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    • 12/04/2021
    • Articles

    European Union and South Korea Conclude Adequacy Talks

    On 30 March 2021, the European Commission and the Republic of Korea successfully concluded their negotiations on adequacy. An “adequacy finding” will enable free and safe data flows from the European Union to South Korea. The conclusion of the negotiations allows the European Commission to adopt an “adequacy finding” under Article 45.3 of the GDPR, confirming that South Korea’s Personal Information Act (PIPA) provides a comparable level of protection of personal data to European data protection laws. Such an “adequacy finding” will cover both private and public sector data controllers established in South Korea. The negotiations on adequacy were initiated in the context of the Free Trade Agreement that was concluded between the European Union and Korea. Within the framework of these negotiations, South Korea has enacted a series of reforms to its data protection laws. For instance, South Korea committed to implementing additional safeguards to protect European citizens’ personal data (e.g., introducing the concept of “pseudonymised information”, as well as the “purpose limitation” principle) and streamlined South Korea’s data protection regulatory authorities to one authority, while previously data protection breaches and issues were handled by multiple agencies. These new rules will be binding on companies importing data from the European Union and enforceable by South Korea’s Personal Information Protection Commission (PIPC). The European Commission will now launch the procedure for the adoption of a formal adequacy decision. This involves obtaining an opinion from the European Data Protection Board and approval by a committee composed of representatives of the EU Member States. Once the formal decision has been adopted, personal data can flow freely from the EU Member States to South Korea without any further safeguards or authorisations such as binding corporate rules and contractual clauses.

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    • 09/04/2021
    • Articles

    Conclusion of Pharmaceutical Pricing Investigation in Austria

    On 2 April 2021, the Austrian competition authority accepted commitments and closed its case concerning pricing strategies alleged to unlawfully hinder entry by generic competitors. More specifically, the pricing strategies in question involved special offers to hospitals of below-cost prices or free products, with higher prices charged for supply to community pharmacies. The attached note provides a summary of the case.

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    • 02/04/2021
    • Articles

    European Commission Starts Revising Pharmaceutical Legislation and Publishes Evaluation Roadmap and Inception Impact Assessment

    Earlier this week, the European Commission (the Commission) started the process of revising the general pharmaceutical legislation – Directive 2001/83/EC and Regulation (EC) 726/2004 - which it labels as one of the flagships of the Pharmaceutical Strategy for Europe (PSE) (see, Van Bael Bellis Life Sciences News Alert of 26 November 2020). Both the general public and the stakeholders are invited to submit their views on the “Combined Evaluation Roadmap/Inception Impact Assessment” (see, attachment). The Commission is seeking contributions on the broad range of issues covered by the PSE such as (i) unmet medical needs in areas outside the scope of the rules governing rare diseases and paediatric medicines; (ii) unequal access to affordable medicines; (iii) new technologies, including genomic sequencing, genome editing, artificial intelligence and medication based on genetically modified organisms; (iv) simplification of applicable rules and procedures; (v) vulnerable supply chains, security of supply and shortages; (vi) competition issues, including the role played by generics and biosimilar products; (vii) incentives designed to stimulate innovation; and (viii) antimicrobials. This initial public assessment started on 30 March 2021 and will end on 27 April 2021. A more thorough public consultation featuring targeted questions will be held in the fourth quarter of 2021. The Commission plans to propose draft legislation one year later in the fourth quarter of 2022.

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    • 02/04/2021
    • Articles

    USTR - 2021 National Trade Estimate Report on Foreign Trade Barriers - Assessment of European Pharmaceutical Markets

    The United States Trade Representative published on Wednesday 31 March 2021 her National Trade Estimate Report for 2021 on Foreign Trade Barriers (the Report; see, attachment). The Report defines trade barriers as “government laws, regulations, policies, or practices that protect domestic goods and services from foreign competition, artificially stimulate exports of particular domestic goods and services, or fail to provide adequate and effective protection of intellectual property rights” (Report p. 1). The Report says to cover significant barriers, regardless of whether they are consistent or inconsistent with international trading rules. As in previous years, the Report focuses extensively on foreign trade and investment barriers for the pharmaceutical industry in Europe (Report, pages 178 and following; pages 185 and following of PDF file). In a familiar lament, the Report decries “several Member State policies affecting market access for pharmaceutical products, including non-transparent procedures and a lack of meaningful stakeholder input into policies related to pricing and reimbursement, such as therapeutic reference pricing and price controls” (Report, p. 178). According to the Report, the lack of transparency and of “due process” gives rise to uncertainty and unpredictability for investment in these markets and is liable to undermine innovation (Id.). The Report cites the “clawback system” as a particularly pernicious system from an investment perspective. It requires pharmaceutical firms to return to the government a specific percentage of the amount spent by Member States over budgetary limits. The report identifies and targets various clawback systems in Member States such as Belgium, Greece, Hungary, Italy, and Romania. The Report also takes issue with inconsistent and lengthy time limits for pricing and reimbursement decisions, even though these procedures are supposed to be limited as a result of the application of the long- standing “pricing and reimbursement transparency” Directive 89/105/EEC. Furthermore, the Report keeps a watchful eye on the patent systems of overseas countries, both in general terms and in their application to the pharmaceutical system. This is why the Report expresses concern over the apparent disregard for patent protection in certain pricing and reimbursement decisions in Italy (Report, p. 179) and maintains earlier criticism of the EU manufacturing and stockpiling waivers, in effect since 1 July 2019, which introduced exceptions to the Supplementary Protection Certificate, the extended patent protection for active substances of medicines (Report, p. 206; see, Van Bael & Bellis Life Sciences News Alert of 13 June 2019).

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    • 01/04/2021
    • Articles

    Court of Justice of European Union Dismisses Appeals By Lundbeck and Others Against Citalopram Pay-for-Delay Patent Settlement Agreements

    The Litigation Chamber of the Belgian Data Protection Authority prohibited a controller from passing on personal data obtained in breach of data protection rules to its legal counsel. The Litigation Chamber did not issue a fine, but the decision serves as a clear message that further processing of such unlawfully obtained personal data, even in the context of legal proceedings, is prohibited. Please click below for a Client Alert on this decision.

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    • 31/03/2021
    • Articles

    Italian Highest Administrative Court Refers Avastin/Lucentis Case for Second Time to Court of Justice of European Union

    We are pleased to present a note on the questions which the Consiglio di Stato, Italy’s highest administrative court, presented earlier this month to the Court of Justice of the European Union (CJEU) in the Avastin – Lucentis case which Hoffmann-La Roche and Novartis have now been litigating in various courts and before several competition authorities around Europe for a considerable period of time. This newest procedural development marks the second time that the Italian court asks the CJEU for help. While the questions lie at the intersection of Italian procedural law and European law, the parties hope to revive what seems to be a losing battle over the off-label use of Avastin® and its interchangeability with Lucentis®, another, more expensive medicine that was specifically authorised for that use.

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    • 30/03/2021
    • Articles

    European Commission Issues Second Competition Comfort Letter in Support of Pharmaceutical Cooperation to Combat Covid-19

    On Monday 29 March 2021, the European Commission’s Directorate General for Competition (the Commission) published its second “new style” comfort letter (see, attachment). It was addressed to the organisers of an online “matchmaking event” that runs on 29 and 31 March 2021 and brings together more than 300 parties involved in the production and supply of Covid-19 vaccines (the event is described in the Commission press release in the second attached PDF document). The event seeks to accelerate connections between vaccine producers and service companies such as contract development and manufacturing organisations, fill and finish service providers, equipment producers and others, to improve planning for current and future vaccine production in Europe. The ultimate goal is to address shortages and increase production capacity along the entire value chain for Covid-19 vaccines. The comfort letter offers both event organisers and participants the assurance that they can proceed without fear that their conduct may fall foul of the competition rules. The concern common to both event organisers and the Commission is the exchange of confidential business information, regardless of whether the parties involved are direct competitors. This is why, in issuing the comfort letter, the Commission imposed several conditions which the parties will have to observe. Accordingly, all event participants will have to limit the exchange of confidential business information to what is indispensable for resolving the supply challenges linked to Covid-19 pandemic. Additionally, if matchmaking meetings involve direct competitors, participants will be precluded from sharing confidential business information regarding their competing products, including information relating to prices, discounts, costs, sales, commercial strategies, expansion plans and investments, and customer lists. These direct competitors will also have to maintain a record of the topics discussed. The new comfort letter follows an earlier such letter which the Commission addressed in April 2020 to “Medicines for Europe” (MfE), a trade association of suppliers of generic and biosimilar medicines. The Commission thus offered support to the MfE’s collective response to the risk of medicine shortages caused by a surging demand for specific COVID-19 hospital medicines (see, Van Bael & Bellis Life Sciences News Alert of 29 April 2020). Both comfort letters apply the principles contained in the Commission’s Temporary Framework to assess under the competition rules possible forms of business cooperation in response to the emergency situation created by the COVID-19 outbreak (see, Van Bael & Bellis Life Sciences News Alert of 9 April 2020). The forms of cooperation which the Commission aims to facilitate mainly concern the life sciences sector.

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    • 30/03/2021
    • Articles

    European Union's Seven-Year EU4HealthProgramme Enters Into Force

    Regulation (EU) 2021/522, which establishes the EU’s action plan in the field of health for the period 2021-2027, entered into force on 26 March 2021 and has applied retroactively since 1 January 2021 (see, text of Regulation (EU) 2021/522 attached). The plan, known as the EU4HealthProgramme (EU4Health) and endowed with a budget of EUR 5.1 billion, is the EU’s response to the Covid-19 pandemic and tackles short-term needs such as the creation of reserves of health crisis relevant products, including essential medicines, vaccines, medical devices and personal protective equipment; disease prevention; and protection against serious cross-border health threats. At the same time, EU4Health is also designed to have a lasting impact by funding the European Health Data Space and increasing intra-EU and international cooperation in health matters. Significantly, EU4Health will address long-term public health challenges, including cancer treatment; mental health; and the reduction of health inequalities. While the European Commission (the Commission) had initially sought a budget of EUR 9.4 billion (see, Van Bael & Bellis Life Sciences News Alert of 29 May 2020), the funding that results from a political compromise between the European Parliament and the Council of Ministers (see, Van Bael & Bellis Life Sciences News Alert of 17 December 2020) will still allow for meaningful health action at the EU level, given its tenfold increase over similar previous EU health programmes. EU4Health will rely on a complex institutional architecture involving the Commission, a dedicated agency called the Health and Digital Executive Agency, eligible legal entities from Member States and third countries, the European Medicines Agency and the European Centre for Disease Prevention and Control. Additionally, the consultative EU4Health Steering Group, which brings together the European Commission and the Member States, will prepare annual work programmes and monitor results.

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    • 25/03/2021
    • Articles

    Belgian DPA Prohibits Use of Unlawfully Obtained Personal Data in Arbitration Proceedings

    The Litigation Chamber of the Belgian Data Protection Authority prohibited a controller from passing on personal data obtained in breach of data protection rules to its legal counsel. The Litigation Chamber did not issue a fine, but the decision serves as a clear message that further processing of such unlawfully obtained personal data, even in the context of legal proceedings, is prohibited. Please click below for a Client Alert on this decision.

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