Senator Mar Roxas, chair of the Senate committee on trade and commerce, articulated his goal to push for the compulsory licensing of the bird flu drug Tamiflu as a “calibrated preemptive response” against a possible pandemic.
“I urge the Department of Health to seek the compulsory licensing of Tamiflu as a calibrated response to preempt the coming and spread of bird flu in the Philippines,” Roxas said. “The health department must work double time to do this because the present compulsory licensing laws impose time delay requisites like publication requirements, notices and hearings before a decision is made by the Intellectual Property Office," he added.
Roxas made this call after the recent announcement of Roche, a leading pharmaceutical company based in Switzerland, to share its technology with other companies and governments “under licenses” to fast track production of the drug.
Demand for Tamiflu, the only drug up to this point which can arrest the spread of bird flu infection, has jacked up phenomenally during the last few months due to increased presence of bird flu virus in Asia.
According to a statement released by Roche, the drug company has increased production of Tamiflu considerably by doubling production in its factories and laboratories and by signing partnership agreements with other factories.
Roche disclosed that under current agreements entered into by company, 13 factories agreed to actively participate in the manufacturing the drug, of which seven are not part of the Roche group.
“The Philippines should take advantage of this openness by Roche and see how our local drug manufacturers could also help in the manufacturing of the said drug,” Roxas said. “Other countries are having a difficult time making orders for the drug. Rather than fall in line for a purchase, why not be part of the team that manufactures Tamiflu? Roche is open to sharing its technology, of which the Philippines could benefit from immensely.”
Roche disclosed that the production of Tamiflu involves going through 10 stages, which takes about 12 months to finally produce in end-user form. It involves very “delicate steps”, Roche revealed, which are carried out in factories especially constructed for the purpose. That’s why the company is open to sharing its know-how to ensure quality control.
The patent for Tamiflu, which runs until 2016, would make it difficult for other drug companies to manufacture it as a ‘generic drug’. Generic drugs are produced when a patent expires and the product becomes public property.
“Because of stringent patent laws, to manufacture a generic Tamiflu is not possible today,” Roxas said. “That is also why I filed Senate Bill 2139 to allow amendments on patent and intellectual property laws in order to bring down the prices of medicines and make them accessible to the general public. We need this law to be passed more than ever especially with the threat of bird flu.”
The H5N1 strain of Bird Flu has caused about 63 deaths in Southeast Asia since December 2003, most were exposed to infected chickens. Vietnam tops the list, followed by Thailand, Cambodia and Indonesia. The United States has already expressed its goal to stockpile more than 81 million courses of Tamiflu, but reports have indicated that other countries have beaten the US to the draw.
Consequently, Roche could only supply two million courses to the US. In case of an epidemic, reports said France, Britain, Norway, Finland and Switzerland could only treat 20% to 40% of their population. The US can only care for 2% of Americans because of the increasing orders from Roche. As of this writing, the Philippines has zero supply of Tamiflu.
“Compulsory licensing of Tamiflu is my version of a calibrated preemptive response to a possible pandemic. It is calibrated because: We are not going against any law; preemptive because we are seeking to secure ample supply of the medicine even before the disease spreads to unmanageable proportions; and a good response, obviously because we are ten steps ahead of the problem.”
At present, there are compulsory license applications pending before the IPO (Intellectual Property Office) since 1992.