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EMA to consider coronavirus' impact on EU medicines supply

Steering group will identify EU-wide actions to mitigate medicine supply risks

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The European Medicine Agency (EMA) has organised the first meeting of an executive steering group, which will address the potential impact of the novel coronavirus on the medicine supply chain in the European Union.

In a statement issued this morning, the EMA said that it is already working with partners in the European medicines regulatory network to monitor the impact of the novel coronavirus – which causes the respiratory illness known as COVID-19 – on pharmaceutical supply chains in the EU.

The executive group provides strategic leadership for urgent and coordinated actions within the EU to determine and address risks impacting the supply of medicinal products, in response to crises caused by major events like the COVID-19 outbreak.

In the context of the COVID-19 outbreak, the group is to identify specific EU-wide actions to protect patients from medicine shortage risks caused by actions taken to contain the spread of the virus.

That could include shortages caused by temporary lockdowns of manufacturing sites in areas affected by COVID-19, or travel restrictions impacting shipment.

The group will also keep patients and healthcare professionals updated with regards to any risks to specific medicine shortages, and the remedial actions that may be taken as a result.

The EMA has also highlighted the important responsibility of pharma companies to ensure the continuity of medicines supply, including putting resilience measures in place such as increasing stock or dual sourcing of products and materials.

The US Food and Drug Administration has also said it is monitoring the possible risks to medicine supply chain risks caused by the COVID-19 outbreak, and has identified a list of drugs which source their active pharmaceutical ingredients (APIs) or finished products from China.

China – the worst affected country and epicentre of the COVID-19 outbreak – is a major manufacturer of a number of APIs used in a number of common drugs, especially in the US pharma market.

According to Reuters, around 88% of APIs used in drugs for the US market were manufactured overseas in 2018, with around 14% in that year produced in China.

The European concern over potential drug shortages comes amid a sharp rise of confirmed cases of COVID-19 in Italy, which today began a nationwide 'lockdown' after case numbers surpassed 9,000.

Although cases seem to be rising in a number of countries, new infections in China and South Korea appear to be slowing down.

AbbVie's Kaletra/Aluvia potential coronavirus treatment?

The growing number of cases in Europe has once again highlighted the need for effective treatments for the COVID-19 infection.

Researchers have been testing a number of existing and pipeline products to determine if they are effective against the virus, with one of those identified as potentially having a positive effect being AbbVie’s HIV treatment Kaletra/Aluvia (lopinavir/ritonavir).

However, although the company supports the experimental use of the HIV medicine as a treatment for COVID-19, AbbVie has said it cannot confirm media reports coming out of China that it is an effective treatment against the virus.

Although AbbVie has donated Aluvia to the Chinese government for experimental use, it said in statement that while it is “working with global health authorities to ensure we meet the need of COVID-19 patients (and) conduct the appropriate clinical trials”, it will also need to “ensure uninterrupted supply of the drug Kaletra/Aluvia for HIV patients around the world".

Article by
Lucy Parsons

10th March 2020

From: Regulatory

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