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Belgian Minister of Social Affairs and Public Health excludes online pharmacies established in other Member States to offer and sell OTC medicinal products via internet in Belgium

In recent newsletters, available here and here, the Royal Decree dated 21 January 2009 regarding instructions for pharmacists was briefly discussed. This Royal Decree inter alia provides in a legal framework for the sale of OTC medicinal products via the internet. The conditions for pharmacies to sell OTC products via the internet already seemed to imply that only pharmacies established in Belgium could dispense such medicinal products via mail order to Belgian patients, even though such interpretation would hardly be compatible with EU legislation.

Some of the - many - conditions which are a prerequisite for such online sales in accordance with the Royal Decree of 21 January 2009 already seemed to exclude foreign online pharmacies from offering and selling OTC medicinal products to Belgian patients. Two of the conditions state for instance that every online pharmacy has to give prior notice to (i) the Belgian Medicines Agency (FAGG/AFMPS) and (ii) to the organization of Belgian pharmacists, "APB".

Recently, in an answer to a written parliamentary question (n° 147, Bulletin of 16 February 2009), the Belgian Minister of Social Affairs and Public Health explicitly confirmed that pharmacies established abroad are excluded from the scope of the Royal Decree and are therefore not allowed to offer and sell OTC products via internet. In reply to the question whether "foreign companies could also make use of this sales channel given the rules of the free market", the Minister indeed left no doubt as to whether foreign pharmacies will not be able to benefit from the new rules on internet sales. The question and answer can be read here (Dutch and French only).

It goes without saying that this interpretation is in direct conflict with both the fundamental freedom of movement of goods and the freedom of establishment in the European Community. In its judgment of 11 December 2003 (C-322/01, DocMorris), the ECJ already confirmed that Member States cannot prohibit the mail order trade via websites of OTC medicinal products if this trade is in accordance with the legislation of the Member State of origin. It remains to be seen whether the new Belgian rules on the online sales of medicines will survive the test with the European rules.

For more information, contact: Benito Boone.

ICANN released a reviewed Guidebook for new gTLDs

In October 2008, ICANN published the first Draft Applicant Guidebook for public comment. Meanwhile ICANN analyzed and considered all comments it received. Early February 2009, a second version of the Draft Applicant Guidebook has been developed to reflect and address, to the extent possible, the comments received.

The second version of ICANN's Guidebook incorporates changes and provides clarification on many issues raised during the comment period. For example additional information on fees and the refund policy is included, updates have been made to the geographical names requirements, and the methodology for resolving string contention has been revised. Additional information on objection standards and standing has also been included and changes have been made to the registry agreement, including further detail regarding registry/registrar separation.

This second version of the Draft Applicant Guidebook is now also available for comment. As with the first Draft Applicant Guidebook, several explanatory memoranda will accompany this version to enable readers to better understand the implementation work.

In addition to comments on the various elements of the Draft Applicant Guidebook, comments were also received on a number of important broader issues relating to the introduction of new gTLDs, such as the overall demand for new gTLDs, trademark protection, security and stability concerns relating to root zone capacity, and the potential for increased malicious conduct such as phishing and spoofing as a result of new gTLDs.

ICANN says that it is taking steps to engage interested parties in dialogue on those issues. These discussions, and progressing the work to develop a final version of the Draft Applicant Guidebook, will be undertaken concurrently.

From an operational perspective, it is not resource effective or efficient to stop this work while discussion is taking place on the broader range of issues. Nor is it the intent to launch the process without resolving these overarching issues. Rather, ICANN says it is the intention to continue engagement with the broader community while working out other implementation details of the program.

For more information, contact: Flip Petillion.

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For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

Thomas De Meese
Partner – Brussels
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Flip Petillion
Partner – Brussels
Phone: +