Global Virtual conference around the corner on PM, delay on IVDR, HTA Update, 1,537 Amendments on European Parliament cancer report

Good afternoon, and welcome to the latest update from the European Alliance for Personalised Medicine (EAPM), in which we touch on the upcoming virtual EAPM conference, the delay in IVDR and progress being made on cancer, writes EAPM Executive Director Dr. Denis Horgan.

Global Virtual conference on PM - Register now!

On 27 October, a virtual conference/webinar will take place, run by EAPM. The banner title is 'A destination in sight: Doing it right to bring personalised healthcare to patients’. We would take this opportunity to invite you to join us for this key event.  You can register here and click on the link to view the agenda here.

The coronavirus outbreak provides health stakeholders with an unparalleled opportunity to examine and emphasise the importance of resilient health systems. 

Given the current global attention to the demands of an adequate health-care system and the heightened interest in public health in general, this virtual conference will address what can be done to ensure that the health systems are resilient enough to not only handle shocks like a global pandemic but also respond those underlying forces that are shaping healthcare needs of cancer patients. 

The event is divided into four distinct roundtables that will focus on a specific region – these round tables are looking at how regions are facilitating bringing personalized medicine into the health-care system.

• 08.00 – 10.30 CET: Asian round table – Asia - A destination in sight: Doing it right to bring personalised healthcare to patients 
• 11.00 – 13.00 CET: Middle East round table – Middle East & Africa- A destination in sight: Doing it right to bring personalised health care to patients 
• 14.00 – 16.00 CET: Europe round table – A destination in sight: Doing it right to bring personalised health care to patients 
• 16.30 – 19.00 CET: Americas round table A destination in sight: Doing it right to bring personalised health care to patients 

You can register here and click on the link to view the agenda here.

Commission delays IVDR start by three to five years

The European Commission has proposed extending the deadline for switching to new in-vitro medical devices rules — including for COVID-19 tests — to avoid supply shortages.

“Shortages at this point in time are unthinkable,” Stella Kyriakides, Commissioner for Health and Food Safety, said in a statement.

The In Vitro Diagnostic Medical Devices Regulation was due to apply from May 26, 2022. But there is a serious shortage in the capacity of notified bodies to certify all existing products on the market.  That’s made it impossible for manufacturers to conduct the legally required conformity assessment procedures in time.

The extension to the application of the new certifying rules will now vary depending on the type of IVD product, the Commission said.

Higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), will now have a transition period until May 2025 and 2026, respectively, while lower risk ones such as class B and A sterile devices, have a transition period until May 2027.  This would lead to significant test shortages at a time of unprecedented demand, with COVID-19 tests falling into IVD test categories. Most at risk are smaller companies, the lobby group said: “The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices.”

These are issues that the European Alliance for Personalised Medicine have put forward over the last months which will be brought to the attention of policy makers. 

It was highlighted during EAPM  expert panels that overall, across the diagnostics sector – and that includes authorities as well as laboratories and manufacturers - significant gaps remain in the necessary preparations, with the risk (and even the inevitability, in some cases) that supply difficulties will emerge, delaying clinicians' access to testing and patients' access to accurate care. "The number of notified bodies is insufficient and they do not have enough of the right staff" is a frequent complaint. 

Manufacturers are already finding difficulty in identifying a notified body for some of their products, and there is particular scarcity of expert panels to provide certification for the more advanced IVDs, as well as insufficient EU reference laboratories. And there are neither clear guidelines on many areas of decision-making, nor wide consensus on possible solutions to the challenges the regulation poses. 

The EU has deliberately provided measures in the 2017 legislation that were designed to ensure a smooth transition and to avoid market disruption. However, those measures now appear insufficient, and the transition is not likely to be smooth. Success depends on a functioning regulatory system being in place. 

Since that is manifestly not the case at present, it is unsurprising that operating under IVDR with Europe's inadequate infrastructure has been likened to sailing a boat while it is being built.

EAPM will be reviewing this revised proposal from the Commission over the next weeks. 

European Parliament Cancer report amendments take centre stage - 1,537 Amendments...

MEPs in the European Parliament’s cancer committee gathered on Thursday (14 October) to discuss proposed amendments to the draft cancer report authored by French MEP Véronique Trillet-Lenoir (Renew Europe). Cancer Committee Chair Bartosz Arłukowicz noted the large number of proposed amendments — 1,537 — as indicating the interest in the report and the need for the committee. 

“We need to make sure that this document is as precise as possible and clearly delineating the path forward,” he said.

As far as EAPM is concerned, we are following the situation closely and working continuously with the European Parliament. EAPM will be reviewing all amendments made and working relevant MEPs with respect to finding a consolidated and compromise approach. 

Of course, diagnostics, public health genomics, real world evidence, access and lung cancer screening as well as prostate cancer screening are high on our political agenda.

Health Technology Assessment

Before the end of the year, the European Parliament is expected to vote in plenary to endorse Europe’s Health Technology Assessment Regulation that was agreed in June between the parliament and Council.

A new EU HTA consortium has been set up and recently won a Commission contract to develop the methodology to perform EU health technology assessments. The EUnetHTA 21 consortium comprises 13 HTA bodies from across the bloc, and it has two years to come up with an assessment that works for all.

Following in the footsteps of medicines regulation, Europe’s HTA bodies have also set up a voluntary Head of Agencies Group that will serve as a support network as work on implementation progresses.

Next year, the Commission will establish a co-ordination group to devise the infrastructure for the new system. National systems also need to prepare how to integrate the new regulation. But there is still time; it comes into effect in 2025.

Conclusions on health union focus on medicines

A version of the ‘Draft Council conclusions on strengthening a European Health Union’, dated 13 October, focuses on drug repurposing, anti-microbial resistance and pharmaceutical resilience, among other topics.

Supply chain challenges that lead to reduced access and availability of medical products, which have been exacerbated by the COVID-19 pandemic, is another area of focus for the agency. The European Medicines Agency (EMA) intends to work with the member states, the Commission, the Parliament, other EU Agencies and patients and healthcare professionals to find ways to improve access and availability, which are today a daily issue across all therapeutic areas.
 
Integrating digital technology into regulatory processes is another goal of the agency, according to the report, with a focus on integration with external stakeholders to create a seamless platform for the Network within the next five years.

The draft conclusions invite the Commission to assess the potential benefit of organizing EU-level public not-for-profit manufacturing of antimicrobial drugs in cases of “in the case of lack of commercial interest.”

They also call on both member countries and the Commission to “support further the elaboration and piloting of a ‘pull’ incentive mechanism for antibiotic procurement in the EU”.

Good news to finish - India to allow foreign tourists after 19 months 

India is set to reopen its borders to overseas travellers as it relaxes Covid-related restrictions amid a drop in daily infections.  Starting Friday, the country will grant tourist visas to travellers arriving on chartered flights.  The facility will be extended to those arriving on commercial flights from 15 November.  Foreign tourists who land in India on Friday will be the first to come into the country in 19 months.  

And that is all from EAPM for this week – don’t forget, you can register for the 27 October EAPM conference here and click on the link to view the agenda here. Stay safe, have an excellent weekend, see you next week.

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