The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: European Commission

Even More Antitrust Scrutiny Pending for Pay-for-Delay Generics Deals

The U.S. Federal Trade Commission published a report today (subtly) entitled “Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions” claiming that settlements between patentees and potential generic entrants where the generic manufacturer is compensated result in delays averaging 17 months longer than the delays in settlements where no compensation is paid. 

“Pay for Delay” is the top “Hot Topic” on the FTC’s homepage, and appears to be getting a lot of attention from Bureau of Competition Director Richard Feinstein: this is is the FTC’s second report on the topic since 2009, and the reports have been accompanied by Congressional testimony, two active cases and “multiple” investigations.

Add to this the announcement by the European Commission this week that it is also investigating these deals, with GSK and AstraZeneca confirming requests for information, and it’s clear the global regulatory heat on these settlements in being turned up.  So far, though, the EU statements are more moderate, with European Competition Commissioner Neelie Kroes reportedly saying only: “We need to monitor this type of agreement in order to better understand why, by whom and under which conditions they are concluded.”

Some more details from the reports:

  • The FTC study looked at 218 final settlements between 2004 and 2009, of which 66 involved “some form of compensation” (the FTC counts non-cash consideration, like agreement not to launch authorized generics, in this group).
  • The EU cites a similar 25% of 200 examined cases where payments were made.
  • The latest FTC report doesn’t provide the primary data, but their analysis shows that “there is less than a 1% chance that this large a difference in average time to entry would be observed if the amount of delay from the two types of agreements were drawn from the same statistical distribution.”
  • The FTC report weights the analysis by the amounts of the annual sales of the applicable drugs, but it says that the “distribution of annual sales figures for drugs covered by these pay-for-delay agreements is not discernibly different from the distribution of annual sales figures for drugs covered by agreements that restrict generic entry with no payment to the generic.”

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Biotech Crop News Crops Up All Over

…with the EU on one side, and Cuba and the U.S. together on the other.

The EU’s council of environment ministers voted overwhelmingly yesterday to allow Austria and Hungary to maintain their empire ban on biotech crops.  When we noted this pending vote a couple of weeks ago, many reporters expected the ministers to be unable to reach a definitive result under the EU voting rules.  However, 22 of 27 ministers voted not to overturn the bans.  With other national bans active or possible in France, Greece and Germany, the European Commission will have its hands full if it continues its attempts in this area without a change in strategy.

On the other hand hemisphere:

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Ups and Downs for Biotech Crops in the EU

Quite an a-maize-ing week (sorry) for biotech crops in the EU:

  • The European Commission announced a proposal to end Austria’s ban on biotech maizes MON810 and T25, saying that Austria had not supplied scientific evidence that the specific nature of Austria’s ecology justified the ban.
  • A report from the French food safety agency, Afssa, saying MON810 is as safe as conventional maize leaked to the press just a few days before Envirmonent Minister Jean-Louis Borloo was due to appear before a committee of European biotech experts to justify France’s ban.   This prompted French Prime Minister Francois Fillon to say Thursday that “France is maintaining the suspension while it awaits a (European) Commission decision which it will respect.”
  • When the committee of experts met Monday, they did not have the “qualified majority” (a population-weighted test) to overturn the MON810 bans in France or Greece, the same result as in December when the voting was to lift similar bans in Austria and Hungary.  Now all four cases will be addressed by the EU’s council of ministers on March 2.
  • This apparently emboldened Germany’s Agriculture Minister, who said the German government may revoke the license it already issued for the GM crop.
  • Last, but not least, today the European Court of Justice issued a ruling that requires EU governments to make the location of GM crop field trials public.  Hopefully long jail terms will deter the “activists” who will no doubt be among those accessing the information.

Meanwhile, in the rest of the world:

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