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”.