Reforms Aim To Combat Counterfeit Medicines - Uhthoff

Reforms Aim To Combat Counterfeit Medicines

By Saul Santoyo Orozco

Uhthoff, Gomez vega & Uhthoff, S.C.

Continuing with its efforts to establish a suitable legal framework to combat various acts of product counterfeiting, the Mexican executive has published reforms to various laws and codes whose main intention is to make life impossible for counterfeiters of medicines and of other medicine products.

The scope of a deadly menace

Counterfeit medicines are the antithesis of real medicines. Although they might look like legitimate products, counterfeit medicines may contain no active ingredients, incorrect active ingredients, inappropriate dosage or be contaminated. Additionally, the packing materials used in these products are usually improper.

This widespread problem could easily be qualified as the most dangerous type of counterfeiting, as not only does it deceive consumers but it also represents a threat to public health, given that in most cases counterfeit medicines not only will not help individuals to treat their illness or condition, but most certainly will provoke harmful side effects and even death.

Counterfeiters of medicines employ new technologies and well-organized criminal operations to profit at the expense of the health and life of individuals. This problem mostly (but not exclusively) affects essentially developing countries and, sadly, in some countries the presence of counterfeit medicines has grown to the extent that you are more likely to buy a counterfeit than a real medicine.

The amendments on the loop

The Mexican executive branch published in the Official Gazette of the Federation an addendum to the Mexican Health Law and to the Federal Code of Criminal Proceedings (FCCP), passed by the Mexican Congress, by which Article 464 of the Federal Health Law has been amended. In the same legal body new Articles 208 bis and 464 ter have been incorporated. A new Section XV to Article 194 has been added to the FCCP. These amendments went into effect on May 26 2006.

The new Article 208 bis of the Health Law defines a false product as follows: when a product is manufactured, bottled or sold by making a reference to a non-existing authorization; or when somebody uses an authorization that was legally granted to another; or when someone imitates a product that was legally produced and registered, the resulting product should be considered to be counterfeit.

The newly amended article 464 of the FCCP establishes that anyone that adulterates, falsifies, pollutes or alters or allows adulteration, falsification, contamination or alteration of processed foods, non-alcoholic drinks or any other substance or product of human use, with risk to health, shall be punished with one to nine years of prison and a fine equivalent to between 100 and 1000 days of the minimum wage. (At current amounts, the fine would be up to about $4,450.)

Furthermore, the new Article 464 ter provides that in the field of medicines, the subsequent penalties shall be applied to individuals(s) that carry out the following conduct:

Anyone  that  adulterates,  falsifies,  pollutes,  alters  or  allows  the  adulteration,  falsification, pollution or alteration of medicines or pharmaceuticals, raw materials or additives for human use or consumption or that manufactures them without the registrations, licences or authorizations determined under the applicable Law, shall be punished with imprisonment from one to nine years and a fine equivalent to 100,000 days of the minimum wage (at current amounts, about $445,000).

Anyone that falsifies, adulterates or allows the adulteration or falsification of packing materials or the legends, information, numbers or identification codes thereof shall be punished with imprisonment from one to five years and a fine equivalent to 50,000 days of the minimum wage (at current amounts, about $225,000).

Anyone that sells or offers to sell, distributes or transports adulterated, falsified or altered medicines, pharmaceuticals, raw  materials  or additives  (not  necessarily  for  human consumption), in commercial establishments or anywhere else or sells, offers to sell, distributes or transports packing materials for medicines, pharmaceuticals (or if the legends, information, numbers or identification codes thereof have been falsified, altered or adulterated) shall be punished with imprisonment from one to five years and a fine equivalent to 50,000 days of the minimum wage.

The addition to the FCCP, section XV of article 194, qualifies the conduct described in article 464 ter as serious felonies. Consequently, the alleged criminal would not have the right to request his release on bail, before or during the criminal proceeding. This will mean imprisonment until a final resolution, and if the alleged criminal is found guilty then he/she will remain in custody.

The importance of the amendments

Although the Mexican authorities have worked together to address the issue of counterfeit medicines and it has been publicized that federal health officials from the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) have implemented numerous actions to trace counterfeit medicines and illegal drugs in Mexican drugstores that have resulted in the temporary closure of several drugstores and in the seizure of tons of counterfeit medicines, these amendments are extremely important since they add more options for attacking the problem and protecting public health.

The new amended provisions to the Federal Health Law and FCCP open the possibility of bringing a criminal action against counterfeiters in the field of medicines and pharmaceuticals. A criminal  action  based  on  this  new  legislation,  together  with  a  trade  mark  enforcement proceeding, would create a sandwich effect strengthening actions against counterfeiters of medicines  using  labels  or  packages  in  an  attempt  to  link  the  counterfeited  product  to  a legitimate mark.

In this context, an adequate enforcement with collaborative efforts by the competent Mexican authorities would not only protect the particular interests of the company affected by the counterfeiting activity but also would deal with the healthcare problem caused by the lack of effectiveness and risks to consumers of using the counterfeited products.

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