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Can Essential Medical Shortages Be Prevented? The EMA May Have a Solution

on Thursday, 16 April 2020.

We recently reported that the European Medicines Agency (EMA) issued a statement to show that it was closely monitoring the impact of coronavirus (COVID-19) on the pharmaceutical supply chain within Europe.

Through the EMA, a Steering Group on medicine shortages has come together to discuss measures with the objective of reducing the impact of the outbreak of coronavirus on pharmaceutical supply chains.

The Group sought to identify and co-ordinate EU-wide action to protect patients when medicines are at risk of being in short supply, eg due to temporary lock-downs of manufacturing sites or travel restrictions affecting shipments. The EMA has now reported that continued availability of medicines, in particular those used for patients with coronavirus, is of critical concern. It says shortages of certain medicines used for patients with coronavirus have been coming through, such as anaesthetics, antibiotics and muscle relaxants for intensive care units. More generally, medicine shortages have increased in recent years, and the pandemic has made this worse, through factory lockdowns, logistical issues due to border closures, export bans, and increased demand as well as stockpiling by hospitals and patients.


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Tackling Supply Disruptions

Now, to help avoid supply disruptions, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events is setting up a system called the i-SPOC (industry single point of contact) system, to ensure rapid interaction on shortages between industry and the EU Executive Steering Group. Each pharma supplier can report directly to the EMA, both for centrally authorised and nationally authorised medicines, anticipated shortages or current shortages of critical medicines used in the context of coronavirus. In parallel, those suppliers will continue reporting such shortages to the national competent authorities.

As with the single point of contact (SPOC) network, set up last year between the EMA and national competent authorities to share information on medicine shortages, this system will be based on the appointment of an i-SPOC representative at each pharma supplier, who will provide information on current or anticipated shortages of coronavirus related medicines to the EMA. This new mechanism will allow better oversight of ongoing supply issues, irrespective of the licensing route and a quicker flow of information with the pharmaceutical industry, with the objective of mitigating and hopefully preventing shortages in the context of essential coronavirus medicines.

Future Protection

The Executive Steering Group has also been considering areas where regulatory rules could be applied, with greater flexibility during the pandemic to secure supply of critical medicines. They have also provided a question and answer document to give further clarity into their regulatory expectations.

These are concerning times, but it is good to see the action that the EMA has been taking to stem medicine supply shortages. No doubt, industry will respond to this call and participate in the scheme.


If you require specialist legal support in relation to medicine shortages or supply disruptions, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320, or complete the form below.

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