On 11 November 2020, the European Commission has announced a range of proposals to build a European Health Union.  The proposed measures reflect on the learnings from the current COVID-19 and previous influenza pandemics and seek to enhance Member States’ preparedness for future health crises, which also includes a greater involvement of the EU.  As part of its set of measures, the Commission is proposing to revise the current EU joint procurement framework.

  1. Current Joint Procurement Framework

In 2010, as part of its “lessons learnt from the A/H1N1 pandemic”, the European Council called for the development of a joint procurement framework for vaccines and antiviral medication.  Subsequently, the European Parliament and Council adopted Decision 1082/2013/EU (the “Decision”) on serious cross-border threats to health, which, among others, provides that the EU and any interested Member States may conduct a joint procurement procedure.  The detailed procedure was then agreed between the Commission and the Member States in the Joint Procurement Agreement (the “JPA”).
Continue Reading European Health Union: European Commission proposes Changes to the Joint Procurement Agreement

Today, October 1st 2020, the updated anti-gift scheme in France enters into force.  The anti-gift rules impose obligations on pharmaceutical, medical device and cosmetics companies when interacting with healthcare professionals (“HCPs”) and healthcare organizations (“HCOs”) in France.  The updated framework was foreseen in the adoption of Ordinance 2017-49 of 19 January 2017 and Decree 2020-730 of 15 June 2020.  This blog summarizes the new French rules.

Continue Reading Entry Into Force of Reinforced Anti-gift Rules in France

On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far.

Since July 4, 2020 the manufacture, marketing and use of perfluorooctanoic acid (“PFOA”), its salts and PFOA-related compounds (collectively, “PFOAs”), and products containing them, is significantly restricted in the European Economic Area (“EU/EEA”).  The restrictions were introduced by a Commission Delegated Regulation amending Annex I to the EU POPs Regulation, and are intended to implement a decision of the ninth meeting of the Conference of the Parties to the Stockholm Convention that was held from April 29 to May 10, 2019.

The new PFOA restrictions will have significant impact on a wide variety of products marketed, and businesses operating, in the EU/EEA, including semiconductors, textiles, firefighting products, pharmaceuticals, medical devices, and materials used in the life sciences industry.  In effect, the new restrictions implementing the Stockholm Convention are significantly broader than the restrictions on PFOAs that were introduced under the EU REACH Regulation in 2017, and which the Commission now intends to repeal.
Continue Reading Manufacturers and Marketers Beware: The EU Adopts New Restrictions on Products Containing PFOAs

The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19.

The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19).

Applications for clinical trials of human medicines or clinical investigations of medical devices

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

1. Summary

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

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA).

The Guidance provides information on changes and protocol deviations that