Generic Manufacturers Seek EU Contribution Generic Manufacturers Seek EU Contribution
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Generic Manufacturers Seek EU Contribution

Pharma Tech Outlook | Wednesday, June 29, 2022

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.”

FREMONT, CA: The pharmaceutical industry's association Medicines for Europe published a letter in which generic medication manufacturers assert that inflation and measures to reduce costs are unsustainable. The letter emphasised that the generic medication business is under special strain and that, for the first time in decades, European inflation has risen beyond 7 per cent. According to the trade association, transportation prices are up to five times more than they were before the epidemic, manufacturing input costs are up 50 per cent to 160 per cent, energy costs are up 30 per cent to 65 per cent, and inflation is making the skilled worker scarcity worse. The letter continues by outlining six adjustments the generic medicine sector wants, adding that such inflationary pressures are irreconcilable with the significant price loss brought on by a decade of rigid price regulation, budget austerity measures, and lowest-price tender regulations. A request to lower the complexity and cost of regulatory compliance is one of the recommended modifications. The industry specifically requests the frontloading of policies included in the Pharmaceutical Strategy for Europe, which calls for regulatory reform and investments in digitalization, such as e-leaflets. The organisation Medicines for Europe also calls for changes to pricing and procurement procedures, saying that "the well-acknowledged relationship between drug shortages and unfair tender practises and pricing systems must now be addressed as a top priority under EU law. To reward enterprises that invest in secure supply and the green and digital transformation, the trade association wants the EU to implement policies like multi-winner and most economically advantageous tenders.

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The trade group asks that the EU classify the production of drugs as essential concerning the availability of limited energy supplies, encourage member states to address inflation following their obligations under the Transparency Directive, and give businesses permission to raise prices in line with inflation, and permit the sector to take part in EU resilience funded projects to support investment in production. The number of good clinical practice (GCP) inspections undertaken in 2021 decreased even more from the low achieved in 2020, according to data from the European Medicines Agency (EMA). EMA oversaw 59 GCP inspections in 2020 as opposed to about 140 a year in 2017, 2018, and 2019, as the pandemic prevented travel for three-quarters of the year. A further decrease in GCP inspections to 36 last year—a 39 per cent decrease—meant that EMA oversaw around 100 fewer evaluations of clinical practices than in a typical year before the pandemic. The drop was attributed by EMA to travel and safety constraints brought on by the worldwide pandemic.

Together with patient-driven organisation EURORDIS, EFPIA has proposed modifications aimed at facilitating access to orphan medications. According to data released by EFPIA, 37 per cent of orphan medications are available in Europe. The percentage is lower than both the 2020 estimate (down 41 per cent) and the all-medications average (down 46 per cent). Less than 10% of orphan medications are accessible in some nations. To improve health technology assessment, pricing, and reimbursement procedures as well as to create a moonshot programme for basic and translational rare disease research, EFPIA and EURORDIS have published six ideas. Throughout the first equity access proposal, a theoretical framework for global differential pricing is covered. The goal is to reduce the cost of medications for rare diseases in less affluent EU member states without affecting the prices paid by their wealthier counterparts. Members of the EFPIA vowed once more to submit pricing and reimbursement requests within two years of acquiring market authorisation.

EFPIA and EURORDIS wish to witness increased cross-national and EU-level cooperation on orphan goods, as well as the use of adaptive pathways and real-world evidence (RWE) in value assessments. To get beyond the uncertainty surrounding the evidence that was available at the time of the marketing permission, the collaborators view RWE and adaptive routes as solutions.

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