“Annual Conference on EU Law in the Pharmaceutical Sector 2015” (event review)

by María Victoria Rivas Llanos

Last 26-27 February 2015, the Annual Conference on EU Law in the Pharmaceutical Sector took place in the Management Centre Europe, in Brussels. The conference was organised by the Academy of European Law (ERA) and chaired by renowned professionals in the areas of European patent litigation and Competition Law in the pharmaceutical sector; namely Christopher Stothers (Partner, Arnold & Porter LLP, London), Ingrid Vandenborre (Partner, Skadden, Arps, Slate, Meagher & Flom LLP, Brussels), Michael Jürgen Werner (Partner, Norton Rose Fulbright LLP, Brussels) and Alexander Natz (Secretary General, European Confederation of Pharmaceutical Entrepreneurs EUCOPE, Brussels).

Among the speakers were also experts from the European Medicines Agency (EMA), London; the European Commission, Brussels; and Les Laboratories Servier, Suresnes.

The event was held in two days.

Thursday 26 February:

Mr. Christopher Stothers opened the session with an introduction to the evolving practice of the CJEU on Supplementary Protection Certificates (SPCs) for pharmaceutical products and the Court’s interpretation of Art. 3 (a)-(d) of the Regulation 469/2009[1].

It was followed by an overview of the proposed new EU Directive on Trade Secrets[2] by Ms. Gill Grassie (Partner, Brodies LLP, Edinburgh) and its impact on the pharmaceutical sector, namely the promotion of innovation and reliability on the trade secrets regime as opposed to the patent system, as well as encouragement of cross-border sharing of know-how. Subsequently, Ms. Grassie made a brief introduction to EMA’s new policy on commercial confidential information and access to clinical trials[3].

Ms. Penny Gilbert (Partner, Powell Gilbert LLP, London) presented the current status of negotiations on the Unitary Patent Package and the potential options for litigation that will be available both for the patentee and the defendant during the 7-year transitional period after the entry into force of the UPC Agreement[4] (European Patent Court vs. national litigation and forum shopping). The new Unitary Patent Package promises to bring greater certainty through a centralised European patent litigation system, as well as being potentially quicker, simpler and cheaper than the current system of national patents.

Mr. Emmanuel Gougé (Partner, Pinsent Masons, Paris) talked about the licensing agreements in the pharmaceutical sector contemplated by the Technology Transfer Block Exemption Regulation (TTBER)[5] and its Guidelines. The TTBER contemplates only bilateral agreements, thus multi-party agreements (e.g., patent pools) fall outside the TTBER and are covered by the Guidelines. Mr. Gougé explained the main changes introduced by the new TTBER 2014 in respect of the TTBER 2004, as regards termination clauses (only allowed on exclusive agreements under the new Regulation) and settlement agreements. Subsequently, Mr. Gougé clarified the meaning of “technology pools” under the new Guidelines and their advantages over individual licensing, as well as their possible downsides for the pharmaceutical industry.

Ms. Ingrid Vandenborre discussed the enforcement of Arts. 101 and 102 of the Treaty on the Functioning of the European Union (TFEU)[6] and the impact on the pharmaceutical sector. Then, Ms. Vanderborre focused on the most recent decisions adopted by the European Commission on patent settlement agreements for the commercialisation of medicines and the Commission’s merger decisions. Finally, Ms. Vanderborre presented the enforcement of the aforementioned dispositions in several EU Member States.

A round table chaired by Mr. Michael Jürgen Werner (Partner, Norton Rose Fulbright LLP, Brussels) and presided by Professor Ian Forrester (Partner, White & Case, Brussels), Ms. Marleen H.J. van der Horst (Partner, BarentsKrans N.V., The Hague) and Ms. Sylvie Jaguelin (Patent Director, Les Laboratories Servier, Suresnes), discussed the threshold between legitimate and illegitimate patent settlements in pharmaceutical patents disputes, on a comparative perspective between the EU and the US legislations. Further aspects of the debate were the “by object” decisions (e.g., Servier and Lundbeck cases, the so called “pay for delay” agreements) in connexion with public policy issues on healthcare, as a possible justification for the “European Commission’s extravagantly hostile policy against patent settlements” (according to Professor Forrester).

Friday 27 December:

The second day started with an update on the Medical Devices (MDs) and the In-vitro Diagnosis (IVDs) Directives[7] presented by Mr. Grant Castle (Partner, Covington & Burling LLP, London). Mr. Grant explained the regulatory scheme for MDs and IVDs in terms of classification, conformity assessment, CE marking, device vigilance and safeguard measures, and the key changes under the amendments recently adopted by the European Parliament on the proposal for a new regulation for both MDs and IVDs[8].

Mr. Aleksandar Rusanov (Legal Administrator, European Medicines Agency, London) explained EMA’s new policy on transparency and access to clinical data documents, according to Art. 80 of Regulation (EC) No 726/2004[9], which is to be applied within the limits of Art. 4 (2) and (3) of Regulation (EC) No 1049/2001[10] and without prejudice of the new Regulation on clinical trials on medicinal products for human use[11], still to come into force. The publication process for clinical reports under the new system is based on two pillars: Terms of Use (ToU) which govern the access to and use of clinical reports, and a user-friendly technical tool allowing access to such clinical reports with two modalities to see the data (clinical reports available on-screen for any user and downloadable clinical reports for registered identified users).

Professor Alexander Natz (Secretary General, European Confederation of Pharmaceutical Entrepreneurs, Brussels) talked about EU legislation on joint procurement for pharmaceutical products[12] and recent practices in the EU Member States’ tendering markets, with special emphasis on the German market as a reference for International Reference Pricing (IRP). Professor Natz finalised with an outline of the principal European bodies concerned with health technology assessment (namely EMA, EURODIS and EUnetHAT).

Ms. Ivone Kaizeler (Directorate General for Trade, European Commission, Brussels) closed the event with a presentation on the main features of the Transatlantic Trade and Investment Partnership (TTIP) between the EU and the US and its implications for the pharmaceutical sector. The agreement, which covers tariff and non-tariff regulatory aspects, aims to strengthen economic partnership between the EU and the US (reducing non-tariff barriers to trade), as well as bringing together international practices and standards. The priorities of the partnership regarding the pharmaceutical sector are: the recognition of Good Manufacturing Practices’ inspections, collaboration on state of the art and on innovative areas, increased exchange of confidential information and the establishment of common standards for paediatric investigation plans.

On a personal note, it was a very high quality event. The conference was well structured and counted with the presence of senior members of European institutions as well as renowned practitioners. It was a privilege to attend and I strongly recommend it for the forthcoming years to anyone with an interest in the pharmaceutical field.

[1] Regulation (EC) No 469/2009 of the European Parliament and of the Council Of 6 May 2009 Concerning the Supplementary Protection Certificate for Medicinal Products.

[2] European Commission, Brussels, 28 of November 2013, COM (2013) 813 final, Proposal for a Directive of the European Parliament and of the Council on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure.

[3] See Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC.

[4] Agreement on a Unified Patent Court (UPC Agreement, 2013/C 175/01); signed on 19 February 2013. See Art. 83.

[5] Commission Regulation (EU) No 316/2014 of 21 March 2014 on the Application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of technology transfer agreements.

[6] Consolidated version of the Treaty on European Union and the Treaty on the Functioning of the European Union 2012/C 326/01.

[7] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, and Council Directive 90/385/ EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices; and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

[8] See Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 – C7-0318/2012 – 2012/0266(COD)); and Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (COM(2012)0541 – C7-0317/2012 – 2012/0267(COD)).

[9] Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

[10] Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents.

[11] Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

[12] Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC; and Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC.