Several months ago, I wrote a piece on the strange story of clinical trial data in the European Health Data Space (EHDS) proposal and predicted (it was not so hard) that some - perhaps - naively ambitious and unintentionally radical provisions will draw a lot of attention and redrafting. Well, it happened.
For context, it is important to note that, in geneneral, the EPP wants the slightest modifications possible to the EHDS proposal and the EPP (shadow) rapporteurs have, so far, submitted ~50 amendments most of which are minor. Except one.
Figure 1 shows the only amendment in which EPP is asking for the deletion of a clause; Unsurprisingly, it's the clause that enlists ‘clinical trial data’ under the meaning of 'electronic health data' available for secondary use. If this amendment passes and the clause is removed this is ‘game over’ for one of the most (again) - perhaps - naively ambitious and unintentionally radical aspects of the Commission's proposal on the #EHDS: the cautious opening of primary clinical trial data to researchers (public and private). But even if this amendment does not pass (not unlikely), there’s a bunch of other amendments that are trying to do what I described in that earlier blogpost that it is bound to happen: creating obligations that already exist to make sure that the EHDS proposal will not alter (not even minimally) the status quo in the (re)use of clinical trial data. See for example:
But clinical trial data is only part of the story. Alongside that, there are countless amendments watering down the Commission's vision on the ‘scientific research / IP rights’ equilibrium. These amendments (examples below) are hugely problematic and shall not pass unchallenged especially in light of the concessions that are/could be made in patients’ consent in secondary use.
Verts/ALE, S&D, Left et. al are fighting for opt-in whilst the EPP suggests one of the most complex opt-out regimes one could think of. This is OneTrust-cookie-banner-level absurd:
Negotiations are ongoing and time-consuming. Yet, watching the saga of clinical trial data unfolding, one cannot help but notice the same old story: Research made easy for private actors while 'public' research is left to confront same old problems and obstacles. With gigantic institutional and political resources required to discuss all -of the so many- aspects of the EHDS proposal, it is difficult to imagine meanigful changes to the established rules for the (re)use of data from clinical trials. No one is really surprised, anyway. We have seen this coming, and it came.
It is this sense of 'inevitability' that should worry us most.
*photo by Louis Reed on Unsplash
