Open Medicine EU

In my previous blog, I covered the apparent change of policy on transparency in the EMA and told how I requested access to various documents in the agency. You can see their letter of refusal again here.

So, I appealed the refusal at some length (see here ). The response (attached) came within the time prescribed for such things but was again negative.

More reasons were given this time, including an explanation of why, in the EMA’s view, release of the documents at that time would undermine their decision making procedures, as in the following extract:

The disclosure of such information prior to the finalisation of the Policy may lead to unnecessary external pressure from various stakeholders that might compromise the final steps of the process and all Agency’s efforts made in the last 12 months to strike a balance between proactive data disclosure,the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information..

The agency also referred to the administrative and other problems involved in disclosing the more than a thousand responses to the earlier public consultation on transparency.

Well, I did not ask for access to every submission but only to communications to and from the Commission and to and from pharmaceutical industry associations. I assume there were a lot less than a thousand of these.

Anyway, why not publish all responses to public consultations? There would be little administrative burden attached to putting in place a policy of publishing on a website a copy of all submissions on matters of public policy as soon as they are received (subject to limited exceptions for personal privacy and genuine commercial confidentiality).

More to the point I could not accept the argument that disclosure of the documents I requested would “seriously undermine” the decision-making process of the agency.

I have referred the refusal to the Ombudsman, and she will now consider it under the rules and principles that guide her work. More later… END

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