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Alleanza Ewropea għall personalizzati Medicine

EAPM: Konferenza virtwali kantuniera, In-Vitro Diagsnostic - Triq tal-blat quddiem!

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Aħna nużaw is-sinjal tiegħek biex nipprovdu kontenut b'modi li tajt il-kunsens tagħhom u biex intejbu l-fehim tagħna dwarek. Tista 'tħassar l-abbonament fi kwalunkwe ħin.

Good morning, and welcome to the latest update from the European Alliance for Personalised Medicine (EAPM). The upcoming virtual EAPM conference is just around the corner, we have an update on the Health Union Council conclusions and progress in Romania on coronavirus vaccinations, jikteb id-Direttur Eżekuttiv tal-EAPM Dr Denis Horgan.

Regulation of the European Parliament and EAPM
Konferenza virtwali

Next week, on 27 October, a virtual conference/webinar will take place, run by EAPM. The banner title is 'Destinazzjoni fil-vista: Nagħmlu tajjeb biex inġibu kura tas-saħħa personalizzata lill-pazjenti. We would take this opportunity to invite you to join us for this key event – more than 100 delegates are registered for the global conference from countries such as China, Japan, Brazil, Egypt, Canada, Ghana, US and of course the EU. You can register hawn u kklikkja fuq il-link biex tara l-aġenda hawn.

L-avveniment huwa maqsum f’erba’ round tables distinti li se jiffokaw fuq reġjun speċifiku – dawn ir-round tables qed iħarsu lejn kif ir-reġjuni qed jiffaċilitaw id-dħul ta’ mediċina personalizzata fis-sistema tal-kura tas-saħħa.

  • 08.00 – 10.30 CET: round table Ażjatiċi – Asja – Destinazzjoni fil-vista: Nagħmluha sewwa biex iġġib kura tas-saħħa personalizzata lill-pazjenti
  • 11.00 – 13.00 CET: Mejda tonda tal-Lvant Nofsani – Lvant Nofsani u Afrika- Destinazzjoni fil-vista: Nagħmlu tajjeb biex inġibu kura tas-saħħa personalizzata lill-pazjenti
  • 14.00 – 16.00 CET: round table ta' l-Ewropa – Destinazzjoni fil-vista: Nagħmluha sew biex tingħata kura tas-saħħa personalizzata lill-pazjenti
  • 16.30 – 19.00 CET: Mejda tonda tal-Ameriki Destinazzjoni fil-vista: Nagħmluha sewwa biex inġibu kura tas-saħħa personalizzata lill-pazjenti

Tista 'tirreġistra hawn u kklikkja fuq il-link biex tara l-aġenda hawn.

In-vitro diagnostic sector - proposed delay to new EU rules

Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR). The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delayed by one year a month before its original date of application in May 2020 due to COVID-19.

EAPM engaged with its stakeholders to understand these challenges. Some of these are outlined below.

reklam


The testing timetable

A remorseless mathematics is imposing itself on current attempts to adapt in time to the new rules. It takes more than 12 months to certify and get tests to bring a product to the market.  It takes 6-12 months for the manufacturer to prepare a technical file, and it takes 3-6 months for manufacturer and notified body to conduct a pre-conformity assessment and sign a contract. A notified body needs 9-12 months to generate a conformity assessment class B and C, with an additional time 4 months for certain categories, and 6 months for a companion diagnostic. Issuing the certificate takes the notified body 1 month. Then for the manufacturer to produce and market the device and for it to pass through the supply chain to the healthcare system and on to patients takes 6 months in the EU and 9-12 months or longer for international markets. These timelines can be subject to further delay because of the impact of the pandemic on human resources, studies and on-site audits, as well as the uncertainty for industry and notified bodies resulting from the lack of crucial EU-level guidance and the under-capacity of notified bodies, with many manufacturers waiting for their notified body to be designated. 

In consequence, for IVDs which rely on CE-marking, some tests will be certified on time. But many other IVD tests will not be certified on time – and these will need to come off the market or seek national derogations through new uncertainties. As an indicator of the gravity of the problem, in February 2021, 78% of IVD companies reported issues starting or completing certification. 

Threats to innovation

Longer term, an obstacle to innovation looms. If labs, health institutions and even companies developing their own tests in novel areas are required to obtain certification through what are currently uncertain – but certainly more onerous - processes, they may be discouraged from pursuing their studies, and innovation will be negatively impacted. Experts in the field suggest that molecular oncology itself is at risk.

There is a particular risk in the high number of LDTs that may be lost through IVDR, and this, said one researcher, "means losing a lot of innovation in human genetics." In what is a varied landscape for approval of testing in Europe, NGS testing for certain cancers is becoming broadly available, but validated in ways that would not meet IVDR requirements. Another participant concerned over the risks to innovation from inappropriate regulation commented that "NGS is here to stay and IVDR should recognise that." A company specialising in tests to monitor drug performance also warned that "the short timeline to a hard stop kills the motivation for new tests." And further cautions were expressed about the risk that the likely prioritisation for certification of existing products is likely to relegate work on innovative products to the back burner.

Nuqqas ta 'gwida

Many stakeholders expressed concern over the lack of clear guidance on the implications of the legislation, and on operational decision-making in the choice and use of tests. Among the key conclusions to emerge from the case examples were the need for guidelines on which technique to use in particular indications. .Guidelines would be valuable on specific mutations, for HTA as well as for certification, to provide a reference for common understanding at national, EU and international level. There is wide support for the development of consensus on a collective way of moving forward. The cases highlighted issues such as the pressure that is likely to emerge for clinicians to use a commercially available test that becomes available with a CE mark, even when it may not necessarily be better in terms of sensivity or specificity, as an LDT already successfully in use. As some stakeholders argue, it is good to move forward with some good in-house tests – and EU guidelines could clarify just which tests those should be. There is not a regulation that can cover every clinical scenario, it was argued. In addition, guidelines on what justifies one or another test will provide a greater degree of security for clinicians, and for patients.

Systemic ambiguities

As a patient representative pointed out – from bitter personal experience – the challenges in diagnosis are urgent not only in terms of technology availability, but also in terms of "the human factor", with significant gaps in training and awareness. His remarks reflected a widely-shared perception that diagnostics suffers from a high degree of incoherence across Europe and across medical disciplines and specialities, aggravated by divergent approaches to value definition of diagnostic tests and to their integration into healthcare and reimbursement systems. In many cases, the potential patient benefit – and healthcare system savings - from earlier diagnosis are ignored in evaluating tests. The relative autonomy of member state decision-making on diagnostic testing compounds the problems, it is argued, and makes it all the more important in the context of IVDR to strengthen the degree of coordination between national and EU levels. Overall, patients criticise the level of patient involvement in decision-making in diagnostics as insufficient. "It will be good to see quality and safety improved by IVDR," said the patient advocate, "but availability and reimbursement will not be solved by this."

F’aħbarijiet oħra ....

Health Union Council conclusions

The draft Council conclusions on the European Health union, put together by the Presidency, will be presented later this week in an informal videoconference of the Working Party on Pharmaceutical and Medical Devices.

Even before the coronavirus, much of Europe grappled with chronic staffing shortfalls in its health systems. It’s little wonder then that the conclusions seek support “for capacity building of professionals working in health authorities and on health systems, in particular for those in the early stages of their careers.” The draft conclusions invite member countries and the Commission “to further explore how the EU, in the context of the stronger European Health Union, could have a more strategic approach in global health and demonstrate a leadership role in the current post-pandemic negotiations at global level.” 

Commission launches consultation on AI liability

The Commission has launched a public consultation on the rules on compensation for damage caused by defective products. A specific focus will be on the use of Artificial Intelligence (AI) in products and services. The Commission invites interested parties to express their views on the revision of the Product Liability Directive and on whether other national liability rules still provide legal certainty and consumer protection in an age of smart and AI-based products and services. This is especially important since the safety of these products and services does not depend only on their design and production, but also on software updates, data flows and algorithms. The public consultation covers questions such as which economic operator should be liable for harm. Another important aspect is the upgrade and refurbishment of products and components, something that is becoming more and more important in our transition to a circular economy.

Romania demands help from EU to fight coronavirus

Romania has activated the EU’s civil protection mechanism, which provides help in emergency situations, and requested enough doses of monoclonal antibody drugs to treat 40,000 patients with COVID-19, the country’s health ministry ħabbret today (20 October). 

The request follows a phone call between Health Minister Attila Cseke and Health Commissioner Stella Kyriakides on Thursday. According to the minister, a number of countries have promised aid. 

Romania is the second-least vaccinated country in the EU, with only Mija 33 of its population having received at least one shot. It’s also dealing with its worst wave of coronavirus infections up until now, with over 700 daily new cases per million people. 

Il-Kummissjoni Ewropea qal that so far it is has delivered 5,200 vials of antibody drugs to Romania, sent from Italy, as well as 200 oxygen concentrators from the rescEU medical reserves, hosted in the Netherlands, and 50 oxygen concentrators from Poland. Denmark will be sending 15 ventilators and eight oxygen concentrators.

U dan kollu mill-EAPM għal din il-ġimgħa - tinsiex, tista 'tirreġistra għall-konferenza tal-EAPM tas-27 ta' Ottubru hawn u kklikkja fuq il-link biex tara l-aġenda hawn. Ibqa 'sigur, agħmel weekend eċċellenti, narawkom il-ġimgħa d-dieħla.

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