The expansion of European small and medium-sized enterprises (SMEs) into the healthcare innovation arena suggests that this should be an important EU policy priority that can significantly benefit the economy, society and citizens, including patients. Deepening and widening of Europe’s SMEs’ growth and activities is part of the EU objectives as set out by the European Commission in its Communications “Small Business Act” for Europe [1] and “Small Business, Big World” [2]. However, innovative healthcare SMEs have struggled to get traction despite the sector being worth more than EUR 250 billion. The 1991 Maastricht Treaty gave the Union new competences in public health and more scope for cross-border cooperation in this area [3]. Nevertheless, health initiatives here have tripped over each other, due to the fact that the delivery of healthcare is a national competence [4]. As such, EU healthcare-driven policy has never truly found its footing as a singular policy area despite the fact that a tenth of the EU’s GDP is spent on healthcare and more than 17 million people are employed in Europe in this sector [5]. Taking into account the necessity of bringing innovation into healthcare, and the willingness of SMEs to undertake the risk to be at the forefront of it, there is a need for a renewed effort to support SMEs so as to provide solutions for citizens and patients throughout the bloc in different healthcare settings [6]. This policy paper brings together two separate strands of analysis: firstly, a policy review of the main challenges and opportunities; secondly, a proposal for policy recommendations.

中文翻译：

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优化现代医疗保健系统中的中小企业潜力：挑战、机遇和政策建议

欧洲中小企业 (SME) 向医疗保健创新领域的扩张表明，这应该成为欧盟的一项重要政策优先事项，可以显着造福经济、社会和公民，包括患者。欧洲中小企业的发展和活动的深化和扩大是欧盟委员会在其欧洲通信“小企业法”中规定的欧盟目标的一部分[1] 和“小企业，大世界” [2]。然而，尽管该行业价值超过 2500 亿欧元，但创新的医疗保健中小型企业仍难以获得牵引力。1991 年的《马斯特里赫特条约》赋予欧盟在公共卫生方面的新权限，以及在该领域进行跨界合作的更多空间。3]。然而，由于提供医疗保健是一项国家能力，因此这里的卫生举措相互绊倒了[4]。因此，尽管欧盟 GDP 的十分之一用于医疗保健，并且欧洲有超过 1700 万人在该行业就业，但欧盟医疗保健驱动的政策从未真正成为一个单一的政策领域[1]。5]。考虑到将创新带入医疗保健的必要性，以及中小企业承担风险的意愿，因此需要重新努力支持中小企业，为整个公民和患者提供解决方案。集团在不同的医疗保健环境中 [6]。本政策文件汇集了两个独立的分析部分：首先，对主要挑战和机遇的政策审查；二是提出政策建议。