Medical Devices Made of Substances: an EU opportunity
A major opportunity to deliver innovation across the EU’s healthcare sector could be lost if implementing rules are used to hinder the application of the new Medical Device Regulation. Colin Mackay reports.
A recent event organised by Confindustria Dispositivi Medici, part of the Forum Risk Management in Florence, saw 300 participants - including healthcare professionals, regulatory agencies, policymakers and the public – discuss how patient access to innovative therapies provided by ‘Medical Devices Made of Substances’ (MDMS) is an opportunity.
MDMS are research-dense innovative products, marketed for the treatment of both established and new conditions. Thanks to the insistence of the European Parliament they are included in the newly approved Medical Device Regulation (MDR).
The implementing acts and other guidelines are under discussion which could potentially alter the applicability of the Regulation for these products if the scope to foster them changes.
Maud Perrudin, the Deputy Director General of AESGP, the European industry association representing the self-care industry, told attendees at the event that the new Regulation would provide the conditions for further improvement.
For this reason, any step back from the applicability of the MDR to MDMS would be to step back in a field where the EU has the potential to be world leader. As Europe’s demographics continue to shift to an older population, the strain on Europe’s healthcare services is continuing to grow.
Older patients often suffer complex health issues, compounded with many comorbidities. Many of these conditions can be managed through using MDMS. These take the form of tablets, syrups and creams, found on the shelves of pharmacies throughout the EU.
These treatments differ from drugs (medicinal products) and rather than having a pharmacological mode of action, they deliver their benefits through other means of action (such as chemical, physical, physiological), which have a particularly low risk profile.
“The challenge today for the European Parliament is to monitor the implementing acts. The parliament can and must ensure that the will of the European Parliament is preserved” Simona Bonafè MEP
While medicinal products’ action is due to one or more single active principles acting on specific targets within the body, MDMS do not have one single active molecule, but act on the body in a physiological way, since they are composed of many different compounds, which are all responsible for the therapeutic effect.
Their multi-target “complex” action is particularly relevant in the case of syndromes, complex diseases and certain everyday recurrent illnesses, where the symptoms may have more than one cause.
This different approach to treatment has been growing for several years and is increasingly gaining traction in many countries. In Italy alone, the MDMS sector supports 600 companies with a turnover approaching €1bn, and is increasingly attracting investment from large pharmaceutical companies.
Fernanda Gellona, Director General of Industry Association Confindustria Dispositivi Medici, Italy told attendees that “The new Medical Devices Regulation is a great opportunity for the sector and the healthcare system to develop innovative products with a physiological action and it will guarantee more safety for the patients. MDMS represent investment, research, innovation, jobs, GDP, as well as a therapeutic innovation.”
Within the MDR products are certified by notified bodies, which are conformity assessment bodies designated by the Commission in accordance with the Regulation.
“Medical Devices Made of Substances’ represent investment, research, innovation, jobs, GDP, as well as a therapeutic innovation” Fernanda Gellona, Director General of Industry Association Confindustria Dispositivi Medici, Italy
This approach offers valuable flexibility, helping speed these increasingly needed products to the patients and stimulating innovation. “I have worked in the pharmaceutical Competent Authority for 13 years before my over 20 years involvement in the medical device Authority”, said Marcella Marletta, General Director of the General Management for Medical Devices and Pharmaceutical Service at the Italian Ministry of Health.
She added, “Medical devices made of substances will not be able to comply with the regulatory requirements of drugs because they have different characteristics which do not match the requirements for drugs. As drugs, they shall never see the market.”
It is clear to Italy, that the medicinal product regulation is not fit for complex substances. Prof. Alessandro Mugelli, Past President of the Italian Society of Pharmacology said, “Demographic change requires different therapeutic approaches. Pharmacologists are open to studying new products with new methods, such as systems biology, so as not to lose the opportunity to develop highly needed therapeutic products with different mechanisms of action.”
Addressing participants at the opening session of the event, Italian MEP Simona Bonafè said she believed that the European Parliament should and must monitor the application of the MDR, pointing out that “We know that certain countries are pushing to protect traditional sectors at a time when we need breakthrough innovation”.
It is important to ensure, at this stage of implementation, that the will of Europe’s decision makers – not least the European Parliament – is respected.
“We need to be sure that the rules we create help broaden the horizon of opportunity for EU companies in other markets, outside Europe” Antonio Tajani MEP
The Parliament had strongly advocated to keep MDMS within the MDR and an interpretation that provided a proportionate approach. “The challenge today for the European Parliament is to monitor the implementing acts. The parliament can and must ensure that the will of the European Parliament is preserved. There are Member States that tend to force the Regulation tangles to safeguard and defend the more traditional sectors.”
Indeed, the innovative nature of the sector is an area of particular concern. Europe boasts considerable expertise in the sector, with the potential to become a global leader in innovating MDMS.
Former European Parliament President Antonio Tajani pointed to the European Commission’s stated ambitions in research and innovation; health must be part of this.
He said, “We need health care for citizens, prevention and treatment of diseases are important and for that we need all tools, and it is good that the MDR has been approved; this will allow us to realise its potential.”
The Italian MEP said, “The EU budget on research, the new research and innovation framework programme Horizon Europe, should be used to promote research in the sector”.
However, he warned that: “We need to be sure that the rules we create help broaden the horizon of opportunity for EU companies in other markets, outside Europe”, adding that “We have to be committed in Europe to guarantee that our companies can access other interested markets outside the EU. Otherwise, we risk allowing Chinese competition to usurp our existing ties with Third Countries.”
The message from the event was clear; maintaining the current status of MDMS is vital. MDR or nothing. Today, patients and practitioners depend on these products for their self-care as well as prescription treatments, especially in delicate populations such as children and the elderly.
In the near future, these innovative products could fill the gaps left by drugs for a synergic therapeutic action, which could benefit the European and worldwide population, which faces increasingly complex conditions such as syndromes and comorbidities. If this is not allowed to happen, it will be an important opportunity lost.
In association with Confindustria Dispositivi Medici
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