1. Concept Of Advertising

On April 2, the European Court of Justice decided that article 86 of Directive 2001/83/EC (title VIII Advertising) is to be interpreted as meaning that dissemination of information about a medicinal product, including its therapeutic or prophylactic properties by a third party may be regarded as advertising within the meaning of that article, even though the third party in question is acting on his own initiative and completely independently of the manufacturer and the seller of such a medicinal product (case C-421/07). It is for the national court to determine whether that dissemination constitutes a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.
The court held that even where it is carried out by an independent third party outside any commercial or industrial activity, advertising of medicinal products is liable to harm public health, the safeguarding of which is the aim of Directive 2001/83/EC. Hence, the situation of the communicator and his relationship with a company which manufactures or distributes the medical product, is a factor which may help to determine whether the communication constitutes advertising, but must be evaluated together with other circumstances, such as the nature of the activity carried out and the content of the message.
Comment: The pharmaceutical company is only liable for medicinal product "advertising" of a third party if the company influenced the third party to disseminate certain (maybe incorrect) information e.g. by paying money. The decision is to be interpreted thus: the fact that the information comes from a third "independent" party can't lead automatically to the conclusion that the information is not to be regarded as "advertising" in terms of the Directive 2001/83. The court intended to avoid that pharmaceutical companies try to advertise by using the media as an assumed independent third party to bypass the legal restrictions laid down in Directive 2001/83/EC.

2. Ownership And Operation Of Pharmacies

Following the opinion of the advocate general Yves Bot (see "Rules & Regulations" CHEManager Europe 3/2009) the court decided on May 19, that Italian and German legislation restricting ownership and operation of pharmacies to pharmacists alone (cases C-171/07 and C-172/07) is justified by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality.

3. New EU Cosmetics Regulation

On March 24, the European Parliament negotiated the commission's proposal and agreed on a compromise text negotiated together with the Council, to recast the European Union's legislation on cosmetics. The basic aim of the new rules is to remove the legal uncertainties and inconsistencies, while increasing the safety of cosmetics and simplifying regulatory procedures in the EU. Thus the new legislation will take the form of a regulation, making it immediately enforceable in all EU member states simultaneously. It will replace the patchwork of 27 sets of national rules that comprise the EU Cosmetic Directive of 1976.
Main aspects of the new regulation:
Strengthened in-market control: In replacing the national procedures the regulation creates a single EU-wide compulsory notification system of cosmetic products and increases the cooperation between the market surveillance authorities.
Compulsory labelling and safety assessment of nanomaterials: For the first time, a European regulation addresses nanoparticles and introduces a safety assessment procedure for all products containing nanomaterials. Cosmetic products containing nanoparticles will have to be notified to the Commission six months prior to being placed on the market. If there is a safety concern, the Commission will consult the Scientific Committee on Consumer Safety. Additionally, all nanomaterials present in cosmetics must be mentioned on the list of ingredients on the packaging.
Stricter rules on CMR substances: The regulation forbids use of substances in cosmetics that are carcinogenic, mutagenic, or toxic for reproduction (CMR). These substances may only be used in exceptional cases under strict conditions.
Common criteria for product claims: The regulation provides that labeling and advertising of cosmetics may only mention the real effects of a product. The Commission is asked to adopt a list determining common criteria for claims which may be used in connection with cosmetics.
The Ban on animal testing is unaffected by the new regulation

Now the Council must approve the regulation. Presumably it will enter into force in 2012, except for certain parts on nanomaterials and CMR substances that will apply earlier.