The final full text of the Trans-Pacific Partnership (TPP) is out, and it will stir up some debate again over the massive trade deal.
But for those watching how the trade pact might affect the international market for biosimilars, the unveiling of the full text doesn’t seem to mean any big surprises.
Outside of the U.S., the data exclusivity for biologics—which is tantamount to the amount of time before a biosimilar can hit the market—will range from a minimum of five years, with additional years of vaguely defined “other measures,” to a firmer period of eight years of exclusivity.
News reports have said the 12-year standard will remain in effect in U.S., and the summary of the deal that U.S. Trade Representative posted today as part of the release of the full text confirmed that. The trade representative's summary says that none of the provisions pertaining biologics will “change any U.S. healthcare program or the data protection that’s existing in U.S. Law.”
The New York Times and and other outlets had previously reported about the five-year minimum, with the add-on years, after representatives of the 12 countries negotiating the TPP came to an agreement in early October.
The trade representative summary makes it seem like there was little difference between the five-year and eight-year periods:
TPP gives partner countries two ways to meet a strong standard for effective market protection. One way is to provide a minimum standard of 8 years of data protection; the other way is to deliver a comparable outcome through a combination of at least 5 years of data protection measures and a country’s other measures (e.g. regulatory procedures or administrative actions).
It will be interesting to see how “comparable outcome” plays out. Three years is a big difference in the world of biosimilars.
The biologics provision of the TPP has come under fire from several directions. Pharmaceutical manufacturers said they wanted American standards applied. Today the Pharmaceutical Research and Manufacturers of America released a statement saying it was reviewing the full text but also reiterated past statements about disappointment that the trade deal didn't impose the U.S. rules and a dozen years of data exclusivity.
Groups like Doctors Without Borders were critical of the TPP creating data exclusivity rules in countries where few, if any, existed and thereby making medications more expensive in low-resource countries.
Here is the full text of the biologics section of the trade pact:
Article 18.52: Biologics 59
1. With regard to protecting new biologics, a Party shall either:
(a) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, 60 , 61 provide effective market protection through the implementation of Article 18.50.1 (Protection of Undisclosed Test or Other Data) and Article 18.50.3, mutatis mutandis, for a period of at least eight years from the date of first marketing approval of that product in that Party; or, alternatively,
(b) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:
(i) through the implementation of Article 18.50.1 (Protection of Undisclosed Test or Other Data) and Article 18.50.3, mutatis mutandis, for a period of at least five years from the date of first marketing approval of that product in that Party,
(ii) through other measures, and
(iii) recognising that market circumstances also contribute to effective market protection.