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€30 billion European Health Emergency Authority in place by start of 2022

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Today (16 September), the European Commission launched what it describes as the missing block in its overall architecture in its European Health Union, a Health Emergency preparedness and Response Authority (HERA) to prevent, detect, and rapidly respond to health emergencies.

Health Commissioner Kyriakides said that it was clear from the pandemic that people wanted the EU to do more. While the EU is now the most vaccinated continent on the planet and its vaccine roll out has been largely successful, Kyriakides said that the actions at the time were ad hoc and the pandemic had shown that a more structured approach is needed. 

Margaritis Schinas, Commission vice president, laid out the background and what he described as the “prophets of doom” trying to convince Europeans that it would not succeed, holding up a frontpage from The Economist showing a tattered European flag, at the top of a syringe, with the heading: “What has gone wrong?” The magazine was from April this year. 

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The EU’s slow start to vaccination at the beginning of the year was largely due to AstraZeneca’s (AZ) failure to respect its Advanced Purchase Agreement. A Belgian court later found in the EU’s favour declaring that AZ had intentionally breached the “best reasonable efforts” and the contractual warranty it gave.

At the start of the pandemic the EU had to take rapid decisions, despite an absence of competency and with the challenge of taking a common approach. It is hoped that the new authority will help overcome the challenges it faced to activate emergency funding and negotiate, procure and distribute medical supplies and vaccines on behalf of its member states. The new structure is designed to learn the lessons and build a more resilient system that is also able to look at other major threats, not just new variants of COVID-19 but other health challenges such as growing anti-microbial resistance to antibiotics. 

HERA is not a new EU agency, but an internal Commission structure, this is partly about ensuring it is fully operational by early 2022. A senior Commission official explained that this was so that it could be set up without delay. The Commission will involve the European Parliament closely in its operation, this is described in an additional decision. 

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HERA has access to  €30 billion, it will not require new money as such, but will draw its funding from the current Multiannual Financial Framework for the period 2022-2027, including the NextGenerationEU top-up (€6bn) and an estimated (€24bn) from other 

EU programmes. Its functioning will be reviewed and adapted on an annual basis until 2025, when a full review will be carried out.

“HERA has a clear mission: ensuring the availability, access and distribution of medical countermeasures in the Union,” said Schinas. “HERA is the EU's response for both anticipating and managing emergencies. HERA will have the clout and budget to work with industry, medical experts, researchers and our global partners to make sure critical equipment, medicines and vaccines are swiftly available when and as necessary.”

Internal Market Commissioner Thierry Breton said: “With HERA, we draw the lessons learned from the crisis: we cannot ensure our citizens' health without industrial capacity in the EU and well-functioning supply chains. We succeeded in upgrading COVID-19 vaccine production in record time, for Europe and the rest of the world. But we need to be better prepared for future health crises. HERA will establish new, adaptable production capacities and secure supply chains to help Europe react fast when needed.”

European Alliance for Personalised Medicine

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

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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.

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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.

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  • 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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European Parliament

EU Health: MEPs call for a future-proof EU pharmaceutical policy

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MEPs call for national and EU measures to guarantee all patients have safe and timely access to essential and innovative medicines, ENVI.

The Committee on the Environment, Public Health and Food Safety (ENVI) adopted on Tuesday, with 62 votes in favour, eight against and eight abstentions, its recommendations on the implementation of the EU’s pharmaceutical strategy and upcoming revisions to the legislative framework.

Addressing the root causes of shortages

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MEPs highlight the need for increasing the affordability and availability of medicines. This means addressing the root causes of shortages, increasing transparency on prices and public R&D funding, promoting collective price negotiations, and introducing measures to support a greater market presence for generic and biosimilar medicines.

MEPs insist that the Commission, member states and the European Medicines Agency should develop an early warning system for medicine shortages, based on a transparent and centralised digital European platform.

Increasing EU resilience and sustainability

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The report also stresses the need for the work of the pharmaceutical industry to be environmentally friendly and climate-neutral throughout product life cycles, while still ensuring patients have access to safe and effective pharmaceutical treatments.

Other recommendations include:

  • introducing an EU therapeutic guide for antimicrobials and coordinated awareness campaigns on antimicrobial resistance (AMR);
  • promoting “Made in Europe” pharmaceuticals by strengthening EU manufacturing and supply resilience;
  • developing adequate capacity for the sustainable production of active substances, raw materials and medicines which reduce dependence on external sources;
  • facilitating the launch of large clinical trials coordinated at the European level;
  • Setting up a wider political High Level Pharmaceutical Forum.

Rapporteur Dolors Montserrat (EPP, ES) said: “The report enhances the EU’s pharmaceutical strategy in view of the next revision and update of EU pharmaceutical legislation, putting patients at the centre of health policies. We must firmly tackle unmet medical needs and foster access to medicines, while promoting the sustainability of our national healthcare systems. At the same time, we must strengthen EU public-private partnerships for a strategically autonomous and resilient pharmaceutical industry, supported by an effective incentives system and ruled by a stable, updated and safety-centred regulatory system.”

Next steps

All MEPs will vote on the report during the November plenary session, the result of which will then feed into Commission’s proposals for the update of EU pharmaceutical legislation in 2022.

Background

On 25 November 2020, the Commission adopted a pharmaceutical strategy for Europe, a major initiative under the European Health Union. Its goal is to give the EU's pharmaceutical policy a long-term vision: to ensure it is crisis-resilient and sustainable, and to reinforce EU's position as a global leader while ensuring access to affordable medicines for patients.

Further information 

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European Alliance for Personalised Medicine

Innovation in genomics services and a global framework to realize this - EAPM Presidency Conference on 27 October – Register now!

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On 27 October, a virtual conference/webinar will take place run by the European Alliance for Personalised Medicine(EAPM). 

The banner title is 'A destination in sight:  Doing it right to bring personalised healthcare to patients’.  

We would like to 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 emphasize the importance of resilient health systems. 

Given the current global attention to the demands of an adequate healthcare system and the heightened interest in public health in general, this online 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. 

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The event is divided into four distinct round tables that will focus on a specific region at the following time which includes.

·       08.00 – 10.30 CET: Asian Roundtable

·       11.00 – 13.00 CET: Middle East Roundtable

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·       14.00 – 16.00 CET: Europe Roundtable

·       16.30 – 19.00 CET: Americas Roundtable

All times are in Central European times so you would need to take account of this in your respective timezone. 

On top of this, we will discuss the implications for personalised health, and how such solutions can be used to manage public health, diagnose and treat diseases as well as predict ill-health and how such solutions can be part of the toolbox to rebuild healthcare systems after the pandemic.  The conference takes a look at this landscape and will discuss a policy framework to facilitate and empower healthcare systems. The framework will look at the following issues:

·       Governance

·       Reimbursement • Infrastructure

·       Awareness

·       Privacy

·       Collaboration

·       Technology

Participants will hear from a variety of experts from the different regions globally, all of which aim to explore how governments can allocate resources between competing public health demands, and how available technologies can help.

We expect to use the discussions as a potential framework for generating policy dialogue between different regions.

Once again, we hope you will join us on 27 October and you can register here and click on the link to view the agenda here.  

For more information, please contact Dr. Denis Horgan, PhD, LLM, MSc, BCL
EAPM executive director, chief editor, Public Health Genomics EAPM, Avenue de l'Armee/ Legerlaan 10,1040 Brussels, Belgium T: + 386 30 607 281
Website

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