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European Alliance for Personalised Medicine

Spring is in the air as EAPM prepares for EU Presidency conference




It is a hopeful time of year for the European Alliance for Personalised Medicine (EAPM) as spring finally unveils itself across the EU and  coronavirus vaccinations proceed apace, writes EAPM Executive Director Dr. Denis Horgan.

New newsletter, 9th EU Presidency Conference

The latest EAPM newsletter is now available for your attention, and it has much in there to grab your attention, such as a link to a lung cancer factsheet, news of the Europe Beating Cancer Plan, information and a link concerning tumour agnostics, and a link to the recent EAPM report on its serology round table. Click here to access the newsletter.

But, most importantly, on 8 March, EAPM will be hosting its 9th EU Presidency Conference. Naturally online, the conference will run from 9-16h, and is entitled ‘Forward together with innovation: The why, what and how of tackling the Implementation Gap for health care in the EU Portuguese Presidency’.

Many of the points raised in this update and in the newsletter will be discussed in the upcoming conference, which will feature a wide range of keynote speakers from across the EU, including Christine Chomienne, vice chairwoman of the Mission Board Cancer at the European Commission, Ortwin Schulte, Health Attaché, Permanent Representation of Germany to the EU, Ceri Thompson, Deputy Head of Unit DG CNECT H3: eHealth, Well- being and Ageing , Gilad Vainer, Molecular Pathologist, Hadassah Medical Center, Israel  and Stephen Hall, regional director, Precision Oncology (CDx), Oncology Region Europe, Novartis.

Registration is still very much open, click here to register, and click here for the agenda.

Commission to propose digital green pass for travel

The European Commission has announced that it will present a legislative proposal for a Digital Green Pass on 17 March. The certificate will contain proof that a person has been vaccinated, results of tests for those who couldn’t get a vaccine yet and may also consider recovery from COVID-19. The Digital Green Pass is aimed at enabling the safe movement of people across the European Union, or further afield.

Asked about the proposal, European Commission spokesperson Christian Wiegand said that if the passes were to be in place by the summer, member states would need to move quickly in their preparations and rollout. He said that countries had already agreed on basic data requirements. The European Commission would take a co-ordinating role ensuring high security standards and helping to connect different national health services.

EU to speed approval of variant-modified coronavirus vaccines

The European Union will fast track approvals of coronavirus vaccines adapted to combat mutations, Health Commissioner Stella Kyriakides has said.  “We have now decided that a vaccine that has been improved by the manufacturer on the basis of the previous vaccine to combat new mutations no longer has to go through the entire approval process. So it will be faster to have suitable vaccines available without compromising on safety.”

The European Commission has come under fire from EU member states over delays to deliveries of vaccines which has seen the bloc lag behind countries such as Britain, a former member, and the United States. Kyriakides is a member of a new task force, led by Industry Commissioner Thierry Breton, to eliminate bottlenecks in production plants and adjust output to new 

EU leaders face coronavirus ‘fatigue’

Despite the slow vaccine rollout in Europe, delayed by almost a month compared to former member the UK, Commission President Ursula von der Leyen said the bloc still aims to inoculate 70% of all adults — around 255 million people — by September.

“This is a goal that we are confident we will reach,” she said.

Border checks remain a sore point. Divisions among EU member countries, including Germany, Austria, Belgium and the Czech Republic, on restrictions to stave off transmission has again raised the specter of travel delays and long traffic backups in a bloc that prides itself on being a seamless market. Michel told reporters that “non-essential travel may still need to be restricted, but measures should be proportionate.”

The leaders were also updated on the movement of fast-spreading new variants of the virus within Europe, with the so-called U.K variant now present in 26 member countries. The variant first detected in South Africa has been identified in 14, while the Brazilian type is known to be in seven. This means that restrictions could well continue through coming months.  “There is a growing COVID fatigue among our citizens. It has been a very trying year, but we should not let up now,” said von der Leyen.

Choosing better lung cancer treatments with machine learning

Researchers say that machine learning could help guide health-care workers’ treatment decisions for lung cancer patients after developing a model that is 71% more accurate at predicting survival expectancy of patients. A team of Penn State Great Valley researchers conducted a study in which they developed a deep learning model that is more than 71% accurate in predicting survival expectancy of lung cancer patients, which is significantly better than traditional machine learning models that the team tested which have around a 61% accuracy rate. Deep learning is a type of machine learning that is based on artificial neural networks, which are generally modelled on how the human brain’s own neural network  functions. 

The team say that the information on a patient’s survival expectancy could help guide doctors and caregivers in making better decisions on using medicines, allocating resources, and determining the intensity of care for patients. The machine learning model is able to analyse vast amounts of data and can include information such as types of cancer, tumour size, the speed of tumour growth, and demographic data.

Next few weeks ‘difficult’ – Michel

EU leaders have discussed how to accelerate the production and rollout of vaccines, amid fears over more transmissible mutations triggering a new surge in cases across the bloc."We know that the next few weeks will continue to be difficult as far as vaccinations are concerned," said 

European Council president Charles Michel. “But we do have the means, we have the resources, we have the capability to succeed over the next few months," he added. More than 50 million doses have so far been delivered to EU member states, which have administered 29 million jabs (almost 7% of the bloc's population), according to the European Commission.

The EU vaccine strategy has come under fire over the slow pace of immunization programmes in member states, compared to the UK, the US, or Israel. Brussels aims to vaccinate at least 70% of its adult population by the end of September but has struggled to receive the doses agreed with 
pharmaceutical companies. 

Following recent delivery delays, EU leaders stressed that predictability was crucial to organising national inoculation programmes, urging vaccine-developers to respect contractual deadlines.

Protecting European consumers: Safety Gate efficiently helps take  dangerous COVID-19 products off the market

The European Commission published its annual report on the Safety Gate, which is the EU rapid alert system helping to take dangerous non-food  products off the market. The report shows that the number of actions taken by authorities following an alert is growing year by year, reaching a new record number of 5,377, compared to 4,477 in 2019.9% of all alerts raised in 2020 concerned products related to COVID-19, mostly masks meant to protect but failing to do so. Other examples for dangerous COVID-19 related products notified in the Safety Gate are disinfectants containing toxic chemicals, such as methanol that can lead to blindness or even death if swallowed, or UV sanitizers that exposed users to strong radiation causing skin irritations.

And that is everything from EAPM at the start of the week – remember EAPM’s EU Presidency Conference on 8 March, click here to register, and click here for the agenda. Stay safe, stay well, see you later in the week.

European Alliance for Personalised Medicine

EAPM: Lockdown loosening, third wave warnings




Welcome, dear health colleagues, to the first post-Easter update from the European Alliance for Personalised Medicine (EAPM). We hope you all had an excellent break and, if you are based in one of the more fortunate countries such as the UK, that you are beginning to enjoy the release from coronavirus lockdown restrictions. EAPM certainly has some busy months ahead, looking forward to work on Next Generation Sequencing (NGS) and Real World Evidence (RWE). That is for the future – for now, here are the updates on the leading health stories of recent days, writes EAPM Executive Director Dr. Denis Horgan.

Not-quite Single Market for medicines

It’s not just inequalities in the distribution of vaccines that is causing worries. A group of MEPs have written to the Commission to push for more equitable access to medicines in the EU, maintaining that currently there’s no “no genuine Single Market for pharmaceuticals”. The current EU rules create unfair discrimination against member states with smaller health systems and pharmaceutical markets. The decision to effectively place a product on the member states’ markets is solely based on the pharmaceutical companies’ commercial and economic interests. While the current legislation provides the industry with the right to place their products on the markets of all member states, there is no mirroring right entitling the member states to get access to those products that have been authorised and placed on the EU Single Market.

It is a known fact that unfortunately private companies often have no interest or incentive to place a medicinal product in the small member states. This situation creates difficulty in accessing affordable medicines for certain patients, higher prices, and often even the withdrawal of particular products. This scenario which is faced by multiple states has resulted in a long-standing structural problem and most member states have joined regional groupings like the Valletta Declaration to try and combat this issue.

Long-term effects of COVID-19

What are the long-term side effects of COVID-19?

Most people who have had COVID-19 expect their symptoms to disappear after a few weeks, but some continue to experience effects months after recovery. People who suffer from persistent symptoms after recovering from the acute illness, also known as “long-haulers,” are often healthy prior to getting infected with COVID-19. This can occur in up to 10% of those infected with the virus.

Common long-term COVID-19 symptoms include:

  • Shortness of breath
  • A lingering cough
  • Chest pain and heart palpitations
  • Dizziness and lightheadedness
  • Fatigue with limited ability to exercise or even perform activities of daily living
  • Joint and muscle pain
  • Loss of taste and smell
  • Sleep disturbances with insomnia and sleepiness during the daytime
  • Gastrointestinal symptoms, such as difficulty swallowing, irritable bowel syndrome (IBS) and indigestion.
  • Depressed mood and anxiety

Because long-term effects of COVID-19 vary from person to person, it is difficult to determine when they will end. The best approach is to be evaluated by your physician or a specialized post-COVID clinic – especially if you have persistent symptoms that are affecting your quality of life. It is also important to seek help if symptoms of anxiety, fear and depressed mood develop.

Digital Green Certificates

The Digital Green Certificate will be a proof that a person has been vaccinated against COVID-19, received a negative test result or recovered from COVID-19. It will be available, free of charge, in digital or paper format. It will include a QR code to ensure security and authenticity of the certificate. The Commission will build a gateway to ensure all certificates can be verified across the EU, and support Member States in the technical implementation of certificates. Member States remain responsible to decide which public health restrictions can be waived for travellers but will have to apply such waivers in the same way to travellers holding a Digital Green Certificate.

Values and Transparency Vice President Věra Jourová said: “The Digital Green Certificate offers an EU-wide solution to ensure that EU citizens benefit from a harmonized digital tool to support free movement in the EU. This is a good message in support of recovery. Our key objectives are to offer an easy to use, non-discriminatory and secure tool that fully respects data protection. And we continue working towards international convergence with other partners.”

Germany’s ICU beds filling up

It has been noted that Germany's seven-day incidence rate had dropped, possibly because of the Easter holidays, but that the number of occupied ICU beds across Germany was increasing "much too quickly".

During the first wave of the pandemic, the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) set up a central registry that records and publicizes the situation in hospitals, or rather in intensive care units, on a daily basis.

A glance at the current map shows that the situation is critical again in some towns and municipalities, meaning that less than 10% of intensive care beds are free — and in some cases none at all. DIVI President Gernot Marx gave a clear statement during a press conference: "Every single day counts; we quickly need a hard lockdown of two or three weeks to lower the number of cases and give us more time for vaccinations."

UK risks third wave

Experts are warning that the UK is risking a third wave as it reopens pubs, hairdressers, outdoor attractions and shops as of 12 April. While prevalence of COVID-19 has fallen to an average of 30.7 per 100,000 across the country, there are hotspots where that rate is double. “However, many people [in those areas] cannot afford to self-isolate,” said Stephen Griffin, of Leeds University medical school. “We need to tackle that issue urgently or the virus will come back again.”

Euthanasia bill fails in France

A bill that would have allowed euthanasia for people with incurable diseases failed last week in France’s National Assembly, despite clear majority support. Because the bill was put on the agenda on a day reserved for a minority group, the chamber had until midnight to pass it. To nip the bill in the bud, a handful of MPs wrote up thousands of amendments to it, making it impossible to debate in a single day.

Romanian hospitals under pressure

According to Romania Insider, Romanian hospitals are overwhelmed. Speaking on Sunday (11 April), Health Minister Vlad Voiculescu said that there were 167 children in hospital — 16 in intensive care — with the minister explaining that they were implementing several measures to manage the cases. According to local media, these include using beds in hospitals that the government had tried to keep for other conditions, such as a cancer institute and another facility for chronic conditions. Voiculescu urged people to wear masks, avoid crowds and stay at home to try and reduce pressure on the health care system. 

Best-case expectations for Q2

In a perfect world, the EU should receive around 470 million doses of approved vaccines by the end of the second quarter. Still, few EU officials believe everything will go according to plan. “We have seen from past experience all sorts of things can go wrong,” said one diplomat this week. One ongoing source of tension is that these second-quarter doses won’t be distributed equally across the EU, because some countries purchased fewer doses than they could have based on their pro-rata allocation. Many smaller and poorer countries, for example, banked heavily on the cheaper Oxford/AstraZeneca jab and purchased fewer mRNA vaccines. Richer countries, like Germany, Denmark and Malta, bought the surplus instead.

And that is everything for now from EAPM – stay safe, stay well, enjo lockdown easing if you can, see you later in the week.

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EU pharma rules, EAPM newsletter and treaties




Another Easter is around the corner, a further EAPM dispatch for your delight and delectation…and more developments in the current COVID-19 crisis as a new holiday looms. With the aforementioned Easter weekend coming up, it will be interesting to see how many Europeans defy strong recommendations to stay at home. And taking into account the day that it is, EAPM’s newsletter is available here, writes European Alliance for Personalised Medicine Executive Director Dr. Denis Horgan.

In other news....

Changes to EU pharma rules en route

The European Commission has inched a little closer to the wide-ranging changes to EU pharma rules envisioned in its Pharmaceutical Strategy, publishing today (30 March) a document that sets out the objectives of upcoming policy reports and proposals on the topic. 

Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe.

The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis. The Commission hopes to deliver the strategy over a number of years.

Its new Pharmaceutical Strategy seeks "to ensure affordable, safe, quality, innovative and solutions-oriented pharmaceuticals for all citizens in the EU", Vice President Margaritis Schinas announced at the strategy's unveiling.  The 25-page document is packed with technical suggestions to fine-tune Europe's pharma system, but the challenge will be to translate these into tangible changes for European consumers. Experts think the strategy — if properly implemented — has the potential to make drugs more affordable, boost the variety of treatments available, drive forward innovation and firm up supply chain resilience. 

COREPER vaccine controversies

An internal squabble with COREPER over extra vaccines was just the latest controversy as the EU tries to speed its inoculation campaign. The decision to seek arbitration among the ambassadors came after Austrian Chancellor Sebastian Kurz virtually sabotaged the meeting by insisting that his country receive extra doses, even though European Commission data shows Austria faring relatively well among EU nations in terms of vaccine supplies. 

Kurz in a corner

A discussion tomorrow (31 March) will focus on Austrian Chancellor Sebastian Kurz’s attempt to get more vaccines. On 12 March, the 34-year-old vehemently accused the EU of unfairly distributing vaccine doses among its 27 member states. 

Lashing out at the ‘EU bazaar’, he demanded adjustments in favor of member states that received less doses than others. Kurz took the dispute all the way to the European Council meeting in Brussels last week, taking precious time away from pressing issues on the agenda—transatlantic relations, a common vaccination “passport,” and possible vaccine export bans. German Chancellor Angela Merkel reportedly got so annoyed with Kurz that she reminded the group that vaccine contracts were signed by member states themselves “and not by some stupid bureaucrats” in Brussels.

Pandemic treaty push

Leaders from 23 countries, the EU and WHO today (30 March) backed a push for a new global treaty to better prepare the world to tackle future pandemics. The call came in an op-ed published internationally that was signed off by leaders from five continents, including Germany’s Angela Merkel, Britain’s Boris Johnson, France’s Emmanuel Macron, South Korea’s Moon Jae-in and South Africa’s Cyril Ramaphosa. “We believe that nations should work together towards a new international treaty for pandemic preparedness and response,” the op-ed said. 

“Such a renewed collective commitment would be a milestone in stepping up pandemic preparedness at the highest political level.”The push to bolster common efforts comes as the planet struggles to combine forces to overcome the COVID-19 pandemic that has killed almost 2.8 million people worldwide. 

The spread of the virus has seen blame traded between capitals and accusations that rich nations have hoarded vaccines as economies around the globe have been battered.

“Together, we must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion,” the leaders said. “At a time when COVID-19 has exploited our weaknesses and divisions, we must seize this opportunity and come together as a global community for peaceful cooperation that extends beyond this crisis.”

ECDC – immune transmission

More than one year into the SARS-CoV-2 pandemic, over 120 million people have been infected with the virus across more than 200 countries. Reinfections following natural infections with the same or a new SARSCoV-2 variant have been reported sporadically and questions remain concerning the duration of immunity following natural infection, and whether asymptomatic reinfected individuals may be able to transmit the virus.

COVID-19 vaccines have been evaluated for their efficacy and effectiveness against symptomatic COVID-19 infection and for reducing and/or preventing mild, moderate, or severe COVID-19 disease, including mortality. However, the vaccine trials have not been designed to measure reduction in transmission risk from infected vaccinated individuals to susceptible contacts.

In this context, it is important to understand the available scientific evidence on the extent to which previous SARS-CoV-2 infection or COVID-19 vaccination prevents onward transmission from infected individuals to susceptible contacts. Therefore, ECDC has conducted a review of published and pre-print literature on duration and characteristics of immunity following a natural SARS-CoV-2 infection due to any variant or after COVID-19 vaccination with any of the EU-authorized vaccines now available.

Evidence from studies specifically designed to assess the impact of previous infection on the risk of transmission is currently lacking. Infection with SARS-CoV-2 does not provide sterilising immunity for all individuals and some who are reinfected might still be able to transmit SARS-CoV-2 infection to susceptible contacts. 

There is evidence that reinfection remains a rare event. Results from cohort studies confirm that the protective effect of previous SARS-CoV-2 infection ranges from 81% to 100% from Day 14 following initial infection, for a follow-up period of five to seven months. Protection against reinfection is lower in individuals aged 65 years and older. 

As the number of individuals acquiring natural immunity increases, the total number of infections is expected to decrease significantly, leading to decreased transmission overall, unless the genetic changes in the circulating variants induce significant immune escape. 

Brain on centre stage

The launch of the OneNeurology Partnership, a new initiative from the European Federation of Neurological Associations (EFNA), has taken place — together with the European Academy of Neurology, European Brain Council, World Stroke Organisation and Alzheimer’s Disease International, the partnership is aiming to raise the profile of brain diseases. The goal is “to build political interest” so that the Commission and member countries pay attention to the disease group and start formulating national-level neurology plans. The Commission can act as an organizer and facilitator to co-ordinate different national plans. 

EU vaccine chief says vaccine passports to be launched in June

Internal Market Commissioner Thierry Breton, who back in February this year was put in charge of the new vaccine production task force by the Commission, has unveiled the prototype of the announced EU vaccine passports.

During an interview for RTL radio and TV channel LCI, Commissioner Breton also said that the new documents which will prove that the traveller has been vaccinated, recovered from COVID-19, or his/her test results in case none of the two first has taken place, will be issued to EU citizens somewhere in mid-June ideally.

“From the moment we can be sure that every European who wants to be vaccinated will have fair access to the vaccine, as will be the case in the next two to three months – it will be good to have a health certificate that demonstrates your condition,” the commissioner said.

The Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, reports.

And that is all from EAPM for now – don’t forget to have a read of our newsletter here, and our very best wishes to you all for a safe and happy Eastertide. Here is the link to our newsletter again. 

Stay safe until next time.

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European Alliance for Personalised Medicine

EAPM: Key health issues for the months ahead as member states work together




There are busy months ahead for the European Alliance for Personalised Medicine (EAPM), with the clocks going forward an hour and COVID-19 hopefully being brought to an end – the informal health council meeting raised key issues that will be the EAPM’s focus, and on which EAPM will be engaging with member states as well as the Council in the months ahead. The key issues from the informal council meeting are provided below, so it can be seen how member states are orientating, writes EAPM Executive Director Dr. Denis Horgan.

Portuguese EU Presidency

Portugal holds the EU Presidency at present, until the end of June – and at the recent informal video conference of 16 March concerning Europe's Beating Cancer Plan, the member state indicated that the pandemic had had an impact on the EU's attempts to combat cancer, which is the second leading cause of mortality in the EU behind cardiovascular diseases. As far as Portugal is concerned, the four key action areas are prevention, diagnosis, treatment and aftercare, adding that the debate would be steered by two questions that covered the long-term sustainability of the proposed measures in the cancer plan and how the plan would take into consideration the different starting points of member states.

Slovenia EU Presidency:  Slovenia will hold the EU Presidency from the beginning of July to end of December 2021 – during the conference, Slovenia indicated it was pleased the Cancer Plan was on the agenda and welcomed the ambitious plan, and indicated that Slovenia was drafting its third cancer plan in order to ensure long-term sustainability. It was added that the Commission working plan would need specific guidelines, and that the Cancer Plan was an important step towards an EU health union.

France:  France indicated that the plan was in line with the country’s own, and there were a number of synergies. Combating tobacco use and the drinking of alcohol whilst promoting exercise would be important, and that the country wanted to see 1 million more screenings by 2025. France also welcomed the plan by the Commission to set up an implementation group in order for MS to be as involved as possible with the decision making process. They also highlighted the key role of existing groups with particular reference to the European Parliament special committee. 

The Netherlands:  The Netherlands commended the Commission's plan and its comprehensive nature - specifically regarding tobacco prevention, the Netherlands "supported having a tobacco free generation by 2040" and underlined that this target had proved "useful in the Netherlands since 2018". The Netherlands further highlighted the importance of medical radioisotopes for the treatment and diagnostics of cancer. The Netherlands welcomed a focus on the security of supply of isotopes for the EU. Innovative treatments would help them achieve their targets, and the Netherlands would be happy to share their work regarding innovative treatments at expert level meetings.

Sweden: Sweden welcomed the debate and the plan as it was in line with their own cancer strategy - a current challenge due to the pandemic, according to Sweden, was that patients did not seek a diagnosis. Screening programmes were also not being used to the same extent as previously due to fear of the COVID virus - regular and thorough monitoring would be crucial to the success of the cancer plan and could be achieved by using key performance indicators (KPIs);underlined the importance of prevention. Sweden supported a public health approach and they looked forward to discussing them in the future - continued dialogue between member states would be crucial. 


Spain welcomed the EU cancer plan and noted that they had recently updated their national cancer strategy, citing progress in early detection, strengthening health promotion, and a focus on health care in childcare and adolescence. Spain indicated that a clear way to make progress together would be the cancer inequalities register. Monitoring social determinants would be crucial and increased co-operation between member states would be needed - as well as work at a technical level via existing groups co-operation at the political level would also be needed. 

Belgium: Belgium congratulated the Commission on the Beating Cancer Plan. Belgium was inspired by the initiative - the impact of COVID on cancer diagnosis and treatment would be seen in the future so the plan was timely, and the country welcomed a focus on the security of supply of isotopes. Stakeholder dialogue would be crucial as too often they did not hit their screening targets.

Germany: Germany indicated that the country had taken important steps towards an EU Beating Cancer Plan, citing that early detection and prevention would be crucial, especially to prolong life for cancer sufferers. EU added value in terms of governance would be important as would a road map and inequalities register, and a solid financial framework would be vital and this decision would need to be made by MS.

Overall, Commissioner Stella Kyriakides welcomed the insightful comments and was pleased that member states shared the Commission's level of ambition, acknowledging it would be a challenging time ahead but it must not be forgotten that Europe had 10% of the global population but 25% of cancer cases. Emphasis on prevention would be crucial, Kyriakides said, and that the plan would change the lives of citizens and they should work together to make a difference.

In other news…

Coronavirus cases rise across Europe

Analysis has found that cases of coronavirus are rising in three-quarters of European countries, with the highest increases happening in central and eastern Europe. Only nine of the 40 European countries analysed recorded fewer cases in the first week of March than they did in mid-February, with Portugal, Spain and the UK registering the largest drops. Spain is the only country that has a lower case rate than it did at the end of September.

EU health programme ‘more than a reaction to the pandemic’

The European Parliament has voted through the new €5.1 billion EU health programme, EU4Health, with 631 votes in favour, 32 against and 34 abstentions. The programme was put together in the thick of the COVID-19 crisis, but it is “more than a reaction to the pandemic”, said EU Health Commissioner Stella Kyriakides, addressing the MEPs in a debate. “With the EU4Health programme, we have the tools at hand to make long-lasting changes,” she said. EU4Health will be a key instrument in the EU’s fight against cancer, addressing lack of screening, early diagnosis and access to treatment. It will also help digitize health care and support the creation of the EU health data space, allowing open sharing of health data. Its medium-term goals include reducing health inequality in Europe. At €5.1 billion, EU4Health will be twelve times larger than its predecessor, underlining the extent to which the pandemic has moved health up the EU agenda. 

General pharmaceutical legislation

From the end of March and during April, the European Commission has announced its intention to publish a road map for the revision of the general pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004). “There is a need to build a holistic, patient-centered, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products from scientific discovery to authorization and patient access,” the Commission writes. The Commission lays out issues it aims to address with the forthcoming strategy, including medicines access and affordability; shortages of needed medicines such as antibiotics and vaccines; and environmental risks related to the manufacturing, use and disposal of medicines. The document also raises three distinct issues related to pharmaceutical innovation to be addressed: the alignment of innovation and public health needs, the funding and capitalization of EU-based biotech research and barriers to innovation within the regulatory framework for medicinal products and new technologies.

That is all from EAPM for now – stay safe and well during the week, and we will be back in touch with you shortly.

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