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Focus on Regulation

PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT REVISED GUIDELINE CONCERNING THE CONDITIONAL MARKETING AUTHORISATION PROCEDURE FOR MEDICINAL PRODUCTS

On 27 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a two month public consultation process on a draft revised Guideline governing the implementation of Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004.

The draft revised Guideline provides guidance on the early grant of a marketing authorisation where less comprehensive clinical data is supplied than is required in a normal application for marketing authorisation. It is intended to provide updated procedural information for applications that are submitted on the basis of Article 14(7) of Regulation (EC) No 726/2004. In accordance with this provision, the European Commission could grant a marketing authorisation to a medicinal product that is subject to specific conditions and annual review by the European Medicines Agency (“EMA”). Continue Reading

White House and EPA Release Final Clean Power Plan With Significant Changes

79637827_US_Newsletter_Half_LandscapeOn August 3, 2015, the White House and the Environmental Protection Agency (“EPA”) released the final Clean Power Plan, which establishes national carbon emissions standards for existing power plants pursuant to section 111(d) of the Clean Air Act.  The Plan is estimated to reduce carbon dioxide emissions by 32 percent from 2005 levels by 2030, at an estimated annual incremental compliance cost of between $5.1 billion and $8.4 billion in 2030.  These emissions reductions will be phased in on a gradual 8-year “glide path” between 2022 and 2030.

Under the Plan, EPA sets state-specific rate-based and mass-based goals that must be achieved.  States will develop and implement tailored plans designed to achieve these goals through reductions in three “building blocks”: (1) improved efficiency at power plants; (2) shifting generation from higher emitting coal to lower emitting natural gas power plants; and (3) shifting generation to zero-emitting renewables.  EPA also issued a proposed federal plan to serve as a model for states when creating their individual plans and which, when finalized, will also serve as a backstop for states that do not have approved plans.  State plans are due in September of 2016, although states in need of additional time may request extensions of up to two years.

In response to public comments received, the final rule includes a number of significant changes from EPA’s initial proposal.  The key changes are summarized in EPA’s “Key Changes and Improvements” document.  For example, the final rule, which added a mass-based goal for each state, is designed to better accommodate cross-state trading programs.  EPA’s proposed federal plan also includes model trading rules for states to use when establishing trading programs under the Clean Power Plan.  Another significant change is EPA’s removal of the “building block 4” demand-side efficiency reductions; the final rule instead focuses on supply-side measures to reduce carbon emissions.  This change is the result of significant industry opposition to “beyond the fenceline” demand-side reductions, which many argued were in excess of EPA’s authority under the Clean Air Act.  The final rule, however, does not get rid of demand-side reductions altogether.  Instead, EPA introduced a voluntary incentive program to reward and encourage early reductions achieved through investments in certain renewable energy and demand-side energy efficiency projects.  The final rule also takes steps to ensure grid reliability, including the addition of a “reliability safety valve,” which would delay the rule for individual states on a case-by-case basis should unforeseen circumstances arise.

The legal challenges to the Clean Power Plan will be significant and take years to resolve.  Under Section 307(b)(1) of the Clean Air Act, petitions for review of national rules such as the Plan must be filed in the U.S. Court of Appeals for the D.C. Circuit within 60 days of the rule’s publication in the Federal Register.   A coalition of State Attorneys General and industry petitioners has already announced that it intends to challenge the Clean Power Plan.

The first critical issue in the litigation is whether the petitioners will be able to secure a stay of the Plan pending review.  Under D.C. Circuit precedent, a stay of a regulation pending review requires the petitioners to show (1) a likelihood of prevailing on the merits, (2) irreparable injury to the petitioners, (3) the substantial harm, if any, to other parties if relief is granted, and (4) the public interest favors a stay.  See, e.g.  New York v. EPA, 2003 WL 25706732 (D.C. Cir. Dec. 24, 2003) (staying a Clean Air Act rule to amend New Source Review).  The D.C. Circuit has already rejected a challenge to the proposed Clean Power Plan, In re Murray Energy Corp., No. 14-1112 (D.C. Cir. June 9, 2015), but that was due to a lack of jurisdiction because the rule was not yet final.  Thus, the legal issues concerning whether the final Clean Power Plan exceeds EPA’s authority remain in play.   Motions for a stay of a regulation generally must be filed within 30 days of the filing of a petition, so the key legal issues should be aired soon.  See D.C. Circuit Handbook of Practice and Internal Procedures at 33 (as amended through June 1, 2015).

EPA also announced on August 3 the Final Carbon Pollution Standards for New, Modified and Reconstructed Power Plants pursuant to section 111(b) of the Clean Air Act.

PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT REVISED GUIDELINE CONCERNING ACCELERATED ASSESSMENT OF MEDICINAL PRODUCTS

On 27 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a two month public consultation process on a revised draft Guideline governing the implementation of the accelerated assessment of medicinal products.

The revised draft Guideline provides guidance concerning the expedited assessment of a marketing authorisation application for a candidate medicinal product. It is intended to provide updated procedural advice concerning the submission of a marketing authorisation application that falls within the scope of Article 14(9) of Regulation (EC) No 726/2004. In order to demonstrate that the legal basis for the accelerated procedure is satisfied, an applicant must demonstrate that the candidate medicinal product is “[…] of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation“. Grant of access to the procedure by the CHMP could reduce the timeframe for delivering an opinion on the marketing authorisation application of a candidate medicinal product from 210 days to 150 days.

Arguments for substantiating an accelerated procedure claim

In the absence of a fixed definition of what constitutes a medicinal product of “major interest”, requests for the accelerated handling of a marketing authorisation will be assessed on a case-by-case basis by the CHMP. The draft revised Guideline identifies a number of arguments that applicants could consider in justifying a request for the accelerated procedure. A request could include the following points:

  • Information that suggests that the candidate medicinal product could potentially reconcile unmet medical needs. Epidemiological data could supplement this argument, as well as supporting evidence from published literature or registry studies;
  • A description of the extent to which it is expected that the candidate medicinal product could fulfil a specific medical need;
  • Evidence which justifies the accelerated procedure from a public health perspective. Where comprehensive clinical data is not available an applicant could submit a brief outline of the primary evidence that is available.

Pre-submission actions

The draft revised Guideline stresses the importance of early interaction with the EMA. Applicants are recommended to engage with a Procedure Manager in the EMA prior to the submission of an accelerated procedure request for a candidate medicinal product. It is recommended that a notification of the intention to submit a request be submitted six to seven months before the actual submission of the marketing authorisation application. The draft revised Guideline also advises applicants to request a pre-submission meeting with the Rapporteurs and the EMA product team at the earliest available opportunity. The applicant must provide the following documentation to accompany an application for authorisation in accordance with the accelerated procedure; (i) the Rapporteur’s briefing note to the CHMP concerning the recommendations on the grant of the accelerated procedure; and (ii) the conclusions reached by the CHMP at the end of the meeting during which the request for the grant of the accelerated procedure is discussed. This information must be submitted two to three months prior to the submission of the actual marketing authorisation application.

It is recommended that the justification for the use of the accelerated procedure consist of between five and 10 pages.

The draft revised Guideline emphasises that the timeframe for the handling of the accelerated assessment procedure must be respected by applicants. It is noted that a delay could affect the assessment of the request by the CHMP and Pharmacovigilance and Risk Assessment Committee (“PRAC”). In cases where a request is submitted for an advanced therapy medicinal product, the timetable will be modified to incorporate an assessment by the Committee for Advanced Therapies. It is also noted that a potential start date for the initiation of an accelerated procedure assessment will not commence in December.

Once the draft revised Guideline is implemented in its final form, it will replace the 2007 Guideline on the procedure for Accelerated Assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004.

The consultation process will remain open until 30 September 2015. Comments may be submitted by interested companies and individuals using the template form indicated on the draft revised Guideline to aa_guideline@ema.europa.eu.

Will the FCC Change Channels on the Delivery of Video Programming?

In December 2014, the Federal Communications Commission (FCC) released a Notice of Proposed Rulemaking (NPRM) that could change the way Americans watch television.  In a closely watched proceeding, the FCC proposed new rules to define which entities should be considered multichannel video programming distributors (MVPDs).  The FCC sought comment on whether providers of IP-delivered video programming should have the same regulatory status as cable and satellite providers.  If—as seems likely—the Commission adopts the rules proposed, qualified providers of video programming over the Internet could gain unprecedented access to programming, but could also be subject to significant new regulatory oversight.

Redefining “Channel” 

Traditional MVPDs are cable and satellite companies that distribute channels of video programming to subscribers.  At the core of the FCC’s proposed rule change is exactly how to define “channel.”  In the past, the FCC has found that only operators who delivered their programming over some facility, such as a cable system or a satellite link, could provide consumers with “channels.”  But with the growth in broadband penetration and capacity, an increasing number of companies have begun delivering separate streams “over the top” (OTT) of consumers’ Internet connection.

The FCC proposes to amend its rules to redefine the term “channels” as “streams of linear video programming.”  (The term “linear programming” or “linear television” describes programming that consumers must watch when the provider offers it as opposed to programming available anytime on demand.)  Under the proposed revised definition, even if an OTT provider does not provide the physical transmission path of a channel, it would qualify as an MVPD by providing multiple streams of programming.  Because the FCC is basing its reclassification on providing “channels,” the proposal does not directly include subscription on-demand providers such as Netflix; non-subscription on-demand providers such Amazon Instant Video and iTunes; or ad-based providers such as Hulu, Roku or YouTube.  Nevertheless, the FCC sought comments on whether it should reclassify any of these other types of providers as MVPDs, too.

The Upside for OTT Providers

Being classified as an MVPD could bring OTT providers two key benefits.  First, MVPDs have program access rights, which prevent one MVPD from withholding affiliated content from an unaffiliated MVPD.  The program access rules are one of the reasons that consumers can watch NBC programming, which is affiliated with Comcast, even though they subscribe to Cox.  The second advantage of MVPD status is eligibility for retransmission consent, which requires broadcasters to negotiate in good faith with MVPDs for retransmission rights and prevents broadcasters from selling exclusive rights to just one MVPD.  Retransmission consent is one of the reasons that cable subscribers have generally been able to watch a variety of broadcast networks through their cable box.

Expanding the definition of MVPD to include OTT providers would therefore provide new video service providers with greater access to linear television programming.

The Potential Burdens of MVPD Status

While there are advantages to gaining MVPD status, OTT providers would also face increased regulatory burdens from the classification.  For example, MVPDs must provide closed captioning and video description services for individuals with disabilities and are bound by the FCC’s Equal Employment Opportunities rules.  The FCC also regulates the volume of commercials on MVPD streams and has a host of requirements, such as signal leakage and inside wiring rules, that logically apply only to facilities-based MVPDs.  Complying with these regulations inevitably comes at a cost, which some OTT providers may not want to pay, and some of these rules — such as the obligation to report and remedy signal leakage from cable lines — simply do not fit the OTT-delivery model.

Stay Tuned

The outcome of the OTT proceeding will not be a cliff hanger for much longer.  FCC Chairman Tom Wheeler has said that he expects a final rule addressing the status of OTT providers to be released in the fall of 2015.  The Chairman will likely have to push through the item over the objections of at least one of the four commissioners at the FCC.  Commissioner Ajit Pai has already announced his opposition to reclassification.  Pai recently said that the Commission should not create a new category of regulated entity in light of the absence of any clear market failure in the MVPD sector.

Once the FCC makes its move, attention will turn to the U.S. copyright office, which is the primary battlefield for programming access rights because the Copyright Office – not the FCC – determines eligibility for compulsory licenses to copyrighted work, which remains the most important step in any programming distribution effort.  Here too, the playing field may be changing.  In a recent case in a California district court, the judge tentatively ruled in favor of treating the online video streaming service FilmOn like a cable company for copyright purposes, while noting that the MVPD rulemaking could change the legal requirements of Internet-based providers under Section 111 of the Copyright Act, which requires that any retransmission of content comply with FCC regulations.

The potential for the FCC and the Copyright Office to change the regulatory landscape for OTT providers should keep everyone watching.

Uncertainty Remains Pending Modifications to French Sunshine Regulations

On 24 February 2015 the French Administrative Supreme Court cancelled parts of the French sunshine regulations, and of a related governmental interpretative document. Pursuant to this decision, French sunshine regulations could be construed as requiring the industry to disclose fees paid under agreements with HCPs and with other stakeholders concerned by the regulations. This decision created uncertainty as to how to comply with this new situation, and whether reporting had to be retroactive.   The position of the French Ministry of Health’s Direction Générale de la Santé (DGS) in relation to this decision was brought to light in a letter dated 16 July 2015 sent to various industry bodies (including the French Pharmaceutical Industry Association (LEEM) and the French Association of Medical Device manufacturers (SNITEM)).   According to the DGS, the industry must update its sunshine reporting to include fees paid to the stakeholders in all agreements falling under the scope of the sunshine regulations i.e. agreements entered into (or being in effect) as from 1 January 2012.   The DGS’ position further maintains the current uncertainty around the regulations, especially in a context where new upcoming French health regulations are supposed to shed light on the manner in which fees are to be reported. These new regulations are expected to be enacted by the end of 2015. In the meantime, French industry associations have responded and challenged the DGS’ position.

9th Annual Global Antitrust Enforcement Symposium

The lawyers in the Antitrust, Competition and Economic Regulation practice at Hogan Lovells are proud to co-sponsor the Georgetown Law 9th Annual Global Antitrust Enforcement Symposium on Tuesday, 29 September 2015.

Join leading international competition enforcement officials, industry professionals, and academics as they discuss and debate antitrust’s cutting-edge issues.

Click here to RSVP.

Click here to download the calendar appointment.


Hogan Lovells would also like to invite you to dinner on Monday, 28 September. The keynote speaker at the dinner will be Terrell McSweeny, Commissioner of the Federal Trade Commission. Additional details to follow. Continue Reading

DRIPA Struck Down by High Court in Judicial Review Challenge

On 17 July 2015, the High Court declared the operative provision of the Data Retention and Investigatory Powers Act 2014 (“DRIPA“) to be inconsistent with EU law, in response to a judicial review claim brought by Conservative MP David Davis and Labour MP Tom Watson (R (Davis & Watson) v Secretary of State for the Home Department [2015] EWHC 2092 (Admin)).

DRIPA was introduced by the coalition government last year, following a judgment of the Court of Justice of the European Union (“CJEU“) that struck down the Data Retention Directive 2006/24/EC (the “Directive“), which had been implemented in the UK by the Data Retention (EC Directive) Regulations 2009 (the “2009 Regulations“). Following that judgment, some telecommunications service providers expressed the view that there was no longer any legal basis for them to retain communications data and indicated that they would start to delete data that had been retained under the 2009 Regulations.

The coalition government considered that this development threatened the ability of UK law enforcement and intelligence agencies to use communications data to investigate criminal activity. It therefore rushed DRIPA through Parliament in an emergency three day fast-track process.

DRIPA gave the defendant Secretary of State powers to issue retention notices to telecommunications service providers requiring them to retain communications data for up to a year. “Communications data” as defined by DRIPA did not include the content of the communication but did include the time and duration of a communication, the telephone number or email address of the originator and recipient, and sometimes the location of the device from which the communication was made. The claimants applied for judicial review, contending that s.1 of DRIPA was invalid under EU law as it was not accompanied by an access regime which had sufficiently stringent safeguards to protect citizens’ rights under the Charter.

The High Court (Bean LJ and Collins J) ruled that s. 1 of DRIPA, which was the operative provision, was incompatible with Article 7 (Respect for private and family life) and Article 8 (Protection of personal data) of the Charter of Fundamental Rights of the European Union (“the Charter“).  The Court granted the application on the basis that “decisions of the CJEU as to what EU law is are binding on the legislatures and courts of all Member States.” In response to the Defendant’s attempts to rely on the jurisprudence of the European Court of Human rights, the Court said that, in this case, the “subtleties of the relationship between UK domestic courts and the European Court of Human Rights” did not arise. The CJEU had, in its Digital Rights Ireland decision, deemed the Directive to be in breach of Articles 7 and 8 of the Charter. It followed that an “identically worded domestic statute would have been found to have exceeded the same limits.” The Court deemed a reference to the CJEU unnecessary given that the Digital Rights Ireland decision was clear and national courts could act in light of that decision.

In order to be lawful, DRIPA would have to be accompanied by an access regime which provided adequate safeguards for the rights protected by Articles 7 and 8 of the Charter. The Court held that the points made by the CJEU in Digital Rights Ireland were made with such emphasis that they were to be understood as “having laid down mandatory requirements of EU law“:

a) the protection of the right to respect for private life required that derogations and limitations in relation to the protection of personal data had to apply only in so far as was strictly necessary. DRIPA therefore had to lay down clear and precise rules governing its scope and impose minimum safeguards to give effective protection against the risk of abuse and unlawful use of data;

b) any legislation establishing a general retention regime for personal data had to be  restricted to the purpose of preventing, detecting and prosecuting precisely defined serious offences; and

c) access to the data retained had to be made dependent on a prior review by a court or an independent administrative body whose decision sought to limit access to the data and its use to what was strictly necessary for the purpose of attaining the objective pursued, and which intervened following a reasoned request of those authorities. The Court dismissed the argument that a requirement of judicial approval prior to the access of data would be unnecessarily bureaucratic or cumbersome.

The Court made an Order “disapplying s.1 of DRIPA to the extent that it permits access to retained data which is inconsistent with EU law” but suspended that Order until 31 March 2016, to allow Parliament reasonable opportunity to legislate for proper safeguards. Given the plain public importance of the case, the Secretary of State was granted permission to appeal. Indeed, the government has confirmed that it intends to appeal the judgment.

Cabinet Office Announces Commission to Review Freedom of Information Legislation

The Cabinet Office has recently announced that a cross-party commission is to look into the Freedom of Information Act 2000 (“FOIA”) in light of apparent concerns that sensitive information is not being sufficiently protected.

FOIA was introduced under the last Labour Government, coming fully into force on 1 January 2005, and allows a private citizen to obtain information held by public bodies across the UK, with a number of exceptions including for confidential, sensitive or personal information. Continue Reading

EMA Begins Publishing the Outcome Of Safety Reports Concerning Nationally Authorised Medicinal Products

On 6 July 2015, the European Medicines Agency (“EMA”) announced that it would begin publishing the outcome of single assessments of period safety update reports (“PSURs”) for active ingredients contained in nationally authorised medicinal products.

Periodic safety update reporting is performed during certain stages of the post-authorisation phase of the medicinal product. The report provides an assessment of the benefit-risk balance of the medicinal product. Such reporting is required in accordance with Regulation (EC) No 726/2004 and Directive 2001/83/EC.

The publication of the single assessment of PSURs for active ingredients found in nationally authorised medicinal products is coordinated by the EMA. The regulatory outcome for the active substance will be published on the EMA’s website. This publication will include a list of medicinal products which contain the concerned active ingredient. In practice, the publication of this information could enable companies to better identify and potentially address the findings of the single assessment concerning active substances.

In cases where the single assessment of the active ingredient leads to the conclusion that a variation to the initial marketing authorisation is required, the EMA will subsequently publish the supporting documentation in every official language of the European Union (“EU”). This could include the following information;

• Scientific conclusions and grounds for variation to the terms of the marketing authorisations;

• Amendments to the product information of the nationally authorised medicinal product(s); and

• Timetable for implementation.

If a variation to the terms of a marketing authorisation is required the marketing authorisation holder must submit an application for a variation to the competent authority of the relevant EU Member State in accordance with Article 23 of Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004.

The publication of the outcome of single assessments of PSURs for active ingredients contained in centrally authorised medicinal products began in July 2012. This information is published as part of the European public assessment report. For both centrally and nationally authorised medicinal products, the publication of the single assessment of PSURs for active ingredients commenced in April 2013. The outcome of the procedure is published on the Community Register of the European Commission.

Marketing authorisation holders of nationally authorised medicinal products are recommended by the EMA to regularly check for updates on outcomes concerning active substances which could potentially affect their medicinal product.

Update on the Implementation of the EMA Disclosure Policy on Publication of Clinical Data

On 24 June 2015, the European Medicines Agency (“EMA”) delivered an update on the implementation of its policy concerning the publication of clinical data.

It is recalled that the EMA Disclosure Policy concerning the publication of clinical data was adopted on 2 October 2014. The EMA Disclosure Policy could enable access by interested third parties to clinical reports and individual patient data submitted as part of a marketing authorisation or post-marketing authorisation for an existing centrally authorised medicinal product. Clinical data that were submitted under the centralised marketing authorisation procedure for a medicinal product after 1 January 2015 could be disseminated to interested third parties. On 1 July 2015, the scope of the policy was expanded to include clinical data submitted as part of an application for an extension of a therapeutic indication or a line extension of a centrally authorised medicinal product.

The update provides stakeholders with information concerning procedural requirements and guidance on the redaction of commercially confidential information and the anonymisation of personal data.

Timeframe for submission of redacted clinical reports

Under the EMA Disclosure Policy, pharmaceutical companies are required to submit their proposals for redaction between Day 181 and Day 220 of the marketing authorisation procedure. Proposed redactions of applications concerning an extension of an indication must be submitted between thirty (30) calendar days pre-opinion and ten (10) calendar days post-opinion. If a marketing authorisation application is withdrawn, the report must subsequently be submitted within thirty (30) calendar days of the notification of withdrawal.

Companies are required to certify that the redacted clinical report reflects the version submitted for scientific review. This declaration may be presented in a cover letter to the EMA. It must confirm that the only difference between the two reports is the proposed redactions.

Issuance of an advance “warning”

Companies could receive up to three (3) notifications as a “warning” to submit a redaction proposal in accompaniment with their marketing authorisation application or line extension application. Such warning could come following receipt of the following letters during the scientific review process; (i) the validation letter from the EMA; (ii) the list of outstanding issues on Day 180 of the marketing authorisation application; and (iii) the opinion letter from the Committee for Medicinal Products for Human Use (“CHMP”). For an extension of a therapeutic indication to a marketing authorisation, companies could receive a “warning” to submit a redaction proposal following receipt of: (i) the validation letter from the EMA; (ii) a request for supplementary information; and (iii) the opinion letter from the CHMP. Finally, in the case of withdrawn applications, a notification could be received following: (i) the validation letter from the EMA; and (ii) the withdrawal letter to the marketing authorisation application.

Redaction procedure

In view of the update provided by the EMA, companies can determine their own methods for redacting proposed commercially confidential information. The final redacted version of the clinical report must however demonstrate conformity with the requirements of the EMA. This includes the requirement to ensure that the text is searchable by providing documents in PDF format. Only text that is not redacted must be retrievable in a search. Redacted text must be clearly provided. Redaction codes which are agreed with the EMA must be identifiable and form part of the document. The final redacted document may be submitted as a separate sequence denoting “Supplemental Information” as part of a separate document in the electronic Common Technical Document format (eCTD) to the EMA. This sequence must be separate from the sequence under which the proposed documents where submitted. A cover letter must be attached with the final redacted version of the clinical report which verifies that it contains the requisite documents for publication.

Companies will have the opportunity to engage in only one round of redaction consultation exchanges. Based on the outcome of the assessment on the proposed redacted information, companies will be expected to update the redacted document to reflect the proposals agreed by the EMA.

Publication of final redacted reports

Publication of the final redacted version of the clinical report could occur within sixty (60) calendar days following the issuance of a European Commission Decision granting or refusing the marketing authorisation application. The timeframe for the publication of a final redacted report submitted as part of an extension of a therapeutic indication or line extension will be sixty (60) calendar days following the outcome of the European Commission Decision. Where an application is withdrawn, publication of the final redacted report could be issued within one-hundred and fifty (150) calendar days of the notification by the company to the EMA. The above timeframes take into account an interim relief period of twenty (20) calendar days in cases where a disagreement arises with the EMA.

Redaction of commercially confidential information

As a general principle, the EMA will not disclose trade secrets or commercially confidential information. However, information contained in clinical reports will only be viewed as commercially confidential information in limited circumstances. The update outlines the conditions which must be satisfied by companies in order to justify the redaction of alleged commercially confidential information contained within the following documents: (i) clinical overviews; (ii) clinical summaries; and (iii) clinical study reports (“CSR”).

A justification table detailing the proposed commercially confidential information to be redacted must accompany the submission of every clinical report. This table must list all the proposed redactions concerning purported commercially confidential information. It may be noted that this tool is also intended by the EMA to facilitate communication with companies. Subsequently, this table will not be subject to publication. Three categories of information are described that will be excluded from the scope of commercially confidential information. This includes: (i) existing information that is available in the public domain, such as clinical trial registries or a patent application; (ii) information that does not contain innovative features and falls within the public knowledge, such as scientific and regulatory guidelines and guidance documents; and (iii) certain general or administrative information, quality related information, non-clinical and clinical related information.

The EMA highlights that the required level of detail must be “specific, pertinent, relevant, not overstated and appropriate” to the proposed justification for redacting the information. The EMA also mentions certain conditions that must be must be satisfied by companies who wish to protect commercially confidential information. The following information must be demonstrated:

• Clear identification of the proposed information to be redacted;

• The innovative features within the context of public knowledge;

• The concerned information constitutes part of an on-going development programme; and

• How the disclosure of the concerned information could undermine the economic interest or competitive position of the owner of the information.

A request for additional information could be prompted by the EMA if the proposed justification is not considered to be sufficiently supported. If the justification is ultimately rejected by the EMA a specific justification code will be provided in the justification table.

Anonymisation of clinical reports

Anonymisation methodologies such as masking, randomisation and generalisation could be deployed by companies in the anonymisation of personal data. Although the EMA does not require a specific technique for the purposes of the anonymisation of clinical reports it does recommend “randomisation and generalisation techniques […] in order to optimise the clinical usefulness of the information published”. Companies must however demonstrate that anonymisation is achieved and  that: (i) singling out, linkability or inference after anonymisation is no longer possible; or (ii) an analysis on the re-identification of risk could be conducted.

The EMA also recommends steps that companies could follow in order to develop an anonymisation process. This includes:

1. Determination of direct identifiers and quasi-identifiers in the dataset (i.e the clinical reports);

2. Identification of possible adversaries and plausible attacks on the data;

3. Data utility considerations;

4. Determination of the risk of re-identification threshold;

5. Evaluation of the actual risk of re-identification;

6. Anonymisation methodology;

7. Documentation of the anonymisation methodology and process.

A report detailing the steps to be taken to achieve anonymisation must accompany the submission of the anonymised clinical reports. This report must outline the company’s approach to the anonymisation of personal data.

Companies that fail to comply with the EMA Disclosure Policy could be subject to remedial action which is yet to be fully determined by the EMA.