/ Bill seeks to modify the marketing of pharmaceuticals in Chile

The Chilean Senate is currently discussing the so-called bill “Drugs II”, which seeks to modify the Health Code of 1967, to update the regulations concerning the bioequivalent medications while avoiding vertical integration between pharmacies and laboratories.

These changes in the regulatory regime of pharmaceuticals in Chile undoubtedly pose great challenges for manufacturers, distributors, pharmacies, drugstores, heath professionals and patients.

The bill is in its initial stage of discussion, and if approved it will bring several modifications to the current legislation, among which we can mention the following:

a. Obligation for doctors to prescribe medications under the “International Common Denomination (ICD)” of the drug.

b. Obligation for pharmacies to inform the public the alternative drugs of ICD, of interchangeable character.

c. Changes on the labelling, 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 fantasy name (or brand) may not exceed one fifth of the space used by the ICD.

d. Extension of powers of the Institute of Public Health (ISP), in order to keep a record of all the medicines, which can be registered only if they have any ICD.

It is feared that if the aforementioned bill is finally approved, it would result in an incongruous reinforcement of the already palpable vertical integration between laboratories and pharmacies, since the latter will be a clearly determining factor in establishing which is the most appropriate medicine for the patient, raising the possibility of adding an important degree of bias on the recommendation of one product versus the other by the pharmacies’ dispensing assistants, thus significantly influencing the patient and his/her final purchase decision.

In addition, given that in Chile there is no yet an effective standardization system on the real bioequivalence of medicines, it is also a major concern that the “Drugs II” bill ends up instrumentalizing a system that restricts the exercise of the medical profession, while reinforcing old and condemnable practices of collusion between laboratories and pharmacies, far from the true and necessary empowerment of the patient, to make an informed decision on so sensitive matters such as health, with all the potentially irremediable consequences this situation can cause.

In case you need more information about this bill, please do not hesitate to contact us at patents@alessandri.cl

Check the bill HERE