Regulatory Focus™ > News Articles > 2022 > 6 > Euro Roundup: Generic manufacturers ask EU for inflation help

Posted 16 June 2022 | By Nick Paul Taylor 

Euro Roundup: Generic manufacturers ask EU for inflation help

2791 Leaders at generic drug manufacturers including Sandoz, Teva and Viatris have written to European Union authorities to request actions that enable them to cope with “rampant cost inflation.”
In a letter published by the trade group Medicines for Europe, generic drug manufacturers make the case that the combination of inflation and “policies that continuously lower prices” is unsustainable. Inflation in Europe is above 7% for the first time in decades and the generic drug industry faces particular pressures, the letter noted. Transportation costs are as much as five times higher than pre-pandemic, manufacturing input costs are up 50%-160%, energy costs are up 30%-65% and inflation is compounding the shortage of skilled workers, according to the trade group.
Further, such inflationary pressures are incompatible with the “substantial price erosion” caused by a decade of “strict price regulation, budget austerity measures and lowest-price tender rules,” the letter continues, before setting out six changes the generic drug industry seeks.
The proposed changes include a request to “reduce the complexity and cost of regulatory compliance.” Specifically, the industry asks for the frontloading of policies proposed in the Pharmaceutical Strategy for Europe, which calls for investment in digitalization, such as e-leaflets, and for regulatory reform.
Medicines for Europe also proposes reform of procurement and pricing models, arguing that “the widely recognized link between medicine shortages and unreasonable tender practices and pricing systems must now be addressed as a high priority in EU law.” The trade group wants the EU to adopt practices such as multi-winner and most economically advantageous tenders to “reward companies that invest in secure supply and the green and digital transition.”
Across the four other requests, the trade group calls for the EU to class drug manufacturing as essential in relation to access to constrained energy supplies, encourage member states to address inflation under their Transparency Directive obligations, clear companies to adjust prices in line with inflation and allow the industry to participate in EU resilience funded projects to support investment in production.
Open Letter
EMA posts another fall in GCP inspections, reflecting ongoing COVID-19 impact in 2021
The European Medicines Agency (EMA) has reported another year-over-year fall in good clinical practice (GCP) inspections, with the number conducted in 2021 falling further from the low reached in 2020.
With the pandemic disrupting travel for three-quarters of the year, EMA oversaw 59 GCP inspections in 2020, compared to around 140 a year in 2017, 2018 and 2019.
The number of GCP inspections fell further to 36 last year, a 39% drop that meant EMA oversaw around 100 fewer assessments of clinical practices than in a typical pre-pandemic year. EMA attributed the decline to “travel and safety restrictions caused by the global pandemic.”
Conversely, good manufacturing practice (GMP) activity rebounded. European authorities conducted 369 GMP inspections last year, more than double  the 170 they carried out in 2020. That number  approached the level performed in some of the pre-pandemic years, although it was still well down on the 497 GMP assessments carried out in 2019.
Press Release, Annual Report
EFPIA proposes changes to improve patient access to rare disease treatments
EFPIA has joined with patient-driven rare disease group EURORDIS to propose changes intended to boost access to orphan drugs.
In April, EFPIA published data showing 37% of orphan drugs are available across Europe. The figure is down on the number for 2020, 41%, and the average for all types of medicines, 46%. In some countries, fewer than 10% of orphan drugs are available.
EFPIA and EURORDIS have published six proposals intended to increase equity of access, improve health technology assessment and pricing and reimbursement processes, and establish a moonshot program for basic and translational rare disease research.
The first equity access proposal covers a conceptual framework for international differential pricing. The idea is to lower the price of rare disease medicines in less wealthy EU member states without dragging down the rate paid by their richer neighbors. EFPIA members also again committed to filing pricing and reimbursement applications within two years of receiving market authorization.
In terms of pricing and reimbursement processes, EFPIA and EURORDIS want to see more EU-level and cross-country collaboration on orphan products and use of adaptive pathways and real-world evidence (RWE) in value assessments. The collaborators see adaptive pathways and RWE as ways to overcome the uncertainty about the evidence that is available at the time of the marketing authorization.
EFPIA Report
PRAC recommends withdrawal of amfepramone obesity medicines over safety risks
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of the marketing authorizations of amfepramone obesity medicines.
Officials have previously enacted measures to restrict the use of the medicines. However, PRAC’s review found the actions have failed to have the desired effect, with the continued use of the medicines for more than the recommended three months putting patients at risk of serious side effects such as pulmonary arterial hypertension.
PRAC also found evidence of use of the medicines by people with a history of heart disease or psychiatric disorders, raising the risk of problems related to their conditions, and during pregnancy. Use during pregnancy could pose risks to the unborn baby.
The pharmacovigilance committee considered introducing additional risk-minimization measures but was unable to identify any actions it felt would be sufficiently effective. As such, PRAC concluded that the benefits of amfepramone do not outweigh the risks and therefore the medicines should be withdrawn from the EU market. The medicines were authorized in Denmark, Germany and Romania.
EMA Notice
EMA starts rolling review of variant-specific version of Pfizer’s COVID-19 vaccine
EMA has begun a rolling review of a new version of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty. The review will initially focus on chemistry, manufacturing and controls (CMC) data for the component against omicron subvariants.
At this stage, it is unclear, even to EMA, whether the adapted vaccine will target one or more variants or subvariants of SARS-CoV-2. Despite that, the agency thinks the program is advanced enough to enter a rolling review, which will start with the omicron subvariant CMC data and then assess additional results as they become available.
The composition of adapted COVID-19 vaccines will depend on recommendations from public health bodies and the World Health Organization, EMA said, as well as the views of regulatory agencies. Those bodies are working “together to determine the appropriate strains for adapted COVID-19 vaccines,” EMA said.
Pfizer and Moderna began clinical trials of omicron-specific vaccines earlier this year.
EMA Notice


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