Tag Archive: EU Health Commissioner


The European Union Attempts to Tackle Obesity

Obesity experts are perplexed over the European Commission’s decision to allow a “health claim” for fructose.  Regulation 536/2013 states: “In order to bear the claim, glucose and/or sucrose should be replaced by fructose in sugar-sweetened foods or drinks so that the reduction in content of glucose and/or sucrose, in these foods or drinks, is at least 30 percent.”  Now, manufacturers of drink products can claim their products are healthier than their competitors by replacing the sucrose and glucose in the product with fructose.  The European Food Safety Authority advised the European Commission on this matter.  They concluded fructose has a lower glycaemic index and does not cause rapid or high blood sugar spikes like sucrose and glucose.  This regulation benefits citizens trying to reduce their glycaemic responses likes those with type 2 diabetes.  However, what about the overall effect of high fructose levels on EU citizens?

Fructose, the simple sugar found in fruits, was once thought to be a healthier substitute for table sugar or glucose.   The moderate amount of fructose consumed naturally from fruits is beneficial, because it allows the body to process glucose better. However, the high amounts of fructose contained in fructose corn syrup are not natural.  The human body processes fructose much less easily than glucose.  Fructose is processed in the liver, and the liver cannot process large amounts of fructose fast enough to turn it into energy. Therefore, the body turns the extra fructose into fats.  The lack of moderation in fructose leads to heart disease, obesity, cancer, dementia, and liver failure.

European obesity experts are concerned about large consumptions of fructose.  It has been linked to the significant rise of obesity rates in the United States and around the world.  The obesity rates in most European countries have doubled over the past twenty years.  More than half the adult population in the European Union is overweight or obese. The argument by obesity experts is that this regulation passed by the European Commission will confuse EU citizens into thinking large amounts of fructose in their products are healthier than sucrose and glucose.

 

Faulty Breast Implants Lead to Increase in EU Medical Device Regulation

The European Union recently decided to place stricter regulations on medical devices after hundreds of thousands of women worldwide received below standard silicone implants made by the French company Poly Implant Prothese (PIP). This silicone-based scandal was partly due to lax EU safety regulations that had done little to scrutinize the 80 national ad hoc agencies that were monitoring medical devices. When compromised, the implants had been known to cause inflammation to body tissues. The implants were made of a cheaper material that had not been approved for medical use, and were rupturing at a rate that was double the industry average.

EU health commissioner John Dalli submitted a proposal that encompassed what was learned from the PIP scandal and would also include the addition of a scrutiny panel, which would monitor the assessments made by the various national agencies. Dalli further mentioned that the panel would have the ability to “pick out medical devices on certain risk-based criteria to decide whether to go into an in-depth analysis of the processes.” In addition to the aforementioned proposed changes, there is also a proposal to expand the legal definition of medical devices to include breast and other aesthetic implants.

There are differing opinions regarding the proposed increase of medical device regulations. Serge Bernasconi, the chief executive of Ecumed, an industry body that represents nearly 22,500 medical technologies in Europe, argued that the regulations that were already in place were more than sufficient and provided a “high level of safety” for patients without causing a delay that would deny them access to life saving technologies. He further argued that by implementing such regulations would effectively stifle European innovation and research to other countries that do not have such regulations, thereby also causing harm to patients.

On the other hand, it is argued by the European Consumer Organisation (also known as BEUC) that the proposed regulations are not going to be strict enough and medical devices should have to undergo the same process as pharmaceutical products. The head of BEUC, Monique Goyens, contends that there is an imbalance regarding the levels of protections afforded to a patient based on whether they “have an artificial heart valve or take medicine for diabetes.” This idea was addressed in a press release made by the European Commission, it was stated that medical devices should not be confused with medicinal products. The distinct difference between the two is that medical devices have a physical principal mode of action. In other words it can serve as a physical barrier or replace support to organs or bodily functions, etc.

The press release further illustrates the proposed changes in regulations to include: clearer rights and responsibilities for manufacturers, better traceability of devices, an adaptation of general health and safety requirements, and a creation of a Medical Device Coordination Group.With these changes, the independent assessment agencies will be provided with more power to monitor the medical devices, including the ability to make unannounced inspections of factories and regular product testing. Because of this increase in power, the EU governments will have to provide better supervision of their agencies.

This proposed legislation is unlikely to occur for two more years, due to the process of needing to be approved jointly by EU governments and lawmakers.




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