The European Union exists to regulate, and therefore it regulates, as Descartes would have said; and in no area is that more true than in that of food law argue food law experts Kasia Wilk & Chris Whitehouse. The European Union is not particularly popular at the moment, and many would like to repatriate a… » read more
Archives for Health & Consumers
The European Medicines Agency has published its letter of reply to the Ombudsman’s concerns about changes in transparency – see my previous blog. The letter makes the point that the new transparency policy is an initiative of the agency itself and is quite distinct from the access to documents regime under Directive 1049/2001, and also… » read more
UPDATE: The Daily Mirror has taken down its article suggesting that Isla Vista killer Elliot Rodger’s consumption of creatine as a sports nutrition supplement may have contributed to his actions following a swift response by the European Specialist Sports Nutrition Alliance (ESSNA). ESSNA’s defence of the substance highlighted its safety record and explained the lack… » read more
May 26, 2014
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
We’re right in the middle of a year of change in the EU. Europe has begun voting and EU politics may look quite different as a result. New things and new faces may be on the horizon but that doesn’t mean that work has stopped on a file of great importance to the Union’s more… » read more
May 18, 2014
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
The Risk-Monger shows that if the implementation of the precautionary principle were rational, then coffee would need to be banned. Fortunately, in this case, normative reflux steps in – our values and love of the benefits blinds us to the real risks and allows us to enjoy coffee despite the evidence.
In continuing to follow the legal challenge by Intermune against the European Medicines Agency I began to wonder if DG SANCO and the European Commission as a whole were fully supportive of the EMA’s initiative on transparency. Perhaps there were expressions of support but I had not seen any. I had also heard, at second… » 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
The more the pesticides industry denies safety accusations, the more guilty they look. The erosion of trust is built into the precautionary blacklist game – a game the industry will never win.
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
April 17, 2014
By Chris Whitehouse Staffing crises and soaring workloads at a UK Government Agency have forced it to throw up its hands in bureaucratic despair, a bizarre email acknowledgment suggests. Two main causes come straight to my mind…
April 10, 2014
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.
Why eCommerce is under attack May I start with a question? What do you think is one of the most innovative businesses in mankind? Commerce. To sell and buy is a business started from peer-to-peer business to mobile business today. Especially in the last two hundred years commerce developed the way to shop from flying… » read more
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
April 3, 2014
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
April 2, 2014
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.
The work we do at the Helen Hamlyn Centre for Design at the Royal College of Art in London focuses on developing projects with a strong emphasis on identifying and understanding everyday situations that people have difficulty with. Our approach is inclusive: we work with many ‘users’ of a product, service or system in order… » read more
March 27, 2014
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
“Nihil novi sub sole” said the Vulgate. That could not be farther from reality when it comes to the MedTech Europe blog. And I am privileged to be the first author to “lay pen to paper” and contribute to MedTech Views, an initiative by MedTech Europe to establish a true platform for dialogue about medical… » read more