Regulation and Implementation of Pharmaceutical and Other Regulations

    November 2007 in “ Journal of Generic Medicines
    Richard Milchior, Estelle Benattar
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    TLDR Europe strengthened medicine regulations, increased protection against counterfeit drugs, and made it tougher to challenge comparative advertising, while also focusing on patent law enforcement and updating plant protection rules.
    In 2007, the European Court of Justice ruled against Spain for failing to implement a directive on traditional herbal medicinal products and upheld the need for authorization of anthroposophic medicinal products under existing directives. Concerns were raised about the parallel trade of medicines and its potential to harm public health and promote counterfeiting, leading to a European Commission study. The UK Court of Appeal addressed trademark protection in the context of comparative advertising for dog supplements. In 2008, the Court of Appeal raised the bar for obtaining interim injunctions against comparative advertisements, making it harder for trademark owners to challenge them. The European Commission developed a strategy to combat counterfeit medicines, including harmonized guidelines and an electronic risk exchange system. The European Court of Justice confirmed that national courts could apply international patent protection law directly, and the UK Patent Court revoked a Merck patent for finasteride used in treating androgenic alopecia due to lack of novelty. The European Economic and Social Committee considered a new regulation to replace an older directive, aiming to protect health and the environment by establishing a list of approved substances for plant protection products.
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