EU Provides Guidance on Drug Supplies in the Wake of COVID-19
The European Commission (EC) has outlined three measures it is taking to advise companies on how they may cooperate with each other in addressing potential drug shortages relating to the novel coronavirus (COVID-19) while maintaining compliance with European Union (EU) competition laws.
First, the EC has published a Temporary Framework Communication to provide antitrust guidance to companies cooperating in response to urgent situations related to the current novel coronavirus outbreak. In this context, the EC is also issuing a “comfort letter” to Medicines for Europe, which represent generic-drug manufacturers in Europe, concerning a specific cooperation project aimed at avoiding situations of shortages of critical hospital medicines. The EC also issued guidelines on the rational supply, allocation and use of medicines to treat COVID-19 to cover any medicine at risk of shortage due to the COVID-19 pandemic.
The Temporary Framework Communication is meant to provide antitrust guidance to companies willing to temporarily cooperate and coordinate their activities in order to increase production and optimize supply of needed hospital medicines during the novel coronavirus outbreak. It explains the main criteria that the EC will follow in assessing these possible cooperation projects. The EC says it has been engaging with companies and trade associations to help in assessing the legality of their cooperation plans and putting in place adequate safeguards against longer-term anticompetitive effects.
The EC says it has been giving oral guidance to companies for the past few weeks (as of April 8, 2020). It is also providing companies with written comfort (comfort letter) concerning specific cooperation projects that need to be implemented in order to address the coronavirus outbreak, especially where there is still uncertainty about whether such initiatives are compatible with EU competition law.
To that end, the second measure taken by the EC is that it is providing a comfort letter to Medicines for Europe to address a specific voluntary cooperation project among pharmaceutical producers, both members and non-members of the association, that targets the risk of shortage of critical hospital medicines for the treatment of coronavirus patients. “Generic pharmaceutical companies produce the largest part of the critical hospital medicines that are now urgently needed in large-scale volumes to avoid shortages,” said the EC in an April 8, 2020 statement in explaining the comfort letter to Medicines for Europe.
Medicines for Europe says it welcomes the temporary framework adopted by the EC to facilitate cooperation initiatives aimed at securing supply of hospital medicines during the COVID-19 pandemic. It noted that the surge in demand for intensive-care unit (ICU) medicines, mostly off-patent medicines, merit particular EU-wide efforts. It noted that ICU medicines to maintain patients on mechanical ventilation include sedatives, muscle relaxants, analgesics, and antibiotics.
“We thank the Commission for issuing a comfort letter and will fully comply with the guidance it requires,” said Adrian van den Hoven, Director General of Medicines for Europe, in an April 8, 2020 statement. “This European coordination is vital to ensure equitable access to patients. As we work on the issue of ICU [intensive-care unit] medicines supply, we hope to continue to cooperate with the EU institutions and member states to help patients in all countries in Europe.”
Lastly, the EC issued guidelines on the rational supply, allocation and use of medicines to treat COVID-19 to cover any medicine at risk of shortage due to the COVID-19 pandemic. Among the measures specified in the guidelines is guidance to EU member states on how they can work with pharmaceutical companies and suppliers of pharmaceutical ingredients to ensure that production and supply of essential medicines can be maintained during the outbreak.
In addition, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership for urgent and coordinated action on shortages within the EU in this pandemic, is currently setting up, with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between industry and the EU Executive Steering Group. With this system, each pharmaceutical company will be required to report directly to the European Medicines Agency, both for centrally authorized and nationally authorized medicines, anticipated shortages or current shortages of critical medicines used in the context of COVID-19. For further details, see related story.