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Careful forward planning is required by pharmaceutical companies conducting clinical trials ahead of the implementation of the General Data Protection Regulation in May 2018.
Submitted: 19 July 2019
The Belgian Federal Agency for Medicines and Health Products (FAMHP) has recently issued an administrative circular clarifying the conditions in which healthcare institutions may request and companies may provide gifts, advantages and benefits in the context of public tenders taking place in Belgium.
Submitted: 20 May 2019
Healthcare and patient data regulation in the ME is changing. This article discusses the new law introducing noteworthy obligations around the collection, processing and transfer of Health Data.
Submitted: 08 May 2019
On 30 April 2019, the European Commission eHealth Stakeholder Group (eHSG) issued a set of proposed guiding principles for reimbursement of "digital health products and solutions" (the Guidance).
Submitted: 23 April 2019
The proposed European legislation to amend the SPC Regulation and introduce a manufacturing waiver (for export and stockpiling) has now been approved by the European Parliament on first reading.
Submitted: 16 January 2019
The Simmons & Simmons Healthcare Hub dinner on 29 November 2018 discussed the challenges associated with the regulation of NHS-funded services and what the wider healthcare sector can learn from them.
Submitted: 26 November 2018
Een nieuwe wet van 30 oktober 2018 houdende diverse bepalingen inzake gezondheid is gepubliceerd in het Belgisch Staatsblad op 15 november (de “Wet”).
Une nouvelle loi du 30 octobre 2018 portant des dispositions diverses en matière de santé, a été publiée le 15 novembre dernier au Moniteur Belge (la « Loi »).
Parallelimporte sind und bleiben ein Dauerbrenner. Namentlich für Medizinproduktehersteller dürfte eine jüngste Entscheidung des OLG Frankfurt am Main von Interesse sein, das die markenrechtlichen Möglichkeiten, gegen Parallelimporte vorzugehen, weiter eingeschränkt hat. Konkret ging es um Parallelimporte mit eigener PZN. In Zukunft ist daher vertraglichen Gestaltungen deutlich mehr Aufmerksamkeit zu widmen, sollen unerwünschte Parallelimporte möglichst weitgehend verhindert werden.
Submitted: 20 November 2018
This article discusses the request for a preliminary ruling under Article 267 TFEU of the Higher Regional Court of Frankfurt am Main referring the question whether the liability of the French insurer Allianz France towards a German appellant for defective silicone breast implants is dependent on the interpretation of the prohibition of anti-discrimination (Article 18 TFEU).
Submitted: 19 November 2018
On 30 October 2018, the European Commission (EC) published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (version 1.20) (the Manual). This is the second time the EC updates the Manual this year, after the last revision took place in April 2018 (version 1.19).
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The Unified Patent Court is coming and will eventually have exclusive jurisdiction over all European Patents and new European Patents with Unitary Effect.
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