The Brazilian government has been attacking the intellectual protection afforded by the WTO TRIPS Agreement to the research-based pharmaceutical industry.
One of the means used to implement this policy is the nationalisation of the production of drugs still protected by patents and data package exclusivity.
The nationalisation programme is called PDP/PPP, by which a government owned pharmaceutical company enters into an exclusive contract with a Brazilian national pharmaceutical company for the monopoly of the sales of particular drugs to the government. Some of these nationalisation efforts have a severe impact on drug quality, increasing the risk of distribution of substandard drugs in the country.
The Interamerican Society of Sanitary Surveillance (SIVS), a non-governmental organisation dedicated to the fight against substandard pharmaceutical drugs and to the implementation of worldwide regulatory standards based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and best practices of pharmacovigilance, achieved an important victory against a public call for 17 tech transfers—worth approximately $500 million in annual sales for the federal government—between the Official Laboratory of the Brazilian Air Force (LAQFA) and private laboratories.
WTO TRIPS, IP, pharmaceutical, SIVS, LAQFA,