# \[e-drug\] Access to documents at the EMA: going backwards rather than forward! **URL:** \ **Category:** e-drug\ **Created:** [June 20, 2013, 7:23am UTC](https://talk.edrugplus.org/t/e-drug-access-to-documents-at-the-ema-going-backwards-rather-than-forward/39094 "2013-06-20T07:23:53Z")\ **Posts on this page:** 2\ **Page:** 1
**Author:** ![Teresa\_ALVES](https://avatars.discourse-cdn.com/v4/letter/t/7ba0ec/32.png) [@Teresa\_ALVES](https://talk.edrugplus.org/u/Teresa_ALVES)\ **Post date:** [June 20, 2013, 7:23am UTC](https://talk.edrugplus.org/t/e-drug-access-to-documents-at-the-ema-going-backwards-rather-than-forward/39094/1 "2013-06-20T07:23:53Z")
E-DRUG: Access to documents at the EMA: going backwards rather than forward! --------------------------------------------------------------------- Dear E-druggers Prescrire has recently written to the Director of the European Medicines Agency after having been denied access to administrative documents. The EMA argues that the ongoing legal proceedings before the European Court of Justice are preventing the agency from implementing its policy on access to documents. Prescrire is appealing that decision. In its refusal letter, the EMA cites the need to protect commercial interests. But our requests pertain to clinical data and to drug packaging, which are matters of public interest. If citizens in Europe are to enjoy the best healthcare possible, then the EMA access-to-documents policy must be ambitious. Our letter is available here: [http://english.prescrire.org/en/79/207/46302/2781/2506/SubReportDetails.aspx](http://english.prescrire.org/en/79/207/46302/2781/2506/SubReportDetails.aspx) At a recent meeting of The Dutch Medicines Evaluation Board, Ben Goldacre made a heartfelt plea for open access to clinical data from all pharmaceutical industry studies, including positive and negative results. MEB's Director Aginus Kalis supported Goldacre's argument. Will other regulatory agencies across Europe follow suit and put the EMA back on track? It remains to be seen. Best wishes Teresa Alves Teresa Leonardo Alves International Policy Adviser Prescrire talves@prescrire.org\ ---
**Author:** ![c.bruneton](https://avatars.discourse-cdn.com/v4/letter/c/3ec8ea/32.png) [@c.bruneton](https://talk.edrugplus.org/u/c.bruneton)\ **Post date:** [June 25, 2013, 8:16am UTC](https://talk.edrugplus.org/t/e-drug-access-to-documents-at-the-ema-going-backwards-rather-than-forward/39094/2 "2013-06-25T08:16:10Z")
(Les effets collatéraux de l'harmonisation de l'enregistrement des médicaments en Europe... qu'en sera-t-il dans les sous-régions UEMOA et CEMAC ? CB) L'Agence européenne du médicament refuse l'accès à des documents administratifs : Prescrire dénonce un retour en arrière inacceptable (Juin 2013) Paris, le 12 juin 2013 Dans une lettre adressée à l'EMA, Prescrire rappelle qu'une politique ambitieuse d'accès aux documents de l'EMA est indispensable pour permettre que les citoyens européens reçoivent les meilleurs soins possibles.