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European Alliance for Personalised Medicine

EAPM: Parliament pushes for more public-friendly plenaries, EU-US Trade and Tech Council promises key work on health, EU cancer disinformation and more…

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Good morning, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week - EAPM’s progress through the first half of 2021 has been solid, with the second half also picking up pace, as we turn the legislative pages of July into August, writes EAPM Executive Director Denis Horgan.

EAPM set to finalize three health papers

During August and onwards, EAPM will be finalizing three papers in the next months on the IVDR legislative revision, NGS/Molecular diagnostic implementation and the EU beating Cancer Plan, as well as the issues related to real-world evidence linked to the EU Health Data space and other policy dossiers.

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More interesting times for Parliament 

European Parliament President David Sassoli, meanwhile, wants MEPs to think about their institution’s future — and perhaps his own. “Time to rethink parliamentary democracy and our work,” he tweeted, adding that he aims to strengthen the institution with an exercise in self-affirmation, for post-COVID times and with the mid-term of the legislative period in clear sight. Sassoli wants Parliament to be engaged in a “broad reflection,” said an official from the institution, about the things it holds dear, including how to increase influence and visibility.

To that end, Sassoli launched a discussion process with five “focus groups” that he expects will deliver results before the summer break. Topics to be discussed, according to officials familiar with the exercise, include reforming the plenary sessions and ways to “foster dynamic debates.” MEPs are also invited to come up with ideas about how to strengthen the institution’s weight in a second focus group talking about Parliament’s prerogatives — that means “legislative and scrutiny powers and oversight, access to information and documents, and budgetary control,” said one official.

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And a new report from the European Parliament’s Beating Cancer Committee does not distinguish between cigarettes and novel tobacco products on key points, signalling a tighter position on tobacco control, with some lawmakers already mobilizing to challenge this. Once passed, the report by the BECA committee will serve as the institution’s position on the European Commission’s landmark Beating Cancer Plan. The plan aims to tighten tobacco control, as smoking continues to be one of the main risk factors for cancer deaths, causing 700,000 fatalities across the EU each year.

Last chance for EHDS feedback

On 3 May, the European Commission published a public consultation on the European Health Data Space (EHDS), which remained open until yesterday (26 July). As a policy initiative, the EHDS aims to provide a common framework across EU member states for the sharing and exchange of quality health data such as electronic health records, patient registries, and genomic data, in order to support healthcare delivery, but also to facilitate health research, policymaking, and legislation. Split into three sections: access and use of personal health data, digital health services and products, and Artificial Intelligence in healthcare, the consultation aims to gauge which policy options are preferred for the implementation of the EHDS. The legislative proposal resulting from this consultation is expected to be adopted in the fourth quarter of 2021. So today (27 July) is the last day for companies, lobbies, and associations to tell the Commission what they think about its upcoming legislation. The Commission will have to find the right balance between granting enough access to health data to boost innovation while keeping that data safe and private. 

AMR progress report

The European Commission has published its 5th progress report on the implementation of the European One Health Action Plan against Antimicrobial Resistance (AMR), which was adopted in June 2017. The key objectives of this plan are built on three main pillars: making the EU a best practice region; boosting research, development and innovation as well as shaping the global agenda. Addressing AMR through a One Health approach is also a priority for this Commission, as flagged in Commissioner Kyriakides’ Missionletter in November 2019. The progress report shows that a number of AMR initiatives have been continued or put in place in recent months. For example, the Commission has adopted in the EU Farm to Fork Strategy a target aiming to reduce by 50% the overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. This objective will be supported by the implementation of the recent Regulations on Veterinary Medicinal Products and on Medicated Feed for which implemented and delegated acts are currently being drafted.

EU-US Trade and Tech Council to start in September

Following European Commission President Ursula von der Leyen and US President Joe Biden’s launch of the EU-US Trade and Technology Council (TTC) at the US-EU Summit in Brussels in June, the TTC, from September, will serve as a forum for the United States and European Union to co-ordinate approaches to key global trade, economic, and technology issues and to deepen transatlantic trade and economic relations based on shared democratic values. This new Council will meet periodically at political level to steer the co-operation, and will, in the wake of the coronavirus pandemic, also seek to find ways for the United States and the EU to collaborate on cutting-edge health-care research and development. 

European Commission Executive Vice-President and Competition Commissioner Margrethe Vestager said: “We have common democratic values and we want to translate them into tangible action on both sides of the Atlantic. To work for a human centered digitisation and open and competitive markets. I very much look forward. This is a great step for our renewed partnership.”

EU digitalization

As part of a greater regional digital transformation strategy, the EU is working to (1) build a supportive ecosystem for emerging technologies; (2) develop regional digital infrastructure; (3) identify shared resources to invest in digitalization; (4) and amplify the region’s voice on digital policy matters in the European Union (EU) and the transatlantic relationship. Digitalization can serve as an economic multiplier by creating efficiencies in non-digital sectors. Institutionalizing interoperable digital solutions to cross-border commerce will allow the region to increase its economic efficiency and long-term competitiveness. But structural challenges are harming that economic potential. Labor shortages, wage and inflation pressures, and lagging home-grown innovation remain key problems that hamper economic—and digital—development. Data show the EU needs to catch up. The workforce lacks essential digital skills, and CEE companies lag behind those in other European countries in integrating digital solutions.

EU cancer disinformation

The European Cancer Organization congratulates the European Commission for its recognition of the great social harms that are created by online disinformation and its resolve to play an active role in combatting the most serious impacts via initiatives such as the Code of Practice on Disinformation. Disinformation can impact cancer care in many ways. Partially false, or misleading information about cancer treatments are common, and belief in health misinformation/disinformation may negatively alter a person’s cancer trajectory by influencing their medical decision making. Social media platforms are often a nexus for the spread of such disinformation. As an example, one research exercise found that of the 20 most shared articles on Facebook in 2016 with the word ‘cancer’ in the headline, more than half the reports were discredited by doctors and health authorities 

Good news to finish - EU vaccinates 70% of adults with one shot

The EU today (27 July) hit its summer target of vaccinating 70% percent of its adults against COVID-19 — depending on how you count it.

Seventy percent of adults in the EU have received one dose, while 57% are fully vaccinated, Commission President Ursula von der Leyen has announced.

Von der Leyen credited the EU with delivering on vaccines after a rocky start earlier this year, stating: “The EU has kept its word and delivered.”

“The catch-up process has been very successful — but we need to keep up the effort,” she wrote in a statement. “The delta variant is very dangerous. I therefore call on everyone — who has the opportunity — to be vaccinated.”

The EU’s goal has been a moving target. The Commission wanted 70% of adults vaccinated by the end of September, although it later indicated that this could happen in July. Earlier this month, the EU executive said countries have enough jabs to fully vaccinate their populations, but today’s announcement is based on one shot. 

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

European Alliance for Personalised Medicine

EAPM: ‘Value’ in health care - who decides? EAPM Oncology Round Table, register now!

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – with just three days left, your last chance is here to register for the upcoming EAPM event this Friday, 17 September, ‘The need for change: Defining the health-care ecosystem to determine value’ that will take place during the ESMO Congress, details below, writes EAPM Executive Director Denis Horgan.

Responsibility for policy formation

The event will take place from 8h30–16h CET on Friday; here is the link to register and here is the link to the agenda

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The conference will take into account the fact that new discoveries - generated from a deeper understanding of the human genome - is driving a paradigm shift in medicine from a one-size-fits-all approach to one which is personalised and targeted to the individual.

This shift is rapidly progressing in oncology but is slower in other areas. And, while there are many barriers to innovation in clinical practice - including market access, scientific, and/or regulatory challenges - the biggest challenge across the healthcare system is the issues related to early diagnosis, value and data.

The differing ideas about what constitutes ‘value’ in modern medicine is a hot topic for debate in Europe and beyond. 

How do we define it? How do we measure a human life – or quality of life - against the cost of a treatment? Do we judge the individual’s contribution, fiscally and otherwise, to society and weigh it against a price? And what about the moral issues involved in such judgments? And who would want to make them?

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Most of us would find that shocking, unfair and inhumane. Yet it happens in a broad sense.

Unfortunately, with an aging population of 500 million citizens, healthcare in the EU has never been more expensive. People are living longer and will, in most cases, be treated for not just one but several ailments during their lifetime. It’s a dilemma, and it won’t go away.

To understand ‘value’ one must first, of course, understand a treatment, plus any other treatment options, and consider what it (or they) can provide.

Patients, when they understand their options, will have their own views on what constitutes value, depending on their circumstances - “Will I get better? Will I live longer? Will my quality of life improve? What are the side effects?”. `

Payers, not surprisingly, when they weigh, as they do, benefits against cost and other considerations, may take a different approach. 

Meanwhile, manufacturers and innovators must operate within limits of ‘value’ that are as yet unclear. 

There is a solid argument that value should always be defined in respect of the customer, Value in healthcare depends on results and outcomes – vital to the patient -  regardless of the volume of services delivered, yet the value is always going to be seen as relative to cost.

All this will be addressed at our conference.  Here is the link to register and here is the link to the agenda.

Among the many speakers present will be Cristian Busoi MEP, ENVI Committee, European Parliament, Szymon Bielecki, DG CONNECT, European Commission and Stefan Schreck, Adviser for Stakeholders relations in DG SANTE, DG SANTE, European Commission.

On to other news....

Health Emergency Preparedness and Response Authority and the Parliament back in Strasbourg...

The European Health Emergency Preparedness and Response Authority (HERA) is intended to be a central element for strengthening the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures. But, according to Peter Liese, the EPP’s health spokesperson in the European Parliament, it doesn’t matter that HERA won’t be an EU agency, he told reporters on Monday morning (13 September). Establishing a completely new agency takes time, Liese acknowledged. “We need to act fast,” Liese said. The authority will instead be housed within the Commission. 

But an even bigger problem for many MEPs is the fact that they are unlikely to get to debate the proposals before they become law. According to the draft proposals, the Commission is proposing a Council regulation based on Article 122 of the EU treaties. This means the proposal would move through without MEPs’ sign-off. 

“HERA will build on EU funding,” which is taxpayer money, and thus has “EP competence to oversight it!” Green MEP Tilly Metz tweeted. 

MEPs have expressed anger after it emerged the European Parliament may not be consulted on the plans.

The backlash comes after the EU executive downgraded the authority to a “dedicated central structure” housed in the Commission, rather than a standalone EU agency.

Under the draft proposals, the emergency biomedical authority will be created using Article 122 as a legal basis — a provision under EU law that does not involve sign-off by the European Parliament.

That legal basis has been used during the pandemic to send emergency funds to EU countries, as well as for other regulations such as the creation of SURE, a program that provided unemployment assistance.

In its HERA draft proposal, the Commission justified its legal choice to “ensure the supply and the timely availability and accessibility of crisis-relevant medical countermeasures.”

One Commission official noted that HERA will be an internal Commission structure, thus “the Parliament isn’t involved”.

MEPs are not happy: “It is unacceptable that under the pretext of crisis emergency, the @EU_Commission and the @EUCouncil break again the spirit of the Lisbon Treaty and exclude the only democratically elected EU institution from the decision-making process,” French MEP Michèle Rivasi tweeted.

In addition, the results of the Parliament’s plenary vote on the proposals to strengthen the European Centre for Disease Prevention and Control (ECDC) and the regulation on serious cross-border health threats are imminent - MEPs discussed the proposal in the plenary Monday afternoon, with most showing support for the proposals.  

As to whether the ECDC should cover noncommunicable diseases (NCDs) in addition to infectious ones, Health Commissioner Stella Kyriakides is against the idea, arguing it could duplicate work done in the member countries and “it would substantially stretch resources within the agency, therefore weakening its focus rather than strengthening it”.

France wants to curb US access to EU data

France’s top cybersecurity official is pushing Europe to stop US law enforcement from accessing critical data stored within Europe by US cloud companies.

European cybersecurity authorities are developing rules for cloud providers like Amazon, Microsoft, Google and others that would impose tougher cybersecurity rules under a new certification scheme, including on data management.

Under an American law known as the CLOUD Act, US companies are obliged to provide foreign data to U.S. authorities if asked. But if Poupard has his way, new EU rules would prevent critical data from ending up with US authorities.

The rule “would exclude the standard American and Chinese services” from offering services in critical sectors in Europe, said Poupard. “This is not about turning our backs on partners. But it’s about having the courage to say that we don’t want non-European law to apply to these services.”

European governments are trying to grow less dependent on US cloud services as part of their drive toward “strategic autonomy,” the idea that Europe needs to keep control over technology policy, in part due to fears of spying and surveillance from the U.S.

The new cloud cybersecurity rule “will be a real test, a real objective for the political will to achieve strategic autonomy in the digital field,” Poupard said. “If we’re not capable to say this, the notion of European sovereignty doesn’t make sense.”

Poupard’s statements come two weeks before US and EU officials meet to discuss cybersecurity, data privacy and other issues at the first meeting of a newly-formed Trade and Tech Council, in Pittsburgh on 29 September.

At a gathering of digital leaders last week in Tallinn, Estonia, US Secretary of Commerce Gina Raimondo lamented Europe’s increasing tendency to impose laws and efforts to keep EU data from being shipped to the US.

“I hope that we can all agree that requirements to keep data localized in country hurt all of our businesses, all of our economies, and all of our citizens,” Raimondo said, adding that data flows were key for avoiding “very expensive threats and attacks” as well as commercial gains.

Good news to finish: Italy to start administering booster vaccine jabs

Italy will start administering a third shot of Covid-19 vaccines to the most vulnerable parts of its population this month, the country’s health minister said.

“There will be a third dose, we will start as early as September,” Roberto Speranza said on Monday at a press conference in Rome.

Last week Mario Draghi, Italian prime minister, said that his government was considering making COVID-19 vaccines mandatory for all people of eligible age. Italy has already made vaccines compulsory for medical workers.

The country has vaccinated just over 70% of all people aged over 12, and Draghi has said he hopes that will rise to over 80% by the end of September.

And that is all from EAPM - don't forget, here is the link to register for EAPM's conference on Friday, and here is the link to the agenda. Stay safe and well, see you soon!

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European Alliance for Personalised Medicine

EAPM: The need for change – EU to the fore on cancer, data governance and HTA

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Good afternoon, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the range of public health scenarios now.  The dramatic improvement in the health of the citizens of Europe over the last two centuries has transformed the continent and the lives of the people living in it. But is Europe able to seize the new benefits that science, technology and forward-thinking public-policy decisions could confer on current and future generations of Europeans writes EAPM Executive Director Dr. Denis Horgan or is it losing the will and capacity to grasp the fruits of progress?

The answer: Yes, EU policymakers makes strides forward with health – EAPM engages

As reflected in COVID 19, its science and technology are certainly not.  Health-care professionals still have a powerful sense of dedication. And research and industry function at an unprecedentedly high rhythm. What is missing from the picture is an overarching vision of how to – or even whether to - exploit all that potential.

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The key issues that EAPM has engaged with this week  and in the last months were on the issues of health data, HTA and cancer, which builds on our conference of 1 July, and the EU Health Data Space which EAPM has championed over recent years. 

EAPM has been actively engaging with a number of European politicians from across the political spectrum in the European Parliament, such as from the Health Committee and the ITRE committee, regarding cancer and the EU Health Data space dossiers.

As recently as this afternoon (16 July) hence the later update, sixty-six MEPs voted in favor with six abstaining to adopt the draft report on the EU data bill. They also received a mandate to negotiate with the Council.   

This is the first bill put forward as part of the EU’s data strategy aims to foster the exchange of data in the bloc and beyond.   According to the rapporteur EPP MEP Angelika Niebler a statement.“The vision is a ‘Schengen for data’, in which data can circulate without barriers and in accordance with European rules.”

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More on this below…. 

Parliament’s health committee votes through health threats report 

The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) has backed a draft report on how to tackle cross-border health threats. 

The vote passed with 67 in favour, 10 against and one abstention. 

The report, authored by French MEP Véronique Trillet-Lenoir of Renew Europe, sets out the Parliament’s position in negotiations regarding the Commission’s proposal to strengthen Brussels’ health emergency response powers, one of the three “health union” legislative proposals. 

It still needs to be ratified in plenary. Trilogues are expected to begin in the fall. The proposal would see the creation of a EU health crisis and pandemic preparedness plan and calls for recommendations for national plans that EU agencies would review. It would also strengthen the monitoring of potential disease threats through improved information gathering and create rules for triggering responses when an EU emergency situation is called. 

MEPs back ‘ambitious’ EU Cancer Plan 

To "support, co-ordinate and complement member states’ efforts to reduce the suffering caused by cancer", that is the hope expressed by the EU Cancer Plan, and that decisive action at EU level — the first of its kind since the early 1990s — can help head off a projected 24% increase in cancer deaths by 2035. 

Such a hike would make the disease the leading killer in the EU. 

The broad strokes of the plan are in line with a previous draft dating back to December which EAPM engaged with then also.   The importance of personalized medicine has been upgraded in the final text, with nearly two pages dedicated to the topic. The plan proposes a programme in 2023, funded through Horizon Europe, to identify "priorities for research and education in personalized medicine". 

Health Technology Assessment deal at last...

After several years, Europe has reached a landmark deal to carry out health technology assessments (HTA) on new products for the bloc. HTA is a research-based tool to support decision-making in healthcare. It works by assessing the added value of new or existing health technologies – medicines, medical devices and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis or treatment – when compared to other health technologies. According to the proposed legislation, member states will co-operate at EU level on joint clinical assessments and joint scientific consultations on health technologies. 

The new legislation calls for the creation of a ‘Member State Co-ordination Group’, with each country represented. The collaborative undertaking will provide valuable scientific information to national health authorities when it comes to decisions about pricing and reimbursement for a health technology, the Council indicated. 

Data regulation moving forward - back to a crucial issue of public trust

There are some signs that the COVID-19 pandemic has prompted people to rethink their attitudes toward sharing personal data when it is used to manage public health and provide essential services and infrastructure. Greater willingness to provide personal data could open up new opportunities and political will to accelerate the implementation of the smart city—an urban planning strategy that harnesses technology, artificial intelligence and data analytics to run cities more efficiently and sustainably.

But although the outlook around personal data may have shifted, there is still a long way to go to secure universal buy-in from all citizens, which will be needed for the potential of smart cities to be fully realized. 

Many remain reticent about making their personal details available for analysis. In a recent in-depth, global survey by White & Case of more than 50 senior professionals and investors working in the smart city space, opinion was split almost down the middle. 

Some 40% of respondents said they are comfortable with sharing/allowing access to personal data for the purposes of developing/improving smart city technology, with 40% saying they are not comfortable doing so and 20% undecided. 

The survey also found that 42% said they would be willing to accept reduced privacy for better services, versus a third who said they wouldn't, with 24 percent undecided. There are signs that the pandemic has prompted people to rethink their attitudes toward sharing personal data. 

Securing access to large volumes of personal data from city inhabitants, and having a clear framework in place for its use sits at the center of many smart city projects. Smart cities rely on the collection and analysis of mass data from citizens, their devices, urban sensors and utilities that can be used to manage traffic, transport networks, and power supply and public services more efficiently. 

Stronger cross-border health care

European MEPs on the parliamentary health committee adopted a set of improved rules to allow the bloc to react more quickly and effectively to cross-border health threats on Tuesday (13 July). 

That includes the EU reducing its dependency on the World Health Organization when declaring a pandemic. “We want to be able to declare our own health emergencies, if needed,” said Esther de Lange MEP, vice-chairwoman of the EPP Group responsible for Economy and Environment and this dossier. “If Europe needs to act, we must not delay measures and wait for the WHO.” Other measures adopted by ENVI included making cross-border planning and staff training mandatory; simplifying joint procurement of health products; and guaranteeing continuous health care for other diseases. 

Bad news at the end: ECDC - New coronavirus cases soar in the EU

The European Centre for Disease Prevention and Control (ECDC) urges EU citizens to get vaccinated and to adhere to the recommended number of doses. This is particularly important taking into account the spread of the Delta variant of SARS-CoV-2, the need to protect citizens, especially those at risk of severe COVID-19, and the desire to open up our societies and relax restrictions. 

European vacationers had hoped this year’s northern hemisphere summer would see unhindered movement and be largely free of travel restrictions, but countries across southern Europe are now scrambling to re-impose pandemic curbs amid alarm at rising cases of the delta variant, a highly contagious coronavirus strain first detected in India. Spain, Portugal, Greece, Cyprus and Malta were among the first countries to start reopening earlier this year but now they are tightening entry restrictions on vacationers who have not received both jabs. 

Abruptly announced restrictions are also adding to the woes to the continent’s airline, tourist and hospitality industries. They had been harboring hopes of a strong business rebound the next couple of months, enough to start repairing the severe economic damage the pandemic has inflicted on them.  

That is all from EAPM for now – don’t forget to check out our report on our latest virtual conference available here, and make sure you stay safe and well and have an excellent weekend, see you next week.

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European Alliance for Personalised Medicine

EU Beating Cancer project takes centre stage with draft report

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Good morning and welcome, health colleagues, to the second European Alliance for Personalised Medicine (EAPM) update of the week – as it stands, more than 150 people have now registered for our upcoming EAPM Slovenian EU Presidency conference on 1 July, so now is the time to join them and book your place before it’s too late, and we also have an update on the European Parliament’s draft report on strengthening Europe in the fight against cancer, writes EAPM Executive Director Dr. Denis Horgan. 

EAPM conference approaches - a reminder yet again...

The EAPM conference will act as a bridging event between the EU Presidencies of Portugal and Slovenia. The conference is divided into sessions which cover the follows areas: Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trus; Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data and finally not least, Session 4: Securing patient Access to Advanced Molecular Diagnostics.

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Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register here, and download your agenda here.

Battling cancer – Parliament’s key draft report

As mentioned in previous updates, the European Parliament has set up a special committee on beating cancer.  It has published its first draft report on the EU Beating Cancer Plan on the last day, which has included a number of items which the EAPM has advocated for in the last months representing key issues representing  the multi-stakeholder nature of its membership. 

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Subdivided into numerous articles, article 66 in the report is of particular attention to EAPM members, saying as it does that huge advances in biology have revealed that cancer is an umbrella term for more than 200 diseases, and that precision or personalised medicine can be made available through the drug targeting of various mutations. 

The report also considers that precision or personalised medicine, consisting of a treatment choice based on individual tumour biomarkers, is a promising way to improve cancer treatment, and encourages member states to promote the implementation of regional molecular genetics platforms and facilitate equal and rapid access to personalised treatment for patients.   

In addition, article 48 in the draft report calls on the Commission to promote, and on member states to strengthen, the role of general practitioners, paediatricians and primary care professionals, given their importance in patient referral to diagnostic tests and oncology specialists, as well as during cancertreatment and follow-up care; calls for the development of multidisciplinary decision-making in the framework of dedicated concertation meetings bringing together various cancer specialists. 

According to article 61, the provisional agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council on 22 June 2021 is welcomed, to harmonize access to innovative cancer diagnosis and treatments.

Perhaps most importantly, article 87 sees an urgent need for a European charter of the rights of cancer patients; calls for this charter to define the rights of cancer patients at every stage of their care pathway, i.e. access to prevention, initial diagnosis and throughout their treatment, and for it to apply equally to all EU citizens, regardless of the country or region in which they live.

In addition, article 105 looks to the ‘Cancer Diagnostic and Treatment for All’ flagship and puts a spotlight on the need for the use of the ‘next generation sequencing’ technology for quick and efficient genetic profiles of tumour cells, allowing researchers and clinicians to share cancer profiles and apply the same or similar diagnostic and therapeutic approaches to patients with comparable cancer profiles.

EAPM looks forward with enthusiasm to all forward progress being made in the fight against cancer.  In this context, EAPM is working on two publications with its experts on NGS and RWE which will  provide additional input/guidance to the European politicians which EAPM is working with. 

HTA political agreement

The Commission welcomes the political agreement on the Health Technology Assessment (HTA) Regulation reached by the European Parliament and the Council on 23 June. The Regulation will improve the availability of innovative health technologies such as innovative medicines and certain medical devices for EU patients, ensure efficient use of resources and strengthen the quality of HTA across the EU. Examples of health technologies include medicinal products, medical equipment and diagnostics. It will also facilitate business predictability, reduce duplication of efforts for HTA bodies and industry and ensure the long-term sustainability of EU HTA co-operation.

Welcoming the agreement, Commissioner for Health and Food Safety Stella Kyriakides made the following statement: “I am very pleased that the European Parliament and the Council have reached a long-awaited political agreement on the Health Technology AssessmentRegulation. The Regulation will be a significant step forward to enable joint scientific assessments of promising treatments and medical devices at EU level.”

Progress on vaccinations welcomed, but further effort urged

The European Council welcomes the good progress on vaccination and the overall improvement in the epidemiological situation, while stressing the need to continue vaccination efforts and to be vigilant and co-ordinated with regard to developments, particularly the emergence and spread of variants.

According to the draft European Council conclusions for the June 24-25 meeting, the Council stated that it “reaffirms the EU’s commitment to international solidarity in response to the pandemic”.

“All producing countries and manufacturers should actively contribute to efforts to increase worldwide supply of COVID-19 vaccines, raw material, treatments and therapeutics, and coordinate action in case of bottlenecks in supply and distribution,” the draft text declares.

The conclusions also reference recent agreements on travel within the EU, stating that member countries would apply these measures “in a manner that ensures the full return to free movement as soon as the public health situation allows.” The Council also plans to welcome the decision to set up a special session for the World Health Assembly to discuss a pandemic treaty, with the EU saying that it will continue to work toward a goal of a treaty.

WHO, WIPO and the WTO agree on intensified co-operation to tackle COVID-19 pandemic 

On 15 June, the directors general of WHO, WIPO and the WTO met in a spirit of co-operation and solidarity to map out further collaboration to tackle the COVID-19 pandemic and the pressing global challenges at the intersection of public health, intellectual property and trade.  Acutely conscious of the shared responsibility to communities across the world as they confront a health crisis of unprecedented severity and scale, the organizations pledged to bring the full extent of the expertise and resources of the respective institutions to bear in ending the COVID-19 pandemic and improving the health and well-being of all people, everywhere around the globe.  

Commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics, and other health technologies was underscored – a commitment anchored in the understanding that this is an urgent moral imperative in need of immediate practical action.  In this spirit, there was an agreement to build further on the long-standing commitment to WHO-WIPO-WTO Trilateral Cooperation that aims to support and assist all countries as they seek to assess and implement sustainable and integrated solutions to public health challenges.  

Within this existing cooperative framework, it was agreed to enhance and focus our support in the context of the pandemic through two specific initiatives - the three agencies will collaborate on the organization of practical, capacity-building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. The aim of these workshops is to strengthen the capacity of policymakers and experts in member governments to address the pandemic accordingly.  The first workshop in the series will be a workshop on technology transfer and licensing, scheduled for September. 

Long COVID concerns

More than 2 million adults in England have experienced coronavirus symptoms lasting over 12 weeks, such as respiratory problems and fatigue, government data suggests. It is double the previous estimate for long Covid. The research by the React-2 study, which has not yet been peer-reviewed, found that 37.7% of those who had symptomatic Covid experienced at least one symptom lasting 12 weeks or more, while 14.8% had three or more persistent symptoms. “The scale of the problem is quite alarming,” said Professor Kevin McConway, emeritus professor of applied statistics at the Open University. It comes as more than 16,000 new confirmed Covid cases were reported in the UK on Wednesday (23 June), the highest daily figure since early February. The newest figures showed another 19 people had died within 28 days of testing positive for Covid-19, bringing the UK total to 128,027. While death figures remain relatively low, the sharp rise in reported cases would appear to make it less likely that ministers will scrap most remaining Covid restrictions before the current four-week delay ends on 19 July. 

Switzerland to re-open 

While countries such as the UK delay their planned lifting of restrictions (as it stands, until 19 July in the case of the UK), Switzerland has announced an even more wide-ranging lifting of restrictions than previously planned. Citizens will no longer be required to work from home; they won’t have to wear masks or social distance at cultural and sporting events; and mass events can go ahead without restrictions on numbers or the need for masks if there’s a requirement for coronavirus certificates.

And that is all from EAPM for this week – have a lovely weekend, stay safe and well, and don’t forget to register here, and download your agenda here, for the EAPM EU Presidency conference on 1 July.

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