On 8 April 2020, the European Commission published its Communication on the “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak” (the “Framework“).
The Commission recognizes that supply chains have been severely disrupted due to COVID-19, combined with
As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of
On 1 April 2020, the Belgian Federal Authority for Health and Medicinal Products (“FAMPH”) adopted a Decision to avoid shortages of medicines and raw materials used in the treatment of COVID-19. It applies for one month from 1 April, renewable. On 2 April 2020, the authority provided further details in a news post
On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency. The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities. The Guidance is intended to ensure that
Over the past months, the Government has regularly posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019. The UK Government has now published four notices
The “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity” is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12 October 2014.
The Nagoya Protocol imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the pharmaceutical, food, cosmetics and other life science sectors. It now has more than 100 contracting parties, including the EU. The key legal source in the EU is Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union.
Continue Reading German government has started enforcement of the Nagoya Protocol and reviews compliance of pharmaceutical companies
This article was originally posted on our sister blog Inside Medical Devices
The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation.
To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be interpreted, this post looks at two recent judgments pertaining to medicinal products before the EU Court of Justice: Joined Cases C-544/13 and C-545/13 Abcur (link here) and Case C-276/15 Hecht-Pharma (link here). Although there are evidently major differences between the medical device and medicines regulatory regimes, these judgments nevertheless provide useful guidance to interpret the notion “(non-)industrial scale” under the draft MD Regulation.
Continue Reading EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept