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Calls for Critical Reform in EU Generic Medicine Procurement Policies to Enhance Supply Security

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The necessity for reform in the procurement policies related to generic medicines is imperative to ensure a more secure supply chain for patients and health systems. Medicines for Europe’s latest position paper sheds light on the critical issue that the current procurement rules in EU Member States, primarily focused on cost reduction, inadvertently contribute to supply consolidation and elevate supply security risks.

The position paper advocates for a strategic overhaul in the tender design process by integrating supply security as a pivotal objective and promoting the adoption of pro-competitive Most Economically Advantageous Tender (MEAT) criteria. These measures aim to encourage manufacturers to fortify their supply chains, thereby enhancing overall supply security.

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Arnaud Maheas, serving as the Chair of the Generic Market Access Committee at Medicines for Europe, has vigorously underscored the paramount importance of establishing comprehensive European Union guidance on the procurement processes as an essential measure for effectively tackling the persistent issue of drug shortages. His advocacy for significant reform in this sector is rooted in the alarming statistic that a staggering 90% of the medicines identified as critical by the European Commission fall within the category of generic medicines. This revelation not only illuminates the critical role that generic medicines play in healthcare systems across the EU but also underscores the urgent necessity for strategic reforms aimed at ensuring the stability and reliability of drug supply chains.

Maheas’ Vision for Strengthening EU’s Generic Medicine Supply Chain Through Policy Reform

Maheas’ call to action is driven by a deep understanding of the complexities and challenges inherent in the current procurement policies, which often prioritize cost reduction to the detriment of supply security and diversity. He argues that the prevailing focus on minimizing expenses has inadvertently led to a fragile supply infrastructure, making the healthcare system vulnerable to shortages that can have far-reaching consequences for patient care and treatment outcomes.

In advocating for EU-wide procurement guidelines, Maheas envisions a more resilient and equitable framework that not only addresses the immediate concerns of drug shortages but also lays the groundwork for a sustainable model of drug supply that values and prioritizes the availability of essential generic medicines. By doing so, he believes that the European Union can take a significant step forward in safeguarding public health, ensuring that all patients, regardless of their location or economic status, have uninterrupted access to the vital medications they rely on.

The emphasis on the need for reform, particularly given the critical nature of generic medicines within the EU’s pharmaceutical landscape, highlights a broader issue of supply chain security and the need for a collective, coordinated approach to procurement policies. Maheas’ advocacy for change is a clarion call to policymakers, healthcare providers, and industry stakeholders to reevaluate and revamp the current systems in place, to build a more robust, reliable, and patient-focused healthcare infrastructure that can withstand the challenges of supply disruptions and meet the evolving needs of the European population.

Generic Medicine

Position Paper Outlines Critical Strategies for Reforming EU Medicine Procurement

The position paper delineates several key recommendations for reform, including the necessity to ensure diversity among suppliers, enhance demand predictability, moderate penalties, and incorporate broader criteria beyond the lowest price in award decisions. These recommendations underscore the importance of robust supply chains and environmental sustainability in procurement decisions.

The position paper proposes several actionable strategies for improving tender design:

  • Encouraging diversity of suppliers by favoring multiple winners in tenders or maintaining several active suppliers in the market,
  • Enhancing demand predictability through sufficient lead times and accurate volume estimates,
  • Mitigating disproportionate penalties for suppliers and allowing price adjustments under justified circumstances,
  • Implementing MEAT criteria that align with EU priorities, such as environmental sustainability and supply chain reliability.

Medicines for Europe’s member companies, which operate across Europe, including 126 R&D sites, and allocate up to 17% of their turnover to R&D investments, are at the forefront of increasing access to generic medicines and driving improved health outcomes. These companies are instrumental in fostering sustainable European healthcare systems by providing high-quality, effective generic medicines and innovating in the fields of biosimilar medicines and value-added medicines. These efforts not only aim to improve health outcomes and system efficiency but also enhance patient safety in hospital settings.

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Resource: Medicines for Europe, February 19, 2024


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