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    • 25/04/2019
    • Articles

    Spanish Competition Authority Raids Pharmaceutical Firm over Suspicions of Abusive Market Behaviour in Relation to Autoimmune Medicine

    The Comisión Nacional de Los Mercados y La Competencia, the Spanish competition authority (“CNMC”), announced today that, earlier this week, it carried out a dawn raid at the premises of an unidentified pharmaceutical firm (see, attached press release). The targeted firm is thought to have abused its dominant position in one or more markets involving the treatment of various unspecified autoimmune diseases. The CNMC suspects that the firm pursued an exclusionary commercial strategy in its dealings with health services (“Servicios de Salud”) and hospitals. The CNMC points out that the medicine at issue went off-patent and that any attempt to corner a market that is supposed to be free following the expiry of relevant patents amounts to a very serious infringement of the competition rules.

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    • 23/04/2019
    • Articles

    European Parliament Approves Manufacturing Waiver and Reduces Scope of SPC-Based Patent Rights in Medicines

    On 17 April 2019, the European Parliament (“EP”) approved a modification to Regulation No. 469/2009 which governs the supplementary protection certificate (“SPC”) for medicinal products. The modification creates a “manufacturing waiver” that encroaches on the operation of the SPC which, broadly, extends the patent protection afforded to active substances of medicines. The modification will allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, for the double purpose of either exporting to a non-EU market where protection has expired or never existed, or stockpiling the medicine during the final 6 months of SPC protection ahead of entry on the EU market once the SPC has lapsed. The “stockpiling” exception goes beyond the proposal which the European Commission initially tabled in May 2018 (see, Van Bael & Bellis Life Sciences Newsflash of 28 May 2018) and did not form part of the text which the Member States determined as their negotiating position in January 2019 (see, Van Bael & Bellis Life Sciences Newsflash of 21 January 2019). Still, the Council of the European Union is now expected to endorse the text adopted by the EP following a political agreement reached among the EU institutions in February 2019. Once published in the Official Journal of the EU, the modification to Regulation No. 469/2009 will enter into force 20 days later and will become directly applicable in all EU Member States. However, the full effects of the SPC waiver will only kick in 3 years after the date of that entry into force, currently expected to be around 1 July 2022. The creation of a manufacturing waiver is regarded as a major victory for the generic and biosimilar industries. Conversely, EFPIA, the European association of innovative pharmaceutical companies, has labelled the move as a “negative signal to the world that Europe is devaluing its intellectual property framework”. EFPIA therefore hopes that the next European Commission, which will take office following the European elections to be held between 23 and 26 May 2019, will “redress the balance, supporting research, development and innovation more broadly” (EFPIA press release of 17 April 2019).

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    • 23/04/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 03

    The March 2019 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law. Please click below to read the issue.

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    • 12/04/2019
    • Articles

    European Commission Publishes Guidance on Interplay between Clinical Trials Regulation and General Data Protection Regulation

    The European Commission published on 10 April 2019 a Question & Answer document on the interplay between General Data Protection Regulation 2016/679 (the GDPR), which entered into force on 25 May 2018, and Clinical Trials Regulation 536/2014 (the CTR), which is currently expected to enter into force in 2020. The Q&A document provides clarifications in areas where the interplay between both sets of rules, which apply simultaneously, is complicated. It recalls that under the GDPR, it will be for data controllers to demonstrate that personal data are processed in accordance with the GDPR. Satisfying this obligation implies respecting the data protection principles, providing adequate information to clinical trial participants, appointing a Data Protection Officer (if required), maintaining records of processing activities and facilitating the exercise of individual’s rights, along with meeting other requirements. The controller should also determine the legal basis for the various processing activities. In this task lies a common misunderstanding which the Q&A document seeks to rectify: the informed consent required under the CTR serves as an ethical standard and procedural obligation, and this should not be confused with consent as a legal basis for the processing of personal data under the GDPR. As regards the legal basis under the GDPR, the Q&A document explains that various processing operations involving the use of clinical trial data, which include operations related to research as well as operations that are required for the protection of health, may rely on a different legal basis. Requesting consent from the participants (in addition to the consent required under the CTR) may be one option, but the Q&A document also offers alternative options, depending on the situation at hand. It will be for the controller to assess and implement the most adequate legal basis. In that regard, if clinical trial data are used for further research outside the scope of the protocol (secondary use), another legal basis may be required. The Q&A document also assesses the impact of the entry into application of the GDPR on ongoing clinical trials which are governed by Clinical Trials Directive 2001/20/EC. In particular, the European Commission indicates that additional information may have to be provided to the clinical trial participants. In principle, the legal basis that was valid under national data protection rules implementing Directive 2001/20/EC prior to the GDPR remains applicable. However, if the processing of clinical trial participant data relies on the participant’s consent, it must be assessed whether such consent satisfies the stricter requirements of the GDPR. If this is not the case, a renewed consent may prove necessary. The full text of the Q&A document can be found here and is also attached.

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    • 09/04/2019
    • Articles

    Belgium - Consumer Rights Association Files Excessive Pricing Competition Complaint Against Leadiant Over Price for Treatment of Rare Disease

    Consumer rights association “Test Aankoop”/ “Test-Achats” (“TA”) piled further pressure on pharmaceutical firm Leadiant when it announced on 5 April 2019 that it had submitted a complaint to the Belgian Competition Authority challenging Leadiant’s allegedly excessive prices for chenodeoxycholic acid Leadiant (“CDCA”) (see attached press release). CDCA is indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”). CDCA was designated as an orphan medicine in December 2014. Unusually, CDCA is highly similar to a medicine with the same active substance which has been indicated for many years for the treatment of cholesterol gallstones. According to TA, back in 2005 this treatment of an adult patient cost EUR 427 per annum. By contrast, the treatment of CTX in reliance on CDCA carries a cost of EUR 153,300 per patient per year. TA maintains that this difference cannot be explained by Leadiant’s research and development activities, which it dismisses as insignificant, or other justifications. The case is understood to be under review by the Dutch competition authority as well. Additionally, it has prompted Vytenis Andriukaitis, the Commissioner responsible for health and food safety, to promise closer scrutiny of the rules governing orphan medicines in the pending assessment of the regulatory framework (see, Van Bael & Bellis Life Sciences Newsflash of 11 February 2019).

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    • 08/04/2019
    • Articles

    French Competition Authority Publishes Report on Distribution of Medicines and on Laboratory Testing

    On 4 April 2019, the French competition authority published a voluminous sector report on the distribution of medicines and on laboratory testing (the “Report” - see attached). The Report is the result of an inquiry which started in November 2017 (see, Van Bael & Bellis Life Sciences Newsflash of 21 November 2017) and which was also the subject of public consultations in October 2018 (see, Van Bael & Bellis Life Sciences Newsflash of 18 0ctober 2018). The Report contains a series of regulatory recommendations which the competition authority says will help pharmacists to become more competitive while continuing to observe their public service obligations in the interest of public health. The Report thus advocates the following measures: • Loosening the rules governing online sales by (i) allowing pharmacies more leeway in having storage facilities further removed from the pharmacy; (ii) allowing pharmacists to pool their online activities by relying on a common website; and (iii) changing the financial thresholds for recruiting assistant pharmacists by no longer considering for that purpose sales of non-medicine products; • Taking additional measures to stimulate take-off of relatively recent public service tasks such as involvement in vaccination campaigns; fostering patient treatment adherence; and the development of telemedicine services; • Considering new public service tasks such as tracking non-communicable diseases or administering specific medicines under narrow conditions; • Relaxing the advertising rules for cosmetics and other non-medicine products as well for the pharmacy business as such; • Increasing the pharmacy’s access to capital; • Allowing specific non-medicine products (such as in vitro diagnostic medical devices) to be sold outside pharmacies – it is unclear how this proposed measure will help pharmacies. The Report also invites the government to reconsider the income of the wholesalers-distributors which live on small margins (often smaller than those of pharmacies that buy medicines directly from suppliers) while having to cope with public service obligations.

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    • 03/04/2019
    • Articles

    European Union Requests WTO Consultations on Turkish Rules Adversely Targeting Pharmaceuticals Produced Abroad

    European Union Requests WTO Consultations on Turkish Rules Adversely Targeting Pharmaceuticals Produced Abroad

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    • 29/03/2019
    • News

    Fifteen Member States Sign Agreements for Supply of Pandemic Influenza Vaccines under Umbrella of Joint Procurement Agreement

    On 28 March 2019 the European Commission announced that 15 EU Member States and the Commission signed framework contracts with the pharmaceutical firm Seqirus for the supply of pandemic influenza vaccines to 30 contracting authorities in these Member States in the event of an influenza pandemic (https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/ev_20190328_memo_en.pdf). The agreements will run for at least 4 years and are subject to a possible extension of 2 more years. Under the agreements, Seqirus will not only supply vaccines but will also reserve part of its weekly manufacturing capacity and will be paid in return an annual preparedness fee. The agreements were concluded under the Joint Procurement Agreement (“JPA”), a framework established on the basis of Article 5 of Decision 1082/2013/EU tackling serious cross-border threats to health. A similar set of agreements was entered into in 2016 to organise the joint procurement of botulinum anti-toxin. A further series of agreements to expand the vaccine coverage is under preparation. Additional joint procurement procedures for diphtheria anti-toxin, tuberculin and Bacillus Calmette–Guérin (“BCG”) vaccines, and personal protective equipment are under consideration. The JPA was conceived of to improve the state of preparedness of Member States for serious cross-border threats to health, ensure equal treatment of patients affected and increase the buying power of Member States when anticipating emergency situations.

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    • 18/03/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 02

    The February 2019 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law. Please click below to read the issue.

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