Until 2010, the publication policy of the EMA was such that inquiries for information contained in marketing authorisation dossiers were generally rejected and the latter categorised as confidential information belonging to the approval holder.
This stance underwent a major shift in November 2010 when the EMA stopped regarding information contained in marketing authorisation dossiers (complete clinical data records) as a protectable trade secret and began to disclose such information accordingly.
To substantiate this transparency policy, the EMA cites recitals 1 and 2 of Regulation (EC) 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Article 73 of Regulation (EC) 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency governs the application of this Regulation to documents of the European Medicines Agency as well.
Recitals 1 and 2 on the justification of making documents as freely accessible as possible read as follows:
“The second subparagraph of Article 1 of the Treaty on European Union enshrines the concept of openness, …
Openness enables citizens to participate more closely in the decision-making process and guarantees that the administration enjoys greater legitimacy and is more effective and more accountable to the citizen in a democratic system. Openness contributes to strengthening the principles of democracy and respect for fundamental rights as laid down in Article 6 of the EU Treaty and in the Charter of Fundamental Rights of the European Union.”
The EMA published its “European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) – Policy/0043” on 30 November 2011 and within this framework began to grant public access to documents forming part of the marketing authorisation dossiers of pharmaceutical companies and therefore, data from clinical studies as well.
A series of additional EMA policies followed on the free access to documents, including in October 2014 the “European Medicines Agency policy on publication of clinical data for medicinal products for human use–Policy/0070”.
Right at the outset, the introduction to the purpose and aim of the policy states that the EMA’s objectives ― protecting and promoting public health and ensuring transparency for patients and society in the rendering of its services ― are of prime importance.
Some see this EMA policy as a precursor to the regulatory content of the new EU regulation on clinical trials, which entered into force on 27 May 2014. This regulation also provides for far-reaching transparency but has not yet entered into application since it requires a new information infrastructure for which the technical basis has yet to be laid. It is expected to enter into application by 2019 at the soonest.
The interplay between the EU regulation on clinical studies and the EMA policy is intended to ensure that all clinical studies submitted within the scope of marketing authorisation procedures are publicly accessible as a general principle.
The decision to bring transparency to entire clinical studies and marketing authorisation dossiers has been enthusiastically welcomed by the EMA and scientists; yet the affected pharmaceutical companies themselves, which have invested a great deal of time and money in clinical studies and their marketing authorisation dossiers, hardly share this enthusiasm. Although many attempts have been made to obtain protection from the courts against the new policy, none have been successful.
Decisions in three primary proceedings before the European Court were recently handed down on 5 February 2018, all upholding the EMA’s transparency policy.
In the three following cases,
– MSD Animal Health Innovation GmbH, Intervet International B.V. v European Medicines Agency, case no. T-729/15,
– PTC Therapeutics International Ltd., European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) v European Medicines Agency, case no. T- 718/15, and
– PARI Pharma GmbH v European Medicines Agency, case no. T-235/15,
the European Court of First Instance ruled on 5 February 2018 that the EMA’s publication of clinical data from marketing authorisation dossiers is legal.
In these proceedings each party sought recourse from the court to prevent the publication of clinical and non-clinical study reports, arguing that these must be regarded as trade secrets and as such, must not be disclosed.
It was the claimants’ position that the entirety of the information in the CHMP reports, especially the protected confidential raw data, the compilation of publicly accessible clinical data and the analysis of this data by various third parties, as well as the general authorisation deliberations, must be generally regarded as confidential. The claimants asserted not only that the especially sensitive parts of the reports should be covered by confidentiality protection, but rather, that this protection must extend to the reports as such, because the sensitive parts are embedded in a series of arguments, which includes questions relating to their respective strategy and together with other public elements of the reports, constitute an inseparable entity with economic value.
In all three cases, the court dismissed a general presumption of confidentiality for such documents, citing the same grounds. The court found pursuant to Article 2(3) of Regulation No. 1049/2001 that the provisions regarding the public accessibility of EMA documents apply to all documents of the agency, in all of its areas of activity, i.e. to all documents the agency creates or receives and which are in its possession. Moreover, the court found that this Regulation is intended to implement, to the greatest degree possible, the public’s right to access documents of administrative bodies including when this right is subject to certain restrictions based on public or private interests. In contrast to contested documents from ongoing administrative or court proceedings, the court found that in the case of Regulations Nos. 726/2004 and 1049/2001, the principle of public access to information prevails; the only exceptions to this principle being those specified in Article 4(2) of Regulation No. 1049/2001, including the exemption for confidential business information.
In light of the need for strict interpretation, the European Court of First Instance found that the Community legislative authority implicitly presumed that the integrity of the authorisation process is not impaired by the absence of such a presumption of confidentiality. For all these reasons, there can be no general presumption of confidentiality for CHMP reports.
It is therefore not possible, the court argued, to presume that these reports are subject to general confidentiality that would cover them in their entirety based on the exception to protect the economic interests of the applicant. The economic value of the dossier on its own is not sufficient to classify it as a trade secret and therefore as confidential. Rather, it is up to the EMA to ensure, by conducting a specific, individual examination of each individual document in the administrative file to determine whether the document is covered as an exception for trade secrets within the meaning of Article 2(4) first bullet point of Regulation No. 1049/2001. For this to be the case, the owner of the dossier must argue and justify in detail the extent to which a potential business risk does, in fact, arise through publication. The purely hypothetical possibility is expressly insufficient, according to the European Court of First Instance.
Therefore, the current status quo is that such authorisation dossiers in their entirety are not to be generally regarded as confidential documents and that non-disclosure should be the exception. As with all regulatory exceptions, the court believes that in this case as well, interpretation should be conservative, paired with strict application.
On 6 February 2018, the EMA therefore cheerfully issued a press release entitled “General Court confirms EMA approach to transparency” and emphasised that in all three cases, the court affirmed the permissibility of the EMA’s conduct per the 2010 EMA policy on access to documents.
According to this decision in the first instance, marketing authorisation dossiers are therefore not generally classified as confidential. Pharmaceutical entrepreneurs, with respect to certain passages of a dossier that they do not desire to have released, must substantially justify in detail why these passages in particular contain data worthy of protection in respect of which the entrepreneurs’ interest in non-publication should prevail.
According to the European Court of First Instance, strict requirements must be met here and all blackening must be justified in detail in light of the regulatory exception to the principle of transparency.
All three decisions are not yet legally binding. At least two of them have been appealed to the ECJ.
