How Policy 0070 differs from the access-to-documents policy
Two European Medicines Agency policies open clinical documents to outside readers: Policy 0070 publishes them, and the older access-to-documents policy, Policy 0043, releases them to whoever asks, so one document can be caught by both. The two differ in legal basis, scope, timing, who anonymises and how the result is marked, and they agree on what must be protected.
Proactive publication against release on request
Policy 0043, the policy on access to documents, was adopted in November 2010, and Policy 0070, the policy on publication of clinical data, followed in October 2014. Both policies aim to enhance the transparency of the regulatory decision-making process, and Policy 0070 also aims to let the scientific community apply the knowledge from past clinical development programmes to future research. Although their objectives are similar, their scope, approach and procedures differ. Medical writers need to become familiar with both policies, because the increased dissemination of regulatory documents will affect how these documents are prepared in the future.
Under phase 1 of Policy 0070, once a medicinal product has received a marketing authorisation, its regulatory clinical documents (clinical study reports, clinical summaries and clinical overviews) must be published on an agency website. The publication is proactive, and readers can view and download the documents.
Policy 0043 sets out the rules for requesting access to documents held by the agency. Under it, anyone may request a wide range of clinical and other documents from the agency without giving a reason; the agency grants the vast majority of requests, and only the requester receives the documents. Requests can be made for clinical and certain non-clinical documents, subject to certain conditions. The agency can refuse access to a document if disclosure would undermine the public interest, an individual's privacy, commercial interest or court proceedings, unless there is an overriding public interest in disclosure.
Legal basis and scope
The sources name different regulations as the basis of Policy 0043: a 2018 comparison of the two policies gives it a direct legal basis in Regulation 45/2001, while a 2024 account says it was developed in accordance with EU Regulation 049/2001/EC. It has been in effect since 1 December 2010. Policy 0070 took effect on 1 January 2015, and it has no direct legal basis: it is a complementary tool for the time before Clinical Trial Regulation 536/2014 comes into force.
In principle, Policy 0043 reaches any document about medicinal products for human and veterinary use that the agency holds. Policy 0070 reaches the clinical Module 2 and Module 5 documents of the common technical document from the dossiers concerned that were submitted through the centralised marketing authorisation procedure; for clinical study reports, these are the body or synopsis, the protocol and its amendments, the case report form and the statistical analysis methods.
What both policies protect
Under both policies, protected personal data (PPD) and commercially confidential information (CCI) must not be released, in order to protect the privacy of individuals and the commercial interests of drug developers. Regulation 45/2001, to which both policies refer, defines personal data as "any information relating to an identified or identifiable natural person". Clinical documents typically contain personal data of study participants, such as participant identification numbers, and may also contain personal data of staff from the sponsor, investigational sites and vendors, such as phone numbers. Policy 0070 defines CCI as "any information … that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant", and Policy 0043 has a similar definition. The agency's questions-and-answers document on Policy 0070 confirms that there "will be no difference in the understanding of CCI in the Agency's assessment" between the two policies.
When documents become available and when the holder's work starts
Under Policy 0070, documents are to be published within 60 days after the European Commission decision, but while the agency has a backlog they are published much later, for example more than a year after that decision. Under Policy 0043, documents become available after the regulatory procedure is finalised, for example after the Commission decision. The details, and exceptions to this, depend on the document type.
Under Policy 0070, the marketing authorisation holder can prepare redaction proposal versions proactively, and while the agency has a backlog the holder may choose to wait for the agency's notification letter, which is not advisable for a large dossier. Under Policy 0043, the work starts when the agency receives a specific request for documents and consults the holder.
Under Policy 0070, the redaction proposal package is due between 30 days before and 10 days after the opinion of the Committee for Medicinal Products for Human Use, but while the agency has a backlog the deadline is the one set in the agency's notification letter, usually several months after the letter. These timelines for the redaction proposal package and the publication step apply to initial marketing authorisation applications, line extension applications and extension-of-indication applications. For the first dossiers, holders were granted only about 2 to 3 months from the agency's notification to the redaction proposal package, and for later dossiers the timeframe was longer, for example up to about 6 months. Under Policy 0043, the holder usually has five working days to comment on a document or batch of documents the agency sends.
Who anonymises and how the result is marked
Under Policy 0070, the marketing authorisation holder gives the initial suggestion for anonymising PPD, as read-through redaction marks, and decides the anonymisation in consultation with the agency, and an anonymisation report is required. Under Policy 0043, the agency gives the initial suggestion, as highlights, and decides the anonymisation after consulting the holder, and no anonymisation report is required. The holder carries out the anonymisation and redactions for both PPD and CCI under Policy 0070, and the agency carries them out under Policy 0043. Under Policy 0043, sponsors can request redactions beyond those the agency makes.
Policy 0070 accepts redaction or other anonymisation methods to protect personal data. In 2018, redacting or masking, which renders information invisible with a coloured bar, was the most widespread method to protect personal data under Policy 0070, and the agency encouraged other anonymisation techniques, such as randomisation and generalisation. Under Policy 0043, redaction is the only accepted method to prevent the release of PPD, since it ensures compliance with the legal requirement to grant access to the original documents. For CCI, redaction is the only way to prevent release under either policy.
Under Policy 0070, redaction marks appear as a blue box with black overlay text for PPD and a black box with red overlay text for CCI, while under Policy 0043 they appear as black boxes without overlay text for both.
Usually more PPD is anonymised under Policy 0070 than under Policy 0043, where the amount is very limited. Teva, for example, chose a fairly conservative approach to PPD in its first two Policy 0070 dossiers, to achieve a very low risk of re-identification. The approach was justified by the permanent public release of the documents and by likely better technological means to re-identify individuals in the future. More and more personal data may also become publicly available over time, which may make it easier to link data from Policy 0070 documents with other public data and re-identify individuals. For these reasons, and because access to documents via Policy 0043 is not public, considerably more PPD was redacted in Teva's first Policy 0070 dossiers than the agency usually accepts for Policy 0043 requests.
Documents caught by both policies
A document in scope of Policy 0070 that was previously released under Policy 0043 still needs a new version, prepared by the marketing authorisation holder, for Policy 0070 publication, even if the same items were redacted for both, because the two policies require different methods to mark or highlight items for redaction. Earlier CCI decisions on documents requested under Policy 0043 but not in scope of Policy 0070 may be relevant for preparing a Policy 0070 dossier, if the same content is also found in a document in scope of Policy 0070.
Previous and parallel Policy 0043 requests for documents on the same product were a major challenge for Teva, in particular in preparing one of its first two Policy 0070 dossiers. To keep CCI redactions rejected under Policy 0043 out of its Policy 0070 redaction proposal package, Teva created a master list of the items accepted or rejected under Policy 0043 as a reference source. However, the agency's decisions on one relevant Policy 0043 request arrived too late to be considered appropriately for all applicable documents in the package. That delay, together with other factors such as the large number of scanned pages and the number and complexity of the CCI items that subject-matter experts suggested, prevented full consistency of the proposed CCI across the documentation at the time of the redaction proposal package. The agency's decisions on the acceptability of CCI were also not consistent between the two policies. Additional discussions with the agency and changes to the CCI were therefore required after the redaction conclusion and after the final redacted document package had been submitted.