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CHILE: Bill seeks to intervene in the commercialization of pharmaceuticals drugs.
By: Francesca Rodriguez Spinelli
The Chilean Congress is currently discussing the so-called Bill “Drugs II” (2015), which seeks to amend the Health Code (1967) and update the regulations concerning bioequivalence, while preventing the vertical integration between pharmacies and pharmaceutical laboratories.
In the scenario of being approved, this Bill will bring several important challenges to manufacturers, distributors, pharmacies, drugstores, health professionals and patients; such as:
- The doctors’ obligation to prescribe medicaments under the “International Common Denomination (ICD)” of the compound.
- Pharmacies would be obliged to inform the customers on the generic versions available for the drugs prescribed by their doctors under the ICD.
- Changes on the labeling, so that the product packaging includes the ICD, using said denomination in a size that is at least one third of the main faces of the packaging, while the trademark may not exceed one fifth of the space used by the ICD.
- Extension of the Institute of Public Health’s powers in terms of granting marketing approvals for pharmaceutical medicaments under their ICD.
From one side, it is feared that if the Bill is finally approved, it would result in an incongruous reinforcement of the already palpable vertical integration existing in Chile between laboratories and pharmacies. In this context, pharmacies could gain even more, because they would be basically in a sort of “comfortable” position, in terms of making of the pharmaceutical seller a key person at the moment of learning about those generic versions available for the patient, who was prescribed by his/her doctor with an ICD, thus significantly influencing the patient’s final purchase decision.
On the other hand, given that in Chile there is not yet an effective standardization system on the real bioequivalence of medicines, it is also a major concern that the Bill could instrumentalize a system that restricts the exercise of the medical profession, while reinforces old and very condemnable collusion practices between the big laboratories and pharmacies, already evidenced and punished by the Chilean institutions in the past (2008-
2012), in view of the concerted price increases of at least 222 drugs, mainly aimed to treat chronic diseases.
The government, through the Ministry of Health, has also proposed a controversial observation to the Bill with the aim of allowing the National Health Service System (CENABAST), to intermediate in the purchase of drugs and medical supplies between manufacturers/distributors and private customers, such as small/community drugstores, in the case of “inaccessibility to pharmaceutical products caused by economic, financial, geographical or opportunity barriers preventing from accessing a determined medicament”.
This could mean a relevant change in the CENABAST’s role, considering that currently it is a public institution only in charge of ensuring the availability of drugs, food, supplies and equipment to the Chilean public health network, thereby intermediating between private suppliers and public customers exclusively.
Thus this initiative of the Ministry of Health could imply an unusual and preoccupying intervention of the government in the commercialization of pharmaceutical products in a quite open market such as the Chilean one, under the premise of still imprecise circumstances of “inaccessibility to pharmaceutical products”, especially considering that those “economic, financial, geographical or opportunity barriers” preventing from accessing a medical treatment and/or drug can respond to multifactorial causes, and that for example, in justified cases and due to public health reasons, our Industrial Property Law provides for legal mechanisms to grant compulsory licenses on pharmaceutical patents.
Francesca Rodríguez is specialized in Industrial Property Law, with an emphasis on matters related to invention patents, utility models, plant varieties and industrial designs.
She joined Alessandri in 2010 and her practice is particularly oriented to help national companies and universities, as well as multinational companies, to protect, prosecute, defend and manage their patent portfolio in Chile and abroad. Her academic background and expertise on the Industrial Property regulations of the Andean Community (Colombia, Bolivia, Ecuador and Peru) additionally gives her the ability to provide legal advice on the patent law system of several key market counties in the Latin American region.
Francesca works with clients whose inventive products and processes are related to as diverse technical areas, as life sciences, mechanical, civil and electrical engineering and 3D printing, among others. Her experience has allowed her to help startups and growing companies to gain value from their intellectual property assets.
Francesca was ranked in Chambers and Partners Global 2013 as “Foreign Expert.
She is a member of the Chilean Industrial Property Law Association (ACHIPI), the American Intellectual Property Law Association (AIPLA) and Secretary of the Board of the Licensing Executives Society Chile (LES-Chile).