BRUSSELS, 9 April (APM) - The European Commission has come out strongly in support of the call from the European pharmaceutical industry for special provisions for manufacturing and distribution during the current coronavirus-inspired disruption, and has won praise from the sector for its engagement.
Commission president Ursula von der Leyen herself announced on Wednesday that she had obtained backing of her fellow-commissioners for formal guidelines "on the optimal and rational supply of medicines to avoid shortages during the Covid-19 outbreak".
The guidelines - which amplify and reinforce a more general response in March to industry requests (APMHE 66563
) - cover not just medicines to treat Covid-19 patients, but also any medicine at risk of shortage due to the pandemic.
Demand from hospital patients
The principal increase in demand, says the Commission, springs from the 30% of hospitalised patients, with many needing oxygen therapy, intubation, anaesthetics, antibiotics, muscle relaxants, resuscitation medicines and anti-diuretics.
Respiratory and cardiac medicines, analgesics, anti-clotting medicines, medical nutrition and large-volume parenterals are also needed for intensive and supportive care.
Non-prescription painkillers, stockpiled by citizens in reaction to the pandemic, are also on the list.
But the guidelines also cover the risk that increased demand for medicines to treat Covid-19 reduces their availability for patients using them to manage their chronic or rare diseases.
On the supply side, the Commission has already formally called on the pharmaceutical industry to increase production capacity for all medicines for which there is an increased demand, and in particular for those for which there is a risk of supply shortages.
The guidelines are addressed to the EU member states - carefully acknowledging their own rights to "organise the delivery of healthcare and retail sales of medicinal products" and to "take exceptional measures to protect public health".
But the Commission is unambiguous in stating that "protectionist measures" - notably export bans and national stockpiling, within and outside the EU - are affecting the global pharmaceutical supply chain.
This "can easily lead to inequitable supply and shortages in the EU and worldwide," it says, noting that “total export bans for medicines are not in line” with EU treaty obligations.
It is urging "all member states to lift unjustified export bans for medicines within the internal market" - even where they are not actually illegal.
A certain level of stockpiling of essential medicines for emergency use is understandable, "for moderate quantities based on epidemiological indications," it concedes, but conducting the stockpiling at EU rather than national level "is the optimal solution".
'Boost production, ease transport'
Pharmaceutical manufacturing - including raw materials and components - should be designated as an essential activity and allowed to continue operating, say the guidelines, adding that member states should aim to increase manufacturing capacity through fiscal incentives and state aid, and that regulators should maximise "regulatory flexibility" over variations to marketing authorisations.
The crisis requires not only a significant increase of production, but might also make it necessary to re-organise supply chains and production lines on a temporary basis, says the Commission.
To reassure companies that they will not fall foul of EU competition rules if they collaborate in these circumstances, it says "the Commission is ready to provide guidance and legal certainty to these companies".
The Commission adds that the guidelines "rely on the EU pharmaceutical industry acting responsibly and with solidarity".
Border controls and administrative procedures should be simplified too, with ‘green lanes’ to ease transport of essential supplies within the EU.
And member states should "consider actions to ensure air cargo capacity for transport of medicines, APIs, intermediates and raw materials”- and at “reasonable shipping rates".
Teva’s Christoph Stoller, in his role as president of Medicines for Europe, "sincerely echoed" the von der Leyen announcement.
He said the generic industry’s supplies remain largely uninterrupted, but "as the pandemic progresses in Europe, we are experiencing bottle necks and unprecedented demand surges".
A spokesman cited "sporadic challenges with border movements" and "challenges with air freight between EU/India/China/US and export restrictions from India".
This needs borders to be kept open, and action to prevent market supply disruptions such as stockpiling or hoarding, Stoller said: "All this guidance demonstrates the power of working together, industry, policy makers, regulators in the best interest of the patients and the healthcare professionals that we serve".
Wholesalers in GIRP also welcomed the guidelines - particularly the recognition that full-service healthcare distributors must be allowed to continue operating at full capacity, with protective equipment for staff and special permits for delivery drivers.
GIRP director general Monika Derecque-Pois said she was pleased that "most of our early thinking and calls have been reflected in the guidelines".