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| | Good morning
After a torrid week in the European Parliament, negotiations on the next College of Commissioners will continue into next week.
It has been confirmed that Trump intends to make Robert F. Kennedy Jnr Secretary for Health and Human Services (HHS). On the campaign trail Trump said he would let him “go wild”. While many powers in the field of health rest with individual states, an anti-vaxx conspiracy theorist at the heart of government has the potential to severely undermine public health both in the US and globally.
There aren’t many EU reactions so far, other than from German Federal Minister of Health, Professor Karl Lauterbach, who hopes for a “constructive collaboration”, but admits that, “it certainly won’t be easy.” |
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| | | | Hungarian Presidency reaches balance on shortage prevention plans |
| During the pharmaceutical working group session held on 12 and 13 November, the Hungarian Presidency of the EU Council achieved a balanced approach among member states on shortage prevention plans (SPP).
On this issue, a large majority of member states support the idea of creating national lists of critical medicines, which they would submit to the EMA's Medicine Shortages Steering Group (MSSG) on shortages and medicine safety.
These national lists would coexist alongside a European list. Member states' critical medicines could be added to the list via implementing acts. "This allows for updates and has reassured member states," a diplomatic source told Euractiv.
Several issues still need to be resolved, starting with the level of flexibility granted to member states on SPP, as well as the possibility of sanctions in case of non-compliance with obligations. Incentives roadblock remains: No progress was made on the thorny issue of incentives. A group of six member states remains opposed to the proposal on the regulatory data protection period.
AMR: On the so-called TEV, transferable data exclusivity voucher’ for priority antimicrobials, providing for a maximum 12 additional months of data protection for an authorised product, the member states requested an analysis of alternative options. Back to the top |
| | Life sciences investment in the EU and the future impact of the pharma package |
| Investors opt for the EU compared to the US for early-stage development due to its ‘world-class’ academic background, yet overall, less capital is given for life sciences investment in the EU, found a report by European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and FTI Consulting.
Investors interviewed for the report said that they preferred the US market because of its scale and the higher pricing of pharmaceutical products.
Put simply, it is much better in delivering a return on investment, the US also offers deeper capital pools, either through IPOs (initial public offering) or by licensing their assets to a larger pharma player. The report concludes that the EU is losing out on scaling-up to the US.
At an event for the report’s launch, Danish Renew MEP Stine Bosse said that in terms of trials over the last 10 years the EU has “lost domain.” She added that the upcoming Pharma Package should be thought of holistically, including the “biotech act, the pharma sector and the medical devices regulation.”
How will the Pharma Package impact investment? The consultants said that the push to lower regulatory data protection and market exclusivity from eight and ten years, to six and nine years, respectively, would “impact on the return of investment and of course, therefore their willingness to invest,” said Katja Murray, Senior Director at FTI Consulting. Back to the top |
| | | | Oliver Varhelyi unlikely to know his fate before next Wednesday |
| The candidate for the position of Health Commissioner, Olivér Várhelyi is unlikely to know his fate before - “at least” - next Wednesday.
A source from the Renew Europe group told Euractiv that the centrist group does not expect a breakthrough before 20 November, nor for the six Executive Vice Presidents whose evaluations remain on hold.
“There is no timetable for formal meetings with the S&D and the EPP at the moment. Even informally, it’s complicated. Tensions are extremely high between the S&D and EPP,” the source added.
The evaluation of the designated European Commissioners has taken a highly political turn after the EPP, ramped up attacks on the designated Vice President for a Clean, Just and Competitive Transition, Spain’s Teresa Ribera (S&D).
The Social Democrats oppose the appointments of the potential Vice President for Cohesion and Reforms, Raffaele Fitto, and Olivér Várhelyi.
A meeting took place between the leaders of the S&D, EPP, and Renew Europe on Tuesday, 12 November, to try to break the deadlock. However, no solution has been found as yet. [TM] Back to the top |
| | | | Court of Justice hearing into Pfizer/VDL text messages starts |
| Today, the European Court of Justice will hold a hearing on the case brought by the New York Times against the European Commission concerning access to text messages between Commission President Ursula von der Leyen and Pfizer CEO Albert Bourla concerning vaccines.
Following the outbreak of Covid-19, the EU’s executive launched a vaccine strategy that included advance purchase agreements (APAs) of promising vaccines from different pharmaceutical companies, including Moderna, AstraZeneca, Novavax or Pfizer-BioNtech, with whom it has signed the largest purchasing contract.
Whatever it takes: At the time the of the exchange of texts the European Commission was on the ropes as it already looked like AstraZeneca would not deliver. The situation was turned around by the Pfizer deal, which was hailed as a triumph.
An article in the New York Times revealed that the successful negotiations had involved text messages exchanged between Von der Leyen and Bourla for the initial purchase of 900 million BioNTech/Pfizer Covid-19 vaccine doses.
Journalist Alexander Fanta, requested the texts and was rebuffed. The European Ombudsman Emily O’Reilly launched a case making her verdict clear on 28 January 2022, stressing that the EU Commission must “do a more extensive search for the relevant messages.”
In January 2023, the New York Times decided to sue the European Commission for failing to make the text messages public. |
| | Ilaria Fevola, Legal Officer at ARTICLE 19, which defends freedom of information says, “If the Court were to side with the New York Times, it would set a powerful precedent, forcing the Commission to release the requested information. This, in turn, could reshape the whole landscape of transparency in the EU.” [CBB, CF] Back to the top |
| | | | MEPs call on EU to address links between racism and mental health |
| On Thursday (14 November), Mental Health Europe held a debate on the mental health burden of racism in the EU hosted by Luxembourgish Greens MEP Tilly Metz.
Metz said that “current policies are failing those most in need. The antidiscrimination directive has been frozen in the Council,” said Metz. “We must renew and strengthen the EU Anti-racism Action Plan to ensure it addresses the specific needs of marginalised communities, particularly in mental health care,” she added.
Racist interactions, such as profiling at borders, trickle down to affect mental health outcomes, such as increased stress and anxiety rates, argued Dr. Emmanuel Achiri from the European Network Against Racism.
Touching on the future mandate and Commissioner-designate Várhelyi’s mental health competencies, MEP Nicolae Ștefănuță (Greens, Romania) said, “I hope we push even more, which is the reason why I was against Várhelyi in the hearing. I don't think [he] can take of people's mental health and these sensitivities such as racism, minorities, and women's rights.”
Why this matters: People from minority ethnic backgrounds are more likely to encounter barriers to mental health services, receive inadequate care, and experience poorer outcomes. The situation is compounded by the lack of culturally sensitive approaches in healthcare systems. [EP] Back to the top |
| | | | EMA revisits Alzheimer drug and grants cautionary thumbs up |
| In July, the EU’s Medicines Agency (EMA) rejected market authorisation for an early intervention Alzheimer’s treatment, Leqembi (lecanemab), due to concerns over brain swelling and potential bleeding in the brain.
After re-examining its initial opinion, EMA has granted market authorisation to Leqembi (lecanemab) for treatment of mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients where specific genetic markers don’t show a vulnerability to swelling and potential bleeding in the brain.
The authorisation by EMA lifts one barrier, but for some healthcare systems the Eisai GmbH drug will still be considered to be prohibitively expensive.
“As with many other conditions, this first drug with a new mode of action constitutes an important advance for the Alzheimer’s disease community in Europe,” said Jean Georges, the Executive Director of Alzheimer Europe. “We now look to companies to adopt reasonable and sustainable pricing policies and to payers to ensure lecanemab is covered by national reimbursement systems.” Back to the top |
| | | | European Disability Card and European Parking Card: 5 June 2028 |
| The directives on the European Disability Card and European Parking Card have been published. EU states now have a deadline of 30 months to adopt the directives into national rules and a deadline of 42 months to begin issuing the cards.
The European Disability Forum (EDF) welcomed the decision saying, “This marks the last step in making the Directives an official law and starts the countdown for member states to implement them. This means that the European Disability Card should be a reality in all EU countries in three years and a half at most: by 5 June 2028.”
The EDF urges EU countries to make strong national laws a priority and to start accepting and issuing the cards as soon as possible. They will be supporting their members in ensuring that national rules underpinning the cards are “ambitious and go beyond the minimum standards”.
EDF says it will maintain its advocacy as the necessary delegated legislation is adopted to make the provisions as strong as possible.
We will also keep our advocacy towards the European Commission to ensure that the technical texts that still need to be developed (the Delegated and Implementing Acts) are as strong as possible.
People with disabilities are far from achieving the full freedom of movement other EU citizens enjoy, say the EDF, which plans to advocate for further legislation to guarantee that persons with disabilities can move and live anywhere in the EU, without losing necessary support. [LW] Back to the top |
| | | | WHO reports 20% rise in measles cases |
| Measles cases worldwide have increased by 20% from 2022 to 2023. While the spread decreased in the Americas, it spiked in Africa and in Europe, where cases saw a 200% rise. According to WHO and the US Centers for Diseases Control and Prevention (CDC) latest global and regional report on measles cases and deaths, Progress Toward Regional Measles Elimination — Worldwide, 2000–2023.
Measles has been proven preventable by receiving two doses of vaccine. However, there are several factors that increase the number of people, specifically children, who are not being vaccinated, including inaccessibility in fragile regions and the rise in vaccine hesitancy.
While around 83% of children worldwide received their first dose of the measles vaccine in 2023, only 74% were administered a second one. An estimated 107,500 people, a majority of whom were young children, died from measles in 2023.
“At this moment, every single country in the word has access to the measles vaccine,” said Dr Natasha Crowcroft, Senior Technical Advisor for Measles and Rubella, Department of Immunization, Vaccines and Biologicals at WHO. “So there is no reason why any child should be infected. There is no reason why any child should die.” [LW] Back to the top |
| | | | | Swedish hospital bed crisis kills 100 patients, doctors call for ‘Vision Zero’ |
| Sweden - One hundred deaths in Swedish hospitals last year could be linked to a lack of staffed hospital beds, or high workload, according to an investigation published in the Swedish hospital doctors’ newspaper.
“This is very serious, and we now need to deal with these problems at a completely new level,” Elin Karlsson, the president of the Swedish Association of Senior Hospital Physicians, told Euractiv.
The magazine of the Swedish Association of Senior Hospital Physicians requested to see the 1,254 reports of serious hospital events – known as Lex Maria reports – that were sent to the Inspectorate for Health and Social Care agency (IVO) in 2023.
Journalists picked out cases where medical experts –often the hospital’s chief physician – assessed that the deaths had been clearly linked to the lack of staffed beds, resources or high workload. Another 341 patients were assessed to have deteriorated due to a lack of beds and staff. For some patients, this meant ‘lifelong consequences’, according to the magazine.
The association is now demanding that Swedish politicians make a broad agreement to work towards a Vision Zero for deaths related to the Swedish bed crisis. Read the full story here, including the responses from Swedish MEPs. [MK] Back to the top |
| | Bulgarian pharma market gained post-pandemic boost, according to new analysis |
| Bulgaria - Bulgaria's pharmaceuticals market experienced significant growth in 2023, with sales increasing 14.7% to €2.7 billion and oncology therapies leading in the hospital drug sales category.
Dimitar Marinov, chairperson of the Union of Pharmacists in Bulgaria told Euractiv that there were two main reasons for the boost, “The first is that after the pandemic in 2022, it turned out that many diseases were not treated, and people began to go for examinations more often and think about their health."
"The second is better diagnosis, which is due to the progress in technology, as well as the extension of life expectancy, which also happens thanks to medicines."
According to IQVIA analysts, the Bulgarian drug market's weaker results before the pandemic were due to state policy, especially the measures taken by the National Health Insurance Fund to limit the costs of innovative products.
IQVIA found that oncology therapies are the leading category in hospital drug sales, with sales growth at €124.4 million. High-cost therapies, with a price of more than €500 per package, appear to be the main factor in the increase in sales.
Shortages: Despite the statistical data on the growth of the drug market, shortages of certain types of drugs in Bulgaria remain.
"We have a further extension of the ban on the export of insulins and antibiotics for children," the Ministry of Health confirmed to Euractiv. Euractiv was told that all shortages are reported and measures taken to ensure the needs of Bulgarian patients.
Earlier this month, the ministry published a draft for public consultation regarding changes to the law on medicinal products in human medicine. The proposed measures envisage faster procedures for supplying the Bulgarian market with medicines from parallel imports. Read more here. [AK and KN] Back to the top |
| | | | | | | | | Case T-36/23 Stevi and The New York Times v Commission Hearing Access to text messages exchanged between the President of the Commission and the Chief Executive Officer (CEO) of the pharmaceutical company Pfizer. |
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| | | | Informal demography meeting, Budapest. Measures to promote active ageing and preserve elderly people’s health, especially their mental health, as well as support for young people, with special attention to their mental health. |
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| | | | | | | | | | | | | Draft Council conclusions on enhancing organ donation &transplantation |
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| | | | | | | | | Today’s brief was brought to you by Euractiv’s Health team |
| | | | | Today’s briefing was prepared by the Health team: Catherine Feore, Clara Bauer-Babef, Emma Pirnay, Thomas Mangin and Lydia Williams. Additional reporting by Monica Kleja, Antonia Kotseva and Krassen Nikolov . Share your feedback or information with us at [email protected]. |
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