A waiver of a special kind of intellectual property protection would allow generic drugmakers to compete with the drugs they mimic in countries outside the EU.
Brand-name drugmakers and the companies that make copycat versions of their medicines are split over a proposal that one side says could take a bite out of its revenue and the other says could foster jobs.
The clash is over a waiver of a special type of intellectual property protection given to medicines developed by the companies who are the first to bring drugs to the market.
This protection, the so-called supplementary protection certificate, can last up to five years. Allowing a waiver of the certificate for manufacturing purposes would give generic drugmakers the chance to compete head-to-head with the drugs they mimic, at least in countries outside of the EU.
The disagreement has reached flashpoint as both sides await a European Commission decision on the waiver before the end of the year.
“This has been my No. 1 issue since I arrived at the association four years ago,” said Adrian van den Hoven, director general of the European generics lobby Medicines for Europe, which is working hard to see the waiver become reality.
The Commission says its underlying goal is to boost manufacturing and jobs in the EU and inject competition into select industries, as it outlined in its October 2015 plan to upgrade the EU’s single market. The manufacturing waiver was proposed as a chief possibility because “it could allow the European generic … medicines industries to create thousands of high-tech jobs in the EU and many new companies,” the Commission said.
The certificates are essentially an extension of branded drugmakers’ patents. In Europe, branded drugmakers get a patent for 20 years when they discover a new drug. But this is just the beginning of their work. They still have to test whether a drug is safe and effective for treating specific diseases. Once all of that is figured out, the company applies to the European Medicines Agency for approval to sell the drug.
These testing and application processes can take up to a decade. That leaves drugmakers with about 10 years to recoup their investment in the drug. So the EU introduced supplementary protection certificates of up to five years to give branded drugmakers as long as 15 years to make their money back, and some profit on top of that, from the drug they developed.
During this timespan, generics manufacturers can’t produce a copy of the branded drugmaker’s medicine within the EU. They can only produce their versions outside EU borders, where the supplementary protection certificate holds no sway.
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