Pharmaceutical innovation and data protection – WTO forum discussion

An interesting discussion was recently started in the World Trade Organization’s community forum on a complex topic — data protection and pharmaceutical innovation.

Posted by KMLybecker

Generating the data necessary to secure regulatory approval has become more extensive and more expensive. Clinical testing has become more difficult and laborious. These regulations and associated costs play an increasingly important role in the pharmaceuticals and agricultural chemical industries, sectors in which product safety and efficacy are of utmost importance. As such, it is necessary to incentivize data generation by providing protection for the investment in data generation. Regulatory data protection serves to protect originator firms against free riding, and safeguards the substantial financial investment involved in drug discovery and regulatory approval.

Customs groups commit to fight counterfeit drug industry

Counterfeit drugs have become a $200-billion-a-year industry and the 176-nation World Customs Organisation (WCO) will sign a declaration later this month to fight the scourge, an official said on Thursday (Source:  Reuters).

Fake or substandard versions of medicines are often hidden in cargoes sent on circuitous routes to mask their country of origin. “We have more fakes than real drugs in the market,” said Christophe Zimmermann, the WCO’s anti-counterfeiting and piracy coordinator. “In 2007-2008 alone, it rose 596 percent.”

The World Trade Organisation says fake anti-malaria drugs kill 100,000 Africans a year and the black market deprives governments of 2.5-5 percent of their revenue.

The Brussels-based WCO represents customs operations globally and has joined with former French president’s Jacques Chirac’s foundation to raise awareness at upper echelons to curtail the illicit industry.

Fake medicines often contain the wrong or toxic ingredients and pose a growing health threat worldwide, especially in poor countries where drugs are sold to treat conditions such as malaria, tuberculosis and HIV.

“If these subjects are not dealt with and strong action not taken, they will be a source of conflict,” said Catherine Joubert, director general of the Fondation Chirac, adding that so far 30 groups had signed the declaration.

In a sign Europe is taking the issue seriously too, justice ministers on the Council of Europe are set to ratify a convention on counterfeit medicines in Istanbul this November.