Open Medicine EU

In a previous blog I said that I had requested access to documents on the dealings between DG Enterprise and pharmaceutical industry associations while the EMA was developing (and watering down) its transparency policy. I was given a few “mostly harmless” documents but the rest were refused on the grounds that they contained material that was protected by data protection laws. I have just submitted an appeal, or “confirmatory application,” against this refusal.

I was told that it was open to me to argue that the documents (that I had not seen) would not undermine the privacy and integrity of (unnamed) individuals. Well, unless and until I see at least a list or register of such documents I am not going to take that route.

I was not told that they could disclose the documents in part by removing any bit that meets any of the exceptions for disclosure such as the protection of privacy. This is the route I have taken in the appeal.

Apologies for all the legalese in the attached appeal but if I don’t take that approach I may meet another refusal or at least a delay in getting access, which I will eventually get, to the documents in question. I am confident about this because Regulation (EC) 1049/2001 on access to documents confers a right on EU citizens (and others in some cases) and in this case me. So long as I assert that right in the correct terms DG Enterprise will eventually respect that right.

It did not have to be like that. They could have said: “We cannot give you these documents because parts of them are private but we could send you them with the private bits removed”, and I would have said: “Yes,that’s fine”. (I probably don’t need to know who actually signed the documents on behalf of DG Enterprise or the industry associations.)

I did point out informally to the Secretariat General that there might be a better way to deal with my request given that I am exercising a right as an EU citizen, and it is possible that this point will meet a sympathetic response. In the meantime, I have gone ahead along the strict legal route, as can be seen in the attached appeal.

On a wider note, the access to documents regulation creates a lot of work for the Commission and other institutions and I can understand that officials, who tend to work very hard indeed in my experience, may get impatient (or “pissed off”) with it from time to time, but it is not just NGOs and individuals that submit such requests. Industry does too; I bet the tobacco industry, for example, has used the regulation to find out exactly who is saying what to the decision makers about tobacco.

There is a way to reduce the workload of officials in dealing with these requests, and that is to give notice that in future all submissions on matters of public policy will be automatically published on a website, subject only to limited exceptions for personal privacy and genuine commercial confidentiality. Why not? END

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