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European Alliance for Personalised Medicine

HERA and Digital Markets Act point way forward for EU health




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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – EAPM held a very succesful conference concerning cancer on 18 September last week, ‘The need for change: Defining the health-care ecosystem to determine value’, with more than 167 delegates in attendance, and a report will be issued next week, writes EAPM Executive Director Denis Horgan.


The EU has created a crisis health authority to deal with future pandemics across the continent. The new Health Emergency preparedness and Response Authority (HERA) is designed to prevent, detect, and rapidly respond to health emergencies. According to the Commission: “HERA will anticipate threats and potential health crises, through intelligence gathering and building the necessary response capacities. 


When an emergency hits, HERA will ensure the development, production and distribution of medicines, vaccines and other medical countermeasures – such as gloves and masks – that were often lacking during the first phase of the coronavirus response.”

 European Commission President Ursula von der Leyen said: “HERA is another building block of a stronger Health Union and a major step forward for our crisis preparedness. With HERA, we will make sure we have the medical equipment we need to protect our citizens from future health threats. 

HERA will be able to make swift decisions to safeguard supplies. This is what I promised back in 2020, and this is what we deliver.” HERA activities will rely on a budget of €6 billion from the current Multiannual Financial Framework for the period 2022-2027, part of which will come from the NextGenerationEU top-up.


EU innovation fragmentation

EU security research is one of the building blocks of the Security Union. It enables innovation in technologies and knowledge that is crucial for developing capabilities to address today's security challenges, to anticipating tomorrow's threats and contributing to a more competitive European security industry. 

The Commission has decided to initiate a series of actions which will enhance the competitiveness of the European security industry and contribute to meeting the aims of the European security policy. In terms of overcoming the fragmentation of the EU security markets for security technologies, without the involvement, commitment and investment of the EU’s security technology and industrial base, innovative solutions would remain trapped in endless cycles of research and would never be deployed on the field.

Therefore, the consolidation of a single EU security market that increases the competitiveness of the industrial base is a primary objective. This consolidation would not only guarantee the security of supply for strategic technologies, but also safeguard, when required, the strategic autonomy of the EU for technologies, services and systems that are critical to ensuring the protection of EU citizens.

Cancer patients ‘protected by coronavirus vaccines’

Vaccinations against COVID are as effective and safe for people with cancer as for those without cancer, new studies suggest. Cancer patients have an “appropriate, protective immune response” to the jabs without “any more side-effects than the general population,” according to the European Society for Medical Oncology (ESMO). 

The researchers said that the studies show there is a need to promote vaccination in patients with cancer. The studies were carried out because people with cancer were excluded from vaccine clinical trials, due to their weaker immune systems as a result of undergoing anti-cancer treatments. Scientists said that a “multitude of studies” with similar conclusions will be presented today (21 September) at the annual ESMO Congress. 

An analysis of 3,813 participants with a history of past or active cancer in a randomised controlled trial of the BioNTech/Pfizer vaccine shows that the most common side-effects of vaccination were as mild – and occurred at a similar frequency – as within the overall trial population of more than 44,000 people.

Making the Digital Markets Act Fit for the Digital Age 

EU lawmakers are drafting a raft of important new regulations which will impact Europe’s digitising economy for decades to come. One of these proposals is the Digital Markets Act (DMA), expected to be adopted in the next term. 

Thousands of amendments were proposed to this regulation before the summer, many of which have been the result of MEPs trying to outdo each other on how tough they can be on ‘Big Tech’. But after the initial posturing, the hard work now starts on drafting legislation that actually works in practise: a DMA that supports the EU’s ambitions to be fit for the digital age. For Brussels to set the pace for tech regulation around the world will require a cool head, and a thoughtful approach. To be fit for the digital age, the DMA needs to be as dynamic and flexible as the sector it will regulate.

Parliament backs plan to phase out animal testing

On Wednesday (22 September), the European Parliament voted overwhelmingly in favor of a resolution that calls on the European Commission to draw-up an action plan to phase out animal experiments. This is a momentous political victory in a region where recent setbacks have occurred for animals in laboratories. 

Top on the list of setbacks is the revelation that the European Chemical Agency has disregarded the longstanding ban on animal testing for cosmetics by demanding additional animal data for dozens of cosmetic ingredients, which has already killed an estimated 25,000 animals. Humane Society International’s stop-motion short film Save Ralph has helped raise awareness on the fact that the public has been misled about the EU’s cosmetics ban. 

Many more animals may die in painful toxicity tests if the European Commission implements its Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, which as proposed would further cement the EU’s “tick-box” approach to chemical hazard assessment based predominantly on animal testing. 

The Parliament’s resolution correctly points out that non-animal approaches based on human biology are the key to better assess chemical safety. That is one of the reasons why, in the US, the Environmental Protection Agency has committed to phase-out its animal tests requirements by 2035, and the Humane Cosmetics Act is gathering steam in Congress. 

The resolution in favor of an action plan to phase out animal testing was championed by HSI/Europe and other animal protection groups, leading European scientists and companies. The overwhelming cross-party support shown by Members of the European Parliament reflects the growing dismay felt toward recent actions and proposals by the European Chemical Agency and the European Commission.

Happy news to finish: US opens up to fully vaccinated travellers 

The US is easing its coronavirus travel restrictions, reopening to passengers from the UK, EU and other nations. From November, foreign travellers will be allowed to fly into the US if they are fully vaccinated, and undergo testing and contact tracing. The US has had tough restrictions on travel in place since early last year. 

The move answers a major demand from European allies, and means that families and friends separated by the restrictions can be reunited. "It's a happy day - Big Apple, here I come!" French entrepreneur Stephane Le Breton told the Associated Press news agency, as he looked forward to a trip to New York City that had been put on hold because of the restrictions. 

White House COVID-19 co-ordinator Jeff Zients announced the new rules on Monday (20 September), saying: "This is based on individuals rather than a country-based approach, so it's a stronger system." "Most importantly, foreign nationals flying to the US will be required to be fully vaccinated," he said. US restrictions were initially imposed on travellers from China in early 2020, and then extended to other countries.

 The current rules bar entry to most non-US citizens who have been in the UK and a number of other European countries, China, India, South Africa, Iran and Brazil within the last 14 days. Under the new rules, foreign travellers will need to demonstrate proof of vaccination before flying, obtain a negative Covid-19 test result within three days of travelling, and provide their contact information. They will not be required to quarantine. 

That is all from EAPM for now – make sure you stay safe and well and have an excellent weekend, see you next week.

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



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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European Alliance for Personalised Medicine

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



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. 


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


·       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

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European Alliance for Personalised Medicine

Focus on IVDR for EAPM by engaging with stakeholders



Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week. As the year moves towards its end, EAPM will be focusing on the implementation of In Vitro Diagnostic Regulation (IVDR) by engaging with our stakeholders in organizing expert meetings with them...a more detailed update will come presently, but more information below, writes EAPM Executive Director Denis Horgan. 


As diligent readers of our update will know, a new EU regulation on In Vitro Diagnostics will come into effect in 2022 and will have a major impact on the evaluation and approval process of IVDs.

In this context, EAPM has organized a series of expert panels on which a report will be forthcoming.


Without some sustainable amendment to IVDR, there is a risk that any niche – and not so niche – IVD medical tests will disappear. Participants in the expert round table reported that some tests simply will not be available if the regime is enforced on the timings envisaged. "There will be real problems ahead." The participant added: "We don't know what tests we will have available next year." Already, availability is uneven across Europe. And now it is apparent that awareness of the impending difficulties also varies widely from country to country, with a high perception of the risks in The Netherlands but still only limited sense of urgency in Hungary.

In addition, companies that decide to seek national derogations for their products in order to maintain them on the market would be obliged to generate a tidal wave of paperwork that could overwhelm their own resources and create a logjam in national regulatory agencies, since there will be upwards of 20,000 products that will need certification for the first time.

Health committee votes through pharma strategy report

MEPs on the European Parliament’s committee on the Environment, Public Health and Food Safety today voted through a report on the Commissions pharmaceutical strategy.  The own-initiative report was passed with 62 votes in favor, 8 against and 8 abstentions. Authored by rapporteur Dolors Montserrat, Spanish MEP from the center-right European People’s Party, the non-binding text represents the Parliament’s input into the Commission pharmaceutical strategy.  


A draft of the report was first published in May and it called on the Commission to redefine incentives for drug development to take into account unmet patient needs. It also asks the Commission to improve price transparency, while still ensuring that the industry remains competitive.  On Monday MEPs passed so-called compromise amendments to the report — which are the result of negotiations between the different political parties in the Parliament. The amendments put a greater emphasis on conditions on public investment into research, antimicrobial resistance and resilient pharmaceutical supply chains. Other proposals include giving the European Medicines Agency greater oversight over drug and device combinations, as well as the creation of an action plan for advanced therapy medicinal products (ATMPS). Next, MEPs will vote whether to approve the report in a plenary session in November. Then, in late 2022, the Commission will publish its proposal to overhaul the EU’s pharmaceutical rules.

Health council

Europe’s health ministers meet today (12 October) in Slovenia — and virtually — for the Health Council, a day that will see EU health resilience at front and centre of discussions. Joined by Health Commissioner Stella Kyriakides, the ministers will discuss the hot button topic of resilient medicines supplies.

Health ministers will also discuss improving the response and preparedness to cross-border health threats; how to strengthen health systems under the EU Health Union banner; and of course, COVID-19 vaccination across the bloc.

ENVI ready to reinforce EU disease prevention

MEPs are ready to negotiate with member states to reinforce the EU’s disease prevention and control framework and jointly tackle cross-border health threats,* according to the ENVI plenary session. The proposal to extend the mandate of the European Centre for Disease Prevention and Control (ECDC) was adopted with 598 votes in favour, 84 against and 13 abstentions. EU member states should develop national preparedness and response plans, and provide timely, comparable and high quality data, MEPs say. They also want to ensure that the ECDC’s mandate is extended beyond communicable diseases to also cover major non-communicable diseases, like cardiovascular and respiratory diseases, cancer, diabetes or mental illness. The legislative proposal to strengthen the EU’s crisis prevention, preparedness and response when addressing future serious cross-border health threats was adopted with 594 votes in favour, 85 against and 16 abstentions. The COVID-19 crisis revealed that further work at EU level is needed to support cooperation between member states, in particular border regions, MEPs stress. The text also calls for clear procedures and more transparency for EU joint procurement activities and related purchase agreements.

Europe can’t agree on how to regulate tech giants

The question of how to regulate tech giants has been high on the agenda for most countries around the world, but a new report today says that Europe is struggling to answer it. The European Union has been working on its plans for several years, and appeared to have reached some kind of consensus last year – which would include limiting Apple’s powers in regard to the App Store, and could also place limits on its ability to acquire companies.  

However, the Financial Times reports that the outline agreement now appears to be unraveling, with arguments between right and left over the extent of the antitrust measures needed: Last year, the EU unveiled a radical blueprint for tech regulation that would put onerous responsibilities on the likes of Google, Facebook, and Amazon to clean up their platforms and ensure fair competition. But since then, the package of measures has become bogged down in the European parliament, and now risks being watered down and heavily delayed. There are even fears in Brussels that the new rules will not be in place before Margrethe Vestager, the EU’s competition and digital policy chief, leaves her post in three years. “It sounded like we had agreed but that is not the case . . . at all. We are a long way from having a common position on this,” Evelyne Gebhardt, a German MEP, said in exasperation during the debate

Medicines and vaccines regulators under scrutiny

Never before have the regulators of medicines — and vaccines — been under such pressure and scrutiny. Among those in the spotlight have been the European Medicines Agency’s vaccines lead Marco Cavaleri and Fergus Sweeney, head of trials and manufacturing at the agency.

It’s tough going, being in Europe’s network of regulators. The pandemic “is placing a sustained and intense demand on the EMRN’s resources,” the article states. With faster decisions, constant monitoring, clear and frequent communication, on top of regular work, “the resilience of EU medicines regulators has never been tested to this extent.”

An EU EUA? The U.S. has issued emergency use authorizations (EUAs) to vaccines and treatments during the pandemic to quicken access to promising solutions. Whereas the EMA has used rolling reviews to quicken assessments, and conditional marketing authorizations. But the agency is open to change. “EUA could in some circumstances provide an additional regulatory tool at EU level, giving more flexibility to EMA to respond to emerging threats and protect public health.”

Life science chiefs present G20 with health policy to-do list

On Friday (15 October), some of the world’s top leaders in the life sciences sector are presenting recommendations to Italian Prime Minister Mario Draghi, the chair of the G20, on how health systems should foster and adopt innovation.

Seizing on a moment when both governments and citizens are highly alert to the life-saving benefits of science and investing in innovation, the sector is setting out both what it needs to thrive and how health systems should adapt to reap the benefits.

“Health is wealth,” Sergio Dompé, president of the 130-year-old family business Dompé Pharmaceuticals and coordinator of the B20 Health & Life Sciences Task Force, told POLITICO. Countries need to view “health as an investment, not as an expense.”

For economies squeezed by the pandemic and facing huge health care backlogs, he said, wearable technologies could help detect and intervene early, preventing bigger problems. The report also recommends building more resilient supply chains through G20 partnerships and supports global collaboration on crisis preparedness. Countries should drive for environmentally sustainable health system solutions, it states.


After taking heavy fire last week at ENVI over the European Parliament’s exclusion from discussions on the formation and role of HERA — the EU’s new Health Emergency preparedness and Response Authority — Health Commissioner Stella 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. 

Good news to finish as a 100-year-old puzzle is solved

The 100-year quest to create a malaria vaccine has succeeded. In a historic day for medicine (6 October), the World Health Organization recommended the widespread roll-out of the new jab in sub-Saharan Africa. Pioneered in Brentford, west London, the vaccine is safe, cost-effective and cuts the chance of young people dying from what was, until 2020, the world’s most deadly infectious disease. The developers, GlaxoSmithKline, should be applauded for their commitment to provide 15 million doses a year at no more than 5 per cent above production cost. Scientists hope that this news will reignite the race to develop other malaria vaccines with even greater potential to stop the parasite.

And that is all for now from EAPM – stay safe, stay well, have an excellent week.

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