It was the one that decided to cut the Seventh Circuit of the US circuit, in one case in which a woman processes Glaxosmithkline (GSK), claiming that her husband committed suicide after ingesting a generic Paxil antidepressant tablet manufactured by another laboratory.
The pharmaceutical giant sought the summary judgment of the action, arguing, in defense of it, that it could not be held accountable for the damage caused by medicine that it did not manufacture or made available in the market.
However, the Court of Appeals, mirroring in two decisions of the US Supreme Court, considered to be possible to accountability for the manufacturer of the medicine reference for damages that may be caused by his generic medicines originating.
The justification for such a decision - and the current position of the Supreme Court - is due to the fact that, in the US, the FDA (Equivalent of ANVISA) prohibits laboratories manufacturers of generic drugs to change its packaging and bulos (albeit Whether it is to alert about newly discovered hazards and precautions) if the laboratory manufacturing the medicine reference does not make these changes first. In other words, generic manufacturers can not be held accountable for incomplete failures and packages in their medicines as they depend legally on the prior alteration of the pack and packaging by the pharmaceutical companies holders of the brand medicines.
In Brazil, the relationship between generic manufacturers and reference medicinal products is regulated by ANVISA through RDC Resolution No. 47/2009, which determines that national laboratories generic manufacturers, by identifying in the package insufficient information In the use / consumption of the medicine, they have to request prior to ANVISA, which will then communicate the laboratory manufacturer of the reference medicine for this to present the changes in the pack or else refer to the decision.
That is, as a matter of bureaucracy, the load of responsibility for damages arising from the consumption of a generic drug ends to be higher for the company's medicinal product holder - whether in the USA, whether in Brazil.
More than a discussion on accountability, this case clearly illustrates the indestructible link between the patented medicine and its generic medicine originated, capable of imposing the patent holder complex responsibilities, with a high financial risk, although have made compulsory licensing or whether relatively, the exclusive right conferred by the patent.
We remind us if the negative economic impacts of actions as those mentioned above will result in possible reduction in R & D investment of the pharmaceutical industries, which already have at their disadvantage the high investment costs in innovation and the low proportion between the Development of drugs (14 years, on average) and patent protection (20 years).
