French Minister for Economic Affairs Emmanuel Macron recently introduced a bill proposing the recognition of legal privilege for in-house lawyers in France, which does not currently exist. However, this recognition was rejected by the Special Commission of the French National Assembly before the bill was passed by the lower chamber - a decision consistent with the Grand Chamber of the European Court of Justice's 2010 ruling in Akzo.… Continue Reading
Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent meeting at which Justice ministers from across the European Union managed to agree on a partial general approach on several aspects of the draft Data Protection Regulation, which aims to set out a general EU framework for data protection. The ministers have … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent set of guidelines issued by the European Union’s Article 29 Data Protection Working Party outlining how EU Data Protection Authorities (DPAs) intend to implement the judgment of the Court of Justice of the European Union in Google Spain SL and Google Inc. … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law blog features two posts of interest to those in the life sciences industry, both written by Reed Smith partner Cynthia O’Donoghue. “EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector” discusses the opposition of a lobbying group, led by the Wellcome Trust, to amendments to … Continue Reading
On December 10, 2008, the European Commission published a series of political measures and legislative proposals, the so-called "Pharmaceutical Package." This series included the "Communication on a renewed vision for the pharmaceutical sector," which reflected on ways to improve market access and develop initiatives to boost European Union ("EU") pharmaceutical research. Through the Pharmaceutical Package, the European Commission aims to make pricing and reimbursement more transparent, increase the development of pharmaceutical research within the EU, improve the safety of medicines worldwide, and reinforce cooperation with international partners.
The European Commission has published three separate sets of proposals amending Directive 2001/83/EC on the Community Code of medicinal products and Regulation 726/2004 on medicinal products obtained through centralized procedures:
1. A proposal amending Directive 2001/83 as "regards information to the general public on medicinal products subject to medical prescription" (Information to patient);
2. A proposal amending Directive 2001/83 and a proposal amending Regulation 726/2004 as "regards pharmacovigilance" (The EU pharmacovigilance system); and,
3. A proposal amending Directive 2001/83 as "regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source" (Counterfeit Medicines).… Continue Reading