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This is a follow up to our previous posts relating to the European Medicines Agency’s (EMA) various policies on access to documents. This continues to be an area of activity for the EMA and there have been a number of developments that have impacted the EMA’s position. Firstly, Brexit has directly affected one of the main pillars of the transparency activities of the EMA, namely the proactive publication of clinical trial data submitted by pharmaceutical companies in support of certain types of regulatory submissions to the Agency (the EMA’s Policy 0070).

Secondly, while the reactive transparency activities of the EMA relating to access to documents in accordance with Regulation (EC) No 1049/2001 (the EMA’s Policy 0043) have been less affected by Brexit, there may be other challenges for the EMA ahead.Continue Reading Latest Developments in the Transparency Activities of the European Medicines Agency

On 6 September 2019, Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (the “Regulation”) was published in the Official Journal of the European Union.

Review of the matters addressed by the Regulation was initially prompted by a European Citizens’ Initiative (#StopGlyphosate), which campaigns against the use of toxic pesticides and for reform of the EU pesticides approval procedure.

The new Regulation principally amends Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (the “General Food Law Regulation”). It also amends eight sector-specific legislative acts, concerning genetically modified organisms, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.Continue Reading Strengthened Transparency in the EU General Food Law Regulation

On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access to documents requests issued from outside the EU.”

Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only “Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents.”
Continue Reading Update to the EMA’s Position on Access to Documents