Generic drugmakers are up in arms about a proposed trade deal between Canada and the EU. Now, thanks to data from a new study, they're grabbing headlines about their beefs. And no wonder: The study finds that the trade agreement could cost Canada $2.8 billion annually, in part by keeping copycat drugs off the market for an extra 3.5 years.
The EU's drug-related proposals include extending data exclusivity to at least 10 years from the current eight years and adding up to five years to patent life on drugs that get bogged down in the approvals process. No surprise that those regulations would favor branded drugmakers, which are already suffering from generic competition and struggling to get new drugs to market.
The study, commissioned by the Canadian Generic Pharmaceutical Association, found that the rules would cost public healthcare payers $1.3 billion and private health plans $1.5 billion per year. "The reasonable inference is that these changes are designed to allow innovating pharmaceutical firms to charge monopoly prices for a longer period," said Aidan Hollis, lead author of the study.
Canada's branded drug association insists that the country's IP protections need updating, and these new rules are one way to do that. "If we want to attract innovation dollars and the good jobs that come along with them, we need a globally competitive regime and we don't have one now," Russell Williams, president of Rx & D, told the Globe and Mail, adding, "without R&D, without innovative drugs, there will be nothing for generics to copy."