European Union: Pricing And Reimbursement For Pharmaceuticals In The European Union: European Commission Proposes Revised Transparency Directive

Today, the European Commission adopted its proposal for a new Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of public health insurance systems ("Transparency Directive" or "Directive"), which is set to replace the current Transparency Directive 89/105/EEC in place since 1989. The Transparency Directive sets the framework for national authorities in EU Member States' pricing and reimbursement ("P&R") decisions for pharmaceuticals and has in the past proven to be an important tool to support transparent market access rules in the EU.

I. The Commission's Proposal

The proposal's draft Directive maintains the Directive's core principles: The draft Directive still lays down a number of procedural safeguards for pharmaceutical companies to ensure transparency and due process in national P&R procedures of EU Member States (e.g. specific time limits for Member States to decide on reimbursement and mandatory statement of reasons based on objective and verifiable criteria for each P&R decision, cf. Art. 3-7).1 Following a stakeholder consultation in early 2011 ("Consultation"), the Commission's draft overhauls a number of the Directive's provisions, and clarifies its scope in line with case law of the Court of Justice of the European Union ("Court of Justice").

The most important aspects of the proposal can be summarized as follows:

  • Extended scope of the Transparency Directive: The Commission proposes to explicitly extend the scope of the Directive to:
    • so-called "demand side related measures" such as financial incentive schemes of public payers to influence the prescription behavior of physicians, e.g. towards the prescription of generic substances (Art. 11 of the draft Directive, cf. Court of Justice, case C-62/09, ABPI); and
    • national Health Technology Assessment ("HTA") procedures as part of reimbursement procedures (e.g. by NICE in the U.K., or by the German Institute for Quality and Efficiency in Healthcare (IQWiG) in the recently established mandatory "early benefit assessment" for innovative products in Germany) (Art. 7(5) and 12).
  • No mandatory EU price list: The Commission has not installed a mandatory EU price list to compare listed/discounted prices for pharmaceuticals across Member States. However, Member States remain free to compare prices and to maintain reference pricing systems (which are in place in almost all Member States).
  • No application to managed entry agreements or similar individual P&R agreements: Managed entry agreements and other individual agreements with public payers remain excluded from the scope of the Directive (Art. 1 (2) (a)). EU law would thus not require disclosure of prices (rebates) agreed in such contracts.
  • Shorter periods for Member States to decide on reimbursement (Art. 3 (3) and 7(4)): To speed up market access, the draft proposes to considerably reduce time limits for Member States to make decisions on pricing and reimbursement (including any HTA proceedings) from currently 180 days to 120 days for innovative products (except for more complex procedures, where the 180 days limit continues to apply) and to 30 days instead of 180 day-limit for generic medicinal products (when the reference product is already included in the national health insurance system).
  • Sanctions for non-compliance with time limits: To increase the effectiveness of the Directive, the Commission proposes strong enforcement measures (Art. 8). In case of non-compliance with the time limits for pricing and reimbursement decisions, a Member State has to designate a body entrusted with the powers to take rapid measures, such as:
    • adopting interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned;
    • awarding damages to the applicant; and
    • imposing a penalty payment, calculated by day of delay.
  • Extended powers of the Commission to monitor adherence to the Directive: The draft contains new procedures to monitor Member States' adherence to its provisions and requires Member States to submit national pricing and reimbursement measures at draft stage (such as laws implementing the Directive at the national level) to the EU Commission for review prior to their adoption (Art. 16).
  • No reassessment of results of marketing authorization procedures in national HTA proceedings: Member States shall not reassess the elements on which the marketing authorization is based, including the quality, safety, efficacy or bioequivalence of the medicinal product (Art. 13).
  • No application to medical devices and personalized medicines: National reimbursement decisions for medical devices remain outside the scope of the Transparency Directive. The same applies to personalized medicines (diagnostic testing and medicines specifically adapted to the patient's needs).

II. Preliminary Assessment

Following its decision to redraft the Directive, the Commission now presents a cautious approach to updating the Transparency Directive and provides a number of helpful clarifications to ensure timely and transparent market access for pharmaceuticals in the EU.

The Commission's proposals for a tighter and more effective enforcement of the Directive are to be welcomed, in particular the proposal of short-term remedies for pharmaceutical companies in case of deviations from the Directive's time limits for national P&R decisions (deviations from the obligations of Member States under the Transparency Directive can currently only be dealt with in lengthy infringement procedures). The obligation of Member States to notify national pricing and reimbursement measures at draft stage, allowing the Commission to monitor compliance with the Directive's transparency requirements, is a welcomed "fix it first" approach and will likely improve the transparency of national P&R procedures.

The draft furthermore includes the helpful clarification that national HTA proceedings are part of P&R decisions and are therefore covered by the Directive's transparency obligations and its strict timeframes for a decision by national regulators. This is significant since HTA proceedings increasingly become a "fourth hurdle" for market access in the EU requiring companies to prove an added therapeutic benefit of their new products over existing therapies to obtain reimbursement/favorable pricing. For instance, a new French law passed in December 2011 principally links reimbursement eligibility in France to the submission of comparative clinical trial data against reference therapies.

Furthermore, it is to be welcomed that the draft does not foresee the disclosure of contractual rebates and reimbursement agreements with public payers (managed entry agreements and other individual agreements on pricing and reimbursement are excluded from the Directive's scope). However, Member States remain free to bypass confidentiality and demand disclosure of such confidential rebates for use in their reference pricing systems, which potentially could lead to a downward trend of prices in the EU. This is an issue e.g. in Germany under the new value-based pricing regime introduced by the major 2010 German pharmaceutical pricing reform (AMNOG).

The proposed extended monitoring powers of the Commission and remedies for applicants in case of non-compliance with the Directive's time limits as well as the application of the Directive to national HTA proceedings and the issue of an EU price list/disclosure of contractual rebates are likely to be intensively discussed in the upcoming legislative process on the Directive. Since these questions are important for market access and pricing strategies in the European Union, further developments on the Commission's proposal should be closely monitored.

III. Next Steps

The Commission's proposal will be debated in the European Parliament and the Council in the coming months. A new Transparency Directive is currently expected to be passed before the end of 2012. The proposal foresees that Member States have to adapt their national laws to the new Directive within 12 months, i.e. in 2013/2014.


1. The Directive does not contain the substantive criteria on P&R for pharmaceuticals in national public health care systems, which are a national competence (each of the 27 EU Member States has its own specific P&R system).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions