BOGOTA, Colombia – Proposed legislation in Colombia would ban generic drugs from the public health system in favor of more expensive branded versions and could, if it passes, pave the way for a similar move with biosimilars and their originator drugs.

Colombian congressman Hernando Padaui introduced the project of law at the lower house in early May and, while it is far too early to predict that the project will become law – it has to be debated and approved by the Colombian congress – it has raised a number of red flags.

"We would not hesitate to describe an initiative like this as far-fetched and like a real eyesore, which is not consistent with either the worldwide trend of prescribing generic drugs or with the Colombian reality of its health system finances fragility, in which there is a great responsibility of the high prices of brand drugs of multinational pharmaceutical companies, which are many times greater than those of generic products," Alberto Bravo, president of the Association of Colombian Pharmaceutical Industries (Asinfar in Spanish), told BioWorld Today. "There is the use of a sophism, a huge lie, as that one that says that generic drugs are not effective, to set the red carpet to branded innovative drugs."

Bravo said that not only would the move cripple the already weak finances of the public health care system but could also lead to the loss of some 30,000 jobs while threatening the future of domestic drugmakers.

In an explanatory statement, Padaui claims that branded or innovative drugs are much safer than generics.

"In recent years, there has been controversy about the substitution of generic equivalents of certain brand named drugs and the standards for assessing the bioequivalence by the FDA for generic forms of critical dose drugs," he wrote.

The Colombian congressman even put into question the standards from U.S. FDA in regard to bioequivalence.

"The essence of the controversy involving critical dose drugs is whether the rules governing FDA bioequivalence are strict enough to ensure that generic formulations of these drugs are clinically equivalent to their brand competitors concerning therapeutic results," he wrote.

Padaui and his staff declined to comment.

Asinfar has rejected the proposal and backed the work and attributions of the National Institute of Surveillance of Drugs and Supplies (Invima for its acronym in Spanish).

"Asinfar categorically rejects this initiative, which is also an insult of the worst type to the scientific, technical and administrative capacity of Invima and the laboratories that produce generic drugs stating, without any substantiation, that are neither efficient nor safe and lack the quality of [those] brand-name drugs [produced by] multinationals, whose aim, not only in Colombia but throughout the world is to abate generic competition and thus impose monopoly prices," said Bravo.

While the proposed ban is aimed at generics, the explanatory statement attached to the proposed legislation suggests patients should be supplied with commercial or brand-named biologics only.

"In the case of biotech drugs, when using a biological system to produce the molecule, they introduce a huge variable element. Since not all laboratories have access to the strain of the bacteria, modification varies somewhat, and the reactor where the process happens will not be the same, there are many influencing factors including temperature, pH, pressure, time, etc. . . . which may cause slight difference in the final product," wrote Padaui.

"All this introduces very significant differences among biologics, therefore, for the case of biologics, there should always be access to commercial drugs," he added.

Bravo said it is clear that the project will affect biosimilars. "When you open a crack in the wall of a dam, sooner rather than later there will be a gap through which all the water escapes," he said.

"The wrong logic of the project also applies to biosimilars with the worst economic and health consequences for patients. But this project will rest in the museum of the absurd initiatives of some congressmen and not in the legal annals of Colombia," he noted.

Bravo has also publically spoken against Afidro, the Association of Pharmaceutical Labs of Research and Development. At the end of the day, many of its 19 associates, producers of innovative drugs, are the ones that could benefit from Padaui´s project.

Asinfar announced an aggressive strategy to offset Padaui´s initiative.

"It is necessary to make a common front with the rest of the Colombian society, including organizations which promote access of the population to drugs, to denounce this threat that every day mutates into new forms to quell and minimize the competition in detriment of the health and welfare of Colombians," said Bravo.