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Regulatory Focus™ > News Articles > 2020 > 4 > EC offers antitrust reassurances to generic drugmakers cooperating on shortages

EC offers antitrust reassurances to generic drugmakers cooperating on shortages

Posted 08 April 2020 | By Zachary Brennan 

EC offers antitrust reassurances to generic drugmakers cooperating on shortages

The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients.

The commission explains how generic firms may need to coordinate on stock management and distribution “so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to antitrust rules in normal circumstances. But in the context of a pandemic like the coronavirus outbreak, such coordination can, with appropriate safeguards, bring important benefits to citizens.”

At the same time, however, the commission said in its communication that it will continue to closely and actively monitor relevant market developments to detect instances of undertakings that take advantage of the crisis to breach EU antitrust law by engaging in anti-competitive agreements, abusing a dominant position, exploiting customers and consumers or limiting production to the ultimate prejudice of consumers.

The support from the commission comes as Medicines for Europe recently sought to underline a call from the European University Hospital Alliance for more European collaboration to prevent drug shortages and to meet the increased demand for ICU medicines.

In related guidelines on avoiding shortages, also released Wednesday, the commission explains what kind of shortages it's seeing: "In EU/EEA countries with available data, around 30% of diagnosed COVID-19 patients are hospitalised, many of them needing oxygen therapy. For patients in critical care who need intubation, a concomitant therapy with anaesthetics, antibiotics, muscle relaxants, resuscitation medicines and anti-diuretics is essential. This has resulted in a considerable surge in the demand for these medicines and medical oxygen. Additionally, respiratory and cardiac medicines, analgesics, anti-clotting medicines, medical nutrition and large-volume parenterals are needed for intensive and supportive care of those COVID-19 patients. There has also been stockpiling of non-prescription painkillers by citizens in reaction to the pandemic."

The US is seeing similar concerns with drugs and FDA updated its drug shortage list last week to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation.

European Commission

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