logo-curiaI have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that started a train of thought on how these cases might influence the medical devices industry, especially because I have already mentioned that these cases may have an impact on some of the proposed ENVI amendments with respect to transparency of clinical information provided for market access, so here it is.

The Abbvie and Intermune cases

A quick and dirty recap for those that are new to these cases: in the EU we have an Access to Documents regulation that entitled citizens to request EU institutions to disclose documents, which can be refused on a number of grounds, among others that these are company confidential information. The regulation setting up the EMA and governing its procedures has a provision on confidentiality of documents in dossiers (article 80). In the past, the EMA would always refuse requests to have access to documentation provided by applicants in a marketing authorisation dossier because it considered the documentation company confidential. At some point, some scientists decided to get the EU Ombudsman involved because they wanted to get access to the clinical data underlying the dossier. The EU Ombudsman decided that the clinical part of the application file did not constitute confidential information in the meaning of article 39 TRIPS and EMA decided to grant access and revisit its policy, at a timely moment because of an increasing call for transparency from the scientific community. So, when competitors of Abbvie and Intermune requested access to the clinical trails part of the application dossiers concerned, the EMA informed Abbvie and Intermune that it was going to grant these requests. To prevent this from happening Abbvie and Intermune independently filed appeals against this decision at the EU General Court in Luxemburg  (which are still pending under case numbers T-73/13 and T-44/13) and filed for injunctions at that same court to enjoin the EMA from letting the djinni of publication out of the bottle, because the appeals did not have the effect of suspending the decisions. They both prevailed, with the President of the Court finding that in view of the large interests at stake, the lack of case law on this point, the fact that confidentiality of business  information is a fundamental right for companies and the fact that non-public information that has been made public cannot be made “un-public” anymore. See here for a good summary of the legal issues in the Intermune case by Arnold & Porter (those in the Abbvie case are identical, with negligibly differing facts).

Transparency in context

Let’s put all of this context.

The EMA has in the mean time adopted a very conservative policy on publication and just says: “Requests for access to documents similar to those contested by AbbVie and InterMune will be considered on a case-by-case basis in the light of the Court orders.” The appeals are underway in a procedure on the merits at the European Court. Judgement may probably be expected last half of 2014.

Both in the revision of the EU Clinical Trials Directive (see amendment 30) and in the revision of the Medical Devices and IVD Directives the ENVI committee proposed an amendment that the clinical substantiation for the market authorization would be public. The pharmaceutical industry was not that happy with this amendment for the Clinical Trial Regulation and we still don’t know what the resulting text for the regulation is because the first reading still has to happen (tentatively scheduled for 10 March 2014). The medical devices industry, for its part, has been surprisingly quiet on this point so far, but maybe they missed it in the fog of war caused by the great number of amendments. I would say this is pretty important stuff that companies would want to engage on in view of the much raised bar for clinical substantiation under the proposed medical devices and IVD regulation proposals.

National competent authorities in the EU in pharmaceuticals are also considering how they can be more transparent about the clinical data underlying the market and are looking at these cases as it will impact their policies too.

Conclusion: the result is a complex multi-level Mexican standoff pending the EU Court’s proceedings on the merits. Authorities being authorities, this will not be a balanced equilibrium because someone will make a move at some point that sets other things in motion, and you do not have to have seen a lot of Tarantino movies to guess what happens then: confusion everywhere.

Why is this important for the medical devices industry?

We don’t know yet if the amendments regarding medical devices and IVD clinical data transparency (there are various) will make it into the Medical Devices and the IVD Regulation, because presently they are only tabled amendments and the ENVI Committee is yet to vote on which of the approximately 900 amendments tabled will be in the ENVI proposal that the EU Parliament’s plenary will vote on. But we will know more by 18 September, when the ENVI committee finally votes. What we do know is that the new regulations will require manufacturers to produce a lot more clinical data (see Eucomed’s position paper chapter 6 for a summary) that will not only be interesting for themselves, but also for competitors (for example the comparative and the equivalency studies the new regulation would require more of would be very interesting for your competitors, as well as scrutiny procedure review of high risk devices ).

What is in the regulation proposals already and unlikely to be changed? Of course there is article 84 in the medical device regulation proposal with its counterpart in the IVD regulation that says that

“all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:[…]

(b) commercial interests of a natural or legal person, including intellectual property rights;”

But hey, that sounds remarkably similar to article 80 of regulation 726/2004 that Abbvie and Intermune were thinking they could rely on until EMA moved the goalpoasts :

“[…] the Management Board, on the basis of a proposal by the Executive Director and in agreement with the Commission, shall adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature.”

In the end it’s really all about how you interpret “confidential” in the light of how transparent you want to be to further what specific interests. Confidentiality is what you want it to be.

The fact that the EU Court does not find it obvious that the information is unprotected should not only be a wake-up call for the EMA and national competent authorities in medicines but also for ENVI Committee and the Council (which is preparing its position behind the scenes for coordination with what comes out of the ENVI vote). The proceedings on the merits in the Intermune and Abbvie cases will determine what kind of clinical information is public and what is not. The question is if the judgments in these cases are in time to make a difference for the legislative procedure for the medical devices regulations. Whether the regulations will be finished before the European elections end of May 2014 is a big item of speculation. If they are not, the judgments may make a difference because the outcome can be taken into account in the legislative process. Otherwise, if the scope of publication of clinical data ending up in the medical devices regulations is larger than the scope that the EU Court rules is allowed in the Abbvie and Intermune cases, the validity EU medical devices regulations might be challenged by industry and others because EU internal market law cannot be contrary to fundamental rights.

In the very hypothetical case that EMA gets more of a role in medical devices market access, which still seems unlikely, we can expect that there will be a more or less synchronised approach to pharmaceutical and device clinical data under an EMA policy. If we end up with the more likely option of the MDCG as proposed by the Commission and the technical files being filed in Eudamed by notified bodies, it is obvious that there are some new actors that will have to decide on their policy in this respect (Commission and MDCG) and those that may need to amend/revisit existing policies.

That’s a lot of known unknowns that can still be influenced to an extent, which is precisely why this is a good moment to start to think about this more from an industry perspective.