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Ombudsman zabrinut zbog promjene politike na agencije za lijekove s obzirom na transparentnost podataka kliničkim ispitivanjima

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10000000000004B0000004B0BB9A6156In a letter to the European Medicines Agency (EMA), the European Ombudsman Emily O’Reilly has expressed concern about what appears to be a significant change of policy concerning clinical trial data transparency. According to documents the Ombudsman has seen, EMA is planning to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen on screen using an interface provided by EMA, as well as imposing wide restrictions on the use of such data.

O’Reilly said: “We were pleased when EMA announced, in 2012, a new pro-active transparency policy, giving the broadest possible public access to clinical trial data. I am now concerned about what appears to be a significant change in EMA’s policy, which could undermine the fundamental right of public access to documents established by EU law. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyze. ”

Promjena od proaktivnog transparentnosti u vrlo restriktivnom politikom?

In the past five years, the Ombudsman has conducted over a dozen inquiries into the EMA. Many concerned refusals to make public documents regarding the authorisation and regulation of medicines by the Agency, including medicines for treating multiple sclerosis, acne, bacterial infections, and obesity. In response to the Ombudsman’s intervention in these cases, EMA appeared ready to adopt a pro-active approach towards transparency.

Nadalje, na 2 travnja 2014, Europski parlament glasovao u korist prijedloga zakona kako bi kliničkim ispitivanjima javnosti podataka. Kao posljedica toga, rezultati svih budućih kliničkih ispitivanja u Europi na kraju treba biti javno dostupan na internetu.

Against this backdrop, the Ombudsman has asked EMA’s Director, Guido Rasi, to inform her by 31 May 2014 how EMA intends to deal with requests for public access to existing clinical trial data. She also asked him to list the reasons and the legal basis for what appears to be a significant change of policy.

The letter to EMA’s Director is dostupan ovdje.

Oglas

Europski pučki pravobranitelj istražuje pritužbe vezane za loše u institucijama i tijelima Europske unije. Bilo EU građana, prebivalište, odnosno poduzeće ili udruga u državi članici, može podnijeti pritužbu pučkom pravobranitelju. Ombudsman nudi brz, fleksibilan i slobodno sredstvo za rješavanje problema s upravom EU. Za više informacija, kliknite ovdje.

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