Who could have imagined the current situation of the allopathic medicament market in Mexico 4 years ago?

Approximately four years ago, a tripartite advertising war in the massive communication media took place between laboratories manufacturing allopathic medicaments, that is, innovative medicaments or patent-protected medicaments, laboratories manufacturing interchangeable generic medicaments (GI’s by their initials in Spanish language), and laboratories manufacturing generic or "similar" (look-alikes) medicaments. In this war, each part enhanced the advantages of their products, emphasizing particularly in their respective costs.

The struggle still persists, and this conflict is being taken to other spheres besides the commercial ambit. For instance, the company "Farmacia de Similares" (Similars Pharmacy), which sells medicaments from the "similar" category, has publicly denounced that the Federal Consumers Representative (PROFECO), the Mexican Institute of Industrial Property (MIIP) and the Ministry of Health (MOH) are acting against it, because on the one hand, the first two organizations have emitted resolutions ordering "Farmacia de Similares" to remove its advertising campaign slogan "the same but cheaper", because it is considered as unlawful competition. On the other hand, "Farmacia de Similares" argues that the MOH is pretending to eliminate it from the market by modifying the standards for governmental acquisitions, because now, the MOH will demand only patent-protected medicaments or interchangeable generic medicaments (GI’s), which satisfactorily approve with the standards of bioequivalency tests.

As it can be seen, this dispute between laboratories is turning more intense as interesting each time, if we take into account that the allopathic medicament market in México is within the first ten in the world, and that it is number one in Latin America. Hence, we do not have to say that too many economical interests are at stake.

Many may wonder why does this conflict exists; well, the answer goes as follows:

Before implementing the interchangeable generic medicament program (commercially designated as GI’s) in 1998, there were only innovative or patent-protected medicaments and generic or similar medicaments in the market.

In 1991, the World Health Organization (WHO) had recommended the Mexican Government implementing a program for interchangeable generic medicaments. It was until 1998, that the MOH reformed the General Health Law (GHL), establishing the basis for the Interchangeable Generic Medicament Program. Since then, all official agreements by which a pharmaceutical product is rendered susceptible to be incorporated to the Interchangeable Generic Medicaments Catalogue, are published in the Official Diary of the Federation.

An interchangeable generic (GI) medicament is a medicament containing the same active ingredient as well as the same pharmaceutical dosage form of the corresponding innovative or patent-protected medicament, having then equal effectiveness and concentration. It also utilizes the same via of administration. Besides, an interchangeable generic medicament is required to approve the standards of the interchangeability tests, which certify it as a pharmaceutically equivalent medicament to the innovative medicament, this GI then showing to be as effective and safe as the innovative medicament, but at a lower market price. One of the main features of a GI is that it must be released in the market once the patent of the innovative medicament is no longer in force.

Now then, the generic or similar medicaments have been in the pharmaceutics market since long ago, conforming, above all, the source of the Basic Chart of consumable resources for the Health Sector. One of the possible reasons this happened was that, well before the enactment of the Industrial Property Law (IPL) of 1991 which was amended in 1994, many inventions were considered as non-patentable, including all types of pharmaceutical and biotechnological inventions. Hence, there was no protection of property rights for innovative medicaments, and therefore, the innovative medicaments market was very reduced.

Thus, from the date said IPL of 1991 was enacted, a broad protection of property rights was totally available for said pharmaceutical and biotechnological inventions. Mexico then became one of the most promising markets in the international sphere for foreign research and development foreign laboratories, as this amendment of the Law allowed innovative medicaments to increase their presence in the national market.

On the other hand, at the same time the GI’s appeared in the market, "Farmacia de Similares" had an accelerated growth in most of the national territory, accompanied by a powerful advertising campaign in the massive media, which slogan wielded that "similars" are equal to the innovative medicaments, but cheaper, although their purity and effectiveness had been questioned by the Health Authorities.

As a response to the "similars" advertising campaign, the manufacturers of GI’s, and of innovative medicaments, initiated, independently, their own advertising campaign in order to work against the "similars" campaign, by making tacit comparisons of the therapeutic effect of said innovative and interchangeable medicaments compared with that of the similars.

Another factor that has played a fundamental role in this conflict is the Sanitary Regulation, which affects at least two actors of this conflict, since, on the one hand, the MOH grants sanitary registrations (marketing authorizations) to all medicaments, without considering if the innovative medicament is still protected under a valid patent, reason for which the interests of said innovative medicaments are affected. On the other hand, however, nor the GHL neither its Regulation consider a continuous renovation schedule for sanitary registrations issued a long time ago, which greatly affects the GI’s.

Delving a little more into the first mentioned aspect, we now will refer to the complain the foreign pharmaceutical laboratories have presented, in the sense that the Health Authorities should not grant the sanitary registration to a generic interchangeable medicament or to a similar medicament until the patent protecting the innovative medicament is due, so the IPL as the international treaties of which Mexico is a party, are respected. Nevertheless, the health authorities have not listened to said petition, arguing that patents are not in their area of competency.

Regarding the second above aspect, it is important to mention that if there is a third laboratory interested in releasing a generic medicament in the market, it can meet with the MOH purity and effectiveness requirements for a generic medicament only by showing any document that certifies said conditions. Said documents can be copies of the studies done originally by the research laboratory for the innovative medicament, which can be obtained via Internet from the Food and Drug Administration (FDA) in the USA.

But, what has caused this war between laboratories?

The advertising war initiated approximately 4 years ago, has originated a great amount of confusion in the public, mainly in the people with less economical resources, because they are filled with ads referring to the advantages of each of the medicament categories. These ads also enhance the differences in prices of one with respect to the others, a fact which is difficult to understand if people do not have the elements at hand in order to make a real comparison.

On the other hand, we can mention that there also is a great deal of ignorance between the medical sector, since there is an elevated number of medics who are not aware of the pharmacological and therapeutic difference between each one of the aforementioned categories of medicaments, independently of their price, fact which aggravates the situation if we consider that the medic is the ideal person to guide their patients and prescribe them the medicament which is the safest and the most effective, so the disorder lasts the least.

Viewing the problem through this optic, I consider that a great sector of the population requiring of medicaments, buy these only because of their low price, without considering the other facts.

Together with the problems mentioned above, it is important to mention that in Mexico, until now, a policy for protection against health risks in matter of medicaments has not been really instrumented, even though the Federal Commission for Protection against Health Risks (COFEPRIS) has been created. The above is completely evident, as there is not any health control or vigilance in stores or drugstores that sell medicaments, since a prescription is not required to buy them even though the label of the medicament quotes according to the law: "prescription is required for selling or supplying of this medicament", these medicaments becoming therefore, "free-access" medicaments. This fact contributes to self-medication in a considerable manner.

With this panorama, it is necessary to attack the problem from the root by giving in-depth solutions and not simply temporary or superficial remedies which partially alleviate the conflict. For that purpose, I consider that it is essential to define a medicament policy suitable to the globalization times we are living, promoting more legal safety and equity in the pharmaceutical sector.

To achieve the aforementioned, it is fundamental to amend the GHL and its Regulations, in order that the granting of the required sanitary registrations is subject to the dispositions of the IPL and to the International Treaties of which Mexico is a party, besides meeting with the requirements indicated in the applicable norm.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.