EC floats cross-sector health innovation partnership

Regulatory NewsRegulatory News | 04 August 2020 |  By 

In a draft document issued 29 July, the European Commission (EC) unveiled its plan for integration of health technology capabilities across the European Union (EU). The plan was lauded by five pharmaceutical and medical technology associations who signed on to a joint statement welcoming the proposal.
Dubbed the Partnership for Health Innovation, the initiative aims to facilitate translational work by creating an EU-wide “health research and innovation ecosystem,” to bolster safe, people-centered, cost-effective innovations that “respond to strategic unmet public health needs” and to “drive cross-sectoral health innovation for a globally competitive European health industry.”
The Partnership initiative is partially congruent with, but supplants and extends, the Innovative Medicines Initiative-2 Joint Undertaking efforts under Horizon 2020. The initiative is overall broader both in terms of included technologies and participants.
The draft proposal cites limited cross-sector collaboration as a chief barrier to achieving innovative health interventions. The European approach to research, regulation, and technology transfer has historically been siloed, to the detriment of the health of EU citizens – and the pocketbooks of companies that are often not globally competitive.
“Despite the EU being a strong global actor in health research, it is still relatively weak in translating research results into tangible health products, services and solutions delivered to the market and adopted by the health care systems in Europe,” notes the Partnership draft. “The slow translation of scientific discoveries into tangible innovations and limited technology convergence lead to dwindling innovation pipelines. This, in addition to insufficient innovative products reaching health care services and patients, poses not only a threat to the competitiveness of EU health research, it puts Europe at risk of becoming dependent on other countries for technological developments and innovative health care solutions.”
The draft document breaks the problem down further to note that an incomplete understanding of health and disease still hampers research and innovation efforts. Additionally, academia and industry have only achieved limited collaboration, owing to culture gaps between the two sectors, compartmentalized academic centers, concerns about publication and confidentiality, and a lack of appropriate funding vehicles.
Similar restricted collaboration is seen within and across sectors of industry, with competition, varying business models, and data interoperability challenges contributing to the segregated environment. Market barriers to innovation have also slowed innovation and collaboration. “The issues around market barriers are exacerbated by the fact that innovations combining different types of technologies do not easily fit into existing regulatory schemes,” according to the proposal.
The proposal outlines six specific but interdependent objectives to flesh out the general goals of the Partnership for Health Innovation schema.
First, participants must achieve a better understanding of the determinants of health and of contributors to disease states identified as priorities. Next, currently fragmented health research and innovation areas should be tied together “across sectors and technologies,” with a focus on public health needs that are currently unmet.
The necessary tools and technologies that will facilitate better “prediction, prevention, interception, treatment and management of diseases” should be put in the hands of the end users of these tools, says the document. The project should be built with an eye to demonstrating that people-centered and integrated solutions are feasible, and digital health tool and data exchange should be used to their fullest extent. The latter goal, according to the proposal, will require a push for health data interconnectivity and interoperability that currently does not exist.  
Finally, regulatory assessments should use “new and improved methodologies and models” to assess the increased value these innovative and integrated solutions bring to health care.
In addition to addressing the data interoperability challenges, the Partnership plans to establish a “pre-competitive space” where individual firms can bring together technology and knowledge in such fields as artificial intelligence, genomics, robotics and nanotechnologies.
This and other interventions, says the proposal, will help health innovation move more quickly to market and make Europe more attractive to health technology investors: “Taken together, the initiative could contribute to strengthening the competitiveness of Europe’s health industry, a cornerstone of Europe’s knowledge-based economy, to an increased economic activity in the production, distribution and sales of health technologies, and thus serve as a tool for increasing technological sovereignty.”
The draft proposal envisions sub-partnerships focused on particular sectors, with key digital enabling technologies, photonic, metrology, and smart networks and services all having specific European Partnerships. Additionally, the proposal would form a European Partnership on Health and Care Systems Transformation and an EU-Africa Global Health Partnership. Personalized medicine, rare diseases, and antimicrobial resistance would each have a dedicated partnership, building on existing initiatives in these areas.
In a joint statement, the European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry (COCIR), the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio, MedTech Europe and Vaccines Europe applauded the new proposal. “For a thriving European research ecosystem, this new partnership will create synergies and complement other features of the European research landscape,” wrote the associations.
The fresh approach is particularly welcome during the upheaval of the pandemic, they added: “Investment in collaborative [research and development] can play a significant role in building health resilience, improving European health systems’ sustainability, addressing the needs of patients across Europe, and driving the region’s economic recovery from the COVID-19 crisis. The pandemic has also underlined the importance of having a large-scale partnership for health innovation to mobilize and coordinate public and private research efforts aimed at tackling global public health threats.”
The draft Partnership proposal acknowledges that funding for a project of this scope must be “robust and flexible,” and will depend on the financial framework that is developed for the 2021-2027 period,  the scope of the EC’s Strategic Research Agenda when finalized, and how in-kind contributions are worked out. Draft legislation is expected later in 2020.
European Commission


© 2022 Regulatory Affairs Professionals Society.

Tags: devices, EU, medical

Discover more of what matters to you

No taxonomy