Category: MEDICINES – EXAMINATIONS

Empowering patients through medical technologies for a healthier future

By constantly investing in existing and future technologies, the medical technology sector contributes to a healthier Europe. The 2023 MedTech Forum looked at some key trends in legislation and business and the role that EU policymakers can play to bring medical innovations to patients in a timely manner.

Europe takes great pride in its robust social security systems and the fundamental principles of equitable healthcare access. Data indicates however that significant efforts are still required to ensure that all patients across the continent enjoy top-tier quality care and unfettered access to medical services and technologies.

Medical technologies empower early diagnoses, timely interventions, and remarkable outcomes. Medical technologies mend, revive, and improve body functions, while telemedicine and connected devices bring patient monitoring to new frontiers. Innovations speed up recovery, safeguard well-being, and equip healthcare workers with vital insights for optimal decisions and fewer complications. By relieving strain on healthcare systems, fostering social and economic vitality, averting complications, and advancing efficiency through cutting-edge data and machine learning, medical technologies are high-tech, high-value game-changers in healthcare. Diagnostic technologies also act as a first line of defence against disease outbreaks and help support their management.

Because of its innovation power, and its positive impact on patients, healthcare professionals, and health systems, the medical technology sector has developed into a key industry with an important economic and societal impact in Europe.

European leadership for the benefit of patients 

Europe’s 34,000 medical technology companies invest heavily in improving existing and innovating breakthrough technologies for the benefit of patients. These companies, 95% of which are SMEs, drive economic growth, provide employment in Europe, and boost EU exports. In doing so, the sector adheres to strict regulatory standards that ensure safe devices which live up to their performance claims. Patient health and well-being in mind, no other region in the world sets such high standards to guarantee that medical technologies are safe for patients and healthcare professionals to use.

Despite Europe’s fundamental strengths in health and medical solutions, there are growing indicationsthat new and existing products will struggle to reach European patients and health systems in a timely manner: 17% of today’s in vitro diagnostics are expected to be discontinued in Europe, particularly among SMEs and approximately 50% of medical device manufacturers are deprioritising the EU market (or will do so) as the geography of choice for first regulatory clearance of their new devices.

MedTech Europe, the leading European medical technology trade association, believes that there are persistent, system-level issues within the European regulations for medical technologies which lead to unpredictability and delays, dampen innovation, and undermine confidence in the long-term viability of the regulatory framework.

To remain a global leader in medical technologies, the EU must deliver a more patient-centred and innovation-friendly regulatory framework that addresses the system-level challenges of today while preparing for the opportunities of tomorrow.

Getting through the maze 

Beyond the medical technology industry’s sector-specific developments, fundamental changes have been brought about in the last decade by the mega trends of digitalisation and sustainability. Such trends contribute to a revolution in the way innovation in medical technologies is happening, driving the need for a more forward-looking regulatory mentality to allow innovation to thrive.

Legislative activity of the EU in this area has been, rightly, immense – and much more needs to be done to ensure that all the rules-in-development which will impact medical technologies will actually work together to deliver products to patients. The EU’s Digital Strategy, driving regulation on artificial intelligence, cybersecurity, and data, including the European Health Data Space and the European Green Deal will legislate tectonic changes, including in the area of product design, are coming with a substantial set of new or updated requirements for medical technologies.

Against this background, substantial legislations are also being revised, such as the ones on Product Liability and Corporate Sustainability Due Diligence. It is paramount to include principles that ensure patients across the EU can benefit from a high level of protection and businesses are provided with legal certainty.

These new rules will significantly impact the way and speed in which technologies can be brought to market and accessed by those who need them. Getting medical technology innovations to European patients and healthcare systems in fact can often feel like navigating a complex and ever-shifting maze.

As a result, whether for R&D investment, clinical research, manufacturing or new product launches, Europe slowly losing ground to other geographies on innovation, because the maze seems to be getting harder to navigate. The EU thus has a big task ahead to further its efforts towards driving harmonisation and creating an environment of legal certainty for businesses.

The slowly approaching end of the EU legislative cycle is a unique opportunity to reflect on what has been achieved and what is still to be done. It is not a time to rush to the finish line but to stay level-headed and look for effective solutions to ensure medical technologies reach patients on time. We need to solve existing challenges in a comprehensive, sustainable manner, setting the tone for a future environment that will allow patients to continue benefiting from first-line, quality medical technologies and more equitable access to healthcare, and health systems to build the long-term resilience they need. The medical technology industry in Europe stands ready to contribute and collaborate to make this a reality.

This article was produced in partnership with Medtech Europe. MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health.

https://www.theparliamentmagazine.eu/news/article/empowering-patients-through-medical-technologies-for-a-healthier-future

A post-emergency COVID-19 vaccine strategy: WHO’s end of emergency declaration spells out hope but challenges remain

The declaration of the end to COVID-19 as a public emergency is a symbolic signpost, but COVID-19 remains a threat and vaccination can play a key role in addressing it.

The declaration of the end to COVID-19 as a public health emergency is a symbolic signpost of the transition from an emergency to a more sustainable mode of preparedness and reaction. COVID-19 remains a threat though, and vaccination can play a key role in addressing it.

Thirty-eight months into the pandemic, and COVID-19 claims a life every three minutes globally. This leaves no room for complacency.

Instead, we need, to remain vigilant, have a coherent approach on vaccination and continue reducing COVID-19 hospitalisations, severe disease, as well as protecting our healthcare systems.

In this regard, Member States should strive for a better coordination among their national vaccination strategies in order to avoid major differences, with the EU having a stronger role through further harmonisation of some aspects of the vaccine administration in the Member States.

At the same time, while predictable pattern of COVID-19 seasonality has yet to be established, the impact of the disease has been much higher during the period corresponding to the traditional influenza season. Therefore, where possible, COVID-19 and influenza vaccination campaigns need to be combined.

Second, we need to reflect on the use of joint procurement as part of the EU’s vaccine strategy.

The strategy has been one of the milestones of the EU’s response to the pandemic. It demonstrated the unity of the EU as a whole, facilitated access to a broad and diversified portfolio of safe and affordable vaccines, and saved the lives of more than a million Europeans since the end of 2020.

Capitalising on this success, we need to go one-step further and, seriously, consider extending it to treatments of very rare types of cancer, especially paediatrics, as well as some rare diseases.

Nevertheless, increasing public confidence in vaccination is a key prerequisite to reach these strategies’ objectives.

As EPP Coordinator at the COVI Committee, I find the major disparities in vaccination coverage between and within Member States as well as the resurgence of vaccine-preventable diseases, such as measles, quite concerning. In order to address these, we have to continue tackling misinformation and disinformation, and reduce vaccination hesitancy through science-based communication on the benefits of vaccination.

Last, we should not forget that these challenges are essentially global. The EU played a decisive role in the global response to the COVID-19, by donating hundreds of millions of doses, and billions of aid to assist developing countries.

Building on that, the EU has to continue playing its role in providing support, improving access to vaccines for LMICs, as well as, boost global health research to develop the technologies and countermeasures, which are necessary to improve health.

By Stelios Kympouropoulos

Stelios Kympouropoulos (EL, EPP) is a member of Parliament’s EMPL and PETI Committees, the SANT Subcommittee and the COVI Special Commmittee.

The Economics of Health for All and the Transformative Power of the Arts

In the first-ever report of its kind, the WHO Council on the Economics of Health for All has outlined a bold new path to reorient economies to deliver what matters – health for all.

The Council has put forward a bold new narrative grounded in new economic wisdom to reorient economies to deliver health for all across four interrelated themes:

  1. Value – valuing and measuring what matters through new economic metrics;
  2. Finance – how to finance health for all as a long-term investment, not a short-term cost;
  3. Innovation – how to advance health innovation for the common good;
  4. Capacity – how to strengthen dynamic public sector capacity to achieve health for all.

Meet the new WHO Goodwill Ambassadors for Arts and Health

The appointments of Fleming and Yende underscore the profound link between arts and health. Engagement in creative activities, such as music, art, and dance, positively impacts physical, mental health, social well-being, and overall quality of life.

Through their roles as Goodwill Ambassadors, Fleming and Yende will promote the integration of arts into healthcare systems, advocate for access to creative arts therapies, and champion the importance of artistic expression in improving health outcomes globally.

Health for All Film Festival

A shortlist of 93 films has been selected for the 4th Health for All Film Festival out of more than 780 entries received.

Watch the shortlisted films here. Winners will be announced on 6 June.

Key highlights from the Seventy-sixth World Health Assembly

As the world faces ongoing health and humanitarian emergencies, the Seventy-sixth World Health Assembly focuses on driving forward health for all. This year’s session of the World Health Assembly determines the immediate and longer-term future of WHO, starting with the program budget for the next two years, key decisions about the sustainable financing of the Organization and changes put in place to improve WHO’s processes and accountability. Delegates also deliberate about the critical role that WHO has in the Global Health Emergency Architecture.
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World Health Organization