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Global conference on PM tomorrow, public-private health initiatives passed and cross-border health care




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Good afternoon, and welcome to the latest update from the European Alliance for Personalised Medicine (EAPM). The virtual EAPM conference hits tomorrow (27 October), writes EAPM Executive Director Dr. Denis Horgan.

EAPM Global virtual conference: Last calls to register 

Tomorrow, 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 health care to patients’. More than 150 delegates are registered for the global conference from countries such as China, Japan, Brazil, Egypt, Canada, Ghana, US and of course the EU. You can register here and click on the link to view the agenda here.

Due to COVID 19 and a perfect storm in healthcare policy, the chance exists to re-align priorities to evaluate the needs of patients, healthcare professionals and health systems to facilitate improved and safer therapies.  There is also space and necessity for enhanced collaboration between regulatory and payer groups. This would have the aim of identifying core outcomes other than survival that can be incorporated into trials, as well as healthcare systems, to generate data throughout the lifecycle.


Among others, the conference will pose the following questions:

  • How can we reconcile rapid access to innovation while incentivising necessary continued research to demonstrate value and societal benefits of new medical products, including IVDs?
  • What are the differences that affect regulatory vs payer decisions in different regions?
  • What specific data elements would allow for efficient assessment of products providing significant benefit to patients?
  • Can we find an agreed global approach to quantifying clinical benefit?
  • Are there clinical outcomes other than survival that can be agreed upon to be used in registration trials and healthcare systems?
  •  How do we best explain the need for both clinical research and ongoing data collection to patients and society and its benefit to both?

We look forward very much to seeing you there! You can register here and click on the link to view the agenda here.

Nine public-private partnership initiatives passed


The European Parliament has voted through nine public-private partnerships under Horizon Europe, which MEPs hope will shape up to be more accessible for small companies, be less bureaucratic and attract further funding from national and European programmes. 

“We were guided by the principles of openness, transparency and inclusiveness, which we want to be cross-cutting right across these partnerships,” said the rapporteur for the file, Maria da Graça Carvalho MEP. Parliament’s goal is to ensure effective spending of the €22 billion budget for the nine so-called joint undertakings, of which €10 billion will come from the EU research programme, Horizon Europe. 

The partnerships will launch a year after the start of Horizon Europe, once the member states give final approval. That is a formality, given they already reached an agreement among themselves in September. 

Parliament’s opinion is non-binding, but the vote will allow member states to officially adopt the legislation at a Council meeting at the end of November. Two of the partnerships, the Innovative Health Initiative and Global Health, will cover drug development in Europe and Africa. 

Cross-border health care - Is it a reality for patients? 

The right for EU citizens to seek health care outside their home country elsewhere in the bloc is enshrined in law. But the rules need changing in order to function better, Croatian MEP Tomislav Sokol of the European People’s Party has said. Tomislav Sokol, a Croatian Christian-democrat MEP, explained at a recent event, “If you cannot get adequate treatment for certain diseases, especially rare diseases in your country, you’re entitled to get this treatment in other member states to be covered by your own health insurance,” adding that many patients are not aware that such a document exists. 

Sokol added that patients are required to pay for the treatment upfront “and then ask for reimbursement afterwards from their home system, which is a big problem.” He said that “especially rare diseases are one of these areas where the member states cannot resolve problems by themselves, and they need help at the European level.”

At present, patients in the EU are able to go to another country to seek treatment under two different EU rules. They can seek treatment through the Cross-Border Healthcare Directive, which involves paying up-front for treatment and seeking reimbursement back home afterwards. 

“Cross-border health is just not utilized enough,” said Sokol. “There’s many reasons for this: people are not aware of the possibilities that exist; the procedure is very complicated and takes a long time.”

Sokol has said that there are three major ways to improve the existing rules. The first is to move authorization rules that are currently in the cross-border health directive into the social security coordination regulation. The merger would simplify reimbursement for patients, and put it on a firmer legal basis. The second proposal is a right to a second opinion. Patients would be able to go abroad to ask experts whether they need treatment in another EU country in cases where local doctors are reluctant. The third fix sought by Sokol is for countries to do more to inform patients about their rights to cross-border health care and to help them in the process

This is an issue that EAPM will follow closely. 

EUCO conclusions

The meeting of EU leaders that ended on Friday (22 October) offered no surprises when it came to coronavirus. Leaders want further co-ordination on travel into and within the EU; the conclusion of negotiations on the health union package; removal of obstacles hampering the global roll-out of vaccines and support for a pandemic treaty. 

Slovenia launches ‘traffic light’ system for startup policy

Slovenia will launch a new system to evaluate EU states’ startup policy today (26 October). The policy programs to support startups are very different across the bloc. The Commission has no competence over crucial parts, such as hiring non-EU staff — which touches upon migration policy — or rewards, which relates to taxation. EU states are officially in charge, but the Commission can try to harmonize the process. 

The “traffic light” system adopted by Slovenia, which currently holds the Council’s presidency, is a visual summary of how EU states perform on five categories: Funding for startups; setting up advanced tech and climate tech startups; attracting talent; going global and working together with big corporations.

Digital Markets Act

This week will codify the Parliament’s position on the EU’s digital competition rules, known as the Digital Markets Act. The economic affairs committee is due to vote on its position today, and the industry committee on Thursday (28 October). The Digital Markets Act (DMA) establishes a set of narrowly defined objective criteria for qualifying a large online platform as a so-called “gatekeeper”. This allows the DMA to remain well targeted to the problem that it aims to tackle as regards large, systemic online platforms. These criteria will be met if a company:

  • Has a strong economic position, significant impact on the internal market and is active in multiple EU countries;
  • has a strong intermediation position, meaning that it links a large user base to a large number of businesses, and;
  • has (or is about to have) an entrenched and durable position in the market, meaning that it is stable over time. 

And that is all from EAPM for today – don’t forget, you can register for tomorrow’s EAPM conference here and click on the link to view the agenda here. Stay safe, enjoy the conference!

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First suspected case of Omicron variant of COVID-19 detected in Switzerland




The first probable case of the Omicron variant of COVID-19 has been detected in Switzerland, the government said late on Sunday (28 November), as the country tightened its entry restrictions to check its spread, writes John Revill, Reuters.

The case relates to a person who returned to Switzerland from South Africa around a week ago, the Federal Office for Public Health said on Twitter.

Testing will clarify the situation in the coming days, it added.

Switzerland has ordered that travellers from 19 countries must present a negative test when boarding a fight to the country, and must go into quarantine for 10 days on arrival.


The list includes Australia, Denmark, Britain, Czech Republic, South Africa and Israel.

Swiss voters on Sunday backed the government's pandemic response plan by a bigger than expected majority in a referendum, paving the way for the continuation of exceptional measures to stem the rising tide of COVID-19 cases. Read more.

Some 62.01% voted in favour of a law passed earlier this year to provide financial aid to people hit by the COVID-19 crisis and laying the foundation for certificates giving proof of COVID-19 vaccination, recovery or a negative test. These are currently required to enter bars, restaurants and certain events.


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Biden warns against Omicron panic, pledges no new lockdowns




US President Joe Biden (pictured) urged Americans on Monday (29 November) not to panic about the new COVID-19 Omicron variant and said the United States was working with pharmaceutical companies to make contingency plans if new vaccines were needed, write Susan Heavey, Alexandra Alper and Jeff Mason.

Biden said the country would not go back to lockdowns to stop the spread of Omicron, and he would lay out his strategy on Thursday (2 December) for combating the pandemic over the winter. He urged people to get vaccinated, get boosters and wear masks. Read more.

"This variant is a cause for concern, not a cause for panic," Biden said in remarks at the White House following a meeting with his COVID-19 team.

"We're going to fight and beat this new variant," he said.


Biden said it was inevitable that Omicron cases, which were first detected in southern Africa, would emerge in the United States. He said officials were still studying Omicron but believed that existing vaccines would continue to protect against severe disease. Read more.

Biden said his administration was working with vaccine makers Pfizer (PFE.N), Moderna (MRNA.O) and Johnson & Johnson (JNJ.N) to develop contingency plans.

Travellers wait to process through a security checkpoint at Seattle-Tacoma International Airport before the Thanksgiving holiday in Seattle, Washington, U.S. November 24, 2021. REUTERS/Lindsey Wasson
Dr. Anthony Fauci listens as U.S. President Joe Biden delivers an update on the Omicron variant at the White House in Washington, U.S., November 29, 2021. REUTERS/Kevin Lamarque     

"In the event, hopefully unlikely, that updated vaccinations or boosters are needed to respond to this new variant, we will accelerate their development and deployment with every available tool," he said.


Biden said he would direct the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to "use the fastest process available without cutting any corners for safety to get such vaccines approved and on the market if needed."

A U.S. travel ban took effect earlier on Monday blocking most visitors from eight southern African nations from entering the country. Earlier flights from South Africa to the U.S. did not screen passengers after the variant was found. Read more.

Biden said the travel restrictions were put in place to give the country time to get more people vaccinated.

Vaccine hesitancy in the United States and around the world has thwarted public health officials' efforts to get the pandemic under control.

Just 59% of all Americans are fully vaccinated, although almost 70% now have at least one dose. Nearly 782,000 people have died from COVID-19 in the United States, according to a Reuters tally.

Much of the United States shut down in early 2020 at the beginning of the pandemic, but economic activity and jobs have bounced back in recent months. Face masks and vaccine mandates are opposed by some Republican politicians, even as health experts tout their effectiveness. Read more.

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Commission hosts second matchmaking event to speed up the development and production of COVID-19 medicines



Today (30 November), the Commission is hosting a pan-European matchmaking event to accelerate and upscale the development and production of COVID-19 medicines in Europe, as part of the actions under the EU Strategy on COVID-19 Therapeutics. Following a first matchmaking event on COVID-19 medicines in July 2021 and a previous matchmaking event on COVID-19 vaccines in March 2021, this event aims at strengthening the participation of EU companies in value chains for COVID-19 therapeutics and speeding up connections among the participants. It also broadens the focus: from therapeutics specifically used to treat COVID-19, to also including those used to treat the symptoms of COVID-19, as well the production of disposable materials, such as syringes, and ingredients needed for making such medicines.

The event gathers companies from the European Economic Area as well as other businesses and organisations included in the portfolio of 10 most promising treatments, presented by the Commission in the follow-up to the COVID-19 Therapeutics strategy. In order to facilitate matchmaking events, the Commission issued a comfort letter in March 2021 (based on the Antitrust Temporary Framework adopted by the Commission on 8 April 2020) providing guidance, relevant also for this event, on how the matchmaking and exchanges between participating companies, including direct competitors, can take place in compliance with EU competition rules. The matchmaking event is organised by the Commission's Task Force for industrial scale-up of COVID-19 vaccines and therapeutics, in close co-operation with the European Cluster Collaboration Platform. The event is also hosted in partnership with the Council of European BioRegions (CEBR) and the European Cluster Alliance (ECA), which are supporting the Commission in running an EU survey to assess EU capacities for COVID-19 therapeutics production. More information about the event is available here.

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