not a transferable asset based solely on the mere will of the parties to a transaction. Rather, it is an authorisation from the competent authorities and subject to compliance with the applicable requirements.
Based on the above, if the Mexican health authorities do not expressly authorise the transfer of a marketing authorisation, the buyer or transferee will not be legally entitled to import, manufacture, market, warehouse or conduct any other act or activity relating to the relevant product. In such cases (which are fairly common in practice), it is necessary to either reverse the merger, acquisition, asset sale, or spin-off or, preferably, design a specific legal structure whereby the formal transferor holds the marketing authorisation for a specified period on behalf of the transferee until it obtains the necessary authorisation from the authorities.
In many cases, and particularly when dealing with international operations, such transfers will be subject to due compliance with a range of requirements – not only by the Mexican entities, but also foreign entities that may be involved in, among other things:
- the manufacturing process; or
- the supply of goods and raw and packaging materials.
The transfer of a marketing authorisation is neither impossible nor treated with disregard by the authorities. However, due to the nature of a permit or authorisation, it is advisable to consider the possible alternatives that may be required before undertaking a merger, acquisition, asset sale, spin-off or similar activity in the pharmaceutical or medical device industry.
For further information on this topic please contact José Alberto Campos Vargas or Juan Luis Serrano-Leets at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email (email@example.com or firstname.lastname@example.org). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.