Regulatory data protection

Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU pharmaceutical law framework
  • Clinical trials, unlicensed supply and compassionate use
  • Obtaining marketing authorisations
  • Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
  • Pharmacovigilance
  • Advertising and promotion of medicinal products
  • Pricing and reimbursement in the UK
  • Supply chains

Who is it relevant for?

The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 8 years PQE. There are no formal entry or membership requirements— please feel free to pass this to colleagues who might be interested in attending.

More information is on the website, and you can sign up here.

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary of recent European Court and English Court decisions in the pharmaceutical area and we will explore the implications for pharmaceutical companies.

Topics

  • How to bring challenges to the European Court
  • The interplay of domestic proceedings
  • Summary of recent European Court decisions, including:
    • Shire on orphan market exclusivity and;
    • Astellas on the role of the Concerned Member State
  • Summary of recent English Court decisions, including Napp on the Article 10(3) hybrid-abridged procedure
  • Changes in the Notice to Applicants regarding RDP, including the “reverse combination” principle
  • The implications for pharmaceutical companies

More information can be found on our website, and you can sign up here. Hope to see you there!

On 11 December 2017, we reported that Advocate General Bobek had opined in Case C-557/16, Astellas Pharma GmbH, that Concerned Member States (CMS) are co-responsible for marketing authorisations granted under the decentralised procedure (DCP).

This morning, the Court of Justice of the European Union (CJEU) handed down its judgment in the case. The Court ruled that:

  • Article 28 and Article 29(1) of Directive 2001/83/EC (the Directive) must be interpreted as meaning that, in the framework of a DCP for the placing on the market of a generic medicinal product, the competent authority of a CMS cannot itself determine the starting point of the regulatory data protection (RDP) period of the reference medicinal product after the close of the coordinated procedure, and when it adopts its decision on the generic medicinal product in that Member State. However, the CMS is part of the assessment procedure, and must verify the expiry of the RDP period (para 29), or not approve the assessment report (para 30).
  • Article 10 of the Directive, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, must be interpreted as meaning that a court of a CMS involved in a DCP, when faced with an action brought by the holder of the marketing authorisation of the reference medicinal product, against the generic marketing authorisation granted in that Member State, is competent to review the determination of the starting point of the RDP period of the reference medicinal product. On the other hand, that court does not have jurisdiction to determine whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with the Directive.

We will post our analysis of the judgment soon.

In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).

The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.

Continue Reading AG opines that CMSs are co-responsible for MAs granted under the DCP

Last month, the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP). During the DCP, the Reference Member State (RMS) has primary responsibility for preparing the assessment report on the medicinal product, and CMSs can raise questions or objections on the grounds of a potential serious risk to public health. This case, a referral from the Finnish Court, asks whether, and if so how, administrative and legal questions, such as the length of the regulatory data protection period, should be resolved in the CMSs, considering that national marketing authorisations (MA) are granted at the end of the DCP.

The hearing highlighted that the Member States and Commission do not agree as to the interpretation of the legislation and case law, and there is a real dispute for the Court to answer. The Advocate General has said he will deliver his opinion on 30 November.

Continue Reading European Court considers role of Concerned Member States