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There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines “ See here for a critique of… » read more

By rebentisch In an interview the US Ambassador to the EU Anthony L. Gardner mentioned the Chicken as an example for myth of campaigners made about T-TIP that T-TIP would “force Europeans to eat” chlorinated chicken. Ambassador Anthony Gardner does not lie, but spreads a dishonest message. Communication like that is not acceptable in Europe… » read more

As AdvaMed and Eucomed prepare for our next Global MedTech Compliance Conference May 20-22, 2014 in Barcelona, Spain, I reflect on the remarkable policy outcomes attributed to our past conference discussions. Our MedTech association-led compliance conferences offer a platform—not available in a commercial compliance conference—to spur discussion and best practices exchange among compliance leaders on… » read more

In 2001, concerns about the competitiveness of Europe’s pharmaceutical industry led the European Commission to form a small, high-level group to investigate. The group, known as G10, chaired by two EU Commissioners and composed of major industry and governmental health stakeholders published its final report in May 2002. A few months ago, the European Federation… » read more

The Risk-Monger recently spoke at a crop protection industry conference on how to prepare data requirements for implementing the new pesticides legislation. I am not sure they liked my main point: that the data they will generate does not matter … at all. Still, they were polite.

It seems common sense that, if an error is found in legislation, then this law should be immediately amended; at the very least, the erroneous provision should not be allowed to influence the course of a related court proceeding. This is not, however, how some EU Member States seem to view such a scenario. Three… » read more

Yesterday (2nd April) the Plenary Session of the European Parliament approved the final text of the Regulation revising the Clinical Trials Directive. The announcement from the Parliament can be seen here. Since this text was negotiated with the Commission and Council (the national governments) it will soon be agreed formally in Council. Today (3rd April)… » read more

What marathons teach us

As marathon season gets started, the Risk-Monger ponders how those with passion can go the distance, and how business leaders that don’t seem to have the stamina continue to lose.

Big risk

What’s the biggest risk factor on earth – causing deaths and diseases for millions? Travel by plain or car? Alcohol and Cigarettes? Bad habits in food consumption? Wars? Sharks? No! It’s not about what’s coming initially in people’s minds. It’s the bad air, too many people are breathing. In 2012, seven million people died of… » read more

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