Assess record for 'Public Consultation on a possible revision of Council Directive 89/105/EEC ("Transparency Directive")'

Transcription

1 Assess record for 'Public Consultation on a possible revision of Council Directive 89/105/EEC ("Transparency Directive")' Respondent profile Please indicate the type of organisation on behalf of which you are responding to this consultation: Please specify the size of your company: -single choice reply- (optional) Please indicate the name of your organisation (for individual respondents, your name and country): -open reply- (optional) Please indicate the country where your organisation has its headquarters or main representative office in Europe: - single choice reply- Please indicate the number of EU Member States and EEA countries (rway, Iceland, Lichtenstein) in which your organisation conducts business: -single choice reply- If need be, can we contact you by Yes to obtain further information about your submission? -single choice reply- Please provide the address where we can contact you -open reply- Contact person -open reply- Job title -open reply- (optional) Day-time phone number -open reply- (optional) Additional contact details -open reply- (optional) I II II.A- ORIGINATOR INDUSTRY Pharmaceutical industry association originator products Large enterprise (more than 250 employees) European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) Registrier number Europ BE - Belgium 27 natz@eucope.org Alexander Natz Secretary General Impact of the current directive Registrier number Europ

2 1.1. How would you describe the impact of the Transparency Directive on: a) Equal treatment between domestic and imported products b) Speed of pricing and reimbursement decisions c) Transparency of pricing and reimbursement procedures d) Availability of legal remedies e) Access to medicines for patients f) Competitiveness of the pharmaceutical industry Very positive Positive Positive impact Positive Positive Please explain your above replies: -open reply- (optional) The Transparency Directive has proven to be an important tool to increase the transparency and the objectivity, of Member States pricing and reimbursement systems. However, several Member States have failed to implement the provisions of the Directive in practice. Moreover, the practical application of the principles of transparency and objectivity is unsatisfactory in many Member States. Therefore, additional clarification on the application of the Transparency Directive is needed. Such clarifications can be provided through guidelines, rather than legislative revision. The Transparency Directive requires that national reimbursement measures must be based on both transparent and objective criteria. By requiring objective criteria in addition to verifiable criteria, Directive 89/105/EEC makes clear that it is not limited to formal requirements, but also imposes a minimum substantive standard that Member States must respect. To comply with the objectivity requirement of the Directive, Member States must at least ensure that their pricing and reimbursement control measures are (i) non-discriminatory and (ii) non-arbitrary. It is clear from the case law of the Court of Justice that a discriminatory or arbitrary reimbursement system cannot be objective. Furthermore, it is one of the primary objectives of Directive 89/105/EEC to ensure that national reimbursement measures are based on transparent criteria. In the explanatory memorandum to the Directive, the Commission explained that the Directive s aim was to prevent a situation where the rules of the game are not clearly defined so that it is difficult to foresee how a given product will be treated (see: European Commission proposal for a Council Directive relating to the transparency of measures regulating the pricing of medicinal products COM (86) 765 final, December 23, 1986, pp. 9-10). Innovative companies increasingly terminate research projects in Phase II and III before incurring the high costs of clinical trials when they feel that Member State buyers or social security systems will be unwilling to pay for an incremental innovation or the new chemical/biological entity (NCE/NBE). There is an urgent need that the rules for these decisions by Member States or social security systems are transparent and fair. Otherwise promising research projects might have to be terminated just because of the fact that the value of the innovation cannot be calculated adequately for example because social security systems do not reimburse for the medicinal product. In the light of this fact, further instruments and an effective jurisprudence are necessary on the national level to ensure transparency. In addition, pharmaceutical companies must be able to foresee with a sufficient degree of certainty how their medicines will be treated under a national reimbursement regime and must be able to verify the soundness of national reimbursement measures against a transparent and objective framework. These problems relate to the implementation and enforcement of the Directive. Therefore, a revision of the Directive is unlikely to address these shortcomings and additional resources are required in order to progress EU infringement proceedings. In particular, pharmaceutical companies must have (1) the right to access the file of the administrative proceedings and (2) the right to be informed about the concerns that exist with regard to the pricing and reimbursement decision on their medicines. Other impacts, please specify: -open reply- (optional) Regarding the competitiveness of the European pharmaceutical industry the importance of the German pricing and reimbursement decisions on innovative pharmaceuticals has to be underlined. 15 Member States are

3 referencing to the German price for innovative pharmaceuticals which means that the German price level directly or indirectly will be of crucial importance also for other Member States and thus for the competitiveness of the European Union. The revision of the German SGB V (Social code) from January 1st 2011 onwards (AMNOG) has significantly extended the practice of regulating the doctors prescription behaviour by therapy instructions to all NCEs and NBEs released to the market in Germany after January 1st From this date on all innovative pharmaceuticals are automatically subject to therapy instructions 6 months after market access. The legal right to appeal against the GBA decision is excluded by law, procedural rights are not granted. Instead of increasing transparency, the German government is doing just the opposite by excluding any legal rights and extending the system of therapy instructions to all innovative pharmaceuticals. The Court of Justice of the European Union (CJEU) in ABPI v. MHRA (case C-62/09, para. 37, 38) confirmed that demandside related measures aiming at doctors prescription behaviour are subject to the Transparency Directive and that the Directive requires all national public health authorities to provide pharmaceutical companies with all the information necessary to verify if decisions are made on the basis of objective criteria. Even though these criteria are not met in the new German early benefit assessment required for all NCEs/NBEs released to the market after January 1st 2011 legal remedies and administrative safeguards have proven to be highly ineffective. Given the fact that the pricing decisions in Germany have an impact on prices in 15 other Member States, an effective enforcement also via EU infringement procedures is of highest importance If there was no minimal EU harmonisation of procedural requirements (and providing that the principle of equal treatment is respected), do you consider that the burden and costs of pricing and reimbursement procedures would be: Higher Please explain and estimate additional/lower burden and costs, if appropriate -open reply- (optional) From a historical perspective one can distinguish a pre-directive period and a post-directive period. For instance, after the May 2004 EU enlargement, the implementation of the Directive in new Member States resulted in a clear improvement in the working of pricing and reimbursement procedures in the new Member States. Over the years the Court of Justice of the European Union has clarified the broad scope of the Directive, noting that it includes all measures impacting pharmaceutical pricing and reimbursement, including supply- and demand-side measures (e.g. HTA, prescribing incentive schemes, etc). The level of harmonization introduced via the Transparency Directive and CJEU case law has proven to be helpful for increasing transparency. 2. Time-limits a) Please specify the actual time taken for pricing and reimbursement decisions of originator products for the three fastest Member States: Country 1 (name + reimbursement only. -open reply- comment; no major problems reported for Germany; we see an urgent need to focus on the objectivity and transparency criteria instead of timelines for pricing and reimbursement decisions

4 Country 2 (name + reimbursement only -open reply- Country 3 (name + comment comment reimbursement only -open reply- 2.1.b) Please specify the actual time taken for pricing and reimbursement decisions of originator products for the three slowest Member States: Country 1 (name + reimbursement only. -open reply- Country 2 (name + comments; we see an urgent need to focus on the objectivity and transparency criteria instead of timelines for pricing and reimbursement decisions comment

5 reimbursement only -open reply- Country 3 (name + comment reimbursement only -open reply- 2.2 The Pharmaceutical Sector Inquiry reported a number of reasons for delays in pricing and reimbursement decisions for originator products. In your opinion, what are the main reasons for delays in pricing and reimbursement approval of originator products: Fragmentation of national decisionmaking processes Requests for additional information Health technology assessment or pharmaco-economic evaluation Publication delays Price conversions within the EU, driven by cross-border price referencing Please explain your above replies -open reply- (optional) EUCOPE would like point to the general objective of the Transparency Directive claiming for better access conditions for innovations in the European Union by increasing the attractiveness of the EU for pharmaceutical R&D investments. In case the Commission sees a need for a review of the Directive and / or guidelines we would especially like to call for a set of rules adapted to the specificities of orphan and ultra-orphan medicinal products notably concerning the fragmentation of national (sometimes local) decision making processes and procedures (notably for smaller companies). In this context the difficulties posed by different requirements (also in terms of HTA appraisals) should be addressed. Other reasons for delays, please specify: -open reply- (optional) With respect to originator products, do you consider that the time-limits of 90/180 days provided are appropriate

6 by the Transparency Directive: - single choice reply Are you aware of countries applying mandatory administrative procedures between marketing authorisation and application for pricing and reimbursement? -single choice reply- Yes Please explain what these procedures consist in and specify their minimum duration: -open reply- (optional) In most Member States vaccines undergo an additional assessment before becoming available to patients. In Germany for example the Ständige Impfkommission (STIKO) gives recommendations in this respect directly influencing pricing and reimbursement decisions. In the UK the Joint Committee on Vaccination and Immunization (JCVI) is competent in this regard. The Commission could clarify in an interpretative communication or in guidelines that the recommendation phase prior to vaccines pricing and reimbursement is covered by the scope of the Directive. 2.5 In the event of non-compliance with the time-limits established by the Transparency Directive, do you consider that appropriate sanctions should be: -multiple choices reply- defined by the competent authorities in each Member State Please explain and, if relevant, specify which role the Transparency Directive could play with respect to sanctions: -open reply- (optional) In this regard we would like to point to the example set out under 1.1 where the German authorities are not applying the Transparency Directive in practice. Control mechanisms via Social Courts have proven to be highly ineffecient mainly due to long procedures. The Commission could clarify in an interpretative communication or in guidelines to what extent an administrative control by national competent authorities is necessary to ensure the application of the Directive at national level. In this context effective tools, also in form of sanctions, could be set out which the Commission considers appropriate. Timelines for review by the competent agencies / courts set out under EU law / guidelines could be an effective tool in this regard. If this is imposed also legal remedies on the level of the courts could be improved. 3. SCOPE OF THE DIRECTIVE 3.1. ECJ/CJEU case law In your opinion, are specific amendments to the Transparency Directive required in order to facilitate the implementation of the case-law of the Court of Justice? - single choice reply- However, the Commission could clarify in an interpretative communication or in guidelines the aspects addressed under 1.1, 2.2, 2.4 and

7 Beyond demand-side measures impacting specifically named medicines, do you consider that the Transparency Directive can play a role in ensuring the transparency of general demand-side measures not aimed at specifically identified products (e.g. incentives to increase generic use, incentives to comply with global prescription budgets, etc.) -single choice reply- The Court of Justice of the European Union (CJEU) in ABPI v. MHRA (case C-62/09, para. 37, 38) confirmed that demand-side related measures aiming at doctors prescription behaviour are subject to the Transparency Directive and that the Directive requires all national public health authorities to provide pharmaceutical companies with all the information necessary to verify if decisions are made on the basis of objective criteria. If the Commission considers it useful to give further guidance in this regard an interpretative communication or guidelines should be the right way to address this. However, EUCOPE considers the CFEU case law as clear and does not see any need for clarification. 3.2.Potentially outdated provisions In your opinion, should specific provisions of the Directive be repealed or amended in order to better reflect the current environment for pricing and reimbursement policies? -single choice reply- In case the Commission sees a need for a review of the Directive and / or guidelines we would especially like to call for a set of rules adapted to the specificities of orphan and ultra-orphan medicinal products notably concerning the fragmentation of national (sometimes local) decision making processes and procedures (notably for smaller companies). In this context the difficulties posed by different requirements (also in terms of HTA appraisals) should be addressed Innovative pricing and reimbursement procedures In the framework of tendering procedures, and in light of the objectives of the Transparency Directive, do you consider that EU and national public procurement law provides sufficient guarantees of procedural transparency? -single choice reply- Yes Please explain which aspects are not covered by EU and national tendering law: -open reply- (optional) Transparency and the equal treatment of bidders should be guaranteed through the application of public procurement law in case medicinal products are substitutable/interchangeable (generics). The detailed framework of the public procurement directives provides for transparency under the specific context of bidding procedures. Tendering is suitable where products are genuinely identical and fully/safely interchangeable. Tenders for innovative pharmaceuticals force different products, though neither identical

8 nor interchangeable, into the same class of medications and this could lead to the exclusion of a range of innovative medicines. The use of tenders may be appropriate for off-patent medicines which are identical, bioequivalent and multi-source. Tenders which procure innovative therapies might negatively impact medical innovation and patient access, thus undermining the Directive s objective of encouraging R&D on new medicinal products. The application of the Transparency Directive should also be restricted to collective cost containment measures. Selective / contractual agreements concerning only parts of the payers / social insurances should remain excluded from scope of the Directive Beyond the obligations of public procurement law, do you consider that Directive 89/105/EEC should provide additional safeguards to ensure a higher level of transparency in the framework of tendering procedures used to determine the price and/or reimbursement of medicinal products? -single choice reply-, see above; objectives of the transparency directive and public procurement law are identical in terms of transparency, clear timelines and objectiveness Do managed entry agreements pose any problem in terms of interface with regular pricing and reimbursement procedures? -single choice reply-, by contrast, risk-sharing, price-volume, outcome-based or performance-based agreements are an important tool for patient access and an incentive for innovation In your opinion, could the Transparency Directive play a role in regulating the interface between managed entry agreements and general pricing and reimbursement procedures? -single choice reply- opinion Difficult to answer. Has to be seen in the context of the national P&R system. The Transparency Directive should be restricted to collective cost containment measures. Selective / contractual agreements concerning only parts of the payers / social insurances should remain excluded from scope of the Directive In your view, are there any other innovative procedures that should be taken into account in a revised Directive? -open reply- (optional) 3.4. Innovative/personalised medicines associated with a diagnostic test or medical device In your opinion, could the Yes

9 Transparency Directive play a role in achieving an increased transparency in the pricing and reimbursement of innovative/personalised medicines associated with medical devices such as in-vitro diagnostics : -single choice reply- EUCOPE would welcome any broadening of the scope of the Directive to medical devices. reason can be seen why transparency and objectivity should govern the market for pharmaceuticals but not for medical devices. Especially in the context of personalized medicine - where diagnostics play an increasing role - this concept has to be recognized in order to give incentives for innovation. The CFEU case law has made clear that the Directive s scope is not limited by its wording. However, any extension of the scope of the Transparency Directive via the recast of the medical devices directive would be the right way to address this problem. 4.Other issues 4.1. Please state any other concerns, difficulties or suggestions you might have as regards the Transparency Directive that have not been addressed in this consultation (e.g. legal clarity, effectiveness or functioning of the directive): -open reply- (optional) 4.2. Please state any other specific actions or amendments you would recommend in order to facilitate or improve the implementation of the Directive: -open reply- (optional) Meta Informations Creation date Last update date User name null Case Number Invitation Ref. Status N Language en PRINT EXPORT RECORD