New reports address generics pricing, innovation in the EU

Regulatory NewsRegulatory News | 01 December 2021 |  By 

A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation of production and withdrawal or products from the market.
“The European Commission has collected a growing body of evidence showing that extreme cost containment policies applied to generic medicines are counterproductive, driving industrial consolidation and supply risks and potential medicine withdrawals from the market for important older, less expensive medicine,” wrote Medicines for Europe in a 26 November press release.
The trade association’s statement calls for these considerations to be folded into the EU Transparency Directive and the Public Procurement Directive, which govern pricing and reimbursement, and tendering of medications, respectively.
A European Parliament report released 23 November offers recommendations to foster off-patent innovation in the EU, which “lags behind the USA,” in this field, according to the report’s introduction. The report summarizes the current state of pharmaceutical innovation in the EU and the US.
The report references a 2018 European Commission report found that patent protection effectively lasted 13 years within the EU, “thanks to supplementary protection certificates which protect the API [active pharmaceutical ingredient] for five more years, adding up to 25 years of API protection, which by extension also protects the pharmaceutical’s price and market from competition.”
Off-patent innovation, however, is a less expensive proposition, though the cost may still be over half that of developing a de novo pharmaceutical. The report proposes four main incentives that target different stages of the repurposing process. First, more research funding and more stakeholder cooperation can jump-start the process.
Next, the sponsor should be given “quicker patient access and commercialization” with expedited movement through the regulatory pathway chosen. After marketing authorization that is linked to market protection is granted, the protection should favor the repurposed pharmaceuticals, according to the report.
Finally, pricing for a new indication of an old drug or a repurposed pharmaceutical should include premiums paid to the sponsor, “rewarding the added value of the pharmaceutical.”
The report reviews previous work within the EU to encourage off-patent innovation, including building out a public-private framework for drug repurposing and the creation of an expert group that has developed a framework “to ease the repurposing of off-patent APIs.” This framework was launched at the end of October.
The full protocol for drug repurposing under the framework is laid out in the Commission report, including the availability of regulatory incentives for marketing authorization holders of certain pharmaceuticals.
These efforts complement the “Horizon Europe” repurposing platform which is slated to received 50 million Euros of funding, and take a page or two from the UK’s Medicines Repurposing Programme, which went live in Marsh 2021. The report suggests using the UK’s repurposing policies and programs “as a basis for further development,” building on existing EU resources. “Off-patent innovation in the pharmaceutical sector represents a largely untapped source of innovation to tackle unmet needs,” wrote report authors.  
Pricing strictures on generics, according to Medicines for Europe leaders, need to be addressed if generics innovation and drug supply security are to be fully addressed.
“Just this week the European Parliament recognized that off-patent medicines provide the majority of accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems, generating costs savings while underpinning the high quality of healthcare,” said Medicines for Europe director-general Adrian van den Hoven. “Our industry is part of the solution, not part of the problem: it’s time to treat it as such. Security of supply needs to be factored into the pharmaceutical policies of Member States. We all need to remember that healthcare is an essential investment, not just a short-term cost.”
Medicines for Europe


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Tags: EC, EMA, EU, generics

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