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!

As reported in our previous post, at the end of last year, the European Commission published a draft amendment to Regulation No 847/2000 regarding the concept of “similar medicinal product” for the purposes of the Orphan Medicinal Products Regulation. Last week, the final Regulation was published: Regulation (EU) 2018/781. The new Regulation is intended to take account of the rise of cell therapies and other advanced therapy medicinal products, the nature of which do not fit neatly into the current definitions.

The final Regulation is very similar to the one released for consultation, with a few minor clarification points added, namely to specifically refer to changes with respect to safety, as well as intended therapeutic effect, when considering whether two advanced therapy products are similar.

The Regulation will enter into force on 19 June 2018.

On 22 March 2018, the European General Court handed down its judgment in Case T-80/16 Shire Pharmaceuticals Ireland v EMA.  Shire had sought annulment of the EMA’s decision refusing to validate its 2015 application for designation of its medicinal product Indursulfase-IT as an orphan medicinal product for the treatment of Hunter Syndrome. This decision is particularly important for innovator companies who invest in R&D for rare diseases, and will likely have an impact on incentivizing this type of research.

Background

In 2001, a Shire product containing the active substance idursulfase was designated as an orphan medicinal product for the treatment of Hunter Syndrome. This was followed in 2007 by the grant of a marketing authorisation for the medicinal product Elaprase, containing the active substance idursulfase, and administered as a solution for intravenous infusion. In parallel, Shire started developing another medicinal product containing the same active substance. However this product, Idursulfase-IT, could be delivered intrathecally, whereas Elaprase did not cross the blood-brain barrier. Intrathecal administration of the new product allowed treatment of cognitive disorders associated with a severe form of Hunter Syndrome.

Continue Reading Shire v EMA: European General Court provides clarification for designation of orphan medicinal products