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European Union

18 February 2021

European Medicines Agency Issues Updated Good Clinical Practice Q&A

On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A).  The updated section relates to access to patient medical records by GCP inspectors from European Economic Area (EEA) Member States.  It stresses the importance of sponsors conducting studies in countries outside the EEA obtaining the prior explicit consent of a clinical trial participant for the review of their medical records by EEA GCP inspectors.

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21 January 2021

A Digital Europe – Digital Health and other Recent EU Data Initiatives

Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade.  The EU’s digitalization, including in the area of health, is one of the Commission’s key priorities and covers a wide range of actions and related initiatives.

Building on prior initiatives, in 2019 the Commission announced six key priorities (since supplemented by the COVID-19 recovery plan) that would shape the coming five years of policy making.  One of these six key priorities is to create a Europe fit for the digital age and work on a digital strategy that will empower people with a new generation of technologies.

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21 December 2020

European Union Implements Changes to Export Control Rules

The EU Dual-Use Regulation regulates exports outside the EU, transfers inside the EU, transit through the EU and the brokering of certain sensitive goods, services, software and technology (referred to as “items”) that are considered “dual-use.” Dual-use items have both military and civil applications. The EU has updated its export control rules for dual-use items to (1) take account of Brexit, (2) ensure consistency with recent developments in international non-proliferation regimes and export control arrangements, and (3) address cyber-surveillance and other security threats stemming from new technologies, reinforce cooperation among competent EU authorities, and impose enhanced compliance obligations (including a requirement to adopt internal compliance programs) on businesses. These updates, which are addressed in turn, will have significant implications for businesses dealing in dual-use items.

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18 December 2020

Schrems II Concerns Regarding U.S. National Security Surveillance Do Not Apply to Most Companies Transferring Personal Data to the U.S. Under Standard Contractual Clauses

The thesis articulated in the article linked here is that (1) nearly all companies relying on standard contractual clauses for data transfers to the US under the EU General Data Protection Regulation are not electronic communications service providers for purposes of FISA 702 (i.e., only companies in the business of providing communications services would be covered) and (2) data transfers from Europe to the US under SCCs may not be targeted under FISA 702 and EO 12333 because they are (i) quintessential “US person communications” because either the data exporter is a U.S. person or the data importer is a U.S. person, or more likely, both are US persons and (ii) received by a person located in the U.S. Accordingly, the concerns expressed by the EU Court of Justice in Schrems II should not be problematic for nearly all U.S. companies relying on SCCs.

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13 November 2020

European Commission Proposes Revised Standard Contractual Clauses

The European Commission (EC), on 12 November 2020, published a draft decision implementing revised Standard Contractual Clauses (draft SCCs) – (the EC’s Draft). The EC’s Draft was published following the Court of Justice of the European Union’s (CJEU) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems on 16 July 2020 (Schrems II), which found (amongst other things) that supplementary protections may need to be implemented when SCCs are used to ensure an ‘essentially equivalent’ level of data protection. The publication of the EC’s Draft comes just one day after the European Data Protection Board (EDPB) published its draft recommendations describing how controllers and processors transferring personal data outside the European Economic Area (EEA) may comply with the Schrems II ruling. The EC’s Draft is open for public consultation until 10 December 2020, after which it will undergo a process of review by representatives of every EU Member State (the Committee) who will each need to provide a positive opinion in relation to the EC’s Draft as part of the EU examination procedure. The European Data Protection Supervisor must also be consulted and it is recommended that the EDPB is consulted. The EC’s College of Commissioners may then adopt the EC’s final decision

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11 November 2020

European Data Protection Board Issues Schrems II Recommendations

Following the Court of Justice of the European Union’s (“CJEU”) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems on 16 July 2020 (“Schrems II”), the European Data Protection Board, tasked with overseeing compliance with the GDPR (“EDPB”), on 11 November 2020 issued its anticipated recommendations describing how controllers and processors transferring personal data outside the European Economic Area (“EEA”) may comply with the Schrems II ruling. These recommendations are applicable immediately but are open for public consultation until November 30. Information on submitting public comments is accessible here.

In Schrems II, the CJEU invalidated the EU-U.S. Privacy Shield program (“Privacy Shield”) and potentially required supplementary protections to be implemented when Standard Contractual Clauses (“SCCs”) are used to ensure an ‘essentially equivalent’ level of data protection.  Under the GDPR, personal data transfers outside the EEA to jurisdictions which are not found to provide an ‘adequate level of protection’ to the data, are restricted unless appropriate safeguards are implemented.  The Privacy Shield and SCCs were two key appropriate safeguard mechanisms used to legitimize transfers of personal data outside the EEA to ‘non-adequate’ recipient countries, referred to as “Third Countries.”

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22 October 2020

SEC Lifts Moratorium on Registration of UK-Based Managers

Recent communications from the U.S. Securities and Exchange Commission (SEC) indicate that the SEC is again considering registration of advisers located in the UK. The SEC had delayed approving UK and European Union (EU) investment managers’ applications for registration since the adoption of the EU’s General Data Protection Regulation (GDPR), due to concerns that the GDPR would impede the SEC’s ability to collect data from, and supervise, these UK and EU investment managers.

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07 October 2020

European Court of Justice Applies Free Movement Rules of E-Commerce Directive to Advertising by Mail-Order Pharmacy

In its judgment from October 1, the European Court of Justice (ECJ) ruled that an EU Member State cannot restrict a mail-order pharmacy, established in another Member State, from using paid referencing on search engines and price-comparison websites to promote its service, unless the Member State clearly establishes that the restriction is appropriate, and does not go beyond what is necessary, to protect public health. The ECJ further found that several other advertising restrictions imposed by France restricted the freedom to provide services under the e-commerce rules, but added that those restrictions may be justified provided that certain conditions are fulfilled, which is for the national referring court to verify.

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02 October 2020

European Commission to Issue New Standard Contractual Clauses by End of 2020

In the wake of the recent Court of Justice of the European Union’s decision in Schrems II, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs met in early September to discuss the long-awaited revision of Standard Contractual Clauses (SCCs). During the meeting, Commissioner for Justice Didier Reynders expressed hope that revised SCCs would be finalised by the end of 2020.

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