Regulatory Focus™ > News Articles > 2020 > 9 > Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects

Posted 10 September 2020 | By Nick Paul Taylor 

Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects

2727 Developers of COVID-19 vaccines used in the European Union will be legally liable in the event of hidden defects or other problems with their products, a senior official at the Directorate-General for Health and Food Safety (DG SANTE) has vowed.
Last month, Reuters reported that differing opinions over the level of legal protection that should be afforded to developers of COVID-19 vaccines were hampering efforts to strike deals for the products needed to protect EU citizens against the coronavirus. While the US government has agreed to be liable for the vaccines, the EU has proven less willing to shift responsibility away from manufacturers.
Members of the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) raised the topic in a discussion with DG SANTE Deputy Director-General Sandra Gallina earlier this week.
Multiple ENVI members raised concerns about the prospect of deals with vaccine developers shifting legal liability. Gallina was adamant that those concerns are unfounded.
“The companies are fully liable. There is no change. It is the system that we know. We would not be so mad as to change such a system,” Gallina said during the debate in Parliament
Gallina said the Commission went into the negotiations with COVID-19 vaccine developers including AstraZeneca, Johnson & Johnson and Sanofi with liability and indemnification as red lines. The goal was to ensure that the rights of all European citizens with regards to liability and indemnification are “totally unchanged” by the agreements.
The Commission has retained those red lines throughout the talks, Gallina said. That hard-line stance has put Gallina in a position to strike agreements that allay the concerns of ENVI members but has also held up negotiations.
“The negotiations have been very difficult because we started with the idea that we want to uphold the status quo. As regards both [liability and indemnification], we did not change an iota of what is in the law,” Gallina said.
Press Release, Debate Replay
EFPIA backs European regulatory network strategy, calls for prioritization
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has given its full support to the European medicines agencies network strategy through 2025, calling it “essential” to the development of innovative treatments for unmet medical needs.
The plan released for consultation earlier this year sets out how the European regulatory network will harness the capabilities of its members to address six areas of focus including innovation, supply chain challenges and antimicrobial resistance. In a brief statement, EFPIA backed the broad proposal but also called for the creation of an accompanying prioritized implementation plan.
An implementation plan is needed given the “all-encompassing nature” of the network strategy document, the trade group said. Through the plan, EFPIA envisions European authorities establishing the clear actions they need to take and ways of measuring progress toward their goals.
EFPIA proposes that European authorities adopt four priority actions that are in line with its own assessment of the future of regulation in the region. Those priorities include escalating work on innovative clinical trials and the establishment of a “more iterative, flexible, integrated product support mechanism.”
EFPIA also suggested establishing a new stand-alone goal focused on patient safety, noting that the group sees value in adding considerations related to patient focused drug development to the part of the network strategy that addresses innovation.
EFPIA Statement
Switzerland extends regulatory exemptions to certain autologous products
Some autologous serum preparations now may be classified as non-standard medicinal products under new regulatory exemptions from the Swiss Agency for Therapeutic Products (Swissmedic).
Switzerland has historically subjected patient-specific products to the same regulations as conventional medicines. The changes announced by Swissmedic this week will free some autologous preparations from those requirements.   
The change is notable as non-standardized medicinal products are subject to different regulatory requirements. Non-standardized medicinal products must be made in facilities licensed by Swissmedic that adhere to good manufacturing practice requirements.
Swissmedic Notice
Swissmedic recalls counterfeit batches of Alexion’s blockbuster Soliris
Swissmedic has shared details of a recall of a falsified batch of Alexion Pharmaceuticals’ rare disease blockbuster Soliris. Promed Swiss SA is recalling the falsified batch produced for the UK and Ireland from its supplied customers.
According to Swissmedic, Promed procured 257 units of the falsified batch from a Turkish supplier over the first six months of 2020. Promed delivered the units to customers in South America. Officials in Brazil issued an alert about counterfeit Soliris with the same batch number as the Promed units earlier in the year.  
The recall was carried out in agreement with Swissmedic as Promed operates under a license from the Swiss regulator. However, the Swiss market was not affected by the falsified Soliris units.
Swissmedic Notice
DKMA oversees stockpiling of COVID-19 essential medicines
The Danish Medicines Agency (DKMA) has overseen the stockpiling of up to nine months of essential medicines. Danish wholesalers used to stockpile 3-4 four weeks of the medicines but have changed their practices in response to COVID-19.
The effect of COVID-19 and responses against it on demand for medicines and the function of plants and supply chains that move drugs around the world is driving a reevaluation of the security of the pre-pandemic system. In Denmark, the reevaluation has manifested in collaboration between DKMA, wholesalers and an organization that manages the supply of drugs to pharmacies and hospitals.
Together, the partners have gradually built up Denmark’s reserve of vital medicines, reflecting fears of the impact of even a short period without access to antibiotics, insulin and asthma treatments. The gradual stockpiling has given Denmark enough vital medicines to supply pharmacies for three months and hospitals for three to nine months.
DKMA Notice
DKMA: Ibuprofen safe in COVID-19
DKMA has ruled ibuprofen safe for use in COVID-19 after completing a study of 9,000 Danes. The DKMA analysis found rates of death, hospitalization and intensive care admission were no higher in COVID-19 patients taking a nonsteroidal anti-inflammatory (NSAID).
Early in the pandemic, the French health minister tweeted that NSAIDs could be a factor in aggravating coronavirus infections and advised people to take paracetamol for fevers. Other authorities saw no cause for concern.
DKMA responded to the reports by asking its Data Analytics Center to work with the University of Southern Denmark to assess if there is an association between NSAID use and negative outcomes in COVID-19 patients. The study found identical rates of death and intensive care admissions among the NSAID and non-NSAID groups. The only numerical difference was a four-percentage point lower rate of hospitalization in patients taking NSAIDs while infected with the coronavirus.
DKMA Notice


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