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Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.
Regulators reached an agreement on the terms of the Trans-Pacific Partnership (TPP) on Oct. 5, 2015, effectively shortening the data protection period for biologics from 12 years to a mandatory minimum of five years. No maximum term was established.
Those in favor of the five-year marketing exclusivity period included Australia and New Zealand, both of which currently already have a five-year data exclusivity period. Exclusivity in Europe is 10 years. The US pushed for 12 years’ protection, as this term was passed as part of the Affordable Care Act. Within the US, the actual exclusivity period will not change-the five-year period is merely a floor number, and can exceed this timeframe. According to analyst Mark Schoenebaum from Evercore ISI, the TPP will actually encourage countries with shorter exclusivity periods to extend its period to eight years through use of certain regulatory and administrative requirements. These regulatory requirements would include the submission of new data from post-marketing pharmacovigilance studies, and these new data could extend the five-year period three additional years, for a total exclusivity period of eight years.
While the Generic Pharmaceutical Association (GPhA) supports exclusivity reductions, and says that shortening of exclusivity periods will be important for biosimilar competition and patient access to medicine, it does not agree with all of the terms of the agreement. Exclusivity based on pharmacovigilance studies is inappropriate, according to the organization, which said in a press release that pharmacovigilance obligations are “a mandate of regulatory authorities for biologics and biosimilars” and “such regulatory requirements do not need to be addressed in trade negotiations, and should not be used as rationale for seeking any additional exclusivity.”
Many other organizations expressed their disappointment with the TPP, including PhRMA’s President and CEO John Castellani, who said in a press release that the current 12-year data exclusivity period for biologics “was not a random number, but the result of a long debate in Congress, which determined that this period of time captured the appropriate balance that stimulated research but gave access to biosimilars in a timely manner.” BIO President and CEO Jim Greenwood also expressed dismay on behalf of BIO, saying that even though the agreement will not affect data exclusivity in the United States, the organization believes “the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients.”
Doctors Without Borders said the decision would delay generic competition and extend current drug monopolies. In an official statement, the organization said the deal would negatively affect drug prices and would have a detrimental affect on all countries, even those outside of the 12 member countries involved in the negotiations. Doctors Without Borders concluded, “the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies.”
Sources: Doctors Without Borders, GPhA, BIO, PhRMA