EU Drug Law Gets Pfizer Support; More Exclusivity “Trades-Off” With Generics

Pfizer CEO Hank McKinnell supports European drug regulation legislation that provides extended marketing exclusivity and speeds the entry of generics.

"That's very positive in that it gives us 10 plus one years on data exclusivity," McKinnell said during Pfizer's year-end earnings call Jan. 22. "The trade-off was some acceleration, Bolar-type acceleration, on generics. For us, that's a very good trade-off."

The legislation establishes 10 years of marketing exclusivity for newly approved products and provides for an additional year when a product receives a new indication.

"Medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of protection and a 10-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those 10 years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications," the ¹ legislation states.

The Council of Ministers had previously amended the legislation by removing any possibility of extending data protection. Current regulations in Europe allow for at most 10 years of marketing exclusivity.

FDA grants five years of marketing exclusivity for a new product, with an additional six months of exclusivity if appropriate pediatric studies are conducted. There is no U.S. mechanism for extending product exclusivity based on new indications, and FDA's three-year labeling exclusivity does not protect branded products from generic entry.

Work on the legislation was done "before the expansion of the EU," McKinnell noted. Such changes "would have made it much more difficult to get into law after the expansion."

The EU legislation also creates a maximum review time of 210 days for granting marketing authorization for medicinal products.

"Member states should take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days of the submission of a valid application," the legislation states.

The European Parliament proposed legislation, rejected by the Council of Ministers, that would have required reviews to take place within five months.

Were the 210-day clock to prove workable, it would create pressure on FDA to reduce its 10-month standard/six-month priority timetables. In the debate leading up to the most recent renewal of the user fee act, FDA said that its review times should not be faster (² , p. 9).

The brand industry also has a favorable impression of the EU legislation's handling of follow-on biologics, which will likely be the next exclusivity issue addressed in the U.S..

The European legislation enumerates the conditions that make biologics difficult to replicate and thus stipulates that clinical equivalence tests must be performed. The Biotechnology Industry Organization has offered its support for the European model (³ (Also see "BIO Likes EU Model For Follow-On Biologics; Standards Are “Appropriate”" - Pink Sheet, 5 Jan, 2004.), p. 25).

The legislation would also grant good manufacturing practice certificates for manufacturers that comply with certain requirements. A recent agreement between FDA and the EU on data sharing for drug products includes the exchange of information on manufacturing issues (⁴ , p. 22).

The European legislation also creates requirements for the reporting of adverse events. "Reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, immediately upon request or at least every six months after authorisation and until the placing on the market," the legislation states.

FDA's proposed safety reporting rule includes provisions intended to ensure the agency receives reports of foreign adverse events and regulatory activities from manufacturers (⁵ (Also see "Foreign Safety Data Sought By FDA Under Proposed Rule On Periodic Updates" - Pink Sheet, 24 Mar, 2003.), p. 27).

Pfizer is negotiating a Florida Medicaid-style deal with Germany under which the company would be "held accountable for the impact on total health care costs" (⁶ (Also see "Pfizer “Evolves” From Rx To Health Care Company: Fla. Medicaid Is Blueprint" - Pink Sheet, 19 Jan, 2004.), p. 19).