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EU drugmakers welcome new dialogue with Commission on corona crisis supplies

by Peter O'Donnell
BRUSSELS, 13 Mar (APM) - Three European commissioners held a teleconference on Friday with European medicine and devices industry representatives on Friday to discuss the potential impact of the coronavirus on the supply of vaccines and medicines, as part of a concerted EU response to tackle the growing crisis.
Health commissioner Stella Kyriakides, Thierry Breton, responsible for industry, and Janez Lenarčič, in charge of crisis management, took part in the call - the first of what is planned to be a weekly exchange to monitor the situation in the shifting context of the pandemic.

Generic firms want 'solidarity'

Medicines for Europe presented clear asks at the meeting, outlining a series of conditions for its members to continue supplying products from their 300 production sites in Europe, and calling for "maximum, pan-European collaboration and coordination" - and a clear understanding at the level of national governments on the need for the supply of medicines across Europe.
"This crisis cannot hinge on national protectionism which could block the circulation of essential medicines," it warned. "There must be solidarity towards countries hardest hit by the outbreak. Hoarding of supplies should be strongly discouraged."
It was essential to avoid export restrictions on manufacturers of medicines or active ingredients, according to Mfe, and any local stockpiling obligations "must be reasonable and clear (how much exactly, who holds the stock, do they have the space to hold the stock, etc.)"
European political leadership will be needed to keep all available pharmaceutical manufacturing in Europe open and running at all times and to expand it where necessary, it argued.
"If a region is struck by an outbreak, we must keep medicine factories open with additional hygiene/control measures. Any stoppage creates a risk in the supply chain and heightens the risk of medicines shortages," said MfE in a statement issued after the meeting.
It also insisted on the need for access to essential equipment like protective clothing or filters. And "we need solutions for employees to keep working if schools close or if there are restrictions on the movement of people".
Transport green lanes should be created for the flow of medicines and their ingredients across national borders, and for air transport between the EU and the USA.
Stress on global supply chains should be eased by adopting clear regulatory guidance, it went on.
MfE welcomed the commission decision for a collaborative platform to review on a weekly basis the development of the epidemic and address together the roadblocks ahead.

EFPIA's cautious reassurance

EFPIA director general Nathalie Moll said after the meeting: "We welcome the proactive approach from the commissioners and the opportunity for regular dialogue at this critical time."
"The continuity of supply of our medicines to patients has been, and remains, of the highest priority," she said.
Her message was mainly of reassurance. "There is limited immediate risk that Covid-19 would impact manufacturing and supply of branded medicines in Europe in the short term," she said.
"While supply and demand vary by product, EFPIA members are not aware of any significant near-term impacts on the availability of our medicines and vaccines."
In terms of potential longer-term impacts, the assessment of EFPIA members is that the situation is fluid but does not at this point point to impacts for their supply chains "unless disruption due to the Covid-19 outbreak is sustained over the next several months."
She added that EFPIA members' business continuity and contingency plans permit them to monitor global and market-specific demands for their products and take careful inventory decisions "because supply disruptions can affect patients globally".
EFPIA itself "will keep an open and constant dialogue with the European Medicines Agency and the European and national authorities as important information becomes available".
"At the same time, researchers from across our member companies will continue the quest to find diagnostics, vaccines and treatments to address the crisis."

Shared intelligence

An EFPIA spokesperson subsequently told APM that the teleconference "was an opportunity to share intelligence with the Commissioners on the likelihood of any interruptions to supply and the potential causes and solutions".
He stressed that current EFPIA information suggests there is only a low risk in the short term.
The meeting - which was at the request of the Commission - was designed to keep everyone up to date, and EFPIA is ready to continue information exchange in this forum and with other relevant partners, he said.
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