Friday, 1 February 2013

Consumer health update

The French medicines agency (ANSM) announced this week that in the next three months it intends to suspend the marketing authorisation for Diane 35 and its generics for acne treatment in France. This is a commonly used medicine across Europe, used not only to treat acne but also as an oral contraception for women and for treatment of other skin conditions. The ANSM considers the risk of thromboembolism that this medicine increases (which has been known for many years now) to be too high in comparison with its moderate success in treating acne. Pursuant to EU law, the ANSM will notify the European Medicines Agency about its plans and appealed for a EU-wide review of this medicine, which may lead to a harmonized action with respect to its marketing across the EU Member States. In the meantime, women who are taking this medicine are advised NOT to stop. (EMA update on Diane 35 and generics used in the treatment of acne) Of course, that does not mean that if anyone feels uncomfortable with it (though, as I have mentioned, the risks were known for quite awhile now), they may ask their doctors if there are any alternative treatments available.


EU Commission in the meantime calls for EU-wide ban on amphetamine-like drug '4-MA', which is a synthetic substance inducing similar physical effects to amphetamines.The Commission appeals to MS to prevent free access across the EU to this drug, since it has been associated with 21 deaths in 4 EU Member States in 2010-2012. So far, it has been made illegal in 10 EU countries. The EU action aims at prohibiting both manufacturing and marketing of this drug, subject to criminal sanctions. (Commission calls for EU-wide ban on amphetamine-like drug '4-MA')


World Health Organisation (WHO) released today a new report on long-term exposure to air pollution which apparently can trigger: atherosclerosis, adverse birth outcomes, childhood respiratory diseases. It may also adversely influence neurodevelopment, cognitive function, diabetes, cardiovascular and respiratory systems. (Newly found health effects of air pollution call for stronger EU air policies) Current EU statistics show that over 80% of EU citizens are exposed to air pollution levels above the 2005 WHO Air Quality Guidelines (AQGs), which has been seen as depriving on average each citizen of 8,6 months of life. The new report recommends that EU modifies its law, since already the current limit of permitted air pollution in the EU's Ambient Air Quality Directive is twice as high as the AQG recommendation. The WHO plans on adjusting the AQGs levels, making them even more strict. We'll see what actions will be undertaken by the European Commission. For now, 2013 has been declared as the Year of Air for EU policies. (apparently it's not the first year of air... - see: here)


The European Commission also sent this week a statement of objections to the pharmaceutical companies Johnson & Johnson (specifically, its Dutch subsidiary: Janssen-Cilag) and Novartis (and its subsidiary Sandoz). It suspects that these companies concluded a so called 'co-promotion agreement' on a strong pain-killer (fentanyl, which is stronger than morphine), as a result of which the market entry of a cheaper generic medicine was delayed in the Netherlands. This, of course, would breach EU antitrust rules. Dutch consumers, as a result of this agreement, could have been left with no option but to purchase the higher priced fentanyl which goes against the EU policy to provide affordable healthcare to EU citizens. The companies may now respond to the objections raised by the Commission. If the infringement of antitrust rules is confirmed, they will be fined. (see more here) To find out more about other enforcement actions in pharmaceutical sector following recent sector inquiry, see here.

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