EUCOPE http://www.eucope.org/en European Confederation of Pharmaceutical Entrepreneurs AISBL Mon, 30 Aug 2010 10:44:17 +0000 http://wordpress.org/?v=2.8.4 en hourly 1 EU Patent: ECJ advocates general doubt compatibility with EU law http://www.eucope.org/en/2010/08/eu-patent-ecj-advocates-general-doubt-compatibility-with-eu-law/ http://www.eucope.org/en/2010/08/eu-patent-ecj-advocates-general-doubt-compatibility-with-eu-law/#comments Mon, 30 Aug 2010 10:44:17 +0000 Matthias Heck http://www.eucope.org/en/?p=855 The advocates general of the European Court of Justice (ECJ) Juliane Kokott takes the view that creating an EU patent litigation system in the planned form would be incompatible with EU law. Several Member States – including Spain, Luxembourg and Portugal – had voiced concerns in this respect, so that in June 2009 the governments requested an opinion by the ECJ. This opinion, which also raises doubts about an insufficient language regime, is not binding for the European Court of Justice.

]]> http://www.eucope.org/en/2010/08/eu-patent-ecj-advocates-general-doubt-compatibility-with-eu-law/feed/ 0 Commission: Public consultation on the future of e-commerce http://www.eucope.org/en/2010/08/ec-public-consultation-on-the-future-of-e-commerce/ http://www.eucope.org/en/2010/08/ec-public-consultation-on-the-future-of-e-commerce/#comments Fri, 20 Aug 2010 12:32:37 +0000 Matthias Heck http://www.eucope.org/en/?p=851 On 10.08.10 the European Commission launched a public consultation on the future of electronic commerce in the internal market and the implementation of the Directive on electronic commerce (2000/31/EC). This consultation includes issues of business development, the legal framework for online pharmacies in the Member States and the safety of purchasing medicines via the internet.

More information can be found here:
http://ec.europa.eu/internal_market/consultations/2010/e-commerce_en.htm

]]> http://www.eucope.org/en/2010/08/ec-public-consultation-on-the-future-of-e-commerce/feed/ 0 Rebate contracts: New DAK tender http://www.eucope.org/en/2010/08/rebate-contracts-new-dak-tender/ http://www.eucope.org/en/2010/08/rebate-contracts-new-dak-tender/#comments Fri, 06 Aug 2010 13:53:02 +0000 Matthias Heck http://www.eucope.org/en/?p=841 The health fund Deutsche Angestellten Krankenkasse (DAK) announced a Europe-wide tender for discount contracts covering 57 active substances (OJ/S S146 of 30.07.10). One active substance constitutes one lot. Drug discount contracts are to be concluded with three bidders for each lot. For 17 lots, the DAK is carrying out this tender also on behalf of HEK – Hanseatische Krankenkasse. Contracts will run from 1st January 2011 to 31st December 2012, with the one-sided option for the DAK of two contract extensions by one year each. Deadline for the submission of offers is 13th September 2010 (12.00 noon), with binding effect to 1st November 2010. The tender can be found here:
http://ted.europa.eu/udl?uri=TED:NOTICE:225806-2010:TEXT:EN:HTML&tabId=0

]]> http://www.eucope.org/en/2010/08/rebate-contracts-new-dak-tender/feed/ 0 Health Claims: Decision on first group of Health Claims list postponed http://www.eucope.org/en/2010/08/health-claims-decision-on-first-group-of-health-claims-list-postponed/ http://www.eucope.org/en/2010/08/health-claims-decision-on-first-group-of-health-claims-list-postponed/#comments Mon, 02 Aug 2010 07:54:03 +0000 Matthias Heck http://www.eucope.org/en/?p=839 On 12.07.10 the Standing Committee on the Food Chain and Animal Health of the European Commission looked into positive evaluations by the European Food Safety Authority (EFSA), according to Article 13 of the Health Claims Regulation. The decision on the first group of positively evaluated claims was postponed, but the majority of Member States basically took a favourable stance on the regulation as proposed by the Commission. Two Member States voiced reservations about market impacts and the implementation practice for evaluated claims. Moreover, some Member States demanded further legal explanations regarding those claims which were not submitted for evaluation by EFSA but are being used on the market.

]]> http://www.eucope.org/en/2010/08/health-claims-decision-on-first-group-of-health-claims-list-postponed/feed/ 0 Rebate contracts: New TK tender http://www.eucope.org/en/2010/07/rebate-contracts-new-tk-tender/ http://www.eucope.org/en/2010/07/rebate-contracts-new-tk-tender/#comments Fri, 09 Jul 2010 13:14:33 +0000 Matthias Heck http://www.eucope.org/en/?p=832 The health insurance Techniker Krankenkasse (TK) has announced a Europe-wide tender for rebate contracts, covering 79 active substances (OJ/p. 127 of 03.07.10). Contracts will be awarded to up to three manufacturers per active substance. The contract term starts on 01.02.11 and lasts at least 24 months, with one lot-related option for extension by a further 12 month period. There is no limitation to lots. Deadline for the submission of tender offers is 26.08.10, 12.00 noon, with validity of tenders to 06.12.10. Tender documents can be requested under
www.tk-online.de/vergabe.

]]> http://www.eucope.org/en/2010/07/rebate-contracts-new-tk-tender/feed/ 0 Patents: Commission proposes translation arrangements for future EU Patent http://www.eucope.org/en/2010/07/patents-commission-proposes-translation-arrangements-for-future-eu-patent/ http://www.eucope.org/en/2010/07/patents-commission-proposes-translation-arrangements-for-future-eu-patent/#comments Fri, 02 Jul 2010 15:08:05 +0000 Matthias Heck http://www.eucope.org/en/?p=829 On 01.07.10 the Commission has issued a proposal on translation arrangements for a future EU Patent. The Commission proposes that EU Patents will be examined and granted in one of the official languages of the European Patent Office (EPO) – English, French or German. The granted patent will be published in this language which will be the authentic (i.e. legally binding) text. The publication will include translations of the claims into the other two EPO official languages. The claims are the section of the patent defining the scope of protection of the invention. No further translations into other languages will be required from the patent proprietor except in the case of a legal dispute concerning the EU patent. In this case, the patent proprietor may be required to provide further translations at his or her own expense. For example, the proprietor may have to supply a copy of the patent into the language of an alleged infringer, or into the language of the court proceedings when this is different from the language of the patent. The Commission expects that the processing costs for an EU Patent covering 27 Member States would be less than € 6200, of which only 10% would be due to translations.

]]> http://www.eucope.org/en/2010/07/patents-commission-proposes-translation-arrangements-for-future-eu-patent/feed/ 0 Competition: Judgement on abuse of dominant position in AstraZeneca case http://www.eucope.org/en/2010/07/competition-judgement-on-misuse-of-dominant-position-in-astrazeneca-case/ http://www.eucope.org/en/2010/07/competition-judgement-on-misuse-of-dominant-position-in-astrazeneca-case/#comments Fri, 02 Jul 2010 15:02:23 +0000 Matthias Heck http://www.eucope.org/en/?p=827 In case T-321/05 the General Court of the European Union confirmed on 01.07.10 the decision of the Commission which found that AstraZeneca abused its dominant market position by preventing the marketing of generic products replicating their medicinal product Losec. The Court considers that AstraZeneca made misleading representations to the national patent offices. Furthermore, the Court states that the fact that pharmaceutical companies can deregistrate their marketing authorisation does not cause such conduct to escape the prohibition laid down in Article 82 EC (Art. 102 TFEU). However, the Commission failed to prove that the deregistration of the marketing authorisation was capable of having an impact on parallel imports. Because of that, the Court reduced the fine from € 60 Mio. to € 52.5 Mio.

]]> http://www.eucope.org/en/2010/07/competition-judgement-on-misuse-of-dominant-position-in-astrazeneca-case/feed/ 0 EFPIA: Review of internal conduct rules http://www.eucope.org/en/2010/07/efpia-review-of-internal-conduct-rules/ http://www.eucope.org/en/2010/07/efpia-review-of-internal-conduct-rules/#comments Fri, 02 Jul 2010 12:34:45 +0000 Matthias Heck http://www.eucope.org/en/?p=825 The European Federation of Pharmaceutical Industries and Associations (EFPIA) has announced a review of internal conduct rules and brought out a first paper for this purpose. New rules are planned to be presented in the 2nd half 2010 and to become binding for all EFPIA member companies and associations within one year after publication. Furthermore, bodies are to be set up at national member associations, in order to monitor the implementation of and compliance with relevant rules.

]]> http://www.eucope.org/en/2010/07/efpia-review-of-internal-conduct-rules/feed/ 0 Commission: Review of the Transparency Directive http://www.eucope.org/en/2010/06/commission-review-of-the-transparency-directive/ http://www.eucope.org/en/2010/06/commission-review-of-the-transparency-directive/#comments Fri, 25 Jun 2010 13:48:40 +0000 Matthias Heck http://www.eucope.org/en/?p=822 The European Commission is planning a review of the Transparency Directive 89/105/EEC and has published a first document with an overview. Results from the Pharmaceutical Forum and from the sector enquiry are to be considered. The Commission repeatedly emphasized a strict application of the Transparency Directive. Forthcoming activities are to take into account the diversity and complexity of national pricing and reimbursement measures. In its decisions the European Court of Justice (ECJ) repeatedly highlighted the need for a wider interpretation of relevant provisions, most recently in case C-352/07 (Menarini).

]]> http://www.eucope.org/en/2010/06/commission-review-of-the-transparency-directive/feed/ 0 EP: Discussion on Information to patients http://www.eucope.org/en/2010/06/ep-discussion-on-information-to-patients/ http://www.eucope.org/en/2010/06/ep-discussion-on-information-to-patients/#comments Fri, 11 Jun 2010 08:53:34 +0000 Matthias Heck http://www.eucope.org/en/?p=809 On 03.06.10 the Health Committee (ENVI) of the European Parliament (EP) discussed amendments to the Commission proposals as regards information to patients (COM 2008 662 and 663). Amendments focused on information in health-related publications (amendments 166-178) and the definition of the term “advertising” (amendments 83-85). The latter impacts not exclusively prescription-only medicines: amendments were also submitted concerning OTC products, even though the Commission proposals are expressly about “medicinal products subject to medical prescription”. For example, amendment 102 demands a ban of TV advertising for OTCs. Moreover, vaccination campaigns are put into question in amendment 103.

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