Despite widespread hopes for a quick shift towards ‘strategic autonomy’, the European Commission has made clear it needs another two years of reflection before coming up with proposals to reduce the risk of shortages caused by over-reliance on third-country medicine production.
The EU’s pharmaceutical strategy, unveiled on Wednesday (25 November), had been expected to mark a milestone in the development of strategic autonomy in the field of European drug manufacturing.
One of its main goals was expected to be the launch of specific actions to avoid a future recurrence of shortages experienced during the COVID-19 crisis, when medicine-producing third countries put in place protectionist measures such as export bans on life-saving drugs.
However, the final Commission proposal has not completely lived up to the initial expectations.
The strategy only provides the opening of a “structured dialogue with and between the actors in the pharmaceuticals manufacturing value chain and public authorities” in order “to formulate policy options and propose actions to strengthen the continuity and security of supply in the EU” at a later stage.
According to the Commission, this cooling-off period will take two years to identify vulnerabilities in the global supply chain of critical medicines, raw pharmaceutical materials, intermediates and active pharmaceutical substances.
“It takes another two years because we need to know exactly how we’re going to move forward,” said Health Commissioner Stella Kyriakides, adding that in order to address shortages, the EU needs to be able to understand what the root causes are.
Therefore, the Commission is also launching a study, expected to be finalised next year, to get a better understanding of the global medicine supply chain and its vulnerabilities.
“Once we are able to understand that, then we can come up with proposals that will last into time as well,” said Kyriakides.
In the midst of the first wave of the pandemic, the Commission had to go through diplomatic channels and ask Indian authorities to lift the export ban on paracetamol and 12 other active pharmaceutical ingredients.
With the supply chain spanning several continents these days, most European pharmaceutical companies have their products manufactured in India, while 70% of the underlying active ingredients come from China.
“This is probably the main lesson of the pandemic: that Europe should be at all times able to rely on a certain capacity,” said Commission vice-president Margaritis Schinas, mentioning personal protective equipment, but also medical equipment, raw materials and pharmaceuticals in general.
Schinas recalled that the pandemic showed, for instance, that no one was practically manufacturing masks in Europe, and that many raw materials are produced by third countries.
“This is what we need to change. The call for an EU strategic autonomy is to make sure that we have the capacity and the resources to identify what we need, act quickly and in a coordinated way,” he said.
According to Véronique Trillet-Lenoir, a French liberal MEP, the launch of a structured dialogue between manufacturers and public authorities is essential to ensure the security and continuity of access to medicines in Europe.
“Through state aid or via the Important Project of Common European Interest (IPCEIs), the European Union could encourage manufacturers to settle on European territory”, she added in a note.
The Austrian Christian-democrat lawmaker Alexander Bernhuber called on the EU to bring the production of medicines back to Europe in order to ensure a reliable and independent supply of medicines to citizens.
“This is how we save human lives. Seriously ill patients must not be dependent on production in China, India or elsewhere,” he commented.
In a parliamentary debate after the presentation of the pharmaceutical strategy, several MEPs highlighted the need to decrease the EU’s dependence on imports of active pharmaceutical ingredients from non-EU countries by increasing their production in Europe and supporting innovation in the EU pharmaceutical industry.
[Edited by Zoran Radosavljevic]