03 Jul 2020
Currently serving at the WHO, Emer Cooke is set to return to the EMA later this year in the role...
A STRUCTURED DIALOG IS NEEDED ACROSS EUROPEAN STAKEHOLDER GROUPS TO PLAN FOR AN EXTENDED CORONAVIRUS OUTBREAK
A “structured dialog” is urgently needed between industry, the European Commission, member states and regulators to “plan for a possible extended duration” of the coronavirus outbreak, according to off-patent industry association Medicines for Europe.
Writing to the European Commissioners for health and food safety, the internal market and crisis management, Medicines for Europe director general Adrian van den Hoven and president Christoph Stoller emphasized that “we do not see any short-term risk to production or supplies in Europe.”
The association had in mid-February identified only a “limited immediate risk to production or supplies in Europe” but pointed to the possibility of more significant longer-term effects depending on the duration of the outbreak. (Also see "EU Off-Patent Industry Sees ‘Limited Immediate Risk’ From COVID-19" - Generics Bulletin, 19 Feb, 2020.)
“We should act now to prevent potential supply risks if the outbreak continues.”
“We have a large manufacturing capacity in Europe that supplies 67% of prescription medicines,” the letter states. “We are coping with the challenges and are prioritizing the supply of medicines to patients as is the mission of our association.” However, it acknowledges, “the uncertainties regarding future developments warrant us to take precautionary measures.”
As such, the letter calls for a structured dialog “to enable regulatory flexibilities to address potential shortages related to active pharmaceutical ingredient production problems, notably the possibility for emergency variation procedures and accelerated regulatory reviews for both active ingredients and for finished products and to move products across different EU markets.”
Medicines for Europe recently set out a series of policy recommendations that it says could help to mitigate the risks of the coronavirus outbreak in Europe. (Also see "Regulatory Measures Could Mitigate EU Coronavirus Risks" - Generics Bulletin, 19 Feb, 2020.)
“We do not yet have full clarity on the production situation in China.”
Such a dialog could also be useful as a channel to exchange information regarding specific pharmaceutical needs – such as antivirals and antibiotics – to address the outbreak, the letter suggests, adding that “we have noted that many of the products proposed to address the virus under the recent Innovative Medicines Initiative proposal are produced by our membership.”
Suggesting that a Europe-wide dialog could be enacted through the recently-established EU executive steering group on shortages of medicines caused by major events – which met for the first time on 4 March – Medicines for Europe also advises that individual member states should “establish parallel dialogues with Medicines for Europe national associations.”
“The combined exchange of national and EU-level information between manufacturers and authorities would be essential to tackle any challenges for medicines supply,” the letter insists.
Acknowledging the significance of China as “a major producer of pharmaceutical inputs, notably of APIs and intermediate products,” Medicines for Europe concedes that “we do not yet have full clarity on the production situation in China because workers are returning in small batches to factories, in accordance with the public health rules in the country.”
According to information from the World Health Organization, Medicines for Europe says, “larger production sites will soon be fully operational, but smaller production sites, producing intermediates, are facing more difficulties.” Meanwhile “logistical issues continue to be a challenge.”
“We are concerned about the recent decision of India to impose export restrictions on certain active ingredients and medicines.”
And addressing India’s recent decision to restrict exports of certain key APIs and formulations – including paracetamol (Also see "India Curbs Exports Amid Coronavirus" - Generics Bulletin, 4 Mar, 2020.) – the association asserts that it is “concerned about the recent decision of India to impose export restrictions on certain active ingredients and medicines. While we believe that the scope of this measure will be limited in impact – affecting a small volume of exports to Europe – we are concerned about measures that clearly disrupt international co-operation.”
The EU, US, India and China “should co-operate on global supply-chain manufacturing issues together with industry to maximize information and efficiency for all patients globally,” Medicines for Europe insists, suggesting that “this could be facilitated by the WHO.”
As Europe sees a growing number of coronavirus cases, measures specifically geared to the region’s medicines industry are needed to maintain production and logistics, Medicines for Europe argues.
Given that its members have production or laboratory sites “in all EU member states except Luxembourg,” the association says, “we should provide clarity for all actors involved in medicines production.”
Member state measures and decrees to limit the movement of people “should clearly recognize medicines production and logistics as essential,” the letter insists, against the backdrop of nationwide lockdown measures recently imposed in Italy, a major supplier of APIs for the European market. “This will enable manufacturers to continue production and related cross-European logistics for the continued supply of medicines.”
“Member state measures and decrees to limit the movement of people should clearly recognize medicines production and logistics as essential.”
And where requested, there should also be guidance on how to maintain production and logistics while reducing the risk of the outbreak spreading, the letter urges, particularly given the significance of Italy as a center for API manufacturing.
“Our industry’s major production centers in Italy are in the outbreak regions in the North of the country,” the association points out, where “there are impacts on the availability of labor and concerns about logistics and transport in and out of the region.”
While “our members in Italy have worked to maintain production and transport in the country for the most part,” Medicines for Europe says, “the further spread of the virus to other regions in Europe close to our manufacturing sites would likely cause similar problems.”
Therefore the association is calling on the Commission to provide clear guidance on transport and logistics issues “to avoid unnecessary disruptions.”
With Medicines for Europe’s members having conducted national-level risk assessments in conjunction with local regulators, the association said it “strongly advises that the Commission and European Medicines Agency aggregate this information to assess the potential risks for supply if the outbreak continues. This would enable the Commission and inform manufacturers of potential supply problems and allow them to shift their manufacturing or their excess stocks to address the problem.”
Legal compliance issues limited the possibility for manufacturer associations to collect and share this kind of information, Medicines for Europe pointed out.
“This information could be used by the authorities to provide information to the whole manufacturing community on production and supply bottlenecks and to find manufacturers who could fill those potential gaps in the system,” the letter suggests.
Medicines for Europe also said its members had voiced concerns over the risk of hoarding within the distribution chain. “Although there are no shortages, this disruption has an impact on the industrial market,” the association said, which “could create irrational incentives for stock hoarding.”
“We advise that the Commission and national authorities actively monitor this risk which could unnecessarily create shortages or stock-outs for patients,” Medicines for Europe urged. “There may also be a need to involve payers in this dialogue to address the economic impact of the outbreak on manufacturing which could have an impact further down the distribution chain.”
A possible decrease in the offer of APIs and intermediates “may result in sudden higher costs to produce medicinal products,” the association suggested, “which may need to be flexibly factored in the dialog with payers and authorities more generally.”
And for certain products, Medicines for Europe recommended considering the possibility of a bulk import exemption into the EU if these products are not widely commercialized in Europe – such as hydroxychloroquine – as “our members are marketing these products outside the EU where they serve a specific health need.”
“For these reasons, we call on you to enact the structured dialog with utmost urgency,” the letter concludes, emphasizing that stakeholders must “act now to prevent potential supply risks if the outbreak continues.”
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
Our team is always happy to hear from you. Please call us at:
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now: