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1 Polepharma Meetings Récents développements législatifs en Europe: Exemple de l‘industrie pharmaceutique allemande 19.09.2012, Dreux Dr. Alexander Natz.

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Presentation on theme: "1 Polepharma Meetings Récents développements législatifs en Europe: Exemple de l‘industrie pharmaceutique allemande 19.09.2012, Dreux Dr. Alexander Natz."— Presentation transcript:

1 1 Polepharma Meetings Récents développements législatifs en Europe: Exemple de l‘industrie pharmaceutique allemande , Dreux Dr. Alexander Natz

2 2 Agenda I.Pricing and Reimbursement strategies in different Member States: Germany II.Revision of the Transparency Directive 89/105/EEC

3 3 New legislation / delegated acts: Transparency directive (COM proposal ) Clinical trials (COM proposal ) Patient Information (COM proposal ) Horizon 2020 (COM proposal ) Medical devices / In-vitro-diagnostics (COM proposal likely on ) Delegated acts anti-counterfeit directive (likely in 2014) Delegated / implementing acts pharmacovigilance ( ) Review EU guideline good distribution practice (GDP) Plus: Recast Directive 2001/82/EC, EMA fee regulation, Variations Reg. (EC) 1234/2008 … 3 Outlook: Regulations / Directives / Guidelines in

4 EUCOPE general objectives (see: 4

5 55 Eucope: the mid-sized companies perspective EUCOPE represents 900+ mid-sized companies via the associations EMIG, BPI, BioDeutschland, SwedenBio, IML, PEF Board represents companies from Sweden, UK, Bulgaria, Italy, Greece, Germany, the Netherlands … Companies represented: B. Braun, SigmaTau, Ferring, Grifols, Biogen Idec Celgene, Alexion, … Recognized stakeholder by EMA, European Commission and the European Parliament Innovative often family owned companies EUCOPE Positions EU Relevance in the context of Directive 2011/62/EU In the EU, approx. 30% of manufacturers of prescription medicines fall within the definition of SME (Commission Impact Assessment, SEC(2008)2674,p. 70).

6 6 EUCOPE Activities Monitoring - Networking - Lobbying - Information - Communication: Establish a network of European pharmaceutical entrepreneurs Represent their interests at the EU institutions Promote business opportunities given by the Community market Create visibility by international conferences and press releases Deliver a regular update on relevant dossiers Maintain and extent contacts with key MEPs and key Commission officials Participate in Consultations, Comitology and Expert Groups Co-operate with other Associations and stakeholders 6

7 77 14 new EUCOPE Members in 2011

8 17 New Members in 2012 Sigma Tau Arzneimittel GmbH (http://www.sigma-tau.de/en)http://www.sigma-tau.de/en Otsuka Novel Products GmbH (http://www.otsuka.de/)http://www.otsuka.de/ Ferring Holding SA (http://www.ferring.com/en/home.htm)http://www.ferring.com/en/home.htm IML (Innovativa Mindre Life Science Bolag - Swedish association for small and medium-sized Swedish life science firms active in R&D) Atlantis Healthcare Group (http://www.atlantishealthcare.com/)http://www.atlantishealthcare.com/ SidleyAustin LLP (http://www.sidley.com/)http://www.sidley.com/ Weimer Pharma GmbH (http://www.weimer.de/en/home.html)http://www.weimer.de/en/home.html SwedenBIO (www.swedenbio.se)www.swedenbio.se PEF (Greek Association of mid sized innovative companies) Miltenyi Biotech (http://www.miltenyibiotec.com)http://www.miltenyibiotec.com Grifols (http://www.grifols.de)http://www.grifols.de Ursapharm (http://www.ursapharm.de/de/home/)http://www.ursapharm.de/de/home/ Diapharm (http://www.diapharm.com/deutsch/index.html)http://www.diapharm.com/deutsch/index.html Fasken Martineau (http://www.fasken.com/en/home/)http://www.fasken.com/en/home/ …. 8

9 99 I. Pricing and Reimbursement in Germany

10 Content: Mandatory discounts up to 16 % (from 6 %) for three years Extension of mandatory discounts to private insurers Early benefit assessment / mandatory discount negotiations –extra benefit (+): agreed discount mandatory from 2nd year –extra benefit (-): amount is set acc. to costs of comparative therapy New package sizes / generic substitution Impact / Outlook: intended savings of 2.2 billion € / year, i.e. almost 7% compared to the overall spending of the statutory health insurers (SHI) in 2009 for pharmaceuticals (30 billion €) Germany: Pricing and reimbursement of innovative pharmaceuticals from (AMNOG) 10

11 Overview of the early benefit assessment procedure 11

12 15 countries set by Arbitration Board: Belgium, Denmark, Finland, France, Greece, UK, Ireland, Italy, the Netherlands, Austria, Portugal, Sweden, Slovakia, Spain and the Czech Republic. Possibility for adaption once per year (with effect from for the first time). Principles set by Arbitration Board for further development of the country basket –Not limited to the Euro countries, but to all EEA countries. –The country basket should cover circa 80 percent of the population of all the EEA countries (excluding Germany). –The basket should include such countries with a comparable economic standing as Germany (GDP per capita in purchasing power standards, Eurostat). Pricing: Impact of other EU prices on German prices / Country Basket 12

13 13 First price negotiation, § 130b SGB V: state of play (June 2012) First price negotiation between GKV-Spitzenverband and MAH: Ticagrelor (Brilique) by AstraZeneca Exact price / rebate confidential until contract finalized Agreed price / rebate applies retroactively as of Agreement was to be expected because German price was already low compared to other EU countries Some companies (e.g. Pfizer, GlaxoSmithKline, Boehringer Ingelheim and Lilly) have ceased / postponed negotiations with GBA over diverging views on apropriate comparator

14 § 35a (1) 10 SGB V Authorized therapeutic indications  (+) Patient Benefit (medical benefit)  (-) Additional Benefit in relation to appropriate comparative therapy (additional medical benefits, added value)  (-) Costs of therapy to statutory health insurance  (+) Quantification of the number of patients and/or definition of limits for the treatment of potential patient groups  (+) Description of the requirements for quality-assured application  (+) Nonetheless, § 12 (1) 1 of the GBA rules of procedure “the extent of the additional benefit must be proven for the number of patients and patient groups, for whom there is a therapeutically important additional benefit.”  Prifenidon (Esbriet ®) case Dossier for early benefit assessment 14

15 HTA in Germany: Need for clarification for preparation of dossiers 15

16 HTA in Germany: Different choice of comparators by IQWiG and company 16

17 17 Germany: Disclosure of Discounts ?

18 Orphan drugs: First early benefit assessment by IQWiG (Pirfenidon) 18

19 Germany: AMNOG reform (16 AMG Amendment) 19

20 28 June 2012: German Parliament passed the so-called 16th AMG Amendment “the actual sales prices in other European countries while weighting the respective turnover and purchasing power parities are taken into account.” Justification: “to ensure comparability” of the prices. Prices in larger countries such as France or the UK gain much more impact on the price negotiations and price setting which is generally welcomed. Prices in lager Member States such as France (65 Mio inhabitants) should have five or six times more influence than e.g. in Greece (11 Mio inhabitants) if the turnover of the product equals this ratio. This change entered into force already on 28 June and thus applies to all upcoming price negotiations. Germany: Weighting of country prices for international reference pricing in Germany 20

21 Effect of the GBA decision for the price negotiations The GBA decision is considered as binding for the price negotiation by the GKV- Spitzenverband. There is no possibility for companies to present additional scientific data during the price negotiations. However, this does not apply to data concerning margins and prices in other European countries. It is likely that this view is shared by the courts. Decisive criteria for the price negotiations Relevant criteria the framework agreement states (Art. 6 Rahmenvertrag): the GBA decision on additional benefit the early benefit assessment conducted by IQWiG and the dossier submitted by the company annual therapy costs of comparable medicinal products the 'actual sales price' in certain European countries (country basket) It is not clear yet what is to be considered as 'actual sales price'. Views of the GKV-Spitzenverband 21

22 Pirfenidone: First OMP HTA benefit assessment (§ 35a SGB V) IQWiG (Institute for Quality and Efficiency in Health Care) saw no quantifiable additional benefit for treating midiopathic pulmonary fibrosis (IPF) over comparators – but assessment is (just) a recommendation for the final G-BA decision : GBA (Joint Federal Committee) decision: a non-quantifiable additional benefit exists for Esbriet used in adults to treat mild to moderate idiopathic pulmonary fibrosis (IPF)  deviates significantly from the IQWiG GBA assessment forms the basis for the subsequent price negotiations on the reimbursement amount. In case no consent is reached within 6 months an arbitration committee will set a reimbursement amount, which is applicable from month 13 after entry into market (§130b SGB V). Case of Pirfenidone/Esbriet as precedent for the assessment of other OMPs: OMP with a yearly turnover of less than 50 Mio. Euro in Germany additional medical benefit neither has to be proven by the marketing authorization holder nor to be assessed by IQWiG/GBA. 22

23 IQWiG assessments: state of play ( ) Negative Decisions Microbial Collagenase from Clostridium histolyticum Azilsartan Medoxomil (as potassium replacement) Bromfenac Linagliptin Pitavastatin Regadenoson Aliskiren/Amlodipin Positive Decisions Abirateronacetat Boceprevir Cabazitaxel Eribulin Fingolimod Pirfenidon Retigabin Ticagrelor Telaprevir 23

24 IQWiG assessments: state of play ( ) Pending Cases: In preparation of decisions: Apixaban / Belatacept / Emtricitabin, Rilpivirin, Tenofovirdisoproxil / Tafamidis / Meglumin / Rilpivirin / Extract from Cannabis Sativa Consultation period: Belimumab / Fampridin / Ipilimumab Started: Vandetanib / Vemurafenib Exempted: Dexmedetomidin No status: Olmesartanmedoxomil, Amlodipin, Hydrochlorothiazid 24

25 IQWiG assessments: Recent decisions : Tafamidis & relevant orphan drugs  will be assessed on the basis of the marketing authorization and the studies on which it was based : Cabazitaxel & relevant diagnostic drugs  the GBA favors the inclusion of diagnostic drugs in the process of early benefit assessment : Rilpivrin (Edurant), Belatecept (Nulojix) and Emtricitabin / Rilpivrin / Tenofovirdisoproxil (Eviplera)  It is remarkable that in two cases the IQWiG (partially) followed the company’s deviation from the comparator set by the GBA : Belimumab (Benlysta), Fampridine (Fampyra), Ipilimumab (Yervoy)  The procedures show that even in case the pharmaceutical company follows the comparator therapy set by the GBA the IQWiG can deny any additional benefit by declaring studies relevant or irrelevant regarding the “optimized” comparator therapy 25

26 26 GBA: state of play (June 2012) Most recent decisions: assessments of Retigabin and Alsikiren / Amlodipin GBA follows IQWIQ decision: No additional benefit Result is based on the finding that the MAH deviated from the comparator set by the GBA MAHs are given the option to submit a new dossier within one year –GBA sees HTA still as “learning system” –The new dossier has to include the comparator set by the GBA

27 27 Assessment of “pre-AMNOG products” (I) - Gliptines GBA decided for the first time to request pre-AMNOG products to undergo early benefit procedures Gliptines:  After linagliptin, early benefit assessment for all other DPP-4 inhibitors in German market (sitagliptin, vildagliptin, saxagliptin)  Parallel evaluation, deadline for dossiers submission:  Until delivery of requests (30.9.): consultation with GBA possible What would that mean: More products already marketed before AMNOG could be subjected to early benefit assessment according to indication groups

28 28 Assessment of “pre-AMNOG products” (II) - Outlook GBA announced that there would be only a "limited start" to look at the pre- AMNOG market, referring to two arguments: 1)Avoidance of competition distortions: manufacturer can still submit a dossier with the comparator set by the GBA at a later point in time despite the opt-out of the procedure for linagliptin 2) High prevalence of indication (type 2 diabetes) and sales GBA considers this call as: singular event with no further implication for pre- AMNOG market However: Danger of future repetition when companies decide to opt out of the procedure and take legal action against the setting of the comparator by GBA Decisive for companies: close watch on procedures regarding (potential) competitor products

29 29 Open Questions Opt Out Scenario in AMNOG: What happens if procedure has been initiated? Does that mean that there is automatically a price set at the end of the procedure? Or: does the company have the opportunity to opt out of the procedure and thereby ending the procedure? Our first analysis points towards a situation whereby the company cannot stop the procedure but we will clarify this in due course So what happens to old products already in the market? How likely is it that GBA picks up “old” product?

30 30 Example Netherlands: Price reductions through tenders Price reductions since for the six top-selling products according to European Commission: Source: European Commission, Pharmaceutical Secor Inquiry, Final Report, , para 376.

31 31 II. Revision of Directive 89/105/EEC (Transparency Directive)

32 32 Transparency Directive: A step in the right direction

33 – 1 March 2012: Commission’s Proposal published – 19 April 2012: ENVI: Antonyia Parvanova (ALDE) appointed as Rapporteur (Shadow Rapporteurs: Zofija Mazej (EPP) and Nessa Childers (S&D) – IMCO (Raporteur Cristian Silviu BUŞOI - ALDE) to give opinion, other Committees (EMPL, ITRE, JURI) declined 19 September 2012: Presentation of Draft Report in ENVI 3 October 2012: Deadline for tabling amendments 6 November 2012: Discussion in ENVI 28 November 2012: ENVI to adopt report 15 January 2013: Indicative Plenary sitting date/1st Reading Spring 2013: Earliest Adoption (Member States to amend national laws within 12 months) 33 Commission proposal COM(2012)84 – Timeline for Adoption

34  Confidentiality of Managed Entry Agreements (MEA)  Scope of the directive (voluntary contractual agreements)  Non-reassessment clause and orphan medicinal products  Enforcement procedures 34 Key Topics

35 Possible changes:  Transfer of ECJ case law (demand-side-related measures) - positive  No mandatory EU list of national prices - positive  HTA-procedures in scope of Directive - positive  Results of MA (Q/S/E) shall not be put in question in P&R decision - positive  Time limits for P&R decisions (15/30 generics - 60/120 innovative medicine)  Managed entry agreements remain confidential - positive  Public procurement law (not Transparency Directive) governs tenders  No inclusion of medical devices - negative  No specific provision on personalized / stratified medicine - negative 35 EUCOPE Positions - Commission proposal COM (2012) 84

36 36 Commission proposal COM(2012)84 includes the following aspects: Proposal does not foresee a mandatory EU price list aiming to compare listed/ rebated prices among Member States which is a positive result. However, Member States remain free to compare prices / introduce external reference pricing. Contractual agreements and managed entry agreements remain excluded from the directive, if on a voluntary basis. EU law will not require to publish the content of price negotiations with payers which is correct and most important from our perspective. However, Member States - again - remain free to require disclosure and bypass confidentiality. Cost containment measures under public procurement law (tenders in generic markets/ some medical devices) remain outside the scope of the directive (Art. 1). This is consistent since public procurement law guarantees detailed procedural rights for bidders and protects the same objectives (objectivity and equal treatment). No mandatory EU price list / Confidentiality of MEA

37 37 The directive defines for the first time the term health technology assessment as “an assessment of the relative efficacy or of the short- and long-term effectiveness of the medicinal product compared to other health technologies in use for treating the associated condition” (Art. 2). HTA agreements (such as the early benefit assessment in Germany by the GBA) therefore fall in the scope of the directive Demand-side-related measures (incentives to physicians such as me-too lists) are in the scope of the directive (see ECJ, ABPI case C-62/09) which we see favorably. It is positive that the time limits for pricing and reimbursement are reduced for both generic (15/30 days) and innovative medicinal products (60/120 days). In cases where national authorities subject medicinal products to HTA procedures the time-limits are longer (90/180 days). HTA definition / demand-side-related measures / time limits

38 38 Art. 15 foresees mandatory consultations of interested parties at national level and the publication of the results. Furthermore a notification procedure for draft national measures is foreseen which would oblige the MS (and national HTA bodies such NICE or GBA) to inform the Commission of any changes of their rules of procedure before implementation (“immediately”) (Art. 16). While we consider it as an important aspect that a preliminary check of the compliance with the provisions of the ‘Transparency Directive’ is introduced, we think that the notified measures should remain confidential. The Commission also has no right of veto (“The observations of the Commission shall be taken into account as far as possible …”). Results of the marketing authorization (quality, safety, efficacy, bioequivalence) shall not be reassessed in HTA decisions which is a positive outcome. Notification of national measures / No reassessment of Q/S/E/B

39  Possible changes:  On HTA: “Member States shall refrain from requesting data and proof of quality, safety and efficacy or bioequivalence of the medicinal product concerned beyond the elements already assessed in the marketing authorization.”  On IPR: ”The protection of industrial and intellectual property rights cannot be a valid ground to refuse, suspend or revoke decisions relating to the price of a medicinal product or its inclusion within the public health insurance system.” 39 HTA / IPR

40 Scope (I) The directive applies to “any national, regional or local measure, whether laid down by law, regulation or administrative action, to control the prices of medicinal products for human use or to determine the range of medicinal products covered by public health insurance systems, including the extent and conditions of their coverage” (Art. 1 (1)) The Directive shall not apply to voluntary contractual agreements between public authorities and the MAH that have as their object to enable the effective provision of this medicine to patients under specific conditions (Art. 1 (2) (a)) national measures intended to determine the prices or the coverage of medicinal products by public health insurance systems which are subject to national or Union legislation on public procurement (Art. 1 (2) (b)) 40

41 Scope (II) The Commission proposal covers the following P&R measures explicitly: Price approval (Art. 3) Price increase (Art. 4) Price freeze and price reduction (Art. 5) Controls on profits (Art. 6) Inclusion of medicinal products in health insurance systems (Art. 7) Exclusion of medicinal products from health insurance systems (Art. 9) Classification of medicinal products in view of their inclusion in health insurance systems (Art. 10) Measures to control or promote the prescription of specific medicinal products (Art. 11) 41

42 Scope (III) Open questions: It remains unclear whether the procedural requirements of the Transparency Directive apply to a HTA-decision itself. Which agreements will be considered as voluntary contractual agreements? To which (non-voluntary) agreements apply mirror-wise the requirements of the Transparency Directive)? Does the proposal require to publish the content of price negotiations with payers? 42

43 (New) Provisions to improve transparency MS shall publish and communicate to the Commission criteria for decision- making process ( Art. 3 (8), 7 (8), 10 (2), 10 (3)) MS shall establish in detail the particulars and documents to be submitted by applicant (Art. 3 (4), 4 (4), 7 (3)) Ms shall not request any additional information which is not explicitly required under national legislation or administrative guidelines in the framework of P&R ( Art. 3 (5), 4 (4), 7 (5)) The requirement of legal remedies has to include effective judicial remedies (e. g. recital 13) MS shall not re-assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy or bioequivalence of the medicinal product (Art. 13) 43

44 Dialogue and enforcement Mandatory consultations of interested parties at national level and the publication of the results (Art. 15) MS shall immediately communicate to the Commission the draft measure envisaged, together with the reasoning on which the measure is based. MS shall take the observations of the Commission into account as far as possible. (Art. 16) No right to veto for the Commission A preliminary check by the Commission seems still helpful. However, the notified measures should remain confidential. Art. 8 introduces a remedies procedure in case of non-compliance with the time limits related to the inclusion of medicinal products in health insurance systems. Therefore MS shall designate an independent body that has the power to adopt interim measures, award damages and impose a penalty payment 44

45 45 ECJ (C-62/09 – ABPI/MHRA – ) on Transparency 38“Consequently, even though Directive 89/105 has as an underlying principle the idea of minimum interference in the organisation by Member States of their domestic social security policies (Case C ‑ 245/03 Merck, Sharp & Dohme [2005] ECR I ‑ 637, paragraph 27), national public health authorities which adopt a financial incentive scheme for the prescription of specific named medicinal products are required in particular to make such a scheme public and to make available … professionals in the pharmaceutical industry the evaluations establishing the therapeutic equivalence of the active substances available belonging to the therapeutic class covered by that scheme.“  demand side related measures fall under the Transparency Directive  in case of comparisons: therapeutic equivalence has to be established + has to be made transparent

46 46 Commission proposal is a mostly positive result However, medical devices should have been included in the scope of the directive and specific provisions should have been laid down for personalized/stratified medicines. EUCOPE welcomes most: No mandatory EU price list Contractual agreements and managed entry agreements remain excluded from the directive, if on a voluntary basis Results of the marketing authorization shall not be reassessed by HTA bodies Next steps –Debate in European Parliament / Council is foreseen in 2012 –EUCOPE Debate in the EP on –Implementation by Member States likely in 2013/2014 EUCOPE position

47 47 Thank you for your attention! Dr. Alexander Natz, LL.M. Director General European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) Rue d`Arlon Brussels / Belgium Tel.:


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